I have 30 years of experience developing cell therapy and gene therapy products, many of which have been for cancer. For the last 23 years, I have been a full-time consultant on manufacturing, regulatory, and strategic aspects of these products, serving more than 200 companies and academic centers in North America, Europe, Asia, and Australia. My expertise in cell and gene therapy includes manufacturing process development and application of QbD, analytics, GMP/GTP operations, apheresis collection, and regulatory requirements. I am the founder and principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell therapy and gene therapy product development, GMP manufacturing, and regulatory affairs.
Throughout my career, I have consulted for more than 180 companies worldwide, providing deep knowledge of key issues such as closed-system processing, scale out/scale up, automation, potency testing, and comparability. My experience covers a wide range of cell and gene therapy products, including CAR-T, NK, and dendritic cell immunotherapy, in vivo and ex vivo gene therapy, CRISPR gene editing, and stem cell regenerative medicine products. Prior to founding Advanced Cell and Gene Therapy in 2002, I was vice president for R&D at Merix Bioscience and director of the University of Minnesota Cell Therapy Clinical Laboratory. My regulatory background includes numerous IND submissions and productive interactions with FDA-CBER Office of Tissues and Advanced Therapies (OTAT), formerly the Office of Cellular, Tissue and Gene Therapies (OCTGT).
I have served as an expert witness in cases involving cell and gene therapy intellectual property, commercialization, FDA regulatory affairs, and GMP compliance, and as a subject matter expert for NIH and CIRM. Additionally, I have performed due diligence for numerous investment firms and Big Pharma. I have served on the USP Cell, Gene and Tissue Therapies Expert Committee, ISCT advisory board, and committees, and frequently speak on regulatory and manufacturing topics at cell and gene therapy conferences and webinars.
A graduate of the University of Pennsylvania School of Medicine, I completed training in clinical pathology and transfusion medicine at Washington University in St. Louis.
Key Milestone Expertise in Drug Discovery & Development:
- Lead Optimization
- Predevelopment (candidate selection)
- IND enabling
- Phase I-III trials
