| David Young, Ph.D.-
President, US Operations.
Dr. Young joined AGI in June 2006 from the GloboMax
Division of ICON plc where he was Executive Vice
President with responsibility for strategic drug
development efforts in the US. Founded by Dr. Young
in 1997, GloboMax was acquired in 2003 by ICON plc,
a global provider of outsourced development services
to the pharmaceutical, biotechnology and medical
device industries.
Prior to forming GloboMax, Dr. Young had a distinguished
career in academia. He was with the University of
Maryland at Baltimore for 11 years where he was
a tenured Associate Professor in the Department
of Pharmaceutical Sciences and the Managing Director
of the Clinical Research Unit. During this period
the US Food and Drug Administration (FDA) placed
major research and education programmes with the
University, providing Dr. Young with opportunities
to work closely with and train FDA staff on various
regulatory science topics, including collaborating
with FDA on establishing various FDA Guidances.
During his career, Dr. Young has worked on over
50 New Drug Applications (NDAs) to the FDA, many
based on the 505(b)2 NDA process, including therapeutic
indication switches and drug delivery reformulations
of known molecular entities (KMEs), five of which
were specifically for products in the GI field.
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