Courts, Challenges, and Controversies: Understanding Critical Developments Shaping the Regulation of

ABOUT THE WEBINAR

While an increasing number of regulatory approvals in the Cell and Gene Therapy (CGT) field has fueled optimism for potential treatments and cures for debilitating and fatal conditions, constant challenges to US FDA oversight – by courts, federal and state legislatures, and rogue “stem cell clinics” - pose serious risks for individual patients and for the entire industry.

This webinar begins with an overview of the U.S. legal landscape governing development and therapeutic usage of stem cell and gene therapies, including several recent, highly-consequential court rulings impacting the FDA and other federal agencies. The webinar then addresses recent state developments that have attracted little public attention, including new iterations of “Right-To-Try” and “Medical Freedom” laws, and their legal and practical impact on experimental stem cell and gene therapies. After exploring the wide-spread availability of unproven stem cell and regenerative interventions currently being offered by stem cell clinics and in other unregulated settings, the webinar will highlight existing risks for individual patients and the entire CGT sector, and ways these may be further exacerbated in the near future. The area of unproven stem cell and regenerative medicine clinics will be discussed in more depth as an exemplar of complex legal, policy and ethical challenges to federal and state regulators.

The webinar will conclude with an interactive panel discussion and an open Q&A for attendees to raise issues and contribute to the discussion. 

 WEBINAR SPEAKERS

Beth Roxland, JD, M.Bioethics

 Webinar Chair

Senior Advisor on Law, Policy and Bioethics
Roxland Consultants, Ltd.
United States

Beth E. Roxland, J.D., M.Bioethics is a seasoned Attorney & Bioethicist with multifaceted experience across Industry, Law, Government & Academia. She serves as the Senior Advisor on Law, Policy and Ethics for Roxland Consultants Ltd., an independent consultancy where she leverages her unique expertise to provide comprehensive yet practical strategic advice and support to life-science, biotechnology & research entities, law firms, hospitals & healthcare practitioners, venture capital & financial institutions, and professional & patient associations confronting complex legal, ethical, operational & communications challenges in the scientific and medical arenas. Roxland is also a practicing attorney, specializing in litigation, regulation, torts, health law, public health & pandemics, and risk & crisis management. Roxland is a frequent public speaker & author, serves on several academic, medical and research oversight boards, and occupies leadership roles in professional societies.

Roxland’s executive experience includes her prior roles as:

  • Johnson & Johnson's Bioethics and Strategy Leader, in the Global Chief Medical Officer's Office;
  • Executive Director of The New York State Task Force on Life & the Law;
  • Special Advisor to the Commissioner of Health on Stem Cell Research Ethics;
  • Senior Litigation Associate at Simpson Thacher & Bartlett LLP;
  • Federal Judicial Law Clerk in the Southern District of New York (S.D.N.Y.); and
  • Adjunct Professor of Law at NYU School of Law. 

Roxland graduated from Columbia University with a Bachelors degree in Biology, and from the University of Pennsylvania Magna Cum Laude with joint degrees in Law and Bioethics (Juris Doctorate – Masters in Bioethics). 

Kirstin Matthews, PhD
Fellow in Science and Technology Policy
Rice University’s Baker Institute for Public Policy
United States

Kirstin R.W. Matthews, Ph.D., is a fellow in science and technology policy at Rice University’s Baker Institute for Public Policy and a lecturer in the Department of BioSciences at Rice University. She is also a track advisor for the Wiess School of Natural Sciences’ Professional Science Master in Biosciences and Health Policy, a core member of the Rice Synthetic Biology Institute, and a steering committee member for Rice’s Medical Humanities Research Institute.

Matthews is the director of the Baker Institute Science and Technology Policy Program and the Center for Health and Biosciences’ Biomedical Research Program. Her research focuses on ethical and policy issues at the intersection between traditional biomedical research and public policy. Specifically, she focuses on regulation and ethical issues associated with emerging biotechnology, including vaccines, stem cells, synthetic biology, and genomic medicine. Matthews also collaborates with Kenneth Evans and Neal Lane to understand how scientific advice is used in and provided for the federal government, including the White House Office of Science and Technology Policy (OSTP) and the President’s Council of Advisors on Science and Technology (PCAST).

Matthews has a B.A. in biochemistry from The University of Texas at Austin and a Ph.D. in molecular biology from The University of Texas Health Science Center at Houston.

Paul Knoepfler, PhD
Professor, Department of Cell Biology and Human Anatomy
UC Davis Health, School of Medicine
United States

Paul Knoepfler is an award-winning scientist who is particularly interested in what controls stem and cancer cell biological behavior.

Known also for his popular blog – ipscell.com – and passionate stem cell advocacy, Knoepfler and his laboratory team focus on how a cell’s pluripotency control machinery goes awry during cancer.

Knoepfler is using cutting-edge genomics technology to better understand why stem cells behave the way they do, and working to determine how cell behavior can be directed toward safe and effective clinical use as well as to develop new cancer therapies for kids.

He is the author of three books including Stem Cells: An Insider’s Guide and has a popular TED talk on CRISPR and designer babies.