Whither biomedical research and development? The place of academic health science centres

To some extent Academic Health Science Centres [AHSCs] are caught between the research push and market pull.

If they prioritise technology transfer, they opt for a research push approach that emphasises the availability of technologies or innovations for market-based actors based on potential commercial application. While the university mission within an AHSC will emphasise the quality of the technology rather than end-user or market benefits, this fails to address the adoption opportunities available from the healthcare service mission.

The primary weakness of ‘research push’ is that the acceptance of new technologies generally depends more on social and cultural factors within clinical communities, than on the merits of the technology itself.

On the other hand, the transformation of research into innovations that can be used to solve problems facing practitioners and patients is ‘market pull’, or perhaps more precisely ‘solution’ pull. Internal research and development communities of an AHSC need to be closely linked to the problems faced by practitioners and patients.

However, researchers often lack the inclination to pursue the innovation exploitation agenda. Indeed, a focus on adoption and the translation of research arises precisely because research productivity has in the past been favoured over solving real-world problems. In healthcare, the problems needing solving are swamped by a vast sea of research and many governments continue to fund research and wonder why they slide down the innovation scale — they value academic citations over patents for instance.

Taking these different configurations of AHSCs into account, the organisational options also need to consider how innovations move from bench to bedside.

A “gated”1 scientific and market-based review process with in-house industry expertise and a network of extramural experts for assessments would create a degree of granularity, enabling assessment of benefit from the initial insight (pure research) through translation to end-user benefits. Some well-known institutions use gated processes to filter research to identify innovations, or to assess market-readiness of research for commercialisation.

In the absence of internal gated processes, institutions may use external expertise. One example is to out-source to market-facing intermediaries the technology transfer process or to commercialisation agents. This brings knowledge of markets through the retained third party. Appetite for risk in life sciences by the private equity and venture capital communities fluctuates over time; in response to this unreliable interest, specialist interest groups with access to capital are more likely to emerge to act as agents to commercialise intellectual property. Many universities have structured such relationships with firms that develop their intellectual property on a licensing basis for instance, so the commercial benefits accrue to that firm, and less to the university, though they will likely get royalties, just not ownership.

AHSCs, though, combine universities and hospitals, and so they need to harmonise where possible differing conditions of employment as these firms could be seen as exploiting these administrative challenges. The technology transfer route which is common takes the context for commercial and entrepreneurial exploitation away from the AHSC. This means that AHSCs will fail to build internal capacity to assess intellectual property and know what to do with it. It also means that all research is viewed as equally worthy, leading to internal lobbying for resources and attention which may not favour the best bets.

An out-sourcing approach is useful when there is little internal interest or more likely little ability at commercialisation. The critical question for any AHSC is to make sure they have a view of the value of their own work. An intellectual property audit, for instance, is often necessary. If the AHSC lacks the ability to understand this, this would be evidence that it has failed to internalise the clinical service priorities from the hospital partner.

A risk facing any AHSC is whether they are being measured by some innovation metric that tracks spin-outs, licenses, or patents (rather than papers published or citations), as it may encourage premature commercial activity, which can take the form of single-technology companies (“one-trick ponies”). These types of start-up generally have high failure rates, and longer time-to-market; they may also be encouraged by a preference for simple licensing deals, reflecting either commercial naivete, impatience or lack of interest (which could be evidence of complacency). Regretfully, metrics such as these can actually hamper the realisation of the translational research agenda and produce less innovation since it measures the wrong thing — companies — rather than solutions (inventions). A gated process would, or at least should, determine whether this were happening.

AHSCs with a strong entrepreneurial perspective may choose to develop their own venture funds to develop and ‘de-risk’ innovations to make them attractive for subsequent acquisition. This is an interesting option as it also encourages the development of a domestic market in which to invest. Whole countries, too, have pursued venture funds as a national strategy with more failure than success as governments are not good at picking winners.2

The US dominates life sciences research for a variety of reasons. One of these may lie in the institutional flexibility tied to the market, and which may be a partnering factor for AHSCs. Many well-established and highly differentiated not-for-profit research commercialisation institutes have been formed in the US, such as MITRE (from MIT) and SRI (from Stanford University), or endowed facilities have been created, such as Battelle and Howard Hughes Medical Institute, while others have emerged as specialists at exploiting particular knowledge domains such as the Santa Fe Institute for complexity or chaos theory. Comparable facilities in other countries that are separate from government are few, as most are tied in one form or another to state paymasters, such Germany’s Fraunhofer and its constituent institutes.

In some European countries, especially now in the midst of a pandemic and associated economic challenges, governments are reasserting a dirigiste role despite compelling evidence that this does not achieve national policy objectives.

Why, for instance, with all that public money sloshing around in the hands of civil servants, did Europe not invent a Google? It may be that national (within the EU meaning member state) labour policies actually hamper the necessary scaling factors to enable success along with the well-know risk aversion of state bureaucracies. One must wonder why there fails to be greater entrepreneurialism at creating novel organisational entities to take forward innovation agendas, themselves, as what such institutions offer is a better way for bringing innovations to market; statist logic of what counts as a company and what counts as employment may be holding back innovation. The challenge for policymakers, though, is distinguishing between enabling the existence of such institutions and letting them function within a mandate with a high level of autonomy versus government determining what it does.

In the end, the options for AHSCs may be constrained by the public funding rules and have little to do with innovation itself. Since healthcare and life sciences innovation is within the top five priorities for almost all countries, along with artificial intelligence, now, it is surprising how we see feet of clay instead.

Setting the policy agenda for AHSCs

Underpinning the notion of an AHSC as a nexus of innovation is whether such a nexus will attract talent and entrepreneurial zeal. Obviously a process of development, extending perhaps over a number of years may be necessary.

A policy agenda for AHSCs would entail thinking about the following:

Should life science research funding be aligned to favour AHSC-type arrangements?

Obviously this would lead to non-AHSCs losing funding and encourage a migration of researchers toward AHSCs. This may not be compatible with national policy goals on local employment and wealth creation based on simplistic notions of clustering. As well, many governments treat academics as ‘public servants’ subject to various rules that hamper career flexibility.

While ensuring that other centres do not suffer from a skills drain as the most talented people may be attracted to the special opportunities AHSCs might provide, we need to be mindful that AHSCs can quite easily poach talent anyway as they are more likely to offer superior opportunities. Increasingly “brain circulation” (as talented people move from country to country and perhaps back home again) describes how researchers move about rather than the narrow and parochial “brain drain”. AHSCs are better positioned than other industries to exploit the global mobility of talent, while research funding and innovations forum-shop for the most favourable locations — an AHSC needs to be seen as a most-favoured location. The trick to enable a virtuous development of research and commercialisation, without the overhang of state bureaucracy.

Should the funding and performance management of higher education and healthcare systems take account of AHSCs tripartite mission?

Since they are expensive, and disproportionately consume the healthcare, research and educational expenditure budgets, they may need to be judged by different performance standards. It might be better that AHSCs are accredited or recognised through explicit criteria rather than a system of self-certification. What this means is that AHSCs may be subject to many state actors with potentially conflicting interests by rent-seeking civil servants and politicians wanting to be associated with winners.

Health professions education in traditional teaching hospitals should be replaced by AHSC supervised training arrangements; the logic here is to ensure that students have access to the best and appropriate clinical learning opportunities, within structured “clinical teaching” centres in healthcare providers. That hospitals are monopoly suppliers of clinical placements limits training opportunities but a focus on quality should prune that tree. It also means that clinical experience in non-hospital environments may be too ad hoc and lack the necessary supervisory rigour.

In addition, this would enable greater career mobility between academe and clinical service, even if such mobility challenged academic appointment criteria, or public sector employment requirements. Enabling greater flexibility here could encourage more entrepreneurs without losing them from training as well as create greater visibility of the value of entrepreneurialism within professional training. It is noteworthy that easy movement between industry and the academic environment is uncommon in many European countries, but is a feature in progressive countries that are rapidly rising up the innovation ranking tables. It is hard for governments to let go, but letting go is what they have to do if we are to have the 21st century we need.

Are current national restrictions on ownership or management of hospitals, universities hampering the development of AHSCs?

In Europe, universities and hospitals would benefit from new ways of organising their interconnected missions, but there is much to be done to understand how they are evolving and what national forces are shaping them as they are in the main, subject to the will of the state.

Investigation is needed to identify the performance, role and function of AHSCs in Europe, and to understand whether they are in fact a nexus of innovation or a quagmire of bureaucratic interference, as this could be a rate-limiting factor in innovation development. The general poor performance of European universities in international ranking may suggest the latter and a misuse of public money.

The potential scope of AHSCs comprises innovations in technologies impacting clinical care (software, medical devices, medicines), and ways of working (demarcation of health professions, clinical workflow). It is necessary to review relevant policy environments to learn at least [1] whether policies enable or inhibit high performing AHSCs where they exist, [2] whether policies inhibit AHSCs coming into existence, and [3] whether policies have perverse consequences on research and innovation production.

What is the best way to design and constitute an AHSC?

The preferences outlined here seek to understand the form/function balance, but we need more empirical evidence within the models to assess whether there is a critical size below which an AHSC may be ineffective in terms of mission attainment. Size alone may not be as important as the ability to align the various components as needed which is more a function of autonomy.

Nevertheless, size does matter to the extent that a small dysfunctional academic/hospital network or partnership will only become a small dysfunctional AHSC. This gives us one reason we need something better than sui generis self-certification as claims of excellence need evidence.

1 A ‘gated’ review process involves assessing an innovation at different stages using specific evaluative criteria. Failing to pass a gate is fatal at that stage, so the process passes through to the end innovations that have passed all the gates (which may also be thought of as filters). Gated innovation processes are used by scientifically-oriented organisations such as NASA and military defence agencies. A gated process must have a failure regime to be meaningful, which has consequences for performance assessment of research productivity.

2See as an example: D Senor, S Singer, Start-up Nation: the story of Israel’s economic miracle. Council on Foreign Relations/Hachette, 2009. This, though, needs to balanced against the more cautionary perspective of the improper role of government in commercialisation in J Lerner, Boulevard of Broken Dreams: why public efforts to boost entrepreneurship and venture capital have failed and what to do about it. Princeton, 2009. A useful comparison of venture funding relevant to this discussion is J Lerner, Y Pierrakis, L Collins, AB Biosca, Atlantic Drift: venture capital performance in the UK and the US, NESTA, June 2011.