Bert Spilker & Associates, LLC Announces the Launch of THE SPILKER REPORT; Unique Publication Focuses On Shortening Drug Development Time.Business Editors/Health & Medical Writers BIOWIRE2K BETHESDA, Md.--(BUSINESS WIRE)--Nov. 4, 2002 Both the length of time and the associated cost it takes for a new drug to reach those it will benefit have become a serious problem which is inhibiting the development of therapies that society sorely expects, needs and demands. Now, to tackle these issues, THE SPILKER REPORT (TM), a new publication from one of the world's foremost authorities on drug development, addresses topics of import in the drug development arena. Each monthly issue, crucially relevant to the pharma and biotech industries, device manufacturers, regulatory agencies, as well as sophisticated investors, venture capitalists and business journalists, comprises eight columns covering regulatory, clinical, and management topics. The content presents insights, ideas, tips and suggestions targeting ways to shorten the time for developing pharmaceutical products by improving approach, methods and efficiency. Each month readers will gain insights and benefits in how to improve efficiency and shorten development time for biotech or pharma drugs, devices and diagnostic products. In this era of increasing pressures to develop drugs, biologicals, devices and diagnostics as rapidly as possible, it is essential to consider every idea and approach that may improve efficiency and shorten time to availability. THE SPILKER REPORT (TM) is written with this in mind and presents observations and lessons collected and learned over a 30-year career in the industry by Dr. Spilker, the world's leading author on multinational drug companies and clinical trials. The first issue will launch January 2003, and may be previewed at: www.spilkerreport.com Monthly topical columns include:
Regulatory Affairs
Commentaries, Practices & Tips
Enhancing Your Meetings with Regulatory Agencies
Case Studies & Exercises: Highlighting actual regulatory
experiences
Clinical Trials
Strategies, Practices & Tips
Case Studies & Exercises: Highlighting actual clinical
experiences
Management Issues
Specific approaches & ideas to improve efficiency
Reflections: Current pharmaceutical issues
Case Studies & Exercises: Highlighting actual management
experiences
Dialogue Forum
Questions from Readers & Responses from Dr. Spilker
Comments from Readers
Information on subscription options for THE SPILKER REPORT(TM)is available by calling 800/490-5676 or by e-mailing sprr@kable.com Dr. Spilker comments "I have learned about many strategies and approaches to drug development that are effective, and decided to pass on this information. My l5 books focus on principles and practices and THE SPILKER REPORT(TM) focuses on tips and strategies that companies can apply and use in a variety of situations. A single idea can save a company months or years and, possibly, millions of dollars." About Dr. Bert Spilker Bert Spilker, PhD, MD, FCP (Fibre Channel Protocol) See Fibre Channel. FCP - Flat Concurrent Prolog. ["Design and Implementation of Flat Concurrent Prolog", C. Mierowsky, TR CS84-21 Weizmann Inst, Dec 1984]. , FFPM FFPM Fellow of the Faculty of Pharmaceutical Medicine (UK) FFPM Firefighter/Paramedic , is well known as the author of 15 books on clinical trial methods and the processes of drug discovery and development. These books are considered by many as the standard references on clinical trials and drug development. He was most recently the Senior Vice President of Scientific and Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: tr.v. co·found·ed, co·found·ing, co·founds To establish or found in concert with another or others. co·found (in 1993) of Orphan Medical, Inc., a public pharmaceutical company that develops and markets important medical products for patients with uncommon diseases. He has received numerous honors including the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Commissioner's Special Citation for work in the orphan medicine area. 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 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 (body, education) University of Minnesota - The home of Gopher. http://umn.edu/. Address: Minneapolis, Minnesota, USA. and Adjunct Professor of Medicine and Clinical Professor of Pharmacy at the University of North Carolina North Carolina, state in the SE United States. It is bordered by the Atlantic Ocean (E), South Carolina and Georgia (S), Tennessee (W), and Virginia (N). Facts and Figures Area, 52,586 sq mi (136,198 sq km). Pop. in Chapel Hill. His medical training in pharmacology and internal medicine was at Cornell Medical College, State University of New York (body) State University of New York - (SUNY) The public university system of New York State, USA, with campuses throughout the state. (Downstate down·state n. The southerly section of a state in the United States. adv. & adj. To, from, or in the southerly section of a state. down Medical Center), University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). at San Francisco, University of Miami This article is about the university in Coral Gables, Florida. For the university in Oxford, Ohio, see Miami University. The University of Miami (also known as Miami of Florida,[2] UM,[3] or just The U Medical School (Ph.D. to M.D. Program) and Brown University Medical School. Additional information is on www.bertspilker.com |
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