Inside the IDMO model: Analytical comparability, regulatory readiness and operational excellence

Isabel Tian is the Director of Scientific Affairs at Cellares, where she is passionate about accelerating patient access to life-saving therapies through automation and innovation. Drawing on experience across process development, CMC, and scientific marketing, Isabel bridges scientific and business strategy to shape product roadmaps, inform executive decision-making, and strengthen Cellares’ position as a global leader in industrialized cell therapy manufacturing. She holds a B.S. in Chemical Engineering from New York University and a Ph.D. in Nanoscale Engineering from SUNY Polytechnic Institute.

Anna McMahon is Director of Regulatory Affairs at Cellares, where she led the AMT Designation for the Cell Shuttle System. With a career spanning both cell and gene therapy and diagnostics, Anna brings expertise in regulatory strategy, compliance, and CMC support. Her background is uniquely grounded in hands-on science — she is a licensed ASCP Medical Laboratory Scientist with experience in academic hospital stem cell labs, giving her a practical foundation that strengthens her regulatory work in the CGT space. Anna holds a Master of Science in Regulatory Affairs from Northeastern University.

Ossama Eissa is Chief Operating Officer at Cellares, where he oversees manufacturing operations and the global expansion of the company's Integrated Drug Manufacturing Organization (IDMO) Smart Factory network. With more than 20 years of experience in pharmaceutical and biotech manufacturing, Ossama brings expertise in commercial-scale production, process development, and manufacturing strategy for cell and gene therapies. His background is uniquely grounded in hands-on operational leadership, serving as site head for the commercial-scale production of two FDA-approved CAR-T cell therapies, Kymriah at Novartis and Carvykti at Legend Biotech, giving him practical, launch-tested experience that strengthens his operational leadership at Cellares. Ossama holds an MBA from the American University in Cairo, a B.Sc. in pharmaceutical sciences from Cairo University, and is a certified Lean Six Sigma Black Belt.