The role of modern biology and medicine in drug development in academia and industry

This symposium addresses careers in drug development in industry; the performance of translational research by academia, industry, and both; and numerous factors pertinent to alliances essential to drug discovery and development. Drug development is a complex process that regularly involves effective collaborations between academic and physician scientists and industry. There are specific occupational factors affecting recruitment of scientists and physicians in drug development programs in industry; ideal backgrounds for successful applicants for positions in industry in drug development; ethical and regulatory considerations particularly germane to the performance of scientists and physicians in drug development programs in industry and at universities; and particular gratifications available to scientists in industry working on drug development. Both similarities and differences characterize the performance of translational research in industry compared with academia. In industry, logistic, operational, and scientific oversight is complex, especially because it often involves relationships with clinical enterprises outside of the corporation. The process is long and arduous from formulation of a good idea in discovery to acceptance of a novel drug in the marketplace. Collaborations and partnerships by industry often involving academia and confrontation of multiple issues are pivotal.     

Industry's challenge to academia: changing the bench to bedside paradigm

The need for interdisciplinary collaboration is arising as a result of accelerating advances in basic science, including massive research and development funding by both government and industry, which has spurred the so-called "nanotechnology revolution" and developments at the intersection of the life and physical sciences, increasing emphasis by federal research funding agencies on interdisciplinary and inter-institutional research and by market influences. A number of barriers presently limit the interaction between academics and industry, including the typically very time-consuming and slow pace of technology transfer, which is compounded in the case of interdisciplinary and inter-institutional licensing, as well as the natural, and understandable, antipathies that exist between academia and industry as a result of their differing missions and approaches to scientific discovery. Moreover, if mechanisms are not in place at the outset of an inter-university collaboration, then the transition of inventions to clinical applications can be fraught with additional complexities and barriers. Policies suggested by the National Nanotechnology Initiative offer a number of ideas for overcoming barriers to multidisciplinary and inter-institutional research and illustrate some of the ways in which academia can structure partnerships with industry that will not only provide needed funding for multidisciplinary and inter-institutional biomedical research in an era of diminishing federal resources, but may permit academia, on the one hand, and industry, on the other, to benefit from the strengths provided by the other without compromising either academia's or industry's basic missions.     

Helping Science and Drug Development to Succeed through Pharma-Academia Partnerships: Yale Healthcare Conference 2013

The theme of the 2013 Yale Healthcare Conference was “Partnerships in Healthcare: Cultivating Collaborative Solutions.” The April conference brought together leaders across several sectors of health care, including academic research, pharmaceuticals, information technology, policy, and life sciences investing. In particular, the breakout session titled “Taking R&D Back to School: The Rise of Pharma-Academia Alliances” centered on the partnerships between academic institutions and pharmaceutical companies. Attendees of the session included members of the pharmaceutical industry, academic researchers, and physicians, as well as graduate and professional students. The discussion was led by Dr. Thomas Lynch of Yale University. Several topics emerged from the discussion, including resources for scientific discovery and the management of competing interests in collaborations between academia and the pharmaceutical industry.     

Time for a change: addressing R&D and commercialization challenges for antibacterials

The antibacterial therapeutic area has been described as the perfect storm. Resistance is increasing to the point that our hospitals encounter patients infected with untreatable pathogens, the overall industry pipeline is described as dry and most multinational pharmaceutical companies have withdrawn from the area. Major contributing factors to the declining antibacterial industry pipeline include scientific challenges, clinical/regulatory hurdles and low return on investment. This paper examines these challenges and proposes approaches to address them. There is a need for a broader scientific agenda to explore new approaches to discover and develop antibacterial agents. Additionally, ideas of how industry and academia could be better integrated will be presented. While promising progress in the regulatory environment has been made, more streamlined regulatory paths are still required and the solutions will lie in global harmonization and clearly defined guidance. Creating the right incentives for antibacterial research and development is critical and a new commercial model for antibacterial agents will be proposed. One key solution to help resolve both the problem of antimicrobial resistance (AMR) and lack of new drug development are rapid, cost-effective, accurate point of care diagnostics that will transform antibacterial prescribing and enable more cost-effective and efficient antibacterial clinical trials. The challenges of AMR are too great for any one group to resolve and success will require leadership and partnerships among academia, industry and governments globally.     

Ecohealth as a Field: Looking Forward

This forum paper proposes a reflection on the “field of ecohealth” and on how best to sustain a supportive environment that enables the evolution of diverse partnerships and forms of collaboration in the field. It is based on the results of a preconference workshop held in October 2012, in Kunming, China at the fourth biennial conference of the International Association for Ecology and Health. Attended by 105 persons from 38 countries, this workshop aimed to have a large-group and encompassing discussion about ecohealth as an emerging field, touching on subjects such as actors, processes, structures, standards, and resources. Notes taken were used to conduct a qualitative thematic analysis combined with a semantic network analysis. Commonalities highlighted by these discussions draw a portrait of a field in which human health, complex systems thinking, action, and ecosystem health are considered central issues. The need to reach outside of academia to government and the general public was identified as a shared goal. A disconnect between participants’ main concerns and what they perceived as the main concerns of funding agencies emerged as a primary roadblock for the future.     

Using systems thinking and open innovation to strengthen aquaculture policy for the United Nations Sustainable Development Goals

In a world of 9 billion people and a widening income gap between the rich and poor, it is time to rethink how aquaculture can strengthen its contribution to the second UN Sustainable Development Goal (SDG) of zero hunger in our generation. The disparity in the level of sustainable aquaculture development at present, between and within countries, especially regarding human access to farmed aquatic food remains highly variable across the globe. This paper offers a fresh look at the opportunities from using systems thinking and new open innovation measuring tools to grow sustainable aquaculture. Political will in many nations is the main constraint to aquaculture in realising its potential as an: accessible source of micronutrients and nutritious protein; aid to meeting conservation goals; economic prosperity generator where benefits extend to locals and provider of indirect social benefits such as access to education and well-being, among others. Resources to enable strong partnerships (SDG 17) between academia, civic society, government and industry should be prioritised by governments to build a sustainable aquatic food system, accessible to all, forever.     

Catalogue

The author presents reviews that identify success factors in music and arts education partnerships between cultural institutions and K-12 schools. She incorporates the evaluation of one Massachusetts partnership, Arts Can Teach (ACT), to examine the connection between partnerships and K-12 arts-program policy decisions. ACT is a collaborative effort among Boston's Wang Center for the Performing Arts, the Lynn Public Schools, and LynnArts, which matched music specialists and teachers in other disciplines with practicing artists for oneyear partnerships. Success factors of the ACT partnership are considered in terms of their similarity to success factors from the literature on music education partnerships. The author discusses implications for increasing and sustaining music and arts education programming and local arts education policy development.     

Opening up the Ivory Tower

Big pharma is increasingly looking to academia for new drug leads and technologies; meanwhile universities are being forced to look beyond the National Institutes of Health (NIH) for funding. This mutual attraction-out-of-necessity is helping to forge new bonds between industry and academia.     

The future of interdisciplinary research and training: how to conquer the silo guardians

We have entered a new era in biomedical research in which large interdisciplinary teams are being established to answer important scientific questions. Scientists of multidisciplinary backgrounds within universities are combining forces and inter-institutional consortia that include alliances between academia and industry are springing up around the country to generate breakthrough advances. A number of driving forces are at work to establish these collaborative research approaches. By contrast, there also are barriers to be surmounted by institutions with silo mentalities for effective partnerships to be established. In order for this new era of research to reach maximal effectiveness, new approaches to education of the young and retraining of established administrators and scientists must take place. These issues were explored thoroughly at the 2006 annual meeting of the Association of Anatomy, Cell Biology and Neurobiology Chairpersons (AACBNC) that was held in Aruba from January 18 to 21. The theme of this historic meeting was the Future of Interdisciplinary Research and Training: Breaking Down the Barriers. In this introductory article, we discuss the formation of a trendsetting Institute of Biomedical Sciences and Technology, the concept of the AACBNC meeting, and the influence of the Institute on the content of the meeting. The proceedings of this meeting, including Nobel Laureate Papers and Nobel Round-Table Discussions on the future of interdisciplinary research and training, are contained in this special issue of Experimental Biology and Medicine, a journal dedicated to the publication of multidisciplinary and interdisciplinary research in the biomedical sciences.     

Best Practices for Core Facilities: Handling External Customers

This article addresses the growing interest among U.S. scientific organizations and federal funding agencies in strengthening research partnerships between American universities and the private sector. It outlines how core facilities at universities can contribute to this partnership by offering services and access to high-end instrumentation to both nonprofit organizations and commercial organizations. We describe institutional policies (best practices) and procedures (terms and conditions) that are essential for facilitating and enabling such partnerships. In addition, we provide an overview of the relevant federal regulations that apply to external use of academic core facilities and offer a set of guidelines for handling them. We conclude by encouraging directors and managers of core facilities to work with the relevant organizational offices to promote and nurture such partnerships. If handled appropriately, we believe such partnerships can be a win-win situation for both organizations that will support research and bolster the American economy.     

Partner preferences in the context of concurrency: What Himba want in formal and informal partners

Research on human mate preferences that distinguishes between short- and long-term partners has been conducted mainly in industrialized societies, where multiple mating and concurrent partnerships are stigmatized. However, cross-culturally, there is significant variation in the frequency and the level of acceptance of such relationships. Furthermore, the dichotomy between short- and long-term partnerships does not fully describe the diversity in actual extra-pair behavior, which ranges from single sexual encounters to multi-year love affairs. Here we present another comparison, between formal (marital) and informal (non-marital) partners, which we feel better captures this diversity. We assess the traits that men and women prefer in each type of partner among Himba pastoralists, where concurrent partnerships are common and accepted for both sexes. We situate our findings in relation to three main explanations for concurrent partnerships: dual-mating, trading-up and multiple investors. We find some similarities with the existing literature in the traits that are listed as important, including physical attractiveness, wealth and intelligence. Our evidence suggest that Himba men follow a dual strategy, preferring hard-working wives and attractive girlfriends. Women's preferences align most strongly with a multiple investors explanation, most clearly articulated through their preferences for wealthy husbands and generous boyfriends. Limited support is also found for a dual-mating strategy in women. These findings suggest that local cultural norms and ecologies modulate mate preferences in important ways.     

School-University Partnerships in Music Education: A Status Report

A survey was distributed to the members of the Music Educators National Conference (MENC)'s Society for Music Teacher Education that presented members with seven questions about the types and nature of their school-university partnerships. The majority of respondents (N = 251) reported that they engaged in multiple partnerships that included not only universities and schools, but also music education associations, community and private arts organizations, individuals, and businesses. The benefits of these partnerships to preservice music teachers were (a) improved learning experiences, (b) the opportunity to gain real-world teaching experience and apply theory to practice, and (c) interaction with musicians and ensembles. The primary benefits to the university and school-based teachers were (a) professional development opportunities, and (b) opportunities for collegiality. Challenges to partnerships were (a) the difficulty of scheduling, (b) a lack of time, and (c) communication. Results revealed that respondents perceive partnerships as being between individuals, that one person usually takes the lead to develop the partnership, and that the benefits of the partnerships outweigh the challenges. Suggestions for policymakers are provided to address the challenges of partnership work.     

Partnership dynamics and strain competition

Models of epidemic spread that include partnership dynamics within the host population have demonstrated that finite length partnerships can limit the spread of pathogens. Here the influence of partnerships on strain competition is investigated. A simple epidemic and partnership formation model is used to demonstrate that, in contrast to standard epidemiological models, the constraint introduced by partnerships can influence the success of pathogen strains. When partnership turnover is slow, strains must have a long infectious period in order to persist, a requirement of much less importance when partnership turnover is rapid. By introducing a trade-off between transmission rate and infectious period it is shown that populations with different behaviours can favour different strains. Implications for control measures based on behavioural modifications are discussed, with such measures perhaps leading to the emergence of new strains.     

Industrial Ecosystem Development at the Metropolitan Level

This article presents the result of a two-year project funded by the U.S. Environmental Protection Agency to identify potential by-products partnerships between industries in a six-county metropolitan area in North Carolina, U.S.A. The project gathered data from 182 industries and institutions in the region regarding (1) by-products that might be usable by other, nearby firms, and (2) the inputs they used that might be furnished from another facility's by-products. These data, which were also linked to geographic information system maps, were used to identify potential regional partnerships for the reuse of materials, water, and energy. Of the 182 participating facilities, probable or possible partnerships were found for 48% during the limited project period. This project demonstrated the value of a local facilitator and the value of specific techniques for identifying and promoting potential by-products partnerships.     

Intermale affiliative behavior in ringtailed lemurs (Lemur catta) at the Beza-Mahafaly reserve, Madagascar

Intermale affiliative behavior was studied in three groups of naturally occurring ringtailed lemurs over a one-year period. The adult males in the sample exhibited affiliative behavior with all other males in their social groups; but affiliative behavior between some male-male dyads occurred markedly more often than between others. These dyads are called “preferred partnerships.” The formation of preferred partnerships did not appear to be influenced by male dominance rank or age-class. Furthermore, these partnerships were of a short-term nature, and none persisted throughout the entire study period. The following factors may explain the absence of rank or age effects, and the brevity of preferred partnerships: (1) frequent fluctuation in the male dominance hierarchy in each study group; (2) the fact that higher-ranking males may not offer specific benefits to lower-ranking males; and (3) the fact that male dispersal affected the male membership of each group over the 12-month study period. The focal males engaged in significantly more affiliative behavior during the lactation period compared with the other reproductive seasons. Migration partners may offer each other predator protection during the transfer process, and although males that transfer together do not engage in alliance or coalition behavior towards resident males, males transferring in pairs or threesomes are in a better position to spot and defend themselves against attack by resident males. Migration partners also provide social contact for each other while in the process of immigration.     

The Effects of Processing Non-Timber Forest Products and Trade Partnerships on People's Well-Being and Forest Conservation in Amazonian Societies

This study evaluated whether processing non-timber forest products (NTFPs) and establishing trade partnerships between forest communities and companies enhance the outcomes of NTFP commercialization. In particular, we evaluated whether product processing, partnerships, or their combination was associated with a number of outcomes related to the well-being of forest inhabitants and forest conservation. We based our analyses on ethnographic and quantitative data (i.e., survey and systematic observations) gathered at seven communities from five societies of the Brazilian and Bolivian Amazon. Our results indicated that product processing and partnerships do not represent a silver bullet able to improve the results of NTFP commercialization in terms of well-being and conservation indicators. Compared with cases without interventions, households adopting partnerships but not product processing were most often associated with improved economic proxies of well-being (total income, NTFP income, food consumption and gender equality in income). In comparison, the combination of product processing and partnerships was associated with similar outcomes. Unexpectedly, product processing alone was associated with negative outcomes in the economic indicators of well-being. All of the investigated strategies were associated with less time spent in social and cultural activities. With respect to forest conservation, the strategies that included a partnership with or without processing produced similar results: while household deforestation tended to decrease, the hunting impact increased. Processing alone was also associated with higher levels of hunting, though it did not reduce deforestation. Our results indicate that establishing partnerships may enhance the outcomes of NTFP trade in terms of the financial outcomes of local communities, but practitioners need to use caution when adopting the processing strategy and they need to evaluate potential negative results for indicators of social and cultural activities. With respect to conservation, the three strategies are promising for reducing deforestation, but more pervasive impacts, such as hunting, might increase.     

A Framework for the Monitoring and Evaluation of International Surgical Initiatives in Low- and Middle-Income Countries

Background

An estimated two billion people worldwide lack adequate access to surgical care. To address this humanitarian emergency, an increasing number of international surgical partnerships are emerging between developed and low- and middle-income countries (LMICs). At present, there are no clear indicators that may be used to assess the effectiveness of such initiatives.

Study Design

We conducted an international qualitative study of 31 surgeons from developed and LMICs involved in international partnerships across a variety of subspecialties. Thematic analysis and grounded theory were applied in order to develop a practical framework that may be applied to monitor and evaluate global surgical initiatives.

Results

Several themes emerged from the study: (i) there is a large unmet need to establish and maintain prospective databases in LMICs to inform the monitoring and evaluation of international surgical partnerships; (ii) assessment of initiatives must occur longitudinally over the span of several years; (ii) the domains of assessment are contextual and encompass cultural, institutional and regional factors; and (iv) evaluation strategies should explore broader impact within the community and country. Based on thematic analysis within the domains of inputs, outputs and outcomes, a framework for the monitoring and evaluation of international surgical initiatives, the Framework for the Assessment of InteRNational Surgical Success (FAIRNeSS) is proposed.

Conclusions

In response to the increasing number of surgical partnerships between developed and LMICs, we propose a framework to monitor and evaluate international surgical initiatives.     

Focus: Rare Disease: mEDUrare: Supporting Integrated Care for Rare Diseases by Better Connecting Health and Education Through Policy

Rare diseases affect an estimated 6-10% of the Australian population, a prevalence similar to that seen in other regions worldwide. These multi-system conditions are often severely debilitating and affect multiple domains of a person’s life. A salient necessity for effective care provision thus, is holistic care, achieved by appropriate and continual multi-disciplinary and cross-sectoral collaboration. Synonymous with this priority for collaborative care, is the need for increased partnerships between the health and education sectors. This partnership has the potential to benefit people with rare disease of all educational ages, but in particular, school-aged children and young adults. More than 70% of rare diseases affect children, and this population often experiences difficulties with overall well-being and functioning, including impaired school performance and confounding mental and social comorbidities. Ensuring adequate schooling needs and experiences along with provision of adequate medical care, is crucial in ensuring overall well-being for this population. For this, effective partnerships between the health and education sectors are paramount. This article highlights fundamental elements of health and education priorities, ingrained in current strategic documents, to build a policy foundation that informs and supports increased inter-sectoral partnerships between health and education services. Shared priorities identified in both sectors’ guidelines, co-developed with those with lived experience of rare diseases, build a strong policy base for future advocative initiatives to mold better integration between the sectors, a partnership which is vital to improving the overall quality of life, experiences and journeys of people living with rare disease.     

Assessing the validity of sexual behaviour reports in a whole population survey in rural Malawi

Background

Sexual behaviour surveys are widely used, but under-reporting of particular risk behaviours is common, especially by women. Surveys in whole populations provide an unusual opportunity to understand the extent and nature of such under-reporting.

Methods

All consenting individuals aged between 15 and 59 within a demographic surveillance site in northern Malawi were interviewed about their sexual behaviour. Validity of responses was assessed by analysis of probing questions; by comparison of results with in-depth interviews and with Herpes simplex type-2 (HSV-2) seropositivity; by comparing reports to same sex and opposite sex interviewers; and by quantifying the partnerships within the local community reported by men and by women, adjusted for response rates.

Results

6,796 women and 5,253 men (83% and 72% of those eligible) consented and took part in sexual behaviour interviews. Probing questions and HSV-2 antibody tests in those who denied sexual activity identified under-reporting for both men and women. Reports varied little by sex or age of the interviewer. The number of marital partnerships reported was comparable for men and women, but men reported about 4 times as many non-marital partnerships. The discrepancy in reporting of non-marital partnerships was most marked for married women (men reported about 7 times as many non-marital partnerships with married women as were reported by married women themselves), but was only apparent in younger married women.

Conclusions

We have shown that the under-reporting of non-marital partnerships by women was strongly age-dependent. The extent of under-reporting of sexual activity by young men was surprisingly high. The results emphasise the importance of triangulation, including biomarkers, and the advantages of considering a whole population.