Keys to Success for Your Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
The integrated summary of safety (ISS) and the integrated summary of efficacy (ISE) are critical components of your new drug application (NDA) submission. Presenting the FDA with a coherent and clear integration of the data from your product development program is imperative and requires a sound strategy and a skillful approach.
Jack Modell, M.D.
Chief Medical Officer
A board-certified psychiatrist with nearly 40 years of experience in clinical research, Dr. Jack Modell has spent a considerable amount of time within both the academia and pharmaceutical/CRO sides of the industry. Pairing his 20 years of teaching, providing patient care, and conducting clinical research with 19 years of clinical drug development experience – proof of concept through market support, medical affairs, successful NDA filings, medical governance, drug safety, compliance, and management – it’s easy to see why Dr. Modell has received several awards and honors for both research and clinical care. While there are few therapeutic areas in which…