CINCINNATI, Jan. 18 /PRNewswire-FirstCall/ -- Kendle , a leading, global full-service clinical research organization, today announced William Sietsema, PhD, Vice President, Clinical Regulatory Strategic Planning, has authored a new book titled "Strategic Clinical Development Planning: Designing Programs for Winning Products." Available in February 2005 from FDAnews ( http://www.fdanews.com/ ), this 22-chapter book is a comprehensive guide for biopharmaceutical companies and drug device manufacturers to help them streamline the clinical trials process, ultimately resulting in faster FDA approvals, shorter overall drug development times and cost savings. Sietsema will "preview" the book in a Jan. 20 audio seminar sponsored by FDAnews titled "Clinical Trials Planning - Running a Lean, Mean Development Machine."
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"This book does an exceptional job providing an overview of the complex drug development process, as well as presenting a wide variety of more detailed information essential to successfully bring a new therapy to market," said Sherry Reuter, Adjunct Professor, Clinical Research Education Programs, George Washington University and Senior Clinical Project Leader, Alexion Pharmaceuticals, Inc. "With this foundation, readers have a strong background for intelligently and efficiently planning clinical development programs with reduced risk and increased potential for approval of new products."
Strategic Clinical Development Planning: Designing Programs for Winning Products will help readers discover how to cut waste, identify which trials are "must do" and which can be delayed, choose the most powerful clinical endpoints to optimize product usage, register products worldwide, manage patient safety and much more. The book includes a foreword written by Ken Kaitin, PhD, Director, Tufts Center for the Study of Drug Development and is loaded with advice based on real-life experience with manufacturers that brought products to market successfully.
"This unique book covers a number of key topics in clinical development - through all phases - as well as discusses the unique study requirements for prescription to over-the-counter switches," said Kevin L. Skare, Ph.D., Senior Director, Global Clinical Operations, Procter & Gamble Pharmaceuticals and Adjunct Professor of Pharmaceutical Sciences at the University of Cincinnati's College of Pharmacy.
Clinical development planning is a core strength for Kendle and a service it provides to biopharmaceutical companies worldwide. "As a CRO, Kendle is exposed to many development programs, which in turn affords us the opportunity to see firsthand which strategies work well and which don't," added Kendle Chairman and CEO, Candace Kendle, PharmD. "Bill's book is yet another example of the world-class clinical development expertise we offer our customers."
As Vice President, Clinical Regulatory Strategic Planning for Kendle, Sietsema contributes to study designs and development programs in analgesics, inflammation, gastrointestinal disease, women's health and skeletal disease. In addition to his responsibilities for managing Kendle's global therapeutic expertise, he helps customers prepare development strategies and design protocols. Sietsema has 21 years experience in the pharmaceutical industry, including positions with Procter & Gamble Pharmaceuticals and Mobay Chemical Corporation. He earned his doctorate in biochemistry from the University of Wisconsin. Sietsema is an Adjunct Professor of Pharmaceutical Sciences at the University of Cincinnati's College of Pharmacy where he teaches drug development principles to medical students, pharmacists and industry representatives.
About Kendle
Kendle International Inc. is among the world's leading global clinical research organizations. We deliver innovative and robust clinical development solutions - from first-in-man studies through market launch and surveillance - to help the world's biopharmaceutical companies maximize product life cycles and grow market share. With headquarters in Cincinnati and more than 1,700 associates worldwide, Kendle has conducted clinical trials or provided regulatory and validation services in more than 60 countries. Investor kits are available upon request from Kendle, 1200 Carew Tower, 441 Vine Street, Cincinnati, OH 45202, or from the company's Web site at http://www.kendle.com/ .
About FDAnews
FDAnews ( http://www.fdanews.com/ ) is the premier provider of domestic and international regulatory, legislative and business news and information for executives in industries regulated by the U.S. Food and Drug Administration and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and FDA's complex and ever-changing regulations.
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20030429/KNDLLOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.com Kendle International Inc.
(Logo: http://www.newscom.com/cgi-bin/prnh/20030429/KNDLLOGO )
"This book does an exceptional job providing an overview of the complex drug development process, as well as presenting a wide variety of more detailed information essential to successfully bring a new therapy to market," said Sherry Reuter, Adjunct Professor, Clinical Research Education Programs, George Washington University and Senior Clinical Project Leader, Alexion Pharmaceuticals, Inc. "With this foundation, readers have a strong background for intelligently and efficiently planning clinical development programs with reduced risk and increased potential for approval of new products."
Strategic Clinical Development Planning: Designing Programs for Winning Products will help readers discover how to cut waste, identify which trials are "must do" and which can be delayed, choose the most powerful clinical endpoints to optimize product usage, register products worldwide, manage patient safety and much more. The book includes a foreword written by Ken Kaitin, PhD, Director, Tufts Center for the Study of Drug Development and is loaded with advice based on real-life experience with manufacturers that brought products to market successfully.
"This unique book covers a number of key topics in clinical development - through all phases - as well as discusses the unique study requirements for prescription to over-the-counter switches," said Kevin L. Skare, Ph.D., Senior Director, Global Clinical Operations, Procter & Gamble Pharmaceuticals and Adjunct Professor of Pharmaceutical Sciences at the University of Cincinnati's College of Pharmacy.
Clinical development planning is a core strength for Kendle and a service it provides to biopharmaceutical companies worldwide. "As a CRO, Kendle is exposed to many development programs, which in turn affords us the opportunity to see firsthand which strategies work well and which don't," added Kendle Chairman and CEO, Candace Kendle, PharmD. "Bill's book is yet another example of the world-class clinical development expertise we offer our customers."
As Vice President, Clinical Regulatory Strategic Planning for Kendle, Sietsema contributes to study designs and development programs in analgesics, inflammation, gastrointestinal disease, women's health and skeletal disease. In addition to his responsibilities for managing Kendle's global therapeutic expertise, he helps customers prepare development strategies and design protocols. Sietsema has 21 years experience in the pharmaceutical industry, including positions with Procter & Gamble Pharmaceuticals and Mobay Chemical Corporation. He earned his doctorate in biochemistry from the University of Wisconsin. Sietsema is an Adjunct Professor of Pharmaceutical Sciences at the University of Cincinnati's College of Pharmacy where he teaches drug development principles to medical students, pharmacists and industry representatives.
About Kendle
Kendle International Inc. is among the world's leading global clinical research organizations. We deliver innovative and robust clinical development solutions - from first-in-man studies through market launch and surveillance - to help the world's biopharmaceutical companies maximize product life cycles and grow market share. With headquarters in Cincinnati and more than 1,700 associates worldwide, Kendle has conducted clinical trials or provided regulatory and validation services in more than 60 countries. Investor kits are available upon request from Kendle, 1200 Carew Tower, 441 Vine Street, Cincinnati, OH 45202, or from the company's Web site at http://www.kendle.com/ .
About FDAnews
FDAnews ( http://www.fdanews.com/ ) is the premier provider of domestic and international regulatory, legislative and business news and information for executives in industries regulated by the U.S. Food and Drug Administration and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and FDA's complex and ever-changing regulations.
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20030429/KNDLLOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.com Kendle International Inc.
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