The development of a new drug as a New Chemical Entity (NCE) or as a New Biological Entity (NBE) is a long journey. The multi-disciplinary experts from Kinesis Pharma guide its clients through the different phases of drug development and registration. For small molecules the journey start with screening many molecules against a (validated) target thought to be representative for a certain disease. Hits for the target are further chemically modified to improve its drug characteristics with the goal of producing a preclinical drug candidate. The selection of the right drug candidate is an important step as substantial investments have to be made to bring the compound to the clinical stage. In this preclinical stage the safety, toxicity, pharmacokinetics and metabolism of the compound will be evaluated often in GLP controlled studies. The pharmaceutical development challenge is the design of drug product, product formulations and manufacturing methods of drug chemicals that are suitable for an early start of non-clinical studies and first-in-man studies. The information gathered from this pre-clinical testing, together with information on CMC (Chemistry, Manufacturing & Control) and the anticipated dose in humans , is submitted to regulatory authorities. If the data package is approved (called IND approval in USA) development moves into the clinical phase where the drug-to-be is further explored, initially usually in healthy volunteers (Phase I), and later on in increasingly larger patient populations to explore (Phase II) and confirm (Phase III) the most optimum dosing schedule. In parallel further nonclinical testing is performed (e.g. carcinogenicity) and the drug formulation is further optimized. All data will be submitted to regulatory authorities for review to request for market approval.
Due to its longstanding experience in the different disciplines of drug development, Kinesis Pharma provides its clients with tailor-made strategic advice and hands-on support. This results in an accelerated and more efficient (faster and cheaper) drug development program, an increased product value and a shorter route to commercialization.
Kinesis Pharma’s multi-disciplinary project managers can assist in a timely execution of the drug development program, making use of Kinesis’ validated network of CROs and CMOs or provide a second opinion on your data (due diligence).