Making medicines

Abstract

The approach to building innovative partnerships between academia and the pharmaceutical industry has expanded to investigate collaborations that offer meaningful outcomes beyond discovery and increased productivity. This case study uses a systems thinking approach to guide the process and analyse the outcome of a partnership undertaken by one pharmaceutical company and academia. The collaborative process established three tiers of evolution over a 3-year period. The outcome was an online module–based course, entitled ‘Making Medicines: The Process of Drug Development’, that provides information about the drug discovery and development process. Both the course development and the final product serve as a useful case study of how collaboration between academia and industry might be achieved. The development process itself is proposed as an appropriate approach for building educational partnerships.

Keywords

Drug development drug discovery medical education online education pharmaceutical industry systems thinking

Over the past two decades, there has been an evolution in the approach to collaborative partnerships between academic institutions and the pharmaceutical industry. The focus has shifted from partnerships measured by tangible, short-term outcomes and pure productivity to those that value an increased emphasis on mutual understanding and respect of the partnership and the organizational culture (Ehrismann and Patel, 2015). The expansion of academia–industry relationships requires the identification of critical aspects of collaboration that drive success. As we look to long-term outcomes of academia–industry relationships, it is important not only to identify but also to foster these critical aspects that drive success. Academia and industry define successful interactions differently, which may introduce competing priorities. To establish effective collaboration, partners must consider common threads of alignment in success measures shared by both academia and industry. Previous studies have identified that the ability to evaluate partners, effective project management, trust of the management processes and feelings of mutual benefit all increase the probability of successful collaboration (Barbolla and Corredera, 2009; Barnes et al., 2002). From the industry perspective, two critical factors affect success: a commitment to the collaboration and a perception of value for immediate industry-focused outcomes (Pertruze et al., 2010).

However, to date, published literature on collaborations between academia and industry has focused on technology and scientific discovery (Barbolla and Corredera, 2009; Ehrismann and Patel, 2015; Pertruze et al., 2010; Wohlin et al., 2012). Discussions of academia–industry partnerships have focused on business and pharmacy education (Heath and Colburn, 2000; Povago-Theotoky et al., 2002; Smith, 2002) or research and education (Yong, 1996). The literature is limited on pharmaceutical and sustainable medical education collaborative projects (Stanley et al., 2005). Historically, the industry has supported research, publication and continuing medical education through a variety of unrestricted educational grants. These grants have supported educational efforts related to a specific disease or therapy. However, the value for each partner has been a source of discussion in the literature (Kessel, 2014). The literature has addressed success factors for academia–industry partnerships in technology and scientific discovery, development and transfer (Barbolla and Corredera, 2009; Barnes et al., 2002; Ehrismann and Patel, 2015; Pertruze et al., 2010; Wohlin et al., 2012), but it has provided limited information that addresses the factors affecting education and training, and little is known about educational collaborations with the health and science professions and the industry.

Historically, the pharmaceutical industry’s influence in medical education and health professions training and its underlying ethical implications has been a topic of ongoing debate in educational culture. There are calls both to eliminate the majority of interactions with pharma and for monitored and transparent collaboration. However, there is also an underlying drive to work with pharma in collaborative partnerships to address funding limitations and increase team diversity for innovation, education and research. When considering limitations, the reasons why academic institutions are reluctant to engage with pharma (outside of research grants) are varied (Table 1).

Table 1.

Barriers to engagement: academia’s perceptions of the risks of engaging with pharma.

Potential bias for financial motivation

Lack of trust

Perceived conflicts of interest

Scepticism about clinical trial data

Inconsistent experiences of working with pharma (research dollars versus commercial interactions)

Professionalism and entitlement

Negative public image and a polarizing political environment

Source: Adapted from Lemmens (2004).

These factors contribute to medical educators’ concern that, while in training, medical students might be unduly influenced by pharma companies, with an eventual negative impact on the physician–patient relationship. However, as the healthcare environment becomes increasingly complex and costly, it is essential for academic institutions, as key healthcare industry stakeholders, to develop effective collaborative and ethical relationships with pharma.

When considering sustainable problem-solving in a complex environment such as medical education, traditional linear approaches address one issue at a time. These approaches can be time-consuming and ineffective because the parts are addressed separately without considering how they function together as a whole. In addressing single barriers or a group of historically identified barriers (Table 1), if they are approached as isolated problems the solutions may be effective only for a brief time period. These solutions are merely temporary fixes because they fail to consider the systemic environment, and for this reason they are not sustainable. For example, when considering medical education and pharma interactions, if ‘lack of trust’ is addressed but concerns over ‘bias’ are ignored, the ‘trust’ gained will be temporary. This trust will soon erode and the effectiveness of the partnership will suffer. Systems thinking, on the other hand, embraces complexity and enhances problem-solving skills. This approach is equipped for diversity in systems and it provides the structure to identify and understand behaviours occurring within a dynamic system. It increases sustainable change and is a much better approach than identifying behaviour in isolation. Sustainable change is greater when there is an understanding and awareness of the environment, including an understanding of how increases or decreases in a certain behaviour can influence system outcomes and success or failure. Industry and business leaders have realized the effectiveness of a systems thinking approach. Systems thinking not only embraces the complexity and diversity of an organization, but also provides sustainable and flexible change which is key to sustainable success across industry and business.

Establishing new approaches and collaborative partnerships can support and expand medical education and scholarship while also creating a positive public perception of the industry. Schools of medicine, nursing, pharmacy and science, as well as residency programmes, are challenged to keep pace with education and training programme growth in response to increasing population-based healthcare needs, all the while facing reductions in educational budgets. On the other hand, the pharmaceutical industry is focused on engaging with the community to increase awareness and understanding, which leads to a positive reputation with the local and global community (Baum, 2016; Steinbrook, 2008). Simultaneously, there is a call for increased interprofessional education across the breadth of the health professions, and partnerships may contribute positively to the dissemination of knowledge across medical disciplines and healthcare-focused industry.

Evidence of this evolution in the pharmaceutical industry can be seen through community healthcare collaborations addressing patient health awareness education and prevention initiatives, as well as in research and development. Initiatives driven by regulatory agencies and sponsors have also assisted in furthering the growth of community trust through improvements in transparency and the disclosure of clinical trial results. The industry has found that education at all levels can be a foundational aspect for increasing public and provider trust (ACGME, 2016; Baum, 2016).

Methods

This article describes the collaborative process between one pharmaceutical company and academia, guided by a systems approach incorporating systems thinking (Johnson et al., 2008; Senge, 1990) to develop an academic online set of learning modules. This collaborative process spanned a 3-year period and consisted of three tiers (Table 2). The outcome was an online module–based course entitled ‘Making Medicines: The Process of Drug Development’ (Figure 1). This course provides online education on the drug discovery and development process and is currently being piloted by Eli Lilly and Company, a pharmaceutical company, and academic medical institutions (Table 3). It is suggested that both the development process and the final product serve as a useful case study in how alignment between academia and industry may be achieved through a novel collaboration. The systems approach described in this article was applied to develop innovative collaborative partnerships (Guan and Zaho, 2013; Iqbal et al., 2015; Meadows, 2008; Mitev and Venters, 2009) and is proposed as an appropriate approach for developing educational collaborations between academia and industry.

Table 2.

Three tiers of the collaborative partnership development.

Tier 1	Year 1	Focused on collaborative concept development
Tier 2	Year 2	Established innovative academia–industry educational partnership
Tier 3	Year 3	Focused on product development with the creation and launch of a collaborative educational online module (Making Medicines)

Figure 1.

Components of the e-learning course established.

Table 3.

Early adopters of the ‘Making Medicines’ course by institution and department.

Institution	Department
Belmont University	School of Pharmacy
Butler University	School of Pharmacy
Franklin College	Undergraduate Studies
Indiana University	Clinical and Translational Sciences Institute
Mayo Clinic	Graduate School of Biomedical Sciences
Marion University	College of Osteopathic Medicine
Michigan State University	College of Osteopathic Medicine
Purdue University	Polytechnic Institute
University of Arizona	School of Pharmacy
University of Iowa	College of Medicine
Tulane University	School of Medicine
University of North Carolina – Chapel Hill	Graduate School of Pharmacy School of Medicine
University of California – Davis	School of Medicine
William Carey University	College of Osteopathic Medicine

Systems approach

This academia–industry project used a systems thinking (Meadows, 2008) model to approach the 3-year process that resulted in ‘Making Medicines: The Process of Drug Development’ (Figure 2). The project was formally initiated in the spring of 2014. The use of systems thinking provides a conceptual framework to understand the interrelationships of the parts and their function as components of the whole (Senge, 1990). In this project, both academia and industry are viewed as whole systems with complex parts and interrelationships. In addition, the systems approach can be used to investigate collaborative relationships within and between academic and industrial environments as they work towards a common goal. Using this approach can increase the understanding of complex systems and improve the effectiveness of actions within those systems (Johnson et al., 2008; Senge, 1990). Although there are many variations of systems thinking, there are three basic aspects that provide the foundational groundwork (Meadows, 2008) (Table 4). Collaborative practice for effective academia–industry innovative partnerships has been proposed in the literature (Guan and Zaho, 2013; Iqbal et al., 2015; Mitev and Venters, 2009). This framework views behaviours and organizational principles of academia and industry as overlapping systems. Using a systems approach supports the effective management of collaboration in an academia–industry partnership. The three foundational aspects of systems thinking were used in each tier of the project.

Figure 2.

A systems thinking model approach to academia–industry medical education partnership.

Table 4.

Three basic aspects of systems thinking.

Function/purpose	Goals and objectives of the system
Elements	Characteristics of the system
Interconnections	The manner in which the characteristics interact with each other, including feeding back into one another

Source: Meadows (2008).

Results (process)

Function and purpose: Investigation and concept identification

The first year of this project incorporated the use of a systems approach, viewing academia and industry as unique and complex systems. The project directed ‘function’ and ‘purpose’ by developing goals and objectives with the overarching aim of collaboration between academia and industry through educational partnership. Guided by the systems approach, Lilly began conceptualizing the partnership by trying to answer the following questions:

Would it be possible to create an educational partnership between healthcare academe and the pharmaceutical industry?

If so, what would the partnership look like?

These questions led to a multi-tiered approach to address and begin to identify the elements or key players in a collaborative academia–industry partnership system.

The first tier included focus groups conducted with medical students for initial discovery. Two primary themes emerged from these groups: (a) the perception of government control over most clinical trials and (b) the perception of selective data use in reporting tilting towards positive patient outcomes by pharmaceutical companies. In past years, concerns have been raised about several issues, including pharmaceutical involvement in funding clinical trials (Chopra, 2003), ghostwriting of clinical trial manuscripts (Ross et al., 2008) and exaggeration of weak science (Titus et al., 2008; Woloshin et al., 2009). In addition, publications such as The Truth About the Drug Companies by Marcia Angell, who was Editor of the Journal of the American Medical Association, also provided narrative supporting negative perceptions of the industry (Angell, 2004).

In 2015, the Institute of Medicine (IOM) released its report on data sharing, which increases transparency and early scrutiny of clinical trial data, including pharmaceutical and government-sponsored clinical drug trials (Institute of Medicine, 2015a). A paradigm shift has been reported in which a partnership culture has emerged, with pharmaceutical companies often leading the drive to increase transparency and facilitate drug development timelines through data sharing initiatives. The financial cost is borne by the trial sponsors, which commonly are pharmaceutical companies (Institute of Medicine, 2015a). The trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has also declared its commitment to this initiative and has developed a process for sharing clinical trial data (Institute of Medicine, 2015b). In addition, studies have found that patient and physician participation in clinical trials positively influences the perception of pharmaceutical clinical research (González-Saldivar et al., 2016). These findings are relevant, as they demonstrate honest perceptions of clinical trials and ethical behaviour. The focus group outcomes provided an opportunity for Lilly to inform the understanding of current and future healthcare providers’ relationships, especially as they relate to the pharmaceutical industry, including misperceptions regarding the drug discovery and development process. This concept aligned internally with Lilly’s collaborative approach, including fostering a positive impact through continued outreach to strengthen community trust and confidence in the pharmaceutical industry. From a systems approach, this provided a set of objectives for the system goal. These findings likewise suggested that, in the education of medical or other healthcare students, there may be gaps in their knowledge of industry processes and regulations. From a systems standpoint, academia, which seeks to fully inform each respective learner community, may have an opportunity and need to provide more comprehensive knowledge about industries that play a role in healthcare delivery, and filling gaps would support the educational mission of any academic institution.

Elements: Identifying key partners and feasibility of educational partnerships

The next step of the process was to identify and engage key system stakeholders to determine whether there was alignment of priorities between the potential partners and defining element characteristics consistent with the systems thinking approach. To investigate this factor, the key findings from tier 1 were presented and discussion was held in external academic arenas to identify concept interest and further define feasibility and value. Further outreach to medical schools, medical associations and leaders in academic medicine was undertaken. Meetings were held with academic leaders to further conceptualize the perceived value of the collaborative partnership, including how an academia–industry collaboration might interact within the systems to expand partnerships beyond medical education grants and continuing medical education activities. This included feasibility discussions, identification of collaboration opportunities with third-party organizations, including PhRMA, and medical associations, including the American Academy of Family Physicians, the American Osteopathic Association, the American Association of Colleges of Osteopathic Medicine (AACOM) and the American Medical Association (AMA), allowing further definition of how a partnership might provide additional meaningful opportunities in medical and healthcare education. The concept was welcomed by the academic community, but key stakeholders expressed concerns about the challenges of healthcare community engagement and about the feasibility of partnerships focused on education and meaningful interactions with the industry beyond research grants. Moreover, the AMA’s and PhRMA’s joint published codes of conduct, introduced in 1998, have maintained consistent influence on the decision-making of academic leadership when considering any level of engagement with the pharmaceutical industry (American Medical Association, 1998; Pharmaceutical Research and Manufacturers of America, 2009). These documents prescribe an expected culture and level of ethical behaviour through expectations of strictly regulated appropriate relationships between the pharmaceutical industry and academia in medicine. As a result, the academic terrain provides limited access to the pharmaceutical industry. This feedback enabled Lilly to better understand these characteristics of the academic system to proactively address and appreciate concerns before they became barriers to the collaborative process.

During the 2013 annual AACOM conference, Lilly and academic leaders concluded that the drug discovery and development process was not included as a core competency for medical education (AACOM, 2012; AAMC, 2014; ACGME, 2016). The International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine has published a set of 60 core competencies under 7 domains for pharmaceutical physicians and drug development scientists, but there are no published competencies for undergraduate medical education (Silva et al., 2013). This further solidified the concept of a gap in education and an absence of formally published educational competencies relative to drug discovery and development across healthcare education. These findings highlighted an opportunity to develop educational content without waiting to focus on a competency structure to enhance the understanding of the drug discovery and development process, which has been validated by several academic leaders throughout the country (Crews et al., 2012; Haga et al., 2012; Johnson, 2013; Manolio et al., 2013; Stanek et al., 2012). During the AACOM meeting, academics discussed the development of an online format or e-learning course to deliver and document learning. Such a format could provide students with access to fundamental knowledge on the drug development process, the regulatory environment in which medicines are developed and the roles of healthcare providers employed by pharmaceutical companies to contribute to drug development. Follow-up research by Lilly validated that a comprehensive, graduate-level e-learning course had not been developed or offered by any organization in the United States at graduate or undergraduate level in medical education. Thus, within the first year, the concept of a drug discovery and development training programme gained traction. The feasibility and value had been identified, and a collaborative partnership between academia and industry for medical education purposes was initiated.

Interconnections: Collaboration-driven project development

During the second tier of the project, Lilly initiated an internally directed process of evolution from concept to educational project. During this stage, Lilly identified system elements through the engagement of internal and external key stakeholders who could likely impact the success of the project. In the initial phase, Lilly retained a healthcare vendor to identify and map details of an e-learning course. At this time, a broad range of questions about development and implementation, including appropriate approaches to discuss this type of education with academia, was identified and addressed. The e-learning course development began using as a guide an instructor-led, in-class drug development course for pharmacy students in one partner academic institution. A draft course outline and wireframe concepts were then created to provide a visual representation of an e-learning system workflow. Next, a steering committee was identified to ensure that the course aligned with academia’s expectations, including learning objectives and course requirements. Steering committee members were identified based on Lilly’s existing relationships with academia. The steering committee included four internally appointed members representing Lilly Medical and Informational Technology. Eight key external members representing academia were invited to join the committee, and five accepted. The nine-member steering committee served as an academic feedback loop regarding the elements and relevance of an e-learning course for academia, and all feedback was used to drive course development. Steering committee discussions addressed potential opportunities for this type of education, including topic and format. They also identified potential barriers and possible strategic plans to address and overcome resistance to a pharmaceutical company developing an educational course for use with academic institutions. Throughout the process, the committee maintained strong agreement that this type of education would have use and value to learners in health-related fields.

Lilly’s next step included the submission of a business case for formal internal review and guidance from the company’s leadership and its compliance, regulatory and legal departments. The case proposed a final product of a self-directed curriculum delivered through a freestanding online platform. This product would also be adaptable by academic centres based on their learning needs and would include multiple topics and interactive elements to engage learners. A seven-module structure was proposed, with each module to be developed to stand on its own or to be used in connection with others. The internal approval process for the proposed course and e-learning platform included the recommendation for inclusion of an additional external academic interprofessional team, whose members would use their areas of expertise to review and recommend course content for each module during development and to provide feedback. Additionally, recommended for inclusion in the course content were the external perspectives of individuals from the National Institutes of Health, the Food and Drug Administration (FDA), as well as a community trial investigator.

The Lilly legal and compliance review teams’ primary concerns were conflict of interest and assurance of an ethical and transparent approach in all phases of the project. There were several additional areas of equal concern. These concerns included, the perceptions of academia and the public at large regarding the industry’s financial gain, the transfer of monetary product value, student access and course credit hour academic value. To address these concerns, Lilly retained an independent valuation firm to obtain market value for the course based on pricing and credit hours for similar available offerings, including third-party education sites, online courses and academic institutions. During this stage, there were multiple meetings with key internal department stakeholders, including information technology, legal, regulatory affairs and privacy, to maintain transparency.

Next, the focus moved to internal consultation on several topics, including contractual matters relating to partnerships with external organizations, the use of drugs’ proprietary names (brand names) in case studies, outside expertise for course content and privacy of information on course participants. Privacy considerations regarding course participants addressed awareness of and strategies to ensure the confidentiality of personal information submitted for the course, including but not limited to name, email address, institution name and course performance data. Discussions were held on the merits of using fictitious drug names but, in the end, it was decided that the use of fictitious names would devalue the course in the eyes of the learners. Drug names were used to improve learner engagement and retention. Once concerns had been addressed, the project was approved internally and the collaboration moved to the next phase.

e-Learning course development

During the next phase, course development began, with additional focus on methods to support credibility, expertise and recognition. Multiple opportunities were investigated, including consultation with PhRMA and the feasibility of developing a pharmaceutical consortium. Barriers to this included time intensity and working with third-party associations, potentially limiting exposure and audience. After much consideration, Lilly decided to develop the course independently, as this approach would provide a level of control to ensure that the product was appropriately tailored for the intended audience. The project goal was to provide a course to future healthcare professionals on a secure platform to preclude inconsistent promotion to the desired population and possible use by an unintended audience.

It was important to reach out to academic institutions to engage with potential student audiences, again drawing on the interconnections using the systems approach. Students would become the end users of the e-learning modules and would be a vital component of the system that encompasses medical academe. The objectives in this process were to gauge interest in an e-learning drug development course and to solicit feedback on how to offer the course to academic institutions. Lilly partnered with a preferred healthcare vendor to conduct research with 50 health science students. This pilot assessed interest in education on drug discovery and development and student preference regarding the level of engagement provided in the online learning platform. The results of the pilot indicated (a) a high interest in the topic area, (b) a student preference for an on-demand e-learning option and (c) an increased likelihood to participate if the course had academic value and was offered for credit or as a programme elective rather than for no credit or as supplemental information.

Interconnections: External outreach

The final stage of this educational project focused on external review of the seven-module course (Figure 1). External consultations with academic leaders were held to further address credibility and ensure the course’s academic soundness and integrity. Initially, it was suggested that a not-for-profit board should be created to review course content. However, following internal discussions with Lilly colleagues to gain insight into not-for-profit boards, including the time and resources required to establish one, it was decided that this was not a feasible option for a single project. As an alternative approach, Lilly created a volunteer academic review panel. Potential members were identified through multiple channels, including the initial steering committee as well as recommendations from existing academic partners, vendors and Lilly medical colleagues.

Lilly planned to establish a review panel with 8–10 members. To ensure adequate participation and anticipate recruitment challenges, 60 potential individuals were identified as potential review team participants, and invitations were launched in three groups of 20 individual invitees at a time. Prior to agreement, participants were informed that participation of approximately 60 h was voluntary and that no compensation would be provided. The first group of invitations achieved participation capacity with 10 acceptances and resulted in a review panel comprised of a diverse interprofessional group of academic and healthcare professionals from allopathic and osteopathic medicine, pharmacy, basic science, nursing, public health, education and the FDA (Table 5).

Table 5.

The academic review panel for ‘Making Medicines’.

Rebecca J. Bartlett Ellis, PhD, RN

John I. Gallin, MD

Sara Jo Grethlein, MD, FACP

Marc Kahn, MD, MBA

John M. Kessler, PharmD

Michael Koren, MD FACC

Bryan Larsen, PhD

Martin S. Levine, DO, MPH, FACFP

Elizabeth K. McClain, PhD, EdS, MPH, FNAOME

Eric Niederhoffer, PhD

Carriann Richey-Smith, PharmD

Brenda E. Vaughan, MD, FAAD

Grant Williams, MD

The review process

The review process was completed in three stages by three unique panels. This approach was used to ensure the transparency, integrity and credibility of all aspects of the final course development.

Panel 1. The first review panel included a Lilly review team of medical experts within the organization. This team’s role was to ensure content accuracy and integrity.

Panel 2. The Academic Review Panel comprised individual experts in academia and research. This panel’s role was to inform the development of content, review draft content, provide candid feedback, review all interactive elements in the course and make recommendations. The total time in this review phase was approximately 60 h. The panel used a virtual review platform, which allowed reviewers to log in online to review content, enter comments, see other reviewers’ comments and respond. Reviewers could access the virtual platform at their leisure during the 2-week open review period.

Panel 3. The third review came from the final approving team, consisting of representatives from Lilly’s legal, regulatory and compliance departments. This newly created team was needed because the standard review teams at Lilly did not have experience with the complexities concerning transfer of value, case studies that included drugs outside Lilly’s products and licensing agreements. This team had the final say on content inclusion or exclusion, including the drugs to be used in case studies, the establishment of parameters and the criteria for content, fair balance and verification of the accuracy and credibility of third-party resources. The team also provided guidance on methods of course offering (e.g. in-kind donation and licence fee), course evaluation, the framework for identifying appropriate organizations to receive the education offering and delineating Lilly teams that could engage in proactive discussions on the course with external partners.

Discussion

Outcomes and next steps

The project demonstrates the feasibility and utility of this approach to academia–industry educational partnerships. The longitudinal process maintained awareness, engagement with elements, interactions and the goals of the system to establish the partnership. The ‘Making Medicines: The Process of Drug Development’ e-learning course was developed, assessed and then successfully launched in February 2016 (see http://www.making-medicines.com/information/). Seventeen institutions integrated the course into their health profession programmes during that pilot year. The next step is to support sustainability. To achieve and sustain success, both parties must see value not only in the outcome, but also in a collaborative educational process (Pertruze et al., 2010).

At the time of writing, the project has attracted the involvement of undergraduate and postgraduate health and science programmes in 23 academic institutions, with more than 1000 learner participants. Lilly has integrated formal feedback surveys into the course and will continue to investigate usage and utility. It will use feedback mechanisms to assess and continue quality improvement, which will be formally disseminated in upcoming manuscript reporting. The future goals are to continue to maintain and identify mutually beneficial areas and to expand educational collaborative partnerships.

Lessons learned

Leaders in the academic realm are willing to collaborate with the industry as long as concerns can be voiced, transparency is maintained and a true partnership is developed. Individuals within academia maintain a greater sense of the importance of the process of collaboration and the value of the relationship in the development phases (Pertruze et al., 2010). The reasons for participation are internally motivated, not financially driven, and vary. Some individuals participated to ‘give back’ by sharing their expertise, while others wanted to be involved in something that could only exist with a collaborative process and found the challenge intriguing.

For the industry to engage in a sustainable partnership with academia, it must identify project need, feasibility and utility across diverse academic terrain, targeting changes in knowledge, behaviour and attitudes or increased awareness.

Challenges

The primary challenges associated with the collaborative process were identifying times and ways to meet and interacting as a group. Many asynchronous approaches were used to enable individual engagement in the process, respecting diverse professional time constraints. However, true collaboration also requires synchronous engagement and real-time discussion, which was limited during several phases of the project. Among the internal challenges was the commitment of time to the project. In order for all project phases to maintain transparency and high integrity levels, multiple meetings and various internal Lilly employees were required. The time commitment for the internal and external panels was a challenge, but it met the need to ensure that the reviews did not have a pharmaceutical bias. The interprofessional review teams provided the required balance through diversity in expertise and maintaining academic soundness throughout.

Conclusions

Implications for academia–industry partnerships

A primary value of academia–industry partnership engagement is in the concept development of innovative projects and the evolution of theoretical concepts to tangible products (Iqbal et al., 2015; Meadows, 2008; Mitev and Venters, 2009). In medical education partnerships, the value is driven by the process as well as the product, resulting in outcomes of intrinsic and extrinsic value from which all partners benefited. From a systems approach perspective, partnerships that are directed by function, innovative elements and interconnection produce and sustain successful innovation through collaboration that would not be feasible for either organization to achieve individually (Iqbal et al., 2015; Meadows, 2008; Mitev and Venters, 2009). The transparency and inclusiveness of the key stakeholders were critical to the project’s success. Engaging potential collaborators from project conceptualization through to implementation helped to strengthen the interconnections. Setting objectives with collaborators early on helped to identify characteristics important to both academia and industry. The resulting product helped to align the priorities of both partners, with academia providing an online course to support the understanding of medicine development, and industry helping to increase awareness of drug development throughout all engagements with the key stakeholders. The result is an enduring educational product that helps both collaborators to achieve their goals, with the process forging relationships that are likely to be sustained into the future.

Footnotes

Acknowledgements

The authors would like to thank Marc Kahn, MD, MBA, of Tulane University for his recommendation to use a volunteer Academic Review Panel. The authors also thank the Academic Review Panel members for volunteering their time and expertise, and Michelle McBroom, MS at Eli Lilly and Company, for her editorial contributions.

Declaration of conflicting interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: In the interests of transparency and to address what might be seen as potential conflicts of interest, the first author, Elizabeth K. McClain, has asked for the following facts to be disclosed. (1) She has served as a medical education consultant for Lilly since 2016. All the activities of this project were completed on a voluntary basis beginning in 2013–14. (2) Since 2015, she has been a voluntary member of Medical Education Advisory Council for Kaplan Education Services – the Council meets annually and includes international representation of approximately 30 different medical schools. (3) She is Associate Dean of Academic Affairs for the William Carey University College of Osteopathic Medicine.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

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