Bruce Levine – VJRegenMed

Updates in cell and gene therapy approvals

Simon Ng — Wed, 02 Mar 2022 11:58:18 +0000

Bruce Levine, PhD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, describes recent approvals and developments within the advanced therapy space, including the FDA approval of ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR) T-cell therapy, in patients with relapsed/refractory multiple myeloma. Dr Levine additionally highlights developments in tumor-infiltrating lymphocytes (TILs), as well the need to focus on Chemistry, Manufacturing, and Control (CMC) standards within the regulatory process. This interview took place at Advanced Therapies Week 2022.

The role of automation in manufacturing CAR T-cells

Simon Ng — Wed, 02 Mar 2022 11:58:17 +0000

Bruce Levine, PhD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, discusses advances in chimeric antigen receptor (CAR) T-cell therapy manufacturing, including developments in automation and shortened T-cell culture. Whilst a 24 hour manufacturing process has been in development, further research is required to assess feasibility. Dr Levine also describes T-Charge, a less labor-intensive novel CAR T-cell platform that expedites the culture time, requiring fewer reagents as a result. This interview took place at Advanced Therapies Week 2022.

Trends and innovations within the advanced therapy sector

Simon Ng — Wed, 02 Mar 2022 11:40:13 +0000

Bruce Levine, PhD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, gives an overview of the future of the cell and gene (CGT) industry, including advances in gene editing, enzymes, and the delivery of advanced therapies. Whilst cell therapies have been effective at targeting hematological malignancies, treating solid tumors remain a challenge due to the immunosuppressive microenvironment. Dr Levine describes the addition of novel modalities such as radiotherapy, vaccines, and oncolytic viruses to overcome this barrier. This interview took place at Advanced Therapies Week 2022.

Highlights from ISCT 2021

admin_vjr_user — Wed, 11 Aug 2021 07:39:33 +0000

Bruce Levine, PhD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, offers some of his highlights from the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021. Dr Levine praises the success of the meeting’s virtual platform and the Presidential Plenary, which integrated the scientific, quality and regulatory and commercialization pillars. In addition, he considers the evolution of how the field looks at and better understands different cell types and therapies, including RNA and extracellular vesicles. This interview took place during the ISCT Annual Meeting 2021.

Challenges facing the translation of cell & gene therapies

admin_vjr_user — Wed, 11 Aug 2021 07:25:43 +0000

Bruce Levine, PhD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, considers the key remaining barriers facing the approval and ultimate clinical adoption of cell & gene therapies. Dr Levine states that the predominant challenge being faced is obtaining clinical trial data, although recent advancements in tools and technologies are rapidly aiding translation to clinical trials. As research moves towards multicenter clinical trials, clinical onboarding and training around cell and gene therapies for the wider healthcare team poses an additional challenge. Finally, novel pricing and reimbursement models are required to ensure patient access to approved therapies in the future. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.

Addressing CAR-T manufacturing challenges

admin_vjr_user — Thu, 24 Jun 2021 17:15:37 +0000

Bruce Levine, PhD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, discusses the key remaining challenges associated with the manufacture of chimeric antigen receptor (CAR) T-cell therapies. The in vivo measurement of potency remains a challenge and the correlation between ex vivo measurements and in vivo potency is still unclear. Once CAR-T cell therapies for solid tumors start to gain regulatory approval in the future, the scaling up of manufacturing is also going to be a significant challenge, which highlights the importance of improving automation and manufacturing processes in order to meet the increased demand. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.

The impact of COVID-19 on validating cell therapy products

admin_vjr_user — Thu, 13 May 2021 14:20:38 +0000

Bruce Levine, PhD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, discusses the impact of COVID-19 on validating cell therapy products. Despite mesenchymal stromal cells having been established as a cell-based therapy for acute respiratory distress syndrome (ARDS), they have yet to be specifically utilized in viral respiratory infections. Dr. Levine also evaluates the recent influx of research on this topic, urging caution as well as stressing patient safety and scientific rationale when creating new proposals. This interview took place during the ESMO TAT 2021 conference.

What to expect at ISCT 2021

admin_vjr_user — Thu, 13 May 2021 14:20:37 +0000

Bruce Levine, PhD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, discusses future sessions at the International Society Cell & Gene Therapy Annual Meeting in New Orleans, LA, of which includes plenary sessions on mesenchymal stromal cells, COVID-19 trials, regulatory oversight, first in man exosome trials, and the applications of CAR-T/NK cells. This interview took place during the ESMO TAT 2021 conference.