The rapid evolution of cancer immunotherapies has increased demand for timely introduction of new therapies and subsequently increased the demand on leading cancer research institutions worldwide. As a leader in cancer therapy research, Roche created the immunotherapy Centers of Research Excellence (imCORE) Network, a worldwide research network designed to more closely connect members in an open environment of shared information, expertise, and decisions. This network is dedicated to increasing the understanding of the underlying science in order to prioritize and accelerate the most promising new treatment options for patients. The network consists of two key pillars, Roche-sponsored clinical trials operational excellence and the imCORE network scientific collaborations. This paper focuses on the Roche-sponsored trial clinical operational excellence aspects of the network. This special contribution introduces the rationale, design, and success factors of sponsored trials within the imCORE Network, including critical components and examples of tangible improvements to clinical trial operations between the company sponsor and the trial sites. Pivotal success factors have included relationship architecture and management, transparent communication channels, open information-sharing, and the development of new processes and tools to overcome historical inefficiencies and challenges of all sizes. The shared dedication of stakeholders to cancer therapy innovation, operational improvement of clinical trials, and a durable, sustainable worldwide research collaborative has made this component of imCORE effective to date. The authors share this experience with the broader research community for the first time, in the same spirit of collective advancement of care for patients with cancer.
e14055 Background: The rapidly evolving field of Cancer Immunotherapy (CIT) has mobilized biopharma to develop promising new treatments while at the same time created a need to expedite the pathway of those new therapies from bench to bedside. This race to bring innovative treatments to patients has engendered heightened levels of competition for the attention of and partnership with the best research institutions in the biopharma industry. Methods: Recognizing this reality, Roche created the immunotherapy Centers of Research Excellence (imCORE) Network: a network of leading cancer immunotherapy centers worldwide. The vision of this network was to partner with sites to streamline the operational delivery of the Roche Genentech portfolio while deepening the collective understanding of the science to prioritize and accelerate the most promising new treatment options for our patients. Creation of a network was not a novel idea, but Roche set out to build a network unique to the biopharma industry – one which was relationship-based where the site/sponsor relationship serves as the foundation for driving both collaborative scientific investigations and operational efficiencies in support of Roche’s clinical trials. While the identification and optimization of promising candidate drugs in the preclinical and translational settings are critical first steps in the drug development process, the initiation and operationalization of early phase clinical trials are equally important in the multidimensional cycle of drug development. Results: See Conclusions. Conclusions: This white paper will provide an overview of imCORE’s origins with a focus on the strategic importance of the site-sponsor relationship and the mutual value that is derived from the combined benefits of these relationships and in conducting early clinical trials more efficiently across Roche’s CIT portfolio. Further examination of communication and operational improvement to support the network will be highlighted as key drivers in creating and sustaining meaningful site/sponsor relationships that better facilitate the operationalization of clinical trials and ultimately brings novel therapies to patients in a more efficient manner than in the past.
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