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May Biomed/Biotech SIG Meeting #2  

Kelly's Deli Conference Center
Next to the entrance to 7519 Standish Drive
FDA/CVM Center
Rockville, Maryland  20855

May 28, 2009    6:00 pm - 9:15 pm

�Oncology Biopharmaceuticals and Preclinical Development - Evolving Regulatory Challenges�

Presented by
Michael Orr, PhD, DABT
Senior Pharmacologist
Division of Biologic Oncology Products, Office of Oncology Drug Products,
Center for Drug Evaluation and Review (CDER), FDA


�Working with the FDA to Test a New Vaccine - Regulatory Science 101 for Basic Researchers�

Presented by
Stuart Shapiro, MD, PhD
NIAID Program Officer & Team Leader
Center for HIV/AIDS Vaccine Immunology (CHAVI; www.chavi.org)
Vaccine Discovery Branch, Vaccine Research Program
Division of AIDS, NIAID, NIH, DHHS

Thursday, May 28, 2009

The Kelly�s Deli Conference Room
7519 Standish Place,
Rockville, MD 20855

6:00 - 6:15 pm: Networking with a light pizza dinner
6:15 - 9:15 pm: Program

Costs: Free to the general public with a door prize drawing

Registration: To attend this event, click here. Please register by Thursday noon, May 28, 2009.

Event Contact: Dr. George Chang at or 240-793-8425.
Program Summary:
Development and regulatory pathway and challenge of oncology biopharmaceutical and vaccine products will be discussed.

For more information and directions to the meeting, see the May 28, 2009 Biomed/Biotech SIG Meeting Announcement.