In- and out-licensing of pharmaceutical products at different stages of development presents various challenges and opportunities, with risks for development failure, financial loss, and legal issues. We discussed these topics with the seasoned experts in this field of pharma with roles ranging from business development, medical affairs , commercial and legal counseling.
Yves Kesch, is senior legal counsel for Novartis, licensing for phase 1 products.
Ezra Pierpaoli PhD is head of medical affairs for Permamed
Martin Valks is Head of Out-licensing at Acino Pharma
Marcus Bain
In summary the different stages have following challenges and opportunities;
👉Phase 1 faces limited clinical data and regulatory uncertainty, but early partnerships can offer funding and expertise.
👉Phase 2 encounters continued uncertainty and competition, yet partnerships can mitigate risks and provide access to technology.
👉Phase 3 entails high costs and regulatory scrutiny, but successful trials can increase value and attract partners.
Overall, careful due diligence and negotiation are crucial to navigate the risks and maximize the benefits of licensing agreements.
Senior General Manager(AFRICA)at BRAWN laboratory limited
3moInterested