New biotech review board planned.
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Advisory Committees↗
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NIH/FDA dispute likely to delay research.
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Advisory Committees↗
Regulating human gene therapy.
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Advisory Committees↗
Genetic engineering. New advisory board approved.
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Advisory Committees↗
Current biotechnological developments in Thailand.
Thailand is very much aware of the potential and the opportunities in biotechnology and has given the utmost effort into the development of biotechnology. In 1983, the government has set up the National Center for Genetic Engineering and Biotechnology (NCGEB). The center operates through a network of research institutes and laboratories in order to maximize and consolidate the limited resources of the country. The center also plays a key role in formulating policies and plans relating to biotechnology as well as in supporting and coordinating biotechnology research and development. A sum of U.S. $8.6 million has been allocated for an initial 5-year program for R D & E activities. The priority consideration is on utilizing various levels of biotechnology for improvement in agriculture, industrial productivity, health, and environment. To facilitate and strengthen the link between research institutions and the private sector, the high-level Science and Technology Development Board (STDB) was established in 1986, with an initial allocation of U.S. $2.9 million between 1986 to 1992 for biotechnology. At present, there are between 400 to 500 scientists and technologists with M.S. or higher degrees actively working in research and development (R & D) in biotechnology and engineering, mostly in universities and government research laboratories. It is expected that approximately 500 graduates with advanced degrees in biotechnology and related fields will be produced during the 5-year plan (1987 to 1991).
Biotechnology↗
Hans Küpper discusses science and venture capital.
Hans Küpper has over 30 years of experience in the biotechnology industry in areas from research to R&D management, technology assessment and business acquisitions. He received his PhD in 1974 from the University of Heidelberg. After additional academic research at the Massachusetts Institute of Technology in the USA and at the University of Heidelberg, Germany, he joined Biogen in 1980. Here, he held various R&D positions, the last of which was Assistant Research Director. In 1985, he joined Behringwerke AG, Marburg, to build up and head the company's Molecular Biology Department and thereafter became Head of R&D of the Immunology/Oncology Business Unit. In 1999 he joined Global Life Science Ventures at their Munich office. Dr Küpper is the author of numerous publications and patents/applications and has also served as a consultant to the Pharmaceutical Industry and the European Commission. He is a board member of several early stage companies in the life sciences.
Biotechnology↗
Perspective: evolution's struggle for existence in America's public schools.
The ongoing creation-evolution controversy in North America thrives on the widespread special creationist beliefs of a significant portion of the public. Creation science supports a literal interpretation of the Judeo-Christian Bible, an earth that is no more than 10.000 years old and created ex nihilo in six days by a monotheistic God, with no new kinds arising since the period of creation, and with a single flood of staggering force shaping layers of rocks and trapping the organisms fossilized within them. Despite decisions in numerous court cases that specifically exclude creationism and creation science from primary and secondary biology classes in America's public schools, creationists now work locally to minimize or remove evolution from science teaching standards. The nationally organized movement to resist the teaching of evolution has proven highly effective, influencing state and district school boards in addition to individual teachers and schools. Thus, if teaching about evolution and the nature of science is to survive in America's primary and secondary schools, scientists must likewise work with teachers and reach out to state and local school boards. In this perspective we outline the typical creationist arguments we encounter from students, teachers, school board members, and neighbors. We explain briefly how knowledge of both microevolution and macroevolution is important in medicine, agriculture, and biotechnology. We describe a science education controversy that arose within our own school district, how we responded, and what we learned from it. Finally, we argue that even modest outreach efforts to science teachers will be richly repaid.
Attitude↗
Scientific journals and their authors' financial interests: a pilot study.
BACKGROUND: The credibility of modern science is grounded on the perception of the objectivity of its scientists, but that credibility can be undermined by financial conflicts of interest. The US Public Health Service and the National Science Foundation issued regulations effective October 1, 1995, regarding the disclosure of financial interests in the submission of grant proposals. Several scientific journals have also established pertinent policies for authors and editors. The objectives of this study were: (1) to select a set of published articles and observe the degree to which a sample of authors hold a financial interest in areas related to their research that are reportable under current standards, and (2) to examine the hypothesis that significant numbers of authors of articles in life science and biomedical journals have verifiable financial interests that might be important for journal editors and readers to know. This paper measures the frequency of selected financial interests held among lead authors of certain types of scientific publications and assesses disclosure practices of authors and journals. METHOD: These objectives were applied to a pilot study of Massachusetts academic scientists who were cited as first or last author in at least one article published in 1992 in 14 leading journals of cell or molecular biology and medicine. We created a database of every original article published in 1992 by 14 leading life science and biomedical journals, supplemented by data sets consisting of (1) Massachusetts biotechnology firms, including their officers and scientific advisory boards, and (2) scientists listed as inventors on patents or patent applications registered with the World Intellectual Property Organization. RESULTS: We examined 1,105 university authors (first and last cited) from Massachusetts institutions whose 789 articles, published in 1992, appeared in 14 scientific and medical journals. Authors are said to 'possess a financial interest' if they are listed as inventors in a patent or patent application closely related to their published work; serve on a scientific advisory board of a biotechnology company; or are officers, directors, or major shareholders (beneficial owner of 10% or more of stock issued) in a firm that has commercial interests related to their research. Applying the criteria to the reference population of journals and Massachusetts academic authors, we measured the following frequencies for lead authors: 0.20 for serving on a scientific advisory board; 0.07 for being an officer, director, or major shareholder in a biotechnology firm, and 0.22 for being listed as an inventor in a related patent or patent application. The joint frequency of articles in the journals reviewed with a lead author that meets one of the three conditions is 0.34. CONCLUSIONS: One of every three articles in our sample has at least one Massachusetts-based author with a financial interest, and 15% of the authors in our sample have a financial interest relevant to one of their publications. For the year 1992, the rate of published voluntary disclosures of financial interest (as defined in our study) is virtually zero, but relatively few scientific and biomedical journals at that time required any such disclosure to journal editors and reviewers. Further research is needed to determine the effectiveness of mandatory disclosure requirements by some journals.
Authorship↗
Cryosystem.
The Cryosystem is an ultra-low-temperature facility for supporting life-sciences payloads in space. It brings together a unique set of facilities for the optimal preparation, preservation and storage of biological samples and protein crystals at cryogenic temperatures. Thanks to its ultra-rapid cooling capability and its relatively large cold volume, it will provide a great improvement in the quality and quantity of science investigations in the fields of life sciences, physiology and biotechnology. The Cryosystem will complete in the ultra-low temperature field (-180 degrees C) the range of freezers provided by ESA to NASA for use on board the International Space Station (ISS), the other two systems being MELFI working in the temperature range from +4 to -80 degrees C, and the Crew Refrigerator covering the range from +4 to -26 degrees C.
Cryopreservation↗
The role of national ethics commissions in Finland.
There are six national ethics commissions in Finland. The National Advisory Board on Research Ethics was first established in 1991, followed by the National Advisory Board on Biotechnology and the Board on Gene Technology in 1995. The National Advisory Board on Health Care Ethics was established in 1998, followed by its Sub-Committee on Medical Research Ethics in 1999. The Co-operation Group for Laboratory Animal Sciences was established in 2001. Only the Board on Gene Technology works as a national authority and gives binding opinions and recommendations about the use of genetically modified organisms. The Sub-Committee on Medical Research Ethics acts a national research ethics committee and gives opinions about research projects. Other advisory boards do not make legally binding decisions, but their expertise gives a lot of power to their opinions and statements. The commissions work in close collaboration with each other, having regular meetings. They arrange seminars and conferences, and share information with each other. The commissions also share duties and information in international collaboration. How the voice and opinions of these commissions is heard in society lies in the wide, multi-professional expertise of their members. Large commissions and wide expertise may make it difficult to find consensus in their opinions and statements, although wide expertise may, more than discussion in a small expert group, help to further process difficult ethical issues. Collaboration between different bodies is important in order to share duties, and also to add more emphasis to the statements and opinions where different bodies share interests. In our country, the interest that national commissions share is research ethics, where the advisory boards and their members have discharged collaborative activities for years.
Advisory Committees↗
[Animal experimentation in Israel].
In 1994 the Israeli parliament (Knesset) amended the Cruelty to Animals Act to regulate the use of experimental animals. Accordingly, animal experiments can only be carried out for the purposes of promoting health and medical science, reducing suffering, advancing scientific research, testing or production of materials and products (excluding cosmetics and cleaning products) and education. Animal experiments are only permitted if alternative methods are not possible. The National Board for Animal Experimentation was established to implement the law. Its members are drawn from government ministries, representatives of doctors, veterinarians, and industry organizations, animal rights groups, and academia. In order to carry out an animal experiment, the institution, researchers involved, and the specific experiment, all require approval by the Board. To date the Board has approved some 35 institutions, about half are public institutions (universities, hospitals and colleges) and the rest industrial firms in biotechnology and pharmaceutics. In 2000, 250,000 animals were used in research, 85% were rodents, 11% fowls, 1,000 other farm animals, 350 dogs and cats, and 39 monkeys. Academic institutions used 74% of the animals and industry the remainder. We also present summarized data on the use of animals in research in other countries.
Animal Welfare↗
Human genome. Storm erupts over terms for publishing Celera's sequence.
A dispute has been raging behind the scenes for weeks over the conditions under which Celera Genomics is prepared to make its human genome sequence data publicly available. The argument went public on 6 December, when geneticist Michael Ashburner e-mailed an open letter to Science's board of reviewing editors and members of the press slamming an agreement on data release that Science had reached with Celera as a condition for accepting its paper for review. This spat is the latest round in an intense rivalry between Celera president J. Craig Venter and leaders of the Human Genome Project, a publicly funded consortium that has produced its own draft human genome sequence.
Biotechnology↗
The National Institutes of Health system for enhancing the science, safety, and ethics of recombinant DNA research.
Oversight of recombinant DNA research by the National Institutes of Health (NIH) is predicated on ethical and scientific responsibilities that are akin, in many ways, to those that pertain to the oversight of animal research. The NIH system of oversight, which originated more than 25 years ago, is managed by the NIH Office of Biotechnology Activities (OBA), which uses various tools to fulfill its oversight responsibilities. These tools include the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) and the Recombinant DNA Advisory Committee. The OBA also undertakes special initiatives to promote the analysis and dissemination of information key to our understanding of recombinant DNA, and in particular, human gene transfer research. These initiatives include a new query-capable database, an analytical board of scientific and medical experts, and conferences and symposia on timely scientific, safety, and policy issues. Veterinary scientists can play an important role in the oversight of recombinant DNA research and in enhancing our understanding of the many safety and scientific dimensions of the field. These roles include developing appropriate animal models, reporting key safety data, enhancing institutional biosafety review, and promoting compliance with the NIH Guidelines.
Animal Welfare↗
Adventurism in biomedical science: Washington University-Monsanto program in biotechnology.
The Washington University-Monsanto relationship has supported innovation in the biological sciences. It has done so in part by making the fence between an industrial and an academic institution more transparent and more easy to cross. A unique means of promoting intellectual adventurism may be lost, however, if this type of relationship is not structured to maximize the likelihood of obtaining products or if products are the only financial benefit that the industrial partner can derive from such interactions (for example other benefits could include governmental R&D tax credits for those relationships that satisfy some minimal criteria for size and/or length of commitment). I hope that this and other forms of industrial-university relationships that encourage discovery by providing institutional support for new ideas will flourish. Whatever their fate, the responsibility for promoting dreams must be shared by all of us: by those who are privileged to have students in their labs, by academic institutions as they seek to define their roles in the next century, by peer review boards, by national science policymakers, and perhaps by industry. I have presented the Washington University-Monsanto collaboration not as a complete answer to the question of how to promote intellectual adventurism in the biomedical sciences but rather as a concrete response to a problem that must be clearly articulated, thoroughly examined, and creatively addressed.
Ethics, Medical↗
Business Ethics 101 for the biotech industry.
Biotechnology companies face ethical challenges of two distinct types: bioethical challenges faced on account of the nature of work in the life sciences, and corporate ethical challenges on account of their nature as commercial entities. The latter set of challenges has received almost no attention at all in the academic literature or media. This paper begins to remedy that lacuna, examining ethical issues that arise specifically on account of the status of biotech companies as commercial entities. The focus here is on three representative issues: product safety, corporate social responsibility, and corporate governance. It is argued that each of these issues poses particular ethical challenges for companies in the biotech sector. In the area of product safety, it is noted that biotech companies face particular challenges in determining what counts as a "safe" product, given the contentious nature of what might count as a "harm" in the biotech field. In the area of corporate social responsibility, the adoption of a "stakeholder approach" and an attempt to manage the social consequences of products pose special challenges for biotech companies. This is due to the enormous range of groups and individuals claiming to have a stake in the doings of such companies, and the trenchant controversies over just what the social consequences of various biotechnologies might be. In the area of corporate governance, biotech companies need to seek out and follow best practices regarding the ways in which information, authority, and influence flow between a company's shareholders, managers, and Board of Directors, if they are to avoid duplicating the ethical and financial scandal that brought down ImClone. An important meta-issue, here--one that renders each of these corporate ethical challenges more vexing--is the difficulty of finding the appropriate benchmarks for ethical corporate behavior in a field as controversial, and as rapidly evolving, as biotechnology. Three programmatic suggestions can be made: Firstly, scholars and others interested in the ethical performance of the biotech sector must seek out and build opportunities for richer interdisciplinary collaboration. Secondly, companies within the biotech sector must seek out expertise and build capacity and competency in dealing with the corporate ethical issues that arise in their sector. Finally, companies in the biotech sector should explore the opportunities for collective problem solving afforded by the existence of local, national, and international industry associations such as the Biotechnology Industry Organization, BIOTECanada, and EuropaBio.
Benchmarking↗
Complexities in ETS-domain transcription factor function and regulation: lessons from the TCF (ternary complex factor) subfamily. The Colworth Medal Lecture.
The ETS-domain transcription factor family can be divided into a series of subfamilies. Elk-1 represents the founding member of the ternary complex factor (TCF) subfamily. By focusing on the TCF subfamily, we can demonstrate the complexities that exist in the function and regulation of ETS-domain transcription factors. This article focuses on Elk-1 in detail and summarizes the functions of other TCFs. The key themes covered include the domain structure of the TCFs, the mechanisms of complex formation with serum response factor, regulation of TCFs by mitogen-activated protein kinase cascades, and transcriptional regulatory properties of the TCFs. Finally, the emerging role of the TCFs in vivo is discussed. A picture is developing indicating that, while these proteins exhibit significant sequence and functional conservation, key differences in their structure and regulation are being identified which may relate to unique functions of these proteins in vivo.
Amino Acid Sequence↗