Wiley Press to Release The Agile Approach to Adaptive Research: Optimizing Efficiency in Clinical Development
(Durham, NC: December 3, 2009) As drug developers face increasing legislative and market pressures to produce more impactful results faster and at lower cost, John Wiley & Sons Publishers announces a new book detailing the latest methods demonstrated to boost efficiency and innovation in clinical research. The Agile Approach to Adaptive Research: Optimizing Efficiency in Clinical Development will be released early 2010 with the aim of educating pharmaceutical, biotech and life science research professionals with new skills crucial to the financial health of the industry and the medical welfare of the global population.
Author Dr. Michael Rosenberg bases the book on more than twenty years of extensive research and clinical experience as founder and president of Health Decisions, a full-service CRO specializing in high-efficiency adaptive solutions. Under Dr. Rosenberg’s guidance, Health Decisions has achieved benchmark successes for its sponsors with its Agile Clinical Development platform—a flexible yet secure network of processes and technology that integrates adaptive design with adaptive operations. The Agile Approach to Adaptive Research presents a thorough explanation of the methodology and practical considerations behind this platform, which, according to Dr. Rosenberg consistently cuts 10 to 40 percent from traditional timelines.
“The Agile Approach to Adaptive Research presents a roadmap to a substantially faster, more efficient way of developing pharmaceuticals,” said Rosenberg. “It applies principles that have allowed other industries to make major leaps in productivity, but which are overdue in the pharmaceutical world. This book shows the practical side of bringing drugs to market much faster while cutting costs and waste, which in turn allows more drugs to be developed and more people to be treated. The implications are quite profound."
For media information, please contact Katie Hendrick, Marketing Specialist, by email at khendrick@HealthDec.com or by phone at +1.919.967.1111 x116.
About the Author
Dr. Michael Rosenberg has been active in clinical research for more than 30 years, designing or conducting more than 300 studies worldwide in a range of therapeutic areas. Early in his career, he realized that excellence in clinical research requires elevating managerial standards to the same high level as scientific standards. He founded Health Decisions in 1989 to develop a more efficient approach to managing clinical trials.
Under his guidance, Health Decisions has been recognized with many high-profile awards, including CIO's Enterprise Value Award and the inclusion in Inc 500 and Technology Fast 500 fastest-growing private and technology-based companies, respectively. Ernst & Young also selected Dr. Rosenberg as Entrepreneur of the Year in Health Sciences.
Before founding Health Decisions, Dr. Rosenberg served as Executive Director and Chief Executive Officer of the American Social Health Organization, Director of the Reproductive Epidemiology Division of Family Health International, and Chief, Reproductive Health Activity, at Centers for Disease Control. He currently serves on the Leadership Council of the Harvard School of Public Health and as co-principal investigator of the Clinical and Statistical Coordinating Center for Contraceptive Research, National Institutes of Health. He has published more than 200 scientific articles, serves on the editorial boards of Current Drug Discovery and Contraceptive Technology Update, and is a reviewer for several journals.
Dr. Rosenberg also serves as Clinical Professor of Obstetrics and Gynecology at the University of North Carolina School of Medicine and Adjunct Professor of Epidemiology at the UNC School of Public Health. He is a Fellow of the American College of Physicians (Internal Medicine), the American College of Epidemiology, and the American College of Preventive Medicine. He completed his undergraduate and medical degrees at the University of California and received a Master's Degree in Epidemiology and Biostatistics from the Harvard School of Public Health.
About John Wiley & Sons
Founded in 1807, John Wiley & Sons, Inc. has been a valued source of information and understanding for more than 200 years; helping people around the world meet their needs and fulfill their aspirations. Wiley and its acquired companies have published the works of more than 350 Nobel laureates in all categories: Literature, Economics, Physiology/Medicine, Physics, Chemistry, and Peace.
Wiley’s core businesses include scientific, technical, medical, and scholarly journals, encyclopedias, books, and online products and services; professional/trade books, subscription products, training materials and online applications and Web sites; and educational materials for undergraduate and graduate students and lifelong learners. Wiley’s global headquarters are located in Hoboken, New Jersey, with operations in the US, Europe, Asia, Canada, and Australia. The Company’s Web site can be accessed at www.Wiley.com. The Company is listed on the New York Stock Exchange under the symbols JWa and JWb.
About Health Decisions
Health Decisions (www.HealthDec.com) is a full-service, global clinical research organization (CRO) specializing in high-efficiency adaptive solutions. Through integrated technology and agile clinical development methods that apply adaptive principles to both trial design and operations, Health Decisions provides sponsors unprecedented transparency and control and produces results 10-40 percent faster than traditional approaches.
Health Decisions is headquartered in Durham, NC, with over twenty years of drug development experience in setting new standards of speed and accuracy for pharmaceutical, biotech and medical drug and device companies in Phase I-IV trials across all major therapy areas. For more information, please visit the company’s website at www.HealthDec.com.
Author Dr. Michael Rosenberg bases the book on more than twenty years of extensive research and clinical experience as founder and president of Health Decisions, a full-service CRO specializing in high-efficiency adaptive solutions. Under Dr. Rosenberg’s guidance, Health Decisions has achieved benchmark successes for its sponsors with its Agile Clinical Development platform—a flexible yet secure network of processes and technology that integrates adaptive design with adaptive operations. The Agile Approach to Adaptive Research presents a thorough explanation of the methodology and practical considerations behind this platform, which, according to Dr. Rosenberg consistently cuts 10 to 40 percent from traditional timelines.
“The Agile Approach to Adaptive Research presents a roadmap to a substantially faster, more efficient way of developing pharmaceuticals,” said Rosenberg. “It applies principles that have allowed other industries to make major leaps in productivity, but which are overdue in the pharmaceutical world. This book shows the practical side of bringing drugs to market much faster while cutting costs and waste, which in turn allows more drugs to be developed and more people to be treated. The implications are quite profound."
For media information, please contact Katie Hendrick, Marketing Specialist, by email at khendrick@HealthDec.com or by phone at +1.919.967.1111 x116.
About the Author
Dr. Michael Rosenberg has been active in clinical research for more than 30 years, designing or conducting more than 300 studies worldwide in a range of therapeutic areas. Early in his career, he realized that excellence in clinical research requires elevating managerial standards to the same high level as scientific standards. He founded Health Decisions in 1989 to develop a more efficient approach to managing clinical trials.
Under his guidance, Health Decisions has been recognized with many high-profile awards, including CIO's Enterprise Value Award and the inclusion in Inc 500 and Technology Fast 500 fastest-growing private and technology-based companies, respectively. Ernst & Young also selected Dr. Rosenberg as Entrepreneur of the Year in Health Sciences.
Before founding Health Decisions, Dr. Rosenberg served as Executive Director and Chief Executive Officer of the American Social Health Organization, Director of the Reproductive Epidemiology Division of Family Health International, and Chief, Reproductive Health Activity, at Centers for Disease Control. He currently serves on the Leadership Council of the Harvard School of Public Health and as co-principal investigator of the Clinical and Statistical Coordinating Center for Contraceptive Research, National Institutes of Health. He has published more than 200 scientific articles, serves on the editorial boards of Current Drug Discovery and Contraceptive Technology Update, and is a reviewer for several journals.
Dr. Rosenberg also serves as Clinical Professor of Obstetrics and Gynecology at the University of North Carolina School of Medicine and Adjunct Professor of Epidemiology at the UNC School of Public Health. He is a Fellow of the American College of Physicians (Internal Medicine), the American College of Epidemiology, and the American College of Preventive Medicine. He completed his undergraduate and medical degrees at the University of California and received a Master's Degree in Epidemiology and Biostatistics from the Harvard School of Public Health.
About John Wiley & Sons
Founded in 1807, John Wiley & Sons, Inc. has been a valued source of information and understanding for more than 200 years; helping people around the world meet their needs and fulfill their aspirations. Wiley and its acquired companies have published the works of more than 350 Nobel laureates in all categories: Literature, Economics, Physiology/Medicine, Physics, Chemistry, and Peace.
Wiley’s core businesses include scientific, technical, medical, and scholarly journals, encyclopedias, books, and online products and services; professional/trade books, subscription products, training materials and online applications and Web sites; and educational materials for undergraduate and graduate students and lifelong learners. Wiley’s global headquarters are located in Hoboken, New Jersey, with operations in the US, Europe, Asia, Canada, and Australia. The Company’s Web site can be accessed at www.Wiley.com. The Company is listed on the New York Stock Exchange under the symbols JWa and JWb.
About Health Decisions
Health Decisions (www.HealthDec.com) is a full-service, global clinical research organization (CRO) specializing in high-efficiency adaptive solutions. Through integrated technology and agile clinical development methods that apply adaptive principles to both trial design and operations, Health Decisions provides sponsors unprecedented transparency and control and produces results 10-40 percent faster than traditional approaches.
Health Decisions is headquartered in Durham, NC, with over twenty years of drug development experience in setting new standards of speed and accuracy for pharmaceutical, biotech and medical drug and device companies in Phase I-IV trials across all major therapy areas. For more information, please visit the company’s website at www.HealthDec.com.