Back to Agenda
Defining the Science of Patient Input to Enhance Drug Development and Approval: Tools
Session Chair(s)
Roslyn Schneider, MD, FACP
Vice President, Head of Global Patient Affairs
Biomarin Pharmaceuticals Inc., United States
Presenters will discuss how patient input and real world evidence can be used to meet the "adequate and well-controlled studies" standard. The panel will discuss the meaning of the science of patient input, and provide examples of successfully using patient input (e.g., in making trial endpoint decisions; weighing benefit/risk; modifying study protocols based on patient input, etc.) within the regulatory context to enhance drug development and approval by incorporating the patient voice. Gaps and challenges with suggested solutions will be discussed, and differences among US and non-US regulatory agencies may be considered.
Learning Objective : Define the science of patient input; Describe the challenges and solutions to successfully incorporating the patient voice into drug development.
Speaker(s)
Evolving Methods of Including Patients' Input in Drug Development
Roslyn Schneider, MD, FACP
Biomarin Pharmaceuticals Inc., United States
Vice President, Head of Global Patient Affairs
Incorporating Patient Preferences in Drug Development and Approval
Kevin Marsh, PhD, MSc
Evidera, United Kingdom
Vice President, Patient-Centered Research
Incorporating the Patient Perspective into a Target Product Profile for Intercepting Alzheimer’s Disease
Bennett Levitan, MD, PhD
Janssen Research & Development LLC, United States
Senior Director, Benefit-Risk Assessment, Global Epidemiology
Have an account?