Course Description:
Chemistry, Manufacturing and Controls (CMC) is among the most frequently underweighted risk domains in small molecule asset due diligence and among the most consequential. 74% of all CRL’s according to the FDA and 91% of all biologic CRLs are related to CMC issues. Gaps in process scalability, and formulation stability can translate directly into delayed milestones, cost overruns, and reduced asset value. Yet CMC packages presented at the deal stage are often early, incomplete, or built around Lab-scale chemistry that has never been stress-tested against commercial realities.This webinar presents a model-informed framework for CMC due diligence in M&A and asset transactions. Drawing on in silico route scouting, process design and scale-up modelling, and predictive stability tools, presenters will show how computational approaches can rapidly interrogate an asset's CMC package to identify hidden risks, quantify their financial and timeline impact, and inform valuation adjustments before they become deal-breaking surprises post-close.Through case study examples attendees will see understand how model inform assessment of CMC risk can be used to identify investment risk a priori and be used to boost valuation in an M&A or asst transaction The session equips BD, finance, and scientific teams with a structured CMC risk lens they can apply to their next deal.
Key Topics:
CMC as a Value Driver: Reframing Risk as a Deal Variable
- Why CMC risk is systematically underweighted in early-stage DD — and what that costs acquirers post-close
- How CMC gaps translate into quantifiable financial exposure: milestone delays, cost-of-goods overruns, and registration timeline slippage
- The inverse case: how a well-characterized CMC package can be used to justify or strengthen valuation
- Framing CMC uncertainty for BD and finance teams: from technical flags to NPV impact
Process Design and Scale-Up: Bridging Lab Chemistry to Commercial Reality
- Process modelling to assess scale-up risk: reaction kinetics, heat transfer, and mixing at commercial volumes
- Yield and throughput projections: translating lab-scale data into cost-of-goods estimates and manufacturing cost scenarios
- Robustness gaps: what limited DoE data reveals — and what it obscures — about process readiness for tech transfer
Predictive Stability and Case Study: From CMC Risk to Deal Impact
- Developing an in-silico predictive modeling of accelerated and real time stability from molecular structure
- Regulatory strategies that can be leveraged to accelerate time to market
Who should participate:
BD & FINANCE
- Business Development Directors and VPs
- Corporate Development and M&A Teams
- Licensing and Partnering Leads
- Valuation and Financial Modelling Analysts
Operations & Leadership
- Executive Sponsors overseeing deal portfolios
- CDMO Technical Operations and Alliance Teams
- Venture Capital and Portfolio Management
- Asset Managers and Licensing Strategy Leads
Technical & Scientific Leadership
- CMC Directors and Development Leads
- Process Chemistry and Scale-Up Scientists
- Analytical and Formulation Development Teams
- Regulatory CMC and Quality Leads
Though this course is being made available on USP’s
Education site, the course content was developed by Pharmatech Associates, a
USP company. USP has not independently reviewed or verified the accuracy
of the course content.