News

Apply Filter View All

Watch CTTI-hosted Webinar on FDA’s Patient Engagement Initiatives

The FDA’s large portfolio of activities to integrate patient engagement throughout the agency was highlighted during a recent CTTI-hosted webinar, now available to watch online. “Patient Engagement in Action: Insights from Patients & the FDA” was held Thurs., Nov. 21, and featured:

  • Andrea Furia-Helms, OC, FDA
  • Michelle Tarver, CDRH, FDA 
  • Robyn Bent, CDER, FDA
  • Diane Maloney, CBER, FDA
  • Theresa Strong, Foundation for Prader-Willi Research                                       

“Patients are at the heart of all FDA activities,” Furia-Helms said. She kicked off the webinar with an overview of the history of patient engagement at the FDA. Participants then reviewed patient engagement activities throughout the process of development and regulatory decision-making for drugs, biologics, and devices.

Bent said that patients are uniquely positioned to inform understanding of the therapeutic context for drug development and evaluation. She added that there is a need for more systematic ways of gathering patient perspectives on their conditions and treatment options.

Strong spoke from the perspective of a patient advocate working with the FDA. She said that the patient perspective, particularly with rare diseases, provides context and nuance to the associated symptoms and challenges within a disease. “We bring some experience about living with the disorder and can hopefully help FDA staff understand that laundry list of symptoms, and tease out what is important to patients and what is keeping people living with Prader-Willi syndrome from living healthy and productive lives.”

CTTI and the FDA have partnered on several patient engagement efforts, including co-creating the Patient Engagement Collaborative (PEC) and collaborating on a recent "Enhancing the Incorporation of Patient Perspectives in Clinical Trials" workshop. Additionally, CTTI has developed a robust set of recommendations and resources that help foster effective patient group engagement.

Additionally, answers to the virtual Q&A session are available here.