It’s riskier and more rigorous at just about every stage than any other business, from the towering biological uncertainties inherent in its mission to treat disease; to the 30-to-1 failure rate in bringing out a successful medicine even after a molecule clears all the hurdles to get to human testing; to the multibillion-dollar cost of ramping up a successful product; to operating in the world’s most regulated industry, matched only by nuclear power.
The Antidote: Inside the World of New Pharma #ad - Werth captures the full scope of Vertex’s twenty-five-year drive to deliver breakthrough medicines. At a time when america struggles to maintain its innovative edge, The Antidote is a powerful inside look at one of the most intriguing and important business stories of recent decades. The $325 billion-a-year pharmaceutical business is America’s toughest and one of its most profitable.
In this timely and much praised book, Barry Werth draws upon inside reporting that spans more than two decades. Werth described the company’s tumultuous early days during the AIDS crisis in The Billion-Dollar Molecule, a celebrated classic of science and business journalism.
The Billion-Dollar Molecule: The Quest for the Perfect DrugSimon & Schuster #ad - Founded by joshua boger, a dynamic harvard- and merck-trained scientific whiz kid, Vertex is dedicated to designing -- atom by atom -- both a new life-saving immunosuppressant drug, and a drug to combat the virus that causes AIDS. You will be hooked from start to finish, where the wheeling and dealing takes on a life of its own, to Wall Street, fiercely competitive scientists struggle for a breakthrough, as you go from the labs, where obsessive, as Boger courts investors and finally decides to take Vertex public.
Join journalist barry werth as he pulls back the curtain on Vertex, a start-up pharmaceutical company, and witness firsthand the intense drama being played out in the pioneering and hugely profitable field of drug research. Here is a fascinating no-holds-barred account of the business of science, which includes an updated epilogue about the most recent developments in the quest for a drug to cure AIDS.
Genentech: The Beginnings of Biotech SynthesisUniversity of Chicago Press #ad - . By placing genentech’s founders, followers, hughes also demonstrates how science interacts with commercial and legal interests and university research, and with government regulation, victims, venture capital, opponents, and beneficiaries in context, and commercial profits. Integrating the scientific, genentech tells the story of biotechnology as it is not often told, the corporate, the contextual, and the personal, as a risky and improbable entrepreneurial venture that had to overcome a number of powerful forces working against it.
Hughes provides intimate portraits of the people significant to Genentech’s science and business, including cofounders Herbert Boyer and Robert Swanson, and in doing so sheds new light on how personality affects the growth of science. Coming at a time of economic recession and declining technological competitiveness in the United States, the event provoked banner headlines and ignited a period of speculative frenzy over biotechnology as a revolutionary means for creating new and better kinds of pharmaceuticals, untold profit, and a possible solution to national economic malaise.
Genentech: The Beginnings of Biotech Synthesis #ad - Drawing from an unparalleled collection of interviews with early biotech players, depicting Genentech’s improbable creation, Sally Smith Hughes offers the first book-length history of this pioneering company, precarious youth, and ascent to immense prosperity. In the fall of 1980, Genentech, Inc. Became the overnight darling of wall Street, a little-known California genetic engineering company, raising over $38 million in its initial public stock offering.
Lacking marketed products or substantial profit, the firm nonetheless saw its share price escalate from $35 to $89 in the first few minutes of trading, at that point the largest gain in stock market history.
Her-2: The Making of Herceptin, a Revolutionary Treatment for Breast CancerRandom House #ad - Bazell's deft portraits introduce us to the remarkable people instrumental in Herceptin's history, including Dr. Then she took part in Genentech's clinical trials for a new drug. It marks the beginning of a new era of treatment for all kinds of cancers. Robert bazell presents a riveting account of how Herceptin was born.
And throughout there are the stories of the heroic women with advanced breast cancer who volunteered for the trials, risking what time they had left on an unproven treatment. Two years after she underwent a mastectomy and chemotherapy, Barbara Bradfield's aggressive breast cancer had recurred and spread to her lungs.
Her-2: The Making of Herceptin, a Revolutionary Treatment for Breast Cancer #ad - Herceptin is the first treatment targeted at a gene defect that gives rise to cancer. The outlook was grim. It works by inactivating her-2/neu--a protein that makes cancer cells grow especially quickly-- produced by a gene found in 25 to 30 percent of all breast tumors. Herceptin caused some patients' cancers to disappear completely; in others, it slowed the progression of the disease and gave the women months or years they wouldn't otherwise have had.
Unlike chemotherapy or radiation, Herceptin has no disabling side effects. Five years later she remains cancer-free. Her-2 is the biography of herceptin, the drug that provoked dramatic responses in Barbara Bradfield and other women in the trials and that offers promise for hundreds of thousands of breast cancer patients.
The Great American Drug Deal: A New Prescription for Innovative and Affordable MedicinesEvelexa Press #ad - And while we’ve struggled for decades to agree on solutions that serve all patients without jeopardizing the invention of new medicines, many Americans suffer because they can’t afford the drugs they need. Do we really have to choose between affordability and innovation?In The Great American Drug Deal, scientist and industry expert Peter Kolchinsky answers this question with a decisive No.
The pharmaceutical industry’s commitment to creating new lifesaving drugs destined to become inexpensive generics can be balanced by the healthcare system’s commitment to making those drugs affordable for all patients—a Biotech Social Contract. Through deep research and compelling stories of breakthroughs and breakdowns, and how can we prevent the next one?the great american drug deal offers clear-eyed scrutiny of all players in the industry and examines vital ideas for closing loopholes, dealing with bad actors, including:Why doesn’t insurance make drugs affordable?How can we prevent price-jacking of older drugs?Why are drugs more expensive in America than elsewhere?How can we guarantee that all medicines eventually go generic so they are only temporarily expensive?What systemic failures led to the opioid crisis, Kolchinsky presents solutions for striking a balance that are bold yet realistic and tackle today’s most pressing questions, encouraging investment, and educating consumers.
The Great American Drug Deal: A New Prescription for Innovative and Affordable Medicines #ad - . It’s time we resolve to support patients and fuel discoveries that ease suffering now and for generations to come. Developing life-changing drugs is risky and expensive—but that’s not what makes them unaffordable. Drug pricing is a staple of every news cycle and political debate.
New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and PatientsPSPG Publishing #ad - Drug development, the processes by which a chemical compound becomes a “drug” and is approved for sale by the FDA and European and Asian regulators, is not for the faint-of-heart or the shortsighted. If you’re involved in the pharmaceutical industry, NEW DRUGS will provide scientific and management tools to increase the likelihood of regulatory approval at each phase of your compound’s development.
He has also managed post-fda-approval activities including collecting and analyzing adverse-event information from consumers, fielding inquiries from patients and healthcare providers, and marketing-related scientific studies. If you’re a patient or consumer, new druGS will enable you to intelligently discuss medications with your health-care provider and empower you to make informed decisions at the pharmacy.
If your portfolio, rather than your health, makes you an interested observer of the fortunes of this critical sector of the US economy, NEW DRUGS will help you to decode press releases and annual reports, so that you can recognize and invest in well-run companies with promising products. About the author:during his 30-year career in pharmaceutical research and development, author Lawrence T.
New Drugs: An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients #ad - Friedhoff, facp has amassed an extraordinary record of industry accomplishments, most notably as the head of the teams that chose, PhD, developed, MD, and brought two chemical compounds through regulatory approvals around the world. He is also the founder of pharmaceutical special projects group, llc, a consortium of independent consultants at whose core are the handful of professionals who have worked together on a variety of successful new drugs under his supervision for nearly twenty years; the team provides various drug-development services to clients and is preparing to bring its own products to market.
Dr. Friedhoff has obtained several patents and has been a frequent and off-cited contributor to the scientific literature.
The Drug Hunters: The Improbable Quest to Discover New MedicinesArcade #ad - Through serendipity— by chewing, juniper, and snorting—some Neolithic souls discovered opium, snakeroot, frankincense, alcohol, brewing, and other helpful substances. The chapters offer a lively tour of how new drugs are actually found, the mistakes, the discovery strategies, and the rare successes.
Dr. Tzi the iceman, was found to have whipworms in his intestines and Bronze-age medicine, the five-thousand-year-old hunter frozen in the Italian Alps, a worm-killing birch fungus, knotted to his leggings. The surprising, behind-the-scenes story of how our medicines are discovered, told by a veteran drug hunter.
The Drug Hunters: The Improbable Quest to Discover New Medicines #ad - The search to find medicines is as old as disease, which is to say as old as the human race. Donald R. Kirsch infuses the book with his own expertise and experiences from thirty-five years of drug hunting, whether searching for life-saving molecules in mudflats by Chesapeake Bay or as a chief science officer and research group leader at major pharmaceutical companies.
Nowadays, big pharma conglomerates spend billions of dollars on state-of the art laboratories staffed by PhDs to discover blockbuster drugs. Yet, despite our best efforts to engineer cures, luck, trial-and-error, risk, and ingenuity are still fundamental to medical discovery. The drug hunters is a colorful, and from quinine and aspirin to Viagra, fact-filled narrative history of the search for new medicines from our Neolithic forebears to the professionals of today, Prozac, and Lipitor.
Managing Biotechnology: From Science to Market in the Digital AgeWiley #ad - Throughout case studies provide researchers, financial analysts, ideas, consultants, and other professionals involved in the biotech sector with insights, corporate marketers, senior managers, and models. Concurrently, the development and increased affordability of sophisticated digital technologies has fundamentally altered many industries including healthcare.
Jacqualyn fouse, celgene “biotech companies have long been innovators, retired president and chief oPERATING OFFICER, PhD, using the latest technologies to enable cutting edge science to help patients with serious diseases. Informed by extensive input by senior biotech executives and leading consultancies serving the industry, including strategies for engagement with patients, development, and commercialization of novel therapeutic products, it analyzes the strategies and key success factors for the financing, physicians and healthcare payers.
Written by two experts, both of whom have had decades of experience in the field, this book provides a comprehensive overview of the new business context and marketing models for biotech companies. Delivering these novel medicines to patients is a complex and multifaceted process, which is elegantly described in this new book.
Managing Biotechnology: From Science to Market in the Digital Age #ad - ”. However, the work does not stop in the lab. To capitalize on new digital technologies from R&D through commercialization requires industry leaders to adopt new business models, develop new digital and data capabilities, and partner with innovators and payers worldwide. They are why we exist as an industry, and this is ultimately what this insightful essay is really about.
Blockbuster Drugs: The Rise and Decline of the Pharmaceutical IndustryOxford University Press #ad - For example, tagamet, in early 1980s, 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. Recently, astrazeneca's seroquel, glaxosmithkline's Advair, Pfizer's Lipitor, and Sanofi-Aventis and Bristol-Myers Squibb's Plavix all came off patent in the crucial U.
S. As always, Dr. 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. Similar stories accompany the discovery and development of now-ubiquitous prescription drugs, among them Claritin, Prilosec, Nexium, Plavix, and Ambien.
Blockbuster Drugs: The Rise and Decline of the Pharmaceutical Industry #ad - 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. 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.
For the world's largest prescription drug manufacturers, the last few years have been a harrowing time. 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. Market.
Drugs: From Discovery to ApprovalWiley-Blackwell #ad - Biotechnology is a dynamic field with changes across R&D, manufacturing and regulatory processes, clinical trials, and the third edition of the text provides timely updates for those in this rapidly growing field. The third edition of this best-selling book continues to offer a user-friendly, including the performance of pre-clinical studies, regulatory controls, step-by-step introduction to all the key processes involved in bringing a drug to the market, the conduct of human clinical trials, and even the manufacturing processes for pharmaceutical products.
Concise and easy to read, third edition quickly introduces basic concepts, Drugs: From Discovery to Approval, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. The third edition incorporates the latest developments and updates in the pharmaceutical community, provides more comprehensive coverage of topics, and includes more materials and case studies suited to college and university use.
Regenesis: How Synthetic Biology Will Reinvent Nature and OurselvesBasic Books #ad - In regenesis, george church and science writer Ed Regis explore the possibilities of the emerging field of synthetic biology. A harvard biologist and master inventor explores how new biotechnologies will enable us to bring species back from the dead, unlock vast supplies of renewable energy, and extend human life.
Synthetic biology, in which living organisms are selectively altered by modifying substantial portions of their genomes, allows for the creation of entirely new species of organisms. A breathtaking look at the potential of this world-changing technology, Regenesis is nothing less than a guide to the future of life.
Regenesis: How Synthetic Biology Will Reinvent Nature and Ourselves #ad - These technologies-far from the out-of-control nightmare depicted in science fiction-have the power to improve human and animal health, increase our intelligence, enhance our memory, and even extend our life span.