Learning Tracks

This panel discussion will educate industry on certain timing issues with applications related to exclusivity. Current laws and regulations governing CMS coding and payment systems for biologics licensed by FDA under the 351(a) BLA or 351(k) BLA pathways have potential to incentivize submission of separate BLAs for products administered under Medicare Part B and Part D. CMS will present information to help explain how these systems work, and FDA will address administrative and regulatory complexities that can arise if companies submit a new BLA for a product that has been licensed previously.

Shana Christrup
Senior Director, Policy, AAM

TJ Garrigan, JD
Senior Advisor, Covington & Burling LLP

Kristi Martin
U.S. Director, Camber Collective

Stacey Ricci, MEng, ScD
Director, Scientific Review Staff, OTBB, OND, CDER, FDA

Mustafa Ünlü, PhD, JD
Policy Staff Director, OTBB, OND, CDER, FDA

Moderator:
Alisha Sud
Director, Policy, AAM