The Biotech Startups Podcast

🧬 Democratizing Cell Therapy Through Regional Manufacturing | Amy Hay (Part 4/4)


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"Sometimes no response is the loudest response of all."

In this episode of The Biotech Startups Podcast, Amy Hay, Chief Business Officer at CTMC, shares how CTMC bridges academia and industry to help lean cell therapy teams reach the clinic faster and more capital-efficiently through a co-development model that bundles manufacturing, regulatory, and operational support so scientists can stay focused on the science while building scalable, commercialization-ready processes from day one. Amy and host Jon Chee dig into why business model innovation—milestone-based contracts and, in some cases, equity alignment—can be as critical as scientific breakthroughs in today’s tough fundraising landscape, and how regional manufacturing, knowledge transfer, and global network alliances are turning cell therapy from a theoretical option into a practical reality for patients around the world.

Key topics covered:

  • CTMC’s mission: Bridging academia and industry to accelerate early cell therapy programs into the clinic.
  • Co-developing with early biotechs: End-to-end support (manufacturing, regulatory, logistics) to reduce time and capital burden.
  • Scaling early to avoid late pain: Building sustainable, commercializable processes and de-risking Phase 1 through commercial.
  • Business model innovation: Milestone-based contracts and equity alignment to create incentives and improve fundraising narratives.
  • Democratizing cell therapy globally: Regional manufacturing, network alliances, and why “the patient is part of the supply chain.”

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Subscribe to the Podcast:Apple: https://podcasts.apple.com/us/podcast/the-biotech-startups-podcast/id1679591994Spotify: https://open.spotify.com/show/2PSL162R2s0zOwU5913Zv4Youtube: https://www.youtube.com/@thebiotechstartupspodcast Website: https://www.thebiotechstartupspodcast.com/ 
Find our guest, Amy Hay at these links: LinkedIn: https://www.linkedin.com/in/amychay/Website: https://ctmc.com/ Find our host, Jon Chee, at these links: LinkedIn: https://www.linkedin.com/in/jonchee
Learn more about Excedr:LinkedIn: https://www.linkedin.com/company/excedr/ Website: https://www.excedr.com
Intro & Outro Songs Created by OkKyojin, Owned by Excedr:Website: https://flow.page/kyojin 
Resources & Articles:
TIL (Tumor-Infiltrating Lymphocyte) Therapy: https://my.clevelandclinic.org/health/treatments/tumor-infiltrating-lymphocyte-til-therapyIND (Investigational New Drug) Application Process: https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-applicationGlobal Access to Cell and Gene Therapies: https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(25)00270-9Melanoma Treatment & TIL Therapy Outcomes: https://www.nejm.org/doi/full/10.1056/NEJMoa2210233​Companies, Universities, & People mentioned:MD Anderson Cancer Center: https://www.mdanderson.org/National Resilience (Resilience Labs): https://www.resilience.com/Varian Medical Systems: https://www.varian.com/Siemens Healthineers: https://www.siemens-healthineers.com/products-services
Henrique Neves, General Director, Hospital Israelita Albert Einstein: https://www.linkedin.com/in/henrique-sneves/
Timestamps: 00:00 Intro01:57 CTMC's Mission and North Star07:51 State of the Cell Therapy Market10:54 Business Model Innovation and Deal Structuring12:25 What an Engagement with CTMC Looks Like15:35 Archetypical Partners and Customers19:46 Building End-to-End Capabilities and Future Developments25:57 Democratizing Cell Therapy Globally28:35 Shout-Outs to Key Supporters and Mentors32:02 Advice to 21-Year-Old Self: Patience and Grace33:41 OutroThe Biotech Startups Podcast gives you a front-row seat to the business and science of building a biotech. Hosted by Jon Chee, CEO of Excedr, the show features honest conversations with founders, execs, and investors about their work, their companies, and how they got there. From scientific breakthroughs to startup lessons, each episode explores what it really takes to grow a life science company—from pre-seed to IPO.
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