This phase of development, generally takes from 1 to 3 years with several hundred patients. It is here that an appropriate choice of drug effectiveness criteria for drug effectiveness, linked to animal models, yet providing a realistic test, of the drug in the patient population, can make a real difference.

Phase III clinical studies Phase III studies show effectiveness and safety in randomized and blinded clinical trials involving thousands of patients. This phase can take 2 to 5 years, and is the most, expensive clinical testing phase. New Drug Application/Marketing Authorization A New Drug Application Inhibitors,research,lifescience,medical (NBA), in the US, or Marketing Authorization (MA), in Europe, documents the safety and efficacy of the proposed drug, and the applications contain all the reports from the drug development process. At, the end of phase III, the evidence proving efficacy and Inhibitors,research,lifescience,medical safety are submitted. The approval process can take 1 to 2 years, TGF-beta inhibitor followed by post-marketing surveillance and extension of the therapeutic indications and patient populations. Fast-tracking Several regulatory issues may be seen Inhibitors,research,lifescience,medical as opportunities. Fast, tracking for very urgent therapeutic needs, such as treatment for acquired immune deficiency syndrome (AIDS), has been introduced by the FDA. Furthermore, the FDA have Inhibitors,research,lifescience,medical issued guidelines on pharmacogenetic

subtyping of patient populations (responders, patients at risk for side effects, rapid metabolizers, etc). Partnership Modern drug discovery and development, depends on a constant partnership between the actors in the project, in the many disciplines which are involved. The partnership between industry and academia is a critical issue, because basic research can lead to many unexpected breakthroughs, of which the researcher may

not appreciate the industrial and medical importance. It is correct, that financial return should be associated with inventiveness. However, the fewer industrial partners there are (as in France), Inhibitors,research,lifescience,medical the Rolziracetam fewer local industrial partners there are for startup biotechnology companies. There is thus a delicate balance between support, of pharmaceutical companies and small biotechnology companies. As the main industrial experience (to avoid the pitfalls shown in Figure 2 for example) is located in pharmaceutical companies, this pragmatic feedback and review is an essential part, of the health of the local industrial environment. It is also essential that research remains very medically oriented, because the patients“ needs come first. Partnership with clinicians and top medical teams is therefore also a key element, for success. However, all of the stages of drug discovery remain an experiment, and must be designed as such.