CTS provides rational and pragmatic answers to diversity of questions emerging through drug research and development by full use of translational science (TS), i.e., by assessing available R&D data and the relevant knowledge-base, from internal/external (public) sources adapting objective and quantitative approaches. Services are provided directly by CTS internal expert consultants, or if appropriate, together with CTS partner consultants and/or partner CROs, when specific scopes of expertise are required, in a flexible and timely manner, thereby responding to the most of research and development needs in global and/or local drug development.
Drug Research and Development
- Intensive assessment of drug candidates or those under development, proposing strategic development plan through regulatory approval. Advices and/or hands-on support are provided to their implementation and to achieve the rational development.
- Comprehensive gap analysis of non-clinical and clinical data packages, proposing clinical pharmacology action plans with TS tools responding to insufficient or missing data identified, aiming facilitaed development strategy through approval.
- Aid productive collaboration among global development team with synergy, as well as help creating efficient partnership between firms/teams, which are distanced geographically or in culture.
- Advice or hands-on support to the regulatory documentations, such as briefing book, correspondences to the authorities, or CTDs (English/Japanese in parallel).
- Aids rational, globally cooperative regulatory strategy, interacting with authorities in respective countries (involving relevant partner CROs, if needed)
- Respond to nonroutine, emerging regulatory requirements, such as specific CMC, MF, regenerative medicine (involving CTS part-time consultants and/or partner CROs).
Modeling & Simulation（M&S）
- Planning quantitative data assessment (M&S) strategy from discovery, clinical development through NDA submission, implementing the modeling as well as training and educations of client staff members.
- Development and efficient application of mechanism-based, “bottom-up” PKPD modeling, such as physiologically-based PK (PBPK) models, to program strategy.
- Population PK (PPK) modeling and simulations on clinical development data to facilitate, justify and/or conclude the clinical development.
- Development of dose – exposure – response models, for pharmacodynamic and clinical end points, and its proactive use for development strategy.