The Biotech Startups Podcast 🧬 Democratizing Cell Therapy Through Regional Manufacturing | Amy Hay (Part 4/4)
Jan 13, 2026
37:13
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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:
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-therapy
IND (Investigational New Drug) Application Process: https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
Global Access to Cell and Gene Therapies: https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(25)00270-9
Melanoma 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 Intro
01:57 CTMC's Mission and North Star
07:51 State of the Cell Therapy Market
10:54 Business Model Innovation and Deal Structuring
12:25 What an Engagement with CTMC Looks Like
15:35 Archetypical Partners and Customers
19:46 Building End-to-End Capabilities and Future Developments
25:57 Democratizing Cell Therapy Globally
28:35 Shout-Outs to Key Supporters and Mentors
32:02 Advice to 21-Year-Old Self: Patience and Grace
33:41 Outro
The 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.