Vaccines, Blood & Biologics
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Public Meeting on the Draft Guidance for Industry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 AM | Public Meeting Registration/Check-in |
|---|---|
| 8:00 – 8:10 AM | Welcome and Opening Remarks Presiding Officer: |
| 8:10 – 9:00 AM | Introductory Talks - FDA Speakers: Rosemary Roberts, MD Marion F. Gruber, PhD Steven M. Fleischer, DVM |
| 9:00 – 9:20 AM | BREAK |
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 Annie Frimm Michael Merchlinsky, PhD John Moulder, PhD Carl C. Peck, MD Kristan A. Phillips Eric A. Rose, MD |
|---|---|
| 10:45 – 11:15 AM | FDA Questions for Presenting Panel |
| 11:15 – 12:45 PM | LUNCH 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 Michael Merchlinsky, PhD John Moulder, PhD Michael C. Powanda, PhD and Elizabeth D. Moyer, PhD Topic Area B – Characteristics of the CBRN Agent that Influence the Disease or Condition and Host Susceptibility Thomas M. Dreier, PhD |
| 1:50 – 2:20 PM | FDA Questions for Presenting Panel |
| 2:20 – 2:40 PM | BREAK |
| 2:40 - 3:35 PM | Session III: Topic Area D - Design Considerations for the Animal Efficacy Studies Ann Hards, PhD Thomas MacVittie, PhD Brian R. Moyer, MS, CNMT Jur Strobos, MD |
| 3:35 – 4:05 PM | FDA Questions for Presenting Panel |
| 4:05 – 4:15 PM | Closing Remarks Presiding Officer: ADJOURN |
Transcript:
Please be advised that as soon as the transcript is available, it will be accessible at:
- Regulations.gov
- Guidance for Industry: Animal Models—Essential Elements to Address Efficacy Under the Animal Rule; Public Meeting
- Public Meeting on Animal Models—Essential Elements to Address Efficacy Under the Animal Rule; and Reopening of Comment Period
Comments to the Draft Guidance: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.
