what CTS does?
What is Translational Science in drug R&D?
In the very first lecture of pharmacology in the school of pharmacy, I learned that drugs are originated from “poison”. This seems to have happened in history by someone finding wisely how to use such substance positively to remove a disease, improve human health and daily life. Through 40 years of my own career in drug discovery and development, the same principle has commonly worked for the program to succeed, i.e., to assess and confirm a positive balance of benefit vs. risk for patients. This has practically been achieved by fully and quantitatively characterized the drug response in the living body with good understanding of underlying mechanisms, which are then tested by clinical studies to confirm the mechanistic understanding. This confirmation often includes existing database or knowledgebase (typically from the literature, or by conducting supplemental research/study) to fill the gaps in observation, eventually assuring that the benefit of drug treatment well exceeds the risk for the patient or not. This process is not easy, because the drug response mechanism often involves many and broad range of influencing elements. They interact to each other in complex manner to the extent that may vary patient to patient. Even for the same patient, the response may differ depending on the environment and conditions. Therefore, the drug research and development process need typically long years and significant amount of financial investment to non-clinical and clinical studies. Unfortunately, it is also the fact that many drug candidates are eventually not approved for clinical use, despite the precious time and financial investment. Translational Science (TS) concept came up as a hope of breakthrough of such R&D dilemma, typically by use of up-to-date Modeling and Simulation (M&S) technologies (1). TS concept with M&S technology intends to achieve rational drug development, eventually to increase the success rate of drug development.
Chuo Translational Science LLC is assisting clients’ development programs, fully providing our consultants’ expertise in TS and M&S technologies that have been proven as essential in many successful development programs to date, also aiming at even more robust and successful development paradigms for the new program.
1) EFPIA MID3 Workgroup, WHITE PAPER, Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation. CPT Pharmacometrics Syst. Pharmacol. (2016) 5, 93-122
CTS Partner Companies
Contract agreement with:
- CMIC Co. Ltd.Group CompaniesCorporate Overview | Group Companies Company NameCMIC HOLDINGS Co., Ltd.Location of Head Office1-1-1 Shibaura, Minato-ku, Tokyo, JapanView MapFounded1992
- NDA Partners, VA, USANDA Partners LLC
- RJR Consulting, Inc.rjrconsultingRegulatory Consulting, Life Sciences Consulting, Pharmaceutical Consulting, Medical Device Consulting, Dietary Supplements Consulting, Biologics Consulting, Bio...
|March 2019||Foundation of Chuo Translational Science LLC (Mar 5, 2019)|
|April 2019||Master Service Agreement with CMIC Co. Ltd.|
|May 2019||Amend the agreement with NDA Partners LLC, from individual consultant (LR Kawai, in 2018) to CTS Corporate contract|
|August 2019||Started to accept service contract as CTS independently|
|October 2019||Attended NDA Partners 2019 Executive Consultant Conference in Washington DC, US, creating business network with US/EU leading consultant (Consulting Service Agreement with RJR Consulting Inc.)|
|December 2019||Co-sponsored “Chair’s Special Seminar” with congress the chair in 34th Annual Congress of Japanese Society for the Study of Xenobiotics (JSSX: https://www.jssx34.org/En/luncheon.html); in addition to the lecture by Leo Kawai, a survey to participants was conducted regarding needs and interest for TS consulting|
|March 2020||CTS Second Fiscal Year started|
|July 2020||Yoshiro Tomono joined CTS as a PMx Expert Consultant. Population PK (PPK) modeling and simulation service by CTS has been set up and applied to clients’ programs.|