Shift Health co-hosted a Product Development Boot Camp with the Global HIV Vaccine Enterprise. The Boot Camp afforded workshop participants an opportunity to discuss best practices, to learn from the experience of other experts and to create an enduring resource and toolkit that will serve the HIV vaccine field and beyond. Product development refers to the multifaceted, long-term, highly regulated process that brings promising new drugs, vaccines and medical devices to the populations who most need them. In fields such as HIV vaccine development, where the absence of commercial incentives can make it difficult for companies to lead this process on their own, inventors need to work in partnership with diverse stakeholders and funders to maximize the social and economic impact of their research. Ryan Wiley, PhD, President at Shift Health, delivered an overview of product development partnerships, which exhibit three common elements: Defined governance mechanisms that enable appropriate participation in decision-making Disciplined approach to communication among partners and with stakeholders IP policies that balance the needs of individual partners with the objectives of the partnership.

1. Shift Health is a healthcare strategy consultancy devoted exclusively to healthcare and life sciences. We work with government, academia,
industry, the not-for-profit sector and healthcare providers to amplify healthcare and research leadership, advance global health innovation and
achieve eminence in healthcare markets worldwide.
Product Development Boot Camp
6 November 2015
Product Development Partnerships (PDPs):
Overview
Dr. Ryan Wiley
President

2. HealthSphere Insights | 2
Product Development Partnerships—A traditional definition
“[PDPs] use public and philanthropic funds to engage the
pharmaceutical 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
It is advisable to keep an open mind when thinking about partnership
arrangements because the landscape has changed dramatically.

3. HealthSphere Insights | 3
There has been a proliferation of innovative partnership models that
transcend the traditional definition of PDPs
1990 2000 20101995 2005 2015
PPP
Program
Pox-Protein
Public-Private
Partnership (P5)

4. HealthSphere Insights | 4
The spectrum of potential partnership configurations is guided by
different underlying priorities and objectives
Goal to reduce burden of
malaria in disease-
endemic countries by
discovering, developing and
delivering new, effective and
affordable antimalarial
drugs..
Goal to improve health—and
economic impact—by
speeding up development of,
and access to, innovative
medicines, particularly
where there is an unmet
medical or social need.
Goal to fund a pre-
competitive research forum
that facilitates development
of breakthrough tools and
technologies that enhance
biopharmaceutical R&D
productivity.
Quebec Consortium for Drug Discovery
Global health priorities
Address lack of commercial incentive
Broadly de-risking R&D
Complement commercial incentive

5. HealthSphere Insights | 5
Changes in the R&D landscape are driving the continued expansion
of PDP models beyond those that fit the traditional definition
Key Drivers
Industry
Rising costs and risks in drug and vaccine development
coupled with thinning pipelines and patent expirations
Governments
Unsustainable healthcare costs, increased global
competition and uncertain global macroeconomic climate
Academia Constrained funding and shifting focus of funders toward
translational science and commercialization
Not-for-profits
Growing demands for accountability and transparency by
discerning stakeholders/donors
Care providers
Emphasis on the value interventions contribute to future
health outcomes requires population-level, real-world data

6. HealthSphere Insights | 6
PDPs—across the continuum—yield shared benefits that no single
partner can achieve on its own
Combine expertise and resources from academia and industry
Spread funding and risk across multiple players
Facilitate dissemination of knowledge across a diverse network
Concentrate on missions rather than development costs
Allocate resources efficiently through stringent project vetting
PDPs—whether traditional or emerging configurations—can
accelerate the translation of R&D from bench to bedside while
supporting affordability and data access.

7. HealthSphere Insights | 7
Despite their diversity, successful partnerships exhibit three common
elements
1
Defined governance mechanisms that enable
appropriate participation in decision-making
2
Disciplined approach to communication among
partners and with stakeholders
3
IP policies that balance the needs of individual
partners with the objectives of the partnership

8. HealthSphere Insights | 8
Defined governance mechanisms that enable appropriate
participation in decision-making
Transparency
Ensure that partners understand issues and their role in decision-
making
Accountability
Clearly specify roles and responsibilities and establish formal
reporting structures
Oversight
Ensure that decision-making bodies enjoy recognized authority to
act on behalf of the partnership
Focus
Establish clear R&D objectives and criteria to guide consistent,
predictable, mission-driven decision-making
1

9. HealthSphere Insights | 9
Case study: Various governance mechanisms are implemented to
overcome challenges intrinsic to these often complex relationships
1
Each partner is an equal
voting-member on an
Executive Committee that
provides strategic leadership
and oversees specific
committees/working
groups, established on as
as-needed basis.
A Scientific Committee
made up of regional thought
leaders advises the
Governing Board, and all
stakeholders have an
opportunity to provide input
at the Stakeholder Forum.
Independent boards that
advise on and guide the Lab’s
strategy are charged with
proposal review/funding,
limiting industry’s
involvement.
Pox-Protein
Public-Private
Partnership (P5)

10. HealthSphere Insights | 10
Disciplined approach to communication among partners and with
stakeholders
PDPs must pursue consensus-based communication plans to
ensure efficient operations, align stakeholder expectations, and
maximize potential for sustainability and enduring impact.
2
Partners
Need to be fully abreast 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 and serving the
public good

11. HealthSphere Insights | 11
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, primary and
secondary 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 Work Plan, Annual
Activity Report and website.
Structural Genomics Consortium

12. HealthSphere Insights | 12
IP policies that balance the needs of individual partners 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
IP ownership terms are frequently subject to negotiations to address
the (often) competing priorities of various partners.
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

13. HealthSphere Insights | 13
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

14. HealthSphere Insights | 14
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
IP remains with originator; non-exclusive license option
Pfizer has the first option to license outputs
‘No strings attached’
There is appetite to experiment with different models that support
integration of industry with academic/NFP collaborators.

15. HealthSphere Insights | 15
Conclusions
Spectrum of PDPs has widened, ranging from addressing ‘market failures’ in
neglected diseases to broadly de-risking product development
Governance, communication and IP/access strategies have diversified—with a
common predisposition toward openness and collaboration
Experimentation with flexible partnership models to advance healthcare
solutions in an environment of constrained resources will continue

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