ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients
Date & Time
Friday, September 6, 2024, 9:00 a.m.–5:00 p.m.
Building 31, Conference Center, The Great Room.
Zoom Link
https://fda.zoomgov.com/j/1613467309?pwd=RFBoRktzRS8xTWdGamVTZit2V3BNQT09
Passcode: 4XK@nL
Summary
This one-day public workshop will be hosted by the FDA/CDER Office of New Drugs in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).
The purpose of the workshop is to solicit input from stakeholders on increasing the enrollment of historically underrepresented population in pediatric clinical studies, and to encourage pediatric clinical study participation that reflects the prevalence of the other disease or condition among demographic subgroups, where appropriate and other topics.
Background
— Clinical trial populations should, in general, align with the population affected by the disease.
— Some populations are frequently underrepresented in clinical trials despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population. Studies that do not include individuals from underrepresented populations can perpetuate and exacerbate gaps in access, gaps in knowledge, and disparities in health outcomes.
— Adequate representation of these populations in clinical trials helps ensure that the data generated in the development program reflect the diversity of the population expected to use the drug or biological product, if approved, and may potentially identify effects on safety or efficacy outcomes that may be associated with or occur more frequently within these populations.
Agenda
To view agenda, please use this link.
Registration
Registration is free. All interested parties are encouraged to register early. This workshop will be held in-person and in a virtual format via Zoom. Registration is required for both in-person and virtual attendance.
On-line registration for in-person attendance will remain open until 8:30 a.m. Eastern Standard Time on Friday, September 6, 2024. Registrants will receive an email confirmation after they register.
In-person, on-site registration will continue throughout the day.
Registration for virtual attendance will be available until 5:00 p.m. Eastern Standard Time on Friday, September 6, 2024.
To add a calendar notification to your personal calendar you may select one of these links: Add to Google Calendar or Add to Outlook Calendar.
Campus visitor information will be sent to in-person attendees prior to the workshop.
On-Site Attendance
For information related to in-person attendance, please visit Public Workshop Information.
Virtual Attendance (Zoom Webinar)
This workshop will be available for virtual viewing via Zoom on the day of the workshop. Information and the link for viewing will be sent to attendees prior to the workshop. If you are unable to download Zoom, you can also use the browser version of Zoom for viewing this workshop.
Special Accommodations
The FDA will make every effort to accommodate people with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email the OND Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov at least 7 days before the workshop. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.
Visiting the FDA Campus and Security
Entrance for public workshop attendees (non-FDA employees) is through Building 1. Non-FDA attendees will be required to present a government-issued ID (e.g., passport, driver's license) before going through security.
All attendees (FDA and non-FDA) attending the workshop in-person will need to pass through routine security check procedures like TSA screening at airports. Laptops, tablets, cell phones, keys, car fobs, coins and other metal items from pockets must be put in a bin or tray. Hats will need to be removed. Outer coats, belts, shoes, watches, or other jewelry do not have to be removed. After passing through security screening, attendees will be directed to the workshop room in Building 31.
For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map.
Food and Beverage Options:
Coffee, beverages, light breakfast items, crafted artisan salads and sandwiches will be available for purchase at the kiosk. The kiosk is the only accessible vendor to purchase food and beverage to non-FDA employees. Please note, the kiosk closes at 2 p.m., should you need an afternoon snack or beverage.
Attendees may bring their own food and beverages; however, the FDA cannot provide use of a refrigerator or microwave.
There are restaurants in near proximity of the FDA White Oak Campus. Before leaving campus, attendees should consider the amount of time needed to return to campus and go through security screening again.