During BIO’s IP & Diagnostics Symposium (BIO IPDX) speakers reviewed the current patent law landscape and evaluated the impact on both the genetic diagnostics and biopharmaceutical sectors. The program offered insight into IP issues for both diagnostics generally and companion diagnostics. The program also explored some of the potential regulatory dimensions.
Working Luncheon & Session 4: Potential Impacts of Regulatory Changes
12:15 – 2:00 pm
Sponsored by: Morgan, Lewis & Bockius LLP
This panel focused on the politicized regulatory environment for laboratory developed tests (LDTs). The panel discussed FDA’s attempt to move from a policy of enforcement discretion to a more regulated environment and the impact on direct-to-consumer tests, personalized medicine and companion diagnostics.
M. Elizabeth Bierman
Dr. Phoebe Mounts
Scott McGoohan | Vice President, Reimbursement & Scientific Affairs, American Clinical Laboratory Association
Alberto Gutierrez | Director of the Office of In Vitro Diagnostics and Radiological Health, Food & Drug Administration
Friday, September 26, 2014
Hilton Alexandria Old Town
1767 King Street
Alexandria, VA 22314