Manufacturing

1. The Near-Term Future Of Exosome Science With Capricor Therapeutics' Dr. Linda Marbán 4/12/2023

   Dr. Linda Marbán, Ph.D., CEO of Capricor Therapeutics, a clinical-stage biotech focused on the development of cell and exosome-based therapeutics for the treatment and prevention of serious diseases, joins Cell & Gene: The Podcast's Erin Harris to discuss the current state and the near-term future of exosomes. Marbán discusses Capricor’s exosome program and the company’s proprietary allogeneic cardiosphere-derived cells (CDCs) and engineered exosomes. She also covers the company's HOPE clinical trial series' progress to treat Duchenne muscular dystrophy (DMD).

2. Pricing, Value, And Access of CGTs With The Dedham Group's Jennifer Klarer, M.Sc.Eng. 1/30/2024

   The Dedham Group's Jennifer Klarer, M.Sc.Eng., Partner and Head of Cell & Gene Therapy, joins Erin Harris on this episode of Cell & Gene: The Podcast for a deep dive into pricing and value for CGTs. Klarer shares a detailed breakdown of the most misunderstood aspects of cell and gene therapy pricing, value, and affordability. She details how manufacturers can get ahead of addressing time-to-treatment issues typically experienced at launch. They cover obtaining adequate investment dollars, and much more. 

3. Cell Therapy's Current Manufacturing Challenges 4/15/2025

   In this segment, Cell & Gene’s Chief Editor, Erin Harris, welcomes the audience and introduces the expert panelists, Rohit Ingale, Head of Manufacturing & MSAT, Arcellx and David O’Donnell, Vice President, Head of Manufacturing, Vor Bio.

4. Hospital Systems & Complex Therapies With University Of Pennsylvania Health System's Kevin Mahoney 8/20/2021

   On this episode of Cell & Gene: The Podcast, University of Pennsylvania Health System’s CEO Kevin Mahoney talks to Host Erin Harris about how hospital systems must evolve to meet the needs of cell and gene therapy patients as these complex therapies are commercialized. They discuss what comprises UPHS and the ongoing innovation it brings to advanced therapies as well as how the Health System stays patient-focused at all costs.

5. 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.

6. 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.

7. A Stem Cell-Derived Treatment For T1D 8/22/2022

   Sernova Corp. is a clinical-stage regenerative therapies company currently focused on insulin-dependent diabetes. CEO and President, Philip Toleikis, Ph.D., details the company's on-going clinical trial to treat Type 1 diabetes (T1D) as well as the very real potential to progress from simply masking symptoms to having a functional cure for T1D. Toleikis also provides his take on the near-term future of regenerative medicine.

8. Planning For Manufacturing Capacity With Kite Pharma's Will Junker 9/26/2022

   Will Junker, Head of Manufacturing Quality at Kite Pharma, talks to Cell & Gene: The Podcast listeners about the challenges associated with capacity planning, whether to partner with a CDMO, and why it's important to prioritize inventory over time-to-market. We also discuss why developing a better understanding of the vector manufacturing process is critical to bringing continuous and secure supply to market.

9. Automating Processes To Scale CGT Manufacturing With PA Consulting's Paolo Siciliano 3/2/2023

   When it comes to manufacturing, many cell and gene therapy companies struggle to automate the diverse processes needed to scale manufacturing. London-based PA Consulting's Associate Partner, Paolo Siciliano, talks to Cell & Gene: The Podcast's Erin Harris about how lean, small biotechs with limited resources and limited funds can strive for automation success. They also discuss what cell and gene therapy companies should do today to address tomorrow’s scalability challenges and what the long-term effects on the business may be from such upfront work.

10. The Future Of Cell And Organ Transplantation In Treating T1D With Dr. Camillo Ricordi 10/10/2023

    Explore the biggest and most troubling challenges facing the treatment of Type 1 Diabetes (T1D) and the future of cell and organ transplantation in treating T1D as well as the latest innovations in biopreservation.