Voluntary Consensus Standard - The Development Process and Your Critical Role

ABOUT THE WEBINAR

In October 2023, the FDA issued a guidance document on Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies. This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate.  

Standardization bodies such as Standards Coordinating Body (SCB) and the American National Standards Institute (ANSI) have helped to introduce and facilitate the VCS process, however, many stakeholders are unclear about the process.

This webinar will discuss the VCS process, what the stakeholders need to know, and how to develop one. A case study of an actual international consensus standard development of tissue-specific MSC biobanking, characterization, terminology with extensive and iterative input from ISCT will also be presented.

KEY LEARNING OBJECTIVES

  • Describe the benefits and use of Volunteer Consensus Standards (VCS) and how they fit into the regulatory process
  • Discuss the process of Parenteral Drug Association (PDA) as a Standards Development Organization (SDO) to develop VCS
  • Discuss a case study for an MSCs ISO standard development that leverages ISCT comments to reach a consensus
 WEBINAR CHAIR

J. Wade Atkins, MS, MLS, SBB (ASCP), CQA, CABP(H)
Supervisor, QA and Regulatory Affairs
NIH Clinical Center
Member of ISCT North America Legal & Regulatory Affairs Committee
United States

J. Wade Atkins is an MT ASCP with a Specialty in Blood Banking, is credential as a Certified Advanced Biotherapies Professional, a certified Quality Auditor through the American Society for Quality and has a Master of Science in Health Care Administration.

For 22 years he has been associated with quality assurance and regulatory affairs for the Department of Transfusion Medicine (DTM) in the Clinical Center for the National Institutes of Health in Bethesda Maryland and is currently supervising a staff of 9 quality associates. He has responsibilities for ensuring compliance with standards and regulations for manufacturing high quality products.

The DTM is a full-service blood bank with a licensed collection facility and a full transfusion service and maintains an active HCTP manufacturing facility that supports roughly 80 protocols and 35 or more of those are regulated by IND at the FDA. The Blood establishment and Center for Cellular Engineering employee about 200 staff.

 WEBINAR SPEAKERS

Catherine (Katie) Zander, PhD
Director of Standards Education & Outreach
Standards Coordinating Body
United States

In her role with SCB, Katie brings a combination of leadership and technical skills gained from her prior experience as a researcher, a postdoctoral community advocate, and a scientific policy advisor in Congress.

Prior to joining SCB, Katie worked in U.S. House of Representatives for the Committee on Energy and Commerce as the American Society of Hematology’s inaugural American Association for the Advancement of Science (AAAS) Science & Technology Policy Fellow. Before the fellowship, she conducted research on rare blood clotting diseases at the University of Alabama at Birmingham, where she also founded a patient education program. She holds a PhD in Chemistry from Binghamton University, where she studied neurotransmitter kinetics.

Christine Aston-Roberts
Senior Standards Manager
Parenteral Drug Association (PDA)
United States

Christine joined the Parenteral Drug Association (PDA) as their Senior Standards Manager in 2017. Prior to this, she was affiliated with the American Type Culture Collection where over 16 years, she served in numerous capacities, to include technical services, a cell biology lab, and as a standards and certification specialist. She served for 13 years in clinical transplant in the histocompatibility lab at the Medical College at Virginia in Richmond, Virginia, Sentara Norfolk General Hospital in Norfolk, Virginia. She also worked as a Senior Donor Services Coordinator for the “Be The Match” program operated by the National Marrow Donor Program/ CW Bill Young Marrow Program in the Washington DC area. She earned her degree from Virginia Tech.   

Sowmya Viswanathan, PhD 
Osteoarthritis Program Scientist, Division of Orthopedic Surgery,
Schroeder Arthritis Institute and the Krembil Research Institute
University Health Network
ISCT North America Regional Vice-President Elect
Canada

Dr. Viswanathan is a Scientist at the Osteoarthritis Program, Division of Orthopedic Surgery, Schroeder Arthritis Institute and the Krembil Research Institute (University Health Network) and an Associate Professor at the Institute of Biomedical Engineering and at the Division of Hematology, Department of Medicine (University of Toronto).

Dr. Viswanathan is leading international efforts to standardize MSC nomenclature and create reference materials for MSC research. Dr. Viswanathan sits on the Standard Council of Canada’s Mirror Committee for International Organization for Standardization (ISO TC276) on Analytical Methods and Bioprocessing, and is on the steering and working committee of an international Standards Coordinating Body (SCB). Dr. Viswanathan is a formal liaison between ISO TC276 and the International Society of Cell and Gene Therapy (ISCT). Dr. Viswanathan is Associate Editor of Cytotherapy, the official journal for ISCT and N. American VIP Elect (2024-2026) for ISCT.