Aaron Levine – VJRegenMed

Tackling unproven cell-based therapies and the impact of COVID-19

admin_vjr_user — Thu, 19 Aug 2021 10:30:48 +0000

Aaron Levine, PhD, MPhil, BS, Georgia Institute of Technology, Atlanta, GA, provides an overview of the current landscape of direct-to-consumer marketing of unproven cell-based therapies in the United States. As the FDA’s enforcement discretionary period comes to an end, Dr Levine hopes to see an increased level of enforcement activity toward stem cell clinics operating outside of FDA guidelines and formal regulatory processes. He also highlights the impact of the COVID-19 pandemic, which saw an increase in the spread of health misinformation and the marketing of unproven cell-based interventions for COVID-19, resulting in enforcement action from the FDA. Finally, Dr Levine expresses his concerns surrounding the unregulated and premature growth of speculative commercial cell banking services. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.

Driving the translation of cell therapies: the importance of manufacturing & building the workforce

admin_vjr_user — Thu, 19 Aug 2021 10:30:47 +0000

Aaron Levine, PhD, MPhil, BS, Georgia Institute of Technology, Atlanta, GA, discusses the importance of addressing manufacturing and workforce challenges in order to drive the translation and commercialization of cell therapies. Given the increased complexity of cell-based therapies compared to other therapeutics, greater attention needs to be paid toward manufacturing and compliance with regulatory authorities before cell therapies can be produced on an industrial scale. Dr Levine also highlights the importance of building the cell therapy manufacturing workforce with education and training within the technical aspects of manufacturing, such as good manufacturing practice (GMP) compliance. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.

ISCT 2021 highlights: therapeutic deception, global regulation & CAR-T

admin_vjr_user — Thu, 19 Aug 2021 10:30:46 +0000

Aaron Levine, PhD, MPhil, BS, Georgia Institute of Technology, Atlanta, GA, offers his highlights from the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021. He calls attention to a regulatory session focused on therapeutic deception in direct-to-consumer marketing of unproven cell and gene therapies and the value of hearing from the United States Federal Trade Commission (FTC) on how they interact with regulatory bodies. In addition, he highlights a global regulatory workshop focused on the different ways in which health authorities deal with novel cell therapies, as well as the meeting’s coverage of chimeric antigen receptor (CAR) T-cell therapy and the development of personalized therapies for solid tumors. This interview took place during the ISCT Annual Meeting 2021.