Product Development

Tells the remarkable story behind the revolutionary miracle cure for cancer, Gleevec, and describes its development by pharmaceutical company, Novartis.

"Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs."
—Doody's Reviews, May 2009

"The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials."
—Chemistry World, February 2009

The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs.

This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter.

Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.

It’s the business of saving lives.

Miracle Medicines goes behind the scenes of the pharmaceutical industry and into the high-security laboratories to tell the stories of the men and women---chemists, physiologists, medical and clinical researchers, engineers---who have chosen to toil for years in the lab in order to transform scientific theories into new lifesaving medicines.

You’ll witness the day-to-day labors, victories and defeats of the dedicated professionals who are waging a war against the diseases that still plague mankind. From the confines of their laboratories, these pharmaceutical adventurers explore unknown territories in health and science.

Miracle Medicines reveals what really happens during the long and uncertain journey that each new drug and its creators must endure from theory, to research, to testing and, finally, FDA approval and delivery to the public. It’s a very human story within the context of fascinating scientific innovation.

Through first hand interviews you’ll also meet the patients who benefit from these manmade miracles and learn how, within their bloodstreams, an ongoing battle is raging.

The drugs profiled are:
* Advair: GlaxoSmithKline’s revolutionary asthma medication, the first packaged as both a control and emergency drug.
* Gleevec: The Novartis’ chronic myeloid leukemia treatment born from decades of medical research in a field of study that was once considered hopeless.
* Humalog: Eli Lilly’s reinvention of insulin to control diabetes has been described as being better than nature
* Lipitor: Pfizer’s miracle antidote for high cholesterol that was nearly lost to the pharmaceutical vaults and has since become the world’s top-selling medicine.
* Norvir: Abbott’s contribution to the fight against HIV that nearly erases all traces of the disease from the bloodstream and prolongs the life of patients.
* Remicade: Created for the treatment of Crohn’s disease, rheumatoid arthritis and other Immune Mediated Inflammatory Diseases, Johnson & Johnson’s revolutionary biomedicine was developed from technology that once was only found in science fiction.
* Seroquel: AstraZeneca’s treatment for both schizophrenia and bipolar mania that has given millions of psychiatrics a new lease on life.

This compelling and truth-revealing book will forever change the way you view the medicines in your medicine cabinet, and the people who create them.

The marketing planning system described in the second edition of this book has been designed to enable marketing and product executives in the pharmaceutical industry to produce a plan which serves as a dynamic management tool. A further orientation to external analysis and a reworking of the application of SWOT analysis, along with extra material on sales forecasting and strategy implementation are included.

This book provides an excellent overview on state-of-the-art of modern organocatalysis. It presents the contributions from leading experts, with backgrounds in academia and industry, to an Ernst Schering Research Foundation Symposium held in April 2007. It will be of interest to those who want a general overview of the topic, but also to those who want to learn more about the state-of-the-art, current trends and perspectives in this highly dynamic field of research.

In this concise and systematic book, a team of experts select the most important, cutting-edge technologies used in drug delivery systems. They take into account significant drugs, new technologies such as nanoparticles, and therapeutic applications. The chapters present step-by-step laboratory protocols following the highly successful Methods in Molecular Biology™ series format, offering readily reproducible results vital for pharmaceutical physicians and scientists.

The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology.

This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.

How many victims of cancer have thought, "If only I could order up a cure"?

Rick Murdock could.

In an extraordinary book that proves that truth can be stranger than fiction, Rick Murdock tells the dramatic story of his fight against a deadly lymphoma that could only be treated with technology developed by his own biotech company, and the equally harrowing battle for the survival of his company in a bruising legal dispute with a multibillion-dollar medical products giant.

Rick Murdock was forty-four years old when he was named CEO of CellPro, a thriving biotech company in Seattle that was reaping the benefits of the biotech boom in the late 1980s and early '90s. Wall Street money fueled the flame of cutting-edge research at start-up companies like CellPro, where dedicated scientists were researching treatments that showed great promise in the fight against cancer and other diseases. But then Rick found a lump in his neck, evidence of the acute mantle cell lymphoma raging through his system. This rare form of cancer had no cure: Without a miracle, Rick would die.

At CellPro, Rick found his miracle workers. In a stunning twist of fate, Rick's staff was experimenting with a radical new treatment for advanced lymphomas, though the scientists were months, if not years, away from success. Knowing they were their boss's last hope, these researchers went to work on the experiment that could save Rick's life. If they were successful, Rick would become "patient number one," the guinea pig for a technology that had never been used on humans.
        
The thrilling race against time to save Rick's life is only part of this remarkable story. For while Rick was fighting for his own life, he was also battling a medical products behemoth named Baxter Healthcare and archaic patent laws that threatened CellPro. If CellPro was put out of business, the promising therapies it had been developing for victims of breast cancer, leukemia, lymphoma, and other deadly cancers could disappear. Patient Number One shares the intriguing story of how entrepreneurs and scientists came together to form CellPro, painting a vivid picture of how researchers work tirelessly to come up with new and better treatments for disease, while their financiers play a high-stakes financial game to make money from these medical endeavors. However, in the tradition of books like A Civil Action, Patient Number One is also an illuminating, often scathing look at how medical research is conducted in America today as the bottom line can get in the way of saving lives. Lawyers, politicians, researchers, executives, and investors all want a piece of the biotech pie and will stop at nothing to preserve their special interests, even if it means keeping life-saving treatments from the people who need them.

From tense courtroom scenes between the Goliath-like Baxter and tiny CellPro to anxious moments in the laboratory with Rick's staff and Rick's own agonizing cancer treatments, Patient Number One takes readers into the fascinating, frustrating world of medical research and how it directly affects us all.

The first edition of Bioactive Compounds from Natural Sources was published in a period of renewed attention to biologically active compounds of natural origin. This trend has continued and intensified—natural products are again under the spotlight, in particular for their possible pharmacological applications. Largely focusing on natural products as lead compounds in drug discovery, Bioactive Compounds from Natural Sources, Second Edition: Natural Products as Lead Compounds in Drug Discovery is actually a completely new volume containing surveys of selected recent advances in an interdisciplinary area covering chemistry of natural products, medicinal chemistry, biochemistry, and other related topics.

Written by some of the most reputed scientists in the field, this second edition includes new chapters from authors who contributed to the first edition as well as many chapters compiled by new authors. Introducing the reader to strategies and methods in the search for bioactive natural products, this book covers topics including:

• Natural sources of bioactive compounds such as aquatic cyanobacteria, filamentous fungi, and tropical plants,
• The tremendous potentiality of metabolic engineering of natural products biosynthesis
• The contribution of emerging or developing technologies to the study of bioactive natural compounds, namely computational methods and circular dichroism
• The potential of natural or natural-derived compounds for specific therapeutic applications: treatment of viral diseases, regulation of hypoxia-inducible factor, antimalarials, modulation of angiogenesis, and antitumor and wound-healing activity
• Selected examples of natural product families and related synthetic analogues, namely polyphenols and campthotecins

Compiled for researchers and Ph.D. students working in interdisciplinary fields, this book will also be appreciated by readers without a background in chemistry interested in bioactive natural products, their biological and pharmacological properties, and their possible use as chemopreventive or chemotherapeutic agents. Conversely, the biological and pharmacological data and methods are accessible by chemists.