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Navigating Cell and Gene Therapy: Insights and Challenges with Dr. Bruce Levine

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Manage episode 432892247 series 3526489
Content provided by Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.

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How do you navigate the complexities of manufacturing cell and gene therapies that are tailored to individual patients? Find out as we sit down with Dr. Bruce Levine from the University of Pennsylvania to unpack the intricacies of clinical research in this groundbreaking field. From the unique emphasis on chemistry, manufacturing, and controls (CMC) to the logistical hurdles of sourcing and modifying patient-derived cells, Dr. Levine offers an expert's perspective on the challenges and advancements that set these therapies apart from traditional drugs. We also shine a light on the vital role of the International Society for Cell and Gene Therapy in driving forward these innovative treatments.
In another riveting segment, we delve into the recent FDA investigation into cases of T-cell malignancies following CAR T-cell therapy. With data gleaned from voluntary reporting databases, we scrutinize causality, immortal time bias, and the need for improved reporting standards. Dr. Levine shares his thoughts on the importance of thorough patient follow-up and effective communication of risks and benefits. We also explore the evolution of cell and gene therapy, tracing Dr. Levine's journey from his early days in immunology research to his pivotal role in shaping the field. This episode is a must-listen for anyone interested in the dynamic and ever-evolving world of cell and gene therapy.

________
Reach out to Ivanna Rosendal
Join the conversation on our LinkedIn page

  continue reading

Chapters

1. Navigating Cell and Gene Therapy: Insights and Challenges with Dr. Bruce Levine (00:00:00)

2. Clinical Research in Cell Therapies (00:00:21)

3. Challenges in Reporting Cell Therapy Data (00:12:25)

4. Evolution of Cell and Gene Therapy (00:22:17)

78 episodes

Artwork
iconShare
 
Manage episode 432892247 series 3526489
Content provided by Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Sam Parnell & Ivanna Rosendal, Sam Parnell, and Ivanna Rosendal or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.

Send us a text

How do you navigate the complexities of manufacturing cell and gene therapies that are tailored to individual patients? Find out as we sit down with Dr. Bruce Levine from the University of Pennsylvania to unpack the intricacies of clinical research in this groundbreaking field. From the unique emphasis on chemistry, manufacturing, and controls (CMC) to the logistical hurdles of sourcing and modifying patient-derived cells, Dr. Levine offers an expert's perspective on the challenges and advancements that set these therapies apart from traditional drugs. We also shine a light on the vital role of the International Society for Cell and Gene Therapy in driving forward these innovative treatments.
In another riveting segment, we delve into the recent FDA investigation into cases of T-cell malignancies following CAR T-cell therapy. With data gleaned from voluntary reporting databases, we scrutinize causality, immortal time bias, and the need for improved reporting standards. Dr. Levine shares his thoughts on the importance of thorough patient follow-up and effective communication of risks and benefits. We also explore the evolution of cell and gene therapy, tracing Dr. Levine's journey from his early days in immunology research to his pivotal role in shaping the field. This episode is a must-listen for anyone interested in the dynamic and ever-evolving world of cell and gene therapy.

________
Reach out to Ivanna Rosendal
Join the conversation on our LinkedIn page

  continue reading

Chapters

1. Navigating Cell and Gene Therapy: Insights and Challenges with Dr. Bruce Levine (00:00:00)

2. Clinical Research in Cell Therapies (00:00:21)

3. Challenges in Reporting Cell Therapy Data (00:12:25)

4. Evolution of Cell and Gene Therapy (00:22:17)

78 episodes

All episodes

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