Abstract
An issue in drug discovery research at pharmaceutical companies is the decline in the probability of market launch, and there is a need to improve the POC acquisition rate by further improving clinical predictability.For this purpose, we need to change the mindset from animal to human at the drug discovery stage, that is, to shift from an animal-based evaluation system to an evaluation system that utilizes human clinical samples, to deepen our understanding of human pathophysiology, and to make efficient of non-clinical research by utilizing human clinical data and samples.In particular, with the aim of improving the efficiency of non-clinical research by utilizing human clinical data/samples, we have established a human sample utilization support team, then we are collecting information on organizations (biobank, academia, supplier, CRO) that can provide various human samples and accumulating know-how on obtaining human samples. In addition, we have built a one-stop support system for surveying human samples to meet research needs, negotiating, and contracting with the organizations, applying to ethical committees, importing samples, and dealing with customs clearance. As results, our researchers can obtain high-quality human samples to meet research needs rapidly/easily. By introducing this system, the number of the research projects that implement target validation, pharmacological evaluation, BM identification, and patient stratification, etc. using human samples from the early stage of drug discovery, has increased, and then, the evidence obtained by using human samples contribute to create drug candidates with high prediction accuracy of clinical effect.In addition, for the streamlining non-clinical research as described above, fresh and/or chronological patient samples are required in many cases. The current situation and challenges in conducting experiments using prospective and fresh human samples are as follows: i) The number of overseas CROs which can obtain patient samples and conduct the experiments with high quality, is not so many, ii) It takes long time to initiate collaborative researches with domestic or overseas academia for contracts, ethical committees, also our researchers have to stay the academia until patient samples are obtained, iii) It is difficult to conduct collaborative research to share outcome/IP with collaborators due to open innovation to acquire good drug candidates. In order to solve these problems, our team is working to strengthen cooperation with the preferred biobanks where fresh and prospective samples can be obtained. As an example, we obtained fresh patient samples from Tsukuba Human Tissue Biobank Center in Tsukuba Univ, which is located near our labs, under the material transfer agreements. Therefore, we can conduct many non-clinical research using fresh samples in our own labs. We will introduce our activities while showing the support flow that was actually constructed.
