Successful Technology Transfer: Lessons from the Translational Medicine Research Collaboration
AlphaBeta Pharma Group, Leatherhead, Surrey, UK
The Translational Medicine Research Collaboration (TMRC) case study discussed here describes a successful venture in technology transfer in medical research and drug development. It illustrates many of the issues and concepts discussed in the chapter entitled “Unlocking the Market Potential of Academic Research.” It also gives insight to some of the complications, unexpected developments, as well as success factors that occur in a real-life setting. It will examine the first 5 years of activity at TMRC, and its executive arm, Translational Medicine Research Initiative Ltd. (TMRI). This case study is relevant because of the unprecedented scale of investment, the model to share risk and reward, and involvement of pharma, several universities, National Health Services, and a regional economic enterprise agency.
Translational medicine is an emerging field that focuses on using biomarkers, new “measurable proteins,” to predict, prevent, diagnose, and treat diseases. This relatively young area of biomedicine uses a patient-driven approach to drug development. TMRC was an ambitious, unique, and innovative collaboration between the Scottish Enterprise (SE), four universities in Scotland, UK (Dundee, Aberdeen, Edinburgh, and Glasgow), four National Health Service Trusts in Scotland (Dundee, Grampian, Greater Glasgow, and Lothian), and the pharmaceutical giant Wyeth.* They developed a model for working together to create a fully integrated network to deliver world-leading clinical research.
Business Premise for Creating Translational Medicine Research Collaboration
The TMRC was set up with the intention of transferring academic research more easily and more rapidly to new commercial companies. There was a common scientific aim, but some differing objectives with respect to the results that needed to be managed. Academia searches for answers to fundamental research questions, which may or may not have direct commercial value. Industry in turn expects to realize tangible results from academic research that can be directly applied to their business needs. Industry’s increased pressure to produce shareholder value forces them to concentrate their research investment on commercially promising projects. Academic research is essential in the process of arriving at commercially viable knowledge but takes a very long time, and, being research, success is far from certain.
In addition to different expectations, there is frequently a mismatch in management styles between the pharmaceutical industry and academic research groups. Large corporate management, which is in general cautious and product oriented, may find that the informal, exploratory, even somewhat “geeky” lab culture within academia incompatible, and vice versa.
Although both parties want to bridge these two worlds and collaborate, the reality is usually that there are too many separate groups, pursuing different objectives. TRMC and TMRI were set up to address this problem. The objective was to create strength and efficiencies through collaboration and coordination.
There were several existing conditions that made the foundation of TMRC and TMRI a logical step, and which were fundamental to their success:
Medical Schools at Renowned Universities
Scotland’s four medical schools—Edinburgh, Dundee, Glasgow, and Aberdeen—have existed for centuries, and each enjoys a well-deserved prestigious reputation. However, they also had some of the cultural insularity and rivalry that this implies. Each institution has great talents, but due to size constraints, the individual university medical schools cannot compete on the world stage in ways to match their history or reputation. It became clear that they would accomplish far more through research collaboration. By joining forces through the TMRC they would be more competitive and better able to match efforts of larger research organizations.
National Health Service Trusts
The four National Health Service (NHS) Trusts in Scotland have coordinated their clinical patient work for decades, but work in a centralized manner yields a vital advantage: data management. Each of the approximately 5 million patients under these NHS trusts has a unique identification code, referred to as a Common Health Index (CHI) number, which links an individual to his or her complete medical history and to family members’ information, and is stored in a central database. This system enables hospitals and doctors to follow all patients, despite address changes, name changes due to marriage, immigration, and so on. The NHS Trust charters include a mandate to carry out clinical research, which can range widely from reducing incidence of bedsores and tackling infection in wards to developing protocols for effective treatment. The chief scientist of the NHS administers this.
With this powerful database, several broad research initiatives could be undertaken. One project that predates TMRC was spearheaded by Prof. Andrew Morris, who later became chairman of the TMRC, studied a disease cohort of 300,000 patients with diabetes to study genetic makeup and incidence of the disease among family members. Another project from 2004, 2 years before the TMRC initiative, “Generation Scotland,” was initiated by David Porteous, Professor of Genetics at Edinburgh University, to track diseases within families, to see if the manifestation of the disease in one individual patient remained an isolated incident or whether it could indicate causes for genetic or behavioral trends that affected family members.*
The Originators of the Idea
The Scottish Government Health Directorate (SGHD) was fortunate to have a brilliant and dynamic chief scientist, Professor John Savill (now Sir John Savill). Alongside that role, he was also the head of the Medical School at the University of Edinburgh. These two organizations have different research missions. The SGHD drives public health strategy for Scotland, and is responsible for the Scottish NHS, whose focus is on clinical research, intended to benefit individual patients. Academia’s research generally focuses on precompetitive research.† It was John Savill who looked to the Medicines Research Council,‡ the Wellcome Foundation§ and the separate medical schools for funding, in an attempt to create a critical mass to undertake the size and type of research projects that would better serve the market, and attract industry investment. Savill convinced the different parties to combine their resources—scientific talent, patient data, and clinical experience, funding, and physical facilities—to a more synergistic result.
Scottish Enterprise
SE is a regional development agency. Its mission is to create a platform for industrial and scientific growth and economic development for Scotland, and to better utilize the existing talent, infrastructure, facilities, and resources, including engaging the local small- and medium-sized company base and creating spinout companies from successful projects. SE’s aims were aligned with those of what was to become the TRMC. Headed by Chief Executive Jack Perry, SE offered crucial matching funds to develop the infrastructure needed to conduct the kind of world-class research that would attract investment from industry. In addition, they showed strong continued support as TMRC projects progressed: for instance, an initial £9.5 m ($14m) SE loan turned to a grant, with £2.7m ($4m) nonrepayable and £6.8m ($10m) repayable.
Wyeth Pharmaceuticals
With the arrival of Frank Walsh, head of Global Research at Wyeth (who is Scottish by birth and American by residence but never lost his accent!), essential input and funding materialized in support of projects for translational medicine. He had been looking for a strategy for streamlined collaboration with academic institutions and hospitals. Wyeth was interested in participation in the TMRC initiative because it was different: it effectively combined resources and cooperation of the medical schools, the NHS Trusts, and the SE. Therefore, Walsh succeeded in committing Wyeth to invest substantial funding (Figure 32.1).
So, all the stars were aligned: the timing was right, willing partners were ready to combine their efforts, and far-sighted champions had emerged to drive the initiative, “… and there was light.” The four stakeholders forming the TMRC were composed of the four Scottish medical schools, represented by their deans, four NHS Trusts;* SE, represented by its CEO Jack Perry, and Wyeth.