Advanced Cell & Gene Therapy company name with logo in dark blue

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Phone Icon (984) 444-4641

celltherapy@ac-gt.com

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Downloadable CV

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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


Expert Witness Experience, Litigation Support

Multiple plantiffs v. Blue Cross Blue Shield of Michigan

Dickinson Wright

Memorial Sloan Kettering Cancer Center and Eureka Therapeutics v. Juno Therapeutics - contract dispute

Susman Godfrey

Lyell Immunopharma v. PACT Pharma – contract dispute

Sidley Austin

Atara Biotherapeutics v. Allogene Therapeutics –trademark case

Sheppard Mullin

University of North Carolina v. Vesta Therapeutics – contract dispute

Robinson Bradshaw and UNC general counsel

Restem v. Jadi Cell – cell therapy patent dispute

Thorpe North & Western

Mitsubishi Tanabe Pharma Corporation v. Kolon Life Science – contract dispute

Sidley Austin

MediciNova v. Genzyme Corporation - gene therapy patent case

Sheppard Mullin

Mueller v. Elutia (Aziyo Biologics), Medtronic Sofamor Danek, Spinalgraft Technologies, DCI Donor Services, and New Mexico Donor Services - personal injury

Smouse & Mason