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.
In this webinar, representatives from Premier Research and Biocentriq host a panel discussion delving into the intricacies of early cell therapy development that shape the path toward clinical trials.
Topics include:
- 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.
Panelists:
Gregory Meyer, Vice President, Regulatory Affairs
Mimi Huang, Ph.D. Toxicologist
Alex Klarer, VP of Business Strategy and Innovation, BioCentriq
Moderator:
Kenneth Ndugga-Kabuye, MD, FACMG, Vice President, Cell & Gene Therapy
