Adverse Effects of Unproven Interventions

When:  Oct 21, 2021 from 09:00 to 10:30 (PT)
Thursday, October 21 - 9:00 PST / 12:00 EST
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Adverse Effects of Unproven Therapies 

An ISCT Presidential Task Force on the Use of Unproven/Unethical Cell & Gene Therapies Webinar

Webinar Description:

Featuring presentations by Farzana Akkas of Pew Charitable Trusts and Jaime Imitola of the University of Connecticut, this webinar will bring an evidence-based, data-driven perspective to the subject of adverse effects and other harms related to the administration of unproven and unlicensed cell-based interventions.

Topics to be addressed in the webinar include physical effects, such as infection and disabilities associated with the administration of unproven cell-based interventions, psychological and financial harms, and harms to public health and credible clinical research. The webinar will also address physician awareness of patients pursuing unproven cell-based interventions, especially in the domain of neurology.

The target audience includes clinicians, scientists, product developers, policy-makers, and members of the regulatory community in the fields of cell and gene therapy. The objectives of the webinar are to educate about the multitude of risks and harms associated with cell-based interventions that lack established safety and efficacy profiles, and to inform clinical practice, regulatory policy, and public understanding of stem cell interventions and the development of stem cell therapies.

Co-Chaired By: 

Laertis Ikonomou, PhD
Associate Professor
Department of Oral Biology
University at Buffalo

Dr. Laertis Ikonomou is an Associate Professor at the Department of Oral Biology, University at Buffalo, The State University of New York. He was awarded his PhD in Biochemical Engineering from the Université Catholique de Louvain in Belgium and received postdoctoral training in Stem Cell and Developmental Biology at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the BU School of Medicine Pulmonary Center.

His major research interests are in the areas of pluripotent stem cell biology, developmental biology and stem cell engineering, with emphasis on foregut and neural crest biology. In addition to his research, Dr. Ikonomou has been involved since 2013 in education and information activities regarding unproven and unregulated cell- and gene-based interventions as a member of the American Thoracic Society (ATS) Stem Cell Working Group and the International Society for Cell & Gene Therapy (ISCT) Presidential Task Force (PTF) on the Use of Unproven and/or Unethical Cell and Gene Therapies. He is currently the chair of the ISCT PTF.

Leigh Turner, PhD
Executive Director, Bioethics Program
University of California, Irvine

Leigh Turner is Executive Director of the University of California, Irvine’s Bioethics Program and a Professor in the Program in Public Health’s Department of Health, Society, and Behavior. He is also a member of UCI’s Stem Cell Research Center and lead’s the UCI’s Institute for Clinical and Translational Science’s Clinical Research Ethics Consultation Service. His current research addresses ethical, legal, and social issues related to stem cells and regenerative medicine products. In particular, he uses approaches from bioethics and the social sciences to examine clinics engaged in direct-to-consumer marketing of unproven and unlicensed cell-based interventions. He also studies ethical issues related to crowdfunding for medical care, cross-border health-related travel, and other topics. Turner is a co-editor of Risks and Challenges in Medical Tourism: Understanding the Global Market for Health Services and The View from Here: Bioethics and the Social Sciences.



Farzana Akkas, MSc
Senior Associate
Pew Charitable Trusts 

Farzana Akkas is a Senior Associate at the Pew Charitable Trusts, where she focuses on strengthening medical product regulation to safeguard patients and consumers. Her work centers primarily on improving FDA oversight of dietary supplements and regenerative medicine therapies. Most recently, she helped lead research at Pew highlighting harms associated with unapproved stem cell products. Prior to joining Pew, Akkas worked as a research fellow at the National Center for Health Research where she focused on a range of health policy topics, including regulatory policies impacting safety of drugs and medical devices. Akkas holds a bachelor’s degree in biomedical sciences and a master’s in health promotion and public health from Kingston and Brunel university in London, respectively.

Jaime Imitola, MD, FAAN
Chief Division of Multiple Sclerosis and Neuroimmunology UConnHealth
University of Connecticut

Jaime Imitola is an American neuroscientist, neurologist and immunologist. Imitola’s clinical and research program focuses on Progressive Multiple Sclerosis and the molecular and cellular mechanisms of neurodegeneration and repair in humans. His research includes the translational neuroscience of neural stem cells into patients. Imitola is known for his discoveries on the intrinsic immunology of neural stem cells, the impact of inflammation in the endogenous neural stem cell in multiple sclerosis, and the ethical implications of stem cell tourism in neurological diseases.