Occasionally, it can be helpful to have someone who is not an expert in your field provide some perspective. While neither of us have scientific expertise in drug discovery, we do have experience with encouraging, inspiring, and leading innovation. As social scientists, we can provide perspective on leading and managing organizational change, as well as suggest models or approaches to change and innovation.

This chapter is the result of a presentation made at the 4th International Drug Discovery and Therapy Conference in Dubai, United Arab Emirates, called “Staying Competitive: Creating and Fostering Innovation in the Workplace.” This chapter fleshes out that concept by incorporating suggestions of models that can be applied to encourage and sustain that innovation. The goal of this article is to provide a viewpoint on models and approaches to enhance innovation that have been successful in other contexts, and to apply those models to the drug discovery process. These models could be applied to a number of systems and processes, as they can be useful analogies or metaphors in a range of contexts. We are also approaching this from the point of view of a consumer of drug discovery, rather than as a producer of drug discovery. Others before us have argued that some of these models might actually be appropriate in the context of drug discovery [1–3], but the additional framework of innovation here contributes a further level of complexity.

In their seminal book, Innovation: The Five Disciplines for Creating What Customers Want, Carlson and Wilmot define innovation as “the process of creating and delivering new customer value in the marketplace.” [4] Innovation is not a magic process, or like a bolt of lightning, but is the result of a disciplined, continuous improvement process with an unrelenting focus on creating the highest customer value. The sustained and disciplined approach to finding solutions to problems through innovation requires time, dedication, and support, but being open to the recursive, trial and error nature of this process can yield measurably different results that solve real problems. Innovation is an intensely collaborative activity by nature and focuses on identified customer or consumer needs.

Why Do People Innovate?

Carlson and Wilmot’s definition [4] implies that the primary motive for innovation is profit, since they describe it as delivering customer value in the marketplace. However, profit is not the only underlying motive for innovation. Recent research has suggested that innovation can still thrive even when financial profit is not the primary goal, because people are driven by mission-related motives and the goal to make the world a better place. Von Hippel suggests that a new model of innovation is focused not on the companies that introduce a product but by the “users” that modify the product for their private return and not for profit [5]. For example, when Microsoft released their interactive Kinect product, users began modifying and improving it. Microsoft initially described this end-user activity as “hacking,” but soon came to recognize the potential for profit, mutual gains, and innovation. While the idea of end users or consumers modifying pharmaceutical drugs may seem far-fetched, this notion of giving freely as part of a shared innovation may provide ground for discussion of alternative models of innovation. In particular, scientists “thrive on solving great problems and live to tackle big challenges” [6]. Science, like software, relies on teams of volunteers, notably graduate students and young professionals, who have an incentive to get involved because it will enhance people’s lives and make the world a better place, as well as enhance their own professional careers. Human beings are inherently motivated to solve problems and address challenges. One specific model that highlights a motive for innovation not related to profit is the Gandhian innovation model proposed by Prahalad and Mashelkar [7]. They demonstrate innovation strategies used in India as a specific example of how pioneers have figured out how to accomplish more with fewer resources for a greater number of people. For example, Tata Motors in India has developed a $2000 Nano vehicle by creating a number of international partnerships to obtain technical expertise. The resulting vehicle fits the needs of the rapidly growing population in India while reducing the size of the vehicle to meet emerging pollution standards. The five tenets of the Gandhian innovation model developed by Pralahad and Mashelkar [7] are a deep commitment to serving the underserved, a clearly articulated vision, audacious goals, recognition of constraints, and a primary focus on people rather than profits. The example of Tata Motor’s Nano car is a clear demonstration of those principles.

However, it is not just employees (in this case, researchers) who provide and sustain innovation in an organization; successful and long-term innovation requires leadership. Without support from leaders, innovative efforts are destined to fail, either in the short term or the long term. That support can include a range of strategies and tactics, such as decentralizing decision-making authority, encouraging risk taking by nurturing innovation-supportive culture, accepting failure as a natural consequence, and rewarding both failures and successes [8].

In addition to encouraging innovation, leaders need to be aware of and overcome possible impediments to innovation. Employees are often resistant to significant change, and are therefore often resistant to innovation in ways that are not immediately apparent. But successful innovation requires collaboration and a significant amount of trust, and leaders can help their employees reach that goal by reducing fear of the unknown. Employees have indicated that they choose to uphold the status quo because they fear unfavorable social impressions with peers, or they have a lack of support for innovation by leadership [9]. Carlson and Wilmot describe what they call the “FUD” factor, which stands for fear, uncertainty, and doubt, which are people’s natural reactions to significant change [4].

How Do We Encourage Innovation?

There are multiple strategies that leaders can employ to encourage innovation and navigate around some of the possible impediments. Wiseman and McKeown describe two types of leaders: diminishers and multipliers [10] (see Table 3.1).

Successful leaders use these concepts of diminishing versus multiplying to empower employees to innovate and collaborate. Another strategy, as suggested by Carlson and Wilmot [4] is to reframe statements related to the “FUD” factor as clues for how to move toward a solution. For example, if an employee says “I’m too busy to do that,” a strong leader can interpret that as a clue that the employee is really saying “I’m out of energy, and need some help.” Finally, strong leaders who want to encourage innovation need to ensure that any misperceptions about the vision or support to reach that vision have been addressed [4].

Why Is Innovation Important?

Innovation is important in all sectors, but Bennani reminds us that it is critically important in the health-care industry, because of the high stakes and human costs involved [6]. There is no shortage of human health problems to solve, and each of those problems bears enormous cost. Innovative strategies for addressing those challenges will enhance human well-being globally, increasing productivity in other sectors.

We need innovation to address the problem that “pharmaceutical drug development costs are increasing, yet the pharma success rate is decreasing.” [3] Innovation is needed to take advantage of new technologies that may assist with the high cost of drug discovery. Innovation is needed to provide drug therapy for those who are most in need, including millions of children who die each year of diseases that are preventable, according to the World Health Organization [11]. This includes the “massive global concern of tuberculosis, since one in three are infected around the world—more than two billion people!” [3] Innovation is needed in drug discovery to continue research on nonpatentable compound and drugs whose patents have expired. Without encouraging innovation, we may very well miss out on the discovery of secondary uses for existing drugs. Finally, we need innovation to move beyond the “patent thickets” that have led to the “tragedy of the anti-commons.” [11] In other words, the proliferation of patents is blocking fundamental tools in biotechnology research which may have led to the underutilization of existing knowledge, due to high costs and lack of cooperation by patent holders [11].

The need for innovation in the pharmaceutical industry, according to Bennani, is that we are in a perfect storm with “falling success rates in the development of innovative therapeutics, pending patent expirations for major drug classes” as well as stricter regulatory environments and the general downturn in the economy [6].

Warnings Regarding Innovation in Drug Discovery

One of the impediments to innovation, according Bennani is that multiple companies are working on similar “blockbuster” drugs, which means there is duplication of efforts and nonproductive investments [6]. The economic model of companies competing in a small market space for the blockbuster drugs has actually backfired and led to the loss of thousands of jobs. However, Bennani also provides a useful warning when examining innovation in the pharmaceutical sector; it is different from other sectors because “when researchers embark on a truly new project, they generally have no idea what the final product will look like.” [6]

One more cautionary note regarding encouraging innovation in the pharmaceutical industry: we need to foster innovation and creativity while at the same time not encourage unethical or overtly risky behavior. Asking employees to engage in innovative practices in any industry can lead them to ethical dilemmas, including breaking rules and standard operating procedures; challenging authority and avoiding tradition; creating conflict competition and stress; and taking unnecessary and dangerous risks. Innovation requires that rules be broken, but especially in health care, there are particular rules and procedures that cannot and should not be broken. The balance of encouraging risks, but not unwarranted risks, is to help employees “understand the types of risks they can take, the scope of risk undertaken, and the potential negative consequences of the organization’s stakeholders.” [12]

Open Source Models

One approach is to incorporate open source models into drug discovery. Open source concepts initiated with the software industry and have seen enormous success, including projects such as the Linux operating system or the Mozilla browser. Other terms related to, but slightly different from, open source concepts are open access, open knowledge, and open innovation. The Open Source Initiative defines open source with an elaborate, 10-point definition, but the main components of that definition involve access to the source code, free redistribution, and intellectual property. The question then becomes whether the open source model can be applied to other industries with similar success. As Rai et al. asked, “Can goodwill, aggregated over the internet, produce good medicine?” [1]

Open source efforts have already taken place in scientific fields; for example, the Human Genome project completed in 2003 [13] shared a number of characteristics with open source software development. Both fields attract the same sort of people, with the motivation (as discussed earlier) to solve challenging problems and make a difference in the world. Applying the concept of open source development to drug discovery could decrease transaction costs, leverage costly investments in technology and resources, and allow researchers the ability to access the intelligence, creativity, and goodwill of their colleagues.

However, the dissimilarities between open source software development and pharmaceutical research are profound and not easily overcome. Software can be developed very quickly, sometimes in a matter of weeks or months, and the technology required is often available to everyday consumers, whereas pharmaceutical research is more often measured in years, and requires advanced scientific degrees and expensive laboratory equipment. The most cost-prohibitive part of drug discovery is not the initial scientific work, but instead the enormous expense of clinical trials and navigating the regulatory approval process. “The application of the open-source approach to drug development may prove to be more useful as an analogy than an application,” notes Janet Hope, a lawyer completing a doctorate on open source biotechnology at the Australian National University, in Canberra. “One reason is that different intellectual property rights apply, and are protected differently. Software usually falls under copyright, which arises automatically and without cost to the author. Biomedical discoveries are generally protected by patents, which are costly to obtain.” [1]

In general, patents are directly linked to innovation [14]. Producing innovative ideas and solutions requires protection of intellectual property, and patents and copyright are the two main tools to accomplish that. However, confounding issues surrounding intellectual property, innovation, and international development have been raised. For patents, these issues include whether patents are being granted for truly novel inventions or for slightly different iterations of existing technologies; when patent protection should be overridden for humanitarian reasons; and the enormous cost of both time and money in securing patents. As an example, discoveries related to the human genome are vital to future biomedical innovation, but it is estimated that 20% of the human genome is claimed by patents [11]. Two-thirds of these patents are owned by private companies, and a similar fraction may be legally questionable on the grounds that they are too broad, not disclosed properly, or overlap other patent claims [15]. One possible solution to this conundrum is the idea of patent pools, which are “consortiums that agree to cross-license patents relating to a particular technology. They are beginning to be used to stimulate research in neglected diseases, allowing both access to select technologies and competitive business practices.” [16] Certainly, patent pools are far more difficult to put into practice than they are to describe, but the idea holds merit and potential.

Masum et al. present an overview of two outstanding examples of open source biotechnology platforms: Cambia and India’s Open Source Drug Discovery (OSDD) [11]. Cambia is a private, nonprofit institute in Australia, and will be discussed later in this chapter. OSDD is a consortium launched in 2007 by India’s Council of Scientific and Industrial Research that “aims to achieve affordable health care through a platform where talented minds can collectively discover novel therapies, as well as bring openness and collaboration to the drug discovery process, and keep drug costs low.” [11] OSDD incorporates a web-based portal that allows participants access to bioinformatics tools, biological information, data on pathogens, and discussion forums, with the aim of breaking down drug discovery into smaller activities with clear deliverables. Participants can contribute anything that helps solve these problems and achieve the goals of these smaller activities, including ideas, software, articles, and intellectual property.

Users must grant worldwide nonexclusive rights to OSDD for the use of any IP rights acquired, which helps contribute to the overall collaboration with all users while still protecting the intellectual property rights of all involved. OSDD’s high-profile backers may also increase the incentive for researchers to participate in the network of collaboration and open source sharing of ideas and resources [11].

As a result of the efforts of OSDD and their partners, there has been a renewed focus on solutions for diseases like tuberculosis and malaria, diseases that disproportionately affect third world and developing countries. More specific information about those accomplishments can be found at OSDD’s website, http://osdd.net. The success of OSDD’s initiatives suggests possible applications of open source development concepts that sidestep some or all of the challenges described earlier. Masum et al. describe such application as including three aspects of open source concepts: open access to underlying information, open licensing practices, and open collaborative methods and platforms [11]. Beyond just sharing software code for collaborative development, open source implies a set of cultural practices, licenses, and innovative collaboration methods that suggests future potential applications for drug discovery. While not a panacea, open source models could encourage collaboration and innovation, and are worth considering for the pharmaceutical industry.

Nonprofit Models

A second possible approach to the current state of pharmaceutical research is the idea of nonprofit organizations. Nonprofit organizations are chartered to address a need and accomplish a mission, rather than to create profits; they are eligible for tax-exempt status, and are often called the “third sector” (the other two being public and private organizations). Nonprofits can play a pivotal role in addressing some of the challenges of drug development because they tend to be focused, nimble, and entrepreneurial. Being nonprofit-focused by law, such organizations conduct cutting-edge research often funded by competitive grants from governments and foundations that are traditionally not accessible to for-profit companies. Nonprofits freely embrace research areas that are shunned by the mainstream industry, as long as those areas serve the mission of the organization, even when the risks are greater and future profits are lower [3].

Stanford Research Institute (SRI) provides a prime example of nonprofit contributions to drug discovery. Founded as the Stanford Research Institute in 1946, it has grown to more than 2000 employees at 20 locations around the world, including a new biosciences laboratory in the Shenandoah Valley of Virginia, where James Madison University is located. By reinvesting all of its profits in internal research and development, SRI has collaborated with the National Institutes of Health, other government agencies, universities, and other organizations to advance new therapies and vaccines to human clinical trials. SRI describes the collaboration process as both an art and a science, and that the best collaborations are “mutually flexible, seek win/win solutions, leave their egos at home, listen first to understand, and play to each other’s strengths.” [3] They also describe numerous ways to collaborate, including fellowships, innovation workshops, in- or out-licensing, philanthropy, outsourcing of research and development, and partnering on funding proposals.

Another example of nonprofit organizations partnering in the drug discovery process is Cambia, a private nonprofit based in Australia. Cambia’s primary achievement has been the launching of Biological Innovation for Open Society (BiOS), an initiative that aims to create a “protected commons” that allows participants to “access, improve, and modify existing technologies without infringing on proprietary rights.” [11] This is done through BiOS licenses, which are similar to Creative Commons licenses used in cultural centers online for creations like photographs, blogs, and other writing, or General Public Licenses (GPLs), used in software development. BiOS licenses also share a great deal in common with the work done by OSDD in India. According to Masum et al.,

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