Navigating Early Cell Therapy Development: The Journey to First-in-Human Studies

Gregory Meyer, Vice President, Regulatory Affairs, Premier Consulting

Greg Meyer has been in the pharma, biopharma and medical device industry for over 30 years and has gained regulatory approvals in more than 20 countries. He has represented companies during numerous interactions with the FDA, European national and EU regulators and the Australian TGA and has worked on the development, submission and commercialization of NMEs and 505(b)(2) products in oncology, neurology and dermatology. His specialty areas include biologics and drug-device combination products.

Mimi Huang, PhD Toxicologist, Premier Consulting

Dr. Madelyn “Mimi” Huang is a Toxicologist at Premier Consulting. She provides expert advice to Premier clients about various nonclinical aspects of therapeutic product development, such as designing nonclinical programs to support clinical studies, writing and reviewing regulatory submissions for global regulatory authorities and crafting regulatory strategies. She has experience in the development of small molecules and cell and gene therapies, as well as in developing drug products via the FDA’s 505(b)(2) pathway.

Dr. Huang obtained her PhD in Toxicology at the University of North Carolina at Chapel Hill and is a Diplomate of the American Board of Toxicology (2022-present). She has published 18 articles in peer-reviewed journals on topics spanning a wide range of toxicology, from basic environmental chemical research to pharmaceutical regulatory strategy.

Alex Klarer, VP of Business Strategy and Innovation, BioCentriq

Alex Klarer has nine years of experience in the pharmaceutical manufacturing space with roles at Genentech, Minaris Regenerative Medicine, and now BioCentriq. He has led the translational process development for a range of cell therapies and ex-vivo gene therapies including T-cell, DC and NK cell immunotherapies, stem cell therapies and MSC-mediated immunoregulation. Alex applies his background in process engineering and manufacturing sciences in his current role as the VP of Business Strategy and Innovation to identify and see through the realization of new, differentiating capabilities for cell and gene therapy manufacturing.

(Moderator) Kenneth Ndugga-Kabuye, MD, FACMG, Vice President, Cell & Gene Therapy, Premier Research

Dr. Ken Ndugga-Kabuye is Vice President of Cell & Gene Therapy at Premier Research. He has extensive experience with clinical programs that leverage cutting-edge approaches in the treatment of disease, inclusive of cell and gene therapies, synthetic biotics, RNA therapies and enzyme replacement therapies.

At Premier Research, Dr. Ndugga-Kabuye partners with cell and gene therapy clients to provide them with end-to-end strategic, clinical, operational and commercial support solutions. He received a Bachelor of Science in Microbiology, Immunology and Molecular Genetics (MIMG) from the University of California in Los Angeles (UCLA) and a medical degree from Ross University School of Medicine. Dr. Ndugga-Kabuye performed his residency and fellowship training in medical genetics and genomics at the University of Washington in Seattle, WA. He is board-certified in clinical genetics and genomics, by the American Board of Medical Genetics and Genomics (ABMGG).