Logistical Information and Registration Link for the April 13, 2011 Diabetes Mellitus and Cardiac Safety Thinktank
Diabetes Mellitus and Cardiac Safety
A Cardiac Safety Research Consortium Think Tank
Co-sponsored by the Cardiac Safety Research Consortium (CSRC) and the United States Food and Drug Administration (FDA)
The CSRC Diabetes Mellitus and Cardiac Safety Thinktank will be held on Wednesday, April 13, 2011 at the FDA White Oak Facility as scheduled.
We look forward to seeing you there.
Wednesday, April 13, 2011
8:00 a.m. – 6:00 p.m.
White Oak FDA Campus, Building 31
10903 New Hampshire Avenue
Silver Spring, MD 20993
The CSRC Diabetes Thinktank will convene faculty experts from the FDA, academia, and industry to discuss key topics relating to developing collaborative projects that will positively impact drug development of diabetes medications. It is recognized that these efforts may be informative to other chronic use therapies when CV risk assessment is important to the drug’s profile.
- More efficient methodologies to meet the Phase 4 CV safety requirements of the Diabetes Development Regulatory Guidance including statistical and operational challenges of developing a single study that spans Phase 3 and 4 studies; statistical and operational challenges of a meta-analysis of multiple ongoing studies
- The use of new approaches to prospectively determine CV safety risk and benefit in large post-approval populations.
- How large databases can be accessed and utilized for safety and benefit evaluations.
- How to further define and explore new approaches to elucidating the benefit side of the Benefit/Risk Analysis for glucose lowering drugs.
Participate in one of three Break-out Sessions, aimed at identifying how a potential research project around the individual session topics could be developed:
- Effort #1: Phase 3 and 4, Pre- and Post-Marketing Continuum Models for Cardiovascular Safety with Diabetic Drugs
- Effort #2: How to Leverage Large Databases For Prospective and Retrospective Safety & Benefit Analyses. Is a CV Safety Warehouse Feasible?
- Effort #3: New approaches to elucidating the benefit side of the Benefit/Risk Analysis; Equipoise of Risk versus Benefits in Diabetes Mellitus Drugs
Hotel rooms are available at the Hilton Washington DC/Silver Spring.
Hilton Washington DC/Silver Spring
8727 Colesville Road, Silver Spring, Maryland, United States 20910
Hampton Inn Silver Spring
8728-A Colesville Road
Silver Spring, MD 20910
Please note, if you are also attending the DIA meeting, you need to contact the L’Enfant Plaza hotel directly for reservations.
L’Enfant Plaza Hotel
80 L’Enfant Plaza
SW Washington, D.C. 20024
All meeting cancellation requests must be submitted in writing via e-mail (firstname.lastname@example.org) or by fax (919-668-7114; Attn: Wendy Sprintz).
Cancellation Policy: Written notification of cancellations must be received on or before April 8 2011. Cancellations from April 9 and April 11 will be subject to a $100 charge. Cancellations received after April 11 will not be refunded.
In the unlikely event the program is canceled or postponed, we will not be responsible for any travel costs or expenses, including cancellation/change penalties assessed by airlines, travel agencies or hotels.
Participants driving to the White Oak Facility should follow the directions and parking instructions provided on the map (below). Again, all thinktank attendees must enter through Building 1.
Metro Station Shuttle:
The shuttle will take you directly to the White Oak Facility from various metro stations. All thinktank attendees must enter through Building 1.
See METRO SHUTTLE SCHEDULE [pdf]
Additional logistical considerations:
Cameras, recordable devices, sharp objects, etc., will not be allowed to pass through FDA security. Laptops, cell phones and jump drives are permitted.
Please contact Wendy Sprintz, Duke Clinical Research Institute
DCRI: (877) 707-2904