The institutional official and postapproval monitoring: the view from 10,000 feet

The role of the institutional official (IO) in ensuring a high-quality program of laboratory animal care and use has received relatively little attention in the literature compared to that of the institutional animal care and use committee (IACUC) or attending veterinarian. Yet the IO is critical to institutional effectiveness. Often not a scientist, especially at colleges and universities, the IO is an executive who bears ultimate responsibility for the care and use of laboratory animals. An IO operates largely through delegation to the IACUC and the institutional veterinarian, yet must maintain a clear view of the program from the executive level--the "view from 10,000 feet." To do so, the IO must bring four critical leadership qualities to the position: (1) vision, (2) a commitment to quality and integrity, (3) strong planning and resource development, and (4) accountability to the laboratory animal program. The IO's ability to act on these qualities and to evaluate the effectiveness of the resulting program requires reliance on a strong program of postapproval monitoring (PAM). Summary data from PAM, based on metrics carefully defined by the IO in consultation with the IACUC and the institutional veterinarian, provide the feedback necessary to guide executive decisions and allow the IO to place the needs of the program of laboratory animal care and use successfully into the larger context of the mission of the institution.     

REPLI: A program in BASIC for determination of approximate sample size

REPLI, a program written in elementary BASIC, calculates the approximate sample size, which is required to detect a desired difference between any two group means in an experiment with n groups for a given probability and at three significance levels of the means difference. A prior knowledge of the variability of data in the groups is expected in order to base the estimate on a rational footing. If this knowledge does not exist, an educated guess and/or several trials with different assumptions on the most likely variability can be used. The a priori estimate prevents that sample sizes are completely out of a reasonable range. Since the program is applicable for experimental settings where several groups need be investigated, it is particularly interesting to users of ANOVA and/or comparable non-parametric tests.     

A monitoring program for Patagonian foxes based on power analysis

Culpeo fox (Pseudalopex culpaeus) and gray fox (Pseudalopex griseus) are heavily culled in Patagonia. Fox populations seem to persist thanks to spatial refuges from which hunted areas are repopulated, following a source–sink dynamics. Sustainable use of Patagonian foxes warrants the design of a monitoring program in nature reserves and areas subjected to predator control. During 7 years, we used visitation indices to bait stations in a national park and neighboring sheep ranches of southern Argentina. We operated bait stations during three consecutive nights and calculated seven indices of relative abundance. For each fox species, we compared the power of different monitoring designs and scenarios that combined visitation indices, effort (number of bait station lines and survey frequency) while controlling for type I error, and magnitude of population change during a given period. We looked at the combinations that produced high power (β ≤ 0.24). The operation of bait stations during several nights markedly increased statistical power. Index 7 (recording visits 72 h after activation) exhibited the lowest variation and improved expected power to detect a population trend. Both fox species could be monitored simultaneously, with power >0.76 in the short term (5 years), activating 24 bait station lines. We conclude that monitoring programs for culpeo fox and gray fox based on bait stations are able to detect marked declines but are less useful to reliably detect moderate increases in abundance, especially in sheep ranches.

     

Drug discovery in academia

Drug discovery and development is generally done in the commercial rather than the academic realm. Drug discovery involves target discovery and validation, lead identification by high-throughput screening, and lead optimization by medicinal chemistry. Follow-up preclinical evaluation includes analysis in animal models of compound efficacy and pharmacology (ADME: administration, distribution, metabolism, elimination) and studies of toxicology, specificity, and drug interactions. Notwithstanding the high-cost, labor-intensive, and non-hypothesis-driven aspects of drug discovery, the academic setting has a unique and expanding niche in this important area of investigation. For example, academic drug discovery can focus on targets of limited commercial value, such as third-world and rare diseases, and on the development of research reagents such as high-affinity inhibitors for pharmacological "gene knockout" in animal models ("chemical genetics"). This review describes the practical aspects of the preclinical drug discovery process for academic investigators. The discovery of small molecule inhibitors and activators of the cystic fibrosis transmembrane conductance regulator is presented as an example of an academic drug discovery program that has yielded new compounds for physiology research and clinical development. high-throughput screening; drug development; pharmacology; fluorescence; cystic fibrosis transmembrane conductance regulator     

Nutritional status and quality of life in a sample of immigrants. A research program

In 2001 a new national research was begun in Italy in order to identify the health, nutritional status and quality of life in the immigrant population. In Bologna area an evident process of demographic decrease in the resident population, coupled with a contemporaneous increase in the number of in-coming immigrants coming especially from Asiatic and African developing countries, has been taking place since 1970. The present program was carried, out in this context, starting with an analysis of the actual bio-diversity in this new multi-ethnic society, with the purpose of giving the same sanitary assistance and surveillance that the Italian population enjoys to the immigrant population as well. The present report analyzes the main anthropological aspects of the program concerning the assessment of anthropometric and psychosocial characteristics of the immigrant population, as well as this group's nutritional habits.     

Towards a global terrestrial species monitoring program

The Convention on Biological Diversity's strategic plan lays out five goals: “(A) address the underlying causes of biodiversity loss by mainstreaming biodiversity across government and society; (B) reduce the direct pressures on biodiversity and promote sustainable use; (C) improve the status of biodiversity by safeguarding ecosystems, species and genetic diversity; (D) enhance the benefits to all from biodiversity and ecosystem services; (E) enhance implementation through participatory planning, knowledge management and capacity building.” To meet and inform on the progress towards these goals, a globally coordinated approach is needed for biodiversity monitoring that is linked to environmental data and covers all biogeographic regions. During a series of workshops and expert discussions, we identified nine requirements that we believe are necessary for developing and implementing such a global terrestrial species monitoring program. The program needs to design and implement an integrated information chain from monitoring to policy reporting, to create and implement minimal data standards and common monitoring protocols to be able to inform Essential Biodiversity Variables (EBVs), and to develop and optimize semantics and ontologies for data interoperability and modelling. In order to achieve this, the program needs to coordinate diverse but complementary local nodes and partnerships. In addition, capacities need to be built for technical tasks, and new monitoring technologies need to be integrated. Finally, a global monitoring program needs to facilitate and secure funding for the collection of long-term data and to detect and fill gaps in under-observed regions and taxa. The accomplishment of these nine requirements is essential in order to ensure data is comprehensive, to develop robust models, and to monitor biodiversity trends over large scales. A global terrestrial species monitoring program will enable researchers and policymakers to better understand the status and trends of biodiversity.     

ECVAM's collaborations with academia

The encouragement of ECVAM's connections with academia through direct collaboration and co-sponsored studentships has resulted in the successful achievement of higher degree qualifications for the young participants, and the development and promotion of alternative methods. So far, 26 students have been registered for higher degrees, of which 13 have been awarded so far, and 16 university departments in nine European countries have been directly involved. When other collaborations are included, the number of ECVAM's interactions with academic institutions rises to 33 departments in eleven countries, including the USA. In addition, through contracts awarded to academic institutions and other forms of collaboration, the prevalidation and validation of alternative methods have been progressed.     

Translational research in academia and industry

Research that bridges between scientific insights and clinical application is one of the most active and exciting areas of current biomedical activity. Much of this translational work occurs through collaborations between academic and industrial institutions, taking advantage of the respective strengths and resources of the two sectors. However, such collaborations sometimes can be challenging due to differences between the cultures and priorities of the two parties. This article discusses the nature of translational research, with a focus on the academia-industry interface, analyzes the factors important for effective collaborations, and describes specific examples of successful translational research programs.     

Development of an estuarine climate change monitoring program

Numerous coastal and estuarine management programs around the world are developing strategies for climate change and priorities for climate change adaptation. A multi-state work group collaborated with scientists, researchers, resource managers and non-governmental organizations to develop a monitoring program that would provide warning of climate change impacts to the Long Island Sound estuarine and coastal ecosystems. The goal of this program was to facilitate timely management decisions and adaptation responses to climate change impacts. A novel approach is described for strategic planning that combines available regional-scale predictions and climate drivers (top down) with local monitoring information (bottom up) to identify candidate sentinels of climate change. Using this approach, 37 candidate sentinels of climate change were identified as well as a suite of core abiotic parameters that are drivers of environmental change. A process for prioritizing sentinels was developed and identified six of high priority for inclusion in pilot-scale monitoring programs. A monitoring strategy and an online sentinel data clearinghouse were developed. The work and processes presented here are meant to serve as a guide to other coastal and estuarine management programs seeking to establish a targeted monitoring program for climate change and to provide a set of “lessons learned.”     

Information costs of reduced-effort habitat monitoring in a butterfly recovery program

Habitat monitoring typically requires a large amount of effort and resources. Project managers are likely to consider cost-cutting options but they may not critically review the information costs of implementing those options. An effort recently began in New York State to monitor critical habitat and restoration progress aimed at recovering the federally endangered Karner blue butterfly (Lycaeides melissa samuelis). Specific strategies were proposed to increase efficiency of fieldwork: (1) estimate larval host plant (wild blue lupine, Lupinus perennis) abundance from cover data, (2) area-based standardization of sample size for nectar sampling, (3) use a minimum cover threshold to trigger nectar species counts, (4) use multiple observers. I quantitatively reviewed these time savers for effects on raw data quality, and for potential effects on interpreting habitat quality as part of recovery criteria. Cover-based models of lupine abundance differed between metapopulation recovery areas, area-based sampling was sufficient to detect over 80% of priority nectar species in most sites, nectar information loss was high due to the minimum cover threshold, and overall results from different observers were similar with one exception. Direct lupine stem counting is recommended over cover estimation, statistical interpolation (rarefaction) and extrapolation (asymptotic estimators) is recommended over area-based nectar sampling, use of minimum cover criteria is strongly discouraged, and field crews need botanical expertise and careful instructions. This example highlights why strategies to save time and money with monitoring fieldwork should be ‘put to the test’.     

High-throughput screening in academia: the Harvard experience

To identify small-molecule modulators of biologic systems, academic scientists are beginning to use high-throughput screening (HTS) approaches that have traditionally been used only in industry. The HTS laboratories that are being established in universities, while differing in details of staffing, equipment, and size, have all been created to attain 1 or more of 3 principal goals: drug discovery, chemical genetics, or training. This article will examine the role that these activities play in 4 HTS laboratories that have been created within the academic community of Harvard Medical School and its affiliated institutions. First, the 3 activities will be defined with special attention paid to describing the impact they are having on how academic biologic science is conducted today. Next, the histories and operations of the 4 Harvard laboratories are reviewed. In the course of these summaries, emphasis is placed on understanding the motivational role that the 3 activities initially played in the creation of the 4 Harvard facilities and the roles that the activities continue to play in their day-to-day operations. Finally, several concerns are identified that must be attended to for the successful establishment and operation of an academic biologic science that has yet to be fully determined. HTS has the ability to provide the tools to test previously untestable hypotheses and can thereby allow the discovery of the unanticipated and the truly novel.