Laertis Ikonomou – VJRegenMed

Tackling therapeutic deception in unproven therapies: highlights from ISCT 2021

admin_vjr_user — Wed, 26 May 2021 16:33:44 +0000

Laertis Ikonomou, PhD, University at Buffalo & The State University of New York, Buffalo, NY, provides an overview of a regulatory session set to take place at the ISCT Annual Meeting 2021 on unproven or unlicenced cell-based therapies and therapeutic deception. In this session, the multidisciplinary panel will discuss some of the deceptive practices used in direct-to-consumer marketing of unproven therapies and how regulatory agencies and legislators are working to address these issues at a national and international level. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.

The current landscape of unproven cell-based therapies

admin_vjr_user — Wed, 26 May 2021 16:33:43 +0000

Laertis Ikonomou, PhD, University at Buffalo & The State University of New York, Buffalo, NY, provides an overview of the evolving landscape of direct-to-consumer marketing of unproven cell-based therapies, a challenge that has been facing the field of cell and gene therapies for a number of years. In line with advancements in the field in recent years, there has been an increase in the prevalence of unproven therapeutic products incorporating perinatal tissues and exosomes being offered to patients, as well as a rise in cell banking services offering the freezing of various tissues such as T-cells. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.

Anticipating a crackdown on unproven cell-based therapies

admin_vjr_user — Wed, 26 May 2021 16:33:42 +0000

Following the development of the US FDA’s regenerative medicine policy framework in 2017, the agency outlined its intent to exercise enforcement discretion for certain regenerative medicine products, giving manufacturers time to submit investigational new drug (IND) and premarket approval applications. With this discretionary period coming to an end, Laertis Ikonomou, PhD, University at Buffalo & The State University of New York, Buffalo, NY, considers how the this might affect the direct-to-consumer marketing of unproven cell-based therapies in the US and the positive impact this could have on the regulation of unproven therapies worldwide. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.