tackling ddw
DESCRIPTION
The role of the pharmaceutical R&D based industry in addressing diseases of the developing world (DDW). - PowerPoint PPT PresentationTRANSCRIPT
© IFPMA 2011
Jon D. PenderVice President, IP & Access, Global Health Government Affairs, Public Policy and Patient Advocacy, GSKChair, Global Health Committee, IFPMA
CEWG Open Forum | Geneva | 6 April 2011
The role of the pharmaceutical R&D
based industry in addressing diseases
of the developing world (DDW)
© IFPMA 2011
Tackling DDWTackling DDW
a combined effort to benefit patients in developing countries
© IFPMA 2011
Industry commits resources to R&DIndustry commits resources to R&D
*(Current industry involvement & partnerships - illustrative only - not comprehensive)
Independent efforts Partnerships/academia Dedicated R&D facilities
R&D for DDW is conducted through multiple channels
© IFPMA 2011
R&D for a New MedicineR&D for a New Medicine
© IFPMA 2011
Industry R&D for DDW is Growing…Industry R&D for DDW is Growing…
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
# R&D Projects by IFPMA Companies, with Product Development Partnerships or alone
© IFPMA 2011
...and increasingly collaborative...and increasingly collaborative
# Medicines and Vaccines R&D Projects with Product Development Partnerships or alone
© IFPMA 2011
Factors for Increased DDW R&DFactors for Increased DDW R&D
© IFPMA 2011
Current Industry DDW R&D is Mostly Early Stage
© IFPMA 20119
Some DDWs are More Neglected than Others
(HAT = Human African Trypanosomiasis or “Sleeping Sickness”)
4 Approved Meds: ALL intravenous or intramuscular, 3 are v. old4 Approved Meds: ALL intravenous or intramuscular, 3 are v. old
0 Approved Meds0 Approved Meds
2 Approved Meds: 1) intravenous & side effects 2) v. expensive2 Approved Meds: 1) intravenous & side effects 2) v. expensive
2 Approved Meds: BOTH less effective against fatal late stage2 Approved Meds: BOTH less effective against fatal late stage
1 Approved Med: Effective, large donation program. Resistance?1 Approved Med: Effective, large donation program. Resistance?
3 Approved Meds: Effective, large donation program3 Approved Meds: Effective, large donation program
3 Approved Meds: Effective, large donation program3 Approved Meds: Effective, large donation program
1 Approved Med: Effective, large donation program1 Approved Med: Effective, large donation program
Source: 2010 IFPMA Status Report
© IFPMA 2011
Funding for R&D for DDW is Growing…
© IFPMA 20111111
….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
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 – 2008-2017USD B
Sources: Global plan to Stop TB 2006-2015; MMV financial plan 2008-2017; DNDi Business plan 2007-2014; Dalberg interviews and analysis.
0.4
2009
0.6
2010
0.9
2011
1.0
2012
1.1
2013
1.2
2014
1.1
2015
1.5
0.3
2008
1.0
2016
0.8
2017
Other diseases
HAT/ VL/ Chagas
Malaria
TB
0.0
1.0
0.5
Mid-range funding need for the next 10 years
USD 8.3 B
Estimated funding needs profile for Neglected diseases R&D drugs – 2008-2017USD B
Sources: Global plan to Stop TB 2006-2015; MMV financial plan 2008-2017; DNDi Business plan 2007-2014; Dalberg interviews and analysis.
0.4
2009
0.6
2010
0.9
2011
1.0
2012
1.1
2013
1.2
2014
1.1
2015
1.5
0.3
2008
1.0
2016
0.8
2017
Other diseases
HAT/ VL/ Chagas
Malaria
TB
0.0
1.0
0.5
Mid-range funding need for the next 10 years
USD 8.3 B
Source: Dalberg for Source: Dalberg for IFPMAIFPMA
© IFPMA 2011
DDW R&D Trends that will Impact Financing
© IFPMA 2011
SummarySummary
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
ConclusionsConclusions
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 201115
Thank You!