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Phase 0/Microdosing Approaches: Time for Mainstream Application in Drug Development

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  • Tal Burt, M.D.

    Dr. Burt is a board-certified psychiatrist with more than 20-year experience in all phases of clinical development and particularly in the early-phase, proof-of-concept (POC), and microdosing stages of clinical development. He has led clinical research programs of drugs and devices in academia and industry, leading him to appreciate the challenges of new treatment development, including the expenses, wastes, uncertainties, and risks involved, and the considerable burden on public health and research ethics that ineffective translational and clinical development lead to. He worked with regulators, industry, academic, and patient advocacy stakeholders to address these challenges and accelerate development of novel therapeutics.

    Dr. Burt has authored 45 peer-reviewed publications in clinical research and drug development including original drug development methodologies such as Intra-Target Microdosing (ITM), randomized-withdrawal designs, assessment of the impact of false-negatives on the productivity of treatment development, the first publications of Vagus Nerve Stimulation (VNS) in major depression, the first comprehensive review of Transcranial Magnetic Stimulation (TMS), and a textbook on Outcomes Measurement in Clinical Psychiatry. He led early- and late-phase developmental programs of neuroscience compounds and was the founding Medical Director of two state-of-the-art POC research units part of Duke’s Global POC Research Network and was the Scientific Director of the network. He is the founder of the Phase-0/Microdosing Network, an international organization of multidisciplinary stakeholders with interests in accelerating translational drug development. He is currently a Clinical Research and Clinical Development Consultant.

  • Malcolm Rowland, Ph.D.

    Malcolm Rowland is Professor Emeritus and former Dean, School of Pharmacy, and member and former director (1996-2000), Centre for Applied Pharmacokinetic Research, University of Manchester, U.K. He is also Adjunct Professor, Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco (UCSF) and Founder Member, NDA Partners. He was President, EUFEPS (European Federation for Pharmaceutical Sciences,1996-2000); VP FIP (International Pharmaceutical Federation, 2001-2009); Board Member, National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs, 2004-2008); and Member, Governing Board, EU Network of Excellence in Biosimulation (Biosim, 2004-2009). He received his degree in Pharmacy and PhD, University of London, and was on faculty, School of Pharmacy, UCSF (1967-75) before taking up a professorship at Manchester (1975-2004).

    His main research interest is physiologically based pharmacokinetics and its application to drug discovery, development and use. He is also strongly associated with clearance concepts in pharmacokinetics. He also participated in the early clinical microdose (CREAM, EUMAPP) trials, Author of over 300 scientific articles, and co-author, with Dr. TN Tozer, of the textbooks: Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications, and Essentials of Pharmacokinetics and Pharmacodynamics. He served as an editor of Journal of Pharmacokinetics and Pharmacodynamics (1973-2007), and since 1977 has organised regular residential workshops in pharmacokinetics.

  • Yuichi Sugiyama, Ph.D.

    Dr. Sugiyama received a Ph.D. from University of Tokyo, School of Pharmacy in 1978. He retired from the University of Tokyo in 2012 and has continued his studies as head of the Sugiyama Laboratory at the RIKEN Innovation Center.

    Dr. Sugiyama is acknowledged as a world-leader in the fields of physiologically based pharmacokinetics and membrane transporters. Dr. Sugiyama is the author of ca. 700 original articles, 70 review articles. Dr. Sugiyama has been the recipient of many awards, including the AAPS Award in 2003, PSWC Research Achievement Award in 2007, ISSX Asia Pacific Scientific Achievement Award in 2008, FIP Host-Madsen Gold Medal in 2009, Medal with Purple Ribbon given by Government of Japan in 2010, BB Brodie Award from ASPET in 2012, Rawls-Palmer Progress in Medicine Award from ASCPT in 2014, the RT Williams Distinguished Scientific Achievement Award from ISSX in 2013 and The Order of the Sacred Treasure, Gold Rays with Neck Ribbon by Government of Japan 2020.

    In addition to his scientific work, Dr. Sugiyama has held leadership positions in several scientific organizations. In particular, he has served as the chairman of board of Pharmaceutical Sciences (BPS) of FIP and Presidents of ISSX and JSSX and strongly promoted worldwide drug metabolism, disposition, transporter research.

February 4, 2021
Thu 9:30 AM EST

Duration 1H 30M

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