Comprehensive Due Diligence for Novel Therapeutics: Beyond IP and FTO
Jonathan S. Caplan
Partner Co-Chair, Intellectual Property
Kramer Levin Naftalis & Frankel LLP
Nishla H. Keiser
Partner
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
David Silverstein
Vice President, Intellectual Property
Rocket Pharmaceuticals, Inc.
In a landscape as multifaceted as biopharma, due diligence extends beyond the realms of intellectual property and Freedom to Operate. It’s a crucial business exercise that encompasses clinical, regulatory, financial, and commercial aspects—each a foundational pillar for the successful launch of novel therapeutics. This session presents a strategic guide for conducting thorough due diligence in the biopharma industry, ensuring that investments, partnerships, and acquisitions are sound, strategic, and positioned for success. Topics of discussion will include:
- Evaluating clinical trial data, regulatory compliance, and approval prospects of the due diligence process
- Analyzing a company’s financial metrics, forecasting revenues, and understanding valuation models specific to biopharma
- Scrutinizing market potential, the competitive landscape, and market strategies for novel therapeutics
- Assessing the scalability of production, supply chain robustness, and quality control systems
- Considering the alignment between entities in M&A, partnerships, or joint ventures