In Search of System‐Wide Productivity Gains ‐ The Role of Global Collaborations in Preclinical Translation

• Published in: Clinical and translational science Vol. 10; no. 6; pp. 423 - 425
• Main Authors: Ussi, Anton E., Kort, Martin, Coussens, Nathan P., Aittokallio, Tero, Hajduch, Marian
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.11.2017; John Wiley and Sons Inc
• Subjects: Animal diseases; Animal models; Animals; Biological properties; Biological samples; Clinical trials; Collaboration; Computer applications; Efficiency; Failure rates; Information systems; Initiatives; Innovations; International Cooperation; Plague; Product development; Productivity; R&D; Research & development; Research projects; Statistical analysis; Tracers; Translation; Translational Medical Research; Europe
• DOI: 10.1111/cts.12498
• ISSN: 1752-8054

[...]in the shadow of 2016's disappointing and abrupt end to the recent uptick in new drug authorizations, cause for optimism is somewhat blunted. [...]with the late stage clinical failure rates remaining stubbornly high , pipeline productivity is clearly sorely in need of efficiency gains. In addition to the lamentable lack of standards in the field, a further major challenge facing translational scientists is a limited understanding of how disease in preclinical animal models translates to humans, which likely further contributes to the high attrition rate in phase II and III clinical trials . Another EATRIS program that can impact systemic inefficiency is underway in collaboration with the European Association of Nuclear Medicine (EANM), to enable multi‐center clinical trials utilizing PET imaging tracers using zirconium‐89 (89Zr), that finds increasing application in so‐called “immuno‐PET” studies of biologicals, nanomedicines, and cells. System‐wide improvements need not be limited to the technical bottlenecks affecting drug developers and research labs. There are a myriad of operational bottlenecks that plague the translational research system, such as efficient access to high‐quality biological samples with associated clinical data, access to pre‐competitive funding for the validation of promising tools such as imaging tracers, and reliability of the peer review system for selection of applied research projects.