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For the world's largest prescription drug manufacturers, the last few years have been a harrowing time. Recently, Pfizer's Lipitor, GlaxoSmithKline's Advair, AstraZeneca's Seroquel, and Sanofi-Aventis and Bristol-Myers Squibb's Plavix all came off patent in the crucial U.S. market. This so-called "patent cliff" meant hundreds of billions of dollars in lost revenue and has pharmaceutical developers scrambling to create new drugs and litigating to extend current patent protections. Having spent most of his career in drug discovery in "big pharma," Dr. Li now delivers an insider's account of how the drug industry ascended to its plateau and explores the nature of the turmoil it faces in the coming years. He begins with a survey of the landscape before "blockbuster drugs," and proceeds to describe how those drugs were discovered and subsequently became integral to the business models of large pharmaceutical companies. For example, in early 1980s, Tagamet, the first "blockbuster drug," transformed a minor Philadelphia-based drug maker named SmithKline & French into the world's ninth-largest pharmaceutical company in terms of sales. The project that delivered Tagamet was nearly terminated several times because research efforts begun in 1964 produced no apparent results within the first eleven years. Similar stories accompany the discovery and development of now-ubiquitous prescription drugs, among them Claritin, Prilosec, Nexium, Plavix, and Ambien. These stories, and the facets of the pharmaceutical industry that they reveal, can teach us valuable lessons and reveal many crucial aspects about the future landscape of drug discovery. As always, Dr. Li writes in a readable style and intersperses fascinating stories of scientific discovery with engaging human drama.

Synthetic materials are a tremendous potential resource for treating human disease. For the rational design of many of these biomaterials it is necessary to have an understanding of polymer chemistry and polymer physics. Equally important to those two fields is a quantitative understanding of the principles that govern rates of drug transport, reaction, and disappearance in physiological and pathological situations. This book is a synthesis of these principles, providing a working foundation for those in the field of drug delivery. It covers advanced drug delivery and contemporary biomaterials.

Drug discovery in the pharmaceutical industry has important consequences for the health and wellbeing of people everywhere. However, the general public knows little about the paths through which basic research findings are translated into products that protect or restore human health: the route from the laboratory bench to the bedside. In Hallelujah Moments, Eugene Cordes reveals how some of the most important and influential drugs have been brought into the practice of clinical medicine through the wit and determination of scientists in academia and industry. He shares his firsthand knowledge of the drug-discovery world, having spent a long and distinguished career in both the academic and industrial settings. These tales are “adventure stories,” and they trace the route of important drugs like Januvia, Primaxin, Capoten, and Zocor from concept to the clinic. Cordes shows us the dynamic and critical thinking needed to create a drug that meets important health needs. These are human stories of imagination, risk–taking, problem–solving, and perseverance. Written accessibly for a non-scientist audience, Hallelujah Moments provides insights into the fascinating world of drug discovery like never before.

This work provides eleven stories of drug discovery and features the scientists who made them. The outcome of the discovery work has provided novel therapies in cancer, cardiovascular medicine, antibacterial and antiviral infectious diseases, parasitic diseases, metabolic diseases, and weight control. Each story begins with the basic biomedical science that revealed the pathway to effective drug therapy and continues with the step-by-step process that leads from insight to a product in clinical practice meeting a defined medical need. The tales feature creative problem-solving by clever and dedicated scientists as they overcame roadblocks to success, hallelujah moments. Each drug discovery story reflects the interface between basic science, medicine, and drug discovery. Embedded in these tales are the societal and medical environments in which drug discovery takes place, the discovery of agents to treat HIV/AIDS, for example. Finally, a series of appendices provides basic chemical background for non-scientists.

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

The stories behind drug discovery are fascinating, full of human and scientific interest. This is a book on the history of drug discovery that highlights the intellectual splendor of discoverers as well as the human frailty associated them. History is replete with examples of breakthrough medicines that have saved millions of lives. Ether as an anesthetic by Morton; penicillin as an antibiotic by Fleming; and insulin as an anti-diabetic by Banting are just a few examples. The discoverers of these medicines are doubtlessly benefactors to mankind--for instance, without penicillin, 75% of us probably would not be alive because some of our parents or grandparents would have succumbed to infections. Dr. Jack Li, a medicinal chemist who is intimately involved with drug discovery, has assembled an astounding amount of facts and information behind important drugs through extensive literature research and interviews with many inventors of the drugs including Viagra and Lipitor. There have been many myths and inaccuracies associated with those legendary drugs. The inventors perspectives afforded this book an invaluable accuracy and insight because history is not history unless it is true. The text is supplemented by many anecdotes, pictures and postage stamps. Both specialist and layman will find Laughing Gas, Viagra, and Lipitor informative and entertaining. Students in chemistry, pharmacy, and medicine, workers in healthcare and high school science teachers will find this book most useful.

Prescription, illicit, and recreational drugs touch all of our lives yet a basic understanding of these chemicals is largely absent among Americans. Jerrold Winter offers a comprehensive account of psychoactive drugs, chemicals which influence our brains in myriad ways. Manifestations of their influence on the brain are quite varied. There may be the comfort provided by opioids to those who are dying or in pain or, in everyday life, the surge of contentment for the users of caffeine, nicotine, heroin, alcohol, or marijuana upon the taking of their drug of choice. Turning to the more exotic, a drug such as LSD may alter the way the world looks to us; it may even inspire thoughts of God. Adding to the purely scientific questions which confront us are the ways in which our society chooses to respond to the presence of psychoactive drugs. Should they be banned and their users sent to prison, tolerated as a reflection of man's eternal search for an escape from anxiety, pain, and the monotony of daily life, or celebrated as therapeutically useful agents? Our Love Affair with Drugs is written for experts and novices alike. There are stories of, for example, how Timothy Leary caused the repeal of the Marijuana Tax Act of 1937. Readers will learn of the transformation by Sir Charles Locock of a drug intended to dampen female sexual activity into the first effective drug for the treatment of the ancient disease of epilepsy. Alexander Shulgin's love of psychoactive drugs and his unconventional research practices illuminate the story of methylenedioxymethamphetamine, a.k.a. Ecstasy, a drug now likely to find value in treating veterans and others suffering post-traumatic distress disorder. Winter links the excitement of drug discovery with the very practical matter of balancing the benefits and risks of these drugs.

Tissue or organ transplantation are among the few options available for patients with excessive skin loss, heart or liver failure, and many common ailments, and the demand for replacement tissue greatly exceeds the supply, even before one considers the serious constraints of immunological tissue type matching to avoid immune rejection. Tissue engineering promises to help sidestep constraints on availability and overcome the scientific challenges, with huge medical benefits. This book lays out the principles of tissue engineering. It will be a useful reference work for those associated with this field and as a textbook for specialized courses in the subject. It is a companion volume to Saltzman's OUP book on drug delivery.

Drugs like Lipitor, Plavix, Taxol, and Zoloft are integral in today's medicinal world. These widely used products save lives and improve the quality of lives, playing a crucial role in everything from cholesterol management to cancer treatment. These advances in medicine were brought into existence after nuanced process of creation, featuring a wide range of chemical and pharmacological experimentation and discovery. Top Drugs: Their History, Pharmacology, and Synthesis provides an in-depth study on ten prominent drugs, outlining the chemistry behind each one's creation. Jie Jack Li, a medicinal chemist and an expert on drug discovery, offers a thorough analysis of the landscape of current drug development. The comprehensive text is divided by health issues, including cardiovascular, cancer, metabolic diseases, and infectious diseases. Each section features individual chapters on significant drugs, outlining the chemistry and history of the drug's discovery. Li begins each chapter with the product's history, providing necessary context. Li then proceeds to describe the mechanism of action, structure-activity relationship (SAR), bioavailability, metabolism, toxicology, the discovery route, and the process route. Top Drugs: Their History, Pharmacology, and Synthesis will acclimate students, scientists, and interested laypersons to the world of chemistry and drug discovery.

Over 25 million people in the U.S. alone have benefited from statins--such drugs as Lipitor, Zocor, Crestor, Pravachol, and other cholesterol-lowering medicines--in preventing stroke, heart attack, and other forms of coronary heart disease. But how did these remarkable, life-saving drugs come into being? In Triumph of the Heart, Dr. Jie Jack Li, a medicinal chemist and expert on drug discovery, tells for the first time the fascinating story of statins. Drawn from discussions with many scientists involved in the discovery and development of these drugs, the book illuminates the human side of science by revealing the role played by persistence, luck, and sudden insight that characterize major discoveries. For scientists in the drug industry, health care professionals, students of medicine, and all those intrigued by the basic human drive to explore and discover, Triumph of the Heart offers a compelling view of one of the most important drug discoveries of our time.