We're excited to announce a special Lunch and Learn session with Thermo Fisher Scientific! Join us for an informative discussion covering the essential CMC (Chemistry, Manufacturing, and Control) considerations needed to transition from laboratory research to Phase 1 clinical trials.

During this session, Thermo Fisher Scientific will provide an in-depth overview of how they support clients in navigating the complex path from bench to clinic. Learn about their approach to creating robust development plans that tackle common challenges and streamline the journey to Phase 1.

Topics include:

• Key strategies for developing drug substance and product to meet Phase 1 clinical requirements
• IND (Investigational New Drug) application-enabling regulatory strategy
• A comprehensive drug development overview
• FDA 101: Navigating the agency and understanding critical submission timelines
• Preparing for IND submission
• Insights on productive FDA meeting preparations and alignment

Discover how the CMC section of your IND can play a pivotal role in delivering your drug substance to patients and ensure your program is supported by a well-aligned development plan. Don’t miss this chance to gain valuable insights that can accelerate your program's success!

Lunch will be provided!

Kevin more than 25 years of experience in chemical synthesis and drug delivery for early- and late-stage  pharmaceutical products. He has supported various active pharmaceutical ingredient (API) synthesis and formulation manufacturing programs, with a focus on solubilization and other drug delivery methods for APIs, and the application of adaptive clinical trials to enable drug product optimization.

Kaitlyn has more than a dozen years of experience in regulatory consulting for early- and late-stage pharmaceutical products, and is responsible for optimizing regulatory strategies from early concept through post-marketing commitments including complex health authority negotiations, expedited pathway assessments, and technical document strategic inputs.  She has comprehensive product development experience and broad therapeutic area understanding.