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
Lyell Immunopharma v. PACT Pharma – contract dispute Sidley Austin
-
Testified before tribunal and in deposition
-
Background research, wrote three expert witness reports and rebuttals of opposing expert witness reports
-
Guidance for counsel on scientific and technical aspects of cell and gene therapy
-
Comments on transcripts of opposing witness depositions, suggested questions for depositions and cross-examination
|
Atara Biotherapeutics v. Allogene Therapeutics –trademark case
Sheppard Mullin
-
Testified in deposition
-
Wrote expert witness reports including rebuttal of opposing expert witness
-
Reviewed transcript of opposing expert witness deposition, suggested questions for cross-examination.
|
University of North Carolina v. Vesta Therapeutics – contract dispute
Robinson Bradshaw and UNC general counsel
-
Wrote three expert witness reports and rebuttals of opposing expert witness reports
-
Guidance for counsel on cell therapy product development and regulatory pathway, suggested questions for depositions
|
Restem v. Jadi Cell – cell therapy patent dispute
Thorpe North & Western
-
Testified in deposition
-
Wrote expert witness reports including rebuttal of opposing expert witness
-
Reviewed and researched patents and related publications, guidance for counsel on cell therapy product development
|
Mitsubishi Tanabe Pharma Corporation v. Kolon Life Science – contract dispute
Sidley Austin
-
Testified before tribunal
-
Background research, wrote three expert witness reports and rebuttals of opposing expert witness reports
-
Guidance for counsel on cell and gene therapy and CGT product development
-
Comments on transcripts of opposing witness depositions, suggested questions for depositions and cross-examination
|
MediciNova v. Genzyme Corporation - gene therapy patent case
Sheppard Mullin
-
Testified in two depositions
-
Testified in court twice (tutorials on gene therapy for judge, by request)
-
Wrote multiple expert witness reports and rebuttals of opposing expert witness
-
Reviewed and researched patents, contracts, and supporting documents
|
|
|
|
|
