Sandra Hennig
Senior RA CMC Strategist Bayer
Dr. Sandra Hennig is an RA CMC Strategist at Bayer, focusing on regulatory CMC strategies for targeted radionuclide therapies and diagnostic radiopharmaceuticals in clinical development. With 12 years’ experience, she brings recognised expertise in quality documentation, health authority interactions, and CMC challenges linked to short-lived radionuclides, targeting moiety manufacture and control, and decentralized radioactive drug product manufacture. As a subject matter expert, she works closely with CMC, quality, supply, nonclinical, clinical, regulatory functions, and external partners to translate TRT innovation into robust, phase-appropriate control and dossier strategies. Engaged in industry associations, she advocates pragmatic, science-driven regulatory approaches.
Seminars
- Comparing the distinct regulatory CMC considerations for kit-based and ready-to-use radiopharmaceuticals, spanning diagnostic and therapeutic applications and small to large vector approaches
- Examining key challenges, opportunities and areas of ambiguity within the evolving radiopharmaceutical regulatory framework, highlighting where further clarity could enable more effective development strategies
- Exploring industry perspectives on current regulatory expectations through practical, publicly available examples, identifying how different product formats are navigating CMC requirements in practice
- Opening the discussion to explore the challenges raised during the presentations, enabling audience-led discussion and exchange on evolving regulatory CMC expectations
Including an interactive regulatory panel and audience Q&A.
