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My secret life (in the gingival crevice).

This paper describes my attempt to develop a new technology for sampling the contents of the gingival crevice. Following a brief introduction on the potential of the gingival crevice as a prognosticator of periodontal health, the problems associated with attempting to fulfill this potential are discussed. These problems include difficulties in identifying a crevice component or property that was correlated with disease, the shortcomings of the paper strip method used for sampling from the crevice, and finally difficulties in defining periodontal disease and finding clinical parameters useful for correlation with biochemical studies. A new technology for sampling the contents of the gingival crevice is described. This technology is based on immunomagnetic capture in which antibody coated magnetic microspheres are introduced into the sulcus. Following the capture of antigens, the microspheres are removed and the amount of antigen quantified by immunochemical assays. This paper describes attempts to develop this technology into a commercial product and includes experiences with raising capital and marketing the discovery. A brief discussion of the role of the scientific community, the practicing dentist and insurance coverage to the technology transfer process is included. Finally, some suggestions for improving the technology transfer process are included.

Antibodies, Monoclonal↗

Clinical evaluation of the modular electromechanical lock actuator for above-elbow prostheses: a preliminary report.

The Modular Electromechanical Lock Actuator (MELA) is the result of research and development (R&D) conducted under the direction of Dudley S. Childress, PhD, at the Northwestern University Prosthetics Research Laboratory (NUPRL), Chicago, Illinois. NUPRL, based upon their experience with prostheses for persons with high-level, upper-limb amputations, developed MELA to provide users with more efficient, versatile control and operation of their existing, cable-operated, positive-locking elbow and wrist components. The design of MELA has advanced to the point where it has the potential to improve the functionality and effectiveness of existing, body-powered or manually positioned above-elbow prostheses. This R&D effort has resulted in a pre-market model that is now ready for the national field evaluation part of the technology transfer process coordinated through the VA Rehabilitation Research and Development Service, Technology Transfer Section.

Activities of Daily Living↗

Gene therapy for pancreatic cancer.

Gene transfer technology has the potential to revolutionize cancer treatment. Developments in molecular biology, genetics, genomics, stem cell technology, virology, bioengineering, and immunology are accelerating the pace of innovation and movement from the laboratory bench to the clinical arena. Pancreatic adenocarcinoma, with its particularly poor prognosis and lack of effective traditional therapy for most patients, is an area where gene transfer and immunotherapy have a maximal opportunity to demonstrate efficacy. In this review, we have discussed current preclinical and clinical investigation of gene transfer technology for pancreatic cancer. We have emphasized that the many strategies under investigation for cancer gene therapy can be classified into two major categories. The first category of therapies rely on the transduction of cells other than tumor cells, or the limited transduction of tumor tissue. These therapies, which do not require efficient gene transfer, generally lead to systemic biological effects (e.g., systemic antitumor immunity, inhibition of tumor angiogenesis, etc) and therefore the effects of limited gene transfer are biologically "amplified." The second category of gene transfer strategies requires the delivery of therapeutic genetic material to all or most tumor cells. While these elegant approaches are based on state-of-the-art advances in our understanding of the molecular biology of cancer, they suffer from the current inadequacies of gene transfer technology. At least in the short term, it is very likely that success in pancreatic cancer gene therapy will involve therapies that require only the limited transduction of cells. The time-worn surgical maxim, "Do what's easy first," certainly applies here.

Adenocarcinoma↗

Gene therapy technology applied to disorders of glucose metabolism: promise, achievements, and prospects.

Gene transfer technology has spawned an entire realm of clinical investigation, collectively referred to as "gene therapy." The feasibility and achievements of gene therapy to prevent and treat glucose homeostasis disorders, with particular emphasis on diabetes mellitus, are evaluated in this review. While a considerable amount of effort has yielded gene delivery vectors based on adenoviral, retroviral, and herpes simplex virus DNA, the number of successful clinical applications has not been as impressive. Despite the number of successes in vitro and in animal models, preliminary safety trials in humans have not yet been attempted. The current state of this science, outlined here, underlines the necessity of marrying gene transfer technology with cell therapy. The ex vivo transfer of gene combinations into a variety of cell types will likely prove more therapeutically feasible than direct in vivo vector transfer. Current efforts aimed at assessing the future of gene therapy for diabetes must, at the very least, take into account the importance of moving successful methods into human safety trials.

Diabetes Mellitus↗

Gene therapy in transplantation.

Facilitation of solid organ and cell transplantation depends on metabolic and immunologic factors that can be manipulated ex vivo and in vivo using gene transfer technology. Vectors have been developed which can optimally transfer relevant genes to various tissues and organs. Interventions aimed at promoting tissue preservation before transplantation, prevention of oxidative stress and immunological rejection have recently become attractive options using viral and nonviral gene delivery vehicles. Further understanding of the mechanisms involved in tolerance induction as well as the facilitation of xenogeneic engraftment have made possible a variety of avenues that can be exploited using gene transfer technology.

Animals↗

Principles and process in the development of the Mayo Clinic's individual and institutional conflict of interest policy.

In 1995, federal regulations required all academic medical centers to implement policies to manage individual financial conflict of interest. At the Mayo Clinic, all staff are salaried, and all medically related intellectual property from the staff belongs to the clinic. Hence, it was necessary to develop a policy for institutional conflict of interest to complement the policy for individual conflicts of interest. This article addresses the principles and process that led to the development of the Mayo Clinic's policies that guide the management of conflict of interest of individuals and of the institution. Empowered by the Bayh-Dole Act, the Mayo Clinic participates in technology transfer through its entity Mayo Medical Ventures. Individual conflicts of interest arising from such technology transfer are associated with Institutional conflicts because all individual intellectual property belongs to the institution, per clinic policy. This policy addresses conflicts of interest that arise in research, leadership, clinical practice, investments, and purchasing. Associated with the statutory annual disclosure on personal consulting and other relationships with Industry, which are guided by federal regulations, all research protocols or grant applications require financial disclosure on initial submission and in annual progress reports. The clinic's Conflict of Interest Review Board was established to review each disclosure and recommend management of individual and institutional conflicts of interest according to policy.

Academic Medical Centers↗

Intranet usage and potential in acute care hospitals in the United States: survey-2000.

This paper provides the results of the Survey-2000 measuring Intranet and its potential in health care. The survey measured the levels of Internet and Intranet existence and usage in acute care hospitals. Business-to-business electronic commerce and electronic commerce for customers were measured. Since the Intranet was not studied in survey-1997, no comparisons could be made. Therefore the results were presented and discussed. The Intranet data were compared with the Internet data and statistically significant differences were presented and analyzed. This information will assist hospitals to plan Internet and Intranet technology. This is the third of three articles based upon the results of the Survey-2000. Readers are referred to prior articles by the author, which discusses the survey design and provides a tutorial on technology transfer in acute care hospitals.(1) The first article based upon the survey results discusses technology transfer, system design approaches, user involvement, and decision-making purposes. (2) The second article based upon the survey results discusses distribution of Internet usage and rating of Internet usage applied to specific applications. Homepages, advertising, and electronic commerce are discussed from an Internet perspective.

Computer Communication Networks↗

Strengthening HIV prevention: application of a research-to-practice framework.

As the HIV epidemic continues to affect at-risk and vulnerable populations, providers strive to improve prevention programs, in part by seeking new interventions with greater effects. Although interventions with scientific evidence of effectiveness are vital to this effort, many challenges limit access to research products. We examine key challenges and offer a framework for moving research to practice, one in which research steps are linked to practice steps and all these activities take place in a complex and dynamic environment. The Replicating Effective Programs (REP) project of the Centers for Disease Control and Prevention and other technology transfer activities illustrate the operation of this framework for HIV prevention. Further actions to improve technology transfer are called for. These include reducing time from study design to practice; learning from field-based implementations; providing guidance about fidelity to, and tailoring of, science-based interventions; improving linkages among consumers, providers, and researchers; and seeking additional resources.

Centers for Disease Control and Prevention, U.S.↗

Cultural aspects of information technology implementation.

Culture sets our values and norms. It is a way of thinking that determines our behaviours, decisions, actions and knowledge. Technology transfer and integration are basically the exchange of the knowledge, know-how and skills through which technology was created and on which its use depends. Culture is deeply rooted in ourselves. We are usually unaware of its influence on our professional activity. Cultures are diverse, and their encounter through technology exchange triggers conflicts that are expressed in objective terms. We need to detect and resolve those conflicts at the right level, i.e. at the cultural level instead of only focusing on the visible 'obstacles' to the deployment of telematics applications. This paper summarises the basic concepts on which we ground a practical approach to detecting and resolving culture-based conflicts in technology transfer and integration. It investigates the relation between cultural preferences and actions. Culture is translated and reduced to a seven dimensions framework. Cultural preferences influence the decision-making process that leads to tangible actions. The structure and dynamics of that process are described as a Change Governance Framework. It considers the control aspects of decision making that are sensitive to cultural preferences, i.e. the way decisions are taken, why, by whom.

Cultural Diversity↗

Distance communication transfer of HIV prevention interventions to service providers.

Most acquired immunodeficiency syndrome (AIDS) service providers are in countries with little access to scientific developments relevant to their programs. It is critical to transfer advances from the scientific arena to service providers on a global scale. Human immunodeficiency virus (HIV) prevention organizations in 78 countries were randomized to receive either a control condition or a technology transfer condition with an interactive distance learning computer training curriculum and individualized distance consultation. Of 42 nongovernmental organizations in the technology transfer condition, 29 adopted the science-based program in their communities or trained other agencies to also use it. Advanced communication technologies can create a cost-effective infrastructure to disseminate new intervention models to service providers worldwide.

Communication↗

Transgenic crops, biotechnology and ownership rights: what scientists need to know.

Ownership of intellectual and tangible property (IP/TP) rights in agricultural biotechnology (ag-biotech) and transgenic plants has become critically important. For scientists in all institutions, whether industrialized or developing country, public or private sector, an understanding of IP/TP rights is fundamental in both research and development. Transgenic plants and ag-biotech products embody numerous components and processes, each of which may have IP/TP rights attached. To identify these rights, a transgenic plant or ag-biotech product must be dissected into its essential components and processes, with each 'piece' analysed under the IP/TP 'microscope'. This product deconstruction is an integral step in product clearance (PC) analysis leading to freedom to operate (FTO). To facilitate a PC analysis, the following points are important: (1) knowing what one has and where it's from, (2) organizing material transfer agreements and licences, (3) researching scientific and patent databases and relevant literature, (4) instituting a laboratory notebook policy, (5) keeping track of ownership of germplasm and plant genetic resources, and (6) promoting ongoing IP/TP management, awareness and training. However, a FTO opinion does not solve the IP/TP issues of releasing a transgenic plant or ag-biotech product; rather, it is a management tool for assessing the risks of litigation. When transferring transgenic plants or ag-biotech to developing nations, scientists from industrialized countries have the heightened responsibility of verifying that IP/TP issues are fully addressed and documented. Successful technology transfer goes beyond research, development and licensing; it is an holistic package leading to long-term partnerships in international development. Managing IP/TP requires capacity-building in scientists and technology transfer offices, in both industrialized and developing countries.

Biotechnology↗

Characteristics of opinion leaders in substance abuse treatment agencies.

OBJECTIVE: This study was part of a larger effort to test the effectiveness of technology transfer approaches related to evidence-based treatment of co-occurring substance abuse and mental health disorders. Specifically, this study examined characteristics of "opinion leaders" as technology transfer agents. METHOD: A network analysis was conducted within four large substance abuse treatment agencies to identify individuals that other counselors sought out for consultation on co-occurring issues. The identified opinion leaders were then compared with other counselors on demographic variables, education and experience, and attitudes and knowledge about working with individuals with co-occurring disorders. RESULTS: The analyses demonstrate that opinion leaders differed from other counselors in competency-related characteristics including more postgraduate education, relevant professional credentials, and years of experience in mental health treatment. They also had greater knowledge of the dynamics and treatment of co-occurring disorders as well as a greater willingness and confidence in working with such clients. CONCLUSION: These results suggest that opinion leaders are used within agencies for information and consultation regarding treatment issues. Therefore, opinion leaders may provide an important vehicle for dissemination and adoption of evidence-based treatment practices in community treatment settings.

Adult↗

Impact of transgenic technologies on functional genomics.

Gene transfer technologies in mammals are the focus of renewed interest owing to the recent emphasis on analyzing gene function in the postgenomic era. Three important developments in this area include transgenics, gene targeting and nuclear transfer or animal cloning. These technological innovations have enhanced our ability to analyze gene function at the level of the whole organism and have provided the means to modify gene expression. This review discusses the origins and current status of transgenic technologies. Various applications and technologies including chromosome engineering, stem cells, gene traps and modification of livestock are presented. The impact of mouse technologies and genomics on functional analyses is also discussed.

Animals↗

Reproductive tract gene transfer.

OBJECTIVE: Gene therapy is a rapidly evolving novel treatment for human disease. This review discusses the latest development in gene transfer technology and its potential use in the female reproductive tract. METHODS: A comprehensive search using the MEDLINE database was performed to review current, innovative trends in gene transfer technology. In addition, articles on reproductive tract gene transfer were reviewed. CONCLUSION(S): Recent developments, such as the Human Genome Project, have generated great interest in the genetic basis of human health and disease. Gene therapy is a rapidly evolving field that uses gene transfer to treat disease. Ongoing research in the field focuses on improving vector technology to enable efficient in vivo gene transfer. Although multiple techniques for gene transfer have been described, no single technique can be used in all instances. The human female reproductive tract is easily accessible and can be readily transfected. In vivo gene transfer has resulted in successful alteration of implantation rates and has demonstrated potential for use in treatment of ovarian cancer.

Animals↗

Adapting an evidence-based intervention: tales of the Hustler Project.

The field of HIV prevention is rapidly moving toward evidence-based practice as the standard way community-based organizations should do business. Current discussion about how to transfer evidence-based HIV prevention programs and practices to community-based organizations favors the perspectives of those scientists who hope to disseminate their programs to service providers. To date, there are few descriptions of community-based organizations' experiences adopting programs presented in the HIV prevention literature. Understanding and learning from community-based organizations' experiences of adopting programs can inform intervention design and the theory and practice of technology transfer. The current article describes one organization's experience adopting the popular opinion leader intervention. Implications for technology transfer are provided.

Evidence-Based Medicine↗

Status of regulatory approval of biotechnology-derived plants and animals.

Development of new technology brings with it decisions regarding regulation to ensure safety in technology transfer. Properly formulated and administrated, such regulations can act as a catalyst for the transfer of new technology, not a barrier. Such regulations must be based on sound scientific principles, and are intended to provide protection for the public, engender public acceptance, and foster communication with the various segments of society. To develop this new technology in a safe and orderly manner field testing of the products/organisms of biotechnology, especially genetic engineering, has been permitted by the U.S. Department of Agriculture (USDA). USDA permits certify the environmental safety of field testing of plants and microorganisms developed through the use of material derived from plant pests. Permits are issued based upon analyses of the biology of the organism, the affected environment, and the precautions taken to ensure environmental protection. Licenses for the use of veterinary biologics, including recombinant vaccines, are also issued.

Animals↗