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Topic

Critical Path for Rare Neurodegenerative Diseases (CP-RND): An Introduction to the Patient Community

Description

This webinar will provide an opportunity to share an overview of CP-RND to the patient stakeholder group and provide the opportunity for feedback and questions from participants

Attendees of the workshop will leave with an understanding of:
• The plan for CP-RND: Stakeholder groups, deliverables, etc.
• The envisioned impact of the CP-RND on medical product development in rare neurodegenerative diseases
• Perspectives from patients, regulators, and industry on the PPP
• Opportunity for feedback and Q&A session

***See below for Speaker details!

Time

Mar 15, 2023 09:30 AM in Eastern Time (US and Canada)

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Message preview	Hi there, You are invited to a Zoom webinar. When: Mar 15, 2023 09:30 AM Eastern Time (US and Canada) Topic: Critical Path for Rare Neurodegenerative Diseases (CP-RND): An Introduction to the Patient Community Register in advance for this webinar: https://c-path-org.zoom.us/webinar/register/WN_fTVrdDcgQca3A9iPL-jcng After registering, you will receive a confirmation email containing information about joining the webinar. ---------- Webinar Speakers Jacqueline Corrigan-Curay, J.D., M.D. (Principal Deputy Center Director in FDA’s Center for Drug Evaluation and Research (CDER) @U.S. Food and Drug Administration (FDA)) Most recently, she served as the Acting Center Deputy Director for Operations, directing center and agency-level priority and initiative programs and leading GDUFA III reauthorization negotiations. Previously, Dr. Corrigan-Curay was director of CDER’s Office of Medical Policy (OMP). In that role, she led the development, coordination, and implementation of medical policy programs and strategic initiatives. She worked collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes. Dr. Corrigan-Curay earned her law degree from Harvard Law School, her medical degree from University of Maryland School of Medicine, and a bachelor’s degree in history of science from Harvard/Radcliffe College in Cambridge, MA. She completed her training in internal medicine at Georgetown University Medical Center, where she also served as a clinical assistant professor of medicine. Collin Hovinga, PharmD, MS, FCCP (Vice President of the Rare and Orphan Disease Programs @Critical Path Institute) Collin Hovinga, PharmD, MS, FCCP, serves as Vice President of the Rare and Orphan Disease Programs at the Critical Path Institute overseeing C-Path’s Rare Disease Cures Accelerator-Data and Analytics Platform and the Critical Path for Rare Neurodegenerative Diseases public-private partnership. Dr. Hovinga completed his Bachelor of Science Degree in Biology and Doctor of Pharmacy degrees from Creighton University in Omaha, Nebraska. He has had a Fellowship at the Food and Drug Administration Office of Clinical Pharmacology and a Masters of Epidemiology from the University of Tennessee Health Science Center. Dr. Hovinga has been active in studying factors that influence the efficacy, safety and the pharmacology of antiepileptic drugs in children, patient adherence to medications, and acute seizure management. Dr. Hovinga is recognized as an expert in neuropharmacology. Walter Koroshetz, M.D. (Director @National Institute of Neurological Disorders and Stroke (NINDS)) Walter J. Koroshetz, M.D., was selected Director of NINDS on June 11, 2015. Dr. Koroshetz joined NINDS in 2007 as Deputy Director, and he served as Acting Director from October 2014 through June 2015. Previously, he served as Deputy Director of NINDS under Dr. Story Landis. Together, they directed program planning and budgeting, and oversaw the scientific and administrative functions of the Institute. He has held leadership roles in a number of NIH and NINDS programs including the NIH’s BRAIN Initiative, the Traumatic Brain Injury Center collaborative effort between the NIH intramural program and the Uniformed Health Services University, and the multi-year work to develop and establish the NIH Office of Emergency Care Research to coordinate NIH emergency care research and research training. Lauren Boak, PhD (Lifecycle Leader, GPS NSRD @Roche) After graduating from Monash in 2007, and publishing three manuscripts in highly regarded international journals, Lauren joined F. Hoffmann-La Roche, Switzerland as a Clinical Science Specialist. Other than six months back in Melbourne for CSL, in the Clinical Safety department, she has worked for Roche in both Switzerland and the United Kingdom ever since. Lauren’s work gives her opportunities to work on potentially transformative medicines and develop experience across multiple fields. She enjoys working with incredibly talented people with an unfaltering focus on making a real difference for patients with devastating illnesses. Ronald J. Bartek (Co-founder/President @Friedreich's Ataxia Research Alliance) Board of Directors/past Chairman, NORD; VP & Board of Directors, Alliance for a Stronger FDA, Board of Directors, Alliance for Regenerative Medicine; Member, NIH/NCATS National Advisory Council; Vice Chair, NCATS Cures Acceleration Network Review Board; member, FDA/CTTI Patient Engagement Collaborative; 4-year member, NIH Neurological Institute National Advisory Council; after graduation from United States Military Academy, West Point, four years as Army officer, as company commander in Korea and Infantry and Military Intelligence officer in Vietnam; Master's Degree, Russian Area Studies - Georgetown University. Michelle Campbell, Ph.D. (Associate Director, Stakeholder Engagement and Clinical Outcomes @U.S. Food and Drug Administration (FDA)) Previously, Dr. Campbell was our viewer on the Clinical Outcome Assessments (COA) Staff and Scientific Coordinator of the COA Qualification Program in OND. Dr. Campbell’s focus is inpatient-focused drug development and the use of patient experience data in the regulatory setting. Prior to joining the FDA, Dr. Campbell spent over 10 years in the academic-clinical setting with research experience including the use of both qualitative and quantitative methods to develop instruments, surveys, program evaluation and the application of various study designs including clinical trials. Dr. Campbell earned her BA in Biology from the College of Notre Dame, her MS in Health Science (concentration in Community Health Education) from Towson University and her PhD in Pharmaceutical Health Services Research from the University of Maryland School of Pharmacy. Celia Witten, MD, PhD (Deputy Director, CBER @U.S. Food and Drug Administration (FDA)) Celia M. Witten, Ph.D., M. D. is the Deputy Director at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA). Between 1996 and 2005 she served as Director of the Division of General, Restorative, and Neurological Devices in the Office of Device Evaluation in the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA). Previous to FDA, she worked for over 10 years as a practicing physician at the National Rehabilitation Hospital (NRH) in Washington, D.C. Her educational background includes a B.A. earned at Princeton University (Magna Cum Laude), a Ph.D. from Stanford University, and an M.D. from the University of Miami School of Medicine. In addition to her academic achievements she is Board Certified in Physical Medicine and Rehabilitation. Philip Green (Patient Advocate @I am ALS) Phil was diagnosed with ALS in August of 2018 at the age of 48. He is a graduate of the University of Washington where he was on the 1991 National Championship UW Football team. He has spent the past 25 years building a career in developing technology solutions for brands such as Sony, Hewlett Packard, and Home Depot. A loving husband to his wife Jennifer, Phil is also a dedicated father to four children (Arianne-20, Hunter-19, Parker-15, and Whitney-12). After his diagnosis, he immediately dedicated himself to making a difference in the fight against this horrific disease. Since his diagnosis with ALS, Phil has made his life’s work improving the fight against this disease. He is active with many patient advocacy organizations and serves as a volunteer patient advisor to several companies working on ALS therapies and technologies.

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