2

Global and National Biomedical Research Environment

BIOMEDICAL RESEARCH ENVIRONMENT AND KEY EMERGENT TRENDS

America’s scientists have been for decades among the world leaders in publishing high-impact biomedical research discoveries. The United States, and especially the National Institutes of Health (NIH), has been a magnet for attracting talented scientists and trainees from around the globe. However, U.S. research and development (R&D) expenditures have relatively stagnated in recent decades, while other countries—especially in Asia—have markedly expanded their investments in R&D and infrastructure. As a result, America’s biomedical leadership position is increasingly vulnerable (Guarino et al., 2018; Lafrance, 2017; Conte et al., 2017; Moses et al., 2015; Huang et al., 2016; Sargent, 2018).

The American research enterprise is a complex interconnected system that is directly and indirectly affected by national and global changes. An array of components is becoming essential for world-class interdisciplinary research in all areas of science. This includes a talented interconnected workforce, adequate and dependable financial resources, and adaptable state-of-the-art facilities having appropriate technology as an infrastructure for research (Figure 2.1) (NASEM, 2018b; NRC, 2014).

To address the time horizon of 20 years in the committee’s charge, this chapter summarizes the factors likely to dominate the research environment for the next two decades. Some dimensions are more widely recognized and have supporting references, while others relate to the individual and collective experience and judgment of committee members. These factors are summarized in Table 2.1. This changing landscape is the contemporary and emerging terrain in which the NIH Bethesda Campus must successfully compete if it is to maintain a global leadership role and to serve as an essential distinctive national security asset.

These trends within the new interdependent biomedical research ecosystem have critical implications for all biomedical and health-related enterprises, including the NIH Bethesda Campus, and especially for the physical built environment and infrastructure in which research is being conducted. Insofar as the built environment is costly and expected to be usable for many years or decades, it must be designed and constructed to be flexible and highly adaptable to meet changing scientific needs and purposes.

TABLE 2.1 The Changing Biomedical/Health Global Research Environment

The dominant paradigms for the past environment for research include (1) biomedical research focus, (2) discovery of underlying structures and processes of biology and materials, (3) distinctive traditional research disciplines, and (4) an abundant talent pool seeking well-defined and supportive career trajectories. The NIH Bethesda Campus has served as a dominant force in this global research landscape and, in terms of aggregate output, the United States has been the leading nation both for the discovery of new knowledge and for the training of future researchers. While a cure for diseases was seen as the ultimate goal of such research, the proximate goal was to secure a greater understanding of normal health and mechanisms of disease. Addressing this proximate goal typically drove discovery, with rewards coming from publications of one’s research and for some biomedical scientists, global recognition through awards such as the Nobel Prizes or Lasker Awards. In such cases, the most successful investigators were recruited to prestigious academic centers that offered improved space and staff resources as well as higher financial compensation (e.g., higher salaries, advanced facilities). Importantly, through all these years, the NIH Bethesda Campus has offered an environment where researchers could pursue their lines of inquiry through use of animal models and working at the bedsides of patients typically cared for as inpatients at the NIH Clinical Center, located on the Bethesda Campus.

Overall, in this highly competitive global environment, the NIH Bethesda Campus faces much greater challenges than it once did in order to provide support facilities for emerging clinical medical problems and associated fundamental hypotheses regarding disease mechanisms. For example, many observers consider the overreaching paradigm for research to be much broader. Today, the overreaching paradigm for research is broader. The model has now evolved to one that is “biopsychosociotechnical,” rather than simply “biomedical,” recognizing that positive impacts from research on human health proceed from understanding and successfully impacting upon all relevant biological, psychological, sociological, and technological¹ dimensions relating to the condition. Far less frequently today is research able to deliver a singular preventive intervention or “cure” like that offered by the polio vaccine or thyroid hormone, although it still happens—as, for example, the development of Gleevec, for treatment of chronic myeloid leukemia, a condition once regarded as uniformly fatal. Major discoveries do continue, such as in the case of key molecules like nitric oxide or techniques such as CRISPR² gene editing. Based on the successes of past breakthroughs, public and elected officials increasingly seek not simply a better understanding of underlying disease mechanisms or a new drug or treatment that palliates or slows the progression of a dreaded health conditions, but instead seek “magic bullets” that cure or totally prevent such conditions. In addition to seeking cures, gaining “intellectual property” and spawning commercial success increasingly drives discovery, creating ethical dilemmas and sometimes catalyzing inappropriate behavior.

Research data that used to reside simply in paper records and then in the closely held databases of individual investigators are today increasingly shared on networks in the cloud. This is an era of bioinformatics, translational bioinformatics, clinical informatics, and population health informatics. The focus has grown from high-performance computing to cloud computing with growing national and global data networks such as those maintained by the National Library of Medicine, also located on the Bethesda Campus and comprising one of the 27 institutes and centers. Access to scientific literature has changed from the Index Medicus to PubMed and related sources of accessing the current state of knowledge. The drive continues toward an open science environment with greatly enhanced transparency and collaboration.

This latter trend is part of the move away from distinctive discipline-specific research. Researchers are required increasingly to broaden their competencies across traditional knowledge domains and co-locate in “scientific neighborhoods” of wet and dry labs for more efficient analysis and testing of current hypotheses. These inter- and intradisciplinary teams can take on bigger and broader topics. Additionally, there is now

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¹ Sociotechnical systems are environments where humans work and interact with technology (Carayon, 2006; Pasmore, 1988). Complex adaptive systems are sociotechnical systems with key characteristics, which carry implications for designing work systems and processes. Plsek and Greenhalgh (2001) define complex adaptive systems as “a collection of individual agents with freedom to act in ways that are not totally predictable, and whose actions are interconnected so that one agent’s actions change the context for other agents.”

² Short for clustered regularly interspaced short palindromic repeats.

increased competition for talent, as the number and diversity of opportunities for young research talent has grown. Today, research organizations compete globally for young scientific talent who previously would have sought out NIH and were more eager to stay “in track” for years prior to advancing in stature. As the newer technologies mature, young researchers are increasingly seeking out and moving to other new and expanded research settings and teams.

Today, the “ordered chaos” of research enterprises—often like their clinical academic centers—function as complex adaptive systems in which core labs and computing clusters exist alongside each other and progress occurs through small gains in changing sets of high-priority questions. Incremental successes are often quickly worked into the fabric of the organization that allow new functionalities. Further, clinical research increasingly has moved from being almost entirely a hospital-based activity to one that often focuses on ambulatory patients. This has also occurred at the NIH Bethesda Campus’s Clinical Center, which addresses unique and rare diseases that are not studied elsewhere. Overall, in this highly competitive global environment, the Bethesda Campus faces much greater challenges than it once did.

THE RESEARCH-BUILT ENVIRONMENT AND KEY EMERGENT TRENDS

The high costs of maintaining infrastructure that is not being actively utilized coupled with the desire to enhance greater productivity and more optimal working conditions had led to biomedical research facilities that are supported by architectural and engineering solutions offering flexibility and adaptability. These facilities must be designed to have flexible space, shared space, and multiple, diverse, and often social spaces used by teams of differing sizes and composition. In such spaces, teams share ideas, collaborate, and have efficient access to computer networks, databases, and communication systems that may span the globe. And while some research is still “slow going,” the pace of discovery has materially accelerated overall.

Recent studies have identified the role of capital assets—equipment, built space, and supporting infrastructure—and their critical role in supporting and enhancing the research enterprise. Public and private organizations are increasingly considering a more complex mix for managing new capital assets for research facilities. Among the considerations are strategies that minimize “stranded space capital assets” and stretch the useful life of new facilities to sustain research discoveries with those features that improve retention and recruitment of scientists.

Perhaps the most widely acknowledged key trend impacting research infrastructure is the increased prominence of “big data,” which simply means collecting massive amounts of raw data, storing it, and then analyzing it and disseminating the findings of the analyses, with the priority often being given to finding or creating actionable data.³ Research enterprises must confront the issue of how much computing resources should they build and maintain on location versus relying on cloud computing capabilities. The considerations involve workforce, space, and perhaps most importantly, capacity to keep up with rapid innovations in information and communications technology including cybersecurity. Options allow one to leverage research performed across multiple geographically dispersed locations and can enhance collaboration between teams and disciplines. From a capital asset management perspective, this underscores the criticality of communications networks to ensure timely and protected transfer of this vast quantity of data, and the dependence of these communications networks on secure and reliable power sources.

A related trend is the development of “Lab on a Chip” (NASEM, 2018a, Chapter 1) modeling to complement and, in some cases, supplement in vivo research models (Gensleron, 2015). As computer-based modeling advances, laboratory facilities may be able to reduce space and resources dedicated to laboratory animal facilities and related capital assets. The reduction in living specimen facilities can significantly reduce mechanical and electrical loads and densities throughout laboratory facilities.

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³ D. Watch, 2016, “Trends in Lab Design,” Whole Building Design Guide, National Institute of Building Sciences, updated August 29, https://www.wbdg.org/resources/trends-lab-design.

A third trend is the radical shifts in medical research equipment, including the introduction of robot-assisted surgical equipment and large-scale sample processing equipment (Fedler, 2014). This equipment is often larger than previous equipment, requiring increases in floor-to-floor heights and load-bearing structural capacities, as well as increasing densities and loads on mechanical and communications services throughout the laboratory facility.

As the nature and pace of biomedical research shifts and accelerates, public and private institutions are facing growing needs for rapidly adaptable research facilities. For some research organizations, changes in the performance of research require renovation of 25 percent or more of laboratory space each year.⁴ The practical implications for potential capital project investments include reassessing structural, mechanical, and electrical system configuration to enable efficient and effective renovations—those specific investments that will reduce laboratory and clinical downtime and quickly facilitate changing research methodologies; fulfill equipment and related infrastructure needs; and create inspired places that will enhance the intensive work environments for scientific and clinical staff and clinical patients and visitors. The concept of “social buildings” that through architecture and flexible design facilitate intentional interactions and sharing of resources should be incorporated into the evaluation and capital planning process.⁵

Successful recruitment, retention, and scientific productivity of an institution’s human resources can rely upon the nature of the collaboration possibilities, including direct opportunities for team-based research.⁶ Research facilities will need to be designed and managed to emphasize easy and effective cross-team collaboration through a variety of working and meeting spaces that are designed to enhance staff interaction and productivity and clinical patient health and recovery improvements.

One additional trend suggests increased research collaboration among public and private organizations, often facilitated by science conducted with shared facilities that include high-cost and specialized equipment and shared clinical capital assets (ACRP, 2018). (See the discussion in Chapter 3, in the section “Selected Extramural and Intramural Research Program Collaborations.”) Since the complexity and risks associated with more rapid research advancements combined with clinical trials are increasing, co-location of activities can significantly improve research and trial outcomes. While some research organizations create special areas or campuses for these interaction teams, others complement current facilities with available visitor spaces. The impacts to the research-built environment can include modifying access security and protocols, reconfiguring workspaces to accommodate visiting teams, and, as noted, earlier, creating adaptable spaces that can be reconfigured efficiently as needed. The multi-institute facilities at NIH are discussed in Chapter 3.

SUMMARY

The nature of and environment in which biomedical research is conducted has materially changed in recent decades and promises to change even more in the years ahead. These changes have implications that may affect the character of the research-built environment and operations of the NIH Bethesda Campus. This is also true for all scholarly (e.g., training) programs attached to the clinical research components.

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⁴ D. Watch and D. Tolat, 2017, “Research Laboratory,” Whole Building Design Guide, National Institute of Building Sciences, updated May 16, https://www.wbdg.org/building-types/research-facilities/research-laboratory.

⁵ D. Watch, 2016, “Trends in Lab Design,” Whole Building Design Guide, National Institute of Building Sciences, updated August 29, https://www.wbdg.org/resources/trends-lab-design.

⁶ Ibid.