Manufacturing

1. An Interview with Dr. Peter Marks 1/5/2023

   Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration (FDA) sits down with Cell & Gene: The Podcast host Erin Harris to discuss the most anticipated areas of innovation in clinical development, and he offers recommendations to companies in their engagement with the FDA in order to make manufacturing more streamlined and cost effective. Dr. Marks also provides advice to listeners about how and when to engage with CBER, and much more.

2. Inside Yescarta's Reduced Median Turnaround Time with Kite, a Gilead Company's Christopher McDonald 2/13/2024

   On this episode of Cell & Gene: The Podcast, Christopher McDonald Global Head of Technical Operations at Kite, a Gilead Company, talks to Host Erin Harris about Kite's recent FDA approval of manufacturing process change resulting in reduced median turnaround time for Yescarta. They talk through the most significant steps Kite took to reach this approval, lessons learned from having worked with the FDA, scaling up technologies for cell therapy manufacturing, and more.

3. Restoration of Immune Balance with Anish Suri, Ph.D., President and CSO at Cue Biopharma 3/2/2022

   Cue Biopharma's Anish Suri, Ph.D., explains why the clinical-stage biopharma is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the body to transform the treatment of cancer.

4. An Interview With Dr. Carl June 8/9/2022

   Dr. Carl June, an HIV gene therapy pioneer and the father of CAR-T cell therapy, joins Cell & Gene: The Podcast to discuss the current state of CAR-T therapy, what's on the short-term horizon for immunotherapy, ongoing manufacturing capacity issues, an update on Emily Whitehead, the first child to receive CAR-T cell therapy on an experimental basis, and more.

5. Commercialization Learnings With Novartis Gene Therapies' President Chris Fox 9/7/2022

   With 20+ gene therapy targets in Novartis Gene Therapies’ pipeline, President Chris Fox and her team are hyper-focused on newborn screenings as the pathway to helping more and more patients. The company's initial gene therapy, Zolgensma, for spinal muscular atrophy (SMA) has been approved in more than 40 regions and countries and has been used to treat more than 2,300 patients worldwide. Fox details what’s next on the commercialization front for the therapy, and she shares advice with Cell & Gene: The Podcast listeners about what it takes to commercialize a therapy,

6. The Future of Tissue-Based Therapies 7/8/2021

   Enzyvant's CEO, Rachelle Jacques, explains the company's lead asset, the roadmap for tissue-based therapies, and more.

7. CMC And Scale Up With Mustang Bio's Robert Sexton 1/19/2023

   Mustang Bio's Robert Sexton, VP Program and Alliance Leadership, explains the why behind the need for this role in any CGT company. Having worked for Novartis, Sanofi, Legend Biotech, and more, with responsibilities having included quality, operations, and order management, Sexton is currently responsible for aspects of CMC. As such, he addresses the industry's top CMC challenges as well as sound advice for future scale up.

8. The Promise Of Genome Editing With Caribou Biosciences' Rachel Haurwitz, Ph.D. 8/15/2023

   On this episode of Cell & Gene: The Podcast, Rachel Haurwitz, Ph.D., CEO at Caribou Biosciences joins Host Erin Harris to discuss the evolution of genome editing, its present state, as well as its undeniable potential. Listen now to learn more about Caribou's chRDNA genome editing technology and how it differs from CRISPR-Cas9.

9. The Future Of iPSCs With BlueRock Therapeutics' CEO Seth Ettenberg 12/8/2022

   BlueRock Therapeutics' President and CEO Seth Ettenberg, Ph.D. talks to Cell & Gene: The Podcast listeners about the company's Phase 1 Clinical Trial for Advanced Parkinson’s Disease. Ettenberg also covers the most promising therapeutic applications for iPSCs currently in development as well as the major regulatory challenges that the field faces for their clinical use. We also cover how far iPSCs have come and what future progress may entail.

10. State-of-the-Art GMP Manufacturing RNA Cell Therapies With Cartesian's CEO 8/19/2021

    Dr. Murat Kalayoglu, CEO at Cartesian Therapeutics, details the cell and gene therapy sector's advancements in RNA cell therapy and the why behind the company's decision to build its own wholly-owned GMP manufacturing facility.