In this webinar, gain insights into overarching regulatory strategies that maximize the effectiveness of interactions with the FDA and other regulatory bodies. Attendees will learn about manufacturing processes to meet the demands of cell therapy clinical trials, including scalability, reproducibility and the establishment of robust quality control measures. The featured speakers will share considerations for designing nonclinical studies that will lay the groundwork for first-in-human and subsequent clinical trials, drawing on real-world case studies.
TORONTO, Feb. 15, 2024 /PRNewswire-PRWeb/ -- 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.
Register for this webinar where representatives from and will host a panel discussion delving into the intricacies of early cell therapy development that shape the path toward clinical trials.
Join Gregory Meyer, Vice President, Regulatory Affairs, Premier Consulting; Mimi Huang, PhD Toxicologist, Premier Consulting; Alex Klarer, VP of Business Strategy and Innovation, BioCentriq; and Kenneth Ndugga-Kabuye (Moderator), MD, FACMG, Vice President, Cell & Gene Therapy, Premier Research, for the on Thursday, March 7, 2024, at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit .
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