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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Agenda: Animal Models – Essential Elements to Address Efficacy Under the Animal Rule

Public Meeting on the Draft Guidance for Industry
Animal Models – Essential Elements to Address Efficacy Under the Animal Rule
Docket Number: FDA-2009-D-0007 

Friday, November 5, 2010

Co-Sponsors:
Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER)

AGENDA

7:00 – 8:00 AMPublic Meeting Registration/Check-in
8:00 – 8:10 AM

Welcome and Opening Remarks

Presiding Officer:
RADM Boris Lushniak, MD, MPH
Assistant Commissioner Counterterrorism Policy
Food and Drug Administration
Deputy Surgeon General, USPHS

8:10 – 9:00 AM

Introductory Talks - FDA Speakers:

Rosemary Roberts, MD
Director
Office of Counter-Terrorism and Emergency Coordination
Center for Drug Evaluation and Research
Food and Drug Administration

Marion F. Gruber, PhD
Deputy Director
Office of Vaccines, Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration

Steven M. Fleischer, DVM
Biologist
Pharmacology/Toxicology Branch
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research
Food and Drug Administration

9:00 – 9:20 AMBREAK

Each speaker will have 10 minutes to present. Please note that 30 minutes have been allotted following the speaker presentations to offer an opportunity for the FDA panelists and subject matter experts to ask clarifying questions.

Presentations

9:20 – 10:45 AM

Session I: Topic Area E - General Comments

Thomas M. Dreier, PhD
BARDA/ASPR/HHS

Annie Frimm
SIGA Technologies, Inc.

Michael Merchlinsky, PhD
BARDA/ASPR/HHS

John Moulder, PhD
Medical College of Wisconsin

Carl C. Peck, MD
University of California San Francisco

Kristan A. Phillips
MacroGenics, Inc.

Eric A. Rose, MD
Representing the Alliance for Biosecurity

10:45 – 11:15 AMFDA Questions for Presenting Panel
11:15 – 12:45 PMLUNCH
A la carte items will be available for purchase on site
12:45 – 1:50 PM

Session II: Topic Areas A and B

Topic Area A - Natural History of Disease/Condition: Pathophysiologic Comparability

Thomas M. Dreier, PhD
BARDA/ASPR/HHS

Michael Merchlinsky, PhD
BARDA/ASPR/HHS

John Moulder, PhD
Medical College of Wisconsin

Michael C. Powanda, PhD and Elizabeth D. Moyer, PhD
M/P Biomedical Consultants LLC

Topic Area B – Characteristics of the CBRN Agent that Influence the Disease or Condition and Host Susceptibility

Thomas M. Dreier, PhD
BARDA/ASPR/HHS

1:50 – 2:20 PMFDA Questions for Presenting Panel
2:20 – 2:40 PMBREAK
2:40 - 3:35 PM

Session III: Topic Area D - Design Considerations for the Animal Efficacy Studies

Ann Hards, PhD
Cleveland BioLabs, Inc.

Thomas MacVittie, PhD
University of Maryland, School of Medicine

Brian R. Moyer, MS, CNMT
BARDA/ASPR/HHS

Jur Strobos, MD
RxBio, Inc.

3:35 – 4:05 PMFDA Questions for Presenting Panel
4:05 – 4:15 PM

Closing Remarks

Presiding Officer:
RADM Boris Lushniak, MD, MPH

ADJOURN

Transcript:

Please be advised that as soon as the transcript is available, it will be accessible at:

Comments to the Draft Guidance:

Written and electronic comments will be accepted after the Public Meeting until January 5, 2011. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to: http://www.regulations.gov and identify comments with the docket number FDA-2009-D-0007.