Abstract
We investigated a number of factors that influence the transfer and commercialization of biotechnology for health care at Cinvestav, a leading Mexican research institute and major contributor to biomedical sciences in the country. Mixed methods were used, where we sent a survey to all the principal investigators (PIs) doing research in health-oriented biotechnology at Cinvestav that we could identify and asked them about their transfer of technologies activities, and interviews were carried out with those PIs who are currently pursuing projects for commercialization. Our results show that, despite a strong publishing record on the international front, most of these scientists lack a business-oriented focus. Further business expertise does not appear to be readily available or helpful at the institutional technology transfer office. Weak collaboration strategies reflected in a low number of key partnerships, together with a lack of private financing, also limit the capacity to transfer and commercialize the technologies being generated. The local scientific tradition and conditions do not seem to be amenable to these kinds of efforts, nor does the government pursue a coherent strategy to promote technology transfer and commercialization in health biotechnology. Consequently, promising projects take too long to develop and usually go to a limited extent through the consecutive patenting and licensing steps, both indicators of commercial activity in academia. The end result is a lack of success in making the results of new scientific knowledge beneficial for public health, a problem experienced not only by Mexico but shared by a number of low-and-middle income countries. We discuss the need for an urgent change in concerted vision by research institutions in developing countries, so as to engage their robust scientific infrastructure with the social and health demands of their populations.
Introduction
The development of biotechnology for health care in emergent countries has received considerable attention since the early years of this century, as it represents a potentially efficient way for addressing public health issues with locally generated means specifically aimed at their growing populations [1], [2], [3], [4], [5]. Research in health-related biotechnology is no longer only found in the United States and some leading members of the European Community, as a number of low-and-middle income countries also have become active knowledge producers in the field. Research has shown that the number of health biotechnology papers authored by researchers from low-and-middle income countries has increased extensively in the two last decades [6]. China, for instance, which occupied eighth place globally in terms of numbers of health biotechnology publications for the period 1998–2001, by 2006–2009 had already escalated up to second place just after the United States [6].
Following the time-tested approach of first copying products originated elsewhere [7], [8], innovative biotechnological creations began to appear in a few of these emergent states [9], [10]. Interestingly, some of those efforts include studies in stem cell research and other cutting-edge biotechnology fields where, due to the immaturity of the field itself, the scope for copying is limited and there is a stronger emphasis on new-to-the world innovation [11], [12], [13], [14], [15].
Still, developing new and potentially useful biotechnology does not by itself result in new products on the market, even in leading economies [16], [17]. Generating new health products, particularly therapeutics, is a risky endeavor with many products failing in clinical trials. It does require complex interactions among the actual technical developers, the policy makers, and the public and stakeholder groups necessarily involved in the process; also the input from the users of new health products has been found to be important for successful innovation [18], [19]. Moreover, it is well known that having allies and private sector partners encourages innovation in universities [20]. Sharing facilities at universities and research centers with the biotechnology industry is indeed a constant factor for success in high-income nations and can be an important instrument for technology transfer [21]. The establishment of most biotechnology companies in these countries has so far occurred through the work of scientists who actively contribute to basic science research, as well as to the development of new technologies derived from that same research activity [16], [22]. The pioneer firms in this sector were established in the United States, where firms such as Cetus, Genentech and Hybritech relied on scientific knowledge provided by the University of California San Francisco, Stanford University and CalTech, while in the Northeast, Biogen was supported by scientists from both Harvard University and the Massachusetts Institute of Technology (MIT) [16], [23], [24]. Similarly, increasing the biotechnology industry in other regions of the United States such as Texas, North Carolina, and Maryland, also involved mixing the essential requirements: basic scientific knowledge and entrepreneurial culture [23], [24].
Likewise in Europe, companies were founded around prestigious scientific institutions, such as the University of Cambridge, UK, which provided the academic background to establish biotech startups and spinoffs engaging researchers as founders [25], [26], [27]. Germany followed the lead of the US and UK by implementing a research and entrepreneurship environment to foster biotechnology, initially based around the University of Mannheim and the University of Heidelberg. Later on, the European Molecular Biology Laboratory (EMBL)—which clusters the German Cancer Research Center (DKFZ), the Center of Molecular Biology at the University of Heidelberg, and the Max Planck Institute for Medical Research (MPI)—strongly contributed to the scientific base in health care biotechnology [27], [28]. Thus, technology transfer and commercialization in health biotechnology have been largely dependent on universities and public research centers.
Bozeman (2000) has reviewed and analyzed the massive literature published on technology transfer and developed a model he calls the Contingent Effectiveness Model [21]. Since around 1980 the United States and other high-income countries started to place an emphasis on domestic technology transfer and have developed a number of policy initiatives to promote such technology transfer. The Contingent Effectiveness Model presents a conceptual analysis of the effectiveness of technology transfer and assumes that those involved in and promoting technology transfer, have multiple goals and diverse effectiveness criteria. The model has five dimensions, which shape the effectiveness of the technology transfer: characteristics of the transfer agent, the transfer media, the transfer object and the recipient as well as the demand environment. It argues that the effectiveness of technology transfer can reflect various meanings, such as market impacts, political impacts, impacts on personnel involved as well as impacts on the resources that are available for alternative purposes and other scientific and technical goals. The Contingent Effectiveness Model therefore focuses the attention on multiple dimensions of technology transfer to understand the various approaches that have been followed in carrying out and promoting the transfer.
In the case of biomedical science, the creation of spin-off firms has been a commonly used transfer medium for technology transfer in countries such as the United States and the United Kingdom [16], [29]. Research on biomedical innovation in developing countries, including in Brazil, Cuba, Egypt, India, Iran, and Nigeria has shown less reliance on spin-off formation and rather the use of several other kinds of pathways for developing a domestic biomedical industry, including a strong reliance on public research institutions [9], [30]. Póvoa and Rapini [31] analyzed the technology transfer process in Brazil and highlighted transfer channels similar to those used in high-income countries, e.g. publications and reports, informal information exchange, training and consulting as well as patents [31].
While technology transfer has been analyzed around the world there is still lack of empirical knowledge on this topic in Mexico, including in the biomedical sciences. Mexico, began to prepare young scientists in biotechnology for both medical and agricultural applications already at the birth of this new science in the late 1970s [32], [33], [34], [35]. With a population of over 120 million, Mexico is presently the 11th-largest economy in the world and a powerhouse in selected exports, both commodities as well as manufactured goods [36]. Since the mid-1990s Mexico is one of three partners (with Canada and the United States) of the North American Free Trade Agreement (NAFTA) and, along with Chile, also one of only two Latin American members in the exclusive Organization for Economic Co-operation and Development (OECD). Yet, although currently ranked as number 71 [37] and therefore within the High Human Development bracket of the United Nations Development Programme (2014), the country also shows one of the broadest breaches in wealth distribution in the world [38]. In fact, it is afflicted by a shocking level of poverty in certain rural regions, and it consistently holds the poorest grades in the periodic assessment of public education systems among the OECD members [39].
A similar odd pattern is observed in Mexican effectiveness regarding science and technology. The number of officially recognized researchers throughout all areas of knowledge now exceeds 21,000 [40], who are distributed in over 388 universities and other academic institutions, with a pooled current output of 11,000 scientific publications in international peer-reviewed journals [41]. Nevertheless, Mexican investment in science and technology has stayed stagnant over the years at less than 0.5% of the Gross Domestic Product [42], as has the meager yield of Mexican patents in use [43]. Only a few Mexican scientists have succeeded in effectively linking their work with industry [44], [45], [46], [47], [48], [49], [50], [51].
Such failure in producing solutions related to its needs is particularly disappointing in the public health area [52]. An increasing prevalence of serious disorders like diabetes and heart disease, combined with steady growth in both the total size and the mean age of the population, will soon demand substantial hikes in expenditure for health care. The latter is still remarkably low in Mexico, at only US $664 per capita [53], in comparison with figures for other countries: US $9146 in USA; US $5718 in Canada; US $1085 in Brazil; US $1074 in Argentina [53]. Yet the nation’s economic system is ill prepared to meet this challenge. Hence, contributions from biotechnology and other biomedical advances would be highly welcome to address this situation. But unfortunately few concrete solutions have materialized so far [1], [32], [45], despite sustained efforts towards the development of medications, treatments, vaccines, devices, and programs for combating infectious and degenerative diseases. Effective action is, thus, urgently needed.
At present time the Mexican health biotechnology industry is composed of 210 companies, according to a recent official survey [54]. Yet, independent studies on this subject have found that most of the firms on this list rely on improving traditional practices instead of switching to current molecular knowledge [55], [56], [57], [58]. In fact, just a handful of small and middle-size local companies are devoted to developing modern biotechnologies for health care, mainly recombinant methods for the biosynthesis of insulin, human growth hormone, and their analogues [55], [59].
Mexican scientists who aim their research at modern techniques in biotechnology are currently found in about thirty universities and public research institutions. The main organizations acknowledged for their scientific productivity in this area include the Biotechnology Institute (IBT) and the Center for Genomic Sciences (CCG), both at the National Autonomous University of Mexico (UNAM), the Center for Research and Advanced Studies (Cinvestav) and its National Laboratory of Genomics for Biodiversity (Langebio, Cinvestav Irapuato), Mexico’s National Institutes of Health, especially the National Institute of Genomic Medicine (INMEGEN), and the Mexican Institute for Social Security (IMSS) [1], [32], [33], [34], [55], [60], [61], [62]. Nevertheless, it is not clear whether there is any ongoing collaboration between these organizations and the incipient healthcare biotechnology industry in Mexico.
Recently, the IBT was granted seven patents (2014) and then five more (2015), all related to the agro and health biotechnology sectors [63], [64], [65]. The technology transfer office (TTO) of this institute reports that eight patents were licensed to start-up companies, two others are presently under agreement for commercialization, and only two are not going through any commercialization efforts [64], [65]. Still, reaching the market will require overcoming challenges like the establishment of spin-offs and building up independent innovation processes, as shown by IBT scientists in their successful experience with the Fungifree AB® biofungicide [51].
There has been some research studying interactions between researchers at universities and firms in Mexico. De Fuentes and Dutrénit [66] analyzed the interaction process of researchers with individual firms in several science-based fields in Mexico. Based on this they argued that the best channels of interaction between these agents for long-term benefit are joint R&D projects and consultancy, shared intellectual property rights, and exchange of human resources.
Given the weak record of the Mexican health biotechnology sector, there is a pressing need to examine why a prominent country with an early start in this kind of research [32], [34] has yet so little to offer in terms of developing solutions aimed at its own mounting problems of public health. Gaining an insight into this problem will provide a better understanding of the operation of the complex system of health biotechnology in the country, which is likely to be relevant to other low-and-middle income countries wishing to promote health biotechnology addressed to their local health needs.
In this paper we focus on the process of producing and transferring new biotechnology for medical use by examining developments originated at Cinvestav, an over 50-years old prestigious Mexican scientific institute. Cinvestav, with headquarters in Mexico City, has a total of nine campuses distributed in eight federal states throughout the country, and its history has run parallel to that of the modern biotechnology boom [35].
Instead of relying on analyzing background information obtained from collected documents, websites and interviews with administrative officials in research institutions, companies and government agencies, we collected first-hand accounts of the contributions of health biotechnology research to medical needs in Mexico by surveying and interviewing scientists at Cinvestav. Of primary interest was finding out to what extent they are carrying out research aimed at health needs in the country; what collaborations and financial help they have sought and obtained for their projects; what steps they have taken towards patenting and licensing their discoveries, and when they expect their final products to enter the market.
Our findings point to clear areas demanding attention from both Cinvestav’s administrators and the wider academic, business and government sectors in Mexico. While the present analysis casts light on the challenges confronted by researchers in Mexico, many of these issues are likely to be confronted also by scientists in other low-and-middle income countries pursuing innovation in biotechnology for health care. Therefore, we are certain it will be helpful for other developing nations looking for new, up-to-date ways to improve health innovation in their countries.
Section snippets
Methodology
Mixed methods were used to study factors affecting the transfer of health biotechnology generated at Cinvestav, involving both a survey applied to health biotechnology researchers asking general questions about their technology transfer activities, and in-depth interviews asking them specific questions about their translational efforts.
The process was started by delivering a brief survey to 166 principal investigators (PIs) affiliated with the life and health sciences departments at Cinvestav,
Extent of research aimed at health needs
We identified 44 R&D projects, with patents or with filed applications, from the 24 PIs we interviewed. In these projects all the PIs were conducting research aimed at applied applications (Fig. 2a). We classified the projects into therapy, diagnostics, disease prevention and nutraceuticals according to their proposed medical use as well as 11 application areas indicated by the PIs we interviewed. We also used a biotechnology product sub-classification where we classified the projects into
Lack of coherent governmental policies
The present study provides a detailed analysis of the status and challenges of technology transfer and commercialization in a prestigious scientific institution in a low-and-middle income country with a medium-sized economy and a relatively robust scientific infrastructure. We showed that at Cinvestav only 54% (34/62) of scientists in biomedical research had an interest in commercializing the product of their research. Less than 19% (12/62) of them had filed for a patent, and a still lower
Funding
NMM received a financial scholarship number 104235 from Conacyt.
Acknowledgments
We are grateful to all the principal investigators we surveyed and interviewed for their kind collaboration during this study. We also thank IIMAS-UNAM for their support to carry out the online survey.