Brent Morse, M.S.

Brent comes to Dark Horse Consulting with over two decades in the biotech industry, bringing experience in process and analytical development, potency assay development, comparability, tech transfers, CRISPR/Cas9 editing, and CMC strategy.  At Dark Horse, Brent has supported clients with a broad range of products across many stages of development.  Recent examples of his work include the following:

• Analytical strategy, including potency, genomic safety, and analytical comparability
• CMC strategy, including gap analysis, risk assessment, and roadmap to IND
• FDA interaction support (e.g., INTERACT, pre-IND, IND, and BLA stage)
• Served as interim department head for an early-stage company

Before joining Dark Horse, Brent most recently served as Vice President of Process and Analytical Development at Vor Biopharma, a biotechnology company developing autologous genome-edited hematopoietic stem cell and chimeric antigen receptor T (CAR-T) products for hematological malignancies. Brent led the development of the 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 was responsible for developing CRISPR’s overall analytical strategy and overseeing external gene editing reagent manufacture supporting both the gene-edited hematopoietic stem cell and allogeneic CAR-T products. Brent’s team supported multiple regulatory filings, including for exa-cel (formerly CTX001), a CRISPR-edited hematopoietic stem cell product for the treatment of beta-thalassemia and sickle cell disease.  Exa-cel was the first CRISPR edited product evaluated in a company sponsored U.S. clinical trial.

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.

• Morse B, Fiedorowicz A. (2024) Control of Analytical Considerations for Gene-Modified Hematopoietic Stem and Progenitor Cell Therapies in BioProcess International. Part 1 — In-Process and Drug Product. BioProcess International. May 10: Guest Column; Part 2 — Starting Materials and Drug Substances. June 19: Guest Column
• Morse B, Manley NC. (2024) FDA's Updated Guidance On Human Genome Editing: New Implications & Remaining Questions. Cell & Gene. Feb. 27: Guest Column.
• Morse, Brent; Mack, Amanda. Considerations for development of gene-edited PSC-based therapies. Cell & Gene Therapy Insights 2023; 9(9), 1341–1352. DOI: 10.18609/cgti.2023.172, November 2023.
• Matthew Li, Brent Morse & Sadik Kassim (2022) Development and Clinical Translation Considerations for the Next Wave of GeneModified Hematopoietic Stem and Progenitor Cells Therapies, Expert Opinion onBiological Therapy, 22:9, 1177-1191, DOI: 10.1080/14712598.2022.2101361

• International Society for Cell & Gene Therapy
• American Society for Cell & Gene Therapy
• American Chemical Society
• American Society of Pharmaceutical Scientists

Vor Biopharma
VP, Process & Analytical Development

CRISPR Therapeutics
Director, Analytical Development

EPIRUS Biopharmaceuticals
Director, Bioanalytical Development

Abbvie
Scientist, Molecular and Cellular Pharmacology

Concert Pharmaceuticals
Scientist, Pharmacology

Adnexus Therapeutics
Scientist, Pharmacology

GMP Genetics
Senior Research Associate, R&D

Antigenics
Research Associate, R&D

Purdue University
M.S., Medicinal Chemistry & Molecular Pharmacology

Western Michigan University
B.S., Chemistry