Manufacturing

1. CGT Manufacturing: Distributed & Digital with Deloitte Consulting's Omkar Kawalekar, Ph.D. 2/25/2025

   Omkar Kawalekar, Ph.D., Senior Manager, NextGen Therapies Manufacturing & Supply Chain Lead, Deloitte Consulting joins Host Erin Harris to share his expert take on how distributed manufacturing models address capacity constraints and supply chain risks, the role of automation in reducing batch-to-batch variability, as well as the power of digital technologies in optimizing production processes. He also covers the key considerations for CGT companies when choosing between in-house manufacturing and CDMO partnerships, and much more.

2. Building Patient-Driven Culture and Leadership Resilience in CGT with Paul Perreault 12/2/2025

   On episode 117, Host Erin Harris welcomes Paul Perreault, Strategic Advisor, Board Member and former CEO of CSL, who shares insights from his decade leading the company through global expansion and the COVID-19 pandemic.

3. Lessons in Automation with Roswell Park Comprehensive Cancer Center's Christopher Choi, Ph.D. 1/1/2025

   On Cell & Gene: The Podcast, Erin Harris interviews Dr. Christopher Choi of Roswell Park Comprehensive Cancer Center about the upcoming cell and gene therapy hub in Buffalo, NY, set to open in 2025. They delve into the transformative role of automation and digital technologies in CGT manufacturing. Dr. Choi also shares practical advice for emerging CGT biotechs on navigating manufacturing challenges during early product development.

4. In Vivo CAR T-Cell Therapeutics With Umoja Biopharma's Dr. Andrew Scharenberg 9/26/2023

   Discuss the evolution of allogeneic, in vivo CAR-T cell therapeutics, recent progress in lentiviral vector manufacturing, and The Colorado Laboratory and Innovation Manufacturing Building.

5. 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.

6. Breaking Down Solid Tumors With Triumvira Immunologics' Dr. Paul Lammers 1/17/2024

   Paul Lammers, M.D., M.Sc., CEO of Triumvira Immunologics joins Cell & Gene: The Podcast to talk to Host Erin Harris about TAC, the company's proprietary T cell Antigen Coupler, which has both autologous and allogeneic approaches. They also discuss targeting relapsed or refractory HER2-positive solid tumors and CLDN18.2-positive solid tumors. And they cover a realistic outlook on the evolution of cancer treatment.

7. Overcoming The Limitations Of CAR T-Cell Therapy With Vittoria Bio's Nick Siciliano, Ph.D. 12/5/2023

   Vittoria Biotherapeutics’ CEO, Nick Siciliano, joins Erin Harris on this episode of Cell & Gene: The Podcast to discuss the company's mission to expand the applications for CAR-based therapeutics by employing novel cell engineering and gene editing technologies.

8. 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).

9. Best Practices For Partnering With A CDMO 8/9/2022

   Emily Moran, VP of Vector Manufacturing and Avi Nandi, VP of Process Development at the Center for Breakthrough Medicines share key considerations on Cell & Gene: The Podcast for biotechs looking to partner with a CDMO. Learn how to reduce risk, lower costs, and better manage expectations when it comes the biotech/CDMO relationship.

10. The Why Behind In-House Manufacturing With Sangamo's Andy Ramelmeier 2/13/2023

    On this episode of Cell & Gene: The Podcast, Host Erin Harris talks to Andy Ramelmeier, EVP Head of Technical Operations at Sangamo Therapeutics, a biotech based in Brisbane, California that applies cell and gene therapy to combat Hemophilia A and other genetic diseases. Ramelmeier explains the why behind the company's decision to build its own Phase 1/2 cGMP AAV in-house facility. He also talks broadly about manufacturing cell and gene therapies and the potential and realistic solutions to needed to drive down manufacturing costs.