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 over 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 21 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…