Vol 4 n° 4 - Drug Development
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3 2 1 ear Colleagues, The 14th Bioclinical Interface conference was held in Rouffach between October 1 and 5, 2002, under the chairmanship of Prof Barry Lebowitz (National Institute of Mental Health, Bethesda, Md, USA), on the theme of “Drug Development.”This scien- tific meeting brought together some of the most important personalities in the fields of drug discovery and drug development. The articles in this issue have been organized into four themes: • Drug discovery. • Proof of concept. • Studies in special indications (including affective and anxiety disorders, schizophrenia, child and adolescent psychiatry, and normal and pathological aging). • Regulatory issues in central nervous system (CNS) drug development, with a focus on antipsychotic agents. The philosophy of our project is as follows: • To increase the amount of information obtained in phase 1 studies (definition of a min- imal dose for a CNS effect, pharmacodynamic characteristics, and molecular profile), leading to a proof of concept in humans using syndromic or symptomatic models. • To be able to write targeted study protocols from the outset with all the information necessary about the original aspects of the agent. • To reduce the time taken for drug development, and simultaneously increase the safety of healthy volunteers and the patients enrolled in studies. On the other hand, we also recognize the need to fulfill the requirements of the regula- tory agencies, which seek both the reduction of side effects of treatments and innova- tion. Indeed, innovation is a difficult problem: it can only be based on existing databases, and requires the validation of new markers and the refinement of specific models. All this is covered in this issue of Dialogues in Clinical Neuroscience. Yours sincerely, Jean-Paul Macher, MD Marc-Antoine Crocq, MD E d i t o r i a l D