First Principles CMC is an independent advisory practice working with biotechnology companies from pre-IND through registration. The work covers strategy, process, manufacturing governance, and regulatory documentation — across the full arc of development.
ben@firstprinciplescmc.comClients come to First Principles CMC when a program needs CMC and Technical Operations thinking that doesn't exist in-house yet, or when a specific technical challenge requires someone who has worked through it before. The practice is independent — the analysis is shaped by the program, not by institutional process or competing priorities.
Engagements are fractional, project-based, or structured diligence. Scope is defined by what the work requires.
The work is organized around the development arc. Each stage builds on the last.
Development strategy that accounts for the full arc — process development approaches, control strategy frameworks, and manufacturing partnerships designed to carry a program through IND and beyond.
Systematic CDMO evaluation and selection, technology transfer planning, and the technical oversight that keeps a program on track through the transition from lab to GMP manufacturing.
CMC authoring, review, and regulatory strategy for global IND and IMPD filings. Documentation that reflects actual process understanding, not template language.
Ongoing CDMO oversight across process changes, scale transitions, and supply chain complexity. Program control through the operational relationships that carry clinical supply.
Control strategy development and refinement, specification setting, and comparability assessments that support manufacturing changes and process evolution through clinical development.
Clinical supply chain design, labeling, packaging, and distribution planning. Integrated with clinical operations to support study timelines and global site requirements.
DoE-driven characterization studies linking CPPs to CQAs, proven acceptable ranges, and design space definition. The technical foundation for late-stage regulatory submissions and post-approval flexibility.
Validation strategy, PPQ protocol design and execution planning, and continued process verification frameworks aligned to FDA and EMA expectations for pre-BLA manufacturing.
CMC strategy and documentation for registration submissions. Registration batch planning, specification finalization, comparability to clinical material, and lifecycle regulatory strategy through approval.
Scope and duration are defined by what the program requires.
Senior CMC and Technical Operations leadership on a part-time basis — covering strategy, CDMO relationships, regulatory submissions, and team development as the program evolves.
A gap assessment before an IND, a CDMO evaluation, a process characterization strategy, a comparability assessment, or a specific regulatory package. Engagement ends when the work is done.
CMC and manufacturing diligence for investors, BD teams, and acquirers. Process maturity, manufacturing readiness, control strategy, regulatory standing, and the path to the next value inflection point.
Fifteen years in CMC and Technical Operations for complex biologics and antibody-drug conjugates, across the full range of development stages — from early process development and IND filings through first-in-human programs and late-stage CMC strategy.
At Mythic Therapeutics, built the Technical Operations function from inception as VP, growing the team to sixteen contributors across process development, manufacturing, quality, and supply chain. The program advanced its first ADC to a first-in-human clinical study. Before that, CMC leadership at Editas Medicine and nine years at ImmunoGen, where work on site-specific antibody conjugation chemistry resulted in multiple issued patents and publications in PNAS, Chemistry & Biology, and the Journal of Molecular Biology.
First Principles CMC was founded in 2025. Current advisory work includes early-stage ADC programs and clinical-stage biotech companies.
Available for advisory engagements. Also selectively considering executive opportunities in Technical Operations and CMC leadership.