global-regulatory-landscape-opportunities-and-challenges

ABOUT THE WEBINAR

Join us for an insightful webinar exploring the evolving regulatory landscape shaping the future of cell and gene therapies (CGTs). This expert-led session will dive into recent and anticipated regulatory decisions and their far-reaching implications for CGT development, approval, and commercialization.

Attendees will gain a global perspective on how collaboration between regulatory agencies is driving alignment and accelerating patient access to advanced therapies. The panel will also examine innovative regulatory strategies, highlighting creative approaches to clinical trial design, selection of endpoints, strategic use of regulatory designations, and integration of real-world longitudinal data to support product development and approval.

With firsthand insights from experienced regulatory professionals, the discussion will also provide actionable guidance for CGT developers and sponsors on how to proactively manage and minimize regulatory risks. Whether you are navigating early-stage development or preparing for submission, this webinar offers a comprehensive overview of the tools, partnerships, and regulatory pathways that can streamline progress and enhance the likelihood of success in this fast-moving field. Tune in to keep up and stay ahead in the dynamic world of CGT regulations.

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KEY LEARNING OBJECTIVES

  • Review recent and upcoming cell and gene therapy (CGT)-specific regulatory decisions and their implications for broader CGT development and commercialization.
  • Discuss innovative regulatory strategies that can accelerate CGT development (e.g. creative study design, use of surrogate endpoints, and leveraging existing longitudinal data).
  • Explore emerging opportunities for regulatory harmonization and collaboration across different geographies.
  • Understand best short-term and long-term strategies CGT developers can take to navigate changes within regulatory bodies.
 WEBINAR CHAIRS

Ksenia Bezverbnaya, PhD
ISCT BDF Committee Member
Manager, Technology & Venture Development
Centre for Commercialization of Regenerative Medicine (CCRM)
Canada

Ksenia Bezverbnaya is a Manager, Technology & Venture Development, at the company creation unit at the Centre for Commercialization of Regenerative Medicine (CCRM), Canada. She helps academic and clinical investigators derisk novel cell and gene therapy technologies and spin out start-up companies across a variety of therapeutic indications. Ksenia has extensive experience in immune cell engineering, preclinical development, and indication selection, and brings an early-stage translational industry perspective to the discussion.

Asthika Goonewardene, MBA
ISCT BDF Committee Member
Managing Director, Equity Research (Biotech)
Truist Securities
United States

Asthika Goonewardene is a Managing Director at Truist Securities, where he focuses on equity research in immune-oncology, cell therapy, and antibody technologies. He has over two decades of experience in biotech intelligence and investment with previous roles at Bloomberg Intelligence, Datamonitor, Piper Jaffray, Amba Research, and OSI Pharmaceuticals. Asthika has been a long-standing member of the ISCT Business Development & Finance Committee, where he championed previous iterations of the Investor Survey and gathered valuable insights on the CGT investment trends.

 WEBINAR SPEAKERS

Bambi Grilley, PRh, RAC, CIP, CCRC, CCRP
ISCT Chief Regulatory Officer
Director, Clinical Research and Early Product Development (Center for CGT)
Baylor College of Medicine
United States

Bambi is the Director of the Clinical Research and Early Product Development Center, Cell and Gene Therapy, at the Baylor College of Medicine. She is a world-renowned expert in Clinical Research and Regulator Affairs with over 25 years of experience in protocol development, study submissions, execution, and oversight of over 1,600 studies. Bambi has been leading cell and gene therapy regulatory guidance, protocol development, quality assurance and quality control programs for over 15 years and currently serves as the Chief Regulatory Officer at ISCT.

Wilson Bryan, MD
Regulatory Consultant
Wilson W. Bryan Consulting, LLC
United States

Wilson Bryan is a regulatory veteran in the regenerative medicine space, who served as the FDA’s Chief of the Clinical Evaluation Branch in the Office of Cellular, Tissue, and Gene Therapies (OCTGT) between 2009 and 2016, and subsequently as the Director of the Office of Tissues and Advanced Therapies (part of CBER) between 2016 and 2023. He brings a wealth of knowledge in regulation of cell and gene therapies, tissue-engineered products, plasma protein therapeutics, and xenotransplantation. Prior to leading the CGT regulation with the FDA, Wilson was an active clinician, clinical investigator, and faculty in the neurology and neuromuscular space for over a decade.

Michael Werner, J.D.
 Healthcare and FDA Regulatory and Policy Attorney
Holland & Knight LLP
United States

Michael Werner is a Washington, D.C., public policy and regulatory attorney of Holland & Knight's Healthcare & Life Sciences Team. He is also a co-leader of the Public Policy & Regulation Group's Healthcare & Life Sciences Policy Team. Mr. Werner has almost three decades of healthcare law, lobbying, regulatory and reimbursement experience in Washington. He focuses on issues affecting FDA-regulated entities, including biotechnology and pharmaceutical companies developing and manufacturing prescription and over-the-counter (OTC) drugs, biosimilars, cosmetics, dietary supplements and digital-health technologies. He is an internationally regarded thought leader in the regulation and reimbursement of cell therapy, gene therapy, tissue engineering and regenerative medicine products. In that capacity, he has assisted numerous companies and product developers navigating these issues and is the principal architect of the Regenerative Medicine Advanced Therapy expedited approval pathway at the FDA. He also has experience in human subject protection issues such as institutional review board (IRB) review and informed consent, as well as conflicts of interest and other bioethics issues arising from research and uses of new technologies. Mr. Werner is the co-founder and senior policy counsel of the Alliance for Regenerative Medicine, the leading global organization representing the cell therapy, gene therapy, tissue engineering and regenerative medicine sector.