KineMed Translational Medicine

Translational Medicine (TM) is the emerging field which focuses on using what is learned in pre-clinical studies to do smarter things in the clinic (either during drug development or in the course of predicting, preventing, diagnosing, and treating diseases). TM also uses what can be gleaned in clinical studies to sharpen and improve what is done in pre-clinical efforts to discover new medicines. TM is a solution to one of the most troubling aspects of pharmaceutical R&D. The costs of developing a medicine can be staggering. The early phases, Phase 1 and 2a, can cost up to $20M. Then, a decision to enter Phase 2b, which can cost $20 – 50M, must be made, usually on the basis of incomplete data on safety and efficacy and entailing some guesswork about optimal dosing regimens. This is then followed by the decision to enter into Phase 3, which can cost easily $200 – 500M and involve over 10,000 patients and last over three years. Most of these decisions, involving the expenditure of many millions of dollars and often causing the deprioritization of other programs, are made in the face of incomplete and usually inadequate information.

Translational Medicine, properly practiced, uses more scientific approaches in early development to “move decision-relevant information to the left in time”, making it available at key decision points, increasing the chances that pharma companies will place good bets about which compounds to advance into later phases of development and which compounds to abandon. By helping pharma companies do a better job of identifying future winning and losing compounds before the expenditure of the mammoth sums required for Phase 3, TM can help increase the number of compounds successfully developed and also reduce R&D costs.