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Rob Zamboldi is the Site Head and General Manager of Novartis’ flagship cell processing operation in Morris Plains, NJ providing worldwide supply of novel CAR-T therapies. Rob was instrumental in the ramp up of the first to market CAR-T, Kymriah ® of which more than 7,000 treatments have been supplied from his facility.
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John Tomtishen is Vice President of Operations at Cellares Corporation. At Cellares, John is responsible for Cellares’ IDMO business, supporting partnership activities, and facilitating accelerated market adoption of Cellares’ Cell Shuttle technology to transform the cell therapy manufacturing paradigm and address industry bottlenecks to accelerate access to life saving cell therapies. John has extensive experience in cell and gene therapies, biologics, and vaccines with diverse roles in Business Operations, CMC/Technical Operations, R&D, Supply Chain, Engineering/Facilities, and Operational Excellence. While at Novartis Pharmaceuticals, John had an integral role in the filing and approval of the first CAR T-cell BLA, Kymriah™ (tisagenlecleucel) for pALL (pediatric acute lymphoblastic leukemia) and DLBCL (diffuse large B-cell lymphoma).
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At the most recent edition of the Pharma Manufacturing World Summit held May 15-16, 2023, in Boston, we spoke with Judith Koliwer, PhD, the Principal Consultant Cell & Gene Therapy Software, Körber Business Area Pharma at Körber Pharma Software. Judith is one of the industry’s leading experts on Cell and Gene Therapies, as she led an academic research group on CGT processes years before these new therapies were approaching commercial manufacturing. At PMWS23 she gave a presentation entitled, “The Iterative Approach to a Digital Cell and Gene Therapy Process – an Overview & Best Practice.” In this interview we discuss what she shared with the audience, as well as her thoughts on current issues and trends pharmaceutical manufacturers need to be aware of as they forge a path into the new frontier of medicine. Give this one a listen!
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