Industry experts shared their insights and expertise on overcoming the most pressing Chemistry, Manufacturing, and Controls (CMC) challenges at LSX Biopharm America on September 11. This article summarizes that discussion.
CMC is central to the drug development process. When properly applied and managed, CMC ensures drug quality, scalability, and timely availability to patients.
Achieving success in CMC can be challenging and industry experts explored these challenges during a panel discussion moderated by Zeid Barakat, Partner at Scimitar Consulting.
The panel featured several industry leaders from the biotechnology and pharmaceutical sectors who shared their insights and viewpoints on navigating the complexities of CMC while avoiding some of the most common pitfalls.
The panel also featured:
- Chase Orsello, Head of Bioprocess Development at Sanofi
- Johannes Roebers, Head of Product Development Division at PLG
- Dan Jacobs, Head of CMC Strategy and Operations at Pioneering Medicines
- Neera Jain, Vice President of Chemical and Pharmaceutical Development and Operations at Syros
- Federico Pollano, Business Development at Rentschler Biopharma
CMC: A strategic asset when correctly applied
Zeid Barakat started the discussion by highlighting how, when executed well, CMC represents a key strategic asset. When correctly applied, CMC is key to ensuring that drug supply reliably reaches patients. However, achieving this depends on approaching the CMC process correctly from the offset.
Federico Pollano underscored the importance of understanding the full regulatory requirements at the earliest possible stage, highlighting how this is especially important for start-ups. Early-stage companies must develop a clear roadmap, incorporating every consideration from initial development to late-stage market considerations.
Early-stage CMC de-risking
Dan Jacobs outlined his work at Pioneering Medicines, highlighting how his organization prioritizes early-stage CMC de-risking. He also emphasized the need for companies to explore long-term considerations, even in the early phases of development. Focusing on CMC risk factors early on in the process allows companies to better avoid expensive issues later on while also creating value.
Johannes Roebers emphasized this point with an example of a UK-based company that neglected CMC in its early stages, resulting in major delays and strategic issues later on.
Collaboration and communication are key
Neera Jain drew attention to the significance of internal and external collaboration, highlighting how decisions around dosing, formulation, and manufacturing should all involve continuous discussion between CMC teams, pharmacokinetics, and other stakeholders.
This communication-focused approach ensures that companies avoid discovering critical CMC issues that have previously been overlooked once they reach late-stage clinical development.
Selecting the right CMO is essential
Working with the optimal Contract Manufacturing Organization (CMO) is key to successful drug development and represents one of the most important decisions for any organization in the field.
Johannes Roebers pointed out that changing CMOs mid-development can be extremely difficult and expensive, meaning it is important to perform thorough due diligence from the beginning.
He also emphasized the need for site visits and the development of close working relationships and engagement with CMO teams, even before making a decision.
Neera Jain added that companies should aim to be their CMO’s ‘best client,’ working to develop a positive collaborative relationship beyond traditional transactional exchanges.
Being a CMO’s best client means providing the same level of support expected of supply partners. This can help foster a stronger collaboration that will ultimately minimize production delays and allow both organizations to anticipate problems better before they reach criticality.
Leveraging technology and AI
Chase Orsello of Sanofi spoke about the potential of machine learning and AI to improve and streamline CMC processes. These technologies are still emerging, but they offer excellent potential in reducing the time and cost commonly associated with drug development.
For example, AI can help teams efficiently analyze vast datasets, identify risks at earlier stages, and make decision-making smoother.
Conclusion
The panel’s discussion highlighted the many complexities of CMC and the importance of adopting a collaborative, strategic, and proactive approach. The key takeaway is that CMC should not just be regarded as a technical hurdle; rather, it should be seen as a key driver of success in drug development, whether this involves de-risking early-stage development, selecting the right CMO, or exploiting the potential of AI.
Acknowledgments
Produced from materials originally authored by Design Space InPharmatics LLC.
About Design Space InPharmatics LLC
DSI provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence.
Whether advocating CMC strategy, directing CMC operations, or developing CMC submission content that represents the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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