Towards a Sustainable Global Infrastructure for Medical Countermeasures

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Towards a Sustainable Global Infrastructure for Medical Countermeasures Institute of Medicine The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products

1 Towards a Sustainable Global Infrastructure for Medical Countermeasures Institute of Medicine The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval Tuesday February 23, 2010 Maria Julia Marinissen, Ph.D. Team Leader, International Partnerships and Initiatives Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services

2 An Overall Global Shortage of Availability and Access to Medical Countermeasures (MCM) The threat of terrorism with chemical, biological, radiological/nuclear (CBRN) agents and the spread of pandemics and other potential emerging infectious diseases are a global issue It is virtually impossible for a single country to fund R&D and acquisition programs for MCM for most or all threat agents There is no large commercial market for public health emergency MCMs and there are few incentives for the pharmaceutical sector to engage in developing them The U.S. has experienced a steadily increasing demand for the supply of MCM to foreign countries 1

3 Increasing Requests to the U.S. for MCM Oct 05 WHO Agreement Smallpox vaccine Mar 06 Thailand BAT Jul 07 France for stockpile BAT 2008 Canada BAT Nov 08 Uganda BAT Feb 09 Argentina BAT for use in infants Apr Sep 09 Multiple H1N1-Related Requests Dec 09 UK Request AIG Jan 2005 March 2010 May 08 Thailand BAT for stockpile Oct 08 UK AIG 2

4 A Case for U.S. Leadership and Investment Good health is a necessary condition for economic development and global prosperity. The United States can improve the lives of millions around the world, while reflecting America's values and protecting and promoting the nation's interests (Recommendations to the new Administration IOM Committee on the U.S. Commitment to Global Health) The U.S. cannot become the world s provider for MCMs A sustainable U.S. infrastructure depends on a larger market place for MCM

5 The Goal and the Approach Goal: Build a sustainable global infrastructure for MCM to address domestic and international public health emergencies Approach: Explore and implement bilateral and multilateral collaborations with: Developed countries and international organizations (GHSI) Developing countries 4

6 Developed Countries: The Global Health Security Initiative (GHSI) GHSI is a forum of like-minded countries for high-level discussion concerning the coordination of public health emergency-preparedness and response policies for CBRN threats and pandemic influenza It was launched in 2001 by the Ministers of Health of Canada, France, Germany, Italy, Japan, Mexico, the U.K., the U.S., and the European Commission. The World Health Organization (WHO) serves as an expert advisor A Ministerial-level summit is held every year to share information and coordinate efforts to improve global health security Senior Officials and technical-level working groups meet regularly to advance specific cooperation issues 5

7 GHSI as a Pathway to Building a Global Infrastructure for MCM December 2007: HHS Secretary made a proposal to GHSI Ministers of Health to jointly address this issue 2008: ASPR held bilateral meetings with U.K., Germany, Canada, France, and the WHO to explain the BARDA and the Public Health Emergency MCM Enterprise (PHEMCE) models October 2008: ASPR held the first GHSI MCM Workshop Attended by 40 GHSI government officials Intended to share information about MCM programs in all countries, EC and WHO Determined areas of interest for collaboration: Information sharing on R&D programs Strategies for stockpiling MCM (e.g. shelf-life extension) Policy and logistics gaps in sharing MCM during international emergencies Collaboration on advanced development of specific products (e.g. pediatric formulation for Prussian Blue) 6

8 GHSI as a Pathway to Building a Global Infrastructure for MCM, continued April 2009: H1N1 influenza pandemic outbreak Limited global surge capacity to manufacture antivirals and vaccines Unequal access to MCM for middle- and low-income countries and the greater risk for global disease spread Lack of an international strategy to harmonize regulatory processes Inefficient international coordination mechanisms to provide assistance to developing countries November 2009: U.S. hosted second GHSI MCM Workshop Attended by 250 GHSI officials and technical subject matter experts from academia, the military, think tanks, and pharmaceutical companies Shared information on R&D program for CBRN and PI Compared best practices on regulatory and legal issues associated with stockpiling and using MCM, authorization for use of unapproved and offlabel use of MCMs during emergencies, stockpiling strategies, and product shelf-life extension Identified current gaps and barriers to international collaboration 7

9 Major Gaps Identified During the 2009 GHSI MCM Workshop Threat Assessment: Improved surveillance of CBRN threats and PI Information sharing and joint development of assessment tools R&D, Advanced Development: Information sharing on R&D agendas to maximize resources and avoid duplication of efforts Harmonization of countries regulatory requirements for market authorization and expedited clinical trial processes Dual-use drugs and innovative treatments for CBRN threats and PI Innovative and modernized vaccine production processes (broad manufacturing platforms) Improved communication channels between Governments and pharmaceutical industry Stockpiles/Use of MCM: Need for point-of-care diagnostic tools, stockpiles, emergency deployment plans, harmonization of treatments and utilization policies 8

10 The GHSI Path Forward Focus on a single threat, determine preparedness gaps and needs, and prioritize areas for collaboration: A scenario-based discussion involving an anthrax incident during a mass gathering event Countries and the private sector will be called upon to provide MCM to host country Contaminated people will travel around the world and MCM will be needed in multiple countries The discussion will take place in June 2010 during the GHSI Senior Officials Meeting Conclusions and potential areas for collaboration will be presented to ministers during the Ministerial Summit in December

11 GHSI Partners Progress on the Road to a Global Infrastructure for MCM Canada Canadian MCM Consortium following the PHEMCE model Equal players in the PHEMCE France A new paradigm for MCM after GHSI discussions (Interagency Coordinating Unit, creation of EPRUS) European Commission Virtual Stockpile for MCM for Pandemics Working group on the liability of MCM WHO Smallpox Vaccine Bank Considering a stockpile for MCM for rad/nuc threats GHSI MCM Workshop presentations ml#summary 10

12 Developing Countries: Building Capacity for Influenza Vaccines Goal: Build regionally-based independent and sustainable vaccine production capacity abroad Seasonal vaccine production capacity as the platform for surge pandemic vaccine production HHS/ASPR involvement: Partnership with WHO: Pilot scale influenza vaccine production, with the goal of developing commercial scale manufacturing in 10 countries Training, laboratory and manufacturing equipment, manufacturing process development, development and validation of product release assay methods, etc. Partnership with PATH: In collaboration with Vietnam to develop GMP CTM for phase 1 and 2 safety and immunogenicity human clinical trials with vaccine produced locally 11

13 International Capacity Building Total Financial Commitment : $40.4 million FY 2005 $1 million ASPR funding to Vabiotech-Vietnam FY 2006 $10 million of emergency supplemental funding to WHO; sub-granted to India, Indonesia, Vietnam, Thailand, Mexico & Brazil FY 2008 $14.4 million of annual funding to WHO; subgranted to six original grantees plus Egypt, Serbia and Romania (WHO independently funds Iran and Korea) FY 2009 $3.6 million to WHO; sub-granted to Russia s Institute for Experimental Medicine; plus $7.9 million to PATH; and $3.5 for rapid diagnostics to support clinical trials 12

14 The Path Forward January 2010: Sustainable Influenza Vaccine Manufacturing Capacity Stakeholders Workshop Hosted by WHO and HHS (BARDA and OGHA IIU) Initiated international discussions to establish a comprehensive framework and strategic plan to create regional, independent and sustainable influenza vaccine production capacity in developing and emerging economy countries. 13

15 Conclusions Building a Global infrastructure for MCM = (196 x Enterprise) Enterprise HHS will continue the international engagement to help build a sustainable global infrastructure for MCM 14

Public Health Emergency Preparedness: Looking Back, Moving Forward U.S. Efforts and International Dimensions

United States Department of Health & Human Services Office of the Assistant Secretary for Preparedness and Response Public Health Emergency Preparedness: Looking Back, Moving Forward U.S. Efforts and International