22nd JSSX Workshop

Sudo Chairman of the Workshop Organizing Committee

Kenichi Sudo, Ph.D.
Drug Metabolism& Pharmacokinetics Research Laboratories R&D Division
Daiichi Sankyo Co., LTD.

The 22nd JSSX Workshop will be held April 17(Thu) through April 18 (Fri), 2008 at the Kamijou Kodo of Showa University. In this Workshop, the titles will be eToxicity Prediction on Human, New observation and new technologies of Pharmacokinetics, Reactive Metabolites, Future Technologies, and Regulatory Affairsh, and will discuss the new ways to predict the side effects of Medical drugs.

In recent years, new drugs which had been developed with massive amount of resources invested on nonclinical and clinical trials, are being pulled out of the market because of their side effects. Also, the percentage of drugs being dropped out for the side effects found during the clinical trial stages have not lessened. Medical drugs are not only expected to show great healing effects towards diseases and illnesses, but the safety of the drugs are a crucial factor. Pharmaceutical companies are expected to accumulate research data in order to answer to these demands.

In the studies of fPharmacokineticsf, various research on evaluation for toxicity developed by reactive metabolites have been performed, based on new technologies found in the 1990s. On the other hand, the ideas on the new FDA guidance regarding the trials for safety of human metabolites are being actively discussed.

With these matters in mind, we have asked 3 distinguished speakers to talk about the background on drugs that have been pulled off the market, the current condition of hepatic toxicity from drugs, and about the biological defense mechanism towards drug toxicity. Also, since the topic on FDA guideline on human metabolites safety trials are the focus of interest, 3 speakers from Pharmaceuticals and Medical Devices Agency, FDA, and Pharmaceutical Company are invited to speak of their ideas on the effective ways towards the metabolites safety trials. From the researchers of the Academic, and Industrial fields, we will discuss in three sessions, the new toxicity evaluation method, developed to predict the side effects on new drugs, and on how they are predicted. On the 1st day, we will discuss new toxicity evaluation methods using animals and gene analysis. On the 2nd day, the topic will be on the current condition of the toxicity evaluation by transporters, and about the aim of pharmaceutical companies on the evaluation of metabolism-based drug-drug inactivation. 3 Drug companies from Europe and Japan will introduce their strategy of evaluating toxicity of the idiocyncratic reaction, which are considered difficult to predict.

With highly-active drugs being developed with new pharmacological actions, researchers of Pharmacokinetics and Drug Safety and other related fields are expected to cooperate closely using metabolomics and other full-length analysis, in order to eliminate the risks of side effects. We look forward to having all people who are working hard to develop new drugs with high safety. Please join us on this occasion.