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Judul:Childhood Cancer Hearing Loss PFDD Meeting (Full Program)
Durasi:04:36:58
Dilihat:734x
Diterbitkan:13 September 2018
Sumber:Youtube
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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 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 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

JANGAN LUPA SHARE DENGAN KLIK TOMBOL DI BAWAH INI


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