VP
of Manufacturing
Mark Fisher, PhD |
Dr. Fisher has
over fourteen years experience with the research and development
of new drug products. Following a doctorate in synthetic organic
chemistry from the University of Melbourne in Australia, he completed
his post doctoral research in medicinal chemistry at SmithKline
and French (1989), in the US. From there followed a career in the
development of new drug products first with SmithKline (1989 - 1994),
with Johnson and Johnson (1994 - 1997), and subsequently with small
pharmaceutical development companies.
As an independent consultant to emerging pharmaceutical companies
he has extensive experience in advising upon, supporting, implementing,
and managing all chemistry related activities required to move products
into and through the international regulatory drug development process.
Through direct involvement with the drug synthesis, analytical chemistry
and product formulation processes, Dr. Fisher effectively manages
all aspects of the CM&C section required to complete the chemical
development of an NCE. His ability to execute in this area is illustrated
in his success in taking a new oncolytic agent from the research
bench to commencement of human trials in under 18 months, without
negative CM&C related comments during the FDA IND review. Through
his extensive knowledge of CM&C requirements Dr. Fisher's specializes
in identifying superior contractors to complete the specific tasks
necessary to advance new chemicals through development.
Finally Dr. Fisher is highly skilled in bringing together the information
from all of the outsourced companies to seamlessly compile the documentation
required for filing with the regulatory agencies.
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