Article Commentary: Technology and Innovation: 2010 a Year in Review

Abstract

The following commentary provides a discussion of the articles published in Technology and Innovation in 2010 and where possible places them into context with those reported in Cell Transplantation. These articles can be divided into the following topics: a) models for innovation and technological commercialization, b) the ethical and legal consequences of the emergence of new technologies, c) research on novel technologies and methods, and d) the difficulties involved in peer review and scientific assessment. The articles shed light on the effects of technological innovation and commercialization on scientific ethical regulation, the establishment of legal standards for the protection of intellectual property, and the development of financial models.

One frequently unconsidered aspect of the studies published in Cell Transplantation is the protection of intellectual property and the development of new technologies. When it was first published in 1991, Cell Transplantation used to regularly feature patent information, but over time the demand for space meant that this was eventually dropped. However, the increase in scientific inventions in university departments and laboratories around the world has called into question our current mechanisms for protecting intellectual property, promoting commercialization, maintaining ethical guidelines, and evaluating academic performance. For this reason, Technology and Innovation, a sister journal to Cell Transplantation published by Cognizant Communication and edited by Paul R Sanberg, serves as an academic forum where these issues can be addressed by academic professionals, researchers, inventors, and entrepreneurs. The objectives of this journal are to cover advances in translational science, provide assessments of specific areas of scientific production, explore the economic issues involved in technological innovation, provide evaluations of government policies and programs aimed at fostering scientific breakthroughs in the US and abroad, as well as critically examining the social, ethical, legal, and environmental impacts of the emergence of new technologies.

While on the surface, this may not seem to be directly relevant to the readership of Cell Transplantation, it is worth noting that several of the articles published in the last 2 years of Cell Transplantation are associated with patents and all publications relate to intellectual property in some fashion, although the majority of it may not be patentable. Unfortunately, the authors do not always state when patented (or patent-pending) material is featured in their article and so the Cell Transplantation articles mentioned herein are comprised primarily of those in which the authors do specify. In addition, Cell Transplantation publishes the abstracts of the American Society for Neural Therapy and Repair (ASNTR) meeting at which the use of patented (or patentable) technology is also frequently featured. In some instances, the content of the research itself is being or has been patented whereas in other cases it may be the use of a specific technology to perform the studies that has already been or will be patented. For example, Zajicova et al. used modified needleless Nanospider^™ technology for the development of the nanofiber scaffolds on which stem cells could be grown in their study. They tested the scaffold and stem cells as a possible treatment for eye injuries with some potential for success. In addition, while there is no mention of a patent application in the article, Richard et al.'s report on a semimanual device for repetitive intramuscular cell injections would appear to be an ideal topic for an application. Where possible in this overview of the publications in Technology and Innovation, similar patents or licensed technologies will be referred to have been published in Cell Transplantation recently.

During 2010, Technology and Innovation published three issues on topics related to scientific innovation and technological translation and commercialization. A total of 24 author contributions were selected for publication in the form of editorials, commentaries, reviews, and articles presenting the results of empirical research on technological advances. Each issue included the work of researchers from multiple disciplines and countries, thus enabling it to appeal to a diverse range of readers. The inaugural issue of Technology and Innovation introduced the readership to a new journal title, editorship, and editorial board. The first and second issues covered a wide range of topics related to innovation, while the third issue focused mainly on peer review and scientific assessment. The articles published in these three issues of Technology and Innovation can be divided into the following topics: a) models for innovation and technological commercialization, b) the ethical and legal consequences of the emergence of new technologies, c) research on novel technologies and methods, and d) the difficulties involved in peer review and scientific assessment.

Four articles presented examples of technology transfer and commercialization. By using the example of the development of a low-cost thermogravimetric analyzer by The Charles Stark Draper Laboratory, Inc. (FL, USA), Polizzotto demonstrated how technologies can be developed to satisfy the needs of particular consumers and have the potential for future commercialization. Another example was presented by Killinger with regards to the laser. According to the author, the use of lasers has expanded beyond the scientific realm and is now commercialized as an optical probe of the surrounding environment for mapping and physical imaging purposes as well as for chemical sensing. Lodato's article on biomimicry and biodesign presented two cases where elements from nature such as a woodpecker and the exterior shells of lobsters were used as a template for the creation of an ice axe and rugged cell phones.

Fries and colleagues presented the SciFlies innovation acceleration model, which involves the creation of a new funding infrastructure to promote scientific innovation and technological translation. This model is based on the establishment of a network of science researchers, citizens who act as financial donors, and innovation policy makers. The goal is to create a new source of funds for the Research and Development field by engaging citizen donors to support science and technology-based research projects. Furthermore, the involvement of policy makers in this same network provides a mechanism to inform both industry and government of the new trends in scientific research that could be funded in order to promote innovation.

Two of the articles published in Technology and Innovation also acknowledged that innovation and the emergence of new technologies have evident legal and ethical consequences. Borlongan and colleagues presented an overview of ethics in stem cell-based therapies in order to propose the establishment of an Ethics Research Consortium. The Consortium would implement ethical principles to analyze the benefits and social consequences of stem cell research in relation to their economic support. This organization would also be in charge of informing the public and policy makers in order to avoid misconceptions regarding the study and implementation of these emerging technologies. This is a topic that is highly relevant to those published in Cell Transplantation, as the majority of publications involve the use of either human or animal tissue and many report on stem cell-based technologies. For example, Cargnoni et al. published two articles using their patented technique of obtaining stem cells from amniotic and placental tissue and their potential use in ischemic heart repair and lung fibrosis. Gonzalez et al. reported on their technology to isolate and characterize umbilical cord lining cells, for which a patent has been filed.

Lloyd and Brown discussed the amicus brief filed by the University of South Florida in the case of Bilski v. Kappos. In this brief, USF argued in favor of expanding the classification of patent eligible matter to include methods of diagnosis, monitoring, and treatment, which could be potentially excluded from the ruling put forward by the Federal Circuit. According to this ruling, eligibility for patents is determined by a machine-or-transformation test whereby a process needs to be linked to a specific machine or a transformation of the article into a different state or entity. The authors contended that this ruling is more restrictive than previous ones and this test could end up excluding methods that could be valuable for medical innovation.

Eight of the articles published in Technology and Innovation in 2010 introduced the readers to specific discoveries and technological innovation in pharmaceutics, nanotechnology, neurology, electroporation, chemistry, bionics, and biodesign. Emerich and Orive reviewed the role of biomaterials in the development of new treatments for brain regeneration and repair. One such example of a biomaterial reported in Cell Transplantation is the three-dimensional biodegradable dermal fibroblast constructs (3DFCs) that were used by Thai et al. in a rat model of myocardial infarction with some degree of success. This technology is licensed to Theregen, Inc. Also loosely related to this is the patented Unisol^™ family of preservation solutions, which were used by Taylor et al. to preserve islet tissue in their study. Chang and colleagues tested the capacity of Octolig^®, a polyethylenediamine covalently attached to a high-surface-area silica gel, for removing pharmaceuticals from waste water. Gilbert and Hickey demonstrated the contributions of interdisciplinary collaboration in the use of electric fields to administer drugs or genes during cancer treatment. Wade and Gutmann explained the effectiveness of the three-dimensional integration of wafer bonding when combined with gas dielectrics. Manning and colleagues analyzed the iron–taxol complex, determining taxol's water solubility and stability, which could improve its medical applications. In a second article, Manning and colleagues explored the benefits of microbial amplification chambers (MACs) for the reproduction of marine microbes responsible for producing marine natural products such as bryostatin (a medicinal agent). Martin and colleagues studied the propagation of antibiotic-resistant bacteria as a result of the administration of monensin and tetracyclines to animal food diets and its effect on human health.

A special issue edited by Alan Moghissi was dedicated to the emerging field of regulatory science, including discussions on both peer review and scientific assessment, making it the largest of the four topics mentioned earlier. Regulatory science addresses the needs of regulatory agencies and is based on scientific assessment, that is, the evaluation of existing scientific knowledge in order to advise organizations on funding decisions, the design and implementation of policies, and the promotion of specific areas of scientific research.

Rothenberg provided a historical overview of the merit review criteria utilized by the National Science Foundation (NSF) from the 1960s to the present, finding that this organization reduced its number of criteria, but introduced factors that go beyond just the science such as the “broader impacts” category. Holbrook explored this observation further and found that societal impact considerations were present in the grant review criteria of five funding agencies, but not all of these organizations presented the same level of theoretical adequacy or visualized societal impacts in the same way. Theoretical adequacy refers to a measurement of the way in which the peer review process can achieve specific values. Bauer analyzed the international peer reviewing of research proposals by the Human Frontier Science Program (HFSP). The author argued that the diversity of reviewers in terms of nationalities and scientific expertise facilitated the fair evaluation of the proposals.

The rest of the articles focused on proposals for different models or alternatives for peer review. Moghissi and Swetnam indicated that confusion currently exists in the public sector regarding the incorporation of peer review into policy decisions. The authors provided a description of the different mechanisms of peer review currently used by government institutions and identified the strengths and weaknesses of each alternative. The article by Yglesias also focused on peer review within the government sector and proposed an Internet-based calibration system to ensure the integrity of the reviewer.

Kaime and colleagues highlighted the benefits of including consumer advocates in the peer review process of Congressionally Directed Medical Research Programs (CDMRP), that is, a group of 18 programs aimed at disease-targeted biomedical research. Glenn indicated that the research programs managed by the U.S. Army Medical Research and Materiel Command (USAMRMC) require a peer review that goes beyond the evaluation of the quality of the science, is capable of ensuring efficiency, and is likely to accomplish technical objectives. Prather-Stroud's article supported the implementation of “technical review” as an alternative to independent peer review. According to the author, technical review refers to the evaluation of the project or proposal by federal, state, and local agencies and could be used in projects that require an expert evaluation, but do not necessarily have the time or need for peer assessment.

The articles published in Technology and Innovation shed light on current trends in technological innovation and commercialization. It was evident from these contributions that scientific discoveries not only promote the advancement of science, but also foster the transformation of ethical guidelines, legal regulations, and financial models. Technology and Innovation will continue to address these issues and act as a forum for members of academia, industry, and government. Our future issues will also include articles on technological innovation in specific fields such as stem cell research. Our first issue in 2011 contains an article by Sladek and Bjugstad on the future of stem cell applications. We hope this article will be the first of many. A high number of publications in Cell Transplantation involve the use of stem cells, including several reviews of their potential use or generation; for example, Fernandes et al. published a review on methods to culture human embryonic stem cells—several of these procedures are likely to have been patented. Some articles discuss stem cells, frequently from companies, whose synthesis has been patented, such as those generated by ReNeuron, Inc., which may prove to be effective in the treatment of stroke and Huntington's disease. The process of isolating the stem cells may also have been patented, such as already mentioned with Cargnoni et al. and Gonzalez et al. Patents could also arise from the use of the cells; for example, Cellpraxis and some of the authors of Hossne et al. have submitted a patent relating to a protocol using autologous bone marrow grafts to treat angina known as Refractory Angina Cell Therapy (ReACT). Companies such as Saneron, Inc. and Natura Therapeutics, Inc. also have licensed technology with respect to the isolation and use of umbilical cord blood cells and use of natural compounds to treat neurodegenerative disorders, respectively. Several of these have been reported on at the ASNTR meeting. There were at least three reports on the use of the Saneron-patented human umbilical cord blood-derived mononuclear cell fraction provided for the treatment of Sanfilippo syndrome, amyotrophic lateral sclerosis, and stroke. Acosta et al. reported on the ability of Natura Therapeutics' natural product formula NT-020 to promote stem cell proliferation and improve spatial memory in aged rats. Finally, the manuscript by Robinson et al. highlights that the identification of a specific mutation with respect to a disease could also be patentable, since they hold a patent for the genetic sequence of mammalian sulfamidase and its study with respect to therapies.

This shows that the intellectual property of research is an important consideration for readers of the journal Cell Transplantation. The new journal Technology and Innovation will help to highlight the overlap between research, as represented by publications in Cell Transplantation and intellectual property as typified by patents and the articles published within Technology and Innovation. Technology and Innovation can be a potential forum for the readers of Cell Transplantation who are interested in writing about patents and technology commercialization.