Advocacy in Action presents… Engaging with the FDA: Opportunities and Boundaries
WHEN: April 27, 2022 at 3:00PM EST
REGISTER HERE
As our community continues down the ever-evolving road of drug trials to enhance the lives of those who have Prader-Willi syndrome (PWS), PWSA | USA invites you to join us for a live webinar featuring two speakers direct from the U.S. Food and Drug Administration (FDA)!
Now more than ever, it’s essential that our community understands the most effective way to have our collective voices heard by those who can directly affect change. This informative webinar will discuss topics such as:
- Understanding patient engagement at the FDA
- Patient voice
- FDA Patient Listening
- Submitting questions and meeting requests
- Patient focus drug development
- CDER Listening Sessions
In addition, we will feature a 15-minute Q & A opportunity at the end of the presentation where attendees will have the opportunity to ask questions directly to our presenters from the FDA. It’s important to note that the Q & A portion will NOT speak to specific information surrounding any drugs seeking FDA approval, but it will provide members of our community with the opportunity to learn how to best engage with the FDA. PWSA | USA is thrilled we can provide this unique opportunity for members of the PWS community and look forward to an exciting and informative presentation.
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SPEAKERS:
Sadhna Khatri, Pharm.D., MPH, MS, MEd
CDR, U.S. Public Health Service
Supervisory Associate Director -Engagement Team
Professional Affairs and Stakeholder Engagement | Office of Center Director
Center for Drug Evaluation and Research | Food and Drug Administration (CDER)
CDR Sadhna Khatri, PharmD, MPH, is a regulatory officer in Professional Affairs and Stakeholder Engagement (PASE) in the Office of the Center Director in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). She is the Supervisor of the PASE Engagement team. She develops strategic contacts and outreach to other federal agencies, members of professional organizations, and health-related societies. She also organizes public workshops for patient advocacy groups, helping increase engagement with the FDA and helping the patient voice be heard in the regulatory process of drug development. Before joining PASE, Dr. Khatri was a senior pharmacist with CDER’s Office of Communications’ Division of Drug Information, responding to public inquiries concerning all aspects of drug review, regulation, and FDA’s MedWatch program. She was also director of the FDA’s Pharmacy Student Experiential Program (PSEP). As such, Dr. Khatri developed and implemented new measures to significantly improve the visibility of PSEP across the FDA, making it a highly-acclaimed and nationally-recognized program for fostering the development of the next generation of pharmacists. Modelling the success of PSEP, Dr. Khatri has also launched a new experiential program for medical students and residents to experience and understand the FDA’s broad regulatory authority and responsibility in protecting the public health. Dr. Khatri joined the FDA from Kaiser Permanente, where she worked as the Director of the Mid-Atlantic Anticoagulation Services. She collaborated with clinical teams to launch a new electronic documentation system and created an automated work flow for clinical pharmacists to route correspondence to the pharmacy and providers. Dr. Khatri earned a Doctor of Pharmacy degree from the University of Maryland School of Pharmacy in 2000. She also holds a Master of Public Health degree from Morgan State University
Susan Chittooran, MSW
FDA Patient Listening Session Program Manager
Office of Patient Affairs
Office of the Commissioner
U.S. Food and Drug Administration
Susan Chittooran is the Patient Listening Session program manager and Sr Health Scientist in the Office of Patient Affairs (OPA) within the Office of the Commissioner at the U.S. Food and Drug Administration (FDA). In her role, Susan manages FDA’s Patient Listening Session program, serves as the liaison between patients and subject matter experts within FDA’s medical product centers, and assists in identifying and coordinating patient stakeholder participation in FDA meetings and workshops. Previously, Susan served as the central point of contact in Patient Affairs for patients, caregivers, and patient advocates who wish to engage with the Agency, resolved patient-related concerns and inquiries, and managed the communications and social media for Patient Affairs. Prior to joining Patient Affairs, Susan spent three years at FDA’s Office of Health & Constituent Affairs (OHCA) where she was responsible for engaging with stakeholders including healthcare professionals, patients and patient advocacy groups, and consumers to incorporate their perspectives in regulatory processes and policies, coordinated FDA’s stakeholder communication calls, and managed portfolios on biosimilars and opioids. She was also responsible for managing and planning the Center for Devices & Radiological Health (CDRH)’s inaugural Patient Engagement Advisory Committee (PEAC) meeting - the only FDA advisory committee that is comprised solely of patients and caregivers. Prior to joining FDA, Susan worked in the New York office of the Women’s Bureau, U.S. Department of Labor for six years where she planned meetings, listening sessions, and events related to agency priority areas with diverse stakeholder groups including other federal agencies, non-profit organizations, foundations, and businesses. She also served as a Special Assistant to former Women’s Bureau (WB) Director in Washington, DC, where she was responsible for supporting the Director and WB leadership in the planning and implementation of the White House Summit on Working Families. A social worker by background, Susan has experience with case management and direct service to clients in various clinical settings in non-profit organizations in New York City. Susan has a Master of Science in Social Work Policy from Columbia University, and a Bachelor of Arts in Psychology from Auburn University.
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.
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 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.
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 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.