Brent Morse, M.S.

Brent comes to Dark Horse Consulting after 20+ years in the biotech industry. He brings experience in process and analytical development, specializing in potency assay development, analytical comparability, process and analytical tech transfers, CRISPR/Cas9 editing, and authoring CMC-related regulatory documentation.

Before joining Dark Horse Consulting, Brent most recently served as Vice President of Process and Analytical Development at Vor Biopharma, a biotechnology company developing genome-edited hematopoietic stem cells and chimeric antigen receptor T (CAR-T) cells for hematological malignancies. Brent led the development of both the Drug Product manufacturing processes and analytical strategies, and oversaw external GMP manufacturing of Cas9, single guide RNA, and lentiviral vector Drug Substances. Brent’s team delivered data packages to support an IND and CTA for VOR33, a CRISPR edited hematopoietic stem cell product engineered to lack CD33.

Prior to Vor, Brent served as Director of Analytical Development at CRISPR Therapeutics, a biotechnology company developing a wide range of gene therapies utilizing their CRISPR/Cas9 gene editing platform. Brent’s responsibilities included developing CRISPR’s overall analytical strategy and overseeing external gene editing reagent manufacture in support of both the gene-edited hematopoietic stem cell and allogeneic CAR-T products. Brent’s team delivered analytical data packages to support multiple regulatory filings, including for CTX001, a CRISPR-edited hematopoietic stem cell product for the treatment of beta-thalassemia and sickle cell disease.  CTX001 was the first CRISPR edited product evaluated in a clinical trial sponsored by a U.S. company.

Brent’s early career was spent primarily in analytical roles at biologics companies, including Epirus Biopharmaceuticals and Adnexus Therapeutics. At Epirus, where he served as the Director of Bioanalytical Development, Brent was primarily responsible for developing biosimilarity and analytical comparability protocols, the scope including Drug Product characterization and release assays, clinical pharmacokinetics, and anti-drug antibody assays. As a Staff Scientist at Adnexus, Brent was responsible for cell-based assay development, potency assay development, and analytical tech transfers to external contract testing laboratories.