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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 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.
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.