
WILLIAM M. WARDELL, MD PhD, WAI's President and Manager,
gained his experience in industry - and before that in academic and clinical medicine --
as pharmaceutical executive, clinical pharmacologist, clinical
trialist, physician and researcher in the US, Europe, and
Australasia.
Dr. Wardell has also helped to shape reforms of the US system for drug and device
regulation at the highest level.
In addition to drug discovery and development, his expertise includes clinical pharmacology, clinical trial methodology, INDs,
NDA approvals, drug safety, drug regulation,
biotechnology, pharmacogenomics, and botanicals. He has lectured widely and has
published over 100 scholarly papers as well as four books on drug development,
regulation, safety, and use.
He is an invited speaker on Drug Development and Regulation at many meetings, where his topics include PharmacoGenomics, Expedited Development
and Approval, Standards of Evidence, Outsourcing Drug Development, Botanicals, Problems Small Companies Have, and How To Increase Success Rates in Drug Development.
As the need arises, Wardell Associates International LLC can summon the resources of additional experts in virtually any specialty, both within the US and internationally, to fill those special needs promptly and cost-effectively.
WILLIAM WARDELL'S PROFESSIONAL EXPERIENCE

Board Memberships: Orphan Medical, Inc., PharMetrics, Inc., PhytoCeutica, Inc.

Scientific Advisory Boards: Protea Biosciences, Inc., QED Solutions, Inc.,
EvoRx, Inc.

Senior VP and Scientific Officer, Covance; also
Founder and Executive Director,
Covance Institute for
Drug Development Sciences

Covance's Medical/Drug Development Consultant for North America

President, Protein Engineering Corporation (now
Dyax)

Senior VP for Drug Development,
Parke Davis

VP, Medical Director, Boehringer Ingelheim USA:
(Head of Medical, Regulatory,
Data/Statistics, Clinical
Safety)

Associate Professor, University of Rochester Medical
Center/Departments of
Medicine, Pharmacology and
Toxicology

Attending, Clinical Pharmacology Service, Strong
Memorial Hospital

Merck International Fellow in Clinical Pharmacology

Co-founder, Center for the Study of Drug Development
(the "CSDD," now at
Tufts University Medical School)

Commonwealth Medical Scholar, University of Oxford
WILLIAM M. WARDELL MD PhD
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