How to avoid 11th hour panic when FDA/EMA requires a scientific advisory review
Your chief regulatory officer has just received FDA/EMA notification that an Oncology Drug Advisory Committee (AdCom/SAG-O) has been scheduled to review your recently submitted NDA/BLA/MAA in 90 days. The implications of this review, to a great extent, will determine the ultimate fate of both your product and often your company itself. While your main focus for the next 90 days will be preparation for the AdCom/response to CHMP, experience informs us that many of the crucial issues that require clarification for this response could be addressed earlier in the drug development process.
This unique, inaugural webinar will introduce what CATO SMS calls “Pre-Anticipation,” which will address critical questions that should be (or should have been) raised before your first patient is dosed in Phase 1 studies. Our thorough review of the types of clarifying questions raised by regulatory agencies often leads to “review” issues for companies’ seeking product marketing authorizations.
Our Pre-Anticipation webinar addresses the critical components that should be incorporated into any clinical development plan. These are some of the issues: importance of getting the dose right; understanding the transition of study drug formulation to final commercialization dose forms; do’s and don’ts of appropriate alterations or tweaks to the statistical analysis plan; understanding the pros and cons of early introduction of quality-of-life instruments in clinical development; and considerations of the selection of the study population to reflect the intended real-world population. This webinar is essential for the many disciplines involved in oncology drug development and should enhance regulatory success.
Original Air Date: Monday, May 18 2020
Time: 10am EST / 7am PST
Duration: 1 Hour
Dr Garnick has expertise in drug development from three important perspectives: As an academic principal investigator on several drugs that obtained regulatory and marketing approval from FDA; as the Chief Medical Officer and leader of clinical development in several biotechnology companies leading to drug approvals in US and Europe; and as an advisor to several FDA divisions as a Specialized Governmental Employee. He obtained his MD from the Perleman School of Medicine at the University of Pennsylvania, and completed fellowships at the National Institutes of Health and the Dana Farber Cancer Institute.
Director Oncology Drug Development Affairs