How to avoid 11th hour panic when FDA/EMA requires a scientific advisory review
Original Air Date: Monday, May 18 2020
Time: 10am EST / 7am PST
Duration: 1 Hour
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.
President, Cato Research
Chief Regulatory Officer
Lynda Sutton has over 40 years’ experience in the drug development industry. She has led teams from Pre-IND to Marketing approval for a variety of products including biologics, drugs and drug/device combination products. As Chief Regulatory Officer, she currently serves as the FDA agent for multiple Sponsors for IND and post-marketing products including two with Breakthrough Therapy Designation. She oversees the preparation of regulatory submissions, and ensures that regulatory requirements for the approval and launch of new products are satisfied.
Marc B. Garnick, M.D.,
Gorman Brothers Clinical Professor of Medicine Harvard Medical School, Beth Israel Deaconess Medical Center
Dr. Marc B. Garnick is an expert in medical oncology and urologic cancer. He has dedicated his career to the development of new therapeutic programs for the treatment of cancer patients and practices at the Beth Israel Deaconess Medical Center. He is the Gorman Brothers Clinical Professor of Medicine at Harvard Medical School. He is Medical Director for Network Cancer Services at BIDMC.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.
Inka Pawlitzky, Ph.D.,
Director Oncology Drug Development Affairs
Inka Pawlitzky, PhD, with over 12 years of oncology translational and drug development experience, heads the Oncology Drug Development Affairs team at SMS-oncology. An immunologist by training (PhD Tufts Medical School, Boston), she completed postdoctoral fellowships (Max-Planck Institute for Immunobiology and Epigenetics and Netherlands Cancer Institute) investigating the regulation of DNA rearrangements and pluripotency mechanisms in tumorigenesis. As senior scientist at Leica Biosystems she gained expertise in companion diagnostics. Since 2017, she is responsible for providing expert consultancy services for clinical and regulatory strategies in the areas of oncology drug and diagnostics development at SMS-oncology.