UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) Open-ended meeting of Member States 2-4 May 2016

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1 A / R D M C F / 1 A d d. 1 A g e n d a i t e m 5 ( g ) Health Product R&D Fund: A Proposal for Financing and Operation UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) Open-ended meeting of Member States 2-4 May 2016 Dr John Reeder, Director TDR 1

2 67 th WHA decision requested TDR via DG to explore a financing mechanism for product R&D in line with principles of CEWG report. Access & affordable products a key principle Delinkage of R&D costs from price Support for open innovation Voluntary pooled fund 67 th WHA Request to TDR To cover Type III, II and R&D needs of Type I suitable for developing countries. Role for Member States in Governance of coordination mechanism. 2

3 TDR report: Health Product R&D Financing Report published March How a potential pooled fund could operate under WHO Member States. Three areas of work: Modelling a financial mechanism Managing an R&D portfolio Developing toolkit for portfolio management 3

4 Process: consulted 130+ stakeholders from 80+ organizations Data collection and analysis undertaken with McKinsey & Company 4

5 Context: Impact of the market on the product pipeline 5

6 How much funding would make an impact? The Portfolio-To-Impact (P2I) model Calculates costs based on expected pipeline launches 6

7 Focus of the TDR Financial Modelling Tool: from preclinical to phase III 7

8 Focus of the TDR Financial Modelling Tool: from preclinical to phase III 8

9 Evaluating Financing Strategies 9

10 Evaluating Financing Strategies 10

11 What the P2I model can and cannot be used for What the model can be used for Directionally estimate preclinical to launch cost of a portfolio of compounds of various archetypes Get an idea of the output (# of launches) from a certain portfolio of projects and the timeframe for product launch Understand the portfolio size needed to generate a certain amount of launched products of various archetypes What the model cannot be used for Estimating the exact cost of preclinical to launch for one compound Estimating the timing or probability of success of individual compounds Estimating the full cost of a portfolio of compounds as Discovery costs or Manufacturing scale-up costs are excluded Basing any decision for an individual product on its conformance (or not) with the model 11

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14 Potential Pipeline and Costs: medium-size pooled fund with a mixed-model strategy Portfolio by numbers per year indicated Reaching a steady state in 10 yrs Annual total costs (US$ millions) 14

15 Toolkit for SWG Portfolio Management 1. Develop a compendium of Target Product Profiles (TPPs) TPP = a technical description of the product requirements Report identifies need for standards to enable comparison Compendium would form part of WHO R&D Observatory Public health need and access as top line requirements Working with a major donor on first 100+ TPPs for the Compendium 2. Use of TPPs in portfolio management + R&D mapping TPP mapped against: Who is working on the TPP Stage of development against milestone agreements Funding requirements / shortfall Greater precision in articulating priorities Better understanding of global efforts Steps towards global coordination 15

16 Proposed TPP structure for therapeutic (Rx) products Context and product overview Patient access Product performance Indication Details/ example attribute description Product indication Product Overall product description (e.g. single vs. combination drugs) Target populations Patient populations Target setting for deployment Target countries Formulation Drug formulation Route of administration Route of Administration Dosing regimen Dosing schedule/pill burden Use setting Clinical use/convenience Price Cost per treatment / Total cost per patient Clinical characteristics Microbiological characteristics Clinical efficacy (day 7) /(day 28) Rate of onset of action Bioavailability Relapse prevention Transmission blocking Proportional reduction in parasite Load Resistance Specificity Safety Interactions Shelf life, stability Storage requirements /Shelf life, stability Other characteristics Other characteristics Other Clinical safety and tolerability, ssafety monitoring requirement Safety in special populations/ contraindications (pregnancy, infants) Drug-drug interactions Compatibility with potential partner drugs 16

17 Framework for portfolio prioritization [TPP fit x Timescale to launch x Impact on DALYs x Risk of failure] 17 17

18 Proposed Governance Structure 18

19 Proposed Governance Structure 19

20 Different Set-ups for SWG: advantages and disadvantages 20

21 Proposed SWG Composition 21

22 Characteristics of the proposed WHO financing mechanism Good fit with the recommendations of CEWG report and WHA67 decision Links global targets / priorities with a mechanism to take action Focus for global R&D means steps towards better coordination Role for disease endemic and donor countries part of governance Many potential donors but ONE funding process (improves efficiency) Pooled fund mean shared risk and shared success Use of existing mechanism plus build on TDR experience and networks Proposed financial mechanism applicable for product R&D for emerging infectious diseases, AMR. 22

23 Report Conclusions & Recommendations Fund of sufficient scale (e.g. 40 projects needing $100M annually ) to ensure driving R&D forward Portfolio of funded projects should be balanced between quick wins and support for innovation in the longer term Need transparent, objective, and non-political decision-making; the SWG members must be chosen for their scientific and technical expertise as well as for their experience in decision-making Fund must access new and additional sources of funding rather than simply pool funds that are already being used for R&D in diseases of poverty i.e. role for all Member States including LMICs 23

24 TDR Team Health Product Research & Development Fund Robert Terry, Manager Knowledge Management Ryoko Miyazaki-Krause, Technical Officer John Reeder, Director 24