Legal and Regulatory Affairs Committee: North America

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 and Objectives

  • Cell Therapy Liaison Meeting: The NA LRA Co-Chairs lead the group of 23+ stakeholder groups in the coordination of this annual meeting with the FDA.
  • 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 and related regulatory news updates to the membership. These watchdog announcements are featured in the Telegraft.

 


Committee Chair:


Karen Nichols, Esq.
Interim Chair

Magenta Therapeutics
Cambridge, MA, United States

 

 

Committee Members:

 

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

Shirley Bartido, PhD
Cellectis
New York, NY, United States

Nancy Collins, PhD
University of Toledo
Toledo, OH, United States
Patrick Bedford, MSc
Celgene
Mississauga, ON, Canada
Judy Anderson MA, MT(ASCP) 
FACT (Foundation for the Accreditation of Cellular Therapy)
Omaha, NE, United States

Kurt Gunter, MD, FASCP
Cell Medica Inc.
Houston, TX, United States

William Janssen, PhD
St. Jude Children's Research Hospital
Memphis, TN, United States

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

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

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

Crystal Ruff, PhD
London Business School
London, United Kingdom
Olive Sturtevant, MSc
Dana Farber Cancer Institute
Boston, MA, United States
Sita Somara, PhD
Wake Forest Institute for Regenerative Medicine
Winston-Salem, NC, United States
Sowmya Viswanathan, PhD
Cell Therapy Program, University Health Network
Toronto, ON, Canada
Yong Fan, MD
A2Z Reg Solutions
Frederick, MD, United States

Jiwen Zhang, PhD
Tmunity Therapeutics Incorporated
Philadelphia, PA, United States

 

 

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