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.