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Public Private Partnerships for Product Development Platforms, Lessons and Challenges for GSPA

Public Private Partnerships for Product Development Platforms, Lessons and Challenges for GSPA. Robert Ridley Director, TDR. Some Useful References. WHO Bulletin Volume 79 (8) 2001 Special theme issue: Public-Private Partnerships

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Public Private Partnerships for Product Development Platforms, Lessons and Challenges for GSPA

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  1. Public Private Partnerships for Product DevelopmentPlatforms,Lessons and Challenges for GSPA Robert Ridley Director, TDR

  2. Some Useful References • WHO Bulletin Volume 79 (8) 2001 • Special theme issue: Public-Private Partnerships • 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 2-940286-21-3 • Upcoming G-FINDER Publication and Report

  3. Evolution of PPPs Buse & Walt (2000) Global public-private partnerships: part I - a new development in health? Bull. World Health Organ. 78 (4): 549-561

  4. 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. Public Sector Reduction of Cost and Risk Private Sector Preferential Pricing The Basis of the PPP Deal(Cost-effective for both sectors)

  6. The PPP Deal in More Detail – MMV example Taken from ref. 2 on slide 2

  7. Significant Growth of PPP's in late 1990's Taken from ref. 2 on slide 2

  8. OTHER AIDS/HIV Malaria TB Funds Flow CICCR The Global Fund for Aids, TB & Malaria Secure GAVI CCA GET GPEP the & VF HIN AAA APOC GAEL ACHAP (Botswana) SIGN Coordin / 2020 Future CPA Disease Roll Back Malaria Vision LFI VITA CVP GBC GWEP Control 2020 PHW TFCSD Micro - Stop TB bicides TB GMP HVI MMV HPTN Malaria MVP IPAAA I MVI JPMW TB New Prod. GFUNC AIDS/STD AMD IDRI ( leishm . et al) HVDDT IAVI Alliance DVP R&D Other Lap - Action IOWH MIM Sequella dap HACI ICC TB TBDI INDEPTH Artesunate Found. PDVI EMVI ADD IPM CONRAD SDI suppo Size ~ ECI Vira - Funding Prod. SSI PSI mune Concept GAELF Transfer DP MNT Foundation Diflucan MSF Italics = Global MDP GDF DND Prod. Stepping ITI Coar AAI NetMark UNFPA Forward Distrib . tem SEAM SEAM Plus contra access GAIN Partners Operat . GRI ( MDRT ) Research TB Solutions ( TB Solutions ( Sequella Sequella F.) F.) Prevention/Vaccine Treatment/Drug Diagnosis/Tests Advocacy/ HealthEduc / Community Mobiliz Note: Funding levels preliminary Source: BCG Analysis, Bill & Melinda Gates Foundation Website, IPPPH database, Partnership websites A lot of activity!(let a thousand flowers bloom?)

  9. 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. Focused Organizations allow for a portfolio approach(e.g. drugs) Figures taken from: Ridley(2002) Nature, 415, 686-693 Nwaka and Ridley(2003) Nature Reviews in Drug Discovery 2, 919-928

  11. MMV example

  12. Broader Application of Portfolio Concept for Public Health (GSPA) New knowledge / discoveries New and improved tools New and improved interventions New and improved strategies New and improved strategies

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

  14. 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 Moving to the next phase?

  15. TDR perspective • Vision: An effective global research effort …… in which disease endemic countries play a pivotal role • Critical Functions Stewardship Harmonised global Research efforts 1 Empowerment DEC leadership in Research 2 Research on Neglected Priorities Enhanced Access to Superior Interventions 3 Innovation Access

  16. Stewardship / Priority Setting • Biennial Report 'status of infectious disease research'

  17. TRG4 DRG6 DRG5 DRG2 TRG2 DRG4 DRG3 TRG1 TRG3 DRG1 DRG3 Decentralised Approach • Reference groups for research and priority assessments

  18. Quality Management Research Network Training Empowerment / Capacity Building • Focus on leadership development

  19. Decentralised Approach • TDR teams managed through Country Institutions • Mobilization of capacity Coordination and Implementation Centres

  20. Innovation Gap for Products

  21. 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 • within developing countries • for pre-competitive discovery

  22. Example of Integrated Drug Discovery Platform Network of Networks / Partnership Model for innovation PK/ Metabolism Network Compounds (Known rationale,diverse, naturalproducts) In Vitro/Vivo Screening Network Capacity Building/ Fellowships HITS HITS Quality Leads LEADS Drug Candidates Optimization HTS Validated Drug Targets Interface with other players Target Portfolio Network Medicinal Chemistry Network Nwaka and Hudson 2006

  23. 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. Mapping of Health Products R&D in the African Continent

  25. Power of Networks – from business to social impact

  26. Quality Assured DiagnosticsGuidelines and Evaluation Networks Russia China Nepal Egypt Haiti Bangladesh Cuba Puerto Rico India Thailand Philippines Sudan Viet Nam Venezuela Cambodia Gambia Nigeria Central African Republic Ethiopia Malaysia Columbia Benin Sri Lanka Cameroon Kenya Congo Uganda Tanzania Rwanda Peru Brazil Zambia Madagascar Swaziland South Africa HAT VL TB SCHISTO Argentina DENGUE MALARIA STI About the cover

  27. 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. More than research is needed for impact

  29. Many constituencies sharing the costs

  30. 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. 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

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