Microsoft PowerPoint - CUHK seminar _Michael Bolger_- combined

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                                                School of Pharmacy
                                                Faculty of Medicine
                                        The Chinese University of Hong Kong

        “How to Improve the Widespread Use of Modeling and Simulation
                    in Drug Discovery and Development”
                                                        Presented by
                                                Dr. Michael B. Bolger
                                                  Chief Scientist
                                        Simulations Plus, Inc. Lancaster, CA
                                   & Adjunct Professor of Pharmaceutical Sciences
                                      USC School of Pharmacy, Los Angeles

Date:             Wednesday, 14 October 2009, 4:30 p.m. – 5:30 p.m.
Venue:            Pharmacy Conference Room, 6/F, Choh-ming Li Basic Medical Sciences Building,
                  The Chinese University of Hong Kong

      For decades, industries like aerospace and automotive have utilized modeling, simulation, and computer assistance in
product design. Life science industries have been much slower to adopt modeling and simulation technology, probably due in
part to the complexities of living systems.
      It is well known that product development failures due to pharmacokinetic issues were common in the 1980s and 90s. In
order to address these issues, in 1996 we started development of software tools for modeling and simulation of the ADMET
characteristics of candidate drug molecules. Simultaneously we developed tools for estimation of biopharmaceutical properties
and for gastrointestinal simulation and physiologically-based PKPD modeling. This type of technology and an increased
awareness of ADMET i            in the h        ti l industry has
                         issues i th pharmaceutical i d t h resulted i a d
                                                                      lt d in decrease i th percentage of d
                                                                                         in the      t    f drug f il      due to
                                                                                                                  failures d t
pharmacokinetic issues.
      The talk will present case studies using GastroPlusTM and ADMET PredictorTM that demonstrate the value of modeling and
simulation in pharmaceutical development. We will discuss the evolution of the Advanced Compartmental Absorption and
Transit (ACAT) model, the early incorporation of saturable gut metabolism and transport, the integration of estimated
biopharmaceutical properties for a purely in silico simulation of Cp vs. time profile, and our development of a flexible
framework for physiologically-based PK/PD in a variety of species and human age groups. We will briefly describe our current
developments in oral cavity, pulmonary, and ocular delivery.
Biographical Sketch
       Upon completion of his doctorate in Pharmaceutical Chemistry from the University of California at San Francisco in 1978
he joined the faculty of Pharmaceutical Sciences at the University of Southern California (USC) School of Pharmacy where he
conducted research and teaching in medicinal chemistry and the computational aspects of drug discovery and development for 23
years. From 1987-1993, simultaneous with his academic duties, he was a founder and Director of Medicinal Chemistry at
CoCensys Inc. There, he studied the chemistry and use of novel neuroactive steroids for treatment of anxiety, epilepsy, and sleep
disorders. Drug candidates emanating from seven of his patents have been tested in Phase I and II clinical trials for petite mal
epilepsy, sleep disorders, and migraine. As a faculty member at USC School of Pharmacy, his research was supported by several
NIH basic science research grants and he published over 50 peer-reviewed publications. Currently, as Chief Scientist at
Simulations Plus, Inc. (Lancaster, CA), he oversees a team of scientist / programmers at in the development of software
programs (ADMET Predictor/Modeler, ClassPharmer, GastroPlus, DDDPlus, and MembranePlus) for estimation of
biopharmaceutical properties, simulations of absorption and bioavailability, automated generation QSP/AR model building, in
vitro dissolution, and cell culture permeability simulation. He was elected to the rank of Fellow of the American Association for
the Advancement of Science in 1996.