The pediatric patient population with chemotherapy-induced hearing loss represents a segment of the cancer survivor community with a severe burden of disease with a great unmet medical need. An externally-led, FDA-approved Patient-Focused Drug Development (PFDD) meeting on September 13, 2018, near Washington, DC will explore these issues in-depth.
The half-day meeting follows the FDA model for externally-led PFDD meetings and will feature a series of facilitated panel and audience discussions, and a webinar with live polling focused on providing the FDA and other stakeholders with patient views on key issues such as:
– Burden of the condition (physical, emotional, financial issues) impacting the daily health-related quality of life;
– Assessments of current and potential future treatments;
– Benefits that patients with chemotherapy-induced hearing loss are looking for in treatments and the risks they are willing to assume in return for more advanced interventions;
– Participation in clinical trials and ideas on trial design to make them more appealing to people with chemotherapy-induced hearing loss.
AGENDA
1:00-1:10 Opening Remarks | Cat Paciente, Momcology
1:10-1:25 Welcome Remarks | Billy Dunn, MD, Director, Division of Neurology Products, CDER, FDA
1:25-1:40 Chemotherapy-Induced Hearing Loss Clinical Overview | Kristy Knight, MS, CCC-A, FAAA, Associate Professor, Audiology Training Coordinator, Oregon LEND Program, Child Development, and Rehabilitation Center, Doernbecher Children’s Hospital, Oregon Health, and Science University
1:40-1:50 Introduction and Meeting Overview | James Valentine, JD, MHS, Meeting Moderator
1:50 – 2:00 Audience & Remote Demographic Polling
2:00-3:10 Topic 1: Living with Chemotherapy-Induced Hearing Loss
– Panel (25 minutes)
– Audience & Remote Polling (10 minutes)
– Moderated Audience Discussion (35 minutes)
3:10 – 3:25 Break
3:25-3:35 Challenges in Clinical Trial Design in Chemotherapy-Induced Hearing Loss | Greg Aune, MD, PhD, Assistant Professor,
UT Health San Antonio-Greehey Children’s Cancer Research Institute
3:35-4:45 Topic 2: Current & Future Treatments from the Patient and Caregiver
– Panel (25 minutes)
– Audience & Remote Polling (10 minutes)
– Moderated Audience Discussion (35 minutes)
4:45-5:00 Meeting Summary | Greg Reaman, MD, Associate Director for Pediatric Oncology, Oncology Center of Excellence, FDA
5:00-5:10 Closing Remarks & Next Steps | George Dahlman, CEO, Children’s Cause for Cancer Advocacy
Adjourn
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- Momcology