08/14/2026
CMC is often associated with regulatory compliance, but the companies that excel in cell and gene therapy know it's much more than that.
On the latest episode of Commercializing Living Therapies with CCRM, host Krista Lamb-Davidson speaks with Katy Spink, Dark Horse Consulting Group, and Craig Beasley, BlueRock Therapeutics, about why Chemistry, Manufacturing and Controls (CMC) can be a true competitive advantage.
They discuss:
✅ What CMC really means in the context of cell and gene therapies
✅ Why CMC strategy should begin long before commercialization
✅ How to balance in-house expertise with consultants, CDMOs and strategic partners
✅ What regulators expect today, and how those expectations are evolving
🚫The common mistakes companies make when they underinvest in CMC, and how to avoid them
Whether you’re leading an early-stage biotech, supporting technology commercialization or working in advanced therapies, this episode offers practical insights into building a stronger path to patients.
Listen at the link below, or find it wherever you stream podcasts.
https://www.ccrm.ca/podcast/