Committees

Charter

The North American Legal and Regulatory Affairs Committee (NA LRA) of the ISCT serves the membership and others working in cellular therapy by providing information regarding U.S., Canadian and international regulations, standards, guidance documents and published best practices and by presenting the regulatory concerns of the membership back to Regulatory Agencies.

Projects & Objectives

• Cell Therapy Liaison Meeting: The NA LRA Lead Designate coordinates and hosts this annual closed meeting with the FDA in collaboration with 20+ stakeholder groups 
• ISCT Annual Meeting: The NA LRA is actively involved in the organization of the ISCT Annual Meeting. The NA LRA topic interests are included in the the Quality and Operations Track. This committee also participates in the review of abstract submissions.
• ISCT Global Regulatory Perspectives (GRP) Workshop: The NA LRA is actively involved in the development of the annual GRP Pre-Conference Workshop that runs in conjunction with the annual meeting.
• Educational Webinars: The NA LRA is involved in the planning of online webinar seminars.
• NA LRA Watchdog: The committee develops frequent watchdog notifications of relevant FDA, Health Canada and related regulatory news updates to the membership. These watchdog announcements are featured in the Telegraft.

Publications

• Current state of U.S. Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizon
• Current state of Health Canada regulation for cellular and gene therapy products: potential cures on the horizon

The Committee

Members

Wade Atkins, MS, MT(ASCP)SBB, CQA (ASQ)
National Institutes of Health
Bethesda, MD, United States

Shirley Bartido, PhD
Takeda Pharmaceutical Company Limited
New York, NY, United States

Patrick Bedford, MSc
weCANReg Consulting Group
Waterdown, ON, Canada

Kevin Bosse, PhD, RAC
Nationwide Children's Hospital
Columbus, OH, United States

Nancy Collins, PhD
University of Toledo
Toledo, OH, United States

Mo Heidaran, PhD
GC Therapeutics
Potomac, MD, United States

Aisha Khan, PhD
University of Miami
Miami, FL, United States

William Lewis, MS, CCRP
St. Jude Children’s Research Hospital
Memphis, TN, United States

Michael Mendicino, PhD
Hybrid Concepts International, LLC
Grand Island, NY, United States

J. Kaitlin Morrison, PhD
UNC Lineberger Comprehensive Cancer Center
Durham, NC, United States

Karen Nichols, Esq.
Vertex Pharmaceuticals
Boston, MA, United States

Charity Njoku, MPH, CCRP
Baylor College of Medicine
Houston, TX, United States

Darshan Patel
Fred Hutchinson Cancer Center
Seattle, WI, United States

Crystal Ruff, PhD, MBA
Takeda
England, United Kingdom

Joseph Schwartz, MD, MPH
Mount Sinai Health System
New York, NY, United States

Sita Somara, PhD
RTI International
Durham, NC, United States

Olive Sturtevant, MSc
Dana Farber Cancer Institute
Boston, MA, United States

Sowmya Viswanathan, PhD
University Health Network
Toronto, ON, Canada

Kara Wacker, MBA
FACT (Foundation for the Accreditation of Cellular Therapy)
Omaha, NE, United States