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

1WG on GSPA FinancingJan 12-13, 2009

Public Private Partnerships for Product Development

Platforms, Lessons and Challenges for GSPA

Robert RidleyDirector, TDR


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


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


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


Private SectorPreferential Pricing

Public Sector Reduction of Cost

and Risk

The Basis of the PPP Deal(Cost-effective for both sectors)


The PPP Deal in More Detail – MMV example

Taken from ref. 2 on slide 2


Significant Growth of PPP's in late 1990's

Taken from ref. 2 on slide 2


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/HIVOTHER

GAELF

ITI Coartem

SDI

IAVI JPMW

Stop TBMMV

MIM

MVPMVI TB Alliance

SequellaFound.

AAI

Artesunatesuppo

EMVI

GAIN

GAELAPOCGAVI & VF GPEP

Roll Back Malaria

HIN

IPAAALap-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

GFUNC HPTN

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


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


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


MMV example


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 knowledge / discoveries

New and improved interventions

Challenge of Translation, Capacity and Coherence



GAELF

TrachomaRBM

StopTB

Global Fund

APOC


EDCTP


MMV

Microbicides

DNDi

GATB

IAVI

FIND

NIH, Trust, Research

councils, etc…

Grand Challenges


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


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


Stewardship / Priority Setting

• Biennial Report 'status of infectious disease research'

tropIKA.net

Disease and ThematicReference Groups

Country Relevancestakeholder


Decentralised Approach

• Reference groups for research and priority assessments

DRG1

DRG2

DRG3DRG4

DRG5DRG6

TRG1

TRG2

TRG3

TRG4

DRG3


Empowerment / Capacity Building

• Focus on leadership development


• TDR teams managed through Country Institutions• Mobilization of capacity

Regional coordinatorsCoordination and Implementation Centres

Decentralised Approach


Innovation Gap for Products

Sources: TDR, MMV, DNDi, TB Alliance, etc.

INNOVATION GAP

100.0

30.0

19.5

10.75.8 4.0 1.9 1.3 1.3

Attrition Rates and Current Neglected Disease Pipelines


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


Compounds(Known rationale,diverse, natural

products)

Validated Drug Targets

HTS

Target PortfolioNetwork

HIT

S CapacityBuilding/

FellowshipsQualityLeads

Optimization Drug Candidates

In Vitro/VivoScreeningNetwork

MedicinalChemistryNetwork

PK/MetabolismNetwork

LEA

DS

Example of Integrated Drug Discovery Platform Network of Networks / Partnership Model for

innovation

Nwaka and Hudson 2006

HIT

S

Interface with other players


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


Mapping of Health Products R&D in the African Continent


Power of Networks – from business to social impact

http://www.bni.com/Admin/Vendors/BannerClickThrough.aspx?BannerId=22&VendorId=13


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

http://www.nature.com/nrmicro/journal/v4/n9_supp/covers/


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


More than research is needed for impact


Many constituencies sharing the costs

National OECD

National MIC

National LIC

WHO

Health RelatedIndustries

Foundations

NGO / Civil Society

Intl. Agencies


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


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

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