Biotech experience in process and analytical development, specializing in potency assay development, analytical comparability, tech transfers, and cross-functional leadership
Product & Process Development
Analytical Development
Facilities, Manufacturing, & Compliance
Regulatory Affairs
Nonclinical Development
Diligence & Business Strategy
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:
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.
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
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:
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.
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