Penn partnered with Novartis in 2012 using an innovative and pioneering partnership program model to develop a new and novel method of cancer treatment: CAR-T cell therapy. This landmark alliance led to the development and ultimate launch of Kymriah, a breakthrough new CAR-T medicine providing a personalized cellular therapy for patients with certain leukemias and lymphomas.
PCI was actively involved in both shaping and negotiating the alliance deal with Novartis and continued to actively manage the alliance program with flexibility over the subsequent eight years. To set the stage, PCI worked collaboratively with Novartis to develop a innovative agreement structure to facilitate the basic research of CAR-T products and technologies, the development of technology to manufacture these products and ability to readily conduct clinical translation of Kymriah and other CAR-T pipeline product. The agreement and follow-on discussions led by PCI Alliances also led to establishment of a system for readily sharing and tracking materials exchanged between Penn and alliance partners.
Much of PCI Alliance’s management involved leveraging unique assets to readily solve unanticipated needs of the program as research developed, including expanding the alliance relationship to include several other academic research institutions in aspects of the pre-clinical and clinical studies, working with contract manufacturing parties to support components of the translational research program, and expanding the PCI Alliance team to ensure Penn was able to meet certain obligations under an alliance programs with reach and complexity that expanded over time. In 2014 Penn put the necessary mechanisms in place to allow to engagement in manufacturing for Phase II multi-site clinical studies. Throughout the alliance relationship, PCI Alliances worked with the Penn researchers and Novartis to restructure the alliance relationship to follow and support the direction of the research program.
Finally, PCI Alliances worked to create mechanisms to facilitate the transition the CAR-T program from translational research laboratories at Penn to Novartis commercialization teams and facilities. In 2017 the FDA approved Kymriah with the first unanimous recommendation for approval to the FDA from the Oncologic Drugs Advisory Committee.