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.
Chief Strategist, Biostatistics & Standards for Regulatory Submissions
Rob Woolson serves as Rho’s Chief Strategist for Regulatory Biostatistics and Data Standards. Mr. Woolson joined Rho in 2007 and has 20 years’ experience as an applied statistician. He has an extensive background working with small biotech and pharmaceutical companies to successfully bridge and navigate the biometrics, CDISC data standards, and regulatory requirements of drug and biologics development. He has advised and supported sponsor companies through 12 marketing applications in several therapeutic areas, including playing a vital role in numerous FDA and Advisory Committee meetings. Mr. Woolson brings this experience to his current role providing strategic guidance to sponsor companies…
Chief Strategist, Biostatistics & Protocol Design
A proven leader in the industry for more than 20 years, Mr. Ben Vaughn serves as Rho’s Chief Strategist for Biostatistics and Protocol Design. In this role, he utilizes his extensive expertise to guide sponsors through marketing applications, regulatory interactions, and the design and analysis of analgesia trials. Mr. Vaugh has supported over 50 pain trials, over 30 marketing applications, and 5 FDA advisory committee meetings (both back room and bullpen) over the course of his career. In the past year alone, he has had speaking roles in 12 FDA Type A, B, and C meetings. His experience spans many…