Public-private partnerships (P3s) have become an increasingly pivotal—almost doctrinal—driver of R&D across the health sciences. But for all the advantages that have made P3s increasingly inevitable, these partnerships have not become less complex.

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Partnerships in Health Innovation:
Expanding Paradigms of Private Profit and the Public Good
Dr. Ryan Wiley
President

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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?

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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

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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

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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

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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.

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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

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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)
Commercially
Unviable
Industry
Led
Catalysts
PPP
Program
Commercially
Driven

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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

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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

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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

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Realizing the full potential of a P3 is often impeded by the diversity
of objectives, priorities and experience among partners
1
Establish 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
2
Instill a predictable approach to communication
among partners and with stakeholders
Partners speak different
languages and with different
audiences, leading to potentially
damaging misunderstandings
3
Develop 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
4
Align 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

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Establish governance mechanisms that enable appropriate
participation in decision-making
Transparency
Ensure partners understand issues and their role in decision-
making
Accountability
Clarify roles and responsibilities and establish formal
reporting structures
Oversight
Ensure that decision-making bodies have authority to act on
behalf of the partnership
Focus
Establish clear R&D objectives and criteria to guide mission-
driven decision-making
1

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Case study: Various governance mechanisms are implemented to
overcome challenges intrinsic to these often complex relationships
1
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)

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Instill a predictable approach to communication among partners and
with stakeholders
2
Partners
Need 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
Public
Requires evidence that activities are mission-driven, ethical
and serving the public good

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Case study: Selected examples of the commitment to communication
across a diverse spectrum of PDPs
2
*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

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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 Product
Knowledge/Technology
Transfer

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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

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Case study: ‘Open innovation’ partnership models exhibit a diverse
array of IP and knowledge/technology access policies3
DegreeofOpennesswithIP
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

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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
Planning
Preparing for all possible outcomes

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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)

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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.

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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

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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.
5
BootCampModules
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

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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

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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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