ISCT in the News

Concerned Stakeholders Issue Call to Action on the Implementation of the EU Joint Clinical Assessment for ATMPs

Jul 9, 2024

ISCT joins 30+ organizations urging all of those involved in the new EU Joint Clinical Assessment (JCA) to recognize and use all types of available clinical evidence, including single-arm trials and real-world evidence, in the assessment of Advanced Therapy Medicinal Products (ATMPs), which include cell and gene therapies.

ISCT Announces Dr. Massimiliano Gnecchi as the Next Chief Scientific Officer

Jun 20, 2024 | ISCT

The International Society for Cell & Gene Therapy (ISCT) is delighted to announce the appointment of Dr. Massimiliano Gnecchi, MD, PhD, FESC as the new ISCT Chief Scientific Officer, effective June 2024 through June 2026.

ISCT States Concerns with Utah Bill Undermining U.S. FDA Power to Protect Patients

Jun 17, 2024 | ISCT

The International Society for Cell & Gene Therapy (ISCT), the translational-focused global community of cell and gene experts today releases a statement addressing the recent legislation passed in Utah with respect to use of placental stem cells. This bill, which took effect on May 1, 2024 (Utah SB0199), attempts to undermine U.S. FDA authority to regulate placental stem cell therapies and poses significant risks for patient safety and the field of cell and gene therapy.

Jacques Galipeau, MD, on Highlights from ISCT 2024’s Presidential Plenary

Jun 8, 2024 | CGTLive®

The presidential plenary of the International Society for Cell and Gene Therapy (ISCT) 2024 Meeting, held in Vancouver, Canada, from May 29 - June 1, brought together leaders of sister scholarly societies. CGTLive® spoke with Galipeau to learn more about the plenary and the highlights discussed between the speakers. He shared the different perspectives that each speaker brought to the discussion, with Sureda speaking about the state of development in Spain with the European Medicines Agency. One challenge, Galipeau noted, was relevant regardless of country, and that is tackling the problem of “deserts” in the treatment landscape.

Sowmya Viswanathan, PhD, on Translating Cell Therapies to the Clinic at ISCT 2024

Jun 15, 2024 | CGTLive®

The Translation to Clinic plenary of the International Society for Cell and Gene Therapy (ISCT) 2024 Meeting, held in Vancouver, Canada, from May 29 - June 1, brought together sponsors developing cell and gene therapies in the clinical stage and earlier research stage. CGTLive® spoke with Viswanathan to learn more about the plenary. She shared the perspectives that each speaker brought to the discussion, including Lim’s early work with extracellular vesicles, BlueRock’s experiences with developing its cell therapy for the potential treatment of Parkinson disease, and Fate Therapeutics’ work with gene-edited cell therapies.

Pediatric Patient Access With Dr. Bambi Grilley

May 29, 2024 | Cell and Gene

In this podcast episode, Dr. Grilley shared her take on the current state of CGT’s global regulatory landscape and her appreciation to Dr. Peter Marks and his team at FDA for their on-going relentless advocacy in moving the field forward. She stressed the need for regulatory framework in countries that currently lack such infrastructure. At ISCT 2024 in Vancouver, Dr. Grilley will take part in the Global Regulators Summit, which brings together leaders from multiple different countries to talk about different issues facing the cell and gene therapy space. The Global Regulators Summit had its inaugural meeting last year, and participants covered the proliferation of unlicensed stem cell products. This year’s Summit will focus on rare diseases.

Dr. Bruce Levine on ISCT and the Future of CAR T

May 2024 | Cell and Gene

In anticipation of ISCT 2024 in Vancouver, Canada, Dr. Bruce Levine is back on Cell & Gene: The Podcast to share information about the event as well as his expertise on the future of CAR-T therapy for solid tumors, autoimmune disease, and more. He talks about his time and learnings as President Elect, President, and Immediate Past President of ISCT. He covers Cellicon Valley and Philadelphia's success as on-going CGT hub, and much more.

In Draft Guidance for Cell and Gene Therapy Industry, FDA Broadens its Approach to Product Potency

Jan 19, 2024 | Precision Medicine Online

In the last days of 2023, the US Food and Drug Administration put out a draft guidance meant to better support drugmakers' efforts to bring novel cell and gene therapies to market.

Experts Comment on FDA Report on Risk of T-Cell Malignancy

Jan 10, 2024 | Drug Discovery World

The International Society for Cell & Gene Therapy (ISCT) has announced the publication in Nature Medicine of an expert consortium commentary addressing a recent statement from the US Food & Drug Administration (FDA) that it is investigating serious risk of T-cell malignancy in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapy. 

CAR T Cell Therapy Is a Comparatively Low-Risk Cancer Treatment: Industry Experts

Jan 9, 2024 | BioSpace

CAR T cell therapy is lower risk than other cancer treatments, according to a prominent group of cancer and cell therapy leaders who published their commentary in Nature Tuesday, a little more than a month after the FDA announced it was investigating the “serious risk” of T cell malignancies in patients who received such treatments. But more information is still needed, the authors stressed.

Cell Therapy Bigwigs Endorse CAR-T in Nature Medicine Article Amid FDA Safety Probe

Jan 9, 2024 | Fierce Pharma

As an FDA investigation into patients developing secondary T-cell cancers rocked the CAR-T world, a group of cell therapy experts, including CAR-T pioneers Bruce Levine, Ph.D., and Carl June, M.D., are lending their support to the emerging immunotherapy in a commentary published in Nature Medicine.

Cell Therapy Research Consortia Responds to FDA's CAR T-Cell Therapy Warning

Jan 9, 2024 | Precision Medicine Online

The International Society for Cell and Gene Therapy (ISCT) on Tuesday published a commentary in Nature Medicine  in response to the US Food and Drug Administration's announcement that it would investigate the risk of T-cell malignancy in patients treated with BCMA- or CD19-directed autologous CAR T-cell immunotherapy.