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.

Ben Vaughn, Senior Statistical Scientist

Ben Vaughn is a senior statistical scientist who has participated in nearly 20 regulatory submissions and is an expert on CDISC implementation and standards. His work has included serving as lead statistician to complete displays and datasets for several ISS/ISEs (as well as the associated pivotal studies); coproducing the ISE for two opioid products; and statistical consultation, display generation and submission work for four separate products for OA knee pain. He has authored responses to various FDA queries regarding NDAs, PMAs, IDEs, and SPAs. Additionally, he has represented sponsors in FDA teleconferences and face-to-face meetings for both OA knee pain products and opioid products.

Rob Woolson, Chief Strategist, Biostatistics and Data Standards for Regulatory Submissions

Rob Woolson is a statistical scientist with 12 years’ experience in the analysis of complex data. He has conducted statistical analyses in all phases of drug development (Phase I through IV, NDAs, and BLAs) and has led SDTM/ADaM dataset conversion projects in multiple therapeutic areas. He has held a leadership role in six CDISC-compliant regulatory submissions, having guided the creation of ISS/ISE statistical analysis plans; integrated analysis dataset design and production; integrated display design and production; and submission-related documentation development. He has authored responses to numerous FDA queries and has represented sponsors at FDA in-person meetings.