Case Study - Estimating the Probability of Technical and Regulatory Success (PTRS)
Challenge - Objectively identify important scientific and regulatory questions and understand their impact on success.
Situation - A small company has two molecules in Ph1 development. Both programs are promising but not without risks. Senior Management wants to understand the risks and how they might impact success.
Solution - A systematic review of medical, clinical, nonclinical, regulatory and CMC questions that needed to be answered prior to approval was compiled. Discussion around the identified risks revealed differences in interpretation in addition to several new risks. Utilizing known industry benchmarks, it was determined if risks identified for each stage of development, and ultimately the program, could be considered more or less risky than the industry standard.
Outcome - Even though both programs were at similar stages of development it was determined that one program was slightly more risky because of a previously under appreciated technical risk. It was agreed that an activity originally slated to be started two years later would begin immediately to determine the likelihood the risk could be retired. Those results, expected to be available at the same time the Ph1 data would help inform the company whether to move the program into Ph2.
How S3B can help identify and manage risk? S3B will work with your team to systematically identify the questions still to be answered and, if necessary, will supplement your team with particular functional representation. S3B will facilitate the discussion on risks and comparison against the industry benchmarks to provide an overall PTRS. S3B can also facilitate the discussion on possible changes to your execution plan to address the outcome.