In an effort to bring together the PWS patient voice, PWSA | USA, IPWSO and FPWR are excited to host the first FDA Externally-Led Patient Focused Drug Development (EL-PFDD) meeting for the Prader-Willi syndrome community. You won't want to miss this impactful event at PWSA | USA's 37th National Convention, June 21-24, 2023, in Orlando, FL. The EL-PFDD meeting itself will take place Thursday, June 22, 2023, from 12:00 - 4:30 p.m. and all are welcome to attend, free of charge with lunch provided. You will be prompted to select to attend the EL-PFDD meeting while registering for the 2023 National Convention.
PWSA | USA Taking Action:
In September 2022, an in-person meeting (the first in-person meeting of ANY organization since the onset of COVID-19) was held with high-ranking members of the FDA (CDER Division) who oversee the department that evaluates potential therapies to treat PWS.
The outcome of that meeting was the suggestion by the FDA to hold an Externally-Led Patient-Focused Drug Development Meeting (EL-PFDD). The FDA explained this program was developed 12 years ago to assist patients and patient advocacy groups to help document the real, unmet needs of their communities.
Now that we have been approved to host this meeting, we look forward to the opportunity for our community's voice to be heard! The EL-PFDD meeting on June 22, 2023, will include 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. If you are unable to attend this meeting in-person and would like to provide a written testimonial, submissions will be accepted until June 9, 2023, and can be sent to advocacy@pwsausa.org.
To find more details about the EL-PFDD meeting, click here to read PWSA | USA's full press release announcement. Your voice matters and we look forward to seeing you there!
The EL-PFDD meeting can be attended in-person or virtually. More details to come.
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.