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Subject Matter Expertise in Cell and Gene Therapy

My consulting firm, ADVANCED CELL & GENE THERAPY, leverages extensive academic and industry experience, and current regulatory knowledge of cell therapy, gene therapy, and tissue-engineered products.

Experienced Expert Witness. I have served as an expert witness in cases involving cell and gene therapy intellectual property, commercialization, FDA regulatory affairs, and GMP compliance in matters that have proceeded to depositions, private arbitration, and testimony in court.
Review Panels. For many years, I have worked as a subject matter expert for NIH-NHLBI, DMRDP, PACT, and CIRM review panels for development funding.
Due Diligence. My scientific and regulatory skills, combined with over 25 years of experience in the gene and cell therapy space allows me to arm my clients with the best information heading into a deal. Most frequently, my clients are investment firms and large pharmaceutical companies.
Consulting. I routinely provide guidance on investor expectations to cell and gene therapy startups seeking funding.

Expert Witness Services

• Provide counsel with relevant scientific background and strategic advice for rebuttals
• Review evidence and investigate background documents
• Advise on varied scientific and technical subjects, including intellectual property, commercialization, FDA regulatory affairs, and GMP

• Testimony in civil and criminal litigation, as well as private arbitration
• Draft well-structured, on-point written reports in accordance with counsel’s instructions while providing objective analysis
• Presents information in a manner accessible to juries and judges