Success Factors and Obstacles in Academia–Industry Partnerships: A Case Study of a Graduate Program within the Bayer–University of Cologne “Privileged Partnership”
1Department of Pharmacology, University of Cologne, Cologne, Germany
2Bayer HealthCare AG, Wuppertal, Germany
The development of new active principles for medication has been the preserve of industrial research and development on the one hand, and of academic discovery and enhancement on the other hand. Even though small biotechnology companies have successfully developed biologicals, the invention or discovery of small molecules has remained the domain of large pharmaceutical companies. Over the past decades, academic pharmacological research has increasingly focussed on the discovery and investigation of the drug targets of small molecules. In this respect, university research plays a key role in the discovery of new therapeutic principles.
Over the past 10 years there was a marked decrease in the number of new chemical entities with novel active principles introduced into the market. This development combined with the ever-rising costs of every single innovation has called into question the commercial sense of pharmaceutical research in industry. Thus, it does not come as a surprise that over the past years, there have been intense discussions in which way the development of new low molecular weight therapeutic principles can be sped up. Uniting the expertise of academia and of the research sector of the pharmaceutical industry might be a successful approach.
As an example for the possible rapprochement of both areas, we will describe and critically analyze here an initiative, which constitutes the framework in which the University of Cologne and Bayer foster and strategically plan their collaboration. In 2008, Bayer and the University of Cologne agreed on establishing a privileged partnership. On the basis of a framework contract, this partnership comprised collaboration in the field of clinical studies on Bayer substances as well as the establishment of a graduate program in pharmacology and experimental therapeutics. We have published the concept and the development of the graduate program elsewhere [1].
Here we want to emphasize the conception of the structure and organization of the program following an analysis of the challenges such a program faces and the aims it wants to pursue. Furthermore, we will analyze typical difficulties encountered in implementing the program in the light of 3 years of experience with the program and based on a first external evaluation. We will report on how we could address these problems in the further development of our concept.
We propose that collaboration in the area of fundamental research without a specific or immediate development or application goal in mind constitutes an excellent foundation for a long-term strategic and effective partnership between an academic and an industrial partner.
SWOT Analysis of an Industry–Academia Partnership
For the planning of the structure and organization of a joint postgraduate program in pharmacology and experimental therapeutics, the leading pharmacological research staffs of both University and Bayer undertook a process analogous to a strengths, weaknesses, opportunities, and threats (SWOT) analysis and identified risks and opportunities of a joint initiative in the area of pharmacological research. Before we proceed to this critical self-analysis we want to summarize some important points from the literature concerning industry–university collaborations. We have consulted a review by Blumenthal from the 1990s [2] from the area of life science research in the United States, a comprehensive analysis of industry–academia collaboration in the United Kingdom [3], and some further important reviews [4–6]. We will include these points in our overall SWOT analysis of an academic–industrial partnership.
Overall, the financial investment of the pharmaceutical industry in collaborations with universities is increasing. However, the total investment into R&D collaborations with universities compared with other industries is still rather small. It has been criticized that most activities have a small financial volume and are of limited duration [2, 3, 5]. The funding of specific projects in the area of clinical research and the recruitment of university professors as independent advisors plays an important role in collaborations of the pharmaceutical industry with universities.
Bayer–University of Cologne Collaboration
Opportunities
The research staff considered the collaboration as a specific opportunity to be able to recruit and educate particularly talented scientists for pharmacological research in academia or industry. By combining the expertise and technological abilities of both partners, they were further expecting a competitive advantage both in the area of fundamental research and in the area of drug development. Finally, both partners perceived a competitive advantage due to the sponsorship. Bayer hoped to be able to advertise its sponsorship activity in a positive way and the University welcomed the extra income of federal state funds coupled to the acquisition of third-party funds.
Risks
Potential conflicts of interests were considered as risks to the collaboration. The financial support by industry of university scientists could lead to public allegations of loss of neutrality on scientific issues. The freedom and independence of university research, which receives primarily public funding, could be brought into disrepute. Other perceived risks were that the organizational and temporal investment for the establishment of the new collaboration could potentially impede the efficiency of the core R&D activities and therefore yield a critical advantage to competitors in decisive areas.
Strengths
We considered the following to be strengths of the collaboration: comparatively fast availability of funding and resources for carrying out projects through an industry sponsorship; the combination of know-how from both areas; the existence of patentable substance libraries at the industry partner; the University’s ability and determination to use innovative chemical processes; the University’s readiness to undertake high-risk projects; the ability of the industrial partner to formulate clear goals and to implement mile stone planning and overall professional project management. The university considered as a strong point that outstanding fundamental research could serve as a source for economically attractive innovations and developments.
Weaknesses
The obligation to conduct socially responsible research that is not primarily profit-oriented was considered a weakness of an industry-university collaboration. With regard to planning periods in the case of industry sponsorship, one had to expect that they would correspond to the short-term, project, and milestone oriented procedures of industry. The scientists also considered as problematic the requirement to match their projects with specific project areas as defined by the upper management especially with regard to the possibility of unexpected research results. This potential source of conflict was resolved to some degree by the very good match between the university and the industrial partner in several areas of research, namely cardiovascular science and oncology. One could foresee that information and communication deficits between and within institutions could pose obstacles to this new form of collaboration. Also bureaucratic procedures could potentially impede research. Joint projects would have to follow both industry and university regulations. Likewise, there was the possibility that the decision and approval paths typical of each institution could obstruct innovative procedures.
It was important to find ways to avoid incompatibilities between the different decision processes.
We have summarized the points made above in a SWOT analysis in the form of a table (Table 18.1). Where risks or internal weaknesses threatening opportunities were identified, we tried to address these problems by defining the aims and planning the organization and structure of the graduate program (http://pharmakologie.uk-koeln.de/graduiertenprogramm) accordingly. In Table 18.1 we have indicated our measures to address problems by black arrows.
TABLE 18.1. Consequences for Structure and Organization Resulting from a SWOT Analysis
Original Concept and Implementation
The history and concept of the graduate program “pharmacology and experimental therapeutics” has been published in detail elsewhere [1]. We want to describe and discuss the program concept here only in so far as it can be derived from and is motivated by the above analysis of strengths and weaknesses. The aims given in the following headings refer directly to the aims given in Table 18.1, which have been derived from the SWOT analysis.
Connecting, Binding, and Simple Governance Structures
For the planning, organization, and realization of the graduate program, we wanted to implement structures, which were already familiar to most of the people involved. The structures should be simple, transparent, and quickly allow the operation of the program. Therefore, the internal structure of the graduate program was modeled on similar programs, for instance those funded by the German Research Foundation (DFG). All principal investigators whose projects are accepted into the program form the so-called “Programmrat” (program council). The program council meets once yearly, preferably at the occasion of the Annual Retreat to exchange information and to discuss strategic questions.
In addition to the program council, the graduate program has further supervisory bodies, which are supposed to ensure that all stakeholders of the program can participate in and agree to its development. The program council elects from among its members the speaker of the graduate program and two additional representatives to the program committee. Bayer, the dean of the faculty of natural sciences, and the dean of the faculty of medicine of the University of Cologne nominate additional members of the program committee (one each). The speaker is responsible for directing the operation of the program and is supported by a program coordinator. The program committee designs the curriculum and develops it further, controls the financial planning, referees new projects resulting from project calls, and decides on the acceptance and funding of projects within the program. The committee also supports the recruitment of new graduate students by participating in applicant job talks and interviews. The program committee, as represented by the speaker and a vice speaker (one will be member of the University one will be at Bayer), reports to a supervisory body of the graduate program—the steering committee. This regulatory body consists of representatives of the University, the University Hospital, and Bayer. Members of the board of directors of all three institutions as well as representatives of the financial boards form the steering committee. The steering committee has the responsibility to supervise and develop the privileged partnership. This includes both development and support of the graduate program and of the area of clinical studies.
The activities of the graduate program and the state of all cooperative studies between Bayer and the University under the framework of the privileged partnership are reported at the twice-yearly meetings of the steering committee. These meetings also serve to discuss the strategic concept and future of the program. Within Bayer, the steering committee is directly subordinate to the Bayer management board. Within the University, it prepares the development of the cooperation for the rector (Figure 18.1).
Familiar Funding Structures but with Faster Operating Sequences
To determine in more detail what kind of scientific projects the future graduates should carry out and to recruit such projects, we decided on a funding structure closely resembling established procedures within the University for other third-party funding. After several initial conversations between scientists from the pharmacological departments of the University and of Bayer with representatives of thesis committees and the Graduate School of Biological Sciences, we invited interested scientists of the medical faculty to discuss about the future graduate program. We had two rounds of discussions with about 25 participants each. In these discussions we reflected upon the common research areas of both partner institutions (cardiovascular sciences, oncology, neurosciences, defense, and intensive care) and narrowed down these areas more closely. We outlined aspects of the University’s methodological and thematic repertoire, which would be especially useful for the education of future pharmacologists: in vivo and in vitro studies for the establishment or generation of disease-relevant animal models reaching from mouse models to large animal models, methods of molecular image generation in vivo, telemetrics, the analysis of biomarkers, and finally, clinical studies. These discussions led to the focus on the scientific areas included in the first (2008) and second (2009) project calls, which offered funding for a period of 3 and 2 years, respectively.
The following additional criteria for the inclusion of projects were determined: scientific excellence of the project, scientific track record of the principal investigator, and his/her experience as a supervisor of natural science and medical graduate students. For the project calls we only allowed 1 month from launching of the project call to submission deadline, from submission deadline to peer review, and from peer review to the decision which projects to accept. We received following the first and second project calls 23 and 9 applications, respectively. The acceptance rate of projects was around 50% (19 out of 35). For three of the accepted projects, intramural funds from Bayer were provided. In the first funding period, seven doctoral theses (PhD) were funded by Bayer sponsorship at the University of Cologne. The funding of seven instead of the intended five to six doctoral students at the University through Bayer was due to the excellent quality of the received project proposals. The medical faculty of the University of Cologne funded three further medical theses (Dr. med. and Dr. med. dent.) over a 2-year period with a less well-endowed stipend. All other projects were exclusively funded by the project PIs. In the end, the percentage of intramural projects at Bayer, which was intended to be one-third of the size of the graduate program, was smaller than planned. While the project call resembled calls for public funding, the proposals needed to be restricted to 10 pages including abstract, introduction, and proposed scientific investigation, planned methods and scientific aims, timetable, publication list, funding track record, and list of previously and currently supervised students. This is about half of the volume of a grant application to the DFG.
This format and the temporal sequence could be implemented without any problems. As expected, some applicants withdrew their application after it became clear that their project was accepted into the program based on program match and quality standards but would not be sponsored by Bayer. However, in the course of the program, we succeeded in winning over PIs to include already funded projects into the program, so that we could achieve a balanced proportion of Bayer sponsored and University-financed doctoral students at the University of Cologne (Figure 18.2).
Focus on Fundamental Research Instead of R&D
In spite of the fact that the first project call had included clinical studies, already the first round of proposals showed that the available funding volume was insufficient for any meaningful clinical studies. As a consequence, only a small number of clinical studies was proposed, none of which was recommended by the reviewers to be accepted into the program. In hindsight, we are able to say that concentrating the doctoral projects on “preclinical” scientific questions warrants the inclusion of projects which have clear scientific milestones and which can be tackled within the framework of a three-year PhD-equivalent doctoral thesis. Concentrating on this type of project also allows avoiding conflicts of interest whose financial background would exceed the mere making available of project funding. These observations are in agreement with similar experiences reported in the literature (see previous discussion). In addition, we learned that projects, which dealt with a basic science question and not an immediately therapeutic objective, were more suited to lead to PhD titles conferred by the natural sciences faculty.
Maximum Transparency
From the start we paid attention to a high degree of transparency in our external communications as we were confronted with allegations from the public that the financial support of the Bayer company would endanger the freedom of scientific research at the University of Cologne. However, in the initial phase of the graduate program, public communication was only possible in a very limited way, for instance, via a publicly available homepage. We faced a number of trivial but not immediately resolvable uncertainties and a certain legal insecurity. For instance, we could not clarify whether a webpage describing the joint program would have to be published in the corporate design of the University, of Bayer, or a newly designed “joint” layout.
Therefore, the homepage was in the first instance designed in a very basic way, foregoing the placement of a Bayer or a University Hospital Logo. Only following the external evaluation of the graduate program, we could clarify within the steering committee how the webpage should be designed. In this context, it is also interesting to note that some scientists from the University of Cologne were not prepared to make the abstract of their research project publicly available. They did not want to endanger their lead over their scientific competitors outside the collaboration by giving away information on their research project.
Clear and Binding Agreements on Confidentiality, IP, and Publication Rights
On the level of the steering committee, it was made clear from the beginning that the publication of doctoral thesis projects should not be delayed or otherwise restricted. Restrictions on publication have been a prevalent problem in industry–academia collaborations [2]. The right to publish was granted to researchers at the University of Cologne, and the ownership of IP rights was contractually regulated.
Concept Designed for Sustainability
Already during the initial discussions, all stakeholders realized that to establish a sustainable collaboration between the University of Cologne and Bayer, a concept aiming for longevity was needed for the graduate program. In the planning of the program, which was in the first instance funded for a 3-year period, we took into account that in case of a positive evaluation by external reviewers after 2 years, we would want to continue the program. Therefore, we decided on two time points of student recruitment for the first funding period so that in the case of a continuation of the program, about the same number of doctoral students would be engaged in different phases of their PhD projects. At the start of the cooperation, we could not predict to which extent and at what pace we could reduce the sponsoring of doctoral positions by Bayer without reducing the volume of the program or its scientific quality. In the meantime, it has become clear that the other advantages of the program (see later discussion) provide enough incentives for many scientists to join the program with funded projects. We may hope that in the long run, the financial support for the administrative overheads and the curriculum of the program alone will be sufficient to recruit excellent scientists and doctoral students into the program.
Openness Concerning Project Proposals
This positive development has certainly been possible because of the extensive overlap in research interests between Bayer and the Medical Faculty of the University of Cologne in the areas of cardiovascular science and oncology. This is reflected in 12 and 9, respectively, project proposals and 8 and 3, respectively, projects accepted into the program in the areas of cardiovascular science and oncology, which constitute the majority of applications and accepted projects. The envisioned methodological focus on animal experiments, imaging, or biomarker research was, however, not reflected in the received project proposals. Most of the accepted projects were using the usual molecular biology techniques and in vitro systems. Only a minority of projects was at all intending the pharmacological characterization of small molecules. In the course of project recruitment we had to realize that a substantial number of PIs did not hand in an application because they wrongly believed that only projects using Bayer substances would be accepted into the program. To the contrary, we believe that a great variety of scientific questions and methodological approaches is appropriate to prepare junior scientists for a scientific career in the pharmaceutical industry as well as academia. For this reason, the selection criteria were revised for the second funding period.
Interinstitutional Communication
It was decisive for the success of this new form of collaboration to improve and intensify the communication between the partner institutions. Therefore, we emphasized opportunities for personal interactions in planning the graduate program. We wanted to encourage networking among the graduate students, facilitate contact between the graduates and scientists, and create opportunities for contacts between scientists within and between all partnering institutions. To serve all these purposes, we designed an obligatory curriculum for the students, which at the same time corresponds to the core graduate program of the umbrella organization Graduate School for Biological Sciences (GSfBS) (Figure 18.3). It contains a 3-year program of curricular activities with a total workload of 900 hours. To monitor the progress of the students, the European Credit Transfer and Accumulation System (ECTS) of awarding credits has been adopted. The graduate program is not an “ECTS Label Program”; it merely uses the European Commission ECTS guidelines to achieve an objective assessment of the students’ learning within the program. The intention of using ECTS points rather than asking for participation in one mandatory training program is to strike a balance between providing students with a curriculum and allowing them to decide for themselves which learning activities are best for them.
Part of the core curriculum is a monthly 2-hour journal club where the graduates report about their own projects or about publications from the literature and discuss under the guidance of moderators from the circle of PIs. These meetings take place alternately at Cologne and Wuppertal. We expect that our students also take part in weekly group meetings at their own institutions.
Once a year we organize a meeting of all principal investigators and all students and additional invited speakers and, on occasion, external reviewers in the form of an Annual Retreat. We spend one and a half days at a retreat location in a pleasant environment with good logistics.
In addition to their supervisor, each of our students has two additional mentors who are updated on the progress of the work at regular intervals and who give recommendations on how the investigation could be continued from their perspective. They also recommend curricular activities to the students. When choosing mentors, we make sure that all three institutions contributing to the program are represented: Bayer, the medical faculty, and the natural sciences faculty. Furthermore, every student in the 3-year program has to undertake a minimum lab rotation of 4 weeks full-time in the partnering institution. In the course of this lab rotation, the student can either gain an overview over the scientific activities of the partnering institution or carry out an experiment following careful planning. This makes particular sense when the methodological expertise is located exclusively or in a particularly advanced way at the partnering institution. Especially these lab rotations have been very useful in establishing personal contacts between the graduates and the scientists of those institutions with which they were not originally affiliated. In this context, the students can develop skills, which cannot usually be acquired in their home lab environment. Furthermore, we expect of our students the participation in two workshops per year. These workshops are partly developed and offered by the program, partly realized by external providers and financed through the program budget provided by Bayer. Subjects offered so far contain biostatistics, project management, mouse genetics courses, a workshop on the ethics of clinical studies, a workshop on presentation skills, and accredited workshops on animal experimentation. The originally envisioned participation of students in undergraduate lectures of, for instance, medicine or chemistry to complement the knowledge base of the graduates according to their individual degrees was not taken up. An interim assessment of the curricular activities of our graduates after 2 years showed that most students fulfilled or exceeded the expected curricular workload. In particular, the opportunities created by the curriculum to get to know one another allowed networking among the students and between the involved scientists of both institutions.
Curricular Support Regarding Core Scientific and Soft Skills
We have described above the content of the curriculum of the graduate program. Initially, we put the emphasis on soft skills courses like project management, presentation skills, or on qualifying students to carry out animal experiments. The acquisition of core scientific skills was expected from working on the thesis project and from project-overarching activities of scientific information exchange (e.g., journal club). Only at the occasion of the first external evaluation of the program did we discuss that due to the small number of pharmacological projects within the program, the targeted communication of specific pharmacological knowledge should in the future receive more emphasis. We will report about this in the section on Curriculum Assessment.
Synergies in Graduate Education within the University
At the University of Cologne there are currently two other programs for young scientists with a similar focus on fundamental medical research and which are also collaborations of the medical and the natural sciences faculties.
With the introduction of the interdisciplinary graduate program Molecular Medicine (IPMM) at the University of Cologne in 2003, a 3-year degree conferred by the medical faculty in cooperation with the natural sciences faculty was first established. The IPMM program has developed a particular curriculum for graduate courses and runs a number of soft skill courses on a regular basis. With the funding of the cluster of excellence CECAD (Cluster of Excellence “Cellular Stress Responses in Aging Associated Diseases”), another strong program for young scientists could be founded at the University. The IPMM program, the CECAD program, and our pharmacology program have shared aims and areas of research. This is also manifest in a considerable overlap of PIs.
Thus, our specialized program forms an additional network with a new focus in an already highly networked environment. In addition, all these programs are under the umbrella program of the GSfBS, organized by the biology group. Also, the GSfBS offers training to students. It has provided a number of high-quality soft skills courses our students could take advantage of. Thus, the cumulative efforts of at least three specialized programs and a more general soft skills umbrella program allow our students to assemble their individual educational programs parallel to their thesis work from the many educational activities on offer. This also allows the critical mass of students to offer courses to students when they most need them. Similarly, this gives the degree problems enough clout to force the University to find solutions, for example, with the introduction of a three-year PhD degree at the medical faculty.
Synergies of Industry and Academia in Vocational Field Exploration
Our graduate program fosters personal communication between the graduate students and PIs at Bayer and the University, especially their mentors and lab rotation supervisors. This allows the students to find out about individual careers in academia and the pharmaceutical industry. In addition, we were able to recruit Bayer Hochschulmarketing to give our students an overview of career options at Bayer and to arrange a meeting with recent graduates who now have a position at Bayer.
Opposing Structures and Other Obstacles within The University
Value Recognition
In the beginning, the program received a mixed reception as reflected in the spontaneous or invited commentaries of University PIs and their reactions. Naturally, PIs liked the financial support for their research by industry. However, the funding provided by the program did not entail all the benefits of third-party funding from other sources. The acquisition of third-party funds is one of the factors in the achievement-oriented remuneration scheme (leistungorientierte Mittelvergabe [LOM]) by the federal state NRW (North Rhine Westphalia). The seven medical faculties of NRW have decided that the “bonification” (betterment) factor for public funding should equal 1.0, whereas the bonification factor for third-party funds from industry should equal 0.3. This corresponds to a recommendation made by the DFG in 2005 [8]. The background for this decision is that in the past, industry funding of medical faculties was primarily in the context of clinical studies with a large financial volume and a low level of peer review scrutiny. For our program, this big difference in bonification constitutes an important disadvantage for attracting the most scientifically successful PIs. In addition to the remuneration scheme by the federal state, there is a bonification scheme in place at the UK Köln—Köln Fortune—which automatically provides 10% extra funds for DFG-funded research and similar percentages for charity-funded research but no additional funds for industry-sponsored research. Thus, there is a discrepancy between the demands on the program projects concerning quality (comparable to the criteria of government funding or funding by charities) and the appreciation the projects receive with regard to the inner-institutional bonification of the acquired third-party funds.
In contrast, the students, which the program could attract, were seen unanimously in a very positive light. Not only the large number of applications (70 after the first advertisement) but also the specific motivation of many selected candidates to work within the framework of a university–industry collaboration was regarded by the principal investigators as a positive selection attribute. We provide some PI comments, as follows:
I think that the student enrolled in the program belongs to one of my better students and this selection bias by the program makes the selected students those who will likely flourish in academia or the corporate sector > BOTH, due to the selection FOR the program AND due to the PROGRAM itself, which provides a very good platform for exchange, a good formal curriculum, and added tasks requiring well managing students surviving in that program.
Students in the graduate program may have undergone somewhat harsher selection than students outside similar programs and have agreed to devote time and effort to the framework program. Thus they have taken a decision for widening their horizons without immediate effect on the progress of their thesis projects.
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