Meeting Highlights - June 20
Plenary sessions
June 20, 2006
10:00 am - 6:00 pm — PROFESSIONALS POSTER SESSION
Arch St. Bridge, 2nd Floor, Convention Center
10:30 am - 12:00 pm
CBER Hot Topics
Chairperson: Diane Maloney, JD, Associate Director for Policy, CBER, FDA
3:30 am - 5:00 pm
Plenary Session: Update from the FDA Office of the Commissioner
Chair: Charles C. Depew, PharmD ,
GSK
The Office of the Commissioner will provide an overview of the Agency?s agenda for 2007-2010. Discussion will include the Critical Path Initiative, PDUFA IV, Advisory Committees, Risk Minerazation, National and International Public Health Issues, Product Registration and Regulatory Decision Making.
Q and A panel session with the Commissioner, Deputy Commissioners, and other invited FDA officials will follow the presentations. Panelists include Janet Woodcock, MD, Deputy Commissioner of Operations and Chief Operating Officer, Office of the Commissioner, FDA; Murray M. Lumpkin, MD, Msc, Deputy Commissioner for International and Special Programs, Office of the Commissioner, FDA.
5:30 am - 6:30 pm
RECEPTION FOR THE 100TH ANNIVERSARY OF THE FDA
Grand Hall, 2nd Floor, Convention Center
Merck Stops HYPERION Trial for Winrevair in PAH Following Positive ZENITH Trial Results
January 30th 2025The Phase III HYPERION trial was stopped early after strong positive interim results from the ZENITH trial demonstrated the efficacy of Winrevair (sotatercept-csrk) in treating pulmonary arterial hypertension, making it unethical to continue.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
