In the fall of 1980, Genentech, Inc., a little-known California genetic engineering company, became the overnight darling of Wall Street, 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. 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. Drawing from an unparalleled collection of interviews with early biotech players, Sally Smith Hughes offers the first book-length history of this pioneering company, depicting Genentech’s improbable creation, precarious youth, and ascent to immense prosperity. 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. By placing Genentech’s founders, followers, opponents, victims, and beneficiaries in context, Hughes also demonstrates how science interacts with commercial and legal interests and university research, and with government regulation, venture capital, and commercial profits. Integrating the scientific, the corporate, the contextual, and the personal, Genentech tells the story of biotechnology as it is not often told, as a risky and improbable entrepreneurial venture that had to overcome a number of powerful forces working against it.

Evidence suggests that medical innovation is becoming increasingly dependent on interdisciplinary research and on the crossing of institutional boundaries. This volume focuses on the conditions governing the supply of new medical technologies and suggest that the boundaries between disciplines, institutions, and the private and public sectors have been redrawn and reshaped. Individual essays explore the nature, organization, and management of interdisciplinary R&D in medicine; the introduction into clinical practice of the laser, endoscopic innovations, cochlear implantation, cardiovascular imaging technologies, and synthetic insulin; the division of innovating labor in biotechnology; the government- industry-university interface; perspectives on industrial R&D management; and the growing intertwining of the public and proprietary in medical technology.

Two years after she underwent a mastectomy and chemotherapy, Barbara Bradfield's aggressive breast cancer had recurred and spread to her lungs. The outlook was grim. Then she took part in Genentech's clinical trials for a new drug. 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. Unlike chemotherapy or radiation, Herceptin has no disabling side effects. 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. Herceptin is the first treatment targeted at a gene defect that gives rise to cancer. 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. Her-2 is a story of dramatic discoveries and strong personalities, showing the combination of scientific investigation, money, politics, ego, corporate decisions, patient activism, and luck involved in moving this groundbreaking drug from the lab to a patient's bedside. Bazell's deft portraits introduce us to the remarkable people instrumental in Herceptin's history, including Dr. Dennis Slamon, the driven UCLA oncologist who played the primary role in developing the treatment; Lily Tartikoff, wife of television executive Brandon Tartikoff, who tapped into Hollywood money and glamour to help fund Slamon's research; and Marti Nelson, who inspired the activists who lobbied for a "compassionate use" program that would allow women outside the clinical trials to have access to the limited supplies of Herceptin prior to FDA approval of the drug. 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. Meticulously researched, written with clarity and compassion, Her-2 is masterly reporting on cutting-edge science.

The #1 NEW YORK TIMES Bestseller The basis for the PBS Ken Burns Documentary The Gene: An Intimate History Now includes an excerpt from Siddhartha Mukherjee’s new book Song of the Cell! From the Pulitzer Prize–winning author of The Emperor of All Maladies—a fascinating history of the gene and “a magisterial account of how human minds have laboriously, ingeniously picked apart what makes us tick” (Elle). “Sid Mukherjee has the uncanny ability to bring together science, history, and the future in a way that is understandable and riveting, guiding us through both time and the mystery of life itself.” —Ken Burns “Dr. Siddhartha Mukherjee dazzled readers with his Pulitzer Prize-winning The Emperor of All Maladies in 2010. That achievement was evidently just a warm-up for his virtuoso performance in The Gene: An Intimate History, in which he braids science, history, and memoir into an epic with all the range and biblical thunder of Paradise Lost” (The New York Times). In this biography Mukherjee brings to life the quest to understand human heredity and its surprising influence on our lives, personalities, identities, fates, and choices. “Mukherjee expresses abstract intellectual ideas through emotional stories…[and] swaddles his medical rigor with rhapsodic tenderness, surprising vulnerability, and occasional flashes of pure poetry” (The Washington Post). Throughout, the story of Mukherjee’s own family—with its tragic and bewildering history of mental illness—reminds us of the questions that hang over our ability to translate the science of genetics from the laboratory to the real world. In riveting and dramatic prose, he describes the centuries of research and experimentation—from Aristotle and Pythagoras to Mendel and Darwin, from Boveri and Morgan to Crick, Watson and Franklin, all the way through the revolutionary twenty-first century innovators who mapped the human genome. “A fascinating and often sobering history of how humans came to understand the roles of genes in making us who we are—and what our manipulation of those genes might mean for our future” (Milwaukee Journal-Sentinel), The Gene is the revelatory and magisterial history of a scientific idea coming to life, the most crucial science of our time, intimately explained by a master. “The Gene is a book we all should read” (USA TODAY).

An unprecedented constellation of experts—leading cancer doctors, policymakers, cutting-edge researchers, national advocates, and more—explore the legacy and the shortcomings from the fifty-year war on cancer and look ahead to the future. The longest war in the modern era, longer than the Cold War, has been the war on cancer. Cancer is a complex, evasive enemy, and there was no quick victory in the fight against it. But the battle has been a monumental test of medical and scientific research and fundraising acumen, as well as a moral and ethical challenge to the entire system of medicine. In A New Deal for Cancer, some of today’s leading thinkers, activists, and medical visionaries describe the many successes in the long war and the ways in which our deeper failings as a society have held us back from a more complete success. Together they present an unrivaled and nearly complete map of the battlefield across dimensions of science, government, equity, business, the patient provider experience, and more, documenting our emerging understanding of cancer’s many unique dimensions and offering bold new plans to enable the American health care system to deliver progress and hope to all patients.

The definitive guide to the myriad analytical techniques available to scientists involved in biotherapeutics research Analytical Characterization of Biotherapeutics covers all current and emerging analytical tools and techniques used for the characterization of therapeutic proteins and antigen reagents. From basic recombinant antigen and antibody characterization, to complex analyses for increasingly complex molecular designs, the book explores the history of the analysis techniques and offers valuable insights into the most important emerging analytical solutions. In addition, it frames critical questions warranting attention in the design and delivery of a therapeutic protein, exposes analytical challenges that may occur when characterizing these molecules, and presents a number of tested solutions. The first single-volume guide of its kind, Analytical Characterization of Biotherapeutics brings together contributions from scientists at the leading edge of biotherapeutics research and manufacturing. Key topics covered in-depth include the structural characterization of recombinant proteins and antibodies, antibody de novo sequencing, characterization of antibody drug conjugates, characterization of bi-specific or other hybrid molecules, characterization of manufacturing host-cell contaminant proteins, analytical tools for biologics molecular assessment, and more. Each chapter is written by a recognized expert or experts in their field who discuss current and cutting edge approaches to fully characterizing biotherapeutic proteins and antigen reagents Covers the full range of characterization strategies for large molecule based therapeutics Provides an up-to-date account of the latest approaches used for large molecule characterization Chapters cover the background needed to understand the challenges at hand, solutions to characterize these large molecules, and a summary of emerging options for analytical characterization Analytical Characterization of Biotherapeutics is an up-to-date resource for analytical scientists, biologists, and mass spectrometrists involved in the analysis of biomolecules, as well as scientists employed in the pharmaceuticals and biotechnology industries. Graduate students in biology and analytical science, and their instructors will find it to be fascinating and instructive supplementary reading.

Don't simply show your data—tell a story with it! Storytelling with Data teaches you the fundamentals of data visualization and how to communicate effectively with data. You'll discover the power of storytelling and the way to make data a pivotal point in your story. The lessons in this illuminative text are grounded in theory, but made accessible through numerous real-world examples—ready for immediate application to your next graph or presentation. Storytelling is not an inherent skill, especially when it comes to data visualization, and the tools at our disposal don't make it any easier. This book demonstrates how to go beyond conventional tools to reach the root of your data, and how to use your data to create an engaging, informative, compelling story. Specifically, you'll learn how to: Understand the importance of context and audience Determine the appropriate type of graph for your situation Recognize and eliminate the clutter clouding your information Direct your audience's attention to the most important parts of your data Think like a designer and utilize concepts of design in data visualization Leverage the power of storytelling to help your message resonate with your audience Together, the lessons in this book will help you turn your data into high impact visual stories that stick with your audience. Rid your world of ineffective graphs, one exploding 3D pie chart at a time. There is a story in your data—Storytelling with Data will give you the skills and power to tell it!

Restriction enzymes cleave DNA at specific recognition sites and have many uses in molecular biology, genetics, and biotechnology. More than 4000 restriction enzymes are known today, of which more than 621 are commercially available, justifying their description by Nobel Prize winner Richard Roberts as "the workhorses of molecular biology." This book by Wil Loenen is the first full-length history of these invaluable tools, from their recognition in the 1950s to the flowering of their development in the 1970s and 1980s to their ubiquitous availability today. Loenen has worked with restriction enzymes throughout her career as a research scientist, during which she came to know many of the leaders in this field personally and professionally. She is the author of several authoritative and widely appreciated reviews of the enzymes' biology. Her book was written with the close assistance of several of the field's pioneers, including Rich Roberts, Stuart Linn, Tom Bickle, Steve Halford, and the late Joe Bertani. The seed for the book was sown at a retirement party for Noreen Murray, to whom the book is dedicated, and its roots lie in a remarkable 2013 conference at Cold Spring Harbor Laboratory that celebrated the people and events that were vital to the field's development. Funding for the book was made possible by the Genentech Center for the History of Molecular Biology and Biotechnology at Cold Spring Harbor Laboratory.

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Author Stephen Hall weaves together the scientific, social and political threads of this story - the fierce rivalry between labs, the fateful clash of egos within labs, the invasion of academia by commerce, the public fears about genetic engineering, the threat of government regulation, and the ultimate triumph of modern biology - to give us an outstanding tale of scientific research."--BOOK JACKET.