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Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

B
Workshop Agenda

Day 1

February 22, 2010

House of Sweden

Anna Lindh Hall

2900 K Street, NW

Washington, DC 20007


Background:

This workshop will examine federal policies and activities that relate to discovery through approval of medical countermeasures (e.g., vaccines, drugs, and diagnostics) for responding to public health emergencies with the potential to rapidly overwhelm the public health and medical systems (e.g., terrorism and pandemic flu). The workshop will explore potential opportunities to enhance this enterprise by evaluating other models or systems that have similar goals of developing medical products with low commercial viability. 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. The countermeasures research and development (R&D) enterprise encompasses many partners from across the federal government, states, and industry, which need to function together to develop the medical countermeasures necessary to sustain

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

national health security. However, certain structural, strategic, and technical elements of the enterprise continue to impede research, development, and production of medical countermeasures. 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.

  • Examine strategies to further enhance the translation of early phase investments in basic science into potential public health interventions.

  • Identify and discuss models for enhancing current partnerships and establishing new ones among federal programs, innovators, and the commercial marketplace to enhance our nation’s capabilities to meet public health emergency preparedness goals.

  • Consider market forces acting on the advanced development biodefense community (pharma/biotech) that incentivize/disincentivize efforts to develop and license products in support of the national response.

  • Examine ways the regulatory oversight process for public health emergency medical countermeasures might evolve and identify ways to enable more efficient approval and use.

  • Review the innovative approaches being used to advance drug development for orphan diseases (i.e., rare, neglected, or tropical diseases) or any other area that does not have a ready and sustainable commercial market (e.g., oncology therapeutics), and identify the shared challenges and opportunities for strategies that might be adopted by the Enterprise.

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

Working Dinner

6:00 p.m.

Welcome, Introductions, and Charge to Workshop Participants

 

GAIL CASSELL, Workshop Chair

Vice President, Scientific Affairs and

Distinguished Lilly Research Scholar for Infectious Diseases

Eli Lilly and Company

6:15 p.m.

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)

 

ROBERT KADLEC

Vice President

Global Public Sector

PRTM

6:55 p.m.

Optimizing the Medical Countermeasure Product Pipeline from the Science Base Through Advanced Development (Paper 2)

 

GEORGE KORCH

Senior Science Advisor

Principal Deputy Assistant Secretary for Preparedness and Response

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

7:15 p.m.

Synthesis of Business Models and Economic and Market Incentives for Vaccines and Therapeutics (Paper 3)

 

JAMES GUYTON

Principal

Public Health and Biodefense Practice

PRTM

7:35 p.m.

National Biodefense Science Board (NBSB): 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.

ADJOURN

Day 2

February 23, 2010

House of Sweden

Alfred Nobel Hall

2900 K Street, NW

Washington, DC 20007

8:00 a.m.

Welcome and Introductions

 

GAIL CASSELL, Workshop Chair

Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases

Eli Lilly and Company

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

8:10 a.m.

Charge to Workshop Participants and Overview of the Federal Public Health Countermeasures Enterprise: Challenges and Opportunities

 

NICOLE LURIE

Assistant Secretary for Preparedness and Response

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

8:30 a.m.

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?

 

PHILIP RUSSELL

Board of Trustees

Sabin Vaccine Institute

9:05 a.m.

International Approaches to Countermeasure Research, Development, and Approval

 

MARIA JULIA MARINISSEN

Team Leader, International Partnerships and Initiatives

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

9:20 a.m.

Defining the Steps of the Critical Pathway: Strategies to Move Forward

 

MARIETTA ANTHONY

Associate Director

Arizona Center for Education & Research on Therapeutics

Critical Path Institute

9:35 a.m.

Commercial Challenges: Perspectives from the Biotech Industry

 

ERIC ROSE

CEO and Chair, Board of Directors

Siga Technologies, Inc.

9:50 a.m.

Commercial Challenges: Perspectives from Big Pharma

 

JOHN REX

Infection Clinical Vice President

Oncology & Infection Therapy Area

AstraZeneca

10:05 a.m.

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.

  • Explore how the considerations of various end users should inform the design of the Enterprise and developmental product profiles.

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
  • Provide CDC and state public health practice experiences and lessons regarding H1N1 pandemic medical countermeasure policies, distribution, and uses.

  • Provide examples of challenges and opportunities faced in developing an anthrax medical countermeasures distribution model.

  • Identify the issues from H1N1 experiences that can be generalized or transferred to questions about the broad range of medical countermeasure programs.

10:45 a.m.

Session Introduction

 

MONIQUE MANSOURA, Session Chair

Director for Medical Countermeasure Policy, Planning and Requirements

Office of the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

10:50 a.m.

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

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

11:10 a.m.

Discussion with Attendees

11:40 a.m.

LUNCH: Atrium Lounge

SESSION III:
OPTIMIZING THE RESEARCH AND DEVELOPMENT ELEMENTS OF THE ENTERPRISE

Session Objectives:

  • 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.

  • Identify and discuss the critical paths and systems approaches needed to optimize the research, development, and approval elements of the medical countermeasures development enterprise.

  • Propose strategies to optimize the federal public health countermeasures enterprise.

  • Identify and discuss models for enhancing collaboration and coordination among relevant federal programs. Examine the enabling technologies and infrastructures that will be necessary.

12:30 p.m.

Session Introduction and Objectives

 

ROBERT KADLEC, Session Chair

Vice President

Global Public Sector

PRTM

12:35 p.m.

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.

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

 

  • Explore opportunities to optimize the public health emergency medical countermeasures enterprise.

    • Propose strategies for enhancing collaboration and coordination within the enterprise, taking into account constraints related to ongoing programmatic activities, budget cycles, overlapping goals, and limitations due to existing federal regulations and departmental policies.

 

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

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

 

Perspective of Prior Leadership

 

D. A. HENDERSON

Former Director, Office of Public Health Emergency Preparedness

Director of WHO Smallpox Eradication Program

Distinguished Scholar, Center for Biosecurity of UPMC

1:30 p.m.

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.

  • Identify potential other models to improve innovation based on national priorities.

  • Examine whether the structure and nature of current investments in science lead to the intended result of potential products or product candidates.

  • Discuss how the Enterprise can be the most collaborative and constructive partners with industry to ensure efficient product development.

  • Discuss how the current investment in basic science can be better exploited to improve the MCM research infrastructure to ensure more coordinated and collaborative research that effectively advances the Enterprise.

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

2:15 p.m.

Panel Discussion: Models for Procuring Science

 

MICHAEL KURILLA, Panel Chair

Director, Office of BioDefense Research Affairs

Associate Director for BioDefense Product Development

NIAID

 

MICHAEL GOLDBLATT

President and CEO

Functional Genetics

 

DAVID WURTMAN

VP, Corporate Development

NexBio

 

BRETT GIROIR

Vice Chancellor for Research

Texas A&M

 

PAUL OWENS

Senior Director, Chorus CMC

Lilly Research Laboratories

2:50 p.m.

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

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

 

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.

ADJOURN

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

Day 3

February 24, 2010

House of Sweden

Alfred Nobel Hall

2900 K Street, NW

Washington, DC 20007

KEYNOTE PRESENTATION: FDA CONTRIBUTIONS TO THE ENTERPRISE: CURRENT AND FUTURE STRATEGIES

8:00 a.m.

Welcome and Introduction

 

GAIL CASSELL, Workshop Chair

Vice President, Scientific Affairs and

Distinguished Lilly Research Scholar for Infectious Diseases

Eli Lilly and Company

8:05 a.m.

Keynote Presentation

 

JESSE L. GOODMAN

Chief Scientist and Deputy Commissioner

Science and Public Health (Acting)

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. Examine the current scientific infrastructure at the FDA and opportunities for the agency to be better prepared for the needs of the countermeasure community. Discuss whether FDA approval should be the standard for all medical countermeasures.

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

8:35 a.m.

Session Objectives and Introduction

 

BORIS LUSHNIAK, Session Chair

Assistant Commissioner for Counterterrorism Policy

Food and Drug Administration

8:40 a.m.

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.

Discussion with Attendees

10:10 a.m.

BREAK

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

SESSION VI:
MARKET INCENTIVES IN THE DEVELOPMENT OF MEDICAL COUNTERMEASURES: IDENTIFYING MARKET OPPORTUNITIES AND ELIMINATING DISINCENTIVES

Session Objectives: How can the federal government better ensure that the emerging basic science concepts are translated into candidate countermeasures? What market issues exist, and what financial incentives are needed to overcome these issues? 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. Consider the impact of contract requirements and use policy on the private sector. Explore strategies to offset the limited commercial marketplace for emergency medical countermeasures. Examine the impact of existing liability provisions.

10:25 a.m.

Session Objectives and Introduction

 

JOHN GRABENSTEIN, Session Chair

Senior Medical Director for Adult Vaccines

Merck & Co., Inc.

10:30 a.m.

Panel Discussion: Other Models, Lessons Learned, and Success Stories from the World of “Orphan Drugs” and Challenging Commercial Products

 

CHANTAL MOREL (via telecon)

Department of Social Policy

London School of Economics

 

MARGARET ANDERSON

Executive Director

FasterCures

 

MELINDA MOREE

President and CEO

BIO Ventures for Global Health

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

 

MARLENE HAFFNER (via telecon)

President

Haffner Associates, LLC

 

VICTORIA SUTTON

Robert H. Bean Professor of Law

Texas Tech University School of Law

 

RAJEEV VENKAYYA

Director, Global Health Delivery

Bill & Melinda Gates Foundation

11:00 a.m.

Discussion with Attendees

11:30 a.m.

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

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

 

BRUCE ARTIM

Director

Federal Affairs

Eli Lilly and Company

 

BRADLEY SMITH

Senior Associate

Center for Biosecurity, UPMC

12:15 p.m.

Discussion with Attendees

12:45 a.m.

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. Discuss opportunities to leverage the expertise of pharma while retaining the innovation from biotech. Explore the role that public–private and private–private partnerships may have in supporting the development of multiproduct technologies and facilities. Identify opportunities for partnerships to help establish smoother transition from discovery to development and testing to regulatory approval for MCMs.

1:30 p.m.

Session Objectives and Introduction

 

RONALD SALDARINI, Session Chair

President

Biological Initiatives

1:35 p.m.

Panel Discussion: Partnerships: Opportunities to Leverage the Expertise of Pharma While Retaining the Innovation from Biotech

 

PHILLIP GOMEZ

Director

Global Public Sector

PRTM

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

 

TERI MELESE

Director of Research Technologies and Alliances

UCSF School of Medicine

 

ROBERT HOUSE

President

DynPort Vaccine Company, LLC

 

DOUGLAS PON

Assistant Vice President

Licensing in Global Business Development Pfizer Inc.

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. Discuss strategies to implement change, including legal, statutory, and regulatory authorities.

2:40 p.m.

Session Objectives and Introduction

 

GAIL CASSELL, Workshop Chair

Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases

Eli Lilly and Company

2:45 p.m.

Panel Discussion: Proposing Paradigm Shifts

 

GILLIAN WOOLLETT

Chief Scientist

Engel & Novitt, LLP

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

 

FRANK GOTTRON

Specialist in Science and Technology Policy

Congressional Research Service

U.S. Library of Congress

 

THOMAS MONATH

Partner

Pandemic and Biodefense Fund

Kleiner Perkins Caufield & Byers

 

BRETT GIROIR

Vice Chancellor for Research

Texas A&M

 

ERIC ROSE

CEO and Chair, Board of Directors

Siga Technologies, Inc.

 

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

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×

3:40 p.m.

Discussion with Attendees: What Options Rise to the Top? 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.

ADJOURN

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 59
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 60
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 61
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 62
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 63
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 64
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 65
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 66
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 67
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 68
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 69
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 70
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 71
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 72
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 73
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 74
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 75
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 76
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
Page 77
Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12856.
×
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During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures are essential to protecting national security and the public's well-being. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)--a partnership among federal, state, and local governments; industry; and academia--is at the forefront of the effort to develop and manufacture these countermeasures. However, despite the PHEMCE's many successes, there are still serious challenges to overcome. Government-funded medical research is not always focused on countermeasures for the most serious potential threats, and it is difficult to engage pharmaceutical and biotechnology companies to develop and manufacture medical countermeasures that have a limited commercial market.

At the request of the Secretary of the U.S. Department of Health and Human Services and the Assistant Secretary for Preparedness and Response, the IOM held a workshop February 22-24, 2010, to address challenges facing the PHEMCE. Workshop participants discussed federal policies and procedures affecting the research, development, and approval of medical countermeasures and explored opportunities to improve the process and protect Americans' safety and health.

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