Us vs. Them: A Biologics Wargame Exercise
Ha Kung Wong
Partner
Fitzpatrick, Cella, Harper & Scinto
Scott Reed
Partner
Fitzpatrick, Cella, Harper & Scinto
Richie Paul
Vice President, Intellectual Property Operations
Alkermes Pharma Ireland Limited
- up-to-date FDA guidances and initiatives regarding biologics, biosimilars and interchangeables
- conducting pre-suit investigations for biologics matters
- the trends and potential impact of PGRs on pharmaceutical manufacturers, including biologics (including insight gained from past IPRs)
- How to plan for and protect resource investment in for both BLAs and aBLA
- Considerations for determining what type of biologic to pursue based on recent FDA actions
- The current impact of IPRs and PGRs on the pharmaceutical industry and how to plan for the potential of bringing or defending against PGRs in the pharmaceutical industry