ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients
Friday, September 6, 2024
Friday, September 6, 2024
9-9:05 a.m.
Welcome and Overview
Lily Mulugeta
Associate Director, Division of Pediatrics and Maternal Health (DPMH)
U.S. Food and Drug Administration (FDA)
9:05-9:10 a.m.
Introductory Remarks
Hilary Marston
Chief Medical Officer
U.S. FDA
9:10-9:25 a.m.
Opening Presentation
Mathilda Fienkeng
Director of Division of Medical Policy Development, Office of Medical Policy
U.S. FDA
9:25-9:40 a.m.
Keynote Talk
Michelle and Michael Burgess
International Children's Advisory Network" (iCAN) Patient/Parent
9:40-10 a.m.
FDA Perspective
Christine Lee
Acting, Associate Commissioner and Director
Office of Minority Health and Health Equity (OMHHE), U.S. FDA
10-10:20 a.m.
Diversity in Pediatric Research: Academic Perspective
Sue Rahman
Chief Scientific Officer
Health Data Synthesis Institute
10:20-10:30 a.m.
Break
10:30-10:50 a.m.
Landscape of Industry-Sponsored Pediatric Trials
Pam Simpkins
Managing Partner, Mezzopointe, LLC
10:50-11:30 a.m.
Panel Discussion
Moderators:
Dionna Green
Director, Office of Pediatric Therapeutics
US FDA
Lois K Lee
Senior Associate in Pediatrics, Division of Emergency Medicine
Boston Children’s Hospital
Panelists:
Sneha Dave
Executive Director, Generation Patient
Florence Bourgeois
Associate Professor, Pediatrics, Harvard Medical School
Ann McMahon
Regulatory Scientist, Office of Pediatric Therapeutics, US FDA
Pam Simpkins
Managing Partner, Mezzopointe, LLC
Sue Rahman
Chief Scientific Officer, Health Data Synthesis Institute
Christine Lee
Acting, Associate Commissioner and Director
OMHHE, US FDA
11:30 a.m.-12:30 p.m.
Lunch
12:30-1:05 p.m.
Inclusive Trial Designs and Methodological Considerations (Case Examples)
Recruitment and Retention/Decentralized Trials-15 min
Rachel Randell
Assistant Professor of Pediatrics
Duke University and Duke Clinical Research Institute (DCRI)
Addressing Diversity in Clinical Trials and Diversity Plans-20 min
Ted Love
Chair of Board of Directors, Biotechnology Innovation Organization
Bella Oguno
Vice President, Development Operations
Nuvig Therapeutics
1:05-1:20 p.m.
Diversity in Pediatric Type 2 Diabetes Trials
Lauren Wood Heickman
Clinical Reviewer
Division of Diabetes, Lipid Disorders, and Obesity (DLLO), US FDA
1:20-2 p.m.
Panel Discussion
Moderators:
Lily Mulugeta
Associate Director, DPMH U.S. FDA
Sue Rahman
Chief Scientific Officer, Health Data Synthesis Institute
Panelists:
Anvita Ambardekar: Patient/Community Representative
Lauren Wood Heickman
Clinical Reviewer, DDLO U.S. FDA
Martha Donoghue
Acting Associate Director, Pediatric Oncology, Office of Oncologic Diseases, U.S. FDA
LaShell Robinson
Head of Diversity, Equity & Inclusion, Clinical Research Department, Takeda
Ki Lee Milligan
Executive Director, Pediatric Center for Excellence, Global Drug Development, Novartis
Ted Love (Virtual)
Chair of Board of Directors, Biotechnology Innovation Organization
Stephen Balevic (Virtual)
Associate Professor of Medicine and Pediatrics, Duke University and DCRI
Rachel Randell
Assistant Professor of Pediatrics, Duke University and DCRI
Christina Edwards
Director of Clinical Trials, National Minority Quality Forum
2-2:15 p.m.
Break
2:15-3 p.m.
Panel Discussion: Community Engagement and Trust Building
Moderator:
Carla Epps
Senior Physician, DPMH US FDA
Panelists:
Billie Jo Kipp
Clinical Psychologist, Indigenous Innovators Collaborative
Nasrin Sari
Patient/Community Representative
Sneha Dave
Executive Director, Generation Patient
LaToya Williams
Community Clinical Director, Inside Edge Consulting Group
Anvita Ambardekar
High School Student, Pediatric Perspective iCAN
3-3:45 p.m.
Best Practices That Help Children and Families to Stay in Clinical Trials
Tamorah Lewis
Sellers Chair, Pharmacology and Pharmacogenetics
Division Head, Clinical Pharmacology & Toxicology
Staff Neonatologist, The Hospital for SickKids
Puja Umaretiya
Assistant Professor, Division of Pediatric Hematology/Oncology
UT Southwestern, Children’s Medical Center
Christina Edwards
Director of Clinical Trials, National Minority Quality Forum
3:45-4:55 p.m.
Panel Discussion
Moderators:
Carla Epps
Senior Physician, DPMH US FDA
Billie Jo Kipp
Clinical Psychologist, Indigenous Innovators Collaborative
Panelists:
Lynne Yao
Director, DPMH U.S. FDA
Tamorah Lewis
The Hospital for SickKids
LaToya Williams
Community Clinical Director, Inside Edge Consulting Group
Florence Bourgeois
Associate Professor, Pediatrics, Harvard Medical School
Bella Oguno
Vice President, Development Operations, Nuvig Therapeutics
Melissa Penn
Director of Patient Engagement R&D, Bayer Pharmaceuticals
Michelle/Michael Burgess
iCAN Patient/Family Representative
Nasrin Sari
Patient/Community Representative
Puja Umaretiya
Assistant Professor, UT Southwestern, Children’s Medical Center
Christina Edwards
Director of Clinical Trials, National Minority Quality Forum
4:55-5 p.m.
Closing Remarks
Lynne Yao
Director, DPMH U.S. FDA
This workshop is co-hosted by the U.S. Food and Drug Administration (FDA) and the Center of Excellence in Regulatory Science and Innovation (M-CERSI).
