Chugai’s mission is to generate a steady stream of innovative products to address unmet medical need and benefit the medical community and human health around the world. Based on this principle, our key priority is to create new drugs with first-in-class*1 or best-in-class*2 potential.
In allocating research resources, we prioritize projects based on the following criteria:
- Criteria for Allocation of Research Resources:
- The compound’s potential for development as a novel medicine that can be clearly differentiated
- Whether it has a scientific basis for addressing unmet medical need
- Whether it is a project that will enable personalized healthcare (PHC)
At various decision points during research, we focus first and foremost on patient need, reflecting our belief that creating medicines truly needed by patients and healthcare providers will lead to Chugai’s medium-to-long-term growth.
- *1 An original drug that is highly novel and useful, and will significantly change the therapeutic system
- *2 A drug that offers clear advantages over other existing drugs in the same category, such as those with the same molecular target
Process and Milestones of Drug Development
- Target molecule identification
- Identify a target molecule that is implicated in a disease process by understanding the real molecular mechanism of the disease.
- Seeds of drug
- Select candidate designed to specifically inhibit the action of a target molecule from several million seeds of drug.
- Verify optimal dose of candidate and method of using it.
- DMPK (Drug Metabolism and Pharmacokinetics)
- Research the process that a candidate is absorbed, distributed, metabolized and excreted by the body.
- GLP (Good Laboratory Practice)
- The practice for non-clinical safety assessments of the drug
- Phase I Clinical pharmacology (Healthy volunteer/Patient)
- Performed on a small number of healthy volunteers (or, for certain therapeutic fields and diseases, on patients) to assess the drug’s safety and the process by which it is absorbed, distributed, metabolized and excreted by the body.
- Phase II Exploratory/Confirmatory (Patient)
- Performed on a small number of consenting patients to determine the safest and most effective dosage and the dosing regimen.
- Phase III Confirmatory (Patient)
- Performed on a large number of consenting patients to confirm the efficacy and safety of the new drug in comparison with existing drugs or placebo.
- Preclinical studies
- A study to assess safety, efficacy and other characteristics of a drug using animal subjects.
- Clinical Development
- A study to assess the safety, efficacy and other characteristics of a drug in human subjects.