Speaking on the above topic is Dr Stewart Geary, VP,Dy Dir Corp Regulatory Compliance&Quality Assurance, Eisai, Japan. He will be presenting at Pre-clinical World Asia 2012, part of a series of conferences at the 5th Annual BioPharma Asia Convention 2012.
Dr Stewart Geary, M.D, has worked at Eisai since 1996 in pharmacovigilance, clinical safety and regulatory science. He is currently a member of the CIOMS IX Working Group on Medicinal Product Risk Management, the Executive Committees of the Japanese Association of Pharmaceutical Medicine and the International Federation of Associations of Pharmaceutical Physicians and serves on the Editorial Advisory Boards for the publications Applied Clinical Trials and IFAPP World. He has previously served as a member of the DIA Advisory Committee Japan, the CIOMS VIII Working Group on Signal Detection, the CIOMS VII Working Group on the Development Safety Update Report and the CIOMS Working Group on Standardized MedDRA Queries. Dr Geary graduated from Harvard College summa cum laude with a bachelorÂ’s degree in chemistry in 1985. He spent a year doing basic research on insulin-like growth factor receptors at Harvard Medical School before attending Stanford Medical School from which he earned an MD degree in 1990. He went on to complete a residency in Urology at the Stanford University Medical Center in 1996. He has published on the Japanese pharmaceutical industry and lectured on global pharmaceutical regulations.
Dr Geary will be speaking on the following topics:
Preclinical safety analysis of innovative drugs: Determining clinical safety in preclinical studies
1. Understanding the general correlation of preclinical with clinical safety results to maximise clinical trial success
2. Comparing between hypothesis-based and bioassay preclinical toxicity testing for improved preclinical testing
3. Resolving drug safety issues in preclinical studies for improved human safety
He will also be participating in the below panel discussion:
Panel Discussion: Optimizing your partnership collaboration for outsourcing preclinical studies in Asia
1. Assessing sustainability of current outsourcing models for preclinical studies in Asia
2. Discussing best practices in your preclinical partnerships to enhance existing partnerships
3. Advancing from transaction-oriented relationships to strategic alliances for process improvements and efficiencies