Sara Mills

Sara joined Dark Horse Consulting in 2016, bringing expertise in aseptic and cGMP manufacturing process development, risk analysis, CMC and regulatory filings, facility design, and project management to advise growing cell and gene therapy companies.

Sara’s range also encompasses experience in managing cross-regional technology transfer, Design of Experiments, establishment of supply chain, ancillary material risk assessment and leading root cause analysis for gene therapies and autologous (CAR-T, immuno-derived and iPSC) and allogeneic cell therapies. During her time at DHC she has been fortunate enough to work on (as of January of 2023) over 80 different products with 70 different clients originating from at least 9 different countries.

Client support that Sara finds particularly rewarding includes jointly developing CMC strategies to allow swift movement with minimal risks so as to maximize success in the long run, harmonization of regulatory strategies across multiple jurisdictions, and putting into place overall process and product development plans for drug products that considers the full timeline (from early phase into late phase and then into eventual commercialization) without undue burden early in development.

• Lead strategist or support for CMC readiness activities to support pivotal clinical manufacturing and process validation for > 5 allogenic and autologous cell therapy and gene modified cell therapy product candidates
• Focused support for numerous clients ensuring suitability of manufacturing process design and raw material strategy to inform early phase clinical development as well as late phase and commercial success
• Major or primary CMC author to 7 IND’s (module 2 QOS and module 3) and contributor to 17 other regulatory filings (FDA, CTA, EMA, MHRA, PMDA, ANVISA) between 2019 and 2023

• Bergam B, Mills, S. (2024) Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy" Cell and Gene. May 24: Guest Column
• Elizabeth Csaszar, Sara Mills, Peter W. Zandstra (2021). Process evolution in cell and gene therapy from discovery to commercialization. The Canadian Journal of Chemical Engineering 2021; 20 April 2021; DOI: 10.1002/cjce.24141.

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Humboldt State University
B.S. in Cellular Molecular Biology