1 wg on gspa financing jan 12-13, 2009 public private partnerships for product development...
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1WG on GSPA FinancingJan 12-13, 2009
Public Private Partnerships for Product Development
Platforms, Lessons and Challenges for GSPA
Robert Ridley
Director, TDR
2WG on GSPA FinancingJan 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 2-940286-21-3
3. Upcoming G-FINDER Publication and Report
3WG on GSPA FinancingJan 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): 549-561
4WG on GSPA FinancingJan 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
5WG on GSPA FinancingJan 12-13, 2009
Private SectorPreferential Pricing
Public Sector Reduction of Cost
and Risk
The Basis of the PPP Deal(Cost-effective for both sectors)
6WG on GSPA FinancingJan 12-13, 2009
The PPP Deal in More Detail – MMV example
Taken from ref. 2 on slide 2
7WG on GSPA FinancingJan 12-13, 2009
Significant Growth of PPP's in late 1990's
Taken from ref. 2 on slide 2
8WG on GSPA FinancingJan 12-13, 2009
A lot of activity!(let a thousand flowers bloom?)
ACHAP(Botswana) GET 2020
The Global Fund for Aids, TB & Malaria
Stepping Forward
IIDRI(leishm. et al)
FundsFlow
Coordin/DiseaseControl
New Prod.R&D
Prod.Transfer
Prod.Distrib.
Operat.Research
Prevention/Vaccine Treatment/Drug Diagnosis/Tests Advocacy/HealthEduc/Community Mobiliz
MDPDiflucan
ActionTB TBDI
GDF
SEAMSEAM
MSFDND
TBMalaria
AIDS/HIV
OTHER
GAELF
ITI Coartem
SDI
IAVI JPMW
Stop TB
MMV
MIM
MVPMVI TB Alliance
SequellaFound.
AAI
Artesunatesuppo
EMVI
GAIN
GAELAPOC
GAVI & VF GPEP
Roll Back Malaria
HIN
IPAAA
Lap-dap
MNT
PDVI
SIGN
SSI
Vision2020
CVP
CONRAD
CICCR
DVP
GWEP
GMP HVI
HACI
NetMarkPlus
ICCADD
PHW
Securethe
Future
Vira-mune
DP
AMD
ConceptFoundation
CCA
GBC
GRI
IOWH
IPM
PSI
TB Solutions (Sequella F.)TB Solutions (Sequella F.)Partners(MDRT)
VITA
GFUNCHPTN
AAACPA
ECI
HVDDT
UNFPAcontraaccess
TFCSD
LFI
INDEPTH
TBMalariaAIDS/STDOther
Size ~Funding
Italics = Global
Note: Funding levels preliminarySource: BCG Analysis, Bill & Melinda Gates Foundation Website, IPPPH database, Partnership websites
Micro-bicides
9WG on GSPA FinancingJan 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
10WG on GSPA FinancingJan 12-13, 2009
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
11WG on GSPA FinancingJan 12-13, 2009
MMV example
12WG on GSPA FinancingJan 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
13WG on GSPA FinancingJan 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
14WG on GSPA FinancingJan 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
15WG on GSPA FinancingJan 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 toSuperior Interventions
DEC leadership in Research
Harmonised global Research efforts
2
3 Innovation Access
16WG on GSPA FinancingJan 12-13, 2009
Stewardship / Priority Setting
• Biennial Report 'status of infectious disease research'
tropIKA.net
Disease and ThematicReference Groups
Country Relevancestakeholder
17WG on GSPA FinancingJan 12-13, 2009
Decentralised Approach
• Reference groups for research and priority assessments
DRG1
DRG2
DRG3DRG4
DRG5DRG6
TRG1
TRG2
TRG3
TRG4
DRG3
18WG on GSPA FinancingJan 12-13, 2009
Empowerment / Capacity Building
• Focus on leadership development
19WG on GSPA FinancingJan 12-13, 2009
• TDR teams managed through Country Institutions• Mobilization of capacity
Regional coordinatorsCoordination and Implementation Centres
Decentralised Approach
20WG on GSPA FinancingJan 12-13, 2009
Innovation Gap for Products
Sources: TDR, MMV, DNDi, TB Alliance, etc.
INNOVATION GAP
100.0
30.0
19.5
10.7
5.8 4.01.9 1.3 1.3
Attrition Rates and Current Neglected Disease Pipelines
21WG on GSPA FinancingJan 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
22WG on GSPA FinancingJan 12-13, 2009
Compounds(Known rationale,diverse, natural
products)
Validated Drug Targets
HTS
Target PortfolioNetwork
HIT
S CapacityBuilding/
Fellowships
QualityLeads
Optimization Drug Candidates
In
Vitro/Vivo
Screening
Network
Medicinal
Chemistry
Network
PK/
Metabolism
Network
LE
AD
S
Example of Integrated Drug Discovery Platform Network of Networks / Partnership Model for
innovation
Nwaka and Hudson 2006
HIT
S
Interface with other players
23WG on GSPA FinancingJan 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
24WG on GSPA FinancingJan 12-13, 2009
Mapping of Health Products R&D in the African Continent
25WG on GSPA FinancingJan 12-13, 2009
Power of Networks – from business to social impact
26WG on GSPA FinancingJan 12-13, 2009
Quality Assured DiagnosticsGuidelines and Evaluation Networks
HATVLTBSCHISTO
DENGUEMALARIASTI
Cambodia
Nepal
India
China
Russia
Sri Lanka
Bangladesh
Viet NamPhilippines
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
27WG on GSPA FinancingJan 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
28WG on GSPA FinancingJan 12-13, 2009
More than research is needed for impact
29WG on GSPA FinancingJan 12-13, 2009
Many constituencies sharing the costs
National OECD
National MIC
National LIC
WHO
Health RelatedIndustries
Foundations
NGO / Civil Society
Intl. Agencies
30WG on GSPA FinancingJan 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
31WG on GSPA FinancingJan 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