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Advertising and Promotion Regulatory Affairs Conference

This event is now offered in a new entirely virtual format.


Session 1: Keynote Address: The Patient Voice: Message and Impact on Healthcare

Session Chair(s)

Micheline  Awad, MBA

Micheline Awad, MBA

  • Director Regulatory Affairs, Advertising and Promotion
  • Neurocrine Biosciences, Inc., United States
FDA recognizes that the patient perspective on new drug benefits and risks, and whether the disease burdens that matter most are addressed, is critically informative to regulatory decision-making. Drug development programs have often failed to explicitly account for the disease burdens and treatment burdens that would matter most to patients and fail to reliably measure these effects in clinical trials. FDA expects drug sponsors to incorporate the patient’s perspective starting early in development to ensure that the investigational product profile and development program incorporate clinical outcomes and endpoints that reflect what matters to patients. This session describes the background and content of a new FDA guidance series to foster patient focused drug development and sponsor use of such outcomes and endpoints. Reliable measures of what matters to patients and evidence of meaningful improvement will not only inform FDA decision making but may also better inform the decisions of other health authorities (e.g., HTA and payors).
Learning Objective :

At the conclusion of this session, the participant should be able to:

  • Articulate why patients’ perspectives are important to the quality of drug development programs
  • Identify the series of FDA guidance related to Patient Focused Drug Development that can guide sponsors on methods and approaches to better incorporate patient perspectives
  • Identify other resources and information available to facilitate a more patient focused approach to drug development

Speaker(s)

Theresa  Mullin, PhD

Speaker

Theresa Mullin, PhD

  • Associate Director for Strategic Programs, CDER
  • FDA, United States

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