DMPK and Safety research
Microphysiological blood-brain barrier (BBB) system to evaluate drug delivery system (DDS) technologies for large molecules
Recently, DDS development of large molecules for the brain via specific target proteins expressed in BBB such as transferrin receptor and glucose transporter has been increased. In addition, although the target protein and delivery mechanism are unknown, other brain DDSs have been also reported. Although animals are widely used for the evaluation of these DDSs, species differences in target protein expression and transport function are major concerns in drug development. Therefore, in this subject, we are looking for an in vitro BBB system that can address the concern in species differences in DDS evaluation.
Development of MS imaging technology equipped with cellular resolution and high sensitivity enabling the pharmacokinetic evaluation of small/large molecules
Accurately understanding the localization of a drug at the cellular level in vivo is useful for efficiently proceeding with efficacy/safety evaluation of drug candidate compounds. In recent years, evaluation of localization at the tissue level has become possible with the development of mass spectrometry (MS) imaging technology. On the other hand, regarding localization of distribution behavior at the cell level, there is some technical problems in measuring it with accuracy due to the limited spatial resolution and sensitivity. Here, we would like to call for research on high-resolution and high-sensitivity MS imaging technology that enables the evaluation of cell-level kinetics of unlabeled small molecules or new modalities.
Technology of ultra-sensitive assay for biomarkers and new modality drug by MS platform using novel assay pretreatment and/or detection systems
Mass spectrometry (MS) has been increasingly applied in biological sample analysis of endogenous biomarkers and new modality drugs (nucleic acids, peptides and proteins such as antibodies), but its sensitivity is insufficient for a small abundance of target. Here, we are looking for a wide range of analytical technologies that can innovatively improve the sensitivity of the method that can be analyzed by MS. As an example, we would like to recruit a new MS analysis technology including front-end separations (not limited to liquid chromatography) that enables highly selective and highly sensitive quantification of endogenous protein biomarkers and a new analysis technology related to its pretreatment method (high recovery immunoprecipitation method or high efficiency enzyme digestion method).
Development of Drug Safety Assessment with Digital solution
Leveraging digital solution could lead the future healthcare such as personalized medicine. Nevertheless, there are still little idea for drug safety specific topic.
We would like to offer idea related to drug safety by digital solution, wearable, data science and so on.
Development of the novel biomarkers or preclinical screening systems to predict drug-induced central nervous system side effects (cognitive impairment, hallucinations, suicidal ideation and drug dependence)
CNS side effects such as cognitive impairment, hallucinations, suicidal ideation, and drug dependence / abuse liability are thought to be occurred when the drugs are used in the clinical, and they are the great interest in society. However, the number of researches focusing on the evaluation and screening for these side effects in preclinical is limited. Thus, the accumulation of knowledge based on the research data is desired. We are looking for research ideas to develop the novel biomarkers or preclinical screening system that could improve the accuracy of prediction or understanding of the mode of action in drug-induced CNS side effects.
The discovery of safety biomarkers using bacteria
Serious adverse events (SAE) often occur with individual differences. However, few models recapitulate individual differences in drug susceptibility. To overcome this issue, in this application, we ask for the proposal which can recapitulate individuals’ different susceptibilities to a drug-induced SAE using bacterial flora such as enterobacterium and dental bacterium.
Development of next-generation in vitro organ model systems mimicking toxicokinetics for toxicity studies
Although in vitro organ/tissue model has been used for investigative and predictive toxicology studies in the various stages of drug development, there are still urgent needs to improve the predictivity of in vivo toxicity results. The expected proposals include researches contributing to a development of biomimetic organ/tissue models mimicking clearance, duration and polarity of exposure, metabolisms, and/or organ transferability of drugs, or its inter-organ crosstalk that offers innovative features not found in conventional approaches including the microfluidic organ-on-chip.
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