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

More ex vivo cell therapy programs are expanding beyond rare diseases into autoimmune indications, bringing larger patient populations that demand commercial-scale manufacturing. That shift is pushing sponsors to face three converging risks: proving manufacturing comparability, navigating regulatory expectations, and scaling operations across global sites. This session brings together experts from Cellares to explore how automated platforms support analytical comparability, how early FDA engagement through the Manufacturing PreCheck Pilot Program reduces late-stage regulatory risk, and what it takes to operationalize consistent manufacturing standards across a global IDMO network.

Isabel Tian

Director of Scientific Affairs

Cellares

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

Director of Regulatory Affairs

Cellares

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.

Neil Saniel

Vice President & General Manager

Cellares

Neil Saniel is Vice President and General Manager at Cellares, where he oversees the manufacturing operations within the network. With more than 30 years of experience in pharmaceutical and biotechnology manufacturing, Neil brings an extensive wealth of expertise in commercial operations with a successful track record in FDA, EMA and other Health Authority inspections. He led the Operations team at Legend Biotech from clinical to commercial site license approval and led the largest expansion of manufacturing capabilities for the US site. Neil holds a Masters of Science in Biology from Montclair State University.

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

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