Us vs. Them: A Biologics Wargame Exercise

October 17, 2018 1:30pm

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)
  Practical takeaway include:
  • 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