Jean Paty, Ph.D.
Chief Scientist and Regulatory Advisor, Outcomes, ERT
Anthony Bower, Ph.D.
Pharmaceutical companies typically only focus their efforts at developing Clinical Outcome Assessment (COA) measures – i.e., Patient, Clinician, and Observer Reported Outcomes (PROs, ClinROs, and ObsROs) - to achieve regulatory approval, and to get their product reimbursed. However, pharmaceutical companies may reap greater benefits from an approach that addresses long-term success in the marketplace. Specifically, an approach to COA development that leads to long term product differentiation will yield continued success in the face of ongoing competition -- that is, ongoing payer acceptance. This webinar will review how drug development strategies that optimize COAs can be used strategically to support regulatory approval and post-marketing success.