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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

A

Workshop Agenda

March 29, 2011

Venable Conference Center
E11200 Capitol Room
575 7th Street, N.W.
Washington, DC 20004


Background:

During public health emergencies such as influenza pandemics or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, drugs, diagnostics, and other medical countermeasures (MCMs) are essential to protecting national security and the well-being of the public. As highlighted in the March 2010 report of the National Biodefense Science Board, “FDA has not been able to fulfill its implicit national security mission, in large part because of a lack of resources…. It is imperative for America’s health and progress for FDA to be provided adequate resources to bring its regulatory science into the 21st century…. Doing so will greatly enhance the FDA’s ability to support MCM development and licensing.”

In August 2010, the Department of Health and Human Services (HHS) released its Public Health Emergency Medical Countermeasures Enterprise Review, which made numerous recommendations to transform the public health emergency countermeasures enterprise to increase its speed, agility, capacity, and success rate, including the promotion of regulatory innovation and investment in regulatory science at FDA. To promote regulatory innovation and investment in regulatory science at FDA, FDA has established an MCM initiative. This initiative seeks to accelerate MCM development towards approval and consists of a multifaceted action plan that includes (1) enhancing the regulatory review process for the highest priority MCMs and related technologies; (2) advancing regulatory science

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

to support MCM development and evaluation; and (3) modernizing the legal and regulatory framework to support public health preparedness and response. Regulatory science for MCM development and evaluation is essential for FDA to establish clear regulatory pathways for product approval based on the most advanced scientific foundations available and realize the promise of new technologies for flexible, rapidly scalable development and manufacturing of vaccines and other MCMs.

This workshop will (1) examine ways to advance regulatory science for MCM development and regulatory evaluation; (2) identify scientific opportunities to improve, simplify, or speed MCM development; and (3) identify tools and methods to improve the predictability and success rate of candidate MCMs.

Meeting Objectives:

  • Provide a broad overview of current efforts underway at FDA and other agencies within HHS and the Department of Defense (DoD) to support the research, development, evaluation, and production of MCMs.
  • Review novel scientific methodologies used by academia and indusry to facilitate development of next generation vaccines, biologics, drugs, and devices.
  • Identify major gaps in currently available tools to predict and evaluate product safety, efficacy, and quality.
  • Identify opportunities for collaboration and coordination with FDA and among relevant federal as well as industry programs to support the MCM initiative’s regulatory science program and to develop better defined pathways for product approval.
  • Identify regulatory science tools and methodologies to address emerging technologies, targets, and novel products as well as innovative approaches for predicting safety and efficacy; for example, biomarkers and in silico modeling.
8:00 a.m. Welcome and Introductions

LESLIE BENET, Workshop Co-Chair

Professor, School of Pharmacy

University of California, San Francisco

JOHN REX, Workshop Co-Chair

Infection Clinical Vice President

AstraZeneca

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×
 
8:10 a.m. Keynote Address: Importance and Promise of Regulatory Science and Charge to Workshop Participants

JESSE GOODMAN

Chief Scientist, Deputy Commissioner for Science and Public Health

Food and Drug Administration

 
8:25 a.m. Enterprise Activities and Needs for MCM Regulatory Science

GEORGE KORCH

Acting Principal Deputy Assistant Secretary for Preparedness and Response

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

 
8:35 a.m. Overview of the MCM Initiative: Challenges and Opportunities

LUCIANA BORIO

Acting Director, Office of Counterterrorism & Emerging Threats

Senior Advisor for Medicine and Public Health, Office of the Chief Scientist

Office of the Commissioner, Food and Drug Administration

SESSION I: ENTERPRISE AND STAKEHOLDER PERSPECTIVES ON NEEDS TO ADVANCE MEDICAL COUNTERMEASURE REGULATORY SCIENCE

Session Objectives:

  • Provide a broad overview of current efforts under way at FDA and within HHS and DoD to support the research, development, evaluation, and production of MCMs.
  • Provide a broad overview of MCM development challenges and where regulatory science can advance MCM development.
  • Identify and discuss the highest-priority MCM regulatory science needs to advance MCM development.
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

Presentation/Panel 1: FDA

8:45 a.m. Session Introduction and Panel Objectives

GEORGE KORCH

Acting Principal Deputy Assistant Secretary for

Preparedness and Response

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

 
8:50 a.m. Presentations: Overview of Enterprise MCM Regulatory Science Agendas: What does the agency need?
 
  • Identify the goals and objectives of MCM regulatory science agenda from the FDA Centers.
  • Identify challenges to and information needs for MCM regulatory science programs.

CAROLYN WILSON

Associate Director for Research

Center for Biologics Evaluation and Research

Food and Drug Administration

SUSAN McCUNE

Deputy Director, Office of Translational Sciences

Center for Drug Evaluation and Research

Food and Drug Administration

MURRAY MALIN

Center for Devices and Radiological Health

Food and Drug Administration

 
9:50 a.m. Discussion/Question and Answer Session
 
10:20 a.m. BREAK
 
Presentation/Panel 2: Enterprise and Other Stakeholders
 
10:35 a.m. Panel Introduction and Objectives

MARY PENDERGAST

President

Pendergast Consulting

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×
 
10:40 a.m. Presentations and Panel Discussion: What do the partners need?
 
  • Identify MCM product development challenges that can be addressed with MCM regulatory science.
  • Identify recurrent and overarching themes for stalled MCM product development and utilization that can be addressed through MCM regulatory science.
  • Discuss highest-priority regulatory science needs to advance MCM development.

GERALD PARKER

Deputy Assistant to the Secretary of Defense for Chemical and Biological Defense Programs
(DATSD(CBD))

Department of Defense

MICHAEL KURILLA

Director, Office of BioDefense Research Affairs

Associate Director for BioDefense Product Development

National Institute of Allergy and Infectious Disease

National Institutes of Heath

RICHARD HATCHETT

Chief Medical Officer and Deputy Director

Biomedical Advanced Research and Development Authority

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

MAY CHU

Director, Laboratory Science Policy & Practice Program Office

Centers for Disease Control

RICK LYONS

Director, Infectious Disease Research Center

Chief Scientific Officer, Infectious Disease SuperCluster Colorado State University

ERIC ROSE

CEO and Chair, Board of Directors

SIGA Technologies, Inc.

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×
 
11:45 a.m. Discussion/Question and Answer Session
 
12:15 p.m. LUNCH

SESSION II: CUTTING-EDGE EFFORTS TO ADVANCEMEDICAL COUNTERMEASURE REGULATORY SCIENCE

Session Objectives:

  • Review novel scientific methodologies used by academia and industry to discover and develop next generation vaccines, biologics, drugs, and devices.
  • Identify major gaps in currently available tools to predict and evaluate product safety, efficacy, and quality.
  • Identify approaches to developing regulatory science tools and methodologies to address emerging technologies, targets, and novel products as well as innovative approaches for predicting safety and efficacy.
  • Discuss a path forward for the MCM regulatory science agenda.
  • Discuss metrics to be used for gauging success of a scientific agen1da for evaluating MCMs.
  • Examine how partnerships and other collaborative approaches can facilitate the advancement and ongoing support of regulatory science for MCM development, evaluation, and utilization.
1:00 p.m. Session Introduction and Objectives

LESLIE BENET, Workshop Co-Chair

University of California, San Francisco

JOHN REX, Workshop Co-Chair

AstraZeneca

Panelists will

  • Provide high-level description of MCM regulatory science tools and state of the science.
  • Discuss regulatory science opportunities and challenges. What is needed to advance regulatory science to undergird regulatory decisions?
  • Discuss highest-priority regulatory science needs to advance MCM development and utilization.
  • Identify opportunities for partnerships and collaboration.
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

PANEL: EX VIVO APPROACHES TO MODELING EFFICACY

1:05 p.m. Panel Objectives and Introduction

LAUREN BLACK, panel chair

Senior Scientific Advisor, Navigators

Charles River Laboratories

 
1:10 p.m. Panel Discussion: Animal Models, In Silico Models, Biomarkers
 
In Silico Models

RAMON FELCIANO

Founder & SVP of Research

Ingenuity Systems

 
Biomarkers

N. LEIGH ANDERSON

Founder & CEO

Plasma Proteome Institute

Animal Models

ELIZABETH LEFFEL
Director of Nonclinical Sciences
PharmAthene

 
1:50 p.m. Discussion with Invited Discussants and Workshop Attendees

DRUSILLA BURNS

Chief, Laboratory of Respiratory and Special Pathogens

Center for Biological Evaluation and Research

JUDY HEWITT

Chief, Biodefense Research Resources Section

Office of Biodefense Research Affairs

DMID/NIAID/NIH

VIKRAM PATEL

Office of Testing and Research

Office of Pharmaceutical Sciences, CDER

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

PANEL: SAFETY AND REAL-TIME MONITORING

2:25 p.m. Panel Objectives and Introduction

CARL PECK, panel chair

Professor, Pharmacology and Medicine

University of California, San Francisco

 
2:30 p.m. Panel Discussion: Post Deployment Surveillance and Side Effects; Toxicology Markers
 
Toxicology Markers

ROBERT HOUSE

President

DynPort Vaccine Company LLC

 
Post Deployment Surveillance and Side Effects
 

KENNETH MANDL
Faculty, Children’s Hospital Informatics Program
Harvard-MIT Division of Health Sciences and Technology

 
2:50 p.m. Discussion with Invited Discussants and Workshop Attendees

MARIETTA ANTHONY

Predictive Safety Testing Consortium

Critical Path Institute

RICHARD FORSHEE

Associate Director for Research

Office of Biostatistics and Epidemiology

Center for Biologics Evaluation and Research

HENRY FRANCIS

Center for Drug Evaluation and Research

Food and Drug Administration

ROBERT C. NELSON

Product Safety Assurance Services, Inc.

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

DONNA MENDRICK

National Center for Toxicological Research

Food and Drug Administration

 
3:20 p.m. BREAK

PANEL: DIAGNOSTICS AND STATISTICAL TECHNIQUES

3:35 p.m. Panel Objectives and Introduction

BRUCE BURLINGTON, panel chair

Independent Consultant

 
3:40 p.m. Panel Discussion: Diagnostics
 
Diagnostics

LT. COL. DANIEL WATTENDORF

U.S. Air Force

Program Manager, Defense Sciences Office

DARPA

 
3:50 p.m. Discussion with Invited Discussants and Workshop Attendees

CHARLES DAITCH

Chief Executive Officer

Akonni Biosystems

DAVID ECKER

Founder, DVP and Carlsbad General Manager

Ibis Biosciences

SALLY HOJVAT

Center for Diagnostics and Radiological Health, FDA

 
4:25 p.m. Panel Discussion: Statistical Techniques
 
Statistical Techniques

STEPHEN RUBERG

Distinguished Research Fellow & Scientific Leader, Advanced Analytics

Eli Lilly & Co.

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×
 
4:35 p.m. Discussion with Invited Discussants and Workshop Attendees

ESTELLE RUSSEK-COHEN

Acting Division Director, Division of Biostatistics

Office of Biostatistics and Epidemiology, CBER/FDA

 

JEFFREY WETHERINGTON

Research Director, Statistics

GlaxoSmithKline

 
5:00 p.m. ADJOURN

March 30, 2011

Venable Conference Center
E11200 Capitol Room
575 7th Street, N.W.
Washington, DC 20004

SESSION II, CONT’D: CUTTING-EDGE EFFORTS TO ADVANCEMEDICAL COUNTERMEASURE REGULATORY SCIENCE

Session Objectives:

  • Review novel scientific methodologies used by academia and industry to discover and develop next generation vaccines, biologics, drugs, and devices.
  • Identify major gaps in currently available tools to predict and evaluate product safety, efficacy, and quality.
  • Identify approaches to developing regulatory science tools and methodologies to address emerging technologies, targets, and novel products as well as innovative approaches for predicting safety and efficacy.
  • Discuss a path forward for the MCM regulatory science agenda.
  • Discuss metrics to be used for gauging success of a scientific agenda for evaluating MCMs.
  • Examine how partnerships and other collaborative approaches can facilitate the advancement and ongoing support of regulatory science for MCM development, evaluation, and utilization.
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×
8:00 a.m. Welcome and Day 2 Overview

LESLIE BENET, Workshop Co-Chair

University of California, San Francisco

JOHN REX, Workshop Co-Chair

AstraZeneca

PANEL: ANTIMICROBIALS, VACCINES, AND VACCINE ADJUVANTS

8:15 a.m. Panel Objectives and Introduction

LINDA A. MILLER, panel chair

Director, Clinical Microbiology

GlaxoSmithKline

 
8:20 a.m. Panel Discussion: Antimicrobials, Vaccines, and Vaccine Adjuvants
 
Antimicrobials

KEVIN JUDICE

CEO & Chief Scientific Officer

Achaogen

 
Vaccines
 

ALAN MAGILL

Director, Division of Experimental Therapeutics

Walter Reed Army Institute of Research

 
Adjuvants

DEBBIE DRANE

Senior VP R&D

CSL Biotherapies

 
9:00 a.m. Discussion with Invited Discussants and Workshop Attendees

ED COX

Center for Drug Evaluation and Research

Food and Drug Administration

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

DAVID FRUCHT

Capt., U.S. Public Health Service

Chief, Laboratory of Cell Biology

Division of Monoclonal Antibodies

CDER/FDA

BASIL GOLDING

Center for Biologics Evaluation and Research

HANA GOLDING

Chief, Laboratory of Retrovirus Research, Division of Viral Products

Office of Vaccines Research and Review, CBER

ED NUZUM

Chief, Biodefense Vaccines & Other Biological Products Development Section

Office of Biodefense Research Affairs

DMID/NIAID/NIH

ALAN SHAW

Chief Scientific Officer

Vaxinnate

 
PANEL: THE FUTURE
 
9:45 a.m. Panel Objectives and Introduction

GIGI KWIK GRONVALL, panel chair

Senior Associate, Center for Biosecurity

UPMC

 
9:50 a.m. Panel Discussion: Synthetic Biology, Computational Biology, and Platform Technologies
 
Synthetic Biology

JOHN GLASS

Senior Scientist

J. Craig Venter Institute

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×
 
Computational Biology

MICHAEL KATZE

Professor of Microbiology

University of Washington

 
Platform Technology

PAT IVERSEN

Senior Vice President of Research & Innovation

AVI BioPharma

 
10:30 a.m. Discussion with Invited Discussants and Workshop Attendees

WILLIAM FOGLER

Senior Director, Portfolio Analysis and Planning

Intrexon Corporation

DONNA MENDRICK

Director, Division of Systems Biology

National Center for Toxicological Research

Food and Drug Administration

HARVEY RUBIN

Executive Director, Institute for Strategic Threat Analysis and Response

University of Pennsylvania

 
11:00 a.m. BREAK

SESSION III: MEDICAL COUNTERMEASURE REGULATORYSCIENCE NEEDS FOR AT-RISK POPULATIONS

Session Objectives:

  • Identify needs that are specific or unique to at-risk populations (e.g., pediatric populations) that should be considered in developing a regulatory science agenda for MCM development.
  • Provide an overview of where regulatory science can advance MCM development for these populations.
  • Discuss a MCM regulatory science agenda for at-risk populations.
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×
Panelists will
 
  • Identify recurrent and overarching challenges for MCM product development, implementation, and use specific to at-risk populations that can be addressed with MCM regulatory science.
  • Discuss highest-priority regulatory science needs to advance MCM development and utilization for at-risk populations. What tools could be used to support regulatory review and determinations of use in these populations in an emergency?
    • Discuss issues for at-risk populations such as: lack of dosing information, and needs for safety and efficacy models.
    • Specific scientific gaps in treating or vaccinating pregnant women.
 
11:15 a.m. Introduction and Session Objectives

JOHN BRADLEY, panel chair

Director, Infectious Diseases

Rady Children’s Hospital San Diego

 
11:20 a.m. Panel Discussion
 
Pediatric

DAVID SIEGEL

NICHD

 
Pregnancy/OB-Gyn

CHRISTIAN R. MACEDONIA

Joint Chiefs of Staff, the Pentagon

 
11:45 a.m. Discussion with Attendees

PRAVIN JADHAV

Center for Drug Evaluation and Research

Food and Drug Administration

NANCY MESSONNIER

Centers for Disease Control

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×

LISA MATHIS

Center for Drug Evaluation and Research

Food and Drug Administration

ROBERT NELSON

Senior Pediatric Ethicist/Lead Medical Officer

Office of Pediatric Therapeutics

Office of the Commissioner, Food and Drug

Administration

 
12:30 p.m. LUNCH

SESSION IV: FUTURE DIRECTIONS—DISCUSSION WITHWORKSHOP PARTICIPANTS AND ATTENDEES

Session Objectives: Discuss what opportunities and challenges exist to implementing the models discussed at the workshop for advancing regulatory science. What should be on the agenda for regulatory science for development and evaluation of MCMs? Discuss strategies and needs to implement the MCM regulatory science agenda.

LESLIE BENET, Workshop Co-Chair

University of California, San Francisco

JOHN REX, Workshop Co-Chair

AstraZeneca

 
1:30 p.m. Discussion with Panelists and Workshop Attendees led by workshop co-chairs
 
  • Synthesize workshop discussions.
  • Propose key opportunities to develop a research agenda and roadmap for the MCM regulatory science initiative.

PHYLLIS ARTHUR

Director, Health & Regulatory Affairs

Biotechnology Industry Organization

GAIL CASSELL, Drug Forum Co-Chair

Visiting Professor, Department of Social Medicine,

Harvard Medical School Vice President, TB Drug Discovery, Infectious Disease

Research Institute, Seattle

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×
 

RICHARD HATCHETT

Chief Medical Officer and Deputy Director

Biomedical Advanced Research and Development Authority

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

CARL PECK

Professor, Pharmacology and Medicine

University of California, San Francisco

ED NUZUM

Chief, Biodefense Vaccines & Other Biological Products

Development Section

Office of Biodefense Research Affairs

DMID/NIAID/NIH

ERIC ROSE

CEO and Chair, Board of Directors

SIGA Technologies, Inc.

 
3:00 p.m. Discussion with Workshop Attendees led by workshop co-chairs

LESLIE BENET, Workshop Co-Chair

University of California, San Francisco

JOHN REX, Workshop Co-Chair
AstraZeneca

 
4:30 p.m. Closing Remarks

JEAN HU-PRIMMER

Senior Advisor for Regulatory Policy

Acting Director, MCMi Regulatory Science

Office of the Chief Scientist

Office of the Commissioner, Food and Drug

Administration

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
×
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×
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13173.
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Whether or not the United States has safe and effective medical countermeasures--such as vaccines, drugs, and diagnostic tools--available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures.

During public health emergencies such as influenza or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, treatments, and other medical countermeasures are essential to protecting national security and the well being of the public. Advancing Regulatory Science for Medical Countermeasure Development examines current medical countermeasures, and investigates the future of research and development in this area. Convened on March 29-30, 2011, this workshop identified regulatory science tools and methods that are available or under development, as well as major gaps in currently available regulatory science tools.

Advancing Regulatory Science for Medical Countermeasure Development is a valuable resource for federal agencies including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), the Department of Defense (DoD), as well as health professionals, and public and private health organizations.

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