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Partnerships in Health Innovation: Expanding Paradigms of Private Profit and the Public Good

Dr. Ryan Wiley

President

Confidential | 2

Key Questions

What is driving the evolution and diversity of public-private

partnerships (P3) in product development?

What challenges must be overcome in order to realize the full potential

of P3s?

What are the success factors and best practices for effective

partnerships?

Confidential | 3

Transform

Health Systems

Amplify Academic

& Research

ImpactAdvance

Successful

Health

Innovation

Shift Health is a global, strategy-through-implementation

consultancy devoted exclusively to the HealthSphere.

We offer our clients in government, academia, industry and the not-for-profit

sector implementation-focused solutions that leverage multi-sector and

transnational partnerships and build capacity, skills and sustainable strategies to

drive patient impact and generate social and economic value.

Shift Health

Confidential | 4

Drive

Portfolio

& Program

Strategy

Identify & Evaluate

Opportunities

Harness

Public-Private

Partnerships

Plan for Product

Development

Risk

Optimize

Medical

Affairs

Enable Effective

Relationships

Navigate the

Innovation

Pathway

Build In-Country

Capacity

Transform

Health Systems

Amplify Academic

& Research

ImpactAdvance

Successful

Health

Innovation

Shift Health is Canada’s premier health and life sciences strategy

consultancy

Confidential | 5

ACADEMIA

*Above organizations represent a selection of Shift Health’s clients

GOVERNMENT NOT-FOR-PROFIT

INDUSTRY

CARE

PROVIDERS

Shift Health works internationally and across sectors to enable

research leadership and advance health innovation

Confidential | 6

Shift Health has worked extensively with P3s to:

Identify, prioritize and engage potential partners

Develop strategic models and supporting business cases

Establish effective governance and management structures

Create and implement contingency, communication, product development

and access plans

Shift Health has planned, assembled and managed over 50 P3s in

biomedical research, infrastructure development and global health

Shift Health has helped clients leverage over $1B in financing from

private and public sources.

Confidential | 7

Public Private Partnerships (P3s)—A traditional definition

As P3s have flourished globally, so too has creative appetite to experiment

with unorthodox models.

“…use public and philanthropic funds to engage the [life sciences]

industry and academic research institutions in undertaking R&D for

diseases of the developing world that they would normally be unable

or unwilling to pursue independently, without additional

incentives.”*

*http://www.mmv.org/partnering/product-development-partnership-model

Confidential | 8

There has been a proliferation of innovative partnership models that

transcend the traditional definition of P3s

1990 2000 20101995 2005 2015

Pox-Protein

Public-Private

Partnership (P5)Co

mm

erc

iall

y

Un

via

ble

Ind

ust

ry

Led

Cata

lyst

s

PPP

Program

Co

mm

erc

iall

y

Dri

ven

Confidential | 9

The growing diversity of potential partnership configurations is

guided by different underlying priorities and objectives

Goal to develop antimalarial

drugs to reduce the burden

of malaria in disease-

endemic countries.

Goal to improve health and

economic impact by

speeding up development of

innovative medicines.

Global health priorities

Address lack of commercial incentive

Broadly de-risking R&D

Complement commercial incentive

Goal to source and capitalize

on external funding

opportunities to advance

R&D portfolio objectives.

Big Pharma

Confidential | 10

Changes in the R&D landscape are driving experimentation with new

models of public-private partnership

Key Drivers

Rising costs and risks in product development coupled with

thinning pipelines and patent expirations

Unsustainable healthcare costs, increased global

competition and uncertain global macroeconomic climate

Constrained funding for early/preclinical testing, and shifting

focus of funders toward commercialization

Growing demands for accountability and transparency by

discerning stakeholders/donors

Emphasis on the value interventions contribute to future

health outcomes requires population-level, real-world data

Industry

Governments

Academia

Not-for-profits

Care Providers

Confidential | 11

Clarifying the expectations of individual partners is critical to

realizing benefits that no single partner can achieve on its own

Industry

Governments

Academia

Not-for-profits

Care Providers

Shared Benefits

Share talent and perspectives

Spread funding and risk

Facilitate knowledge mobilization

Advance common objectives

Allocate resources efficiently

Expand innovation opportunities

Gain

RISK

Bring

Confidential | 12

Realizing the full potential of a P3 is often impeded by the diversity

of objectives, priorities and experience among partners

1Establish governance mechanisms that enable

appropriate participation in decision-making

Power dynamics are challenged

by the need to share authority,

make joint decisions and hold

partners accountable

2Instill a predictable approach to communication

among partners and with stakeholders

Partners speak different

languages and with different

audiences, leading to potentially

damaging misunderstandings

3Develop IP policies that balance the needs of each

partner with the objectives of the partnership

Creation of IP is both an

incentive to innovate and a

barrier to collaboration

Cultivate an industry mindset by applying business

discipline early in technology development5

Technology development efforts

are often disconnected from

market and business principles

4Align partners around the conditions, processes and

timelines for making products/technologies available

While product access is the goal,

agreeing to access terms can be

complicated by divergent

economic expectations

Confidential | 13

Establish governance mechanisms that enable appropriate

participation in decision-making

TransparencyEnsure partners understand issues and their role in decision-

making

AccountabilityClarify roles and responsibilities and establish formal

reporting structures

OversightEnsure that decision-making bodies have authority to act on

behalf of the partnership

FocusEstablish clear R&D objectives and criteria to guide mission-

driven decision-making

1

Confidential | 14

Case study: Various governance mechanisms are implemented to

overcome challenges intrinsic to these often complex relationships1

A Scientific Committee

made up of regional

thought leaders advises the

Governing Board.

Diverse Board of Directors

representing the public and

private sectors and patient

advocacy groups.

Each partner is an equal

voting member on an

Executive Committee that

provides strategic

leadership.

Pox-Protein

Public-Private

Partnership (P5)

Confidential | 15

Instill a predictable approach to communication among partners and

with stakeholders2

PartnersNeed awareness of activities, challenges and forthcoming

decisions/milestones

Scientific

Community

Desires publication of data and opportunity to discuss

scientific results

Funders Expect financial transparency and accountability

PublicRequires evidence that activities are mission-driven, ethical

and serving the public good

Confidential | 16

Case study: Selected examples of the commitment to communication

across a diverse spectrum of PDPs2

*Sabin PDP (originally the Human Hookworm Vaccine Initiative)

Multi-pronged outreach

strategy targeting patient

groups, schools, radio

stations, digital media and

policymakers.

Published >100 peer-

reviewed articles since

2000 and established ‘PLoS

Neglected Tropical Diseases’

journal.*

Discloses audited financial

results, including industry

partner contributions,

through its Annual Activity

Report and website.

Structural Genomics Consortium

Confidential | 17

Develop IP policies that balance the needs of each partner with the

objectives of the partnership

Affordable product that will

be sold at cost or at a very

low margin

Control access to

technology with potential

to generate revenue

3

Not-for-Profit

Partners

Industry

Partners

Rapid data publication

with no restrictions to open

access databases

Marketable product that

provides a reasonable return

on investment in selected

markets

Target ProductKnowledge/Technology

Transfer

Confidential | 18

Case study: IP policies are driven by different strategic objectives3

Will negotiate an exclusive

global license

Licenses must be royalty-free

in malaria-endemic countries

IP will be transferable to

manufacturing partners

Provisions are adaptable on a

‘case-by-case’ basis

IMI plays a neutral, advisory

role during IP negotiations

Policy was co-developed by and

applies equally to all partners

Supports drug access for high-

risk populations

Promotes collaboration,

innovation and economic growth

Confidential | 19

Case study: ‘Open innovation’ partnership models exhibit a diverse

array of IP and knowledge/technology access policies 3D

eg

ree o

f O

pen

ness

wit

h I

P

Data submitted to an open access database

IP remains with the originator; option to partner with Lilly

Pfizer has the first option to license outputs

‘No strings attached’

Flexibility when establishing models allows partners to tailor policies to suit

individual organizations and achieve the goals of the P3.

IP placed in public domain; non-exclusive license option

Confidential | 20

Align partners around the conditions, processes and timelines for

making products/technologies available4

Stakeholder

Engagement

Understanding market conditions and the needs

of end users

Setting Targets

and Thresholds

Informing the case for investment by modelling

demand and forecasting impact

Contingency

PlanningPreparing for all possible outcomes

Confidential | 21

Case study: A clear target product profile and public health impact

modelling are key drivers of the P5’s access planning efforts4

LESSONS LEARNED

Proactive stakeholder communication

Plan for success

Forecast demand and public health impact

Pox-Protein Public-Private Partnership (P5)

Confidential | 22

Case study: P3s in the medical technology space have adopted

differing approaches aimed at optimizing access to health innovation4

Focused on advancing

regulatory science to

understand and evaluate

medical technologies and

expedite product

development and access.

Supports partners in

building capacity for

innovation procurement

and/or evaluation studies

relevant for procurement of

medical technologies.

Confidential | 23

Cultivate an industry mindset by applying business discipline early in

technology development5

Decision-

making

Use stringent thresholds (e.g. probability of

success) to evaluate and prioritize opportunities

Product

Development

Align all partners around a clear target product

profile (TPP)

Project

Management

Set and adhere to an overall product

development plan and program strategy

Confidential | 24

Case study: The Global HIV Vaccine Enterprise, together with Shift

Health, held a 2-day Product Development Boot Camp.

The Boot Camp equipped stakeholders with concepts and tools used by

industry to drive product development.

5B

oo

t C

am

p M

od

ule

s

Pipeline and portfolio considerations

1

Target Product Profile (TPP)

2

Moving vaccine concepts from bench-to-clinic

3

Planning for trial success

4

Product development partnerships: best practices

5

Confidential | 25

Conclusions

P3s have become an increasingly pivotal driver of R&D

Partnerships have flourished globally and are becoming increasingly complex

Governance, communication and IP/access strategies have diversified—with a

common predisposition toward openness and collaboration

Experimentation with flexible partnership models to accelerate innovation and

advance healthcare solutions will continue

Confidential | 26

The changing models employed by P3s are reshaping how

organizations like Shift Health work

Expertise in health

research strategy,

facilitation and project

management.

Expertise in

implementation training

strategies and

operationalizing

healthcare infrastructure.

In partnership with UHN, Shift Health supported HMC in the

establishment of a world-class Academic Healthcare System.

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