Childhood Cancer Hearing Loss PFDD Meeting (Full Program)

Published On: September 13, 2018
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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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Since 2004, UT Health San Antonio, Greehey Children’s Cancer Research Institute’s (Greehey CCRI) mission has been to advance scientific knowledge relevant to childhood cancer, contribute to understanding its causes, and accelerate the translation of knowledge into novel therapies. Greehey CCRI strives to have a national and global impact on childhood cancer by discovering, developing, and disseminating new scientific knowledge. Our mission consists of three key areas — research, clinical, and education.

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