Emerging biopharma companies (EBPs) are responsible for a record 65% of the molecules in the R&D pipeline without a larger company involved, with greatest focus placed on oncology, infectious disease, and vaccines. In Asia Pacific, there is a robust growth in numbers and sophistication of EBPs. Some are started by local entrepreneurs with innovative scientific approaches and some by established pharmaceutical manufacturers of generics who want to move aggressively into the research-based realm of the industry. Most of them aspire to venture into markets such as US and Europe.

Bringing new drug assets to US and European markets requires careful commercial planning, especially given the regulatory nuances. Join this webinar to learn the best practices for EBP client in bringing new drug assets to the US and Europe markets.

Why you should attend

• Learn how to identify size of opportunity for drug assets in US market, and determine the cost required for market development and launch phases
• Gain insights into key commercial planning activities in the early stages of drug development and identify key milestones for investment to support out-licensing/outsourcing or hybrid go to market efforts
• Learn more about clinical development and regulatory processes in the US and Europe market, and FDA's guidance on race & ethnicity diversity and inclusion in clinical trials

Speakers:

Dean Giovanniello
Senior Principal, Brand & Commercial Strategy, IQVIA Consulting

Michel F Denarié
Sr. Principal, Regulatory Affairs & Drug Development Solutions, IQVIA