Re-inventing Drug Development

The biopharmaceutical industry has entered an era of unprecedented change and challenge, characterized by increasing pricing pressures, rising rates of attrition in the product development lifecycle, and decreasing scientific innovation. The most successful products are losing patent protection, and pipelines have been unable to fill the gap. This book explores the evolving definition of innovation in therapeutic product development and begins to examine its effects on the life sciences R&D industry.

Historically, scientific innovation alone was sufficient to maintain ROI and deliver on unmet medical needs. However, with many forces now conspiring to increase pressures on the commoditization of drug development, industry support for truly novel, often high-risk development has eroded. This calls for a drastic redefinition of what "innovation" is. While innovation in the pharmaceutical R&D industry has historically been applied to major advances in therapy and unmet medical needs, we now need to see innovation increasingly defined in terms of financial, marketing (e.g. branded generics and emerging markets), pharmacoeconomic, and operational innovation.

In this book, contributors drawn from the executive ranks of clinical development practitioners and stakeholders―from biopharmaceutical companies, clinical research organizations, academia, the financial community, and the patient perspective―have all come together to provide their expertise and visions. Their goal is to start a dialogue about ways to radically improve therapeutics development and get more and better medicines to the patients who need them, as fast as possible, in the most cost-efficient manner.

Jeffrey S. Handen, PhD, is vice president of professional services with Medidata Solutions, Inc. Dr. Handen has published in multiple peer-reviewed and business journals, presented at numerous industry conferences and scientific meetings as an invited speaker, and served as past editor-in-chief of the Industrialization of Drug Discovery compendium. Before joining Medidata Solutions he was with Merck Research Laboratories for 6 years as a director of portfolio and project management helping to plan, manage, and execute Merck’s clinical development portfolio. Prior to Merck, Dr. Handen held management consulting positions with Computer Science Corporation and IBM Business Consulting Services (formerly PricewaterhouseCoopers Consulting). With over 20 years of experience in pharmaceutical and biotechnology research and development, process reengineering, and systems and process implementation, Dr. Handen has also held research and management positions with the University of Pennsylvania and the National Institutes of Health. As vice president of professional services for Medidata Solutions, Dr. Handen is responsible for overseeing clinical development business process integration, solution architecting for optimizing clinical trials design execution and development, implementation of data-driven metrics, and developing and implementing operational metrics to improve clinical research processes. He holds a PhD in neurosciences from George Washington University as well as a BS from Duke University.