Potential COVID-19 Products: Choosing the Right Path with FDA
Information is being shared by FDA in an ongoing fashion as they manage response to the current COVID-19 pandemic for ongoing and planned clinical research. If you are considering development of a product for treatment of COVID-19 or COVID-19-related indications, ensuring no time is wasted between idea and engaging FDA via the appropriate pathway with all the required information is essential. In this webinar, we’ll review the pathways you might consider, based on the development phase and overall goals for your product, and discuss the information and data necessary to help FDA expeditiously review your proposal and move it forward.
Kevin Barber, Ph.D.
Vice President, Regulatory Strategy & Submissions
Combining extensive strategic leadership, scientific knowledge, and regulatory expertise, Dr. Kevin Barber supports Rho’s clientele in the development and execution of integrated regulatory strategies and clinical development plans for drugs, biologics, and medical devices. With close to 25 years of experience in regulatory affairs and product development, Dr. Barber is a regulatory expert across all phases from preclinical through product launch and post-approval life cycle management. His significant experience moderating regulatory authority meetings and preparing and filing regulatory submissions includes more than 40 US INDs and more than 40 global marketing applications. Throughout his career, Dr. Barber has participated in…
Theresa Scocca, Ph.D.
A Research Scientist with almost a decade of experience in clinical research, Dr. Theresa Scocca currently serves as Program and Regulatory Lead on programs at various stages of development. From Pre-IND interactions and IND submissions through marketing application submissions, Dr. Scocca has worked on a variety of products including drugs, biologics, medical devices, and combination products. In addition to leading regulatory submissions, Dr. Scocca has participated in FDA meetings and authored her share of protocols, various clinical summaries for marketing applications, briefing packages, and approved product labels. Her experience encompasses a variety of therapeutic areas, including multiple infectious disease programs…