CMC Strategy Forum 2007

Introduction

Final Program Schedule

Preliminary Program Schedule

Organizing Committee

Sponsors

Online Registration Center

Hotel Information

Travel Center

Conference History

Position Papers

For More Information

DOWNLOADS

CMC Strategy Forum Final Program is now available.

DIRECTIONS

From BWI Airport (32 miles)
Take I-95 South to I-495 West towards Silver Spring/Chevy Chase. Take 355 South in direction of Bethesda/Washington, DC which turns into Wisconsin Avenue.

From Dulles Airport (24 miles)
Take Dulles Access Road East to I-495 to Wisconsin Avenue South, Exit 34 South. Hotel is on the right – 2 miles.

From Reagan National Airport (18 miles)
Take George Washington Parkway to I-495 North to Wisconsin Avenue South, Exit 34 South. Hotel is on the right – 2 miles.

PARKING

Self parking: $15 Sunday to Thursday nights; $12 Friday and Saturday nights

Valet parking: $20 Sunday to Thursday nights; $17 Friday and Saturday nights

TRANSPORTATION

BWI – Baltimore/Washington Airport
32 miles

Dulles Airport
24 miles

Reagan National Airport
18 miles

Airport Shuttle and Buses

• BWI: $40 one person plus $10 each additional person

• Dulles: $30 one person plus $8 each additional person

• Reagan National: $25 one person plus $8 each additional person

Taxi

• From/to BWI: approximately $60 - $65 each way

• From/to Dulles: approximately $50 - $60 each way

• From/to Reagan National: approximately $25 - $35 each way

• From/to Union Station: approximately $25 - $30 each way (25 minutes by Metro (take Red Line to Bethesda)
  

 

We are pleased to announce the creation of the CMC Strategy Forum, A Section of the CASSS. The objective of the CMC Strategy Forum is to provide an environment for the development of technical and regulatory consensus positions regarding topics of interest. Consensus positions regarding topics of interest to will be communicated to the FDA and Industry through appropriate mechanisms (e.g., publications). The CMC Strategy Forum is intended to:

• Establish a biotechnology industry forum that focuses on industry and FDA CMC concerns identified at the annual meeting.

• Foster collaborative technical and regulatory interactions that advance discussions to consensus concepts for our mutual benefit.

• Provide this information to the FDA to allow them to merge good scientific practices with good regulatory practices.

• Further examine the technical and regulatory issues raised at meeting and develop plans to address them.

The Forum will also provide a venue for discussing the latest bio-molecular methods and their practical application to biotechnology pharmaceuticals and other health related products. This includes both method and instrumental advances that are used for product characterization, process development, and validated in-process, release and stability tests.