1 WG on GSPA Financing Jan 12-13, 2009 Public Private Partnerships for Product Development Platforms, Lessons and Challenges for GSPA Robert Ridley Director, TDR

2 WG on GSPA Financing Jan 12-13, 2009 Some Useful References 1.WHO Bulletin Volume 79 (8) 2001 –Special theme issue: Public-Private Partnerships 2.Combating Diseases Associated with Poverty: Financing Strategies for Product Development and the Potential Role of Public Private Partnerships –A report based on a meeting –Principle Authors: Roy Widdus and Katherine White –Publisher: Initiative on Public Private Partnerships for Health, 2004 –ISBN Upcoming G-FINDER Publication and Report

3 WG on GSPA Financing Jan 12-13, 2009 Evolution of PPPs Buse & Walt (2000) Global public-private partnerships: part I - a new development in health? Bull. World Health Organ. 78 (4):

4 WG on GSPA Financing Jan 12-13, 2009 Examples of Success (non-exhaustive) Mefloquine for malaria (1984) –Roche and Walter Read Army Institute of Research and TDR Ivermectin for onchocerciasis (1987) –Merck and TDR Cyclofem monthly injectable contraceptive (1989) –HRP, PATH, Rockefeller Foundation – Concept Foundation Eflornithine for African Trypanosomiasis (1991) –Marion Merrell Dow and TDR Miltefosine for Visceral Leishmaniasis (2002) –Zentaris, ICMR and TDR Paediatric 'dispersible' Coartem (2007) –Novartis and MMV Amodiaquine - artesunate fixed dose combination (2007) –Sanofi-Aventis and DNDi Mefloquine – artesunate fixed dose combination (2008) –Farmanguinos and DNDi Meningococcal Vaccine (2009) –SIL, WHO/IVR and PATH

5 WG on GSPA Financing Jan 12-13, 2009 Private Sector Preferential Pricing Public Sector Reduction of Cost and Risk The Basis of the PPP Deal ( Cost-effective for both sectors)

6 WG on GSPA Financing Jan 12-13, 2009 The PPP Deal in More Detail – MMV example Taken from ref. 2 on slide 2

7 WG on GSPA Financing Jan 12-13, 2009 Significant Growth of PPP's in late 1990's Taken from ref. 2 on slide 2

8 WG on GSPA Financing Jan 12-13, 2009 A lot of activity! (let a thousand flowers bloom?)

9 WG on GSPA Financing Jan 12-13, 2009 Some Important Product Development PPP's Aeras TB vaccine Foundation CONRAD (Contraceptives R and D) DNDi (Drugs for Neglected Diseases Initiative) FIND (Foundation for Innovative Diagnostics) IAVI (International AIDS Vaccine Initiative) IOWH (Institute for One World Health) IPM (International Partnership for Microbicides) MMV (Medicines for Malaria Venture) MVI (Malaria Vaccines Initiative) TB Alliance (for TB drug development) Supporting / Initiating Organizations include: WHO (TDR, HRP, IVR); Rockefeller Foundation; PATH; Wellcome Trust; Gates Foundation; MSF; various governments; World Bank; others

10 WG on GSPA Financing Jan 12-13, 2009 Focused Organizations allow for a portfolio approach (e.g. drugs) Figures taken from: Ridley (2002) Nature, 415, Nwaka and Ridley (2003) Nature Reviews in Drug Discovery 2,

11 WG on GSPA Financing Jan 12-13, 2009 MMV example

12 WG on GSPA Financing Jan 12-13, 2009 New and improved tools New and improved strategies New knowledge / discoveries New and improved interventions Broader Application of Portfolio Concept for Public Health (GSPA) New and improved strategies

13 WG on GSPA Financing Jan 12-13, 2009 New and improved tools New and improved strategies New knowledge / discoveries New and improved interventions Challenge of Translation, Capacity and Coherence New and improved strategies New and improved tools GAELF Trachoma RBM StopTB Global Fund APOC New and improved tools EDCTP New and improved tools MMV Microbicides DNDi GATB IAVI FIND NIH, Trust, Research councils, etc… Grand Challenges

14 WG on GSPA Financing Jan 12-13, 2009 Moving to the next phase? Conclusions of 2004 IPPH meeting Develop common performance measures for PPP's Coordinate clinical trial capacity development Harness potential of disease- endemic countries Ensure financial sustainability of PD PPP's Communication and Coordination Fully recruit industry potential GSPA elements Priority Setting for R&D Promoting R&D Building and Improving Innovative Capacity Transfer of Technology Management of IP Improving Delivery and Access Promoting Sustainable Financing Mechanisms Establishing Monitoring and Reporting Systems

15 WG on GSPA Financing Jan 12-13, 2009 TDR perspective Vision: An effective global research effort …… in which disease endemic countries play a pivotal role Critical Functions Stewardship Empowerment Research on Neglected Priorities 1 Enhanced Access to Superior Interventions DEC leadership in Research Harmonised global Research efforts 2 3 InnovationAccess

16 WG on GSPA Financing Jan 12-13, 2009 Stewardship / Priority Setting Biennial Report 'status of infectious disease research'

17 WG on GSPA Financing Jan 12-13, 2009 Decentralised Approach Reference groups for research and priority assessments DRG1 DRG2 DRG3 DRG4 DRG5 DRG6 TRG1 TRG2 TRG3 TRG4 DRG3

18 WG on GSPA Financing Jan 12-13, 2009 Empowerment / Capacity Building Focus on leadership development

19 WG on GSPA Financing Jan 12-13, 2009 TDR teams managed through Country Institutions Mobilization of capacity Coordination and Implementation Centres Decentralised Approach

20 WG on GSPA Financing Jan 12-13, 2009 Innovation Gap for Products

21 WG on GSPA Financing Jan 12-13, 2009 Need for Innovative and Inclusive R&D Models Industry model –Dedicated in house facility –Specific project or mini-portfolio partnership for a disease Academic model –Compound screening –Dedicated units for Genomics, HTS, Chemistry –Specific PPP projects, and network activities PPP model involving portfolio management –One or few diseases –Coordinated projects of academia, industry in the north and south. Few dedicated product R&D coordination mechanisms a)within developing countries b)for pre-competitive discovery

22 WG on GSPA Financing Jan 12-13, 2009 Compounds (Known rationale, diverse, natural products) Validated Drug Targets HTS Target Portfolio Network HITS Capacity Building/ Fellowships Quality Leads Optimization Drug Candidates In Vitro/Vivo Screening Network Medicinal Chemistry Network PK/ Metabolism Network LEADS Example of Integrated Drug Discovery Platform Network of Networks / Partnership Model for innovation Nwaka and Hudson 2006 HITS Interface with other players

23 WG on GSPA Financing Jan 12-13, 2009 Pre-competitive Innovation – Network Approach Discovery and Innovation Pre-competitive academic and private sector networks for drugs and diagnostics Agreements established, including IP New lead compounds discovered Initiation of an African Network in Abuja, October 2008 –Business plan for African based organization to be developed –Interest from other regions also

24 WG on GSPA Financing Jan 12-13, 2009 Mapping of Health Products R&D in the African Continent

25 WG on GSPA Financing Jan 12-13, 2009 Power of Networks – from business to social impact

26 WG on GSPA Financing Jan 12-13, 2009 Quality Assured Diagnostics Guidelines and Evaluation Networks HAT VL TB SCHISTO DENGUE MALARIA STI Cambodia Nepal India China Russia Sri Lanka Bangladesh Viet Nam Philippines Malaysia Thailand Columbia Venezuela Puerto Rico Cuba Argentina BrazilPeru Haiti Benin Central African Republic Swaziland Congo Gambia Uganda Ethiopia South Africa Madagascar Tanzania Kenya Sudan Egypt Nigeria Cameroon Zambia Rwanda About the cover

27 WG on GSPA Financing Jan 12-13, 2009 Quality Assured 'Point of Care' Diagnsotics Define acceptance and evaluation criteria Access and evaluate marketed diagnostics –Manufacturers agree to publication of data Acceptable tests go on to WHO procurement list –Syphilis tests (6) –Visceral Leishmania tests (1) –Gonnorea and Chlamydia (0) –TB (0) –Malaria (40 tests under evaluation) Country capacity needed for both evaluation and continued testing of batch quality

28 WG on GSPA Financing Jan 12-13, 2009 More than research is needed for impact

29 WG on GSPA Financing Jan 12-13, 2009 Many constituencies sharing the costs

30 WG on GSPA Financing Jan 12-13, 2009 Impact of Public – Private Partnership and Networks Cost and time-effective product development (and delivery?) where limited markets –Impact on health and health equity Developing innovative capabilities that can feed broadly into health and other sectors –R&D targets are increasingly set as percentage of GDP –EU target 3%; AU target 1% Linking academia, industry and public policy

31 WG on GSPA Financing Jan 12-13, 2009 Challenges Sustain (and enhance) gains of last decade Coherent competition in non-market, environment –Element 1of GSPA (Priority setting) –Pre-competitive networks Engaging Developing Countries –As generators of innovation and not just end users and evaluators of innovation Access, Delivery …. –Importance of policy dimension where markets limited or where public sector drives the market