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Biotechnology's foreign policy.

From its inception, biotechnology has been a uniquely international enterprise. An American and an Englishman working together elucidated the structure of DNA almost 50 years ago; more recently, the Human Genome Project linked researchers around the world, from the Baylor College of Medicine in Houston to the Beijing Human Genome Center. Today our industry's researchers hail from African villages and Manhattan high rises; from Munich and Melbourne; from London, Ontario, and London, England; from Scotland and Nova Scotia--New Scotland; from Calcutta and Calgary. But in the beginning, the infrastructure that supported these efforts--intellectual property, venture capital, streamlined technology transfer--was less widely dispersed and the world's brightest biotech researchers clustered in only half a dozen scientific Meccas. Previous technological revolutions have spread around the world. Following in their footsteps, biotechnology's global diaspora seems inevitable, especially since governments are promoting it. But as our science and business emigrate from early strongholds in the United States, Canada and Europe across oceans and borders and into new cultures, international tensions over biotechnology continue to grow. In just the last few years, controversies have rolled over R&D spending priorities, genetic patents, bioprospecting, transgenic agriculture and drug pricing. My premise today is that our industry needs to formulate its first foreign policy, one which is cognizant of the miserable judgments and mistakes of other industries--and avoids them.

Biotechnology↗

Academic-industrial relationships: opportunities and pitfalls.

Over the past 50 years, academic-industrial collaborations and technology transfer have played an increasingly prominent role in the biomedical sciences. These relationships can speed the delivery of innovative drugs and medical technologies to clinical practice, creating important public health benefits as well as income for universities and their faculty. At the same time, they raise ethical concerns, particularly when research involves human subjects in clinical trials. Lapses in oversight of industry sponsored clinical trials at universities, and especially patient deaths in a number of trials, have brought these issues into the public spotlight and have led the federal government to intensify its oversight of clinical research. The leadership of Harvard Medical School convened a group of leaders in academic medicine to formulate guidelines on individual financial conflicts of interest. They and other groups are working to formulate a national consensus on this issue.

Conflict of Interest↗

The ARC organizational and community intervention strategy for implementing evidence-based children's mental health treatments.

This paper reviews the implications of organizational and community intervention research for the implementation of effective mental health treatments in usual community practice settings. The paper describes an organizational and community intervention model named ARC for Availability, Responsiveness and Continuity, that was designed to support the improvement of social and mental health services for children. The ARC model incorporates intervention components from organizational development, interorganizational domain development, the diffusion of innovation, and technology transfer that target social, strategic, and technological factors in effective children's services. This paper also describes a current NIMH-funded study that is using the ARC intervention model to support the implementation of an evidence-based treatment, Multisystemic Therapy (MST), for delinquent youth in extremely rural, impoverished communities in the Appalachian Mountains of East Tennessee.

Appalachian Region↗

HIS priorities in developing countries.

Looking for a solution to fulfill the requirements that the new global economical system demands, developing countries face a reality of poor communications infrastructure, a delay in applying information technology to the organizations, and a semi-closed political system avoiding the necessary reforms. HIS technology has been developed more for transactional purposes on mini and mainframe platforms. Administrative modules are the most frequently observed and physicians are now requiring more support for their activities. The second information systems generation will take advantage of PC technology, client-server models and telecommunications to achieve integration. International organizations, academic and industrial, public and private, will play a major role to transfer technology and to develop this area.

Costs and Cost Analysis↗

A conceptual framework for transferring research to practice.

Systematic evaluations of efforts to transfer research-based interventions and procedures into general practice at community drug treatment programs have been limited. However, practical experiences as well as results from studies of technology transfer and organizational behavior in related fields provide a basis for proposing a heuristic model of key factors that influence this process. The successful completion of four stages of activity typically involved in program change (exposure, adoption, implementation, and practice of new interventions) appears to be influenced by several organizational considerations (e.g., institutional readiness for change, resources, and climate) as well as staff attributes. Assessment instruments for measuring organizational functioning (based on ratings aggregated for staff and patients in a program) are introduced, along with preliminary evidence for their validity. A better conceptual understanding of the process of program change and common barriers that may be encountered is needed for effectively transferring research to practice.

Academies and Institutes↗

Gene transfer to subdermal tissues via a new gene gun design.

Although particle-mediated gene transfer technology (gene gun) has been applied for gene transfer to external tissues, the application of this technology to other tissues has met with limited success. Here we report the development of a new design of a gene gun that uses helium discharge to propel DNA-coated gold beads that are suspended in liquid. Higher discharge pressures allow for the delivery of DNA to deeper tissues. Using the new gene gun to deliver a luciferase expression plasmid resulted in higher levels of gene expression in the skin than observed with conventional guns, as well as in subdermal tissues, including subcutaneous tumors. Even when using as little as 125 ng of DNA, gene expression in skin and muscle reached its peak level at 24 hr postbombardment and remained for at least 1 week. The use of a LacZ expression plasmid showed that gene expression was distributed throughout the skin with no observable pathology. The new gene gun was used to deliver a model tumor rejection antigen (a modified human papilloma virus [HPV] E7 gene) to mice. All of the treated animals developed protective immunity against HPV-positive tumors. These results demonstrate that our new design can be used in standard gene gun applications and extends the reach of gene gun technology to tissues that were previously unavailable.

Animals↗

Assessing organizational readiness for change.

A comprehensive assessment of organizational functioning and readiness for change (ORC) was developed based on a conceptual model and previous findings on transferring research to practice. It focuses on motivation and personality attributes of program leaders and staff, institutional resources, and organizational climate as an important first step in understanding organizational factors related to implementing new technologies into a program. This article describes the rationale and structure of the ORC and shows it has acceptable psychometric properties. Results of surveys of over 500 treatment personnel from more than 100 treatment units support its construct validity on the basis of agreement between management and staff on several ORC dimensions, relationships between staff organizational climate dimensions and patient engagement in treatment, and associations of agency resources and climate with organizational stability. Overall, these results indicate the ORC can contribute to the study of organizational change and technology transfer by identifying functional barriers involved.

Humans↗

Academic-industrial collaboration: the good, the bad, and the ugly.

Academic-industrial collaborations and technology transfer have over the past 50 years played an increasingly prominent role in the biomedical sciences. University partnerships with industry can expedite the availability of innovative drugs and other medical technologies, bringing both important public health benefits and a source of income for universities and their faculty through a variety of financial arrangements. However, these relationships raise ethical concerns, particularly when research involves human subjects in clinical trials. Lapses in oversight of industry-sponsored clinical trials at universities, and especially patient deaths in a number of trials, have brought these issues into the public spotlight and have led the federal government to intensify its oversight of clinical research. The leadership of Harvard Medical School convened a group of leaders in academic medicine to formulate guidelines on individual financial conflicts of interest. They and other groups are working to formulate a national consensus on this issue.

Academic Medical Centers↗

Economic effects and spin-offs in a small space economy: the case of Canada.

Canada, through a well-focused space program (telecommunications, earth observation, robotics), has succeeded in developing a space industry largely based on SMEs. The result has been significant economic benefits and technological spin-offs. In this article, the results of two programs, the ESA (European Space Agency) and the STEAR (Strategic Technologies in Automation and Robotics), are compared. The ESA program has generated significant indirect effects and spin-offs for Canadian exports. ESA's reputation and network have enabled SMEs to increase export sales of both space products and other commercial products derived from space technologies. The STEAR program has been highly successful in promoting a new generation of SMEs for space robotics, encouraging both spin-in and spin-offs of technologies. The analysis highlights the complementarity of mission- and diffusion-oriented programs in the technology transfer process.

Canada↗

Biomarkers and pediatric environmental health.

It is now possible to identify biochemical and/or cellular changes in humans due to exposure to an environmental toxin. These changes are called biomarkers and are currently used in research studies to identify individuals exposed to specific toxic substances. Advances in the field of biomarker technology may have important implications for the detection, prevention, and treatment of certain diseases in children. This technology may enable physicians to screen children who have no clinically detectable illness for evidence of exposure to specific toxins. Such information could lead to implementation of preventive measures and development of new therapeutic strategies. However, several important issues, including potential adverse consequences resulting from the widespread use of this technology, must be considered prior to its utilization within a clinical setting. Leaders of the pediatric and public health communities should recognize the paucity of scientific data in the pediatric environmental health area, and new approaches to this important aspect of child health should be developed. This article will address several of the issues involved in pediatric environmental health and consider questions that should be answered as the potential for technology transfer becomes a reality.

Adult↗

The interactions between clinical informatics and bioinformatics: a case study.

For the past decade, Stanford Medical Informatics has combined clinical informatics and bioinformatics research and training in an explicit way. The interest in applying informatics techniques to both clinical problems and problems in basic science can be traced to the Dendral project in the 1960s. Having bioinformatics and clinical informatics in the same academic unit is still somewhat unusual and can lead to clashes of clinical and basic science cultures. Nevertheless, the benefits of this organization have recently become clear, as the landscape of academic medicine in the next decades has begun to emerge. The author provides examples of technology transfer between clinical informatics and bioinformatics that illustrate how they complement each other.

Academic Medical Centers↗

How farmers in Switzerland perceive fertilizers from recycled anthropogenic nutrients (urine).

We studied acceptance of a urine-based fertilizer product using a mail survey of 467 Swiss farmers. We distinguished among four production types: organic or IP farming, and with or without vegetable production. Considering that the idea of urine-based fertilizers is new, acceptance among the answering farmers was surprisingly high, with 57% explicitly stating that they thought it was a good or very good idea, and 42% willing to purchase such a product. The farmers of different production types did not differ strongly in their attitude towards urine-based fertilizers. Especially IP and vegetable farmers, who purchased additional fertilizers anyway, seem willing to accept urine-based fertilizers, hereby preferring a grainy, odorless ammonium nitrate fertilizer. Absolutely essential is a hazard-free product: 30% of all farmers had concerns regarding micropollutants. Based on fertilizer data, we demonstrate an existing demand for the nutrients N, P, and K in Switzerland, which could be partially substituted by a recycled urine product. Finally, we discuss methodological requirements of social science surveys. To obtain representative data on an entire population in a mail survey, multiple contacts with respondents are necessary. We argue that information and participation of stakeholders at an early stage is essential for successful technology transfer.

Adult↗

Medical and surgical applications of space biosensor technology.

Researchers in space life sciences are rapidly approaching a technology impasse. Many of the critical questions on the impact of spaceflight on living systems simply cannot be answered with the limited available technologies. Research subjects, particularly small animal models like the rat, must be allowed to function relatively untended and unrestrained for long periods to fully reflect the impact of microgravity and spaceflight on their behavior and physiology. These requirements preclude the use of present hard-wired instrumentation techniques and limited data acquisition systems. Implantable sensors and miniaturized biotelemetry are the only means of capturing the fundamental and critical data. This same biosensor and biotelemetry technology has direct application to Earth-based medicine and surgery. Continuous, on-line data acquisition and improved measurement capabilities combined with the ease and flexibility offered by automated, wireless, and portable instruments and data systems, should provide a boon to the health care industry. Playing a key role in this technology revolution is the Sensors 2000! (S2K!) Program at NASA Ames Research Center. S2K!, in collaboration with space life sciences researchers and managers, provides an integrated capability for sensor technology development and applications, including advanced biosensor technology development, spaceflight hardware development, and technology transfer and commercialization. S2K! is presently collaborating on several spaceflight projects with dual-use medical applications. One prime example is a collaboration with the Fetal Treatment Center (FTC) at the University of California at San Francisco. The goal is to develop and apply implantable chemical sensor and biotelemetry technology to continuously monitor fetal patients during extra-uterine surgery, replacement into the womb, through birth and beyond. Once validated for ground use, the method will be transitioned to spaceflight applications to remotely monitor key biochemical parameters in flight animals. Successful application of NASA implantable biosensor and biotelemetry technologies should accelerate the advancement of this and other modern medical procedures while furthering the exploration of life in space.

Aerospace Medicine↗

Virtual reality for autism communication and education, with lessons for medical training simulators.

This study is adapting Virtual Reality (VR) technologies to teach children with autism new coping skills that may then be generalized in their everyday lives. It helps to understand that children with autism are challenged by a sensory overload and by aversions to a variety of auditory, visual, and tactile stimuli. In addition, their ability to attenuate and/or ignore these stimuli differs from that of the "typical" child. Therefore, our goals were to: 1. assess the potential of each of the children (both with and without verbal skills) for sustained interaction with task environments, 2. to identify which visual, auditory, and kinetic VR components would be attractive to our test group, 3. to identify each child's ability to attenuate and/or ignore a variety of distractors, and 4. to build new "pivotal behaviors" [2] for learning. These pivotal behaviors include: improvement of time-on-task, meaningful and consistent interaction with the real world, and screening out extraneous environmental stimuli. Our findings to date have been very encouraging, and we will continue to investigate the role of VR as a tool for generalized learning and the modification of pivotal behaviors. This ongoing study also provides technology transfer of communications applications from government, universities and businesses out into telemedicine and elementary schools.

Attention↗

Barriers that impede the adoption of pediatric information technology.

BACKGROUND: Information technology (IT) is a critical but underused component of health care. Many factors contribute to the inconsistent adoption of IT. OBJECTIVE: To review the literature to better elucidate barriers that are likely to affect the adoption of IT by pediatric professionals. DATA SOURCES: Manuscripts were found using a MEDLINE search combining the terms medicine, information systems, and technology transfer. I also obtained references cited by relevant articles. Finally, I explored the Internet using http://www.google.com and http://www.northernlight.com. STUDY SELECTION: Articles discussing barriers or factors affecting the adoption of IT were considered for inclusion. Articles unrelated to clinical IT were excluded. DATA SYNTHESIS: A variety of barriers exist that affect the adoption of useful technologies. Situational barriers include challenges imposed by the current national health environment, financial and legal risks associated with technology purchasing and use, and access to technology. The most significant barrier is that pediatric health care practitioners may lack the knowledge or training to use IT effectively. CONCLUSIONS: Although some barriers exist that may be challenging to overcome, other barriers, such as the lack of knowledge about the uses of IT, are imminently solvable. Efforts to overcome these barriers should begin in earnest and should include educating stakeholders in the care of children and adolescents, as well as improving the knowledge about various technologies available to support pediatric and adolescent health care.

Biomedical Technology↗

Paediatric nephrology in countries with limited resources.

This paper summarises a symposium concerned with the provision of care for children with kidney disease in developing countries. Better organisation of services is required to prevent waste of resources, with the emphasis on team work between professionals, shared care with local health care personnel remote from the paediatric nephrology unit and good communications. Families need to be educated and provided with appropriate information so that they can care for their child at home. Technology should be simple and robust and the staff using it should be fully trained to maintain it in use. Therapies should be definitive where possible, because long-term supervision of treatment is often difficult. Effective but inexpensive medications should be used where possible. Twinning of developing and richer countries is valuable to transfer technology, help with training and assist in care through the development of personal contacts.

Child, Preschool↗

Gene-based strategies for the immunotherapy of cancer.

T lymphocytes play a crucial role in the host's immune response to cancer. Although there is ample evidence for the presence of tumor-associated antigens on a variety of tumors, they are seemingly unable to elicit an adequate antitumor immune response. Modern cancer immunotherapies are therefore designed to induce or enhance T cell reactivity against tumor antigens. Vaccines consisting of tumor cells transduced with cytokine genes in order to enhance their immunogenicity have been intensely investigated in the past decade and are currently being tested in clinical trials. With the development of novel gene transfer technologies it has now become possible to transfer cytokine genes directly into tumors in vivo. The identification of genes encoding tumor-associated antigens and their peptide products which are recognized by cytotoxic T lymphocytes in the context of major histocompatibility complex class I molecules has allowed development of DNA-based vaccines against defined tumor antigens. Recombinant viral vectors expressing model tumor antigens have shown promising results in experimental models. This has led to clinical trials with replication-defective adenoviruses encoding melanoma-associated antigens for the treatment of patients with melanoma. An attractive alternative concept is the use of plasmid DNA, which can elicit both humoral and cellular immune responses following injection into muscle or skin. New insights into the molecular biology of antigen processing and presentation have revealed the importance of dendritic cells for the induction of primary antigen-specific T cell responses. Considerable clinical interest has arisen to employ dendritic cells as a vehicle to induce tumor antigen-specific immunity. Advances in culture techniques have allowed the generation of large numbers of immunostimulatory dendritic cells in vitro from precursor populations derived from blood or bone marrow. Experimental immunotherapies which now transfer genes encoding tumor-associated antigens or cytokines directly into professional antigen-presenting cells such as dendritic cells are under evaluation in pre-clinical studies at many centers. Gene therapy strategies, such as in vivo cytokine gene transfer directly into tumors as well as the introduction of genes encoding tumor-associated antigens into antigen-presenting cells hold considerable promise for the treatment of patients with cancer.

Animals↗

Advances in telecommunications concerning epilepsy.

Telemedicine is a rapidly expanding discipline. Looking back on a long tradition of telemetric measurement and transmission of brain electrical data, one might ask how relevant telecommunication techniques have become for clinical work in epileptology. In principle, communication can be either between patient and doctor or between doctor and doctor. The former includes telephone reports on frequency and severity of seizures and on mental and physical state. Because of the special problems of patients with epilepsy, the need for traveling should be minimized. To maintain close contact, telemetric transmission of electroencephalograms (EEG), seizure video-registration, and monitoring of anti-epileptic drug (AED) blood levels from home are desirable, but the technical tools now available are not of sufficiently high performance for these applications. However, physicians and medical units can communicate using high-rate data transfer. There are major problems with this technology. Transfer rates using the internet are not fixed. Moreover, using six digital telephone lines simultaneously, good-quality transmission of a 3-min video may take more than 1 h, restricting interactivity. In contrast to imaging (e.g., magnetic resonance imaging), there is no generally accepted protocol for handling EEG/electrocorticography data. There are also legal problems relating to the responsibility for failures and safety of personal or medical data. Nevertheless, the expenses of installation and use of such equipment appear justified by the expected benefits, for the patients (avoiding travel and multiple investigations, checking diagnosis and therapy, amending quality of life), for the physician (sparing equipment and manpower, accelerating and improving diagnosis), for the epilepsy center (increased database for expert systems, improved logistic and data storage) and, finally, for insurance providers (reduced overall costs). When the neurosurgical procedure is remote from the place of presurgical evaluation, telecommunication should be obligatory.

Confidentiality↗