Index of Conference Proceedings


Book Description




Oversight and Review of Clinical Gene Transfer Protocols


Book Description

Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.




New Serial Titles


Book Description

A union list of serials commencing publication after Dec. 31, 1949.







Cell Culture Engineering


Book Description

Since the introduction of recombinant human growth hormone and insulin a quarter century ago, protein therapeutics has greatly broadened the ho- zon of health care. Many patients suffering with life-threatening diseases or chronic dysfunctions, which were medically untreatable not long ago, can attest to the wonder these drugs have achieved. Although the ?rst generation of p- tein therapeutics was produced in recombinant Escherichia coli, most recent products use mammalian cells as production hosts. Not long after the ?rst p- duction of recombinant proteins in E. coli, it was realized that the complex tasks of most post-translational modi?cations on proteins could only be ef?ciently carried out in mammalian cells. In the 1990s, we witnessed a rapid expansion of mammalian-cell-derived protein therapeutics, chie?y antibodies. In fact, it has been nearly a decade since the market value of mammalian-cell-derived protein therapeutics surpassed that of those produced from E. coli. A common characteristic of recent antibody products is the relatively large dose required for effective therapy, demanding larger quantities for the treatment of a given disease. This, coupled with the broadening repertoire of protein drugs, has rapidly expanded the quantity needed for clinical applications. The increasing demand for protein therapeutics has not been met exclusively by construction of new manufacturing plants and increasing total volume capacity. More - portantly the productivity of cell culture processes has been driven upward by an order of magnitude in the past decade.




World Meetings


Book Description




HIV I: Molecular Biology and Pathogenesis: Clinical Applications


Book Description

The cumulative death toll from AIDS has reached 16.3 million individuals, and more than 33 million persons are currently living with HIV-1. Although it is one of the most-widely studied viruses, many mysteries remain about this pathogen. In this comprehensive two-volume set, HIV-1: Molecular Biology and Pathogenesis, leading investigators in HIV research present a timely picture of the molecular mechanisms which guide HIV-1 expression and replication and provide the most current clinical strategies for combating this virus. Twenty-six teams of experts unravel structure-function interactions of HIV-1 with host cells and the resulting pathological consequences, review strategies fo treatment, and describe ongoing progress in developing animal models and prophylactic vaccines.The two volumes, covering viral mechanisms and clinical applications, respectively, are written by an international collection of AIDS expers from North America, Europe, Australia, and Asia. - Detailed insights into viral packaging, expression, and assembly - Mechanistic understanding of how HIV interacts with receptors and infects cells - Delineation of virally encoded regulatory processes unique to HIV - Clinical Applications: - An updated review of current chemotherapeutics for HIV - New concepts in the discovery and design of novel anti-HIV drugs - The latest developments in HIV-vaccine research







Index Medicus


Book Description

Vols. for 1963- include as pt. 2 of the Jan. issue: Medical subject headings.




Biotechnology


Book Description

Biotechnologyâ€"the manipulation of the basic building blocks of lifeâ€"is rapidly advancing in laboratories around the world. It has become routine to refer to DNA fingerprints and genetically engineered foods. Yet the "how to" of biotechnology is only the beginning. For every report of new therapies or better ways to produce food, there is a Jurassic Park scenario to remind us of the potential pitfalls. Biotechnology raises serious issues for scientists and nonscientists alike: Who will decide what is safe? Who will have access to our personal genetic information? What are the risks when advanced science becomes big business? In Biotechnology, experts from science, law, industry, and government explore a cross-section of emerging issues. This book offers straightforward explanations of basic science and provides insight into the serious social questions raised by these findings. The discussions explore five key areas: The state of the art in biotechnology-including an overview of the genetic revolution, the development of recombinant DNA technology, and the possibilities for applying the new techniques. Potential benefits to medicine and the environment-including gene therapy, the emerging area of tissue engineering and biomaterials, and the development of therapeutic proteins. Issues in technology transfer-focusing on the sometimes controversial relationship between university research centers and industry. Ethics, behavior, and values-exploring the ethical issues that surround basic research and applications of new technology, with a discussion of scientific misconduct and a penetrating look at the social impact of genetic discoveries. Government's role-including a comparison of U.S., European, and Japanese policies on pharmaceutical and biotechnology development. Biotechnology is here to stay, and this volume adds immeasurably to understanding its multiple aspects and far-reaching implications. This book will be of interest to scientists and industry leaders involved in biotechnology issues-and it will be welcomed by the concerned lay reader. Frederick B. Rudolph, Ph.D., is a professor of biochemistry and cell biology at Rice University and is executive director of the Institute of Biosciences and Bioengineering. Larry V. McIntire, Ph.D., is the E. D. Butcher Professor of Chemical and Biomedical Engineering at Rice University and is chair of the Institute of Biosciences and Bioengineering.