The book is authored by a multidisciplinary team of researchers, clinicians, and marketers from industry and the medical/ pharmaceutical community. They collectively have done extensive work in drug development, measured by the many product applications prepared and ushered through regulatory authorities, by scope and quality of institutions and companies at which they worked, by number of years devoted to research and product development, and by hundreds of publications. The experience base in research and product development is several hundred years collectively at 30 pharmaceutical and biotechnology companies, plus professorships, teaching positions, and research directorships at 20 health science centers or universities.
Ronald P. Evens, Pharm.D., FCCP
The editor is Ronald P. Evens, Pharm.D., FCCP, who currently is President of MAPS 4 Biotec, Inc, and Clinical Professor, University of Florida, Jacksonville, FL. Dr. Evens has more than 20 years of industry experience (clinical research, product development, marketing support, and leadership) at Amgen Inc. and Bristol-Myers Company, plus more than 20 years of academic/health science center experience as a professor at seven medical/pharmacy universities in Buffalo, NY; Lexington, KY; San Antonio, TX; Memphis, TN; Los Angeles, CA; Chicago, IL; and Gainesville, FL. His professional record also includes 12 national health care advisory boards, more than 100 publications, 14 book chapters, and many lectures on biotechnology, drug development, and related topics at national professional organizations and universities. Dr. Evens received a B.S. in pharmacy at University of Buffalo, Pharm.D. at University of Kentucky; internship at E.J. Meyer Memorial Hospital; clinical residency at A.B. Chandler Medical Center in Lexington, KY; plus a strategic leadership certificate at Center for Creative Leadership and a marketing certificate at University of Southern California, Marshall School of Business; Fellowship with American College of Clinical Pharmacy.
The multidisciplinary editorial board has extensive experience (collectively more than 100 years) in industry at major pharmaceutical companies and/or leading universities in research, education, and product development. Their publications number in the hundreds, and the training of fellows and young researchers hallmarks their careers.
Robin Campbell, Ph.D.
CEO, SinusPharma, Thousand Oaks, CA (previously, Vice-president, Oncology, and product team leader at Amgen; manager at Ciba-Geigy; B.S. at University of North Carolina, Chapel Hill, Ph.D. in microbiology and immunology at Wake Forest University).
Joel Covinsky, Pharm.D.
Consultant, Kansas City, MO (previously, Vice-president at Aventis, Hoescht-Marion-Roussell, and Marion-Merrell-Dow in clinical research and product planning; associate professor at University of Missouri at Kansas City Medical School; B.S. in pharmacy at Philadelphia College of Pharmacy and Sciences, Pharm.D. at University of Kentucky, clinical residency at A.B. Chandler Medical Center, Lexington, KY).
Thomas S. Foster, Pharm.D.
Professor, Pharmacy Practice and Anesthesiology, Colleges of Pharmacy and Medicine, University of Kentucky, Lexington, KY (previously, B.S. in pharmacy from University of Buffalo, Pharm.D. at University of Kentucky, and clinical residency at A.B. Chandler Medical Center, Lexington, KY).
Professor of Medicine, Associate Vice-President of Research, College of Medicine, Northwestern University, Chicago, IL (previously, B.S. at City College of New York, M.D. at University of Rochester, and pulmonary fellowship at Boston University).
Salomon A. Stavchansky, Ph.D.
Professor of Pharmaceutics, Alcon Centennial Professor of Pharmacy, College of Pharmacy, The University of Texas at Austin, Austin, TX (previously, B.S. in pharmacy at National University of Mexico, Ph.D. at University of Kentucky).
The 24 chapter authors are experienced in the industry as researchers, marketers, and clinicians and/or are experienced university faculty in research, clinical practice, and education. These authors average more than 20 years of experience and many serve as faculty at major universities, which includes fellowship training in drug development. The pharmaceutical and biotechnology companies represented by the authors are substantial in number, diverse, small and large, well-established old guard and start-ups, and influential players in research and product advances (Abbott, Agouron, Amgen, Armour, Aventis, Bristol-Myers, Cato, Ciba-Geigy, Cognetix, Cumberland, Elkins-Sinn, Endo, Immunex, Lederle, Marion-Merrell-Dow, Novartis, Ortho, Pfizer, ProCyte, Radiant, Sankyo Pharma, Schein, Solvay, Squibb, Upjohn, Warner-Lambert, and Xoma). The university experience base includes faculty appointments at 16 prestigious institutions over their careers (alphabetical order), for example, University of Cincinnati, University of Connecticut, Harvard University, University of Kentucky, Mercer University, University of Missouri at Kansas City, University of Nebraska, New Jersey College of Medicine and Dentistry, University of North Carolina at Chapel Hill,
Northwestern University, Ohio State University, University of the Pacific, University of Southern California, University of Tennessee, University of Texas, and University of Utah.
Vijay Bhargava, Ph.D. (Metabolism and Pharmacokinetics Chapter)
Vice-president and Global Head of Metabolism and Pharmacokinetics at Novartis Pharmaceutical, East Hanover, NJ (previously, senior director at Aventis and Hoescht-Marion-Roussel; assistant professor at University of Nebraska; B.S. in pharmacy at Bombay University, Ph.D. in Pharmacokinetics and Biopharmaceutics at Virginia Commonwealth University).
John J. Brennan, Ph.D. (Psychiatry)
Group director, Solvay Pharmaceuticals for Clinical development, Medical Affairs, Clinical Pharmacology, and Bioanalytical Chemistry for Men's and Women's Health, Marietta, GA (previously, Squibb Institute for Medical Research, Ortho Pharmaceuticals; B.A. in chemistry at Temple University, Ph.D. in pharmaceutical sciences at Philadelphia College of Pharmacy and Sciences).
Howard A. Burris, III M.D. (Oncology)
Director of Drug Development, The Sarah Cannon Cancer Center, and associate, Tennessee Oncology PLLC, Nashville, TN (previously, B.S. at U.S. Military Academy at West Point, M.D. at University of South Alabama, residency and fellowship at Brooke Army Medical Center).
James F. Cahill, M.S., Ph.D. (Manufacturing and Formulations)
Vice-president, Biopharmaceutical Sciences, Cato Research, Ltd., Richboro, PA (previously, Armour Pharmaceuticals, Rorer Pharmaceuticals, Elkins-Sinn, Inc, International Diagnostics Inc, Princeton Labs; B.S. at Capitol University, M.S. and Ph.D. in microbiology and immunology at University of Utah).
Stephen F. Carroll, Ph.D. (Discovery)
President, Altair BioConsulting, Seattle, WA (previously, Vice-president, Scientific and Product Development, Xoma, LLC; Vice-president, Preclinical Research, Xoma; assistant professor, Harvard University; B.A. in biology at University of California at San Diego, Ph.D. in microbiology at University of California at Los Angeles).
Joel Covinsky, Pharm.D. (Governance and Planning)
Ronald P. Evens, Pharm.D., FCCP (Health Care and Industry Overview; Governance and Planning; R&D Outcomes; Medical Affairs and Professional Services).
Michael W. Jann, Pharm.D. (Psychiatry)
Professor and Chairman, Pharmacy Practice and Pharmaceutical Sciences, Research Director, Mercer University, Atlanta, GA (Previously, B.S. at California State University, Los Angeles, Pharm.D. at University of Southern California, psychiatry residency at University of Tennessee).
Suzanne F. Jones, Pharm.D. (Oncology)
Associate Director, Drug Development, The Sarah Cannon Research Center, associate, Tennessee Oncology, Nashville,
TN (previously, Pharm.D. at University of North Carolina at Chapel Hill, residency and oncology fellowship at University of Texas Health Science Center at San Antonio).
Nancy L. Kercher, M.B.A. (Regulatory Affairs)
President, Strategic Biotechnology Consulting, Seattle, WA (previously, Vice-president, Regulatory, Immunex; positions at Abbott and Upjohn; B.S. in chemistry and M.B.A. at Western Michigan University).
Jeffrey Kluger, M.D. (Cardiovascular Diseases)
Clinical Professor of Medicine, University of Connecticut, and Director, Heart Rhythm Service, Hartford, CT (previously, M.D. at New York Medical College, residency at Beth Israel Hospital of New York, cardiology fellowship at Cornell University Medical Center).
Paul Litka, M.D. (Operations)
Consultant in pharmaceutical industry and clinical research organizations, Salt Lake City, UT (previously, Vice-president, Clinical Drug Development, Anesta Corporation, Senior Vice-president, Clinical Research and Regulatory Affairs, Magainin Pharmaceuticals, and also senior positions at Institute for Biological Research and Development, Inc., SmithKlineBeecham Laboratories, and SmithKlineFrench Labs; B.S. in languages at New York University, M.D. at College of Medicine and Dentistry of New Jersey, residency at St. Michaels Medical Center).
Thomas Lytle, BBA, MBA (Commercial Division)
Senior vice-president, Cytogen, Morrisville, NJ (previously, Vice-president, New Product Marketing and Strategic Planning, Amgen Inc.; vice-president, Lederle Labs and Pfizer, Inc; B.A in marketing at Western Michigan University, M.B.A. at LaSalle University).
Leo Pavliv, R.Ph., M.B.A. (Manufacturing and Formulations)
Vice-president, Operations, Cumberland Pharmaceuticals, Nashville, TN (previously, Cato Research, LLC, Agouron Pharmaceuticals, ProCyte Corporation, Interferon Sciences, Parke-Davis/Warner-Lambert; B.S. in pharmacy and M.B.A. at Rutgers University).
Ralph H. Raasch, Pharm.D., FCCP (Infectious Diseases)
Associate Professor, Department of Pharmacy Practice, School of Pharmacy, Clinical Associate Professor, School of Medicine, University of North Carolina, Chapel Hill, NC (previously, B.S. at University of California at Davis, Pharm.D. and residency at University of California at San Francisco).
Shashank Rohatagi, Ph.D., M.B.A. (Metabolism and Pharmacokinetics)
Director, Sankyo Pharma, Parsippany, NJ (previously, Director in Pharmacokinetics at Aventis; B.S. in pharmacy at Birle Institute of Technology and Sciences, Ph.D. in pharmacokinetics at University of Florida, M.B.A at St. Joseph's University).
Carl L. Roland, Pharm.D. (Study Operations)
Director of Clinical Research, King Pharmaceuticals, Cary, NC (previously, assistant professor at University of Utah,
Pharmacotherapy and Pharmacoeconomics Center; Vice-president, Clinical Development, Cognetix, Inc., research positions at Glaxo-Welcome and Anesta Pharmaceuticals; Pharm.D. at University of Illinois, Chicago, IL).
Jun Shi, M.D., M.Sc., FCP (Metabolism and Pharmacokinetics)
Director, Clinical Pharmacology and Drug Dynamics, Forest Laboratories, St. Louis, MO (previously, Director at Aventis; M.D. at Shanghai Medical University, M.Sc. at Southern Methodist University, postdoctorate in pharmacokinetics at University of California at San Francisco, fellow in Clinical Pharmacology).
Lewis Smith, M.D. (Types of Studies)
Jessica Song, M.A., Pharm.D. (Cardiovascular Diseases)
Clinical assistant professor, University of Pacific, and clinician at Santa Clara Valley Medical Center, San Jose, CA (Previously, B.A. in chemistry at University of Washington, M.A. in chemistry at Johns Hopkins University, Pharm.D. at University of California at San Francisco, residency and fellowship in cardiology at University of Connecticut Medical Center).
Roland Garritsen VanderHoop, M.D., Ph.D. (Psychiatry) Endo Pharmaceuticals, Senior Vice-president, Research & Development & Regulatory Affairs, Chadds Ford, PA (previously, SVP, R&D & Chief Medical Officer, Serologicals Corp.; VP R&D & Chief Scientific Officer, Solvay Pharmaceuticals; B.S., Ph.D. and M.D. at University of Utrecht, The Netherlands).
Elaine S. Waller, Pharm.D., M.B.A. (Regulatory Affairs) Vice-president, Regulatory Affairs & Quality Assurance, Sonus Pharmaceuticals, Seattle, WA (previously, Chief Operating Officer, Radiant Research; senior positions at Hoechst-Marion-Roussel; associate professor, University of Texas at Austin, College of Pharmacy, and assistant director, Drug Dynamics Institute; B.S. in pharmacy and Pharm.D. at University of Missouri at Kansas City).
Philip D. Walson, M.D. (Pediatrics)
Professor of Pediatrics & Pharmacology, University of Cincinnati, Director of Clinical Pharmacology Division, Cincinnati Children's Medical Center and Chief Scientific Officer of Pediatric Clinical Trials International, Cincinnati, OH (previously, Professor of pediatrics at Ohio State University and Chief of Clinical Pharmacology and Toxicology; Medical Director of Clinical Pharmacology at University of Arizona; B.S. at University of California at Berkley, M.D. at University of California at San Francisco, pediatrics residency at University of Chicago, NIH fellowship in cardiology at University of California at San Francisco).
C. Michael White, Pharm.D, FCCP. (Cardiovascular Diseases)
Associate professor, University of Connecticut, School of Pharmacy, Co-director, Arrythmia & Cardiac Pharmacology & Research Group, Hartford Hospital, Hartford, CT (previously, B.S. in pharmacy and Pharm.D. at Albany College of Pharmacy, fellowship at Hartford Hospital; fellowship with American College of Clinical Pharmacy).
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