Case Studies
These sample case studies highlight the kinds of CMC challenges we frequently help clients overcome as they prepare for U.S. clinical trials.
1
Client Profile: Seed-stage oncology startup, no internal CMC lead
Challenge: Company was 5 months from a planned IND submission but had no formal stability plan or control strategy. Internal teams were focused on preclinical and fundraising.
Solution: Design a Phase 1-appropriate stability protocol and impurity control strategy using limited available data. Identification of key gaps, projection of ICH-aligned timelines, and coordination with CDMOs to accelerate method qualification.
Result: A complete Module 3 was delivered within 3 months. IND accepted with no CMC comments. Client secured Series A shortly after.
2
Client Profile: Preclinical stage immunology company entering Phase 1
Challenge: Client attempted a self-authored IND using CDMO templates. FDA issued a clinical hold due to inadequate specification limits and incomplete manufacturing sections.
Solution: A CMC gap assessment, rewriting of key Module 3 sections, and leading written FDA correspondence and resubmission.
Result: Hold lifted in 30 days. Client retained us long-term for strategic oversight through Phase 2 scale-up.
3
Client Profile: Virtual pharma company developing a CNS small molecule
Challenge: They had hired a CDMO and a formulation CRO, but lacked a unified regulatory strategy or plan to track critical quality attributes across sites.
Solution: Mapping of an integrated CMC development plan, defining data ownership responsibilities, and guiding the CDMO toward a clear Phase 1 deliverable package.
Result: The prevention of duplicated studies, cuts to unnecessary spending, and getting the CMC data locked 2 months ahead of the target date. IND filed with confidence.
Professional Endorsements
These quotes reflect feedback I received in past roles before founding Nexus CMC Advisors. They speak to the same thoughtful, strategic, and reliable CMC approach I now bring to every client engagement.
4
Transitioning from a Phase 2 to Phase 3 IND
An emerging pharma company with successful Phase 2 data now faces the complexity of preparing for Phase 3 — which means new validation requirements, scale-up of manufacturing, and agency expectations around comparability and control strategies.
Nexus CMC Advisors could help map out the transition, define what needs to change in Module 3, and build a Phase 3-ready CMC plan that supports both the IND and future marketing applications.
5
Overlooked CMC Risks Before Tox
A startup with a solid toxicology plan may unknowingly be missing critical CMC components — like an adequate container closure strategy, formal impurity limits, or method qualification.
We help teams prioritize must-have Phase 1 activities, while also identifying low-effort, high-impact improvements that prevent delays downstream.
6
Academic Spinout Without Templates or Timelines
An academic team with a promising compound might be ready for GLP tox, but lacking any CMC document templates, quality system, or structured regulatory roadmap.
In this case, we could offer a modular approach: building a Phase 1-appropriate Module 3, training the founding team on regulatory expectations, and guiding the transition from academic-grade to clinical-grade documentation.