Activity Provided By:

Postgraduate Institute for Medicine (PIM) and PlatformQ Health Education, LLC working in collaboration with the National Organization for Rare Disorders (NORD).

Clinical Development and Regulatory Oversight of Cell and Gene‐Based Therapies from Development to Post‐Marketing

Overview / Abstract:	Target Audience This activity is intended for primary care providers, internal-medicine specialists, pediatricians, pulmonologists, cardiologists, endocrinologists, gastroenterologists, hepatologists, neurologists, neuromuscular specialists, infectious-disease specialists, obstetricians/gynecologists, rheumatologists, dermatologists, hematologists, oncologists, neonatologists, genetic counselors, social workers, psychologists, nurse practitioners, physician assistants, nurses, and pharmacists Learning Objectives Upon completion of this activity, participants should be better able to: Summarize the key steps of development programs for gene therapies, identifying how and why some programs may differ from others Explain the role of the FDA in providing regulatory oversight from development to post marketing Faculty Alessandra Biffi, MD Professor of Pediatrics Director, Division of Pediatric Hematology, Oncology and Stem Cell Transplant University of Padua Kevin Flanigan, MD Director, Center for Gene Therapy Robert F. & Edgar T. Wolfe Foundation Endowed Chair in Neuromuscular Research Director, Nationwide Children’s Hospital Center for Research Translation in Muscular Dystrophy Therapeutic Development Abigail Wexner Research Institute Nationwide Children’s Hospital Professor of Pediatrics and Neurology The Ohio State University Kimberly Goodspeed, MD Assistant Professor of Pediatrics, Neurology Division University of Texas Southwestern Medical Center Dallas Stephan A. Grupp, MD, PhD Section Chief, Cellular Therapy and Transplant Director, Cancer Immunotherapy Program Children’s Hospital of Philadelphia Novotny Professor of Pediatrics Perelman School of Medicine at the University of Pennsylvania John Kessler, MD Davee Professor Davee Department of Neurology Northwestern University Julie A. Parsons, MD Haberfeld Family Endowed Chair in Pediatric Neuromuscular Disorders Professor of Clinical Pediatrics and Neurology University of Colorado School of Medicine Children's Hospital Colorado Perry B. Shieh, MD, PhD, FAAN Professor of Neurology and Pediatrics David Geffen School of Medicine at UCLA University of California, Los Angeles
Expiration	Apr 22, 2022
Discipline(s)	Nursing CNE, Pharmacy CPE, Physician CME, Physician Assistant CME, Psychology CE
Format	Online
Credits / Hours	1.0 AMA PRA Category 1 Credit(s)™
Accreditation	ACCME
Presenters / Authors / Faculty	Faculty Alessandra Biffi, MD Professor of Pediatrics Director, Division of Pediatric Hematology, Oncology and Stem Cell Transplant University of Padua Kevin Flanigan, MD Director, Center for Gene Therapy Robert F. & Edgar T. Wolfe Foundation Endowed Chair in Neuromuscular Research Director, Nationwide Children’s Hospital Center for Research Translation in Muscular Dystrophy Therapeutic Development Abigail Wexner Research Institute Nationwide Children’s Hospital Professor of Pediatrics and Neurology The Ohio State University Kimberly Goodspeed, MD Assistant Professor of Pediatrics, Neurology Division University of Texas Southwestern Medical Center Dallas Stephan A. Grupp, MD, PhD Section Chief, Cellular Therapy and Transplant Director, Cancer Immunotherapy Program Children’s Hospital of Philadelphia Novotny Professor of Pediatrics Perelman School of Medicine at the University of Pennsylvania John Kessler, MD Davee Professor Davee Department of Neurology Northwestern University Julie A. Parsons, MD Haberfeld Family Endowed Chair in Pediatric Neuromuscular Disorders Professor of Clinical Pediatrics and Neurology University of Colorado School of Medicine Children's Hospital Colorado Perry B. Shieh, MD, PhD, FAAN Professor of Neurology and Pediatrics David Geffen School of Medicine at UCLA University of California, Los Angeles
Sponsors / Supporters / Grant Providers	Astellas Gene Therapies; AVROBIO, Inc.; Biogen; CRISPR Therapeutics, Inc.; Helixmith Co., Ltd; Orchard Therapeutics; REGENXBIO Inc.; and uniQure, Inc.
Keywords / Search Terms	Relias LLC Relias LLC., FreeCME., Cell and Gene‐Based Therapies Free CE CME

Access Activity

CORE Higher Education Group, CESearchEngine.com, and our advertising partners do not endorse and do not verify the accuracy of the content in the activities presented on the CESearchEngine.com website or within our mobile apps.CORE Higher Education Group, CESearchEngine.com, and our advertising partners are not responsible for errors, omissions, or misrepresentations contained within activities presented on the CESearchEngine website or within our mobile apps. For complete details, please read the CESearchEngine.com Terms of Service. Site Map