3/19/2009 Meet the Authors!
Visit LWW at ACSM’s Health & Fitness Summit March 25-28 in Atlanta.
Stop by LWW Booth #301 & 303 and Meet the Authors!
Walter R. Thompson, Ph.D., FACSM, the editor of ACSM’s Guidelines for Exercise Testing and Prescription, 8th edition, at our booth #301, 303 on Thursday, March 25th from 3:30 to 4:30 p.m.
JoAnn M. Eickhoff-Shemek, Ph.D., FACSM, and David L. Herbert, J.D., authors of Risk Management for Health/Fitness Professionals, at our booth #301, 303 on Friday, March 26th from 12:00 to 1:00 p.m.
2/17/2009 Bert Spilker, PhD, MD, FCP, FFPM: Guide to Drug Development
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Guide to Drug Development
978-0-7817-7424-6 |
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For the first time a comprehensive resource of drug development information is available in a single volume for all professionals and students involved in drug development. Guide to Drug Development: A Comprehensive Review and Assessment covers all major topics involved in drug development as well as many tangential ones.
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- Chapters present approaches, options, methodologies, as well as the author’s perspective about what makes sense and what does not.
- Twenty-six chapters are included on clinical topics.
- Many chapters deal with Regulatory Affairs, each of the functional departments involved in drug development, and interactions of R&D and Production with Marketing.
- Approaches for successful development of drugs, biologics, devices, diagnostics and other products are discussed, as well as pitfalls to avoid.
- Case studies are included throughout the text and in three chapters at the end of the book.
- Questions to consider are listed at the end of every chapter as a starting point for readers to discuss issues among themselves.
- 320 figures and drawings are primarily flow diagrams or other schematics to provide an overview and perspective(s) on a specific issue. The 250 tables present facts in an easily accessible format.
- Much of the material presented is unavailable in other texts (e.g., chapters on pharmacopolitics, pharma-think academic-think and government-think).
- The reader-friendly index is highly detailed to make the search for material easier to locate.
I may be contacted at bspilker@comcast.net. My website is www.bertspilker.com.
| Spilkerisms |
| Spilkerisms provides key pearls on development of drugs, biotech products, medical devices, diagnostics, vaccines from a clinical, regulatory, marketing, pharmaceutical, genomic, proteomic and media perspective. These pearls are posted each week. Reader feedback is welcomed. View the Spilkerisms Blog |
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Bert Spilker, PhD, MD, FCP, FFPM
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Bert Spilker, PhD, MD, FCP, FFPM, is an independent consultant who works with a large number of pharmaceutical, biotech and medical device companies, primarily in the areas of regulatory affairs, clinical trials and development. His work focuses on creating strategies, preparing and reviewing documents, arranging FDA meetings and solving problems.
He was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA (Pharmaceutical Research and Manufacturers of America) based in Washington, D.C. He was President and cofounder (in 1993) of Orphan Medical, Inc., a public pharmaceutical company that develops and markets important medical products for patients with uncommon diseases. He is well known as the author of 15 textbooks on clinical trial methods and the processes of drug discovery and development. These books are widely considered to be the standard references on clinical trials and drug development. He has worked at four major pharmaceutical companies for over 20 years (Pfizer, Philips-Duphar, Sterling-Winthrop, and Burroughs Wellcome) in medicine discovery, development, and management. He served on the Steering Committee for the International Conference on Harmonization, or ICH, and has received numerous honors including the FDA Commissioner’s Special Citation for work in the orphan medicine area.
He is Clinical Professor of Pharmacy Practice at the University of Minnesota and Adjunct Professor of Medicine and Clinical Professor of Pharmacy at the University of North Carolina in Chapel Hill. He is visiting professor of clinical pharmacology at the University of Illinois Medical School. His medical training in pharmacology and internal medicine was at Cornell Medical College, State University of New York (Downstate Medical Center), University of California Medical School in San Francisco, University of Miami Medical School (Ph.D. to M.D. Program) and Brown University Medical School. |
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