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[A capability to promote the utilization of human samples for improving the |clinical response predictability in the pharmaceutical company].
Okimoto, Risa; Fujimura, Takao; Mihara, Kayoko.
Afiliación
  • Okimoto R; External Capability & Laboratory Operations Applied Research Management, Applied Research & Operations, Astellas Pharma Inc.
  • Fujimura T; External Capability & Laboratory Operations Applied Research Management, Applied Research & Operations, Astellas Pharma Inc.
  • Mihara K; External Capability & Laboratory Operations Applied Research Management, Applied Research & Operations, Astellas Pharma Inc.
Nihon Yakurigaku Zasshi ; 159(5): 300-303, 2024.
Article en Ja | MEDLINE | ID: mdl-39218674
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 proof-of-concept (POC) acquisition rate by further improving clinical predictability. For this purpose, we need to deepen our understanding of human pathophysiology, and to make efficient of drug discovery research by utilizing human samples and data due to the change in mindset from "animals" to "humans" at the drug discovery research stage. In particular, with the aim of improving the efficiency of drug discovery research by utilizing human samples/data, we have established a human sample utilization support capability, then we are supporting the acquisition of appropriate human samples/data to meet each drug research need with collecting information on organizations that can provide various human samples and accumulating know-how on obtaining human samples/data. In addition, we have built a one-stop support system for surveying human samples/data, negotiating, and contracting with the organizations, obtaining ethical committee approvals, importing samples, and dealing with customs clearance. As results, our researchers can obtain high-quality human samples/data to meet their research needs rapidly/easily. By establishing this capability, the number of the research projects that implement target validation, pharmacological evaluation, BM identification, and patient stratification, etc. using human samples/data from the early stage of drug discovery, has increased, and then, the evidence obtained by using human samples/data contribute to create drug candidates with high probability of clinical effect. We will introduce our activities while showing the support flow that was actually constructed.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Industria Farmacéutica / Descubrimiento de Drogas Límite: Humans Idioma: Ja Revista: Nihon Yakurigaku Zasshi Año: 2024 Tipo del documento: Article Pais de publicación: Japón

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Industria Farmacéutica / Descubrimiento de Drogas Límite: Humans Idioma: Ja Revista: Nihon Yakurigaku Zasshi Año: 2024 Tipo del documento: Article Pais de publicación: Japón