Jarrod Denham

Jerrod Denham

PRINCIPAL

Nineteen years of experience in CMC for cell and gene therapies, including technology transfer, process development, quality by design, manufacturing, regulatory and facility design.

ABOUT JeRROD​

Over the past two decades, Jerrod has led process engineering, development and manufacturing teams within several biotechnology companies developing cell and gene therapy products. At Dark Horse Consulting, he advises biotechnology companies on upstream and downstream process engineering, manufacturing and regulatory through all phases of manufacturing from pre-clinical to commercial. Utilizing his specialized skills in Lean Six Sigma, formalized root cause analysis, statistical data analysis, design of experiments, technology transfer and facility design, he has solved problems relating to CMC of both cell and gene therapy products.

Jerrod is a pioneer of cell therapy process engineering, manufacturing, and dose preparation. While at Geron Corporation, he was involved with research, process engineering, pilot production, early stage manufacturing and dose administration in support of the world’s first IND for an hESC-derived product. At ViaCyte, Jerrod was responsible for process verification, technology transfer, and pilot production in support the world’s first IND for an hESC-derived combination product (cells + encapsulation device) for type 1 diabetes mellitus. Most recently, he led process development activities in support of multiple U.S. FDA CMC amendments, which allowed for the use of hCNS stem cells in Phase II clinical trials for two clinical indications at Stem Cells Inc. He has also led the technology transfer of both autologous and allogeneic product dose preparation procedures at 13 U.S. clinical sites.

 

EXAMPLES OF RECENT WORK

  • Provided Person in Plant (PIP) technology transfer support for UK based company’s cell therapy drug product cGMP manufacturing at US CMO for Phase I/II clinical trial
  • Established Lean Six Sigma, formalized root cause and statistical data analysis methodologies for private gene therapy company developing clinical rAAV based products
  • Designed and built-out 1500 sq. ft. state of the art pilot plant facility to produce rAAV gene therapy drug products for pre-clinical and IND enabling studies
  • Consulted on cGMP facility designs for 3 US clients for manufacturing of both cell and gene therapy drug products
  • Authored CMC Quality sections for US, Canada, Japan and European regulatory submissions for 2 ex vivo genetically modified cell therapy products

 

SELECTED PUBLICATIONS

 

PAST EXPERIENCE

StemCells, Inc.
Director, Process Engineering & Manufacturing Sciences

ViaCyte, Inc.
Associate Director, Process Development Engineering

Geron Corporation
Senior Manager, Process Engineering
Senior Manager, Cell Processing and Manufacturing

 

EDUCATION

University of California, Los Angeles
B.S. Physiological Sciences