Financing Influenza Vaccine R&D WHO GAP-II Geneve, Switzerland July 13, 2011 Robin Robinson, Ph.D. Deputy Assistant Secretary & Director HHS/ASPR/BARDA 0
Vaccine Development is Risky, Lengthy, & Expensive PHASES PRODUCT PIPELINE Preclinical Development IND Discovery Phase I Phase II Phase III Licensure NIH NIH ($11.8B) Valley of Death BARDA ARD BARDA ($540M) BLA Production & Delivery Project BARDA BioShield ($5.6B) Licensed Product 1-3% 5-17% 10-25% 18-35% 45-70% 90% PROBABILITY OF SUCCESS TO LICENSURE TIME PIPELINE PHASE COST 3-7 yr 0.5-2 yr 1-2 yr 2-3.5 yr 2.5-4 yr 1-2 yrs $100M -130M $60-70M $70M-100M $130M-160M $190M-220M $18M-20M 1
Pre-2003 Pandemic Influenza Vaccine Goal & Strategy Egg-based Vaccines Demand for Healthcare Services 22-24 24 weeks Increase Supplies of Critical Materiel Current Healthcare Capacity 2
Pre-2004 Targets for Influenza Vaccine R&D Funding Basic research: virology, immunology & epidemiology Product R & D Virus strains Vaccine discovery Vaccine early development Vaccine advanced development Vaccine post-licensure Surveillance: virus strain, disease burden, & vaccine effectiveness Vaccine AE monitoring
Influenza Vaccine R&D Funding: Age of Public Private Partnerships Vaccine Industry Governments: Intramural & Extramural Academia Non-Government & Philanthropic Organizations Venture Capital
Pre-2004 Influenza Vaccine R&D Funding Sources $100 s M Govt. Funding Primarily for Basic Research & Early Vaccine Development through Annual Appropriations 5
U.S. Pandemic Influenza Strategic Plan (2005) Establish domestic production capacity and stockpiles of countermeasures to ensure: immediate vaccination of front-line personnel and at-risk populations; and vaccination of the entire population after the emergence of a virus with pandemic potential;
Influenza Vaccine R&D Strategy - 2005 Near-term Fortify egg-based influenza vaccine mfg. capacity Mid-term Develop antigen- and dose-sparing vaccine approaches with adjuvants Develop cell-based influenza vaccines Long-term Develop recombinant- and molecular-based influenza vaccines Develop universal influenza vaccines
2004-2009 2009 Pandemic Influenza Vaccine Goal & Strategy Cell-based Vaccines + Adjuvants H5N1 Pre-Pandemic Vaccines Egg-based Vaccines Demand for Healthcare Services 22-24 24 weeks Increase Supplies of Critical Materiel Current Healthcare Capacity 8
2005-2009 Targets for Influenza Vaccine R&D Funding Basic research: virology, immunology & epidemiology Product R & D Virus strains Vaccine discovery Vaccine early development Vaccine advanced development Vaccine post-licensure Surveillance: virus strain, disease burden, & vaccine effectiveness Vaccine manufacturing: mfg. process, lot release assays, & stockpiling Vaccine distribution Vaccine administration Vaccine AE monitoring
Pre-H1N1 Pandemic Influenza Vaccine R&D Funding Sources $100 s M $10 s B USG Funding through Annual (Basic Research & Early Development) & Supplemental Appropriations (Advanced Development. Mfg. & Stockpiling) 10
Influenza Vaccine R&D Funding: Post-2009 Challenges Pandemic vaccination realities Post-pandemic fatigue among senior leaders in all sectors Budget austerity in governments Economic pressures in industry from stockholders for reliable opportunities & faster ROI Venture capital investments in biotech are drying up
Post-2009 2009 Pandemic Influenza Vaccine Goal & Strategy Egg- & Cellbased Vaccines + Adjuvants Pre-Pandemic Vaccines Recombinant Vaccines Demand for Healthcare Services 12-16 weeks 16-20 weeks Increase Supplies of Critical Materiel Current Healthcare Capacity 12
Changing Tides for Influenza Vaccine R&D Funding Sources $100 s M $10 s B $1 s B 13
Influenza Vaccine R&D Funding: Possible Solutions Sets Near-term Nurture Public Private Partnerships with more cooperative agreements in light of static funding (e.g., use Govt.-sponsored core services) Shorten influenza vaccine manufacturing timeline Utilize multi-purpose product technologies Complete studies for cell-based vaccines towards licensure Complete studies for vaccines with adjuvants towards licensure for pandemic & some seasonal usages in special populations Support multi-product, flexible mfg. facilities Mid-term Support vaccine distribution & administration R&D Continue support of recombinant- & molecular-based vaccines Support vaccine R&D from end-to-end (discovery administration) Long-term Continue support for universal influenza vaccine development