An Academic Model for Cell & Gene Therapy Asset DevelopmentPublished: February 14, 2019
Cell Therapy Quality/ CMC & Analytics
New treatments for neoplastic, infectious and monogenic diseases employing cell and/or gene therapy modalities are at the forefront of modern medicine. Many of these treatments are initially discovered in academic research centers and require significant development prior to out-licensing for commercial development and regulatory approval. Over the past 20 years, numerous academic institutions have elected to build infrastructure to perform the required early translational science and clinical testing “in house” before seeking a commercial partner. Product development requires careful planning and management to realize the full benefit of what is often a significant financial investment. Multiple stakeholders participate in this process and outcomes depend heavily on the vision, planning and financial commitment of the institution. Described here are common considerations and practices for creating a sustainable cell and gene therapy asset development program at an academic institution.DOI: 10.18609/cgti.2019.004
Submitted for review: December 31, 2018
Citation: Cell & Gene Therapy Insights 2019; 5(1), 27–34.