Sustainability: The R&D Pipeline for Neglected Disease Vaccines Elizabeth L. Ponder, PhD May 4, 2011...
-
Upload
roy-leonard -
Category
Documents
-
view
214 -
download
0
Transcript of Sustainability: The R&D Pipeline for Neglected Disease Vaccines Elizabeth L. Ponder, PhD May 4, 2011...
Sustainability: The R&D Pipeline for Neglected Disease Vaccines
Elizabeth L. Ponder, PhD
May 4, 2011
Global Vaccines 202X: Access, Equity, Ethics2-4 May 2011
The Franklin Institute Science MuseumPhiladelphia, USA
BIO Ventures for Global Health (BVGH)
We have a unique perspective. We look at health problems facing poor countries through a dual lens:
Expertise in Industry Expertise in Global Health
Mission: BIO Ventures for Global Health is an independent, non-profit organization whose mission is to save lives by accelerating the development of novel, biotechnology-based drugs, vaccines, and diagnostics that address the unmet medical needs of the developing world.
Mission: BIO Ventures for Global Health is an independent, non-profit organization whose mission is to save lives by accelerating the development of novel, biotechnology-based drugs, vaccines, and diagnostics that address the unmet medical needs of the developing world.
The Global Health Primer provides a landscape analysis for neglected disease products
• Updated online database for 17 neglected diseases: www.bvgh.org/globalhealthprimer.aspx
• Covers drugs, vaccines, and diagnostics
• Highlights product needs and opportunities
There are 12 approved and 160 vaccines in development for neglected diseases
106 Products in Clinical
Development
Preventive vaccines receive the largest portion of neglected disease R&D funding
G-FINDER ANALYSIS:
Mary Moran & Javier Guzman, Policy Cures
Neglected disease vaccines are in development by 169 organizations representing 35 countries
Developer Type Number of Organizations
Academic/Research Institution 67
Biopharmaceutical Company 52
Government 29
Product Development Partnership (PDP)
17
Other 4
Total 169
80
55
12
1210
6
Number of Developers per Country
Looking across the vaccine landscape, several trends emerge:
• Newer vaccines in development for neglected diseases are increasingly scientifically complex due to new technologies and targeting more challenging organisms
• Proof of concept trials for new vaccines are progressing, but scientific learning beyond efficacy from these efforts has been minimal
• A lack of financing options, clear policy statements, or WHO prequalification of an approved vaccine severely limits access
Early Innovation
Clinical Proof of Concept
Approval and Access
Early-stage neglected disease vaccines focus on newer technologies
No approved vaccines in humans
In use in approved vaccines
Parasitic diseases represent the majority of neglected diseases but the minority of products
Unicellular parasitic diseases:• Malaria• Sleeping sickness• Chagas disease• Leishmaniasis
Multicellular parasitic diseases:• Schistosomiasis• Soil transmitted helminthiasis• Onchocerciasis• Lymphatic filariasis
Proof of concept studies are advancing but still have a long way to go
Disease Proof of ConceptR&D Investment
(G-FINDER)
ETEC Partial protection from Cholera vaccine $15.6 million
Dengue Data expected Q4 2012 $115.7 million
HIV 30% efficacy in Phase III trial $1,374 million
Malaria30-50% efficacy in a series of Phase II trials
$116.4 million
SchistosomiasisPhase III trial as adjunct to MDA in progress
$9.5 million
ShigellaOn market vaccine in China provides ~60% efficacy
$14.0 million
Tuberculosis BCG protects against systemic TB $187.0 million
PATH and BVGH (2011) The Case for Investment in Enterotoxigenic Escheriscia coli Vaccines.Clemens JD et al. (1988) J Infect Dis 158: 372-377. Peltola H et al. (1991) Lancet 338: 1285-1289. Rerks-Ngarm S et al. (2009) NEJM 361: 2209-20. Casares S et al. (2010) Vaccine 28: 4880-94. PAHO et al. (2004) “Progress in Shigella vaccine development.” in Vaccines: preventing disease & protecting health. Colditz GA et al. (1994) JAMA 271: 698-702WHO (2004) Weekly Epidemiological Record 79: 27-38Moran M et al. (2011) Neglected Disease Research and Development: Is the Global Financial Crisis Changing R&D? Policy Cures.
Neglected disease vaccines challenge the traditional industry model for clinical evaluation
As products fail, or show only partial efficacy, how do we decide what to do next?
• Traditional Industry Model: How can we help vaccines that will fail, fail faster?
• For Neglected Diseases: How can we help vaccines that will fail, not just fail faster, but also fail smarter? How can we maximize learning from vaccine trials with partial efficacy?
Clear policy and financial support improve vaccine access
Disease Product (Company)Initial
ApprovalYear of WHO
Prequalification GAVI supported? Current UsePneumococcal Disease
Synfloris (GSK) Europe,
20092009
Yes, AMC44 countries as of
2009Prevnar 13 (PCV13 – replacement for PCV 7 which was approved in the U.S. in 2000; Pfizer)
U.S., 2010 2010
Rotavirus RotaTeq (Merck) U.S., 2006 2008Yes
23 countries as of 2009Rotarix (GSK) U.S., 2008 2009
Clear policy and financial support improve vaccine access
Disease Product (Company)Initial
ApprovalYear of WHO
Prequalification GAVI supported? Current UsePneumococcal Disease
Synfloris (GSK) Europe,
20092009
Yes, AMC44 countries as of
2009Prevnar 13 (PCV13 – replacement for PCV 7 which was approved in the U.S. in 2000; Pfizer)
U.S., 2010 2010
Rotavirus RotaTeq (Merck) U.S., 2006 2008Yes
23 countries as of 2009Rotarix (GSK) U.S., 2008 2009
Cholera Dukoral (SBL Vaccin, Sweden)
Sweden, 1991
2001
NoLimited, need
more data on roll in outbreaks
Shanchol (Shantha Biotechnics, India)
India, 2009 -
mORCVAC (VaBiotech, Vietnam)
Vietnam, 2009
-
TyphoidVivotif (Crucell)
Switzerland, 1981
-No, shortlisted for
future support
In travelers and select endemic
regionsTyphim Vi (Sanofi-Pasteur)
U.S., 1994 -
Key needs for future neglected disease vaccine development include:
• A focus on parasitic disease vaccine development to understand the technical feasibility and potential health impact
• Increased investment in the integration of scientific research questions with efficacy studies for vaccines to maximize return on public investment
• More operational and clinical research on existing vaccines to support the development of clear policy statements, accelerate WHO prequalification, and inform decisions on new product needs
Early Innovation
Clinical Proof of Concept
Approval and Access