The LICR Clinical Trials Model
The traditional pathway for translating scientific discoveries into clinical therapies imposes distinct roles on academia and industry. Academia generates the discovery; industry refines the discovery into a product. Thus the clinic door becomes the line of demarcation between two separate domains.
The LICR clinical trials model differs from the conventional paradigm, and was specifically developed to address our conviction that early-phase clinical investigations are the last step of the initial discovery phase, and not the first step of a new drug development phase.
- Our laboratory and clinical research are closely integrated during early-phase clinical studies. This provides the foundation for rational and informed decisions for later clinical development.
- We take responsibility for regulatory applications and approvals, processing and producing clinic-grade study agents, and ensuring that the trials comply with internationally recognized and approved standards.
- Our Clinical Trials Program is coordinated centrally by the Office of Clinical Trials Management. Trials are conducted at multiple clinical centers, each integrated with a laboratory, and each applying standardized techniques for monitoring and/or clinical evaluation. This model allows the parallel testing of many single trial variables, thus efficiently and rapidly comparing multiple clinical strategies.
Our clinical trials model enables us to control the early clinical evaluation and development of our discoveries. We believe that this commitment, from the discovery level, through reagent production, standardization of delivery, monitoring, and clinical evaluation, to the final licensing of therapies for marketing, is essential to achieve our ultimate objective — translating our discoveries into patient benefit.