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 & 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

Chair

Kevin Bosse, PhD, RAC-US, CABP(H)

Nationwide Children's Hospital
Columbus, OH, United States

Members

Wade Atkins
National Institutes of Health
United States

Shirley Bartido
Takeda Development Center Americas, Inc.
United States

Sai Bhadimipati
Moderna
United States

Lynn Csontos, RAC US, RAC Devices
Stemcell Technologies
Canada

Danielle DiTirro
ESP Leadership Development Program (2024-2026)

Millipore Sigma
United States

Lucia Fernandez, PhD

ESP Leadership Development Program (2025-2027)
VintaBio
United States

Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP
Immediate Past Chair
Baylor College of Medicine
Houston, TX, United States

Mohammad Heidaran
Cellx Inc.
United States

Janet G. Johnson
Terumo Blood and Cell Technologies
United States

Aisha Khan
University of Miami
United States

Adam Lee

ESP Leadership Development Program (2025-2027)

Thermo Fisher Scientific
United States

Michael Mendicino
Hybrid Concepts International (HCI), LLC
United States

J. Kaitlin Morrison
UNC Lineberger Comprehensive Cancer Center
United States

Charity Njoku
Baylor College of Medicine - Center for Cell and Gene Therapy
United States

Darshan Patel
Fred Hutchinson Cancer Center
United States

Crystal Ruff
Takeda
United Kingdom

Yossi Schwartz
FACT
United States

Vince So, MS
Xcell Biosciences
United States

Sita Somara
Soma Life Science Solutions 
United States

Olive Sturtevant
Dana-Farber Cancer Institute
United States

Sowmya Viswanathan
University Health Network
Canada