The Public Health Emergency Medical Countermeasures Enterprise Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary (2010) / Chapter Skim
Currently Skimming:
Appendix B: Workshop Agenda
Appendix B: Workshop Agenda
Pages 59-78
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 59... ...
As charged by the Secretary of Health and Human Services, the Office of the Assistant Secretary for Preparedness and Response is leading a review of the entire public health emergency medical countermeasures enterprise, to be completed in the first quarter of this year. Because there is a limited commercial market for most medical countermeasures, the government has had to create incentives to encourage private-sector pharmaceutical and biotech companies to develop the needed products.
|
From page 60... ...
The presentations and discussions at this workshop are intended to assist federal officials in conducting a thorough review of the "pipeline through approval" spectrum of our national programs and to assist in the ultimate goal of improving the efficiency and effectiveness of the countermeasures enterprise. Meeting Objectives: • Identify and discuss strategies to optimize the federal public health emergency medical countermeasures enterprise, and explore resources and/or other supporting components needed for accomplishing goals of countermeasure discovery, development, approval, and production.
|
From page 61... ...
Needs and Opportunities to Advance the Countermeasures Enterprise RANDY LARSEN Executive Director, Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism Presentation of White Papers 6:35 p.m. Case Studies of the HHS Medical Countermeasure Programs (Paper 1)
|
From page 62... ...
: Medical Countermeasure Markets and Sustainability JOHN GRABENSTEIN Senior Medical Director for Merck Vaccines Member, National Biodefense Science Board 7:50 p.m. Discussion with Attendees 8:15 p.m.
|
From page 63... ...
The Public Health Perspective on Medical Countermeasure Development, Acquisition, and Use THOMAS FRIEDEN Director Centers for Disease Control and Prevention SESSION I: THE COUNTERMEASURES ENTERPRISE: OVERVIEW OF THE CHALLENGES AND OPPORTUNITIES 8:50 a.m. Past and Present Enterprise Efforts: Why Are We Where We Are and What Models Are Most Likely to Succeed?
|
From page 64... ...
Discussion with Attendees 10:30 a.m. BREAK SESSION II: MEDICAL COUNTERMEASURE EXPERIENCES FROM PANDEMIC INFLUENZA AND ANTHRAX PLANNING: IDENTIFYING LATE-STAGE ENTERPRISE ISSUES THAT IMPACT EARLY STAGE DECISION MAKING Session Objectives: • Provide context for the countermeasures enterprise given the ultimate use of medical countermeasures.
|
From page 65... ...
Panel Presentations DANIEL JERNIGAN Deputy Influenza Director Centers for Disease Control and Prevention SUSAN COOPER Commissioner Tennessee Department of Public Health DAMON ARNOLD (via telecon) Director Illinois Department of Public Health ANDREW PAVIA George and Esther Gross Presidential Professor Division of Pediatric Infectious Diseases University of Utah School of Medicine
|
From page 66... ...
Panel Discussion: The Countermeasures Enterprise: Current Constraints and Opportunities to Move Forward • Review the structural and strategic elements of current efforts by the relevant federal agencies to support the research, development, and production of emergency medical countermeasures, including consideration of the underlying infrastructure that supports these efforts. • Discuss the current constraints of the structure and organization of the countermeasure enterprise.
|
From page 67... ...
NIH ANTHONY FAUCI Director National Institute of Allergy and Infectious Diseases, NIH Department of Health and Human Services BARDA ROBIN ROBINSON Director Office of the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response Department of Health and Human Services DoD KENNETH COLE Medical Director Nuclear and Chemical and Biological Defense Programs Office of the Deputy Assistant to the Secretary of Defense Department of Defense
|
From page 68... ...
Discussion with Attendees 2:00 p.m. BREAK SESSION IV: OPPORTUNITIES FOR ENHANCING TRANSLATION OF BASIC SCIENCE: MODELS TO IMPROVE INNOVATION THAT RESPONDS TO NATIONAL PRIORITIES Session Objectives: • Explore how our investment in basic research is currently "procured" and "exploited" to yield products for the advanced development pipeline.
|
From page 69... ...
Discussion with Attendees 3:20 p.m. Panel Discussion: Strategies to Improve Portfolio Management: Translating Basic Science PHYLLIS ARTHUR, Panel Chair Director Health & Regulatory Affairs BIO
|
From page 70... ...
70 EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE Overview: Current Process for Making Go/No Go Decisions MICHAEL KURILLA Director, Office of BioDefense Research Affairs Associate Director for BioDefense Product Development NIAID Panel Discussion DAVID PERRYMAN President & CEO Zirus GEORGE PAINTER CEO Chimerix TYLER MARTIN Chief Medical Officer Dynavax PATRICK IVERSEN Senior Vice President Strategic Alliances AVI BioPharma JOHN REX Infection Clinical Vice President Oncology & Infection Therapy Area AstraZeneca 4:00 p.m. Discussion with Attendees 5:00 p.m.
|
From page 71... ...
Food and Drug Administration SESSION V: OPPORTUNITIES FOR ACCELERATING APPROVAL OF MEDICAL COUNTERMEASURES: EVOLVING THE REGULATORY FRAMEWORK Session Objectives: Review current regulatory authority and discuss current barriers to approval of products emerging from the countermeasures enterprise. Identify and discuss innovative approaches to facilitate effective regulation of countermeasures for rapidly emerging and/or rare public health threats, while still ensuring appropriate review of safety and efficacy data.
|
From page 72... ...
Panel Discussion GERALD PARKER Principal Deputy Assistant Secretary Office of the Assistant Secretary for Preparedness and Response Department of Health and Human Services MARY PENDERGAST Founder, Pendergast Consulting Former Deputy Commissioner of the FDA JEANNE NOVAK CEO and President CBR International Corp. LUCIANA BORIO Medical Reviewer Office of Vaccine Research and Review Center for Biologics Evaluation and Research Food and Drug Administration GAIL CASSELL Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases Eli Lilly and Company 9:40 a.m.
|
From page 73... ...
Explore the impact of the animal efficacy rule and opportunities to decrease its impact on the product development time frame while still ensuring appropriate review of safety and efficacy data. Discuss the advantages and disadvantages of establishing a consolidated federal intramural program to support translational and preclinical studies.
|
From page 74... ...
Panel Discussion: Market Incentives WESLEY YIN Assistant Professor Department of Economics Boston University THOMAS MONATH Partner Pandemic and Biodefense Fund Kleiner Perkins Caufield & Byers DAVID GILBERT Director Infectious Diseases Providence Health & Services DAVID RIDLEY Assistant Professor The Fuqua School of Business Duke University
|
From page 75... ...
LUNCH: Atrium Lounge SESSION VII: THE ROLE OF PARTNERSHIPS AND ALTERNATIVE BUSINESS MODELS Session Objectives: Examine how partnerships (public–private, private– private, and public–public) and alternative business models can be established to mitigate the risk for each sector.
|
From page 76... ...
2:05 p.m. Discussion with Attendees SESSION VIII: "BLUE SKY" SESSION Session Objectives: Explore options to bring about a paradigm shift to the public health countermeasures enterprise from research, development, and approval.
|
From page 77... ...
BRUCE ARTIM Director Federal Affairs Eli Lilly and Company CHUCK LUDLAM Former Counsel, Senator Joseph Lieberman Former Principal Lobbyist for The Biotechnology Industry Organization PHILLIP GOMEZ Director Biodefense and Public Health Practice PRTM
|
From page 78... ...
What Have We Not Considered? GAIL CASSELL, Workshop Chair Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases Eli Lilly and Company 4:30 p.m.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.