Biopharmaceuticals (includes Biologics)
Strategic
Kimberly Belsky, MS
Head of Regulatory Policy and Intelligence
Rodger Thompson, BS, Mechanical Engineering, Missouri S&T
President
Sierra Decision Consulting
Jennifer Weidman
Mallinckrodt Pharmaceuticals
Determining a probability of regulatory (registration) success (PRS) is a key driver in determining the overall probability of technical and commercial success and influences budgeting, resource planning, etc. Participants will understand how PRS is defined, what key benchmarking work has been completed to assess more or less risky scenarios, and a decision sciences approach to estimating PRS to avoid bias using and focus on facts.