On June 17, 2021, representatives from PWSA | USA, FPWR and experts in the field of Prader-Willi syndrome research met with the FDAโs Center for Drug Evaluation and Research to discuss issues related to PWS clinical trials.
The purpose of this meeting was to promote dialogue between PWSA | USA, FPWR and members of the PWS patient community to ensure that the FDA has a full understanding of the unique challenges of PWS. PWSA | USA and FPWR shared information on the dire unmet medical need, the communityโs tolerance for risk and uncertainty of benefit as it relates to new treatments, and the impact of the COVID-19 pandemic on PWS clinical trials. We also discussed the PWS communityโs perception as to what constitutes meaningful changes in addressing hyperphagia and other behavioral aspects of PWS, the unique challenges of performing clinical trials in the PWS population, and considering those concerns, discussed how to efficiently advance new medical products that may be safe and effective for PWS.
After an opening statement from FDA, PWSA | USA, and FPWR led the discussion, sharing the perspectives and concerns of the PWS community, with time for questions and discussion with FDA staff on specific topics of interest.
Following the Patient Listening Session, representatives from PWSA | USA and FPWR compiled notes that were taken into one organized and informative document. This summary provides key information shared at the meeting and reactions from the FDA.
Please click hereย to read the full summary of PWSA | USA and FPWRโs Patient Listening Session meeting with the FDA.
Perry A. Zirkel has written more than 1,500 publications on variousย aspects of school law, with an emphasis on legal issues in special education.ย He writes a regular column for NAESPโsย Principalย magazine and NASPโsย Communiquรฉย newsletter, and he did so previously forย Phi Delta Kappanย andย Teaching Exceptional Children.
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.
Dr. Amy McTighe is the PWS Program Manager and Inpatient Teacher at the Center for Prader-Willi Syndrome at the Childrenโs Institute of Pittsburgh. She graduated fromย Duquesne University receiving her Bachelorโs and Masterโs degree in Education with a focus on elementary education, special education, and language arts.
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.
Staci Zimmerman works for Prader-Willi Syndrome Association of Colorado as an Individualized Education Programย (IEP) consultant. Staci collaborates with the PWS multi-disciplinary clinic at the Childrenโs Hospital in Denverย supporting families and school districts around the United Statesย with their childโs 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.