Kineticos Life Sciences Management Consulting Capabilities 2016

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www.kineticos.com

Kineticos – Capabilities Overview

2Property of Kineticos © Copyright 2016

Kineticos is a specialized management consulting firm serving the life science industry. The firm is focused on identifying opportunities to drive strategic growth and achieve operational excellence for its clients around the globe.

About UsKey Facts

A Differentiated Approach…

Specialized focus in life sciences Real world expertise from decades in industry Strategic thinking Tactical execution capabilities Systematic methods and processes


Life Science Ecosystem

Regulations

Unknown Variables

Foreign Exchange Risk

Geo-Political Risk

Changing Market Needs

Pricing Pressures

Competitive Threats

Market Innovation

We view the life science industry as an evolving ecosystem. This ecosystem is defined by its network of interactions. As with any ecosystem, there are unpredictable emergent properties that result from the interactions of its participants. A company’s viability is dependent on its capacity to anticipate changes on the horizon and respond as new challenges emerge.

About UsThe Life Science Industry Ecosystem

CMOs CROs

Patients

Distributors

LaboratoriesProviders

Regulators

Payers

Biopharma


As a management consulting firm with unique knowledge and experience across the life science industry ecosystem, Kineticos—through its three practice areas—is ideally positioned to help companies thrive.

Our practice areas and service areas include:

About UsOur Practice Areas and Service Areas

Biopharmaceutical Biopharmaceutical Services Diagnostics

Corporate Strategy and Development

Medical Affairs Strategy Commercial Strategy Regulatory

Corporate and Business Unit Strategy

Sales and Marketing Operational Execution

Corporate Strategy and Development

Technology and Innovation

Operational Excellence


Biopharmaceutical PracticeOverview and Capabilities


The Biopharmaceutical practice at Kineticos assists growth-oriented pharmaceutical and biotech companies realize their commercial potential at the corporate, portfolio and product levels.

Service areas include:

Corporate Strategy and Development Medical Affairs Commercial Strategy Regulatory

Business Model Design

Portfolio Strategy Geographic Market

Entry Opportunity

Assessment In- and Out-licensing Private Financing

Medical Affairs Strategic Planning and Operations

MSL Architecture, Management, and Support

Real World Evidence/Registry Study Strategy

New Product Planning Strategic Launch

Planning Post-Marketing

Strategy and Planning Lifecycle Management Marketing Excellence

Global Regulatory Strategy

Product Development

Regulatory Operations and Submission Management

Biopharmaceutical PracticeOverview and Capabilities


Our Corporate Strategy and Development services combine our in-depth experience and industry knowledge with benchmarks and competitive analysis to help biopharmaceutical companies make critical strategic, financial, and, business development decisions.

Business Model Design Portfolio Strategy Geographic Market

Entry StrategyOpportunity Assessment

In- and Out-licensing Private Financing

• Situational Analysis

• Market Segmentation

• Value Proposition Development and Validation

• Target Market Prioritization

• Business Model Optimization

• Market Opportunity Assessment

• Initial Target Product Profile Development

• Target Product Profile Revenue Forecasts

• Valuation Tradeoff Analysis

• Strategic Plan Development

• Geographic Market Opportunity Analysis

• Competitive Landscape Assessment

• Market Entry Risk Assessment

• Prioritized Market Entry Plan


• Competitive Landscape Analysis

• Target Product Profile Development and Validation

• Target Product Profile Revenue Forecast

• Term Sheet Development

• Market Opportunity Assessment

• Partner Identification/Prioritization

• Outreach Management and Meeting Support

• Due Diligence

• Deal Term Negotiations

• Investment Strategy Prioritization

• Investment Package/Dossier Development

• Investor Outreach Management

• Due Diligence Process Management

• Deal Term Negotiations

Biopharmaceutical PracticeCorporate Strategy and Development


Our Medical Affairs executive services help Biopharmaceutical companies strategically plan, organize, and operate with greater efficiency. Therefore, maximizing the value of their Medical Affairs function.

Medical Affairs Strategic Planning & Operations

MSL Architecture, Management and Support

Real World Evidence/Registry Study Strategy

• Medical Affairs Infrastructure & Optimization

• Medical Affairs Executive Talent Identification & Recruitment

• IIT Study Operations Team & Process Design

• KOL Advisory Board Design• Cross-Functional

Communication Facilitation• Industry Relationship

Management • Financial Planning & Analysis

• MSL Field Deployment Strategy• MSL Recruiting• MSL Outsourcing and Training• MSL Management • Key Performance Indicator

Tracking

• Disease Based Registry Study Development

• Internal Support & Executive Sign-Off

• Field Based Execution Plan for Registries

• Strategy & Development of Internal Study Operations

• Investigator Steering Committee• Vendor Selection Process &

Management

Biopharmaceutical PracticeMedical Affairs


Our Commercial Strategy services help biopharmaceutical companies maximize the commercial value of their products across all phases of the product lifecycle.

New Product Planning Strategic Launch Planning

Post-Marketing Strategy and Planning Lifecycle Management Marketing Excellence


• Market Segmentation

• Global Opportunity and Needs Assessment

• Target Product Profile Development and Validation

• Target Product Profile Revenue Forecasts

• Valuation Tradeoff Analysis

• Strategic Plan Development

• Customer Segmentation

• Optimal Labeling Strategy

• Revenue Target Development

• Critical Success Factor Prioritization

• Product Positioning and Messaging

• Global Market Uptake and Payer Acceptance Modeling

• Global Market Assessment

• Segmented Market Action Plans


• Product Opportunity Prioritization

• Opportunity Tradeoff Analysis

• Lifecycle Management Plan

• Marketing Strategy Development

• Marketing Organizational Planning

• Marketing Excellence Training

• Project Implementation Support

• Post-Implementation Feedback

Biopharmaceutical PracticeCommercial Strategy


Our Regulatory services are designed to help biopharmaceutical companies to solve complex regulatory challenges, as well as reduce risk and expedite the development process, by applying a premier level of expertise to every client engagement.

Regulatory Strategy Product Development Regulatory Operations & Submission Management

• Regulatory due diligence evaluations

• Regulatory strategies and development plans (global perspective)

• Agency interactions and meetings (includes development/preparation of agency meeting requests and packages)

• Strategic labeling review and preparation (TPP)

• Orphan Drug Designation support and expedited programs

• Non-clincial study design and oversight

• CMC consultation and vendor oversight

• Clinical study design and clinical study management/oversight

• Compliance services (GMP, GLP, GCP, and QSR)

• Qualification/general audits

• Pre-approval inspection readiness programs

• Regulatory submission planning• Regulatory submission authoring (all

CTD section for investigational and marketing applications)

• Regulatory submission publishing (eCTD, NeeS)

• Pre- and post-approval submission maintenance

• Change control evaluation and implementation

• Registration and drug listing services• State licensing services

Biopharmaceutical PracticeRegulatory


Our PeopleMark Osterman, Senior Vice President

Mr. Osterman, Senior Vice President of Kineticos’ Biopharmaceutical Practice, adds more than 25 years of experience in the biopharmaceutical industry to the team.

Mr. Osterman held roles in sales, clinical, and marketing at GlaxoSmithKline before moving to Johnson & Johnson, where he launched their stem cell internal venture and was responsible for the cardiovascular, pulmonary, metabolic, and mimetibody therapeutic areas in the Global Biologic Strategic Marketing. Mr. Osterman then served as Senior Vice President responsible for commercial operations and business development at Discovery Labs before

accepting a position as Vice President of Global Marketing at Solstice Neurosciences. Immediately prior to joining Kineticos, he founded the Osterman Strategy Group, a boutique management consulting firm, where he worked with large and emerging biopharmaceutical companies.

Mr. Osterman earned a dual BA in Business Management and Economics from North Carolina State University.

Areas of Expertise:• Global Strategic Marketing• New Business Development• Merger and Acquisition Strategy• Organizational and Leadership Development


Our PeopleGlen Martin, Senior Vice President

Mr. Martin, Senior Vice President of Kineticos’ Biopharmaceutical Practice, adds more than 22 years of experience in the biopharmaceutical industry to the team.

Mr. Martin held roles in sales for several start up Biopharma companies before moving to Pharmion. While at Pharmion, Mr. Martin held management roles in Sales before becoming the National Director of the US, MSL program. Mr. Martin then moved to Celgene, as they had acquired Pharmion in 2008. While at Celgene, Mr. Martin held multiple leadership roles in Medical Affairs. Starting with Senior Director, Outcomes Research & Operations, and being promoted to Executive Director, Strategic Planning &

Areas of Expertise:• Oncology• Commercial & Medical Affairs Field Deployment Strategy and Management• Medical Affairs Strategic Design• Medical Affairs Operational Excellence

Operations for US, Medical Affairs. Covis Pharma, a unique start up company, brought in Mr. Martin to serve as Vice President of Oncology Sales. Following the acquisition of Covis, and prior to joining Kineticos, Mr. Martin served as Senior Vice President , Medical Sciences for Ashfield Healthcare.

Mr. Martin earned his BA in Phsycology from La Salle University in Philadelphia, PA.


Our PeopleShailesh Maingi, Founder and CEO

Mr. Maingi founded Kineticos in 2012 and develops long-term and day-to-day execution strategies. Mr. Maingi serves on the

Board of Directors at Gallus Biopharmaceutical, a biopharmaceutical CMO, and he also

serves on the advisory boards of Novolipid and Enci Therapeutics, two startup

biotechs based in North Carolina. In addition, Mr. Maingi is a guest lecturer for the MBA program at the Kenan-

Flagler School of Business at UNC-Chapel Hill.

Prior to founding Kineticos, Mr. Maingi was a senior executive at Cardinal Health/PTS and Sigma-Aldrich/Supelco, where he held leadership roles in strategy, business development, and marketing. Mr. Maingi earned a BS in Chemistry from UNC-Chapel Hill and an MBA from Golden Gate University.

Areas of Expertise:• Corporate Strategy and Execution• Research and Innovation• Business and Corporate Development• Process Improvement / Change Management


Project Team MembersMyung Soo Kim, PhD – Analyst

Dr. Kim is currently responsible for supporting the delivery of customized management consulting solutions to clients across the life science ecosystem. Additionally, he is the lead author on several Kineticos research reports. Prior to joining Kineticos, Dr. Kim co-founded NeuroNostix, an innovative company focused on developing best-in-class therapeutics for CNS disorders.

Dr. Kim graduated from the Eshelman School of Pharmacy, Division of Molecu-larPharmaceutics at UNC–Chapel Hill. Prior to earning his PhD, Dr. Kim received a BS in Biology from UNC–Chapel Hill.

Areas of Expertise: • Market Research• Technical Writing• Project Management• CNS


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Kineticos Life Sciences Management Consulting Capabilities 2016