New biotech review board planned.
Explore the source record for details and available documents.
Advisory Committees↗
SEARCH · Search PubMed
Results for “Biotechnology Science Board”
Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.
Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.
NIH/FDA dispute likely to delay research.
Explore the source record for details and available documents.
Advisory Committees↗
Regulating human gene therapy.
Explore the source record for details and available documents.
Advisory Committees↗
Genetic engineering. New advisory board approved.
Explore the source record for details and available documents.
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 NUS MBBS-PhD programme: nurturing clinician-scientists for tomorrow.
The MBBS-PhD programme is a significant milestone in medical education in Singapore. In July 2000, the Faculty of Medicine, National University of Singapore launched this programme in collaboration with the Institute of Molecular and Cell Biology, with support from the Economic Development Board, and the Agency for Science, Technology and Research, Singapore. The objectives of the programme are to nurture and develop the talents of the brightest medical students by integrating clinical and basic biomedical research training, as well as to stimulate advanced basic and applied research in areas of growing importance to clinical medicine. The programme also aims to train clinician-scientists who will interface basic biology and clinical practice to solve biomedical problems and spearhead biomedical research initiatives in Singapore. Successful MBBS-PhD graduates can pursue career tracks in clinical research, basic biomedical research or in the biotechnology industry.
Curriculum↗
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↗
Consensus document on European brain research.
Brain disease psychiatric and neurologic disease combined represents a considerable social and economic burden in Europe. Data collected by the World Health Organization (WHO) suggest that brain diseases are responsible for 35% of Europe's total disease burden. An analysis of all health economic studies of brain diseases in Europe, published by the European Brain Council (EBC) in June 2005, estimated the total cost of brain disease in Europe in 2004 to be Euro 386 billion. That burden is set to grow, mainly due to the fact that the European population is ageing. Investment in brain sciences does not match that burden now, let alone in the future. Brain research received only 8% of the life science budget in the European Commission's Fifth Framework Programme, which represents less than 0.01% of the annual cost of brain disorders for that period. Over the last decade, Europe has been losing ground to the USA and Japan in terms of both basic and clinical research. Many of Europe's young researchers are taking up posts in the USA and staying there. Big pharmaceutical companies are fleeing Europe for the USA, taking their drug development programmes with them. Research in the brain sciences now holds the promise of therapies that halt and even reverse neurodegeneration, of better diagnostic tools, neural prostheses for the paralysed and drugs for depression and anxiety that are tailored to the individual, thereby eliminating or reducing side effects. Our growing understanding of the normal brain could lead to better prevention of brain disease and to more effective teaching methods. The need for innovative treatments has never been greater, and Europe boasts clusters of excellent researchers in biotechnology who could collaborate with brain scientists and the pharmaceutical industry to realise this promise. But if Europe is to seize these opportunities and meet the challenge of brain disease, it needs to go forward on the basis of greater collaboration between countries, greater collaboration between industry, academia and patient organisations, and increased investment in the brain sciences. The EBC was formed in 2002 to bring together scientists, clinicians, the pharmaceutical industry, charities and patient organisations from all over Europe to campaign for these goals. It takes a novel, bottom-up approach to research policy, and in developing this consensus document, it aims to promote a greater and more focused effort in this area, to improve public understanding of the brain sciences and above all, to support brain research as a priority under the European Commission's Seventh Framework Programme (FP7, 2007-2013). The research programme outlined here was first conceived by the EBC board. An outline was sent to all member organisations and a number of individual experts for comments. Following that, a table of contents was developed. The 45 research themes were written by groups of experts from across Europe who represent a wide range of disciplines. Each one contains a proposal for future research on a specific brain-related theme which the EBC believes could form the basis of one or more integrated projects or strategic targeted research projects (STREP) funded under FP7. The EBC has deliberately focused on the major diseases and then described the basic research needed to understand and treat or perhaps even cure those diseases. The programme is therefore constructed "from man to molecule" and not the other way round, with equal importance attached to basic and clinical research. The EBC suggests that each of the proposed integrated projects or STREP should be awarded a budget in the order of Euro 10 to 15 million. In addition, brain research should be treated as an important element of many other parts of FP7, such as the European Research Council and research programmes on information technology and the causes of violence. Any research programme that concerns human behaviour should, by definition, take account of brain research. The EBC envisages that the priority for brain research it proposes at the European level will translate into higher priority for brain research at the national level, and this document may also serve as a starting point for the development of national consensus programmes. It seems likely that consensus conferences on brain research in Europe may further develop the themes and ideas discussed here. An EBC task force may also be established to further the consensus process. In general, increasing funding in the brain sciences would bring enormous economic returns by lightening the burden on healthcare systems and increasing the productivity of affected individuals-and might easily pay for itself. The human and social returns of such an investment are inestimable. And the time to act is now.
Biomedical Research↗
Assessing commercial feasibility: a practical and ethical prerequisite for human clinical testing.
This article proposes that an assessment of commercial feasibility should be integrated as a prerequisite for human clinical testing to improve the quality and relevance of materials being investigated, as an ethical aspect for human subject protection, and as a means of improving accountability where clinical development is funded on promises of successful translational research. A commercial feasibility analysis is not currently required to justify human clinical testing, but is assumed to have been conducted by industry participants, and use of public funds for clinical trials should be defensible in the same manner. Plant-made vaccines (PMVs) are offered in this discussion as a model for evaluating the relevance of commercial feasibility before human clinical testing. PMVs have been proposed as a potential solution for global health, based on a vision of immunizing the world against many infectious diseases. Such a vision depends on translating current knowledge in plant science and immunology into a potent vaccine that can be readily manufactured and distributed to those in need. But new biologics such as PMVs may fail to be manufactured due to financial or logistical reasons--particularly for orphan diseases without sufficient revenue incentive for industry investment--regardless of the effectiveness which might be demonstrated in human clinical testing. Moreover, all potential instruments of global health depend on translational agents well beyond the lab in order to reach those in need. A model compromising five criteria for commercial feasibility is suggested for inclusion by regulators and ethics review boards as part of the review process prior to approval of human clinical testing. Use of this model may help to facilitate safe and appropriate translational research and bring more immediate benefits to those in need.
Biotechnology↗
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↗