CGTLive’s Weekly Rewind – August 18, 2023

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Review top news and interview highlights from the week ending August 18, 2023.

Welcome to CGTLive™’s Weekly Rewind! We’ve compiled 5 highlights from this week’s coverage of advances in gene and cell therapies, including FDA actions, notable research, and interviews with experts across the field.

1. No AdComm Meeting for Sickle Cell Therapy Lovo-Cel

Bluebird's gene-edited cell therapy has a PDUFA date of December 20, 2023.

2. David Boyer, MD, on Potential Advantages of Suprachoroidal Gene Therapy for Neovascular AMD

The senior partner at Retina Vitreous Associates Medical Group discussed new findings from the AAVIATE study of RGX-314.

3. FDA Places Formal Clinical Hold On 2seventy bio's Trial for Acute Myeloid Leukemia CAR-T In Relation to Patient Death

The formal hold comes approximately 2 months after Seattle Children’s paused the trial in accordance with the clinical study protocol stopping rules.

4. Dilsher Dhoot, MD, On Reducing Treatment Burden in Diabetic Retinopathy With Gene Therapy

The adjunct clinical assistant professor, ophthalmology, Keck School of Medicine, University of Southern California discussed unmet needs with the current treatment landscape for DR.

5. FDA Lifts Partial Clinical Hold on Arcellx’s Trial for Multiple Myeloma CAR-T CART-ddBCMA

The partial clinical hold was originally placed in June 2023 in relation to the death of a patient participating in the trial.

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Alexandra Gomez-Arteaga, MD
Pietro Genovese, PhD, the principal investigator at the Gene Therapy Program of Dana-Farber/Boston Children’s Cancer and Blood Disorder Center
Akshay Sharma, MBBS, a bone marrow transplant physician at St. Jude Children’s Research Hospital
Caspian Oliai, MD, MS, the medical director of the UCLA Bone Marrow Transplantation Stem Cell Processing Center
Genovefa (Zenia) Papanicolaou, MD, an infectious diseases specialist at Memorial Sloan Kettering Cancer Center
Akshay Sharma, MBBS, a bone marrow transplant physician at St. Jude Children’s Research Hospital
John DiPersio, MD, PhD, the director of the Center for Gene and Cellular Immunotherapy at Washington University School of Medicine
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