Cell and gene therapies are transforming modern medicine, but their path to market is fast and complex. They often jump from small trials to global launch at record speed, putting pressure on analytics, supply chains, and partnerships. Success depends on making smart choices about what to build in-house and what to entrust to expert partners.

Daniel Galbraith knows these challenges intimately. With decades of hands-on experience and as Chief Scientific Officer at Solvias, Daniel has witnessed firsthand the seismic shifts in analytical development for advanced therapies. He’s been on every side of the table: troubleshooting manufacturing snags, scaling up from a single batch to hundreds per month, and guiding companies as they choose between in-house development and relying on a CRO’s muscle.

In this episode:

• How evolving cell and gene therapy timelines are driving the need for true CRO-drug developer partnerships (00:00)
• The unique challenges of scaling CMC analytics from early trials to global commercialization (02:51)
• Key pitfalls to avoid when outsourcing to CROs—especially around communication, scheduling, and troubleshooting (06:26)
• Deciding whether to build capabilities in-house or outsource to a CRO, and how to find the right balance for your team (08:41)
• The critical importance of strong project management for juggling relationships between developer, CRO, and CDMO (09:51)
• Daniel's perspective on the future of combination therapies and what the analytical landscape will demand of CROs (13:33)
• Practical advice for building transparent, open CRO partnerships that support your goals (15:21)

Facing scale-up challenges or a first CGT launch? This conversation shares practical strategies to advance therapies efficiently.

Tune in for actionable insights on CMC, outsourcing, and analytical development.

Connect with Daniel Galbraith:

LinkedIn: www.linkedin.com/in/daniel-galbraith-26a6138

Solvias website: www.solvias.com

Email: daniel.galbraith@solvias.com

Next steps:

Need fast CMC guidance? New on-demand CMC advisory: Get 20 expert answers/month in 1 day + monthly strategy call. → Learn more: https://stan.store/SmartBiotech/p/ondemand-cmc-expertise-for-biotech-founders

Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call

Preparing for your IND? Grab our Startup Founder CMC Dashboard in Notion to help you track tasks, timelines, and risks in one place at https://stan.store/SmartBiotech/p/discovertoind-cmc-dashboard-for-startup-founders

One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.

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