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

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharma Manufacturing & Supply Chain, Cell and Gene Therapy,
  • Thursday, March 07, 2024

For cell therapies, the roadmap to first-in-human studies is marked by critical scientific and regulatory milestones that require careful planning, expertise and collaboration from various stakeholders. From rigorous nonclinical studies to cell manufacturing processes to overcoming regulatory complexities, each milestone represents a significant step forward in bringing these transformative treatments to patients in need.

Join this webinar where representatives from Premier Research and Biocentriq will host a panel discussion delving into the intricacies of early cell therapy development that shape the path toward clinical trials.


Gregory Meyer, Premier Consulting

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.

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Mimi Huang, Premier Consulting

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.

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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.

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(Moderator) Kenneth Ndugga-Kabuye, Premier Research

(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).

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Who Should Attend?

This webinar will benefit Managers and above at biotech and specialty pharma companies with job functions including, but not limited, to:

  • Clinical operations
  • Medical affairs
  • Project management
  • Regulatory affairs

What You Will Learn

Attendees will gain insights into:

  • Overarching regulatory strategies that maximize the effectiveness of interactions with the FDA and other regulatory bodies
  • Manufacturing processes to meet the demands of cell therapy clinical trials, including scalability, reproducibility and the establishment of robust quality control measures
  • Considerations for designing nonclinical studies that will lay the groundwork for first-in-human and subsequent clinical trials, drawing on real-world case studies

Xtalks Partner

Premier Research

Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions. Visit

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