Target to POC Development
Traditional drug and clinical development is a very expensive and time consuming process which has many failures. The path to success can be accelerated and improved by using Translational Research and Development processes.
Translational R&D uses data from discovery biology and animal models of disease to design early clinical studies that will rapidly demonstrate that the drug candidate will have the desired clinical efficacy. This early 'Proof of Concept' is a key to decision making on whether to invest in further time consuming and expensive clinical trials.
Proof of Concept studies often use biomarkers of disease symptoms or progression as well as determining if the drug candidate is acting at the desired target at doses that are demonstrated to be safe.
Focusing on early development to pick the winners substantially increases the chance of overall success. Translational R&D conducted by ChemDiv provides Proof of Concept data in less time and at a fraction of the cost typically seen in the pharmaceutical industry and plays a critical role in mitigating the very expensive risks associated with full scale clinical development.
ChemDiv has developed an efficient process to undertake all the drug substance and pre-clinical safety requirements needed for First Human Dose (FHD), subsequent First Efficacy Dose (FED) and Proof of Concept (POC) studies in patients. ChemDiv conducts all studies according to regulatory requirements and has successfully prosecuted a number of clinical Proof of Concept studies.
Initially Single Ascending Doses (SAD) are administered to normal volunteers and in a number of cases the drug can then be tested in patients given Multiple Ascending Doses (MAD) to determine if the drug is producing evidence of therapeutic potential at doses that are well tolerated by the patients. Recruitment of patients for these studies is rapid, the quality of data outstanding and suitable for continuing studies in larger patient populations for Proof of Concept and clinical trials approved by the FDA and European Regulatory Agencies.
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