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Defining the Science of Patient Input to Enhance Drug Development and Approval: Tools
Session Chair(s)
Roslyn Schneider, MD, FACP
Principal, Rozmd Patient Affairs Consulting LLC, 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
Principal, Rozmd Patient Affairs Consulting LLC, United States
Incorporating Patient Preferences in Drug Development and Approval
Vice President, Patient-Centered Research, Evidera, United Kingdom
Incorporating the Patient Perspective into a Target Product Profile for Intercepting Alzheimer’s Disease
Executive Director, Benefit-Risk Assessment / Epidemiology, Johnson & Johnson, United States
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