An Invitation to the 21st Workshop of the Japanese Society for the Study of Xenobiotics The theme of this yearfs workshop reflects todayfs strict conditions for drug development. Many bottlenecks exist during the development of drugs; unless these bottlenecks are removed, the efficient and prompt development of drugs will not be possible. Accelerating the drug discovery process, improving the success rate, and improving predictions of effectiveness, safety, and ADME in humans have been listed as bottlenecks during the drug discovery stage. Meanwhile, early confirmation of POC (Proof of Concept) and the upgrading and enhancement of clinical trials have also been listed as bottlenecks during the drug development stage. Solutions to drug-development bottlenecks are being examined from various perspectives. Systems Biology is expected to be effective for selecting and validating drug targets, and screening drugs in todayfs post-genome era. The advancement and development of gin silico drug development technologyh is also expected to improve predictions of effectiveness/toxicity (safety) as well as physicochemical and ADME properties. By focusing on these topics in this workshop, we hope to find solutions to help accelerate the drug development process. Candidate drugs are often found to be ineffective or toxic during clinical trials, forcing the drug to be withdrawn from development. This situation was clearly portrayed in a recently published review (Nature Reviews Drug Discovery, 2004, 3, 711-715). Earlier this year, the FDA issued a guidance, gExploratory IND Studies,h on how to prove effectiveness and safety in humans during the very early stages of clinical development. In PK/PD trials that examine the potential of a candidate drug, effectiveness is often evaluated by identifying and measuring a biomarker. The development of genomics, has clarified the link between ADME changes and/or adverse effects of drugs and gene mutations, and this information will be useful for the proper application and approval of drugs, as well as providing important information for drug development. By focusing on the above topics, we hope that the lectures will help solve numerous bottlenecks, and increase the efficiency of drug development. We have limited the number of lectures in this workshop, compared with previous workshops, to enable more time to be spent on each presentation. Therefore, the lectures should be more comprehensive and complete and hopefully, will elicit active discussions among the participants and lecturers. We hope that this workshop will contribute to the elimination of bottlenecks and enhance the acceleration and efficiency of drug development. |
