Gollub Proposal

CIRM’s Strategic Roadmap for Continued Innovation CIRM RFP #2382

Proposal and Qualifications

James Gollub Associates LLC

May 15th, 2013 JAMES GOLLUB ASSOCIATES CIRM PROPOSAL

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TABLE OF CONTENTS

Overview ....................................................................................4

A. Qualifications and Experience of Firm ..............................................5

Overall Experience: Innovation Pipeline Context ................................................................. 5

Overview of Team Experience Relevant to CIRM’s Core Objectives ........................................... 6

Anchor Framework ..................................................................................................... 9

Project Profiles [2008 to 2012] ..................................................................................... 12

Areas of Core Competency .......................................................................................... 20

Team Member Profiles ............................................................................................... 21

SRI Team for CIRM Project .......................................................................................... 29

SRI Biosciences Staff ................................................................................................. 30

C. Comparable Projects ................................................................. 38

Children’s Hospital of Oakland Research Institute (CHORI) [2013] .......................................... 38

MCA Foundation - Biomedical Institute of the Americas [2012] .............................................. 38

Washington Clean Energy Strategy [2010-2011] ................................................................. 40

Texas Energy & Petrochemical Cluster Strategy [2008] ....................................................... 41

D. Proposal ................................................................................ 43

Introduction ........................................................................................................... 43

Framework—Innovation Roadmap and Strategy Process ....................................................... 46

Process Summary—Four-Phase CIRM Strategic Roadmap Development ..................................... 51

Phase I: Mobilize—Ready Public-Private Stakeholders ......................................................... 57

Phase II: Analyze—Diagnostic Baseline of State of Regenerative Medicine and Assessment of Models 58

Phase III: Catalyze—Prioritize Recommended Models for CIRIM .............................................. 64

Phase IV: Realize—Provide Operating Structure of Recommended Model for CIRM Strategic Roadmap for Continued Innovation ............................................................................................ 67

Project Management and Schedule ................................................................................ 73

Proposed CIRM Strategic Roadmap for Contiunued Innovation White Paper Budget ..................... 81


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Appendix A: Team Resumes ............................................................ 84

JAMES GOLLUB, BA, MS .............................................................................................. 85

STEPHEN MARSHALL, BA, MBA ...................................................................................... 92

AMY G. RASSEN, BA, MSW ........................................................................................... 94

CHRISTOPHER G. MILLER, BA, MBA ............................................................................... 100

PAUL KALLMES, BSEE, MS ........................................................................................... 104

ANNIKA BARNES, BA, MA ............................................................................................ 107

MAX MORGENOV, BA, CFA .......................................................................................... 109

SRI Staff CVs .......................................................................................................... 112

APPENDIX B: Innovation Pipeline Models ............................................ 140

Table 1. Discovery Institution Models ............................................................................ 141

Table 2. Development Institution Models ....................................................................... 142

Table 3. Deployment Institution Models ......................................................................... 145


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Overview

James Gollub Associates LLC is pleased to submit our proposal and qualifications to

CIRM to prepare the White Paper on CIRM’s Strategic Roadmap for Continued

Innovation. As called for in the RFP we provide four proposal elements:

• Qualifications and Experience of Firm: How our firm’s overall experience

demonstrates our ability to successfully complete the Scope of Services

Required, including similar services provided over the past five years,

highlighting experience with state or local governments on similar

engagements; experience relating to regenerative medicine, drug development, and venture finance; and track record of developing and

implementing multi-party, public-private funding approaches.

• Qualifications of Staff/Resumes: Identification and profiles of staff who will provide the services required by the proposal, including years and type

of experience for each person, years at current firm and prior service. Full

resumes of all team members are provided in Appendix A.

• Comparable Projects: Brief list and description of comparable projects

successfully concluded with the last five years, with samples and references

required on Form II.

• Proposal: Detailed program of work by phase and task—including sources of

information to be used, the management plan and schedule, as well as

budget for preparing the CIRM Strategic Roadmap for Continuing Innovation

white paper.


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A. Qualifications and Experience of Firm

James Gollub Associates LLC was established to continue and expand the over 35

years of specialized research and consulting in the field of innovation-driven economic

strategy of its founder, leveraging the core competencies of associates. The list of

similar services provided have all been developed and directed by James Gollub or,

where indicated, by a James Gollub Associate team member. Further, Gollub was a

research center co-director at SRI International for many years and has secured SRI’s

Bioscience group commitment to support this consulting assignment (described

following this section and in the section on Staff).

Overall Experience: Innovation Pipeline Context

For the purposes of this proposal we believe that providing an overview of the

continuity of work carried out by our team’s founder is important for setting the stage

for a current update on our advisory services on innovation strategy and

implementation.

James Gollub began conducting research on the role of institutes and universities in

solving public problems for the National Science Foundation (NSF) while at SRI

International in the late 1970s and early 1980s. These studies led to a practical

framework for the design of public and private policy for enhancing the flow of

innovation from science to the marketplace of public needs. This is what we now call

“innovation pipeline” strategy.

Lending weight to understanding the innovation pipeline, Gollub and his team began

researching and applying cluster-based economic development in the early 1980s,

always being brought in to regions at the economic “inflection” point. This began

under financing from banks and governors focusing on the “rust belt” economy (Great

Lakes), then the expanding Sunbelt and Southwest (Austin and Florida), continued to emerging Southeast Asia (Bangalore, Hong Kong, Osaka and Tianjin, China), then

served transforming Eastern Europe (Jena, former East Germany, Slovenia, Slovakia,

and South Hungary), returned to focus on post-cold war US (Silicon Valley, New York


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City, Southeast Los Angeles, Oakridge, Albuquerque, Hanford), and then growing Latin

America (NE Brazil, Dominican Republic, SE Argentina).

Through many regional strategy projects, Gollub and team have assessed the

investment attractiveness of given industries in a geographic region against the

capacity to provide investment capital. Our team facilitates collaborative solutions to

improve, on the one hand, the inputs impacting the quality of deal flow and, on the

other, preparing angel and venture capital markets to better target and serve

emerging or transforming investment markets.

Overview of Team Experience Relevant to CIRM’s Core Objectives

National Science Policy

Jim Gollub led three projects 1978 to 1980 for NSF and Congress on the National

Science Foundation’s State Science Engineering & Technology (SSET) Program and

related initiatives. The first study evaluated and determined strengths and

weaknesses of state S&T initiatives. A second study examined the role of universities

in performing research and development addressing public policy issues across

strategic themes, such as environment and health, and made recommendations on

alternative mechanisms to enhance input. A third project assessed the role of

universities and institutes in addressing statewide economic development challenges

and profiled relevant models. Consistent lessons learned arose from those projects and set the stage for our consultation to state and local institutions, domestically and

internationally.

State Technology & Institute Strategy

Following the completion of the National Science Policy projects, our team was asked

to advise the governors’ offices in Michigan, Minnesota, and New York to develop and

implement science and technology policy programs during the 1980s and early 1990s.

During this time we were also asked to prepare strategies and business plans for new

translational research and commercialization entities. Among the first of these

initiatives was the strategy and business plan for the Michigan Biotechnology Institute


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(MBI International). That institution, originally seed funded by the state, through the

Michigan Strategic Fund, has now been successfully operating for 30 years, staying

consistently within the mission and structure recommended by Gollub and associates

in 1983. Other institutes and centers from Finland (Bioteknia/Kuopio) to Japan

(Research Institute for Systems Science/NTTD-Tokyo) to Texas (SATAI) planned by

Gollub and team have been running continuously for 10 to 20 years.

Metropolitan Public-Private Strategies

From the mid-1980s through 2010, Gollub and his team were increasingly asked to

serve state and metropolitan leadership commissions, councils and corporations to

shape highly collaborative strategies for accelerating innovation-driven economic

growth—emphasizing technology-driven enterprise development. Universities and

institutes were always key partners in the strategy process, for obvious reasons. The

analytic work focused on: (1) appraising overall performance of the state or regional

economy, (2) benchmarking the competitive performance and position of specific

industries — such as biotechnology and information technology, (3) assessing the

advantages and disadvantages in strategic inputs needed to enable transfer of

knowledge to market — including skills, intellectual property, capital, logistics and

governance factors. The strategy process work was “hands on” and involved our

“convening the marketplace” of demand and supply stakeholders and facilitating

steps to define shared challenges, agree on priority actions and shape collaboratively

executed business plans for new initiatives. Over 30 innovation-driven economic

strategy initiatives directed by Gollub were carried out for regions from Austin to

Silicon Valley and from Bangalore to Osaka.

Federal Strategy Guides

Our method of strategy development gained federal visibility over this period and

Gollub produced strategy guides and articles on competitive strategy (such as,

Cluster-based Economic Development: A Key to Regional Competitiveness, US

Department of Commerce, EDA, 1997 and “Clusters 2.0: The Local Reality of

Globalization”, EDA America, 2004) as well as presentations to public-private forums


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on innovation-driven economic development that focus on how to build collaborative

solutions or “bridges” along the innovation pipeline (such as “Building the Innovation

Pipeline: Capturing “Technology” in Your Economy at the International Economic

Development Council, 2011).

Advising Institutional Investors and Funds

During the late 1990s and early 2000s, Gollub and his team were increasingly called on

by institutional investors and venture funds to provide guidance on how best to

combine venture stage investment and economic development. This was a period at

which state pension funds were for the first time preparing to allocate a portion of

their asset base to venture funds or funds of funds. The rules guiding these decisions

emphasized avoiding fiduciary risk and conflicts of interest. However, there was a

major shift underway. After Gollub had completed directing the first strategy for the

Silicon Valley (Joint Venture Silicon Valley: An Economy at Risk, 1992) which led to

forming the public-private partnership, JVSV Network, his team was approached by

CALPERS and STRS to clarify options on how to invest in state and sub-state

(metropolitan level) industries. Gollub conducted a series of workshops for pension

fund managers and prepared a report for a pension fund association (World Pension

Forum) on how to calculate internal rates of return for economic development

focused investments. Following this, Gollub authored a report for the same client

identifying for public and private pension funds investment opportunities in South

Africa.

Gollub’s team then worked with a private venture fund that managed allocations of

state funds and worked with development commissions in New York to analyze

comparative investment opportunities for technology ventures, such as biotechnology,

between New York and nine other major regions, such as Boston, Chicago, Dallas, and

San Francisco. Gollub presented these findings as a featured speaker at the annual

New York Venture Forum, explaining how regions differ in terms of input advantages

vital to formation and growth of technology industries.


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Anchor Framework

The innovation pipeline framework that James Gollub Associates proposes to apply to

CIRM’s needs has two decades of preceding research and application. This framework

has been applied to public-private initiatives directed by Gollub at the state and

regional focused on fields of innovation from biosciences to clean technology, to

information technology, energy and nanotechnology. The key value of this framework,

simple as it may appear, is that it helps stakeholders better understand the flow of

innovation activities and allocation of resources. While perhaps more “linear” than

reality, separating the three stages is helpful:

• Discovery—Science to Innovation: Academic through translational research.

• Development—Innovation to Solution: Translational research through

enterprise or product.

• Deployment—Solution to Market: Enterprise growth to full scale or acquisition.

This framework is described in the Proposal section in more detail. However, the key

point is that the Gollub team has helped scientists, business leaders, investors and

particularly public leaders better understand the differences in needs at key stages

and how to define and deliver the necessary economic and operational inputs—

“bridges”—between stages to enable a higher volume and more successful flow from

knowledge to market. In each of the projects successfully carried out by the Gollub

team profiled below, this basic framework has helped decision makers more clearly articulate their needs and express their preferences and commit to policies and

institutions that build needed bridges.

Public-Private Process

As Gollub and team have carried out many strategies and planning processes for

public agencies and public-private partnerships over the years, we have found that

using a consistent, “navigable” strategy formation process is very helpful to all

concerned. While the labels used may sound “glib” they actually help leadership

groups, from governor’s councils to research institute management to public-private

advisory councils, align expectations and focus their attention the objectives of each


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collaborative step. Not every project profiled next has the same depth or “weighting”

placed on tasks. Yet virtually every project profiled next shared these steps:

• Mobilize—Ready Public-Private Stakeholders: Engage public-private leaders at

state and local level to support an innovation pipeline initiative.

• Analyze—Diagnostic Baseline: Systematic quantitative and qualitative analysis of “inputs” and “outputs” at each level of the innovation pipeline (discovery,

development and deployment) to determine comparative strengths and

weaknesses of assets.

• Catalyze—Craft Collaborative Solutions: Organize, convene the marketplace of key input and output stakeholders and facilitate collaborative strategy process

to defined shared challenges, prioritize actions, and prepare agreed upon

business plans for new solutions.

• Realize—Build New Implementation Partnerships: Work with leaders (“stewards” in our jargon) and direct institutional and market stakeholders to

review, confirm and commit to a clear business or operating plan to implement

and sustain new solutions.

SRI Biosciences Team Qualifications

James Gollub was a research center co-director and professional at SRI International

from 1976 to 1992 and has maintained ties to SRI over the years. As SRI has strong

bioscience capabilities as a CRO, Gollub reached out and invited their team to serve

as technical advisors to the James Gollub Associates team. James Gollub Associates

has negotiated an agreement with SRI to provide technical support to the CIRM

project at a level separate from and above the proposed budget as a part of our menu

of service options (see proposal and budget). We believe these complementary

capabilities could be an important resource for the strategic roadmap assignment. For

this reason, the following introduces SRI International. The team of bioscience

professionals are later profiled following introduction of the core James Gollub Associates team.


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For more than 50 years, SRI Biosciences has worked with academic, commercial,

foundation, and government clients and partners to bring new therapies and

biomedical technologies to market through basic research, pharmaceutical discovery,

and preclinical development.

SRI Biosciences integrates all of the R&D resources necessary to take biomedical

innovations from idea to early phase clinical testing. SRI also uses biosciences

technology to understand disease mechanisms, identify promising leads, and translate

preclinical candidates into clinical development.

In its capacity as a full-service CRO, SRI Biosciences has worked with clients to

conduct bioscience research, and advance more than 100 drugs to human trials, and

SRI’s own pipeline has yielded several marketed products. Core areas of therapeutic

expertise include cancer and metabolism, immunology and inflammation, infectious disease, and neurosciences. SRI also conducts bioscience research and development to

produce new biomarkers, drug delivery technologies, medical devices, and systems

biology tools. SRI serves as a complete and reliable source for idea to early phase

clinical strategy and development, including chemical synthesis, screening, efficacy,

formulation, pharmacokinetics, safety, clinical manufacturing, regulatory support,

clinical strategy and clinical trials. SRI offers passionate champions, multidisciplinary

teams, rigorous science, a commitment to excellence, and strict adherence to

regulatory guidelines. Applying the SRI Five Disciplines of Innovation™, our staff adds

value seamlessly, with diverse biomedical capabilities and state-of-the-art facilities.

Note: Detail on SRI team members is described in Qualifications of Staff/Resumes.

http://www.sri.com/research-development/biomarkers

http://www.sri.com/research-development/medical-surgical-devices

http://www.sri.com/research-development/computational-biology

http://www.sri.com/research-development/computational-biology

http://www.sri.com/sites/default/files/brochures/sri_biosciences_ideatoind_overview.pdf

http://www.sri.com/sites/default/files/brochures/sri_biosciences_ideatoind_overview.pdf

http://www.sri.com/engage/innovation-programs


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Project Profiles [2008 to 2012]

The eight projects profiled here were all developed and directed by James Gollub

over the past five years. Each project pertains to the core themes central to the CIRM

RFP emphasizing development and implementation of public-private

initiatives/structures. (If CIRM requests, James Gollub Associates can provide further

examples of biomedical focused strategies carried out prior to this five-year window.)

Client: Children’s Hospital of Oakland Research Institute (CHORI) [2013]

Objective: Ensuring CHORI’s Future—Achieving Value through Preserving Key Assets

This early stage consultation was aimed at advising CHORI as it seeks to preserve its

research and operational autonomy under future organizational and administrative

structures as its parent entity, Children’s Hospital (CHRCO) transitions to become part

UCSF. The Gollub team introduced and used innovation pipeline framework to identify

and present the strengths of CHORI. Under the initial phase of this project James

Gollub associates then conduced collaborative work sessions with top management to

establish the core case for CHORI and set the stage for future development. This

analysis identified the assets to protect, based on CHORI’s 54 years of operation, its

standing as 11th nationally in NIH awards ($50M, including stem cell research), its

growing IP-base that is being commercialized, its strong non-university research staff,

and its efficient administration (overhead and contract administration) and extensive

research facilities.

The innovation pipeline framework was used to present strategic new directions that

CHORI can pursue — including expanding existing translational research by expanding

contract research organization (CRO) activities, establishing a dedicated venture fund

focusing on pediatric innovation, and anchoring a strong biomedicine-focused

economic presence in the East Bay. If and when their transaction with UCSF moves

forward CHORI proposes to complete a next generation strategy based on assessing

options and implementing them through new partnerships.


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Client: Medical Center of the Americas (MCA) [2011-2012]

Objective: Vision, Strategy and Business Plans for New Biomedical Institute and

Technology Center (ongoing client confidential work)

Medical Center of the Americas Foundation, a regional non-profit funded by the public

and private sectors, determined that to address the medical challenges facing their region and to grow jobs that they should create a new biomedical institution to

conduct translational research, technology commercialization, and enterprise growth

anchoring a new biomedical technology park. In this project (directed by Gollub

through E-Cubed Ventures), a rigorous process was carried out in three phases. Phase

I Vision involved convening stakeholders to build a public-private mission and vision

and commitment to founding a new innovation-driven institution, technology center

and a surrounding technology park. In the Phase II Strategy, our team executed an

intensive strategy development process that explored the following in-depth:

(1) Discovery—Analysis and benchmarking the inputs and outputs of each level of the

region’s innovation pipeline. This included assessing specific areas of biomedical

research competencies within biomedicine, bioengineering and biosciences across

four universities to define candidate focus for new translational research initiatives

that leveraged cross-institutional competencies.

(2) Development—Evaluation of the strengths and weaknesses of technology

commercialization capabilities in the region—from mining IP from universities to

capitalization and management of biomedical deals to market maturity.

(3) Deployment—Retention and concentration of enterprise growth and industry

attraction in biomedicine.

(4) Public-Private Models—Identification and analysis of 40 examples of “bridge”

models and 10 case studies for enhancing innovation flow to market, covering

translational research, commercialization and economic concentration.

(5) Strategy—Collaborative process with deans, scientists, industry and investors

around key biomedical competency themes to review models and determine optimal

configuration of “innovation bridges” to link the continuum of science to

marketplace.


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(6) The strategy proposals were presented and reviewed with MCA Board and invited

participants with the results approved for next steps.

In Phase III Business Plans our team prepared the overall plan for a new institute—the

Biomedical Institute of the Americas—that will comprise three “divisions for each of

which we prepared operational business plans. These included the Translational

Research Consortium a new function designed to concentrate on focusing a critical

mass of capabilities on target fields in biomedicine, linking talent from across regional

universities, bringing new sources of revenue to the region, including growing

contract research organization (CRO) services; Development Corporation—A new

entity that will mine intellectual property, fund proof of concept projects, organize

and manage new enterprise and a dedicated biomedical angel network to be

leveraged over time with an internal seed fund pool; Biomedical Cluster Growth—An

internal operation to bring together existing biomedical firms (there are 100 in the

region), foster their competitive growth and support attraction of biomedical firms,

through forming a new clinical trials network. This new entity, the Biomedical

Institute of the Americas, has successfully served as a rallying point for health and

economic concerns. Through the strategy and business planning process led by

Gollub’s team, MCA was able to secure active participation from three regional

universities, $55M in funding for operations and construction of the BMIA technology center, a commitment of land to the tech park with the city only taking 10 percent of

the net profit from leases once occupied.

Client William Osler Health Group (regional Canadian health authority) [2010]

Objective: Leverage Hospital Complex as Biomedical Innovation Center

This initial project in the Toronto area (Brampton) was commissioned by hospital

management to introduce the innovation pipeline framework as a means for

leveraging their new hospital complex and its’ associated competencies to achieve

triple bottom-line outcomes—institutional visibility, revenue and economic impact.

Gollub and his team convened regional leaders to explore how this framework could

be used to enable the hospital to anchor a biomedicine innovation-driven hub that


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will lever surrounding economic development, including those of MaRS, intended to

accelerate growth of biomedicine-based innovation.

Client: Governor’s Clean Energy Leadership Council (Washington) [2009-2010]

Objective: Washington State Clean Energy Innovation Strategy

This project co-directed by Gollub in conjunction with Navigant Consulting applied the innovation pipeline framework to the field of clean energy technology for the

state of Washington. While not focused in biosciences, the approach used has

parallels to CIRM objectives. The project began by briefing and preparing a statewide

leadership group—the Washington Clean Energy Leadership Council—to consider

models for accelerating technology development, commercialization and deployment

in the state. The team then analyzed the continuum of Washington state strengths

and weaknesses in four fields—biofuels (agriculture and forest), energy efficiency,

wind power and power technology. For each field the team analyzed capacity to

generate discovery (research expenditures and intellectual property), carry out

development (screen, proof of concept, commercialization) and deploy innovation

(enterprise formation and retention).

Based on the appraisal of current position, the team identified and reviewed models

for enhancing clean energy-driven innovation, from prior projects as well as new

searches. This then led to preparing recommended models for consideration by

Washington State’s Clean Energy Leadership Council. The recommendations

emphasized two public-private approaches—market-pull and innovation-push. The

market-pull model focused on how to align key market demand factors to “draw”

innovation from proof of concept to pilot scale to full deployment—while capturing

economic utility. In a complementary manner, the innovation-push model emphasized

overcoming hurdles to early stage clean energy enterprises and creating input-

advantages that would permit them to grow within Washington State.


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The team met with the CELC to present findings at each stage of the strategy process

and facilitated interactive discussion from members, focusing on how best to position

recommendations to meet market and legislative realities facing the governor. The

CELC approved a set of public-private recommendations that were delivered to the

governor and state legislature for further implementation.

Client: United States Agency for International Development [2010]

Objective: Prefeasibility of Information Technology Innovation Center/Technology

Park

This project was carried out at request of a sovereign bank for an assessment of the

feasibility of growing information technology-driven enterprise to serve global

markets within a technology park in their capital (Ramallah, West Bank). This project

was contracted to Gollub’s team at E-Cubed Ventures through the USAID prime

contractor (Carana Corporation) under the Enterprise Development and Investment

Promotion (EDIP) program. Gollub’s team had previously prepared a comprehensive

business plan for an information technology incubator/accelerator for this region that

had been approved for funding and development.

On behalf of the sovereign bank, Gollub’s team carried out the multi-step study. First,

the team briefed leaders and ministers on the innovation pipeline framework and the

role of cluster development. This emphasized focusing on knowledge economy

structure and how to feed innovations to the market. Second, the team met with and

analyzed the needs and potential of a sample of local firms to serve global

information technology markets. Third, the team interviewed 10 global Silicon Valley

firms to determine their readiness to contract with, invest in, or acquire information

technology firms in this region. As we learned, while many companies were not aware

of the outsourcing potential of this region, several were already moving ahead—

including HP, Cisco, and others. Fourth, the team conducted an international review

of technology center/technology park models that could serve as a micro-economic

hub for enterprise growth to both secure local firms and attract international


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partners. Fifth, having presented the prefeasibility assessment and provided a guide

to technology center or park development to the client, the team provided a game

plan for leveraging the capital from a private equity fund being planned by the

sovereign bank with US and International investment partners.

Client: Department of Regional Development and Industry (Queensland, Australia) [2008]

Objective: Economic Analysis and Structure of Smart Communities: Lessons Learned

(White Paper)

This project built on a prior consultancy carried out by Gollub and team to prepare

the business plan for a joint venture for an internationally-focused contract research

organization (CRO) and commercialization services across three Queensland

universities (QUT, Queensland University, Griffiths University). This initiative involved

building case studies of four biomedicine-focused “smart communities” that brought

together university research, new translational and contract research intermediaries,

and enterprise-and-industry focused concentration. The goal was to explore how to

expand and concentrate biomedical innovation-driven development. The cases

included “smart communities” in Mission Bay, Illinois Medical District, Toronto

Discovery District and Stockholm Science City. The cases examined the history,

founding organizational role, current operational structure, key legislative

requirements, and economic impacts. The case study materials were presented to and

then used by the state of Queensland and the City of Brisbane to plan and grow a new

biomedical smart community.

Client: Governor’s Competitiveness Council (Texas) [2008]

Objective: Texas Energy and Petrochemical Cluster Strategy

The Governor of Texas tasked his Competitiveness Council to shape the next

generation strategy for the energy and for petrochemical industry development in the

state. The Gollub team, through ICF International, began this work by creating two,


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separate, stewards groups to support and guide the collaborative strategy process and

report to the Competitiveness Council during each phase of the strategy process.

The first phase of the project analyzed key international trends and forecasts shaping

Texas’ existing energy (power) industry as well as its petrochemical industry. This was

then followed by a rigorous comparative assessment of the structure of the energy

and the petrochemical industry, including the entire industry value-chain and its

dynamics (growth/decline, starts/failures, moves in/moves out). This assessment

examined and benchmarked Texas’ key inputs to each industry, including innovation,

human resources, capital, logistics, resources, and governance. With this information,

a three-stage collaborative strategy process was carried out to define shared

competitiveness challenges, agreed upon actions and to build public-private teams for advancing a portfolio of prioritized initiatives through the state as well as new public-

private partnerships.

Gollub and team managed collaborative working groups of 90 top executives from

across the energy industry and separately from the petrochemical industry to reach

agreements on needed innovations, workforce preparation, capital and governance

changes to enable each industry’s growth, given competition and market trends. Recommended energy strategies included proposed new partnerships to enhance

energy extraction, storage, and transmission for wind, biofuels, clean coal, nuclear,

and oil shale and parallel directions for the petrochemical industry. The

recommended strategies were then presented to the Competitiveness Council,

revised, approved, submitted to the governor, and have since been the priority focus

for energy and petrochemical growth and competitiveness in Texas.


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Client: SPUR and PG&E [2008]

Objective: Assess the Evolving Pattern and Structure of the San Francisco Bay Area

Clean Technology Cluster

The purpose of this project was to improve understanding of the position of clean

tech in the local economy and develop recommendations for strengthening SF’s clean tech industry. The key questions were: How many clean technology businesses exist in

the Bay Area today, where they are located, what types of work are they doing, how

they fit into the economy and what conditions are essential to their success. We then

recommended how to use an R&D and demonstration institution and technology

commercialization mechanism focusing on strategic segments of clean technology

could differentiate San Francisco from competing regions. The process we used

assembled database of over 400 clean technology firms in the Bay Area, analyzed

their economic characteristics using firm-level data, conducted a survey of these

firms, and interviewed a range of local executives, policymakers, and experts in the

clean technology space. The project informed San Francisco leaders about the

differences and challenges the City faces in growing this industry. The results were

used to support new directions by the City to foster within-city growth and

concentration of clean technology centers for research, development and enterprise,

including at Hunters Point.


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B. Qualifications of Staff/Resumes

This section of the James Gollub Associates response to the CIRM Roadmap for

Continued Innovation RFP provides an overview of our team by:

• Areas of core competency relative to CIRM RFP themes. • Profiles of each team member in terms of experience, CIRM-specific

competencies, services history and education. Note: SRI team member profiles follow those of James Gollub Associates team.

• Resumes for team members are provided in an appendix to this section.

Areas of Core Competency

Our team comprises experts who professionally know or have previously directly

worked with James Gollub on a prior biomedical institute strategy initiative and are aligned and committed to perform key tasks.

As two Optional Service Modules to our core project team, available on CIRM budget

approval, we have negotiated a subcontract with SRI International (where Gollub

worked for 16 years). SRI is a leading CRO that has agreed to provide their top

biosciences experts in stem cell research, pre clinical trials, clinical trials and commercialization to support our team effort in a manner that complements our core

capabilities in institutional planning and financial development.

We further are fortunate to have a relationship with World Pension Forum (WPF), an

association of all major pension funds, to whom Gollub has previously consulted. The

WPF will assist James Gollub Associates in examining viability of investment fund models for regenerative medicine ventures to major institutional investors

(particularly in California such as CalPERS and STRS) and their money managers as

well as directly to the State Comptroller and Treasure, as may be appropriate.


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The management of the team is described in the Proposal section.

Table 2.1 – CIRM-specific competencies Public/Private

Initiative & Innovation Models

Regenerative Medicine/Drug Development

Venture Finance (From IP to Market)

Implementing Multi-party Public-Private Funding

J. Gollub XXX X XX XXX S. Marshall X XX A. Rassen XXX XXX C. Wilson XX XXX XXX P. Kalmes X XXX X A. Barnes XX X M. Morgunov XX XX X SRI Team XXX

Table 2.2 – Staff competencies by task focus Market

Analysis & Data Mining on R&D, IP, Ventures

Case Studies on Innovation Bridge Models

1-to-1 Interviews with Demand & Supply Executives

Collaborative Work Sessions with Stakeholders

Roadmap Strategy Recommending Priority Model & Impacts

Specification of Operational Features of Integrated Recommendation

J. Gollub XXX XXX XXX XXX XXX XXX S. Marshall

XX XX XXX XXX XX XX

A. Rassen XX XXX XX XX XX XXX C. Wilson XXX X XXX P. Kalmes

XX XX XX X XX XXX

A. Barnes XXX XX X X XXX X M. Morgunov

XX XX XX X XX

Team Member Profiles

The following profiles of all team member were prepared specifically for this

proposal. Full resumes of all team members are provided in Appendix A.


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James Gollub, BA, MPL

Founder & Managing Director (core team)

Experience: 36 years of research and consulting globally on innovation-driven

economics serving science and technology agencies, governor’s competitiveness

councils, public-private partnerships, universities, institutes and investors in

analyzing, planning and implementing “bridges” between science and innovation,

innovation and solutions, solutions and markets.

CIRM-Specific Competencies

• Discovery: Delivery of vision, strategy and business planning for innovation-driven biomedical institutions that integrate translational research and contract research organizations (CRO) through a range of public-private partnership mechanisms.

• Development: Advice, facilitation and business planning of new vehicles for increasing commercialization deal flow and expansion/leverage of capital.

• Deployment: Planning mechanisms to capture the value of research-based innovation in the economy for institutions and sponsors/partners through cluster building, tech centers and technology parks.

Current & Prior Service

• James Gollub Associates LLC, founder, 2013 to present • E-Cubed Ventures LLC, Co-founder, 2009-2012 • ICF Consulting, SVP, Global Economic Development, 2000-2009 • Information Design Associates (IDeA) [Founder], 1995-1999 • DRI/McGraw-Hill, Principal, Economic Competitiveness, 1992-1994 • SRI International, Co-Dir., Center for Economic Competitiveness, 1976–1991

Education

• M.S. Urban & Regional Development, USC, 1976 • Certificate for dual masters degree in Gerontology and Planning, USC, 1976 • A.B., Psychology, University of California, Berkeley, 1974 • National Oceanic and Atmospheric Administration (NOAA) Sea Grant Fellow,

1974-1976


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Stephen Marshall, BA, MBA (core team)

Experience: 30 years of qualitative and quantitative research and consulting to

corporations focused on developing value-added strategies in complex technology-

driven businesses.

CIRM Specific Competencies

• Demand Analysis: Deep experience in organization, planning and execution of surveys, direct interviews and collaborative working groups to assess needs of stakeholders among institutions, pharmaceutical industry, financial investors and government pertaining to funding and investment, development and utilization of emerging technologies.

• Supply Analysis: Identification and assessment of range of marketplace and competitive alternatives to addressing demand-driven needs emphasizing emerging technology development and delivery.

• Operationalization: Preparation and delivery of corporate value operationalized in quantified economic and financial terms.


• James Gollub Associates (core team) 2013-present • BIA/Kelsey, Research Director 2006-2012 • The Kelsey Group, Associate 1996-2005 • Pacific Telesis, AVP of Corporate Strategy 1993-1995 • Marakon Associates, Senior Manager 1988-1993 • First Manhattan Consulting Group, Associate 1985-1988 • J.P. Harkins Inc., Associate 1979-1985 • Boston Consulting Group, Consultant 1978-1979

Education

• MBA. Harvard University, 1978 • B.A. American History (minor Economics) University of Michigan, 1974


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Amy Rassen, BA, MSW (core team)

Experience: 35 years researching, strategizing and implementing business models for

non-profits.


• Implementation: Delivery of strategy and business planning for research-based private foundation focused on discovering the causes of asthma

• Knowledge: Participation in private venture to change the way personalized healthcare decisions are made by combining the power of proprietary cloud-based expert systems with insights from the nation’s top clinical experts

• Operations: Leadership in creating systems and management of organizations and focused projects


• Principal, Rassen and Associates, 2006 to present • Undersecretary for Clinical Services (Acting), California Department of

Corrections and Rehabilitation, 2008 – 2009 • Founder and Executive Director, American Asthma Foundation, 2007 – 2008 • Associate Executive Director, Jewish Family and Children’s Services of San

Francisco, the Peninsula, Marin and Sonoma Counties (JFCS), 1985 – 2006 • Founder and Director, Parents Place, 1981 - 1985

Education

• M.S.W., George Warren School of Social Work, Washington University, 1971 • Licensed Clinical Social Worker, 1974 to present • B.A., History, Brandeis University, 1968


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Christopher G. Miller, BA, MBA (core team advisor)

Experience: 13 years directly establishing and managing venture and private equity funds, serving as CFO over multiple funds in biomedicine, biomedical devices and medical IT, and related technical fields, building on history of national and overseas health care industry CFO roles. CIRM-Specific Competencies

• Structure: Formation of general partnerships and organization of venture fund limited partnerships in specific theme areas (biomedicine), private equity funds, and large family funds.

• Deal Flow: Expertise in criteria for screening and selecting biomedical investments to build viable portfolios for venture funds as well as in assembling and executing strategic acquisitions to build companies within fund.

• Management: Systems and procedures for managing limited partners, board, investments/enterprises within fund based on theme-focused structure.


• James Gollub Associates (advisory team), 2013-present • PhyMedica, Co-founder & CFO (EMR firm), 2008-present • The Special Opportunities Group LLC (founder/VC fund dev.), 1999-present • BioStar Private Equity Biotech Fund, CFO ($100M) • AM Richmond Holdings LLC, founder/fund manager, 2010-Present

o AM Richmond Capital LLC, ($490M) o AM Richmond Capital LLC 2 ($600M)

• Thermia Vision Systems, CFO, 2008-present • Prime Source Global Advisors, CFO (serving Chinese client), 2011-present • Star Scientific, CFO and Director (anti-carcinogen R&D), 2000-2007 • Community Bankers Trust Co., Board, 2007-2009 • Chinese Medical Manufacturing and China JV, 2000-2006 • Gilder Group LLC, CFO, 1998-1999 • American Healthcare Ltd, (JV China), Chairman, 1994-1998 • International Medical Care, Ltd., Founder, 1992-1993 • Hospital Corporation of America, CFO/EVP, 1991-1992

Education

• MBA Harvard Business School, 1987 • BS Civil Engineering, US Military Academy (West Point), 1980


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Paul Kalmes, BSEE, MS (core team advisor) Experience: Decades of experience developing and managing intellectual property

across technology industries, from strategic patenting through commercialization

options including licensing and acquisition to and from sources of innovation and

business development of emerging fields of technology.


• Intellectual Property Management: Innovation capture and strategic patenting from public and private sources, competitive intelligence and IP landscape assessment, IP risk characterization, IP valuation and assessment, worldwide licensing program development, including license and contract negotiation.

• Business Development: Extensive business development experience focusing on IP management across industries at different stages, including oversight of product design processes, marketing, distribution, pricing and financing strategies, including joint venture negotiation and management.

• Product Development: Development of long-term IP-driven, product roadmaps, identification and characterization of product development opportunities, guidance of design, engineering, supply chain, manufacturing, sales, and marketing.


• Metis Partners, IP Management Services 2009 – Present • Lighting Sciences Group Corp, IP Strategy 2007 – 2009 • Color Kinetics, Director Licensing 2005 – 2007 • Rockwell Scientific Licensing, Director BD 2003 – 2005 • Ophthalmological Surgery Entity, Management 2002 – 2003 • KPMG/IP Value, Senior Manager, IP 2001 – 2002 • Yet2.com, Director, Business Development 2000 – 2001 • M/K Systems Inc., President/Director R&D 1996 – 2000 • Progetto Sella, Founder/Author 1993 – 2000 • Snohomish County, PUD, Research Engineer 1990 – 1993 • Design Engineer, Freelance 1981 – 1987

Education

• MPA, Risk Assessment, University of Washington • BSEE, Northeastern University


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Annika Barnes, BA, MA (core team)

Experience: Management, technical analytic and strategic planning role in projects to

define market need and to develop initiatives to accelerate flow of innovation to

market and economy in fields from biosciences to clean technology.


• Assessment: Experience in conducting survey and case studies applying economic and institutional criteria to define and appraise models for innovation and their impacts.

• Development: Use organizational, economic and market analysis to plan innovative technology development programs.

• Communications: Transform complex technical data into concise reports and presentations accessible to a broad audience

Prior Services

• James Gollub Associates (core team, senior associate), 2013-present • University of California, Office of the President (analyst), 2012-2113 • E-Cubed Ventures, Senior Associate (reported to Gollub on MCA), 2011-2012 • Element Strategic Partners, Principal (worked with Gollub team), 2008–2011 • Imperium Renewables, Inc., Project Manager, Strategic Development, 2007–

2008

Education

• MA, Johns Hopkins University – School of Advanced International Studies, Washington, DC, and Bologna, Italy

• BA, University of Washington


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Max Morgunov, BA (core team advisor)

Experience: Served investment community and consulting projects in defining fund options, performing due diligence on models for biomedical institute (among others), identifying capital sources, securing capital for hedge and venture funds. CIRM-Specific Competencies

• Models and Sources: Capacity to examine structure and match of core elements of different funds against both investor market readiness as well as specific needs of expected investment portfolio.

• Due Diligence on Options: Experience in step=by-step appraisal of market and institutional variables associated with possible new investment funds as well as investment candidates.

• Structuring New Entities: Knowledge of capital market dynamics needed to design and secure investment from multiple sources for new investment entities focusing on innovation.

Prior Services

• GWTC, LLC, Co-founder, dir., commercial facilitation – biomed devices 2011--Present

• E-Cubed Ventures, Associate (reported to Gollub on venture models 2011—2013

• Equity Management Associates, LLC (hedge fund) dir. marketing and BD 2009—2010

• SAC Capital Advisors, LLC (international equity derivatives), ops analyst 2007—2008

• AEI, Inc., Late stage VC-Investment banking fund ($350M), intern 2006

Education

• BA, Colgate University, 2003 • Chartered Financial Analyst (CFA) • CFA Society of San Francisco, Affiliate Member


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SRI Team for CIRM Project

SRI International (SRI) is pleased to support James Gollub Associates, LLC in an

advisory capacity, if approved as an Optional Service Module, as part of its proposed

project to provide strategic roadmap support to the California Institute for

Regenerative Medicine (CIRM).

SRI is an independent, nonprofit, non-endowed corporation chartered by the State of

California. The institute's founding purpose has not changed: SRI is committed to

discovery and to the application of science and technology for knowledge, commerce,

prosperity, and peace. For more than 50 years, SRI Biosciences has worked with

academic, commercial, foundation, and government clients and partners to bring new

therapies and biomedical technologies to market through basic research,

pharmaceutical discovery, preclinical development, and entry into the clinic.

Based on this experience, SRI proposes to provide advice and guidance on institutional

strategies for the translation of novel stem cell therapies and platforms from the

bench to the clinic.

SRI understands that the focus of James Gollub Associates’ assignment will be to: (1)

Identify and analyze a range of institutional mechanisms to finance and execute

research, development and commercialization objectives (e.g., endowed

foundations/institutes, CROs and commercialization entities, pre and post-venture

capital financing); (2) evaluate, match and recommend a target approach/model,

and; (3) prepare the operational plan for the recommended/integrated option.

SRI will provide a team of staff scientists as advisors to this anticipated project who

understand the biomedical "innovation pipeline" from translational research through

clinical trials Phases I and II to further commercialization. If approved as advisors, SRI

professionals will be asked to review and comment on specific output generated by


page 30

James Gollub Associates’ core project team in each phase of the project. In Phase II

the SRI team will be asked to review a set of organizational models in terms of how

well they address the scientific and engineering objectives of moving innovation down

the pipeline. In Phase III the SRI team will be asked to comment on the prioritized

options, again, in terms of match of options to addressing research, development and

commercialization. In Phase IV the SRI team may be asked to provide a final review of the operating plans for the recommended options.

SRI Biosciences Staff

SRI proposes to make available to James Gollub Associates staff with decades of experience in the discovery, development and clinical translation of therapies and

biomedical platforms directed at addressing important health needs. The proposed

Biosciences staff provides this project with:

• Technical expertise in stem cell technologies and regenerative medicine and in designing product development plans for advancing cell therapies to the clinic

• Leadership in establishing and directing nonprofit institutions, particularly focused on health and biomedical research and discovery and development of therapies with the priority of making them available to patients

• Experience in the varied landscape of pharmaceutical development: large pharma, biotechnology industry, startups, university labs, preclinical and clinical contract research organizations, foundations, and research and development for the National Institutes of Health

• Excellent track record of successful Investigational New Drug applications to the FDA

• Extensive experience advising academic researchers on preclinical development steps and strategies. SRI initiated the PharmaSTART™ program that assisted university researchers in moving lead compounds from discovery stage in to the clinic

• Leadership in establishing SRI as one of the founding partners, along with the University of Arizona and the Food and Drug Administration, of the Critical Path Institute (Tucson, AZ) which is developing new paradigms for the more rapid development of new drugs


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Executive Staff Team

A description of the relevant experience of key SRI staff available to support this program is included in the following biographical

sketches; staff CV’s are included in Appendix A.

Joseph Rogers, Ph.D., joined SRI's Biosciences Division in 2012 as Executive Director

of a new Health Sciences Section that brings together researchers from SRI's Center

for Health Sciences with SRI's Center for Neuroscience and Metabolic Diseases. This

combination offers SRI clients and partners more integrated bench-to-bedside capabilities in areas such as addiction, alcoholism, Alzheimer's and Parkinson's

diseases, Down syndrome, sleep disorders, and more.

Rogers received his Ph.D. from the University of California, San Diego, his B.A. from

Emory University, and was a postdoctoral fellow at the Salk Institute. He has been

investigating inflammatory and other pathogenic mechanisms in neurodegenerative diseases for nearly three decades, and received a Lifetime Achievement Award from

the national Alzheimer’s Association for that body of work. He also has major

interests in epigenetics and regenerative medicine. Roger’s laboratory is the only one

to successfully culture neuronal progenitors and their progeny from rapid brain

autopsies of Alzheimer’s, Parkinson’s, and normal elderly subjects. In addition, his lab

has developed methods to drive differentiation of IPS and other progenitors to high

yields of a dopamine (DA) phenotype. This work is currently funded by an IR&D Award

from SRI International, with the intent of applying the technology to non-human

primate models of Parkinson’s disease.

Before joining SRI, Rogers served as founder and president of the Sun Health Research

Institute (acquired by Banner Health System). Under his leadership, the institute

became internationally recognized for its research on age-related neurological

diseases, and is a National Institutes of Health (NIH)-funded National Alzheimer's


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Disease Center. He has served on numerous boards, including the American Geriatrics

Society, Arizona Alzheimer's Association, NIH Working Group on Neuroimmunology,

Arizona Governor's Task Force on Alzheimer's Disease, Arizona Legislative Task Force

on Stem Cell Research, and the Pacific Alzheimer's Institute. A reviewer and editorial

board member for numerous scientific journals, Rogers has more than 150 scientific

publications. His research on Alzheimer's disease has been continuously funded by the NIH for the last 25 years. Rogers also holds patents related to the diagnosis and

treatment of Alzheimer's disease.

Nathan Collins, Ph.D. is the Executive Director of Drug Discovery in the

Biosciences Division at SRI International. Collins is responsible for

research and development in the company’s Centers for Cancer,

Immunology and Infectious Disease, and Chemical Biology which

conduct basic and translational research into disease mechanism and

drug discovery. Prior to joining SRI, Collins was Vice President New

Product Development for San Diego-based Discovery Partners

International, where he was involved in the development and marketing of several

new technologies in high throughput drug discovery. Collins started his industrial

career at Arris Pharmaceuticals (which later became Axys Pharmaceuticals, and then

Celera Genomics) in the discovery and development of small molecule drugs for protease inhibition, as well as small molecule cytokine mimetics of EPO and hGH.

Collins has over twenty years of experience in the biotechnology industry and over ten

years of executive management of drug discovery from basic research through to

clinical candidates. He also has developed and commercialized high throughput

technologies for drug discovery, and has led business development efforts to locate and close major deals around diverse programs with biotech companies, major

pharma such as Pfizer, Merck, Takeda, Daiichi, Roche, Sanofi Aventis, P&G, Pentax

and others. He pioneered the concept of ‘compound management’ as a business

opportunity and subsequently won the NIH Roadmap Small Molecule Repository.

Collins has a Ph.D. in chemistry, and BS (honors) in chemistry and mathematics from

the University of Southampton. He was a postdoctoral research fellow at the

University of Arizona’s Departments of Chemistry and Biochemistry.


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Jon C. Mirsalis, Ph.D. is Managing Director of the Biosciences Division and Executive

Director of Preclinical Development at SRI International in Menlo Park,

CA. Dr. Mirsalis has extensive experience in the development of drugs

for a broad range of indications including infectious disease, cancer and

CNS. He currently manages two large programs for the National

Institute of Allergy and Infectious Diseases (NIAID) for the development

of promising therapeutics for the prevention and treatment of a broad

range of infectious diseases including TB, malaria, influenza, polio, anthrax, plague,

and Ebola. He has previously managed similar programs for both cancer

chemopreventive and therapeutic agents for the NCI and brain imaging agents for the

NIMH. He has personally been involved in the development of over 50 therapeutics

that have entered clinical trials and several have reached the market. Before joining

SRI in 1981, Dr. Mirsalis was a postdoctoral fellow at the Chemical Industry Institute of

Toxicology, where he developed the in vivo-in vitro hepatocyte DNA repair assay,

which is now widely used as a screen for potential carcinogens by government and

industry. He is the author of over 100 publications and abstracts. Dr. Mirsalis received

his B.S. degree in zoology/molecular biology from Kent State University, his M.S.

degree in genetics from North Carolina State University, and holds Ph.D. degrees in toxicology and genetics from North Carolina State University. Dr. Mirsalis has an

adjunct faculty appointment with the University of California-Santa Cruz, where he

lectures regularly on genetic toxicology and carcinogenesis. He has recently served on

the Board of Scientific Councilors for the National Toxicology Program, the Advisory

Board for the Critical Path Institute, and is a past member of the FDA’s Over-the-

Counter Product Review Committee. Dr. Mirsalis has been certified by the American

Board of Toxicology since 1983.

David Sahner, M.D., Senior Director of Clinical Translation, leads SRI’s

Phase 1 Clinical Trials Unit organization. Sahner is a board certified

internist and infectious diseases expert with 15 years of chiefly

industry-based experience in the research and development of drugs,

biologics, and devices, superimposed upon a background of nearly 10


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years of clinical practice following his fellowship training at Brown University. His

experience base subtends (1) provision of clinical expertise and scientific support to

Discovery, Research, and Preclinical functional lines (2) formulation of strategy

(development strategy, synthesis of target product profiles, strategic evaluation of

early ideas and product concepts), (3) tactical activities (e.g., study site and vendor

selection, organization of Data Monitoring Committees), (4) execution at all phases of drug development (i.e., medical monitoring, IND and NDA submissions, authorship/co-

authorship of clinical study reports, investigator brochures, other study-related

documents, regulatory briefing documents, abstracts, posters and manuscripts), and

(5) line management. Relevant to this proposal is his collaboration with basic

researchers at SRI on a potential approach to bone regeneration using stem cells and

clinical experience in the design and implementation of a vaccine trial enrolling

subjects undergoing hematopoietic stem cell transplantation.

He was the clinical lead responsible for the Sustiva supplemental New Drug

Application, which led to significant revised labeling pursuant to the conclusion of 168

weeks of follow-up in a Phase 3 study, and he assisted the development team in their

preparations for a successful Advisory Committee meeting which subsequently

culminated in the approval of Reyataz. Previously Sahner has held clinical positions of

progressively increasing responsibility and leadership at Chiron, Bristol-Myers Squibb,

Pfizer, Vical, and Nektar Therapeutics where he served as Vice President of Clinical

Development. Sahner has a history of repeatedly successful interactions with

Regulatory agencies, experience with numerous types of submissions and regulatory

meeting types/formats, as well as deep expertise in executional, tactical and

strategic elements of R&D. He has consulted for over half a dozen

biotechnology/biopharmaceutical companies and the private equity space.


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Technical Staff

Toufan Parman, Ph.D., D.A.B.T., is the Director of General Toxicology

in SRI International’s Biosciences Division. Dr. Parman has over 10 years

of experience in managing and conducting toxicology and PK studies on

a wide variety of pharmaceutical products, chemotherapeutic agents,

vaccines, monoclonal antibodies, proteins, and cell-based therapies,

including the design of preclinical development plans for stem cell

projects. She has developed and filed a patent on a novel method for delivery of stem

cells to the brain via the nasal passages.

Parman is an experienced toxicologist with broad technical proficiency in chemistry,

neurotoxicology, molecular and cell biology, pharmacology, and reproductive and

general toxicology. As a result, she has the ability to integrate molecular and cellular

approaches to assess pharmacological outcomes for small molecule drugs, proteins,

and recombinant DNA. Dr. Parman has expertise in developing and implementing

preclinical plans in support of IND/NDA submissions for various small molecule drugs,

such as those used for treatment of malaria, cancer, and neurodegenerative diseases;

and biologics, such as vaccines, viruses, proteins, and recombinant DNA. Dr. Parman

has produced seminal results and contributed both conceptually and technically to her

fields of expertise, as demonstrated by her publications in high-ranking peer-reviewed

journals such as Nature Medicine, FASEB Journal, Toxicological Sciences, and Drug

Metabolism and Disposition.

Dr. Parman received her B.Sc. with honors in Chemistry from Dalhousie University

(Nova Scotia, Canada) in 1991, her M.Sc. in Physical Organic Chemistry in 1993, and

her Ph.D. in Pharmaceutical Sciences from the University of Toronto in 2000. Dr.

Parman’s graduate work focused on drug metabolism and disposition and mechanistic

toxicology. After completing her Ph.D., she received a Postdoctoral Fellowship Award

to work at the Laboratory of Cellular Oncology at the NCI (2001–2003) to pursue

training in the area of cell signaling and cancer. Dr. Parman continued her


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postdoctoral training in the area of cell signaling and cancer at the

School of Medicine, Department of Hepatology and Gastroenterology,

Stanford University.

Lucia Beviglia, Ph.D., recently joined SRI as the Director of Cancer

Pharmacology in the Center for Cancer and Metabolism. She has over 20

years of experience in academia and pharmaceutical industry and gained strong background and expertise in cancer biology, hematology, immunology, and

pharmacology. Prior to SRI, Dr. Beviglia held senior scientific positions with OncoMed

Pharmaceuticals, Corgentech, and Celera.

Beviglia received her Ph.D. from the University of Perugia, Italy, and held

postdoctoral scientist and fellowship positions at the University of North Carolina, UCSF, Temple University, and Mario Negri Institute, Milan and Santa Maria Imbaro

(Italy). She is skillful in the design, development, validation, and execution of a broad

range of in vitro, in vivo, and ex vivo models to evaluate efficacy of clinical

candidates and anticancer agents, to determine an effect of treatment on

tumorigenicity and frequency of cancer stem cells in multiple cancer types, and to

analyze predictive and PD biomarkers. Her expertise includes angiogenic and novel

experimental models of cancer metastasis and humanized tumor assays utilizing

known and new sensitive imaging methods of detection.

The past seven years at OncoMed, Lucia played a key role in developing preclinical

novel and predictive tumor models with patients-derived tumor xenografts, and

designed in vivo studies that contributed to successful identification of predictive and

PD biomarkers for clinical implementation of proprietary antibodies drug candidates.

Her work demonstrated the potential value of Disseminated Tumor Cells (DTCs) as a

surrogate tissue of breast cancer for analysis of biomarkers in response to treatment.

Moreover, she has advanced the scientific knowledge of cancer stem cells in multiple

epithelial malignancies and demonstrated that chemotherapy enriches for cancer

stem cells that are left behind in the primary tumors after treatment. Her work has

contributed to the understanding of the stem/progenitor hierarchic organization of


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tumor initiating cells in epithelial tumors. Important results from her studies with

melanoma orthotopic models have revealed the cancer stem cells as a new

mechanism of drug resistance, e.g. relapse of B-RafV600E mutant melanoma treated

with the inhibitor Vemurafenib.


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C. Comparable Projects

The following is a brief list of comparable projects carried out over past five years, all

described in detail among other completed projects in the Qualifications and

Experience of Firm. Two of these are focused on biomedical institutions and two are

focused on state level innovation initiatives, all using similar in core steps and

intensive involvement of public private partners. Examples of earlier comparable

projects carried out for institutional clients, such as the University of California

(UCOP), or on biomedical institute development are also available on request:

Children’s Hospital of Oakland Research Institute (CHORI) [2013]

• Client: CHORI, a division of Children’s Hospital of Oakland. • Focus: Initial positioning of CHORI to optimize autonomy as they face

merger into UCSF (project is new and at earliest stage). • Process: Review of models of autonomous R&D institutes and collaborative

review process with CHORI management. • Outcome: Initial recommendations to sustain position of CHORI. Project

continuation pending outcome of merger decisions. • Sample of Work: NA (proprietary) • Contact: Raja Prasad, Vice President

o E-mail: [email protected] o Phone: (510) 450-7602 o Web: www.chori.org

MCA Foundation - Biomedical Institute of the Americas [2012]

• Client: Medical Center of the Americas (MCA) a public-private NGO dedicated to fostering regional health solutions as well as economic growth around biomedicine.


page 39

• Focus: Create a mechanism to “bridge” and harness biomedical research assets across multiple universities to create new solutions, new sources of revenue and growth of biomedicine-driven economic development.

• Process: Completed a three-phase initiative including vision, strategy and business plans for a new bioscience institute and technology center. Each phase carried out with intensive engagement and review by the large MCA public-private board. Phase I Vision presented overall framework and built public-private commitment to the initiatives; Phase II Strategy carried out analysis and benchmarking of biomedical capabilities and competencies against competitors and trends, did a national analysis of a continuum of models for translational research, commercialization and cluster growth, then used a collaborative process to review assets against models and prioritize preferred structure, this was then reviewed and approved by the MCA board; Phase III Business Plans completed an integrated plan for the overall operating structure of the new Biomedical Institute of the Americas and the structure of each component.

• Outcome: Completed deliverables for each phase, including regional public-private vision and commitment to form new combined entity; the collaborative strategy for a new biomedical institute, and; an integrated business plan for the new institute comprising three divisions: translational research consortia, biomedical commercialization corporation and fund, and a cluster entity designed to support biomedical enterprise growth via a new clinical trials network and a biomedical tech park. The strong leadership and public-private partnerships led a decision by the City and public utility to channel $55M to this new biomedical institute for launching its technology center and building.

• Sample of Work: MCA BMIA Strategy (attached in PDF) • Contact: Emma Schwartz, President and CEO, Medical Center of the

Americas o E-mail: [email protected] o Phone: 915) 269-2569 o www.mcamericas.org

mailto:[email protected]


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Washington Clean Energy Strategy [2010-2011]

• Client: Washington Clean Energy Leadership Council (CELC) a public-private entity formed by the governor’s office following Senate Bill 5921 was established to oversee clean energy strategy development and policy.

• Focus: Develop an action-focused strategy to accelerate formation, expansion and attraction of clean energy-driven innovation in Washington State.

• Process: Working with the CELC the project team (Gollub, co-director and Navigant, the prime contractor) completed three phases. In Phase I the team introduced the innovation pipeline framework to CELC and assessed four segments of the clean energy innovation asset base in Washington relative to global trends and competitors in order to screen and prioritize target technology segments for development, which were then reviewed and agreed to by the CELC. In Phase II, the team analyzed comparative innovation models and evaluated those against prioritized Washington assets and input advantages, which were then reviewed with the CELC to determine priority clean energy innovation packages. In Phase III the team developed two state-level public-private models for consideration. One model focused on “market-pull” models for stimulating demand and growth of clean energy technology. The other model was a “supply-push” model that concentrated on providing the flow of investment capital for proof of concept, pilot stage and enterprise growth acceleration. These were reviewed, modified to meet CELC preferences, and signed-off by the CELC.

• Outcome: The project delivered detailed presentations for the first two phases and an integrated report for the third phase of recommendations. These were accepted by the CELC and presented to the governor for consideration and adoption. A new Washington Clean Energy Partnership was formed to support implementation following project completion.

• Sample of Work: Washington State Clean Energy Leadership Plan Report: Accelerating Washington Clean Energy Job Growth, 2010, 92 pages, available at website.

• Contact: Marc Cummings, Chair of CELC, from Pacific Northwest Labs (PNL). o E-mail: [email protected] o Phone: (206) 528-3015 o Web: wacleantech.org/clean-energy-leadership-council

http://wacleantech.org/wp-content/uploads/2011/08/CELC_Navigant-Final-Report_Final.pdf

http://wacleantech.org/wp-content/uploads/2011/08/CELC_Navigant-Final-Report_Final.pdf


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Texas Energy & Petrochemical Cluster Strategy [2008]

• Client: Governor’s Competitiveness Council (contracted through State Workforce Commission)

• Focus: In-depth strategies and proposed actions for the state and public-private partners to achieve goals of meeting Texas’ future energy needs, generating new sources of revenue from energy and petrochemicals development and innovation, and capturing economic benefits of energy and petrochemical industry concentration and growth within Texas.

• Process: This project was directed by James Gollub as senior vice president of ICF International and once launched carried out three phases of work: Phase I conducted a rigorous assessment of both energy and petrochemical industry market trends in terms of demand and supply and identified Texas’ position and implied market challenges. Phase II analyzed and benchmarked the structure and competitive performance of the energy and petrochemical clusters in Texas. This include in depth appraisal of industry dynamics—formation/death, expansion/contraction, moves in/moves out, as well as assessment of Texas’ advantages or disadvantages in key inputs for enabling industry formation and growth, including human resources (preparation, advancement, renewal), innovation (discovery, development and deployment), capital (formation, expansion, restructuring), logistics (transportation, transmission, communication) and governance (taxation, regulation and administration). In Phase III a range of models to address industry challenges were identified and then shared with a large public-private working group of industry and input providers who were facilitated to collaboratively define shared challenges, priority actions, and commitments to work on actions. Based on this array of inputs a Texas energy and petrochemical cluster strategy was developed that made explicit recommendations for actions to enhance energy and petrochemical extraction, generation, storage and distribution and associated economic impacts.

• Outcome: The strategy was reviewed and finalized with industry and institutional leaders through multiple roundtables and when finalized, submitted to and approved by the governor. The strategy is in place and has guided state programs on innovation, workforce, capital and logistics


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infrastructure. These two clusters were part of a broader program of cluster strategy.

• Sample of Work: o Summary Report:

governor.state.tx.us/files/gcc/Councils_Report_to_the_Governor.pdf o Full Report:

governor.state.tx.us/files/gcc/ICFs_Report_to_the_Governor.pdf • Contact: Doug Ridge, Director, Employer Initiatives for Economic

Development o Phone: (512) 463-1986 o E-mail: [email protected] o Web: www.governor.state.tx.us



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D. Proposal

Introduction

CIRM is seeking a strategic roadmap for continued innovation. Given CIRM’s distinctive

history, legislative charter and operating mission, a roadmap for continued innovation

must deliver an integrated and sustainable solution. Working from CIRM’s prior

internal identification of strategic needs and current operating structure, James Gollub Associates has crafted a specific roadmap building process. This process,

building on our prior experience in vision, strategy and planning for biomedical

innovation, will deliver a White Paper requested in the RFP addressing these goals:

• Analyze Models: Identify and assess a continuum of models that can be applied

to sustaining CIRM’s continued innovation. • Integrated Recommendation: Screen models against demands and

opportunities that CIRM is chartered to address as well as institutional and market-based feasibility and from that recommend an integrated structure that CIRM can consider for use for in sustaining continued innovation.

• Operating Plans: Prepare the operating plan for the recommended model, defining mission, structure, operational functions, including advanced screening and matching of potential partners, setting the stage for possible implementation.

James Gollub Associates will complete the proposed Strategic Roadmap for Continued

Innovation within a four-month time frame. We propose a four-phase process with

specific core tasks carried out within the budget CIRM has requested. However, in

each phase of work, in additon to the core tasks, our team has carefully defined

Optional Service Modules that CIRM is invited to consider adding to the core. The

budget for the proposed work, which appears later, provides the estimated cost for

core tasks as well as the Optional Service Modules.


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To accomplish CIRM objectives James Gollub Associates offers a core team of four

professionals experienced in innovation system assessment, strategy development and

planning of a range of innovation “bridge” entities for translational research, contract

R&D, technology commercialization and innovation investment. We also offer access

to three other team experts in venture financing, intellectual property management

and commercialization to support core task or optional modules of activity as may be required.

Moreover, to ensure the technical accuracy and relevance of insights at each step

James Gollub Associates has a brought SRI International’s Bioscience’s group onto our

team as two Optional Service Module (see Phase II, Optional Module 2 and Phase IV

Optional Module 6). As a CRO with deep experience in pre-clinical trials and clinical trials development, they will bring objective appraisal of the scientific and technical

need, match and effectiveness of specific models to the CIRM’s innovation mission to

complement and reinforce the James Gollub Associates analytic findings (Disclosure:

Mr. Gollub was a director of a research and consulting center at SRI from 1976 to

1992).

Further, James Gollub Associates has established a working relationship with the World Pension Forum (WPF) and its members (pension funds and their money

managers) and key stakeholders (such as the California Comptroller and Treasurer) to

enable assessment of the feasibility of alternative investment mechanisms that CIRM

might consider moving forward. (Disclosure: Mr. Gollub has previously consulted to

WPF on investment economic issues).

The balance of this proposal provides the following:

1. Framework & Process: The approach to examining innovation needs and

options for CIRM and how this is carried out through a four-phase strategy process.

2. Work Plan: The rapid paced four-phase process, tasks and data sources that will be used to generate the CIRM Strategic Roadmap White Paper.


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3. Management Plan: How James Gollub Associates will work with CIRM leaders at each step to ensure alignment with expectations and needs in delivering the White Paper, including the project schedule and key meetings, collaborative sessions and presentations.

4. Budget: The proposed budget for this initiative, including estimated price for optional modules of activity.


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Framework—Innovation Roadmap and Strategy Process

CIRM was established to enable and accelerate innovation in regenerative technology.

This distinctive mission was launched and supported by California citizens at a time

when public and private R&D and financial investment were not sufficient to achieve

advancement in this field. Since its inception, CIRM expenditures on research,

development, training and facilities have accelerated progress in regenerative

technology substantially. As CIRM nears the end of its original 10-year period of

legislatively approved funding the challenge as to how to best reinforce and continue

innovation needs to be addressed.

Answering that question requires applying a framework for viewing how ongoing

innovation is progressing, what needs are shaping that progress, and what existing or

new actions can be targeted to address those needs—the CIRM Strategic Roadmap.

This framework needs to be dynamic and reflect both the evolution of the field of

regenerative medicine as well as how funders and markets perceive and respond to

that evolution. This framework is described next, followed by a brief outline of the

strategy development process James Gollub Associates will use to prepare the CIRM

Strategic Roadmap for Continued Innovation White Paper.

Framework

CIRM was established to serve as a catalytic engine and a bridge to enabling innovation in regenerative medicine, and the changes that have taken place in the

field of regenerative science and technology merit consideration of an evolving view

of CIRM role. There are naturally many stakeholders whose view of where CIRM action

should concentrate is based on their own history of past research and view of its

importance. There are those who look to CIRM to contintue to finance translational

research at a greater scale, including next stages of development, such as clinical

trials phases 1 and 2. And likely there will be calls for CIRM to make venture capital

placements at a time when stem cell enterprises may be viewed as high risk.


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All this is to be expected. A dynamic road map for CIRM innovation might, indeed, call

for a portfolio of strategic activities.

To that end, the road map for continuing CIRM innovation should be guided by a

framework that defines where CRIM’s actions fill a crucial “gap” along a continuum not adequately served by other parties. Specifically, James Gollub Associates

proposes to apply an “innovation pipeline” perspective as a means for organizing the

analysis of models for CIRM and the shaping of key recommendations. The framework

we propose offers a continuum of points where institutional intervention—bridging—

can take place to move innovation from inception to market. That is, bridges where

CIRM can and should intervene to fulfill its mission in the absence of existing

capability or readiness.

The innovation pipeline framework we propose focuses on the economic roles played

by intermediaries at each stage of movement from inception to full market presence.

These are outlined below in terms of objectives, key inputs and typical outputs (see

also Figure 1):

• Discover—Science to Innovation: Basic science through translational research

and contract R&D. o Inputs: Expenditures on science grants, targeted translational research

programs or institutes, pre-competitive industry consortia, and contract research funding for pre-clinical and clinical trials Phase 1 and 2.

o Outputs: Quantity of “innovation feedstock”, including science publications, trained graduates, particularly intellectual property and pre-commercial applications.

• Develop—Innovation to Solution: Commercialization of “innovation feedstock” for the marketplace.

o Inputs: Expenditure on innovation mining, screening, proof-of-concept, leading to enterprise formation with seed and venture capitalization.


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o Outputs: Higher volume of completed venture stage investments based on lower risk deals leveraging multiple sources of capital.

• Deploy—Solution to Market: Capture of revenue and generation of economic impacts from innovation delivery to and growth in markets.

o Inputs: Expenditure on resources enterprises need to successfully grow and compete, including workforce skills, innovation support, next stage capital, facilities/logistics and governance (regulation/taxation).

o Outputs: Rising levels of direct revenue to innovation sources and investors from innovation transactions (royalty and equity), growing employment and state tax revenue from concentration of start-ups, existing firm expansion and attraction of suppliers as well as buyers to specific clusters and facilities (technology zones or parks) within the state.

In this model, the question that can guide identification and assessment is “where is

there a gap or failure impeding the flow of innovation?” Then, based on diagnosis of

the constraints or limits on innovation flow to market, the next question is “what

intermediate bridge or bridges can overcome the constraints and permit continued

and accelerated advancement of innovation to market?”

After decades of experience in this area, our team has found that the innovation

pipeline is becoming much less compartmentalized than it was historically. This is a

good sign and sets the stage for CIRM to explore the reinforcement of its current

activities along with consideration of new models, and, perhaps an integrated model

that will permit CIRM to track and address needs that neither the existing federal

research system, foundations, corporations and investments are able to adequately

address as practices currently stand.


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Figure 3.1: Innovation Pipeline

Innovation Pipeline Goal: Generate flow of focused breakthroughs; prove their utility, capitalize and launch; capture value through direct revenue and economic impacts

Figure 3.2: Innovation Pipeline Flow


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Our team will use this innovation pipeline framework to structure and guide the

identification of potential CIRM roles that can be expanded or added. We will review

the materials previously prepared for CIRM as well as build on our own prior work.

The following illustrate the steps we will take:

• Discovery Analysis: As we examine the state of Discovery in regenerative medicine, we will determine whether there is a crucial “inflection point” in the state of this field of science where there is a crucial need and opportunity for a larger scale of translational research than is currently available, even with NIH program funding. This demand-side condition would then be used to identify and screen models for supplying appropriate forms targeted translational research support. And, as will be shown in the work plan, we have previously profiled a variety of such translational research institutes and related entities, that we will now update, expand and match to CIRM needs.

• Development Analysis: As we examine the state of Development in

regenerative medicine, we may find that there is a growing flow of early-stage enterprises seeking venture stage funding that are not able to obtain the investment capital required. On further learning why this is the case—whether due to the perceived lack of readiness in specific applications, perceived stem cell-related technology risks, or competition from mainstream biotechnology opportunities—we will then be able to screen a range of venture state funding models and their structure to determine what structure might best address the market need and lever investment resources. Again, we have previously profiled an array of early-stage technology funding mechanisms from seed stage through venture stage, which we will now update, expand and match to CIRIM needs.

• Deployment Analysis: CIRM’s mission is to advance the use of regenerative

medicine to address health care needs. To that end, we will examine deployment of regenerative innovation in the market to the degree that CIRM wishes. Should we be asked to do so by CIRM under a specific Optional Service Module (not proposed here), we are prepared to examine the downstream economic impacts of regenerative medicine industry growth and clustering. This would amplify the prior economic impact work carried out for CIRM. However, in this case the analysis would focus on the aggregation and


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concentration of enterprises and institutions associated with regenerative medicine within metropolitan regions. This would demonstrate the primary, secondary, and indirect economic impacts to the extent the proprietary data we would use permits. However, in conjunction with analysis of other models we will provide a brief overview of illustrative models showing how cluster-related support roles by CIRM could generate visibility for CIRM as well as create multi-client programs generating revenue to and managed by CIRM.

Process Summary—Four-Phase CIRM Strategic Roadmap Development

To carry out preparation of the CIRM Strategic Roadmap for Continued Innovation,

James Gollub Associates proposes to use a proven process for strategy development

with diverse public-private stakeholders focusing on exactly what CIRM is seeking to

develop. This four-phase, fast-track, process applied to CIRM and described in detail in the Work Plan that follows includes the following (see also Figure 3.3):

• Phase I. Mobilize—Ready Public-Private Roadmap Stakeholders. Under our

core task proposal we will work with CIRM management to establish an internal

advisory group that will provide feedback and guidance on the preparation of

the strategic roadmap.

Weeks 1-4: With specific meetings continuing throughout the project.

Optional Service Module 1. Build and Manage Stewards Group for CIRM:

James Gollub Associates can, as we have in many other initiatives, engage

public-private leaders external to CIRM to serve as advisors and stewards to

support the development of the CIRM innovation roadmap. This is particularly

important in the case of CIRM as we have found the collaborative process sets the stage for future acceptance of the roadmap recommendations. Under this

module, we would work closely with CIRM to define and build agreed upon

internal and external stakeholder roles in this initiative. This group wlll meet

at the close of each phase to provide objective feedback, guidance and support


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to the roadmap process. This phase is designed to set the stage for internal

decision-making as well as build external support.

• Phase II. Analyze—Diagnostic Baseline-State of Regenerative Medicine and Assessment of Models. The core objective of this phase of the project is to identify and analyze institutional models in a manner that provides greater

depth of insight than prior studies and matches models to regenerative

medicine needs and potential CIRM roles. We will achieve this by rapidly

assessing the baseline-state of regenerative medicine using available CIRM and

external reports and publications (no primary research) and from this we will

then develop search criteria, identify model institutions and organizational

approaches, analyze screened cases to build a “portfolio” of targeted models.

The outcome of this phase is a briefing on regenerative medicine development

demands and assessment of alternative action models for consideration. This

will provide core working materials for the next phase.

Weeks 1-10: Beginning at launch of project continuing into Catalyze Phase.

Optional Service Module 2. SRI International Technical Support: SRI

International’s Bioscience unit has agreed to work under subcontract to James

Gollub Associates to provide their deep expertise in all aspects of the contract

research organization (CRO) focusing on the continuum of regenerative

medicine development and specific demands for intervention/support from

pre-clinical trials throug phase 1 and 2. If agreed to, we will have SRI review

findings arising from all Phase II tasks, including the two proposed optional

modules described next.

Optional Service Module 3. Analyze Regenerative Medicine Innovation Dynamics: We strongly believe that developing a CIRM strategc roadmap for

continued innovation should be guided by an understanding of inputs and

outputs at each level of the regenerative medicine innovation pipeline. To that


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end, James Gollub Associates offers to conduct further analysis we believe will

be important to guiding the strategic road map.

We propose to carry out a systematic quantitative and qualitative analysis of

“inputs” and “outputs” at each level of the innovation pipeline (discovery,

development and deployment) that determine comparative strengths and

weaknesses of innovation assets and identifies strategic options to ensure

sustainable flow. This is the heart of what CIRM is seeking, building on prior

work CIRM has carried out internally and commissioned. Here we offer to first

conduct data-driven analysis of the state of regenerative research expenditure

patterns, IP generation directions, and enterprise development to inform the

current terrain that the Roadmap will cover.

Optional Service Module 4. Innovation Demand Factor Interviews: With or

without the analysis of the current state of innovation, we concurrently

propose to carefully conduct interviews with demand-side stakeholders in

universities, the pharmaceutical and biotechnology industry, among

institutional and private investors and key government agencies to map out the

innovation-driven demands on which the CIRM strategic roadmap show focus.

(Note: CIRM can decide whether or not James Gollub Associates can or should

disclose CIRM interests in this inquiry).

• Phase III. Catalyze—Craft Collaborative Solutions and Shape the Right Model. Having analyzed the models that will advance CIRM’s strategic roadmap for

continued innovation, the objective of this phase of work is to now

recommended the priority model or integrated, hybrid, model. Building from the analysis of models James Gollub Associates will now conduct limited

interviews with key stakeholders who would be impacted by or impact, the

CIRM model. These stakeholders would include CIRM executives and a

purposeful, but limited, sample of researchers, pharmaceutical and

biotechnology industry leaders, investors and public agencies. Based on the

input from stakeholders and James Gollub Associates analytic inferences about

the responsiveness of specific models, the outcome will be assessment of


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models and recommendation of a prioritized integrated solution to CIRM

strategic roadmap needs.

Weeks 4-12: Logistics for setting up interviews start as soon as possible.

Optional Service Module 5. Three-Collaborative Strategy Work Sessions: Our

team has repeatedly found that crafting an innovative, feasible and acceptable model is often best achieved by bringing on diverse stakeholders to help shape

its form early on and from their commiting to support planning and

development. To that end, James Gollub Associates offers to bring together a

carefully crafted working group of respected stakeholders to collaboratively

review the challenges facing regenerative medicine, consider alternative

models (prepared in the previous phase) and CIRM opportunities, and then

prioritize an existing or hybrid model for further development. Participants

would include stakeholders in: regenerative research, the pharmaceutical and

biotech industry, federal agencies (NIH/FDA) and California agencies and

legislature. Through this collaborative working group process the models will

be screened and matched to crucial innovation roadmap needs and CIRM

operational structure.

Optional Service Module 6. SRI Bioscience Unit Input to Recommended Model: SRI will have made earlier inputs to the James Gollub Associates

analysis of models. At this point, if agreed to by CIRM, they will now provide

input on the recommendations arising from this phase, including the

collaborative work sessions, if convened. SRI will provide its knowledge of

moving biomedical innovations through phases of development to market and

provide comments on the technical strengths and weaknesses of the

recommended models. This is considered to be valuable due diligence on the

CIRM Strategic Roadmap.

• Phase IV. Realize—Define Operational Elements and Ready Implementation Partnerships. When CIRM strategic roadmap models have been analyzed and


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recommended, the key next step is to define the operational parameters for

enabling model implementation. To that end, James Gollub Associates will

prepare an operations plan for the recommended initiative for CIRM leaders

and make recommendations on how to build commitment to implementation.

Our team will work from project start to engage leaders (and stakeholders,

where agreed upon) in supporting future CIRM directions, within the limits of budget, schedule and CIRM wishes. In this process we will present key elements

to CIRM leaders at each phase as well as support CIRM to engage key

institutional and market stakeholders in expressions of interest. The outcome is

a clear operating plan defining mission, structure, and operations to guide

implementation of the new initiative.

Weeks 12-16: Consistent with task flow, unless schedule is modified by CIRM.

Optional Module 7. Briefings and Feedback Sessions with Selected Stakeholders: To the extent that CIRM was open to using the collaborative

planning process to help define the model and is now open and prepared to

introduce the recommended model and its operating features to stakeholders,

James Gollub Associates believes that a follow-up work session to brief and

secure feedback from key stakeholders and potential partners in the model will

be valuable. Our team would organize and facilitate this work session and

summarize the confirmations, differences and commitments to moving ahead.

This core process is carried out with close participation of the CIRM client at every

phase or step and is designed to bring together the demand and supply-side of the

marketplace early on to reach solutions that optimize how existing resources are used

and to harness new resources to achieve shared objectives. Please note that, as mentioned later, that James Gollub Associates believes that the tasks at hand,

particularly if including any of the optional modules, might best be implemented over

a six-month period, rather than four months.


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Figure 3.3

Phase I Mobilize:CIRM Dynamics

Phase IIAnalyze:Baseline & Models

Phase IIICatalyze:Model Recs

Phase IVRealize:Model Operations

ProposedTasks

Internal CIRM Coordination:• Weekly Meetings• CIRM Briefings at

Each Phase• Leadership

Sessions

1. Stewards Group Formed & Used To Guide Strategic Roadmap Process

OptionalModules

• Baseline Synthesis of CIRM Data to Define Demand.

• Search, Screen & Analysis of Models

• Deliver Model Analysis

2. SRI International Subcontract to Provide Tech Advice

Model Demand/Supply Analysis:3. Innovation

Indicators Data:4. Interviews w/

Stakeholders

• Interviews with Stakeholders to Prioritize Model Match to CIRM

• Deliver Priority Recommendations

5. Collaborative Model-Focused Work Sessions with 35-65 Stakeholders/ Participants to:

• Define Challenges• Prioritize Actions• Confirm Operational

Features & Interest/Readiness to Partner

• Identify & Profile Operational Components of Integrated Model

• Deliver Model Operations

6. Briefing & Feedback Sessions with Stakeholders& Partners

7. SRI International Provides Tech Advice on Model Operations

Summary of Proposed CIRM Strategic Road Map Work Plan & Option Modules


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CIRM Strategic Roadmap Detailed Work Plan James Gollub Associates will carry out the following four-phase work plan over a four-month (16 week) period, unless this time frame is modified in agreement with CIRM. Each of the phases is described in detail below in terms of the phase objectives, tasks objectives, task activities and data sources, and concludes with the Phase deliverable and timing. Optional Modules of work are described following each Phase (in blue).

Phase I: Mobilize—Ready Public-Private Stakeholders

Phase Objectives: Establish an internal CIRM group to help guide the Strategic

Roadmap process comprising CIRM executives and selected advisors (if time permits

and agreed upon by CIRM). This group will help track, engage external leaders where

needed, and review the preparation of the White Paper this initiative moves ahead.

Phase I Timing: Week 1 through 4, with ongoing meetings throughout the project.

Phase I Tasks

1. Hold Launch Meeting: Plan and convene project start with CIRM management.

2. Strategy Process Briefings: As may be agreed to, plan and convene internal briefings with CIRM-designated leaders and advisors (expanded steward meetings

are outlined in Optional Service Module 1).

3. Strategy Schedule: Review and confirm the project schedule moving forward,

including weekly meetings and phase-by-phase meetings and major CIRM briefings.

Phase I Deliverable: Internal Project Management Plan and Advisory Roles

Our team will prepare an agreed-upon project schedule and management plan,

including the Stewardship group structure, if agreed upon. As indicated above, our

team will hold preliminary rounds of preparatory meetings to ensure direction and

roles match CIRM needs and expectations.

Optional Service Module 1. Build and Manage Stewards Group: If such a group is not


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already in place, and if agreed to, James Gollub Associates will work with CIRM to

organize an advisory and support group of external public-private leaders whose

interest in regenerative medicine and CIRM is strong and who can be drawn from to

provide objective support to guide and assist strategic roadmap process—particularly

with regards to recruit other participants. This group may be eight to fifteen

individuals from research, pharmaceutical/biotech industry, investment finance, and government agencies and legislature. Stewards would meet at the beginning and end

of each phase of the project (five to six 2-hour meetings over four months).

Phase II: Analyze—Diagnostic Baseline of State of Regenerative Medicine and Assessment of Models

Phase II Objectives: Define the status of regenerative medicine development

applying the innovation pipeline framework (baseline), then identify factors

constraining or enabling advancement of regenerative medicine to market readiness

(demand), and use this information to identify and examine the current range of

models applicable to those needs, assessing the structure and operational match of

models to needs (supply) to inform CIRM options and recommendations.

Phase II Timing: Weeks 1-10

Phase II Tasks

1. Review Status of Regenerative Medicine Landscape: Use existing CIRM reports and external research reports and publications to build a practical profile of discovery, development and deployment status of regenerative medicine and implications of demands for intervention by CIRM. In this analysis we will briefly profile elements such as the following to guide research into models:

• Resource concentration: Where regenerative medicine research funding and activities are concentrated and where resources come from.

• Key institutional recipients and resources: Which organizations lead regenerative discovery, development and deployment.

• Active companies: What existing or new firms are active in regenerative


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medicine R&D and their areas of focus.

Task II.1 Timing: Weeks 1-8

2. Innovation Supply—Identify and Analyze Models and Partners for CIRM Objective: Identify, profile, screen and prepare analytic cases on models of “bridging” solutions to address emerging Strategic Roadmap goals, needs and opportunities, for advancing regenerative innovation that align with CIRM needs and readiness. Note: This will build on existing and new content. a. Select Case Samples: The James Gollub Associates team will build a portfolio

of screened models to analyze building from the baseline information assembled and pre-existing in-house information: • Existing Models: Our team will start from the models used in the recent

analysis for CIRM and add candidates from the 40 case example models of discovery, development and deployment entities we have previously identified (see Appendix A).

• Screen: We will prepare and apply criteria to screen these models as a first level match to CIRM needs or demands based on model inputs and outputs relative to key needs and roadmap options (see Figure __ with range of models, not including Deployment focused cluster development).

• Supplement: We will supplement this first round of candidates with models based on a carefully orchestrated search.

b. Classify Range of Models: As previously discussed with CRIM, the range of model cases we identify and screen will include but not be restricted to: • Discovery--Translational research institutes that are or are affiliated with

an endowed operating foundations as well as a mix-funding contract research organization (CRO), like an SRI or part of SRI dedicated to stem cell pre-clinical trials and Phase 1 and 2 pre-commercial activity.

• Development--Commercialization entities that are capitalized to mine IP, fund proof of concept, screen and either sell packages of IP or start-risk reduced companies from which exits occur via early acquisitions by pharmaceutical or biotech firms, as well as, specialized venture funds or fund of funds capitalized by private and institutional investor LPs, focusing on venture stage stem cells companies.

• Deployment—Cases where the formation of cluster groups and alliances anchored by an intermediary, such as CIRM, has been used to launch pre-competitive R&D projects and consortia to developed shared breakthroughs


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that would accelerate commercialization of biomed/stem cell enterprise among existing and newly formed firms, also fostering economic aggregation and economic multipliers at the local level.

Figure 3.4

Range of Model Options for CIRM Consideration*

Foundation OperatingFoundation

EndowedInstitute

Endowedor Free-Standing CRO

DevelopmentCorporation(integrated Incubator)w/Seed Fund

SpecializedVenture Fund(LP leveraging Institutional capital)

Fund of Funds

Grants toTargets

Structured TR Programs & Grants to Others

Structured TR Leveraged Research Programs &Consortia

Contract R&D for Public & Private Sector, & Start-ups

IP screen, Proof-of-Concept, Seed Funding &Management to Exit

LimitedPartnershipFocused onPortfolio in Targeted TechnologyField

DistributedPortfolio ofTargeted InvestmentsLeveragingCapital & Management

Inputs

OutputsDistributedIP

IP FeedstockFor Application

IP Feedstockfor Application,License Royalty,IP Sales

Contract Revenue, IP RoyaltyEquity in Spin-offs

Equity in Spin-offs& Early Exitvia Acquisition

ConcentratedVentureStage ExitsAcquisitionor IPO

DistributedVentureStage ExitsAcquisitionor IPO* Excluding cluster development

c. Define Assessment Variables: The analysis of cases will be informed and

guided by the demand-side needs—that is the “match” to functional needs we will have identified. This is intended to enable deriving more specific and deeper analytic insights. Examples of variables to be analyzed will include:

• Innovation Mission/Focus: Stage of innovation addressed, from Discovery

(basic, applied and translational research) to Development (commercialization and venture investment) to Deployment (cluster value-chain growth and microeconomic concentration). The first two categories will be the priority focus.

• Structure: Organizational schematic and legal charter of model entity, whether a public agency, non-profit, operating or conventional endowed


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foundation, contract research organization, development corporation, or a seed or venture investment fund.

• Operations & Management: How each element of the model entity functions, whether through direct grant or matching grants, contract R&D, IP management (formation, mining, packaging, licensing, sale), and financing (seed or venture stage placement); how it manages relationships with researches or enterprise, including management of intellectual property ownership and equity participation.

• Scale and Impacts: How has the operation of the model impacted the field of innovation? The impact variables reviewed will match the model.

• Match to CIRM-related Demand: How the specific structure and operations can serve the mission and demands facing CIRM and generate direct and indirect financial support for evergreen (continuous) operations.

d. Complete Analysis of Models: Our team will complete preparation of a carefully selected array of models that have been identified, screened and assessed against Innovation Roadmap objectives and conditions. The outline for this report will be discussed and agreed upon with CIRM to optimize utility.

Task II.2 Timing: Weeks 4-10 (Model cases will be identified & screened early) Phase II Deliverable—CIRM Strategic Roadmap for Continued Innovation: Analysis of Strategic Needs and Assessment of Models The outcome of this phase of work will be a report integrating the elements of this phase and will prepare Strategic Roadmap working materials. These will include: (1) assessment of regenerative medicine innovation needs/trends, (2) analytic assessment of screened innovation models. These materials will be drawn from in the next phase of the CIRM Strategic Roadmap process. Our team will prepare, present and discuss deliverable results with CIRM leadership and executive team.

Phase II Optional Service Modules

Optional Service Module 2. SRI International Technical Support

Objective: Provide enhanced technical appraisal of demand for models and technical functions that models should or could serve. As noted earlier, SRI International’s Bioscience unit has agreed to work under subcontract to James Gollub Associates to provide their relevant expertise in all aspects of the contract research organization (CRO) focusing on the continuum of


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regenerative medicine development from pre-clinical trials through phase 1 and 2. In this phase of the proposed strategic roadmap preparation professionals from the SRI team will provide input on key “demand-side” questions at a high level of resolution as well as provide constructive analytic insights into the range of models that James Gollub Associates will have identified.

Optional Service Module 3. Innovation Indicator Analysis—Regenerative Medicine Dynamics

Objective: Conduct a data-driven analysis of the status of regenerative medical technology today to inform and guide subsequent steps, maximizing synthesis of existing CIRM data, but doing new analysis where essential and agreed upon. a. Discovery: As needed, supplement core data with the following:

• Research Expenditures: Analyze NSF HERD data on individual university research expenditures by project theme, focusing on regenerative medicine to determine trends and patterns.

• Science Publications: Analyze Thomson Reuters Web of Science data to map science citation patterns by quantity, citation frequency, and geography.

• Intellectual Property: Analyze Thomson Reuters Innovation Professional data on intellectual property generation trends and distribution by regenerative medicine themes.

b. Development: As needed supplement core data with the following:

• Start-ups: Analyze CIRM as well as AUTM data on university start-ups or spin-offs in biomedicine and then follow-up to determine patterns of regenerative medicine.

• Incubation: Analyze reports from NBIA on biomedical incubation, seeking inputs on regenerative medicine cases.

• Ventures: Use Dow Jones VentureSource and other related data to map out placements in regenerative medicine.

c. Deployment: As needed supplement core data with the following:

• Corporate Value Chain: Use BIO, BayBio and LARTA association data to track biomedical companies, screen to determine activity in regenerative medicine, determine location, and stage of deployment.

• Clustering: Use D&B Nets data and/or Dow Jones VentureSource or Thomson Reuters Strategy & Competitive Intelligence data — depending on which offers the most relevant information for CIRM — to develop a “map” to track specific location patterns and dynamics of biomedical companies focused on regenerative medicine (as feasible).


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Optional Service Module 4. Deliverable—Regenerative Medicine Innovation Status: This task will produce a detailed briefing presentation synthesizing present data on the status of regenerative medicine and patterns of innovation today. The presentation will establish basic contentions about the strengths and weaknesses of the current flow of innovation through key stages to market and use these to guide next steps in the Roadmap process.

Optional Service Model 4. Innovation Demand Factor Analysis—Identify Needs Among Beneficiaries of CIRM Support

Objective: Address the question of which models should CIRM to consider by starting with a limited appraisal of demand—what is really needed to bridge market gaps. This will be carried out on a limited basis through interviews with 15-20 key sources of need and downstream beneficiaries. These would include:

a. Research: University deans and faculty involved with translational research

funded by CIRM. This will be based on a list of candidates provided by CIRM. b. Industry: Pharmaceutical and biotech industry executives concerned with

encouraging (or discouraging) regenerative medicine R&D. These will be identified through discussions with CIRM and through James Gollub Associates contacts with pharmaceutical and biotechnology industry.

c. Investors: Institutional investors, their money managers, corporate venture funds and general managers of major venture funds. These interviewees will be identified through discussions with CIRM and with our team’s connections to the investment community, including venture capital, corporate and institutional investors.

d. Government: Federal (NIH, NSF), state government (agencies and legislature). These interviews will be based on priorities agreed upon with CIRM management.

Optional Service Module 4. Deliverable: Input to white paper or free standing document on external factors creating demand for CIRM-type interventions and innovation bridges to enable strategic road map and enable advancement of regenerative medicine innovation.


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Phase III: Catalyze—Prioritize Recommended Models for CIRIM

Phase III Objectives: Build candidate roadmap directions from prior analysis,

determine which models best match roadmap directions for continued innovation,

assess these models with selected reviewers across key stakeholder groups, and

generate a clear recommendation or recommedations based on integrated synthesis of

findings.

Phase III Timing: Week 4 to 12

Task III.1. Prepare CIRM Roadmap Elements

Objective: Build candidate roadmap directions from prior analysis.

a. Extract priority discovery, development and possible deployment directions in regenerative medicine for CIRM from on prior analysis of trends and models.

b. Combine priority directions into range of directions for use in assessing models.

Task III. 2 Assess Models Against Roadmap Using Criteria

Objective: Determine which models best match roadmap directions

a. Establish ranking criteria for use in classifying model strengthe of match to CIRM strategic roadmap options and priority directions.

b. Apply criteria to the range of models to ascertain match and implications for concurent or exclusive utilization.

c. Summarize matches and trade-offs with individual models and across models.

Task III.3 Review Roadmap Models with Selected Stakeholder Reviewers

Objective: Present and review screened/ranked models to selected stakeholder reviewers (five to ten leaders selected with CIRM) to further screen and weigh perspectives, to add external views of the strategic roadmap and the means for its implementation.

a. Prepare briefing for reviewers.

b. Conduct Individual reviewer meetings or one group discussion (if agreed to).

c. Summarize key points from review of strategic roadmap and model options.


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Task III.4. Prepare Strategic Roadmap Model Recommendations for CIRM Objective: Review, assess and integrate findings of Phase I, II and III into a draft report describing a recommended model to support CIRM’s Strategic Roadmap for Continued Innovation.

a. Outline: Our team will prepare a report outline that synthesizes and incorporates the content from Phases I, II and III into a draft CIRM Strategic Roadmap. This draft will focus on presenting the business case for a specific new integrated or hybrid model to fulfill key mission to sustain and continue innovation in regenerative medicine.

b. Draft: We will complete a draft report following the outline. c. Submit: This draft report will be submitted as the key Phase III deliverable for

CIRM. d. Present & Discuss: Our team will be prepared to present the findings in a

PowerPoint briefing and discussion with CIRM leaders and executive team. Task III.3 Timing: Weeks 11-12 (beginning during work session period; concluding within two weeks after) Phase III Deliverable—Draft CIRM Strategic Roadmap for Continued Innovation: Recommended Model(s)

As described above, we will prepare an integrated deliverable that analyzes the range

of priority models, distills or combines model elements into recommended structure

for CIRM packaged as the draft CIRM Strategic Roadmap for Continued Innovation. This

deliverable will next be followed by the Phase IV deliverable focusing on the

operating plan for the recommended model and its implementation.

Phase III Optional Service Module

Optional Service Module 5. Collaborative Strategy Process to Shape Model

Objective: Bring together demand and supply-side stakeholders (“convene the

marketplace”) to review challenges facing advancement of regenerative medicine

innovation from demand and supply vantage points, review selected models prepared


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for stakeholders, and to facilitate prioritizing model elements and optimizing the

selection and structure of the model. We have found this an extremely effective,

structured process, for concurrently examining demand and supply issues and focusing

stakeholders on collaborative outcomes from research to investment.

1. Plan Stakeholders Work Sessions: James Gollub Associates team members will prepare and manage detailed work plan for a collaborative process that will engage demand and supply-side stakeholders to constructively assist in shaping both the CIRM Strategic Roadmap. Three rounds of collaborative work sessions are proposed each with from 35 to 85 executive participants. Each work session will consist of a dynamic two hours of brief introductions, stage-setting presentation, and, intensive facilitated roundtable discussion focusing on a specific issues and outcomes. James Gollub Associates will work with CIRM to identify participants to invite. Candidates from across California and more broadly can include:

• Scientists: University faculty funded by CIRM. • Industry: Pharmaceutical and biotechnology executives concerned with

regenerative medicine and related or interdependent fields. • Investors: Seed and venture funds as well as corporate and institutional

investors and their money managers either active or interested in this area of opportunity.

• Foundations: Major foundation research institutions, sponsors and donors concerned with advancement of medical innovation.

• Government: State of California representatives (as appropriate), federal agency (NIH and FDA) concerned with emergence and approval of regenerative medicine.

2. Convene Marketplace—Three Strategic Roadmap Sessions: James Gollub

Associates will manage and facilitate three rounds of work sessions to define agreed upon priority challenges facing regenerative medicine, specify action priorities for consideration, define operating features of new directions (e.g., integrated model), and elicit commitments to support next steps.

• Session 1: Define Challenges Facing Regenerative Medicine Innovation—This

first session will present baseline analysis and facilitate articulation of challenges as perceived by both demand and supply-side stakeholders.

• Session 2: Specify Priority Directions and Model Attributes—This second

session will examine potential solutions and structures that could be implemented by CIRM alone or with partners to accelerate continued innovation in regenerative medicine focusing on the challenges identified in


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Session 1 and the models analyzed and presented by the consultants.

• Session 3: Define Model Operating Options and Potential Partners—During this third and final round stakeholder participants will now review a set of proposed operational plans prepared by the consultants and further develop insights into the requirements for structure and implementation of the integrated or hybrid model elements they have helped define. Participants will be asked to break out into pre-assigned subgroups based on specific model elements to collaboratively generate their inputs and report back and then prioritize operational features. As a concluding step, the consultants will ask those in the room to show hands as to their interest and readiness to help advance the future steps in advancing the CIRM Strategic Roadmap and the further development of the model to which they have already contributed so much. The show of hands will be a signal to thank everyone and promise follow-up, and in doing so end the session.

Optional Service Module Deliverable—Collaborative CIRM Strategic Roadmap and Model Recommendations. Building on the work carried out to this point, a briefing will be prepared that highlights the innovation roadmap challenges for regenerative medicine, specification and confirmation of priority models, and key operational structural features of the recommended model. Phase IV: Realize—Provide Operating Structure of Recommended Model for CIRM Strategic Roadmap for Continued Innovation

Phase IV Objectives: Provide a practical operational plan for use in the development

and implementation of the recommended model for CIRM’s Strategic Roadmap for

Continued Innovation.

Phase IV Timing: Weeks 12 to 16

Phase IV Tasks

1. Outline Operational Factors for Recommended Model: The consulting team will outline for CIRM the proposed operating factors for the recommended model or models. This will be guided by:


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a. Phase I inputs: CIRM leadership and advisory group priorities, always reflecting CIRM’s publicly charter status.

b. Phase II: Stakeholder-driven needs and assessed matching models. c. Phase III: Collaborative insights and recommended model or models for

CIRM to sustain innovation in regenerative medicine

Task IV.1 Timing: Week 12 2. Prepare Operating Elements for Model: Our consulting team will then define the

operational building blocks or elements required to enable implementation. As noted above, this set of operating elements will be reviewed and confirmed with CIRM before being completed. The following are only illustrative dimensions that are expected to be prepared for CIRM:

a. Mission: Purpose of new model or models pertaining to advancing innovation in regenerative medicine, informed by analysis and collaborative process.

b. Structure: Organizational composition and legal features of the recommended model or models derived from assessment of models that match CIRM roadmap goals along the innovation pipeline in advancing regenerative medicine. Note that this structure may be an integrated structure or hybrid of elements agreed upon in the Strategic Roadmap process. That is to say, there may possibly be individual or integrated components across innovation needs along these illustrative lines or for that matter, entirely different directions:

i. Discovery: A combined institutional-operating foundation-CRO model to accelerate flow of science to innovation at the clinical trials level with the institute structuring specific cross-institution initiatives via a new CIRM-linked center and participating in downstream commercialization outcomes.

ii. Development: A development corporation linked to a specialized limited partnership venture model to enable growth of venture transactions in regenerative medicine and returns for CIRM (over time).

iii. Deployment: Coordination or support for enhancing competitive advantages for existing regenerative medicine enterprises as an emerging cluster and enhance valuation and growth of CIRM associated enterprises.

c. Funding & Revenue Model: Based on the structure of the model or models, types of funding requirements and revenue sources will be defined, including identification of specific candidates. These may range from:

i. Endowment: For specific institutional functions focused on translational research that would leverage external funds.

ii. Revenue: Grants, contract R&D, and syndicated research consortia,


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as well as possible new IP ownership royalty streams (if permitted in the future for CIRM).

iii. Equity Transactions: Financial participation by CIRM either directly in regenerative medicine start-ups via an early stage seed fund or through a limited partnership (LP) in a venture capital fund, with associated rates of return (which will depend on each structure and market conditions).

d. Program Initiatives: Specification of initial activities pertaining to continued innovation in regenerative medicine that will be introduced and launched over a given time period. These will be drawn from the CIRIM Strategic Roadmap as proposed activities for the recommended model or models. Hypothetical programmatic directions for models could possibly include:

i. Discovery—CIRM Translational Research Institute: 1. TR Centers: Funding of research targeting a specific problem

in regenerative medicine managed by CIRM across institutions. 2. CRO: Funding of pre and clinical trials phase 1 and 2 programs,

through a CIRM formed or managed CRO or CRO network, leveraging CRIM endowment and specialized grants, to attract contract funding from with individual firms or syndicated consortia.

ii. Development—CIRM Development Corporation and LP Venture Participation

1. Development Corporation: Management and screening of early and market ready regenerative medicine deals to enhance venture capital flow, acceptance and success.

2. Regenerative Medicine LP: Participation as a limited partner (LP) in a full-scale, market-driven, regenerative medicine-focused venture capital fund capitalized by CIRM in conjunction with major institutional and/or corporate investors overseen by managing partners.

iii. Deployment—CIRM Cluster Initiatives for California 1. Coordinating Regional Regenerative Medicine Clusters: Low-

cost initiative, off-set by membership fees, focusing on building the continuum of development and growth advantages for enterprises and supporting institutions in regenerative medicine innovation.

2. Targeted Program Interventions: Use of endowment to leverage critical solutions facing regenerative medicine industry growth, including workforce training (leveraging state of California funds), innovation challenges (linking to CIRM institute and its CRO), access to capital for later stage growth (linking to venture fund), and regulatory navigation (CIRM


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continues to advocate on state and federal regulatory matters for the emerging industry).

e. Partners: A key aspect of operationalizing the recommended CIRM models for continued innovation will be identifying and growing partnerships ready to support, collaborate, fund or invest in the regenerative medicine roadmap. Through out the project the consulting team will identify these prospective partners, engage them in the strategy process and prepare them, as feasible, to serve as advocates, supporters and direct partners for the next generation of CIRM. These partners will include those of long standing with CIRM, as well as potential new stakeholders and allies:

i. Research: Universities recognizing that affiliation with CIRM and its mission and planned translational research and development will benefit their institutions, faculty and future enterprises.

ii. Investors: Major institutional investors (including state pension funds), corporate venture funds as well as existing venture funds will be interested in aligning themselves with potential new directions in biomedicine that might increase deal flow and minimize risk.

iii. Agencies: The public mission of CIRM and its potential triple bottom-line returns to the state and nation should encourage a range of agencies to consider how CIRM represents an ongoing “bridge” to generate and capture value. The triple bottom-lines include: solution of citizen health problems, revenue enabling greater sustainability of CIRM, and economic impacts from CIRM expenditures within the state and key hubs.

iv. Corporations: The pharmaceutical and biotechnology industry should find CIRM’s role as providing a flow of new innovations for the marketplace at reduced front-end costs. While they may also see regenerative medicine as an eventually “disruptive” field to conventional health interventions (e.g., drugs), they should seek to at least track and participate in the wave of innovation that CIRM is enabling.

f. Implementation Process: A crucial consideration for CIRM will be how to implement the recommended model or models that CRIM approves. As a last element of this project the consulting team will outline a developmental pathway for advancing the formation, launch and operation of the new model or models. The implementation process specifications will lay out expected requirements for internal team building, such as that might be, external partnering (as alluded to above) and the progression of business planning and external contracting that will be needed to move forward.

Task IV.2 Timing: Weeks 12-14 3. Review with Stakeholders: Once the operational plan is drafted, the James


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Gollub Associates team will introduce and review the draft plan with CIRM and, with CIRM’s permission with a selected advisory group of stakeholders (or the stewards, if in place as well as ‘volunteers’ from the collaborative work sessions, if that option is utilized). Task IV.3 Timing: Week 15

4. Review with Potential Partners: Within the time limits of this effort, the

consulting team will take the operating plan briefing and explore potential roles and requirements from prospective public and/or private partners, whether financial (direct donors, funders, investors) or institutional (existing institute or CRO). Task IV.3 Timing: Weeks 15-16

5. Finalize Operating Plan: Having completed the preceding steps our team will integrate reviewed operational components into full operating plan draft for the new model or models. Task IV.4 Timing: Weeks 15-16

Phase IV Deliverable—CIRM Strategic Roadmap for Continued Innovation—Part II Model Operating Plan

Complete an operating plan for the recommended model or models for achieving CIRM

roadmap objectives for regenerative medicine. This document will integrate key

factors from both beneficiaries and partners needed to enable scale-up and launch of new model. Our team will review the outline and draft report with CIRM executives

during preparation. We will then prepare a summary of the operating plan, present

and discuss this with CIRM leaders and governing board. The follow-up on review with

CIRM leaders and board will conclude this assignment.

Phase IV. Optional Service Modules Optional Service Module 6. SRI Bioscience Unit Technical Input on Recommended Model Operations: SRI will have made earlier inputs to the James Gollub Associates analysis of models. At this point, if agreed to by CIRM, they will now provide input on


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the recommended operations arising from the previous phases of work, including the collaborative work sessions, if convened. SRI will provide its knowledge of moving biomedical innovations through phases of development to market and provide comments on the technical strengths and weaknesses of the recommended models and its operational requirements as they pertain to regenerative medicine. This is considered to be valuable due diligence on the CIRM Strategic Roadmap.

Optional Service Module 7. Briefing and Feedback Sessions with Selected Stakeholders: James Gollub Associates proposes that CIRM permit and support holding work sessions with selected stakeholders who may be impacted by or who may impact the operations of the model recommended to implement the CIRM roadmap for continued innovation. This work session, ideally, will build from contacts generated during the strategic roadmap process as that may help build support for the directions proposed. The size of this group may range from 15 to 35, with representation consistent with the user and partner perspective described earlier. The outcome of this follow-up session will to two-fold: To ensure the range of structures are well defined and crafted and to sustain engagement of stakeholders, particularly those that might become key partners as implementation moves forward—whether from the pharmaceutical and biotechnology industry or from the investment community (e.g., institutional investors or money managers).


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Project Management and Schedule

This section describes how James Gollub Associates will manage the project while

working closely with CIRM leadership executives on ensuring that the analysis,

recommendations and operating plan align with expectations.

Management Structure

The proposed CIRM Strategic Roadmap for Continued Innovation project will be

managed by James Gollub Associates LLC as follows:

Core Team

These four professionals will be responsible for managing all phases of work: • James Gollub: Will serve as project director and day-to-day manager of work

program execution, including direct work with CIRM leaders, facilitation of collaborative work sessions, and generating key deliverables, building on his decades of experience managing a wide range of public-private initiatives on innovation strategy—including the recent strategy and business plan for the MCA - Biomedical Institute of the Americas (BMIA).

• Steve Marshall: An expert in business use of innovation, including the pharmaceutical industry, will be responsible for industry, university, government focused demand-side analysis that will drive the strategic roadmap and will lead the analysis and operational structure of priority investment models.

• Amy Rassen: An expert in foundation development and institutional operations,

including biomedical research foundations, as well as public-private interface, will serve as project leader of institutional supply-side model assessment, particularly foundations and institute models, match to roadmap needs and operational requirements.


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• Annika Barnes: A professional in the innovation-driven economics field, will support day-to-day project operations, particularly lead the data-driven analysis of the current state of regenerative medicine, manage integrated development and analysis of the portfolio of innovation models, development of their operations, building on recent similar work. She will coordinate the collaborative working group process, as may be agreed upon with CIRM.

James Gollub Associates Advisory Team These three colleagues will be available as required on core tasks. They bring specific expertise on investment models, institutional finance and commercialization. • Chris Miller: A professional CFO and multiple venture fund developer, including in

biomedicine, will serve as the team expert in reviewing models for innovation investment identified as candidates for CIRM.

• Paul Kallmes: A professional developer of innovation-driven IP portfolios and their

management to commercialization across multiple industries will serve as the team expert on how each model can best enable harness intellectual property to achieve solutions, returns to CIRM and economic impacts in California.

• Max Morgunov: A licensed professional in the securities field with prior experience

in screening public and private innovation investment models in biomedicine will lead the screening and appraisal of these models.

SRI International Team If one or more of the proposed Optional Service Modules are agreed upon, SRI will provide technical input across key phases under subcontract to James Gollub Associates (see earlier Qualifications of Staff for details as well as the Proposed Detailed Work Plan):

• Joseph Rogers, Ph.D., Executive Director of a new Health Sciences Section

expertise in integrated bench-to-bedside capabilities in areas such as addiction,


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alcoholism, Alzheimer's and Parkinson's diseases, Down syndrome, sleep disorders, and more.

• Nathan Collins, Ph.D. is the Executive Director of Drug Discovery in the Biosciences Division at SRI International and is responsible for research and development focused on basic and translational research into disease mechanism and drug discovery with over ten years of executive management of drug discovery from basic research through to clinical candidates.

• Jon C. Mirsalis, Ph.D. is Managing Director of the Biosciences Division and Executive Director of Preclinical Development at SRI International and has extensive experience in the development of drugs for a broad range of indications including infectious disease, cancer and CNS and has personally been involved in the development of over 50 therapeutics that have entered clinical trials and several have reached the market.

• David Sahner, M.D., Senior Director of Clinical Translation, leads SRI’s Phase 1 Clinical Trials Unit organization with an experience base that includes: (1) provision of clinical expertise and scientific support to Discovery, Research, and Preclinical functional lines (2) formulation of strategy, (3) tactical activities, (4) execution at all phases of drug development, and (5) line management.

• Toufan Parman, Ph.D., D.A.B.T., is the Director of General Toxicology in SRI International’s Biosciences Division with over 10 years of experience in managing and conducting toxicology and PK studies on a wide variety of pharmaceutical products, chemotherapeutic agents, vaccines, monoclonal antibodies, proteins, and cell-based therapies, including the design of preclinical development plans for stem cell projects.

• Lucia Beviglia, Ph.D., recently joined SRI as the Director of Cancer Pharmacology in the Center for Cancer and Metabolism with over 20 years of experience in academia and pharmaceutical industry and gained strong background and expertise in cancer biology, hematology, immunology, and pharmacology.

Coordination & Collaboration with CIRM Executives

James Gollub Associates understands the importance of close communication and

collaboration with CIRM. To that end, we are committed to the following:


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• Weekly team meetings: Our project director, who has previously met with CIRM leadership, and appropriate team colleagues, will meet with CRIM’s executive team from the start through the completion of this initiative. During our meetings we will review project tasks to ensure alignment with expectations, to share outlines of draft deliverables and findings, and ensure that the content and its presentation is acceptable to CIRM leaders and, ultimately, its governing board.

• Inclusion in strategy process: We will provide the opportunity for CIRM leaders and executive team to participate in any collaborative work sessions proposed under optional modules carried out with industry, institutional, investor and government stakeholders that will be planned and facilitated, unless CIRM wishes to remain outside of that process.

• Phase briefings: Our team will prepare briefings on each phase’s outcomes for

presentation and review with CIRM leaders review at the close of each phase.

• Communications: James Gollub Associates has on its team Academy and Emmy Award winning communications experts. If CIRM requests, James Gollub Associates is prepared to provide recommendations and proposals pertaining for building visibility and sustained interest in the strategic roadmap that CIRM is pursuing. This can include options for expanding the network of participants who will have participated in the strategy process to communications opportunities for reaching the broader public and building support for CIRM and its strategic roadmap for continued innovation.

Project Schedule

James Gollub Associates proposes to carry out its work for the CIRM Strategic

Roadmap for Continued Innovation over four-months. The feasibility of this schedule

will be dependent, to some degree, on seasonal factors, and the availability of those

being studied and asked to participate in work sessions. While we recommend a six-month time frame, our commitment is to deliver expected output in a timely manner.

The flow of phase tasks will overlap, as is natural in this form of strategy

development.


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The expected time frame by phase and task is as follows, with time impact of

optional modules noted (but note that all tasks, including optional modules could be

most readily completed within a six month time frame, if that were possible):

• Phase I. Mobilize—Internal Preparation/Building Advisory Group: Weeks 1-4

o Deliverable: Internal plan for project meetings, formation of

steward/advisory group (if agreed to), and coordination of roadmap steps leading to final White Paper.

o CIRM Meetings: Intensive front end meetings, followed by weekly planning and management sessions with CIRM.

o Optional Module 1: Build and Manage Stewards Group: No time change.

• Phase II. Analyze—Diagnostic Baseline of State of Regenerative Medicine and Assessment of Models: Weeks 1-10

o Deliverable: CIRM Strategic Roadmap for Continued Innovation: Needs and Analysis of Models

o CIRM Meetings: Weekly briefings on analytic tasks (as noted above), leading to the Phase II briefing/presentation/discussion with CIRM leadership on innovation demand and the findings of the in-depth analysis of models, close of Week 8.

Phase II.1—Review Status of Regenerative Medicine: Week 1-8

(overlapping with concurrent tasks) Phase II.2—Innovation Supply—Identify and Analyze Models and

Partners for CIRM: Week 4-10

o Option 2. SRI International Technical Support: Ongoing during phase o Optional Module 3.Innovation Indicator Analysis—Regenerative Medicine

Dynamics: Needs 4-8 weeks o Option Module 4. Innovation Demand Factor Analysis—Identify Needs

Among Beneficiaries of CIRM Support: Needs 8 weeks


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• Phase III. Catalyze—Collaborative Strategy Process (Model Recommendations): Weeks 4-12

o Deliverable: CIRM Strategic Roadmap for Continued Innovation: Recommended Model

o CIRM Meetings: Weekly briefings (as noted above), CIRM participation in the three collaborative work sessions (as deemed appropriate), and Phase III briefing/presentation/discussion with CIRM leadership on the roadmap findings and recommended model or model.

Task III.1—Prepare CIRM Roadmap Elements: Weeks 4-10 Task III.2—Assess Models Against Roadmap Using Criteria: Weeks

10-11 Task III.3—Review Roadmap Models with Selected Stakeholder

Reviewers: Weeks 11-12 Task III.4—Prepare Strategic Roadmap Model Recommendations

for CIRM

o Optional Module 5. Collaborative Strategy Process to Shape Model: 8 weeks—6 logistics, 2 for meetings, 1 for results

• Phase IV. Realize—Provide Operating Structure of Recommended Model for

CIRM Strategic Roadmap for Continued Innovation Weeks 12-16

o Deliverable: CIRM Strategic Roadmap for Continued Innovation: Operations Plan

o CIRM Meetings: Weekly briefings focusing on roadmap and model operations parameters, review by stakeholders and potential future partners, leading to final briefing/presentation/discussion with CIRM and to presentation to CIRM governing board Week 16. Task IV.1—Outline Operating Functions for Recommended Model:

Weeks 12 Task IV.2—Prepare Operating Elements for Model: Weeks 12-14 Task IV 3—Review with Stakeholders: Week 15 Task IV.4—Review with Potential Partners: Week 15-16


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Task IV.5—Finalize/Present Operating Plan to CIRM: Week 16

o Optional Module 6. SRI International Review of Operational Models: Timing aligned with all other tasks.

o Optional Module 7. Briefings and Feedback Sessions with Selected Stakeholders: 4-6 weeks logistics to take place 4 weeks before project completion.


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Figure 4.1 Project Schedule by Task


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Proposed CIRM Strategic Roadmap for Contiunued Innovation White Paper Budget

Overview of Budget

James Gollub Associates LLC has developed this proposal based on a step-wise approach that

has been effective in building public-private support and commitment to implementation for establishing new public-private biomedical initiatives.

The method used involves a fast-pace, intensive, analysis and process that will generate a

useful understanding of demand-side factors, the range of matching feasible supply-side models for CIRM to consider along with the key operational elements, including identification of prospective partners for implementation. For this reason, each phase of the proposed CIRM

Strategic Roadmap has a carefully thought through flow and scale of activity kept to the financial minimum required.

As James Gollub Associates LLC wants to ensure that CIRM derives what it needs from this Strategic Roadmap White Paper we are prepared to adjust and reconfigure phases and tasks.

Our goal is to ensure that CIRM finds the structural options that most support its ongoing mission and permits the highest degree of sustainability under future political and financial

conditions.

Proposed Budget

James Gollub Associates LLC proposes a budget for this four-phase CIRM Strategic Roadmap

for Continued Innovation for a fixed price of $98,500. Seven Optional Service Modules are also offered for CIRM’s consideration. The summary of proposed labor and material costs (minimal) by phase is as follows. Note that the Analyze phase content flows into and enables

the subsequent Catalyze and Realize phases:

• Phase I--Mobilize: $8,000 • Phase II--Analyze: $45,000


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• Phase III--Catalyze: $25,000 • Phase IV--Realize: $20,500

The table below provides the breakout for labor and expenses for each phase and task

in dollars:

Table 4.1: Proposed CIRM Strategic Roadmap for Continued Innovation White Paper Phase I.

Mobilize Phase II. Analyze

Phase III. Catalyze

Phase IV. Realize

Total

Labor 8 45 25 19 97 Expense 0 .5 .5 .5 1.5 Total 8 45.5 25.5 19.5 98.5 (In ‘000s of USD)

Table 4.2: Proposed CIRM Strategic Roadmap Optional Service Modules* Phase

I.Mobilize

Phase II.

Analyze

Phase III.

Catalyze

Phase IV.

Realize

Total

Optional

Service

Modules

1.

Stewards

Group

2.

SRI Tech

Inputs on Model

Functioin &

Impacts

3.

Regenerative

Medcine

Innovation

Status &

Dynamics (multi-source

data

assessment)

4.

Stakeholder

Demand Factor (~20

Interviews w/target

stakeholders)

5.

Three

Collaborative Stakeholder

Work Sessions

(35-65 participants)

6.

SRI Tech

Inputs on Model

Operations

7.

Stakeholder

Follow-up on

Operational Features

Est.

Labor

Cost

16 25 25 46 42 25 16 195

Expense 1 .5 18 (data) 2 2 .5 1 25

Total 17 25.5 43 48 44 25.5 17 220

(In ‘000s of USD)

* Each option is specifically designed to enhance the flow of Strategic Roadmap development

and can be added as CIRM deems appropriate.


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Note that James Gollub Associates LLC is prepared to manage the costs of this project

within the fixed price budget of $98,500. However, if analytic questions shift or

optional modules are added, budget will need to be adjusted accordingly.

There may be minor costs associated with this project that might be paid directly by

CIRM, if agreed upon. These costs could be associated, for example, with the logistics

of invitations, conference room and refreshment and parking costs associated with

hosting the three work sessions proposed in Phase III. These will be discussed and how

they are managed agreed upon in advance.

If any changes in the work plan are requested by CIRM and/or James Gollub Associates

and are mutually agreed, James Gollub Associates LLC will request a contract

modification to reflect the reallocation of resources and budget.

For further information or discussion, please contact:

James Gollub Managing Director James Gollub Associates LLC Office: (415) 789-0300 Mobile: (415) 302-1793 e-mail: [email protected]

www.jamesgollubassociates.com


http://www.jamesgollubassociates.com/


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Appendix A: Team Resumes

James Gollub Associates Core Team Resumes

James Gollub, BA, MPL

Stephen Marshall, BA, MBA Chris Miller, BA, MBA

Amie Rassen, BA, MSW Paul Kallmes, BEES, MS Annika Barnes, BA, MA

Max Morgunov,BA

And

SRI International Advisory Role Resumes

Joseph Rogers, Ph.D. Nathan Collins, Ph.D. Jon C. Mirsalis, Ph.D David Sahner, M.D.

Toufan Parman, Ph.D., D.A.B.T Lucia Beviglia, Ph.D.


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JAMES GOLLUB, BA, MS

MANAGING DIRECTOR JAMES GOLLUB ASSOCIATES LLC

Professional Focus

Support nations, regions, industries and particularly institutions in growing high-performing, equitable and sustainable economies based on innovation-driven development.

Competencies

Enabling institutions, enterprise and economies at the “inflection point” to learn and

change—whether at the national, state or local level. Achieved this through “convening the marketplace” to form needed new partnerships that use existing resources in new ways. These partnerships may be between businesses, businesses and institutions, between

institutions, these stakeholders and the workforce. Specific competencies include:

• Leadership: Organized and managed complex innovation-driven sustainable prosperity

initiatives globally for economies facing major change. • Innovation: Co-founder of applied cluster-based economic strategy method and

integrated innovation-driven economic strategy. • Analysis: Demonstrated capacity to diagnose and reveal strategic factors that shape

overall economic performance, industry competitiveness and institutional economic input advantage.

• Strategy: Completed successful initiatives for nations, states, metropolitan regions and individual institutions to shape bottom-up, market-driven, collaborative directions including launch of new implementation partnerships and investments.

• Management: Proven track record in building and managing consulting teams of 5 to 25, securing operating funding and in organizing and directing large scale, stakeholder-driven, multi-industry, initiatives domestically and internationally.

• Communication: Highly experienced motivational and technical speaker at national and multinational forums and author of books, reports and articles on innovation-driven development, competitiveness, and sustainability.


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Employment History

• James Gollub Associates LLC, founder, 2013 to present • E-Cubed Ventures LLC, Co-founder, 2009–2012 • ICF Consulting, SVP, Global Economic Development, 2000–2009 • Information Design Associates (IDeA) [Founder], 1995–1999 • DRI/McGraw-Hill, Principal, Economic Competitiveness Group, 1992–1994 • SRI International, Co-Director, Center for Economic Competitiveness, 1976–1991

Education

• M.S. (MPL) Urban & Regional Development, USC, 1976 • Certificate for dual degree in Gerontology and Planning, USC, 1976 • A.B., Psychology, University of California, Berkeley, 1974 • National Oceanic and Atmospheric Administration (NOAA) Sea Grant Fellow, 1974-1976

(thesis published in honors series)

Publications

• Reports and Articles: Author of many strategy reports, best practice strategy guides, and articles on economic competitiveness strategy, innovation, and consumer behavior.

• National Agency Reports: Many articles and reports prepared for federal agencies, commissions, and associations on new policy directions, including, among many others:

o Clusters 2.0: The Local Context of Globalization (EDA America, 2002) o Regional Cluster Strategy and Successful Science & Technology Parks (Economic

Development Commentary, 2000) o The Southwest as a Region of Innovation (DOE/Sandia Labs, 1999) o America’s Regions in the Global Economy (HUD, 1998) o Cluster-based Economic Development: A Key to Regional Competitiveness (US-

EDA, 1997) o Rediscovering Governance: Helping Ourselves—A Guide to Community Problem

Solving (HHS, 1985) o Nonservice Approaches to Problems of the Aged: A White House Mini-

Conference—Findings (AOA,1981) • Books: Author and co-author of three books:

o The Decade Matrix (Addison-Wesley, 1991) o Japanese Companies in American Communities (co-author, Japan Society of New

York, 1992) o The Role of State Colleges and Universities in Economic Development (co-

author, ASCU, 1981)


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Public Speaking

• Lecturer: Served as guest lecturer at Stanford, UC Berkeley and San Francisco State University on regional and industrial competitiveness and strategies for sustainable economies.

• Facilitation/Mediation: Planned, presented and facilitated regional and/or community-wide, industry-specific and investment-focused forums and workshops in over 40 projects globally.

• Conferences: Featured speaker at conferences on competitiveness, innovation and investment, as well as on the convergence of economy, energy and environment (IEDC, IASTP, AURP, World Bank, USAID, World Economic Forum, World Pension Forum, others).

• Workshops/Forums: Conducted scores of leadership workshops on competitiveness, innovation and collaboration in developing and transforming economies from Silicon Valley and New York to Bosnia, Bangalore and Beijing, as well as for the White House Mini-Conference on Aging (1980).

Professional Experience by Theme

A. National Policy—Innovation, Competitiveness and Community Problem Solving • Contribution to Field: Through national agency sponsored research developed and applied

new frameworks for addressing pressing national and regional challenges: o Market Change: Generated means for systematically changing market behavior by

integrated steps to: inform—linking and aggregating demand and supply to achieve scale and speed; enable—changing law and administrative practices to grow demand and foster supply; induce—enhancing demand with incentives and to reduce supply costs, and; sustain—using vertical or lateral redistributive policies to stimulate demand and scale-up supply.

o Innovation Pipeline: Developed “innovation pipeline” framework that builds links to capture economic value at every step: Discovery—translating science into innovation; Development—converting innovation into solutions, and; Deployment—Growing solutions to market aggregations (clusters).

o Cluster Competitiveness: Was an early co-developer of the field of cluster-based economic development nationally and internationally. Brought a bottom-up, rather than top-down perspective to regions that demystified microeconomic principals and put them to work in new collaborative ways: Thinking regional to compete globally; Focusing on clusters as economic engines, not individual companies; Building economic input advantages to form, retain and attract clusters, and; Collaborating to create key advantages through convening the marketplace and enabling use of existing resources in new ways to improve how markets work.

• National Policy Projects: Research and consulting initiatives that Gollub developed and

directed globally:


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o Domestic Innovation: Conducted early research for the National Science Foundation (NSF) on the role of state governments and universities in innovation-based development including assessment of national innovation programs for Congressional Committees and later the benchmarking of state and metropolitan regions in terms of specific innovation input and output factors.

o US Competitiveness: Introduced cluster-based economic development strategy to national, state and local practitioners through two US Economic Development Administration (DOC/EDA) projects as well as through work for the Department of Housing & Urban Development (HUD/PD&R).

o International Development: Through the World Bank Group, USAID and directly for national governments, advised overseas clients on national diversification, cluster and corridor development as well as private investment strategies—from the Persian Gulf and Africa to the BRIC nations (Brazil, Russia, India, China).

o Community Problem Solving Under Budget Constraint: Developed and managed a series of projects for HHS and other US agencies (NIMH, AOA) titled “Rediscovering Governance” that showed how existing resources could be used in new ways to solve market inefficiencies or inequities in addressing community problems—from housing to workforce preparation to healthcare. This led to demonstration projects in counties and broad diffusion of framework and best practices with public interest group partners.

o Regional Challenges for National Policy: Prepared White Paper for first term Obama Administration Transition Team titled “Maximizing Stimulus Impact: Making Integrated Investments to Strengthen US Regional Economies” (2008).

B. Regional Competitiveness & Sustainability Strategy • Contribution to Field: Assessed domestic and international trends shaping high

performing economies and used these lessons to shape a now proven approach to competitiveness strategy and implementation partnerships for nations, states and metropolitan regions globally. Emphasized how to achieve investment readiness and sustainable prosperity.

• Regional Projects: Examples of initiatives developed and directed by Gollub on regional competitiveness and sustainabilty strategy:

o Domestic: Carried out comprehensive cluster portfolio strategies for Albuquerque, Austin, Baton Rouge, Silicon Valley, New York, Ottawa, San Francisco and Southeast Los Angeles as well as states from Connecticut to Ontario and British Columbia.

o International: Breakthrough economic strategies for Bangalore, British Columbia, Calgary, Edmonton, Hong Kong, Ontario, Ottawa, Osaka, Thailand, Heilongjiang, Tianjin, Maribor/Slovenia, Bratislava/Slovakia, Baranya/South Hungary, Bosnia.


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C. Industry Cluster Strategy • Contribution to Field: A co-founder of the field of cluster-based economic development.

Completed industry cluster-specific competitiveness strategies starting from analysis of Midwestern US industry producer supply-chain dynamics during “rust belt” continuing to hot new cluster-centers in the Southwest to cluster centers and hubs globally. These initiatives worked from the local “bottom-up” to global market competitiveness engaging business leaders, supply chain and public economic input institutions domestically and globally in new collaborations.

• Cluster Strategy Projects: Examples of cluster-specific initiatives developed and directed by Gollub by cluster phase of life cycle:

o Emerging: Carried out initiatives focused on clean technology, biotech, fuel cells, information technology, new media/creative industries, and nanotech from Washington State to Connecticut and from Queensland, Australia to Heilongjiang, China—including directly consulting on new enterprise growth.

o Expanding: Initiatives focused on “ready to grow” clusters such as semiconductors, financial services, energy and petrochemicals, tourism from Scotland to Texas.

o Transforming: Strategies for clusters undergoing immediate structural change such as automotives, aerospace, and logistics cluster initiatives from Mississippi to Osaka.

D. State Innovation and New University Roles • Contribution to Field: Began by advising universities on how to understand and maximize

their economic impacts as partners in the surrounding regional economies in the early 1980s with Case Western, Cleveland State and Cuyahoga Community College (1982) and then assessing the Michigan Research Excellence Program (1986), the New York State Centers of Excellence in Advanced Technology (CATS) Program (1992) to craft “innovation pipeline” framework.

• University Impact & State Innovation Projects: Gollub developed and directed a flow of strategy initiatives for governor’s offices and commissions as well as universities and university systems focusing on accelerating innovation to market and measuring and providing guidance to expand university economic impacts:

o State Innovation: Advanced to enabling universities to evolve a new mission in innovation-based economic development beginning with Michigan Strategic Fund (focused on University of Michigan, Michigan State, among others) in the mid-1980s, then State of Minnesota in late 1980s, the State of Maryland Technology Strategy 1990 with Johns Hopkins and University of Maryland and University of


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Baltimore and later the Governor’s New Jersey Innovation Triangle Strategy (2006) working closely with the presidents of Princeton, Rutgers, and NJIT among others.

o University Economic Impacts: As budget issues became major threats to universities assessed the economic impacts of the University of California System on California (“It Starts Here,” 2003), then the impact of California State University system (“Working for California,” 2005) and the individual impact assessment for CSU San Diego (2007), among others. Now routinely work with multiple universities to build new links to regional and global marketplace.

E. Technology Institutes and S&T Parks • Contribution to Field: Developed and repeatedly applied an effective micro-economic

approach to planning the economic case and structure for innovation centers, such as technology institutes and science and technology parks, with the triple bottom-line objective of increasing technology solutions for public needs, increasing institutional revenue, and generating and retaining economic impacts.

• Technology Institute and S&T Park Projects: Gollub developed and directed a wide range of initiatives to shape the vision, strategy and business plans for technology centers, institutes and technology parks:

o R&D and Commercialization Centers: Beginning in the 1980s prepared the vision, strategy and business plans for university-affiliated and independent R&D institutions and technology commercialization organizations (including incubators and accelerators) designed to foster economic growth. These have included R&D centers in biotechnology, digital media, bio-products, MEMS from Michigan to Tokyo to Ontario and Finland—some clients have now been operating for 10-to-30 years (SATAI/StarTech Foundation, NTT Data RISS, MBI International) and most recently we planned the MCA Biomedical Institute of the Americas.

o Science & Technology Parks: As many tech parks became “orphan real estate”, we began to offer vision, strategy and business planning—and now have advised 15 science and technology parks and centers globally that serve as “next generation micro-economies” that enhance flow of science to innovation, innovation to solution and solution to market within and from surrounding metro regions. Examples include: MCA BMIA Technology Center and Technology Park, West Bank IT Park (Ramallah), Algeria Sidi Abdellah Cyber Parc, the UC MBEST Center (Monterey, CA), University of Sunshine Coast Technology Precinct, the Sandia Science & Technology Park (Sandia, NM), University of Idaho Research Park, the Salerno Science Park, among others.

F. Consumer Behavior and Market Strategy • Contribution to Field: Developed early framework on aging and consumer behavior based

on cohort value market segmentation. This broke stereotypes and enabled companies and public programs to better understand and serve consumer needs over the lifetime (the SRI


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LifeSpan Program). Directed projects, authored reports (“Lifestyle and Values of Older Adults” and “Not the Same Old Story”) and articles to help business and government define aging identity and needs not solely against chronological change (whose epidemiology varies) but more as cohorts bringing their period-and-segment specific identities and values with them through time. This was the focus of Gollub’s book: The Decade Matrix (Addison-Wesley, 1991). Gollub also was one of the earlier developers of product-specific market segmentation typologies that he used to help industry and government understand consumer differences in beliefs and behavior and how to effectively communicate to target audiences.

• Consumer Behavior and Market Strategy Projects: Gollub developed and directed a host of research and advisory service initiatives for industry as well as federal agencies focused on consumer market segments and aging:

o Aging and Health: Building on gerontology background, directed early National Institute on Drug Abuse (NIDA) initiative on drug abuse among older adults focusing on patient, physician, pharmacist interactions. Then directed a collaborative national initiative to develop market-acceptable long-term care insurance working with insurance industry and state insurance commissioners. Subsequently advised the Administration on Aging (AOA) and later, the Social Security Administration (SSA) and the National Commission on Employment Policy on expected patterns of older adult work, retirement and risk management. During that time completed strategies for major consumer corporations and institutions in real estate, finance and healthcare sectors on understanding older adult consumer market segments.

o Consumer Behavior: Recognizing that conventional marketing lacked the ability to identify and track enduring consumer traits, developed a new framework for product-specific segmentation and delivered effective consumer market strategies for banks (BofA, Money Store), insurers (Blue Cross), consumer product firms (Avon, Pillsbury), publishers (Lante) as well as information technology companies (Microsoft). These projects focused on how to understand and communicate with target segments—applied this in economic development strategy initiatives.

o Workforce Dynamics: Having carried out a study for the National Commission for Employment Policy titled “Older Worker Employment Comes of Age: Practice and Potential” (1985) Gollub then applied age-cohort segment insights to address Silicon Valley company challenges in understanding and managing a workforce comprising employees from multiple age cohorts whose language and values did not always align (Sun, Intel).


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STEPHEN MARSHALL, BA, MBA

SENIOR ASSOCIATE JAMES GOLLUB ASSOCIATES LLC

Professional Focus

Develop value-adding strategies for advertising and promotion in the local market, particularly by Small and Medium Business (SMB). Focus is typically on the transition to emerging technologies and media, and the change dynamics impacting industry and market

structure. Client base consists of search engines, online media publishers, infrastructure providers and digital ad agencies selling products and services into the SMB market.

Competencies

• Strategy Development: Developing business cases and value-added business strategies in complex, technologically-driven markets. Understanding the needs and competencies of multiple stakeholders, both internal and external to client companies.

• Industry, Market and Business Analysis: Designing and performing empirically-based research into the value-chain, business economics, distinctive competencies and competitive advantages of multiple players in rapidly-evolving business environments.

• Quantitative Research: Building and executing attitudinal and behavioral surveys, conjoint analysis, and surveys of small populations (below statistically significant size). Performing industry-leading research on SMB behavior and spending to reach the local market.

• Qualitative Research: Conducting direct interviews and collaborative working groups to assess needs of businesses, financial investors, and end users in the development and implementation of emerging technologies.

• Communication: Presenting synthesized findings to senior managers, working groups

and conferences, using a variety of formats (extemporaneous speaking, prepared presentations with visual aids, webinars, etc.)


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Employment History • James Gollub Associates (core team), 2013-present • BIA/Kelsey, Research Director, 2006–2012 • The Kelsey Group, Associate, 1996-2005 • Pacific Telesis, AVP of Corporate Strategy, 1993-1995 • Marakon Associates, Senior Manager, 1988-1993 • First Manhattan Consulting Group, Associate, 1985-1988 • J.P. Harkins Inc., Associate, 1979-1985 • Boston Consulting Group, Consultant, 1978-1979

Education

• MBA. Harvard University, 1978 • B.A. American History (minor Economics) University of Michigan, 1974

Public Speaking

• Conferences/Workshops: Regular speaker (featured speaker, moderator, panelist) at conferences on SMBs and advertising, media, online, local. Often present findings of original research

Community • Charter member of Social Venture Partners, San Francisco (affiliate of Social Venture

Partners International, Seattle WA) • Active in various community organizations • Athletically active


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AMY G. RASSEN, BA, MSW


Competencies

• Discovery of Causes of Disease: Through involvement in the start-up of a national disease-focused foundation, knowledge of the complexities of going from targets to pharma, including funding strategies

• Healthcare team leadership: Expertise in assessing healthcare systems for aging adults, including medical, mental health and long-term care needs, and designing efficient and effective service delivery systems that are cost effective.

• Content knowledge in range of health and social service fields: Far-reaching health and social service content knowledge “cradle to the grave,” including age and life cycle related program and business development, initiation of research studies and publication of articles and manuals.

• Organizational Development: Assessment of organizational strengths and challenges; implementation of effective management; executive coaching and leadership development.

• Communication: Expertise in working with committees and diverse staff to enable rich discussion of organizational objectives, inclusion of stakeholders in processes, and understanding among key partners of agreed upon directions and deliverables; extensive experience in developing documents, reports and presentations that promote understanding and use of information by a broad range of partners; skilled in designing and facilitating conversations that support organizational learning and approaches to increase effectiveness.

• Turning around faltering organizations: As an Interim Executive Director or Consultant working with organizations vital to the community challenged to maintain functionality and seeking to sustain viability.

• Strategic planning and evaluation: More than 35 years providing leadership to non-profit organizations, planning programs and businesses, ensuring revenue generation, evaluating projects and working to accomplish organizational objectives.

• Communal context: Extensive experience working in the local community; first-hand familiarity with local and national organizations as well as philanthropic commitments and choices.


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• Organizational assessment and capacity building: Comprehensive knowledge and experience in making possible organizational sustainability through Board involvement, developing resilient infrastructures and hiring quality personnel.

• Knowledge of the Non-Profit World: Knowledge of and familiarity with organizational practices of nonprofits, government agencies and foundations including strategic planning, program development, governance, grantmaking, capacity building and evaluation.

Professional Accomplishments and Experience

Principal, Rassen and Associates, San Francisco, CA, 2006–Present

• Head of a consulting firm that partners with public agencies, non-profits, foundations and philanthropists to create, provide and/or improve strategies, services and/or programs with specific focus on:

• Start-ups: feasibility studies, projections and initiating new non-profit enterprises • Turn-arounds: capacity building; correcting operational, staffing and board-related

problems; restoring a positive bottom line. • Management: leadership and support for board of directors, staff and community

stakeholders to organizations in executive leadership transition. • Systems: assessing and revamping service delivery systems to ensure effective, efficient

and cost effective service delivery

• Effective internal structures: Creating systems, resource development and management; establishing written policies and procedures.

• Service development: Implementing proven approaches to long-term sustainability.

• Personnel management: Developing employment handbooks, job descriptions, and employee evaluations; ensuring employee satisfaction.

• Effective leadership: Coaching executive directors in providing vision and direction • Institutional advancement: Shaping an organization's future and aligning future

directions with resource development.


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Client List (partial):

Ashby Village Attendance Works Congregation Beth Sholom Eldergivers/Connecting the Generations Family Connections Family Resource Network First 5 San Francisco In-Home Supportive Services Consortium Jamestown Community Center

Jewish Community Federation of San Francisco, The Peninsula, Marin And Sonoma Counties National Council of Jewish Women, San Francisco Section Opportunity for Independence

Sage Elder Care Solutions San Francisco Department of Public Health,

Community Behavioral Health Services Sweetwater Spectrum Training Academy for Personal Caregivers and Assistants

Interim Executive Director, Standing Against Global Exploitation, San Francisco, CA, 2011-2012

• Provided leadership to an organization on the verge of closure; returned the organization

to financial health; initiated a fund development plan; addressed systems and capacity-building issues; restructured staffing; rebuilt the board of directors; facilitated day-to-day management; and laid the foundation for the permanent executive directors’ success.

Undersecretary for Clinical Services (Acting), California Department of Corrections and Rehabilitation, Sacramento, CA, 2008 – 2009

• Consulted in the revamping of the health care system for California's 170,000 adults incarcerated in California’s 33 prisons, under the direction of the U.S. Federal Receiver’s Office:

• Headed a team of approximately 40 professionals from a variety of disciplines, including mental health, medical, nursing, dental, custody and corrections rehabilitation to develop a health care service delivery model that would ensure an integrated and coordinated approach to providing health care services to inmate-patients


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• Drafted staffing plans for new facilities involving 1,300 staff positions and over $111 million in annual personnel costs

• Worked closely with facility design and construction staff to create a prototype for new health care facilities to house mentally and/or chronically ill inmates

• Advised the Chief Executive Officer of Health Care on strategic planning, organizational development and tactics to achieve goals

• Authored papers on best practices for Patient-Centered Care, Team-Based Care, Foundations of Care and A Model Service Delivery System for use in planning

Executive Director, American Asthma Foundation, San Francisco, CA, 2007 – 2008

• Working closely with founding philanthropists, started-up a national foundation to

prevent, treat and find the causes of asthma: • Worked collaboratively with foundation leadership to develop a vision and strategic plan

to lead the organization • Initiated and implemented administrative systems • Worked closely with foundation leadership to raise over $13 million over a twelve-month

period • Provided fiscal stewardship to the foundation, including the development of accounting

and monthly reporting procedures; filed tax reports • Oversaw fundraising planning and implementation, including identifying resource

requirements, researching funding sources, establishing strategies to approach donors, preparing written materials and administrating fundraising recommendations

• Directly solicited contributions • Oversaw the development and implementation of a marketing plan, the design of

communication tools and the distribution of promotional materials • Developed and maintained internal systems to track donor activity, grant-making,

financial accountability, human resource management and other systems to ensure a smooth-functioning, legally compliant organization with management controls

• Determined staffing requirements for organizational management and program delivery; recruited and selected employees

• Developed and implemented personnel policies; managed the human resources of the organization including implementing a performance management process for all staff


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Associate Executive Director, Jewish Family and Children’s Services of San Francisco, the Peninsula, Marin and Sonoma Counties (JFCS), San Francisco, CA, 1985–2006

• For 28 years provided the vision and direction for a large non-profit agency and was instrumental in founding national, statewide and local organizations to improve the lives of children, seniors and their families. Developed pioneering programs that have been replicated around the country; she is one of a handful of leaders who has shaped the family support movement in the U.S.

• Grew an agency serving 6,000 people a year to 40 programs in five counties serving 55,000 individuals a year and a $28 million operating budget, in partnership with the Executive Director

• Provided vision and leadership for business and program development • Oversaw fiscal planning and management of programs • Created innovative, cutting edge “cradle to grave” programs that have been nationally

recognized and replicated • Raised over $20 million annually from fees and contracts • Directed internal operations, including responsibility for 800 employees and supervision of

executive management staff across 12 offices in five counties; hired and terminated staff • Developed relationships with local and national foundations to secure over $3.5 million

dollars in grant awards on an annual basis • Set the preconditions for effective fundraising; worked closely with development staff to

meet annual fundraising goals • Oversaw program evaluation; developed research projects, outcomes-based quality

assurance and improvement programs, including benchmarking objectives • Worked collaboratively with a 30 member Board of Directors to develop, implement and

monitor the agency’s strategic plan and annual work plans • Represented the Agency to the community on policy and planning matters

Interim Executive Director, Rhoda Goldman Plaza Assisted Living Facility San Francisco, CA, 2004

• Turnaround of an organization (on Loan from JFCS) • Stabilized a $7 million Jewish housing facility for 155 elderly people in keeping with

community expectations and Title XXII regulations • Provided a vision for the future, involving residents, the Board of Directors and employees • Developed personnel systems; oversaw 150 employees; hired and terminated staff • Improved staff morale through team building, open communication and recognition of

accomplishments


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• Developed an effective working relationship with the Board of Directors, focused on capacity building, role differentiation, collegiality and common purpose

• Developed and implemented financial accountability systems, including monthly reports, cash flow and annual projections, reports to bond holders; health, worker’s compensation and liability insurance plans; capital expenditures

• Handed over to incoming Executive Director a fully occupied, strong, accountable organization

Founder and Director, Parents Place, San Francisco, CA, 1981-1985

• Founded and operated one of the first family resource centers in the U.S. • Developed a vision for a comprehensive, strengths-based system of support for families

with young children that has been replicated in over 200 communities

Coordinator, New Parenthood Program, San Francisco, CA, 1978–1981 Medical Social Worker, Children’s Hospital of San Francisco, San Francisco, CA, 1974–1976 Clinical Social Worker, Jewish Family Services, St. Louis, MO, 1970–1971 Child Welfare Worker, Division of Welfare, State of Missouri, St. Louis, MO, 1969–1970 VISTA Volunteer, U. S. Government, East Los Angeles, CA, 1968–1969

Education and Licensure

• Brandeis University, Waltham, Mass., Bachelor of Arts, cum laude, 1968 • Washington University School of Social Work, St. Louis, Masters of Social Work, 1971 • Licensed Clinical Social Worker LCS 4536, 1974-present • Residential Care Administrator (inactive), 2006-present


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CHRISTOPHER G. MILLER, BA, MBA

VENTURE CAPITAL STRUCTURE & MANAGEMENT ADVISOR JAMES GOLLUB ASSOCIATES LLC Competencies

• Structure: Development and planning of venture capital and private equity funds. • Financing: Securing capital for investment funds and specific projects, including

acquisitions, domestically and internationally. • Management: Preparation and implementation of investment fund operations, serving

as CFO for multiple funds in strategic fields, including medical devices and systems. Professional History

Co-Founder, Director/CFO – PhyMedica (was CodeBlue Solutions), January 2008–Present Helped to raise approximately $6M in different offerings. Responsible for all financial matters, acquisitions (Catalis in May 2009 and MedFli in December 2009), major contracts, solving high-value problems with customers, and meetings with critical customers.

Director and CFO – Catalis, Inc., May 2009–Present

Catalis raised more than $32 million over 10 years to create an Electronic Medical Records system. Responsible for their reorganization / restructuring and PhyMedica took over 51 percent control, which is now 68 percent. Responsible for financial matters, including negotiations, working out agreements, ensuring that customers are happy and managing staff. Co-Founder, Chairman and CFO: Atlantic Media Tech, LLC, March 2013–Present Buying a division from Clear Channel and will be the largest media advertising business in mails in North American by year-end. Also making an investment in the UK. Co-Founder, Chairman and CFO – Agile Brigade, LLC, March 2013–Present Assists clients in implementing Microsoft’s Agile technology, which is software on how to write software. Company is veteran and disabled veteran focused. Co-Founder, Chairmand CEO - AM Richmond Holding, March 2010-Present Holding company for two funds that are focused on two individual families.


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Co-Founder, Chairman and CEO - AM Richmond Capital, LLC, April 2013-Present A long-term, single-family, investment fund for which Miller is the sole manager. The target size is $490 million. Co-Founder, Chairman and CEO – AM Richmond Capital 2, LLC, April 2013–Present A long-term single-family fund for which Miller is the co-manager. The target size is approximately $600 million. Co-Founder and CFO – Cordia Bancorp, May 2009–December 2010 This company was set up to obtain a banking license so that it could take over a large failed FDIC bank. The first step was to go through the Federal and State approval processes to get a banking license and to do so, the acquisition of a local bank became a key criteria. Took over 60% control of the Bank of Virginina (BOVA) in December 2010. Co-Founder, Chairman and CFO – Themis Vision Systems, Nov 2008–Present Hyperspectral camera company which has a variety of infrared and ultraviolet cameras. Bought out the assets from a company that was failing. Funded the company myself for one year and then raised $500,000 at a $4M pre-money valuation. Responsible for sales Responsible for all non-technical staff, including sales, operations, and finance, which has been up to 6 full & part time persons. Responsible for opening certain new markets for sales, and negotiating IP agreements and cooperative agreements. Co-Founder, Chairman and CEO - Prime Source Global Advisors, February 2011–Present Prime Source was set up to cater to one Chinese client with assets of approximately $180 billion. We are working on a major transaction between this Chinese client and a US Fortune 50 client. Additionally, am responsible for showing the Chinese company certain company supply chain acquisition possibilities in the United States. CFO - Enabledware Digital Signage, January 2009–Present Enabledware provides industry-leading software that allows our clients to easily manage and deliver medical content to terminals, digital signs and other formats. With offices in the US, UK and India, we are a Cisco Development Partner for video platforms. CFO – Star Scientific (NASDAQ: STSI), 2000-Nov 2007

Technology oriented tobacco company with annual sales have ranged from approximately $75–$223 million, and market cap has ranged from $75 million to $500 million. Has 13 patents focusing on products and processes for substantially preventing the formation of the most


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abundant and potent carcinogens in tobacco (tobacco specific nitrosamines). Created an innovative and now industry-wide practice for the two-tiered pricing system, re-positioned 100 person sales-force in four states, raised $96 million in ten equity private placements, $25 million in sale-leaseback and other lease transactions, $9 million in a convertible debt placement, and successful completed an innovative private tax ruling regarding a $37 million long term escrow account which netted the company approximately $16 million of cash. Founder/Chief Executive Officer, The Special Opportunities Group LLC, 1999–Present

Created a series of technology venture capital funds based on the Gilder paradigms. Focus on optical networking, photonics, and wireless systems, raising and investing approximately $27 million. Other consulting/advisory/director engagements • CFO, BioStar Private Equity Fund: Approximately $100 million biotech VC fund which

focuses on medical devices, and was on BOD of Setagon, Inc. (a stent coating company sold for $100 million).

• Board member and Chairman of Audit Committee – Community Bankers Trust Company (AMEX: CBTC) for 2 years until March 2009.

• China Fabrication: Set up sales, service support and assembly operations in China for a $225 million in sales US Corp,

• China Manufacturing JV: Advised a $600 million and an $8 million business in setting up manufacturing and Joint Ventures in China.

Chief Financial Officer – Gilder Group, LLC, 1998-1999 Helped grow George Gilder’s publishing company of 7 individuals, 1 newsletter with 12,000 subscribers (partnered with Forbes Magazine) and 1 annual conference in 14 months to 4 newsletters (the primary newsletter with 60,000 subscribers), 6 conferences a year, and a staff of 35 persons. Founder and Chief Executive Officer - American Healthcare Ltd, 1994-1998 Chairman - Total Quality Healthcare [Cooperative Chinese JV company] Founded company to set up the first network of joint venture medical facilities. Successfully obtained licensing and permits to open seven medical centers in different cities under a single Joint Venture structure, the first time this has occurred in China.


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Founder/CEO - International Medical Care, Ltd, 1992-1993 Founded company that set up the first operational Western Medical Centers in Beijing and Tianjin with foreign doctors. This was the first joint venture in China involving a foreign partner in the field of primary health care with foreign doctors. Chief Financial Officer and Executive Vice President - Hospital Corporation of America International (HCA International), 1991-1992 Closed a $10 million mortgage financing, converted financials from US to UK GAAP (including writing up assets by more than $+22 million), closed a $110 million stock swap merger with a UK company which owned 11 hospitals, and negotiated and closed the sale of a $4 million property. Went public in the UK as Hospital Corporation International (HCI). Operationally responsible for planning and developing worldwide projects, including the design, start-up, operational standards, and marketing of the American Medical Center (AMC) in Moscow, which was very successful.

Director, Financial Services Group - The Turner Corporation, 1988-1991 Turner is the largest commercial construction firm in America with annual sales at that time of $3.2 billion. Developed the structure for and financed an $18 million leveraged ESOP. Recommended first variable rate financing structure which saved approximately $3 million over a 3-year period - on both revolving credit facilities and ESOP financing. Assisted in structuring a $32.5 million revolving credit facility. Developed the financing component and banking contacts for a design-build-finance package that resulted in 10% of the bottom line profitability of company.

Investment Banking Associate, Bear Stearns, 1987-1988 Helped structure and finance municipal construction projects, including a $118 million state office building project and a $59 million bridge bond offering.

Education

• Harvard Business School, 1985-1987 • Captain, US Corps of Engineers, 1980-1985 • Reserves – US Army Major, 1985-2001


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PAUL KALLMES, BSEE, MS

INTELLECTUAL PROPERTY & COMMERCIALIZATION ASSOCIATE JAMES GOLLUB ASSOCIATES LLC Competencies

• Strategic management of intellectual property: Worldwide licensing program development; license and contract negotiation; innovation capture, strategic patenting, competitive intelligence/IP landscaping; IP risk characterization, IP valuation and assessment; specific expertise in LED industry IP

• Business development: Extensive business development experience in LEDs and other industries; oversight of product design processes, sales, marketing, distribution, pricing and financing strategies. Joint venture negotiation and management; sales force and rep support and oversight; extensive experience in business development in fluid start-up settings

• Product development: Identify and characterize product development opportunities; develop long-term product roadmaps; provision of design, engineering, supply chain, manufacturing, sales, and marketing.

PROFESSIONAL EXPERIENCE

Metis Partners Inc., Consultant IP Management, 2009–Present Co-founder of Metis Partners Inc., a specialty consulting firm focused on intangible asset management, debt restructuring, portfolio valuation, patent brokering. Providing consultative services to a variety of companies in the US, Europe and Asia in the development of IP portfolios. Advising on IP portfolio development and deployment, business development, market positioning, venture investments, engineering management, sales and marketing, product development.

Lighting Science Group Corp., IP Strategist and General Manager, 2007–2009 Responsible for all aspects of IP portfolio management, including IP creation, protection, strategic patenting, competitive intelligence and landscaping, risk characterization, guidelines and policies for portfolio development, portfolio valuation and value extraction, negotiation of licenses and other agreements, participation in post-merger integration activities, due diligence in M&A, IP consultation to executives and investors.

Color Kinetics, Director of Licensing, 2005-2007

Management of large patent portfolio for monetization and deployment worldwide; contact and negotiation with potential licensees; educate potential licensees on the benefits of licenses; manage license pipeline; develop strategic alliances with partner companies in wide range of industries; develop policies on development and long-term deployment of


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intellectual property in OEM and licensing; create and implement intellectual property management and value extraction methodologies.

Rockwell Scientific Licensing, Director of Business Development, 2003-2005

Responsible for a broad range of technology development, licensing, and new business activities, including the assessment and characterization of value in IP portfolios; interaction with scientists and engineers in numerous technology fields; methodology development for IP management software platforms; strategy and execution of technology development opportunities, including IP protection strategies; oversight of in-house venture capitalists; marketing and sales research; extensive consultation with internal and external IP counsel; drafting and management of technology licenses; continuous refinement of IP management.

Ophthalmological Surgery Enterprise, Management Contractor, 2002–2003

Responsible for fund-raising, business development, and resource use for non-profit organizations to provide eye surgery services in developing countries. Develop fundraising campaign, devise strategic outreach and implementation plans, acquire design and construction services, provide for facility construction, propagate organizations’ high-volume, high-quality, low-cost medical care delivery mechanism in other countries.

KPMG/IP Value, Senior Manager, Intellectual Property, 2001-2002

Responsible for value realization through various IP management strategies. Interface with technical staff to identify and develop opportunities. Developed strategies and proposals for value extraction from diverse portfolios. Conducted extensive research into IP management software platforms and their applications.

Yet2.com, Director, Business Development, 2000-2001

Participated in early-stage development of intellectual property marketplace. Worked in all aspects of technology transfer, including portfolio assessment, application research, customer training. Acquired a thorough grasp of non-traditional sales process in IP settings and fast-emerging markets.

M/K Systems Inc., President/R&D director, 1996-2000

Set strategy and direction for 30-year-old company, changing it from a manufacturing to an intellectual property-based development organization; drove development of new technologies and instruments; developed markets world-wide; developed strategic partnerships with other manufacturers for sales, marketing, and instrument development; negotiated terms and licensed technologies.

Progetto Sella, Founder, editor, and author, 1993-2000

Created organization to enable publication of the prize-winning large-format photography book Summit: The Photographs of Vittorio Sella, 1879-1909; ran affiliated photo gallery;


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conceived, wrote, and edited the book; assisted in North American photographic exhibition; led 1998 Siniolchu Himalayan Expedition.

Snohomish County P.U.D., EMF Researcher/Engineer, 1990-1993

Implemented EPRI-sponsored study of possibly carcinogenic effects of power lines on humans; conducted field research on exposure levels, policy recommendations to management. Substation design engineer: Designed switchgear, regulatory, and safety equipment installations in power distribution facilities; upgraded existing substations and local distribution networks.

Design Engineer, Freelance, 1981-1987

Worked as a design engineer in process flow and control instrumentation, power distribution, alarms and controls, for corporations such as General Foods, Sweetheart Plastics, Boise Cascade Paper Co., Siemens AG

Languages: Fluent German, Russian,

Education

• MPA, Risk Assessment, University of Washington, Seattle, WA, 1990 • BSEE, Northeastern University, Boston, MA, 1984


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ANNIKA BARNES, BA, MA


Experience

Senior Associate, Gollub and Associates, San Francisco, 2013-present

Project management, in-depth economic analysis, and strategy development.

Business Analyst, University of California Office of the President, Oakland, CA, 2012-2013

Operational analysis and process improvement at the UC System level

Senior Associate, E-Cubed Ventures, San Francisco, CA, 2011–2012

• Applied economic and market analysis to create innovative technology industry development programs

• Managed project teams, emphasizing efficient workflow, collaboration and top-quality deliverables

• Transformed complex technical data into concise reports and presentations accessible to a broad audience

Principal, Element Strategic Partners, Seattle, WA, 2008–2011

• Cofounded a boutique consulting firm serving the clean energy industry (www.elementstrategic.com), achieving profitability in the first year and average revenue growth of 40 percent per year

• Fostered strong client relationships and loyalty by delivering outstanding results in the areas of project and business planning, sustainability strategy, cost analysis, communications and government relations

• Collaborate with policy makers, industry leaders and the environmental community to promote clean energy goals

• Managed cross-functional teams to design, market and fund biomass, solar and energy efficiency projects

• Raised over $3 million in federal, state and foundation grants for clean energy projects in three years


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Project Manager, Strategic Development Group, Imperium Renewables, Inc., Seattle, WA, 2007–2008

• Managed new technology development projects at Imperium, a large renewable fuel producer

• Led a team of 12 engineers and scientists and 22 subcontractor organizations as proposal manager on a $63 million DARPA Advanced Biofuels project

• Promoted twice in one year, due to stellar performance and aptitude for greater responsibility

Research Associate, The Institute of International Finance, Washington, DC, 2005–2007

• Conducted research and analysis of Latin American economies for international banks and financial institutions

• Wrote briefs, created presentations and edited all the department’s economic reports, upholding the Institute’s reputation for data quality

• Hosted prestigious executive-level economic conferences in Latin America, always coming in under budget

• Earned a promotion for willingness to expand role beyond research to writing and project management

Education

• MA, Johns Hopkins University – School of Advanced International Studies, Washington, DC, and Bologna, Italy. International Relations and International Economics, 2004, Specialization in emerging markets

• BA, University of Washington – The Jackson School of International Studies, Seattle, WA. International Studies, 2000, Specialization in development economics; awards include National Merit Scholarship, Dean’s List 1996–2000

Additional Skills

Language: Spanish (fluent), French (intermediate), Arabic (basic), Italian (basic)

Computer: Electronic databases include Bloomberg, Factiva, Thomson Reuters Datastream, Thomson Innovation, Westlaw. Applications include Microsoft Access, Excel (VBA and pivot tables), Visio, SharePoint; Adobe Creative Suite; Salesforce. Statistical tools – EViews, R, STATA. Languages – SQL.


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MAX MORGENOV, BA, CFA


Competencies

Drawing on a comprehensive understanding of the full enterprise life-cycle in the context of the capital ecosystem to analyze, structure, and recommend institutional funding vehicles that systematically support enterprise formation and simultaneously satisfy certain economic requirements and institutional mandates. Specific competencies include:

• Researching and Modeling Investment Entity Operations: Knowledge of, as well as capacity to research and model, a variety of fund structures, match core elements of these fund structures against both investor and market requirements, and model and test operating parameters, such as return targets and profiles, liquidity requirements, specific institutional mandates, and other conditions.

• Market Research and Analytical Processes: Experience in step-by-step appraisal of economic, market, and investment variables that may effect new fund prospects, and ability to recommend investment policies and methodologies, given specific objectives and mandates. Ability to structure analytical processes and deal flow screening tools to streamline new entity investment activities.

• Structuring New Entities: Knowledge of capital market dynamics needed to design and secure investment from multiple sources for new investment entities. Ability to assess institutional investor needs and appetites in order to position new investment entities in the marketplace. Experience in structuring internal operations and strategy of investment entities to accommodate for the requirements of investors and partners, as well as meet prevailing standards of practice.

• General Analytical Skills: Command of a wide variety of analytical tools and methodologies combining bottom-up quantitative and qualitative analysis pertaining to specific enterprises, with top-down analysis encompassing industries and economies. Thorough understanding of the investment styles and analytical processes of a wide variety of investment entities, public and private, and how they interact to create the capital formation pipeline.

• Entrepreneurship and Business Operations: Experienced in providing strategic consulting to, and structuring engagements with a variety of enterprises in the areas of business development, capital raising, international operations, private and public partnership formation, and others. Entrepreneur-level insight into critical business growth and development inputs.


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Professional Focus Served investment community, consulting, and entrepreneurial projects in defining fund options, performing analysis and due diligence on capital formation models for biomedical institute (among others), identifying capital sources, and creating and executing capital raising strategies in the asset management and venture contexts. Applied an understanding of the institutional investment community, capital markets, entrepreneurship, and a broad spectrum of analytical methodologies to create optimized strategies for young, innovation-focused enterprises, as well the institutions that that capitalize and incubate them.

Experience

GWTC LLC, Co-founder/director, 2011–Present Engaged in full spectrum of operational and principal activities in a strategic consulting and commercial facilitation entity, with interest in industrial processes, medical and biomedical devices, energy, IT, and other areas. Responsible for sourcing and screening potential clients based on deep business due diligence and thematic fit, consulting on capital raising, creating partnerships and operating structures, creating relationships between clients and potential partners and customers, public and private, and a wide variety of other functions. E-Cubed Ventures LLC, Associate (reporting to Gollub), 2011-2013 Institutional Investment Funding and Ecosystem Analysis. Researched and recommended capital formation models as part of strategy for development of biotechnology research park and industry cluster in El Paso, TX, as initiated by Medical Center for the Americas Foundation. Also engaged in valuation, client screening and due diligence, transactional, market research, and economic analysis toward intellectual property-centric venture development, across projects. Equity Management Associates, LLC dir. marketing and BD, 2009-2010 As a marketing and business development director for Equity Management Associates, LLC (EMA), a successful hedge fund with public and private investment interests, analyzed institutional investment landscape, and helped aligned EMA strategic focus, investment process, operational infrastructure, process presentation, performance and risk analysis with institutional investment standards, to meet market needs. Also helped revise the strategic positioning of the fund, built a cohesive articulation of EMA brand and philosophy by engaging in and systematically characterizing investment process; overhauled communication materials and strategy presentation to convey revised message to a wide variety of institutional investors such as funds-of-funds, public and private endowments, family offices, and other institutions. Developed relationships with new institutional investors previously unavailable to EMA. SAC Capital Advisors, LLC, operations analyst, 2007-2008 As a middle office operations analyst for SAC Capital, LLC, a highly sophisticated and diversified asset management firm, developed and refined tools and processes for significant


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improvement and automation in a wide variety of derivatives trading-related areas, such as market value/cash reconciliation of complex derivative transactions, custodial and prime-brokerage issues, corporate actions processing, compliance and collateral validation, and others. Developed an understanding of the infrastructure considerations in operating a complex investment practice, and their effect investment and strategic decisions. AEI, Inc., Intern, 2006 As an investment banking intern for AEI, Inc., an investment banking practice specializing in late-stage venture capital transactions, worked to focus institutional investment placement effort by conducting institutional investor profile and requirements research, public market comparable analysis, due diligence on $350MM of innovation-centric deal flow, and placement team deal briefings.

Education

• B.A. Philosophy, Japanese, Colgate University, 2007

• Chartered Financial Analyst (CFA) Candidate - Exams Completed, Charter Pending


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SRI Staff CVs

• Joseph Rogers • Nathan Collins • Jon Mirsalis • David Sahner • Toufan Parman • Lucia Beviglia

May 10th, 2013 CIRM PROPOSAL James Gollub Associates

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APPENDIX B: Innovation Pipeline Models

Note: The three tables presented herein were prepared by James Gollub and team for

the Medical Center of the Americas (MCA) in 2012 as an input to the MCA – Biomedical

Institute of the Americas strategy and business plan. Initially over 40 cases were

identified that matched the client’s range of needs as defined through a rigorous

analysis and collaborative process with university research, public and private sector

stakeholders. From these profiles 10 cases were selected for indepth analysis. From

these analytic findings the parameters for the operating plan for a new integrated,

hybrid, institute were developed and the business plan prepared, which is now being

implemented.


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Documents

Gollub Proposal