This blog recaps our discussion at LSX Biopharm America on September 11, during which industry experts shared their insights on overcoming the most pressing CMC challenges.
CMC (Chemistry, Manufacturing, and Controls) plays a pivotal role in drug development. When done right, CMC ensures drug scalability, quality, and timely availability to patients. But achieving success in CMC is often a challenge, as discussed by industry experts during a recent panel moderated by Zeid Barakat, Partner at Scimitar Consulting. The panel featured esteemed leaders from across the pharmaceutical and biotech sectors, sharing their insights on navigating the complexities of CMC and avoiding common pitfalls.
Panelists:
- Zeid Barakat, Partner at Scimitar Consulting (Moderator)
- Chase Orsello, Head of Bioprocess Development, Sanofi
- Johannes Roebers, Head of Product Development Division, PLG
- Dan Jacobs, Head of CMC Strategy and Operations, Pioneering Medicines
- Neera Jain, VP of Chemical and Pharmaceutical Development and Operations, Syros
- Federico Pollano, Business Development, Rentschler Biopharma
1. CMC: A Strategic Asset When Done Right
Zeid Barakat opened the discussion with a critical observation: CMC, when executed well, can be a major strategic asset, ensuring that drug supply reaches patients reliably. But achieving this depends on doing things right from the start.
Federico Pollano highlighted the importance of understanding the full regulatory requirements early on, especially for startups. Early-stage companies must have a clear roadmap that covers everything from initial development to late-stage market considerations.
2. The Importance of Early-Stage CMC De-Risking
Dan Jacobs shared his experience at Pioneering Medicines, where early-stage CMC de-risking is a priority. He emphasized the need for companies to think long-term, even when they are still in the early phases of development. By focusing on CMC risk factors early, companies can avoid costly surprises down the road and create value.
Johannes Roebers added a cautionary tale of a UK-based company that neglected CMC early on, leading to significant delays and strategic missteps.
3. Collaboration and Communication are Key
Neera Jain brought attention to the importance of internal and external collaboration. She emphasized that decisions on dosing, formulation, and manufacturing should involve continuous dialogue among CMC teams, pharmacokinetics, and other stakeholders. By doing so, companies can avoid reaching late-stage clinical development only to discover that critical CMC issues have been overlooked.
4. Selecting the Right CMO is Critical
Choosing the right Contract Manufacturing Organization (CMO) is one of the most important decisions in drug development. Johannes Roebers pointed out that changing CMOs can be more difficult and costly than anticipated, making it critical to conduct thorough due diligence from the start. He emphasized the need for site visits and deep engagement with CMO teams before making a decision.
Neera Jain added that companies should strive to be their CMO’s “best client,” fostering a collaborative relationship that goes beyond transactional exchanges. As your CMO’s best client and offering the same level of support expected of supply partners, a stronger collaboration can be fostered to minimize production delays and anticipate problems before reaching criticality.
5. Leveraging Technology and AI
Chase Orsello of Sanofi discussed the potential of AI and machine learning to enhance CMC processes. While these technologies are still emerging, they hold the promise of reducing the time and cost associated with drug development. AI can help teams analyze vast datasets more efficiently, identify risks early, and streamline decision-making processes.
Conclusion
The panel’s discussion underscored the complexities of CMC and the need for a strategic, collaborative, and proactive approach. Whether it’s selecting the right CMO, de-risking early-stage development, or leveraging AI, the key takeaway is that CMC is not just a technical hurdle—it’s a critical driver of success in drug development.
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