About the Editors
LIONEL D. EDWARDS, MB, BS, LRCP, MRCS, DipRCOG, FFPM, is Senior Director of Medical Affairs
for Novartis USA, and President of Pharma Pro Plus Inc., a drug development consulting company. Dr.
Edwards has been involved in all aspects of clinical trials for over 33 years on many different research drug
and devices in 10 therapeutic areas. Previously, he was Vice President of Clinical Research at Bio-
Technology Pharmaceutical Corporation, a small biotechnology firm operating both in the United States
and internationally. Prior to this, he worked at Noven Inc., a small Skin Patch Technology firm with large
internationally licensed partners – CIBA and Rhone Poulenc Rorer. He was Assistant Vice President,
International Clinical Research at Hoffman-La Roche, Senior Director of Schering-Plough International
Research, and Director of US Domestic Gastrointestinal, Hormonal, and OTC Research Departments.
Dr. Edwards chaired the PMA Special Population Committee, and also sat on the Institute of Medicine
Committee for Research in Women, sponsored by the US National Instutes of Health. He also served on the
efficacy subcommittee Topic 5 (Acceptability of Foreign Clinical Data) for the International Committee on
Harmonization (ICH).
Dr. Edwards is a Fellow of the Faculty of Pharmaceutical Medicine and an Adjunct Professor at Temple
University Graduate School of Pharmacology. He has taught for the Pharmaceutical Education & Research
Institute for over 12 years and was on the teaching faculty of the National Association of Physicians. He is a
founder member of the American Academy of Pharmaceutical Physicians. Dr. Edwards has homes in New
Jersey and Florida.
ANDREW J. FLETCHER, MB, BChir, (Cantab), MS (Columbia), DipPharmMedRCP, FFPM was
formerly the Senior Assistant Editor ofThe Merck Manual, and is Adjunct Professor of Pharmaceutical
Health Care at Temple University School of Pharmacy. He graduated from Cambridge University and
St. Bartholomew’s Hospital, London, briefly trained in Neurosurgery, joined CIBA-Geigy in the UK as
Medical Advisor, then European Medical Director for Syntex, and joined Merck, first in the international
division after graduating in business studies from Columbia University, New York City, then as Assistant
Editor ofThe Merck Manual. He teaches pharmaceutical medicine, bioethics and medical and scientific
writing at Temple University’s School of Pharmacy. He is a founder member and former trustee of the
Academy of Pharmaceutical Physicians and Investigators (formerly the American Academy of Pharma-
ceutical Physicians). Dr. Fletcher resides in Ohio.
ANTHONY (‘Tony’)W.FOX, BSc, MBBS, FFPM, FRCP, MD(Lond), DipPharmMedRCP, CBiol, FIBiol,
is President of EBD Group, a consultancy with offices in San Diego and Munich. From the Royal London
Hospital, after general clinical training, he was Rotary International Fellow at Emory University (Atlanta)
and CIBA-Geigy Fellow at Harvard. Industrial positions at Procter & Gamble and (then) Glaxo Inc. came
next. He has also been a clinical and regulatory Vice President within a small pharmaceutical company.
Among many societies, Tony was a Charter Member, Trustee, and Education VP of the American Academy
of Pharmaceutical Physicians, and is a liverymanguardantof the Worshipful Society of Apothecaries of
London. He is an Adjunct (i.e. honorary) Associate Clinical Professor in the Skaggs School of Pharmacy and