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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

Dr John Reeder, Director TDR

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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• 67th 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 • 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.

67th WHA Request to TDR

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• Report published March 2016.

• 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

TDR report: Health Product R&D Financing

http://www.who.int/tdr/capacity/gap_analysis/en/

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

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Context: Impact of the market on the product pipeline

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How much funding would make an impact?

The Portfolio-To-Impact (P2I) model

Calculates costs based on expected pipeline launches

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

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

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Evaluating Financing Strategies

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Evaluating Financing Strategies

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What the P2I model can and cannot be used for …

What the model can be used for … 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

• 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

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Potential Pipeline and Costs: medium-size pooled fund with a mixed-model strategy

Portfolio by numbers per year indicated

Annual total costs (US$ millions)

Reaching a steady state

in 10 yrs

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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’

Toolkit for SWG Portfolio Management

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Proposed TPP structure for

therapeutic (Rx) products

Details/ example attribute description

Dosing regimen • Dosing schedule/Pill burden

Product • Overall product description (e.g. single vs. combination drugs)

Target populations • Patient populations

Formulation • Drug formulation

Use setting • Clinical use/convenience

Price • Cost per treatment / Total cost per patient

Shelf life, stability • Storage requirements /Shelf life, stability

Patient access

• Clinical efficacy (day 7) /(day 28) • Rate of onset of action • Bioavailability • Relapse prevention

Clinical characteristics

Product performance

Other characteristics • Other Other characteristics

Microbiological characteristics

• Transmission blocking • Proportional reduction in parasite Load • Resistance • Specificity

• Clinical safety and tolerability, ssafety monitoring requirement • Safety in special populations/ contraindications (pregnancy, infants)

Safety

Interactions • Drug-drug interactions • Compatibility with potential partner drugs

Route of administration • Route of Administration

Context and product overview

• Product indication Indication

• Target countries Target setting for deployment

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Framework for portfolio prioritization

[TPP fit x Timescale to launch x Impact on DALYs x Risk of failure]

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Proposed Governance Structure

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Proposed Governance Structure

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Different Set-ups for SWG: advantages and disadvantages

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Proposed SWG Composition

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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.

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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

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TDR Team

Robert Terry, Manager Knowledge Management Ryoko Miyazaki-Krause, Technical Officer John Reeder, Director

Health Product Research & Development Fund