Join us for an Externally-Led Patient-Focused Drug Development Meeting (EL-PFDD) at PWSA | USA's 37th National Convention, June 21-24, 2023!
This is an FDA program and the first for our PWS community!
On Thursday, June 22, 2023, in conjunction with our PWSA | USA National Convention in Orlando, Florida, PWSA | USA will host an Externally-Led Patient-Focused Drug Development meeting (EL-PFDD) where the U.S. Food and Drug Administration (FDA) and other stakeholders will be in attendance. The meeting will take place between 12:00 - 4:30 p.m. EST at the Hilton Orlando Buena Vista Palace.
This historic event is intended to help educate the Agency, the public, and other stakeholders about the challenges of living with Prader-Willi syndrome (PWS) and to underscore the unmet needs of the PWS community.
The June 22nd meeting will be offered in-person and livestreamed virtually and will allow for patient testimonials, as well as remote audience participation. The meeting agenda will focus on two patient panels and audience discussion sessions on living with PWS, treatments for the disease, and potential clinical trials for PWS. It will also encourage patients and caregivers impacted by PWS to participate in a brief survey following the EL-PFDD. The anonymous information gathered will be used to help guide and inform content for this meeting, the development of a meeting report that will be issued to FDA, as well as future PWS related activities.
Registration to attend the EL-PFDD meeting and 37th National Convention will be available soon. Click here to read our full press release announcement and learn more about this incredible opportunity for our community!
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"This FDA sponsored program will allow regulators and policymakers on the Hill to hear directly from patients and caregivers about what it is like to live with and care for those who have PWS.
We believe that understanding the patient journey can help the FDA make more informed decisions as they review potential therapies for PWS and will assist pharmaceutical companies in the design of clinical trials for PWS patients.”
- Paige Rivard, MBA | CEO
Mom to Jake (12)
Jennifer Bolander has been serving as a Special Education Specialist for PWSA (USA) since October of 2015. She is a graduate of John Carroll University and lives in Ohio with her husband Brad and daughters Kate (17), and Sophia (13) who was born with PWS.
Perry A. Zirkel has written more than 1,500 publications on various aspects of school law, with an emphasis on legal issues in special education. He writes a regular column for NAESP’s Principal magazine and NASP’s Communiqué newsletter, and he did so previously for Phi Delta Kappan and Teaching Exceptional Children.
Evan has worked with the Prader-Willi Syndrome Association (USA) since 2007 primarily as a Crisis Intervention and Family Support Counselor. Evans works with parents and schools to foster strong collaborative relationships and appropriate educational environments for students with PWS.
Dr. Amy McTighe is the PWS Program Manager and Inpatient Teacher at the Center for Prader-Willi Syndrome at the Children’s Institute of Pittsburgh. She graduated from Duquesne University receiving her Bachelor’s and Master’s degree in Education with a focus on elementary education, special education, and language arts.
Staci Zimmerman works for Prader-Willi Syndrome Association of Colorado as an Individualized Education Program (IEP) consultant. Staci collaborates with the PWS multi-disciplinary clinic at the Children’s Hospital in Denver supporting families and school districts around the United States with their child’s Individual Educational Plan.
Founded in 2001, SDLC is a non-profit legal services organization dedicated to protecting and advancing the legal rights of people with disabilities throughout the South. It partners with the Southern Poverty Law Center, Protection and Advocacy (P&A) programs, Legal Services Corporations (LSC) and disability organizations on major, systemic disability rights issues involving the Individuals with Disabilities Education Act (IDEA), Americans with Disabilities Act (ADA), and the federal Medicaid Act. Recently in November 2014, Jim retired.