The science to support personalized medicine is moving at a rapid pace. There are a number of companion diagnostics in the marketplace as a result of successful co-development programs and post-launch strategies. Regulatory bodies are beginning to develop guidance and communications, but companion diagnostic regulatory submissions are advancing faster than guidance. Therefore, challenges remain in terms of anticipating regulatory requirements for the approval of drugs with companion diagnostics.
By understanding current challenges and evolving regulatory trends, participants can best assess their co-development regulatory strategy and adapt it appropriately. This is very important since drug and diagnostic development can take years to complete and teams need to plan for possible future regulatory requirements. This webcast will take a critical look at case studies, available tools and strategic considerations along the co-development pathway to enable efficient development, risk mitigation and generation of supportive evidence that meets regulatory body requirements.
Learning Level(s): Basic & Intermediate
Upon the webcast's conclusion, you should be able to:
- Recognize what strategic considerations need to be evaluated throughout co-development
- Sort through pros and cons of various co-development study designs
- Understand current US labeling requirements for both drugs and diagnostics
- Recognize key trends influencing regulatory requirements
- Understand what evidence is essential for filing drug and diagnostic submissions
- Consider what is most important when selecting a diagnostic partner
Christine Gathers, senior director, Eli Lilly and Company Christine Gathers, senior director of regulatory affairs-diagnostics, has worked at Eli Lilly and Company for 24 years and has had a multitude of experiences spanning the pharmaceutical value chain. Her experience includes: manufacturing, LRL development, program medical, business development, strategic asset management, US brand planning, sales, Lilly Research Labs strategy, diagnostic and experimental medicine, tailored therapeutics group leader and regulatory. In her current role, Gathers provides portfolio support for companion diagnostics. This includes collaborating with diagnostic manufacturers on the development and registration of the diagnostic. She is building regulatory capability in diagnostics for Lilly while also driving a number of external policy efforts. Her efforts support Lilly's commitment to deliver improved outcomes for individual patients. Gathers holds an MSc in pharmacology from Butler University and an MSc in biology from Purdue University, and has earned Regulatory Affairs Certification (RAC).