Transcript Funding R&D for diseases of the developing world - Jon Pender, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) ppt, 3.88Mb

The role of the
pharmaceutical R&D
based industry in
addressing diseases
of the developing
world (DDW)
Jon D. Pender
Vice President, IP & Access, Global Health Government Affairs, Public Policy and Patient Advocacy, GSK
Chair, Global Health Committee, IFPMA
CEWG Open Forum | Geneva | 6 April 2011
© IFPMA 2011
Tackling DDW
Basic Research
- Academia
- Government
Agencies
- R&D Industry
Research &
Development
- R&D Industry
- Product
Development
Partnerships (PDP)
Manufacture
- R&D Industry
- Generic Industry
Access and
Delivery
- Governments
- Foundations
- Private Sector
- Civil Society
a combined effort to benefit
patients in developing countries
© IFPMA 2011
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)
© IFPMA 2011
R&D for a New Medicine
© IFPMA 2011
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...”; 200610, IFPMA Status Report
© IFPMA 2011
...and increasingly collaborative
# Medicines and Vaccines R&D Projects with Product Development Partnerships or alone
© IFPMA 2011
Factors for Increased DDW R&D
Product
Development
Partnerships
Large Scale
Donor Funding
for Access
Increased notfor-profit R&D
work
New
Approaches
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Current Industry DDW R&D is Mostly Early
Stage
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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
© IFPMA 2011
Funding for R&D for DDW is Growing…
© IFPMA 2011
….But a Funding Crisis is Looming
Dalberg Study 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
Estimated funding needs profile for Neglected diseases R&D drugs – 2008-2017
USD B
1.5
Mid-range funding need
for the next 10 years
USD 8.3 B
1.2
1.1
1.1
1.0
1.0
1.0
0.9
0.8
Other diseases
0.6
HAT/ VL/ Chagas
Malaria
0.5
0.3
0.4
TB
0.0
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
Sources: Global plan to Stop TB 2006-2015; MMV financial plan 2008-2017; DNDi Busi ness plan 2007-2014; Dalberg inter views and analysis.
Source: Dalberg for
IFPMA
11
© IFPMA 2011
DDW R&D Trends that will Impact Financing
Maturing
Pipeline
Some Avenues
of Research
Prove Fruitless
New Funding
Sources /
Incentives
• More projects entering expensive later stages (clinical trials)
• Need to invest in trials infrastructure & regulatory frameworks
• Regulatory delays can be significant (e.g. ~4 years in S. Africa)
• From Development, return to Basic Research (e.g. Dengue)
• Implications for total funding and for overall timeframe
• Advanced Market Commitment (AMC)
• Priority Review Voucher (PRV)
• Recognition of Importance of DDW R&D
© IFPMA 2011
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
© IFPMA 2011
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
© IFPMA 2011
Thank You!
© IFPMA 2011