Denis M. Boyle, BA, MS, PhD Expert Witness
Curriculum Vitae

Contact Information

  • Company: CMC BioPharma Consulting, LLC
  • Phone: 608 235-0245
  • Cell: 608 235-0245
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Specialties & Experience

General Specialties: Intellectual Property and Biomedical Engineering

Specialty Focus: Patent Infringement, Biopharmaceuticals, Bioprocess Technology, Biologics Manufacturing, Recombinant Proteins, Biochemistry, Engineering-Chemical, Engineering-Biomedical, GMO, Genetics, Microbiology, Natural Products Chemistry, Biomedical Research

Education: PhD, University of the Witwatersrand; MS, University of Louisville School of Medicine; BA, University of Louisville

Years in Practice: 30+


Additional Information

Dr. Denis Boyle is an internationally recognized bioprocess expert with more than 25 years of experience in the development, validation and patent protection of technologies to produce biopharmaceuticals for commercial launch. He has been a leader of protein therapeutic development teams for Pfizer spanning nearly 20 years, including 4 years leading the successful introduction of several validated GMP animal health vaccines. He led both microbial and mammalian upstream production technology development teams and is recognized as a downstream bioprocess and chromatography expert, and personally directed the successful tech transfer and scale up to pilot and GMP commercial scale of multiple recombinant protein products. These products ranged from engineered growth factors or fusion proteins in E. coli requiring refolding, PEGylation or other chemistries, to high solids fermentations of secreted proteins in yeast and to monoclonal antibodies from Chinese hamster ovary (CHO) cells. He also designed or completed Process Characterization and Process Validation studies for the successful registration and commercialization of biopharmaceuticals. He has been involved at all stages of product development with a focus on the fundamental science, IP, critical production technologies, troubleshooting, technical writing, due diligence and partnering interactions, and overall product strategy direction. He has been an invited speaker on multiple occasions, member of the scientific organizing committee for the RP-HIC conference, an extensively published author and referee and has received awards for his publications.