Aug 29, 25 2025
The CMO’s Role in Building a Scalable Biotech Strategy
The CMO’s Role in Building a Scalable Biotech Strategy
Dr. Goldstein reflects on lessons learned from leading clinical programs in small molecules, biologics, gene therapies, cell therapies, and drug-device combinations. The discussion highlights what remains consistent across modalities such as the need for regulatory clarity and cross-functional alignment, and what differs significantly, particularly in manufacturing complexity, immune responses, and development timelines.
Other key themes include:
- Why time is an underappreciated constraint in biotech
- The strategic role of the CMO in manufacturing oversight and decision-making
- How to balance regulatory and commercial thinking in early development
- Building teams that function as integrated units, not parallel functions
- Advice for early-career CMOs seeking to grow beyond clinical roles
This episode offers practical insight into how biotech leaders can operate more effectively across the full development arc, from IND to commercialization, without losing sight of the clinical and patient perspective.
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