The drug discovery and development process is getting longer, more expensive, and no better. The industry suffers from the same clinical attrition and safety-related market withdrawal rates today as it did 20 years ago. Industrialization of Drug Discovery: From Target Selection Through Lead Optimization scrutinizes these problems in detail, contrasting the promise of technology and industrialization with the challenges of using the tools available to their best advantage. The book explores early successes, examines the current state of the art, and provides a strategic analysis of the issues currently facing drug discovery. Introducing the historical background and current status of the industry, the book delineates the basic tenets underlying modern drug discovery, how they have evolved, and their use in various approaches and strategies. It examines, in detail, the regulations, requirements, guidelines, and draft documents that guide so many FDA actions. The editor devotes the remainder of the discussion to industrialization, compound and knowledge management functions, the drug screening process, collaboration, and finally, ethical issues. Drawing on real-life, from-the-trenches examples, the book elucidates a new approach to drug discovery and development. This modern-day, back-to-basics approach includes three steps: understand the science, unravel the story, and then intelligently apply the technology, bringing to bear the entire armamentarium of industrialization techniques, not just automation, to the discovery process. Using these steps, you can meet the goals of more specific targets, more selective compounds, and decreased cycle times. In effect, you can look for a bigger needle in a smaller haystack. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.

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.

The drug discovery and development process is getting longer, more expensive, and no better. The industry suffers from the same clinical attrition and safety-related market withdrawal rates today as it did 20 years ago. Industrialization of Drug Discovery: From Target Selection Through Lead Optimization scrutinizes these problems in detail, contrasting the promise of technology and industrialization with the challenges of using the tools available to their best advantage. The book explores early successes, examines the current state of the art, and provides a strategic analysis of the issues currently facing drug discovery. Introducing the historical background and current status of the industry, the book delineates the basic tenets underlying modern drug discovery, how they have evolved, and their use in various approaches and strategies. It examines, in detail, the regulations, requirements, guidelines, and draft documents that guide so many FDA actions. The editor devotes the remainder of the discussion to industrialization, compound and knowledge management functions, the drug screening process, collaboration, and finally, ethical issues. Drawing on real-life, from-the-trenches examples, the book elucidates a new approach to drug discovery and development. This modern-day, back-to-basics approach includes three steps: understand the science, unravel the story, and then intelligently apply the technology, bringing to bear the entire armamentarium of industrialization techniques, not just automation, to the discovery process. Using these steps, you can meet the goals of more specific targets, more selective compounds, and decreased cycle times. In effect, you can look for a bigger needle in a smaller haystack. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.