Scaling autologous CAR-T manufacturing for autoimmune and larger patient populations

Stephan O. Krause, PhD, is a biopharmaceutical quality and analytical science leader with over two decades of experience advancing global standards across biologics, cell therapies, and analytical control strategies.  As Executive Director for Analytical Strategy at Bristol Myers Squibb, he leads analytical strategy development and lifecycle execution for cell therapy products across global sites.  Stephan brings a rare blend of deep technical skills and strategic standard-setting experience, having held leadership roles at AstraZeneca, MedImmune, Bayer, and other companies.  He is the recipient of over a dozen publication and industry recognition awards and is known for his PDA leadership.  He currently serves on several advisory boards and chairs several high-impact task forces, including PDA TR for Phase-Appropriate QMS for ATMPs and ANS-07 Analytical Standard Development.  He earned his PhD in Analytical Chemistry and Biochemistry from the University of Southern California, where his research explored enzymatic mechanisms through isotope-labeled ATP hydrolysis studies.

Katie Jorgensen is the site head of BaseCamp Waltham, ElevateBio’s flagship genetic medicine biomanufacturing facility. Since joining, she has been instrumental in accelerating the development and manufacturing of cell and gene therapies and strengthening partnerships with biotech and pharma innovators. Previously at the company, Jorgensen served as vice president, commercial operations and CMC program management.

Under Jorgensen’s leadership, ElevateBio has expanded its industry impact by consistently exceeding partner expectations. Her team has optimized end-to-end processes from development to manufacturing, significantly improving efficiency and enabling partners to achieve more in less time.

Jorgensen’s efforts have contributed to an impressive 98%-plus batch success rate across cell therapies, viral vectors and mRNA programs. Additionally, her leadership has contributed to multiple advancements for partner programs, including an accelerated timeline—by a year—to an investigational new drug application for a lead program. She has also reduced a manufacturing process timeframe for an investigational CAR T therapy, leading to getting important therapies to patients faster. Most recently, the site achieved certification for commercial readiness (Dark Horse Consulting), showcasing the maturation of systems and a focus on quality, scalability and manufacturing excellence.

Jorgensen’s leadership serves as a blueprint for ElevateBio’s new BaseCamp Pittsburgh facility, expected to be operational in 2027. She champions a culture of excellence and empowerment, particularly encouraging women leaders to drive continued innovation and meaningful impact.

Prior to ElevateBio, Jorgensen spent a decade at AbbVie, recently serving as director, manufacturing and tech transfer. She has a Master of Science in engineering management from Tufts University and a Bachelor of Science in biomedical engineering from the University of Connecticut.

Alaina Schlinker leads Global Field Application Support for Fresenius Kabi’s Lovo and Cue cell processing systems. Her team partners with therapy developers to integrate automated platforms from pre-clinical process development through commercial manufacturing. With more than a decade in cell and gene therapy, Alaina has played a key role in the evolution of the Lovo system and contributed to the launch of Cue. She holds a PhD in Chemical Engineering from Northwestern University.

Kurtis Carlisle is a biotech supply chain leader with nearly two decades of experience guiding teams and building global networks to bring therapies to patients. He currently serves as Vice President of Supply Chain at Cabaletta Bio, where he oversees end-to-end supply chain strategy, vendor partnerships, and patient operations to support autologous cell therapy programs in clinical development. Since 2021, Kurtis has been deeply engaged in the cell therapy industry, leading supply chain and external manufacturing functions that enable patient-specific therapies to advance through clinical trials and toward commercialization. Throughout his career, Kurtis has held senior leadership roles at companies including TCR² Therapeutics, Viela Bio and AstraZeneca, where he built and led supply chain organizations that supported everything from first-in-human trials to global commercial launches. His expertise spans demand and supply planning, global distribution, cGMP operations, and organizational development, with a consistent focus on creating scalable systems and teams that enable innovation.