Tackling DDW

1. The role of the pharmaceutical R&D based industry in addressing diseases of the developing world (DDW) Jon D. PenderVice President, IP & Access, Global Health Government Affairs, Public Policy and Patient Advocacy, GSKChair, Global Health Committee, IFPMACEWG Open Forum | Geneva | 6 April 2011

2. Tackling DDW a combined effort to benefit patients in developing countries

3. Industry commits resources to R&D R&D for DDW is conducted through multiple channels Independent efforts Partnerships/academia Dedicated R&D facilities *(Current industry involvement & partnerships - illustrative only - not comprehensive)

4. R&D for a New Medicine

5. Industry R&D for DDW is Growing… # R&D Projects by IFPMA Companies, with Product Development Partnerships or alone • R&D for TDR 10 Priority Diseases: • Chagas- Dengue- Human African Trypanosomiasis- Leishmaniasis- Leprosy- Lymphatic Filariasis- Malaria- Onchocerciasis- Schistosomiasis- Tuberculosis • 1 project = 1 compound in development OR 1 screening programme for 1 disease • Source: 2005, Moran et al. “New Landscape...”; 2006-10, IFPMA Status Report

6. ...and increasingly collaborative # Medicines and Vaccines R&D Projects with Product Development Partnerships or alone

7. Factors for Increased DDW R&D

8. Current Industry DDW R&D is Mostly Early Stage

9. Some DDWs are More Neglected than Others 4 Approved Meds: ALL intravenous or intramuscular, 3 are v. old 0 Approved Meds 2 Approved Meds: 1) intravenous & side effects 2) v. expensive 2 Approved Meds: BOTH less effective against fatal late stage 1 Approved Med: Effective, large donation program. Resistance? 3 Approved Meds: Effective, large donation program 3 Approved Meds: Effective, large donation program 1 Approved Med: Effective, large donation program (HAT = Human African Trypanosomiasis or “Sleeping Sickness”) Source: 2010 IFPMA Status Report

10. Funding for R&D for DDW is Growing…

11. ….But a Funding Crisis is Looming DalbergStudy for IFPMA (2007) • Total Funding for PDPs to 2007 = USD 0.5 billion • Est. funding to take current PDP pipelines to approval AND to augment inadequate pipelines for Most Neglected Diseases = USD 8.3 billion Source: Dalberg for IFPMA 11

12. DDW R&D Trends that will Impact Financing

13. Summary • DDW R&D has increased substantially • Increased activity by Product Development Partnerships • Increased investment, in-kind & not-for-profit contribution by industry • Current DDW R&D is mainly in less expensive earlier stages • Funding requirements will increase as more projects move into clinical trials • Industry is working to help expand and improve current DDW efforts • Current volume of DDW R&D inadequate to deliver enough new medicines for all the most needy diseases • Shortfall is significant – funding to date perhaps 10 % of what is needed • Additional funding critical to achieve adequate range of new medicines & vaccines for the Most Neglected Diseases

14. Conclusions • R&D Industry welcomes new sustainable proposals that complement the current innovation system • IFPMA committed to the implementation of the relevant provisions of the GSPoA • Pools • Tech transfer • Factors for new successful proposals: • able to be implemented in the short to medium-term • sufficiently credible to engage key funding sources • endorsed by key providers of research and development • demonstrably non-erosive of existing efforts

15. Thank You!