As the pharmaceutical industry continues to shift more towards biologics and hybrid drug entities, it becomes increasingly imperative that the small and large molecule bioanalysis worlds work together to efficiently arrive at go/no-go decisions. This webinar will address these trends as well as the impact on drug development and regulatory requirements for drug approval. The current business landscape of biopharma, the competitive landscape for CROs, and the benefits and challenges that an overseas provider may encounter when working with U.S-based sponsors will also be addressed.
What will you learn?
- An overview of the current development and bioanalysis of small molecule drugs, biologics and hybrid technologies such as antibody–drug conjugates
- How regulatory bodies are reviewing these data, and which changes in requirements are being applied in the drug approval process
- The current business landscape of biopharma in the U.S., and the competitive landscape for CROs outside of the U.S.
- The current benefits and challenges an overseas provider may encounter when working with U.S-based partners or sponsors
Who may this interest?
- CROs, Pharma and Biotech companies focused on small and large molecule development and bioanalysis
- Scientists, Managers, Directors in these settings
Stephanie Pasas-Farmer has held a range of scientific, business management and operational leadership positions across contract research and global pharmaceutical organizations, including Frontage Labs, Wuxi AppTec, Galleon Pharmaceuticals, BMS and Merck. She currently provides R&D, regulatory and commercial consulting services to early-stage pharmaceutical and biological drug development organizations in the field of bioanalysis. Dr Pasas-Farmer is a frequent contributor to peer-reviewed publications and industry conferences on current bioanalytical topics. She is also an active steering committee member of the Development and Discovery divisions of the national Applied Pharmaceutical Analysis (APA) meeting.