The members of the editorial board of this book have been professional associates in health care and research in the industry and academia during the editor's career, as well as friends. Each brings his own base of experience and talents to this scholarly work. Their advice and engagement as editorial advisors and authors have enriched the content and were indispensable to me as the editor. The authors comprise 24 talented group of researchers, clinicians, and educators in health care, both industry and academia, who offer the readers of our book their extensive, varied knowledge and broad experiences. Over a 35-year career in health care, academia, and the industry (both the biotechnology and pharmaceutical worlds), I have been blessed with the unique opportunity to work with many thought leaders and creative scientists, leading clinicians, bright students, and top-flight business people, many of which are editors and authors in this book.
For the editor, my friends, colleagues, co-workers, department heads, staff, and bosses, and students as well, have all served me well as advisors and mentors. They have taught me much about science, research, education, business, human nature, patient care, and professionalism. And most important to me in my life, these associates have fostered in me the desire to care for, assist, and lead people in all walks and all levels of life, to learn, succeed, and evolve. Even at the risk of leaving someone out, I will enumerate some of these special people; my high school teachers, Mr. Felsinger and Ms. Scime in Buffalo, New York, and professors, Drs. Paul Parker, Ann Amerson, and Charles Walton in Kentucky; my residency comrades, Drs. Robert Talbert, Rusty Ryan, John Kerege, and Bob Anderson; my Pharm.D. fellows that I trained, Brock Guernsey, David Magnuson, Donald Fraser, and William Clementi; my good friends and business and academic colleagues, Edward Kinney, Bill Ashton, Craig Books, Kathy Wiltsey, Tommy Beard, Philip vonHolle, Thomas Lytle, John Perry, and Stephen Allen, Drs. Robert Elenbaas; Cliff Littlefield, Joel Covinsky, Elaine Waller, Thomas Foster, Lewis Smith, and Robin Campbell; my bosses, Drs. James Doluisio, Bill Miller in academia, and Ed Fox, Paul Dawson, Stanley Benson, and Kevin Sharer in industry; my manage ment team, Drs. Donna Mapes, Gary Hubler, Jeanne Flynn, August Salvado, Homa Yeganegi, Alan Rosman, Stanfell Boone, David MCFadden, Larry Green, Billwelch, Bill Carter, and Grant Lawless. My family has been more than instrumental in supporting me and serving as a guiding light; my parents, Dorthea and William Evens, my children, Andrew Evens, Julie Evens, and Alexander Evens, and my wife, Sally Ann Evens. I have devoted much of my last 25 years of professional life to drug development, people development, and professional education; this book is the major effort in my career to pull all these learning opportunities together and share them with young clinicians, students, and future researchers, and their mentors.
The chapter on commercialization reflects Tom Lytle's thoughts and experiences, as well as the thoughts of many others with whom he has worked for more than 30 years of experience in sales, marketing, and launching new products in the pharmaceutical and biotech industry. It is not possible to thank or recognize each person in a chapter like this, so the author takes this opportunity to recognize that what is presented here reflects my own ideas on the subject, as well as the collective thinking and best practices of many past and current industry leaders. Their contribution to my training, thinking and knowledge on this topic is recognized and deeply appreciated.
In the preparation of this book and educational materials, special thanks are in order to Amgen Inc, who provided an educational grant to the University of Florida Foundation to cover some of the book's production costs. No Amgen input was sought or given in any way in writing this scholarly endeavor regarding the content or style. No review or editing was permitted. The editor, editorial board, authors, and publisher had full and independent control of the content, examples, and formats.
As a guide for the course directors and users of the book and CD-ROM, several references are provided that offer information (statistics and reports) about the pharmaceutical and biotechnology industries and also disease statistics useful for product development. The title and publisher along with Web r BIO: Biotechnology Industry Organization; Washington, D.C. www.bio.org
k Center watch; Boston MA 02210 www.centerwatch.com
r CMS: Centers for Medicare & Medicaid, HHS ; Washington, D.C. www.cms.hhs.gov/
r CSDD: Tufts Center for Drug Development ; Boston, MA 02111 www.tufts.edu
r E&Y: Ernst & Young ; San Francisco, CA www.ernst&young.com r FDA: Food & Drug Administration; Rockville, MD www.fda.gov
r IMS: IMS Health; Plymouth Meeting, PA 19462 www.IMShealth.com
r PhRMA: Pharmaceutical Research & Manufacturers Association, Washington, D.C. www.phrma.org
k R&D Directions; Med Ad News: Engel Publishing; Newtown ,PA 18940 w[email protected]
Figure. Information Sources sites are listed below for 10 such resources, among the literally hundreds of health Web sites. Industry statistics and drug development issues in the industry can be found in Web sites from the government, industry organizations, industry service organizations, journal publications, and a university-based service. In the text below, I will list altogether 20 such sites.
The industry sites (3) come from the Biotechnology Industry Organization, Pharmaceutical Research and Manufacturing Association, and various individual company Web sites. Government sites (5) include the Food and Drug Administration and the Centers for Medicare and Medicaid Services in the United States; in addition, three other government sites will contain useful information from the U.S. Centers for Disease Control and Prevention, the U.S. National Institutes of Health (various institutes based on disease areas such as the National Cancer Institute and National Institute for Mental Health), and the European Medicines Evaluations Agency. Health care information is available from foundations and related health organi zations that support research and patient care for specific diseases (e.g., National Headache Foundation, American Diabetes Association, American Society for Clinical Oncology, Alzheimer's Foundation, Osteoporosis Foundation). Service organizations (4) that support and evaluate the industry and related health care community for drug research are also available with Web sites and reports (e.g., Thomson/CenterWatch, IMS Health, Ernst and Young, Parexel International Corporation, and Boston Consulting Group). The leading university-based organization for industry and related health care information is the Tuft's University Center for the Study of Drug Development in Boston, Massachusetts. Journal publications (5) are yet another choice for health care and industry information and statistics (e.g., R&D Directions and Med Ad News from Engel Publications, Pharmaceutical Executive from Advanstar Communications, and Nature Reviews Drug Discovery and Nature Biotechnology from the Nature Publishing Group). These resources were used in the writing of this book.
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