Author Correction to: Gene Patents in Canada: Is There a New Legal Landscape?

An error was subsequently identified in the article, and the following correction should be noted.

Gene Patents in Canada: Is There a New Legal Landscape?

In 2016, the Children's Hospital of Eastern Ontario (CHEO) announced the settlement of its patent lawsuit against US-based Transgenomic, Inc. At issue in the case was CHEO's ability to test for gene mutations associated with long QT syndrome (LQTS) that are described in Transgenomic's patents. CHEO challenged the patents as invalid, and Transgenomic ultimately agreed to license them on a royalty-free basis to CHEO and other healthcare institutions for LQTS testing and research. While widely celebrated in the media, the ethical rhetoric surrounding the settlement has at times obscured the practical and legal context in which it was made and will operate. Here, we provide a nuanced account of the events surrounding the settlement and its implications for research and clinical care. Although the settlement is remarkable for the transparency of its terms and its inclusion of a license intended to benefit unaffiliated test providers, we conclude that another significant implication of the settlement may be its elimination of the opportunity to clarify an increasingly confused area of Canadian law against a backdrop of continued international controversy surrounding the patenting of genes and gene-based diagnostic and therapeutic methods.

More Haste, Less Speed: Could Public-Private Partnerships Advance Cellular Immunotherapies?

Cellular immunotherapies promise to transform cancer care. However, they must overcome serious challenges, including: (1) the need to identify and characterize novel cancer antigens to expand the range of therapeutic targets; (2) the need to develop strategies to minimize serious adverse events, such as cytokine release syndrome and treatment-related toxicities; and (3) the need to develop efficient production/manufacturing processes to reduce costs. Here, we discuss whether these challenges might better be addressed through forms of public-private research collaborations, including public-private partnerships (PPPs), or whether these challenges are best addressed by way of standard market transactions. We reviewed 14 public-private relationships and 25 underlying agreements for the clinical development of cancer cellular immunotherapies in the US. Most were based on bilateral research agreements and pure market transactions in the form of service contracts and technology licenses, which is representative of the commercialization focus of the field. We make the strategic case that multiparty PPPs may better advance cancer antigen discovery and characterization and improved cell processing/manufacturing and related activities. In the rush toward the competitive end of the translational continuum for cancer cellular immunotherapy and the attendant focus on commercialization, many gaps have appeared in our understanding of cellular biology, immunology, and bioengineering. We conclude that the model of bilateral agreements between leading research institutions and the private sector may be inadequate to efficiently harness the interdisciplinary skills and knowledge of the public and private sectors to bring these promising therapies to the clinic for the benefit of cancer patients.

Opportunities and challenges for the cellular immunotherapy sector: a global landscape of clinical trials.

Global investments in cellular immunotherapies reflect their curative potential. Our landscape of clinical trials will aid developers, investors, adopters and payers in planning for adoption and implementation along realistic time horizons. Trend data enable stakeholders to adapt their business models and capacity to bring immunotherapies to the clinic. For cancer, trends suggest a shift from cancer vaccines to adoptive cellular transfer, alongside a focus on solid tumors. Academic centers, mainly in the USA, lead in early-phase clinical trials and target identification; but industry involvement has increased fourfold over the past two decades. Trends indicate an increasingly personalized approach to onco-immunology, which raises challenges for cost-effective manufacturing and delivery models. Overcoming these challenges provides opportunities for innovative biotechnology firms.

Personalised medicine in Canada: a survey of adoption and practice in oncology, cardiology and family medicine.

Introduction In order to provide baseline data on genetic testing as a key element of personalised medicine (PM), Canadian physicians were surveyed to determine roles, perceptions and experiences in this area. The survey measured attitudes, practice, observed benefits and impacts, and barriers to adoption. Methods A self-administered survey was provided to Canadian oncologists, cardiologists and family physicians and responses were obtained online, by mail or by fax. The survey was designed to be exploratory. Data were compared across specialties and geography. Results The overall response rate was 8.3%. Of the respondents, 43%, 30% and 27% were family physicians, cardiologists and oncologists, respectively. A strong majority of respondents agreed that genetic testing and PM can have a positive impact on their practice; however, only 51% agreed that there is sufficient evidence to order such tests. A low percentage of respondents felt that they were sufficiently informed and confident practicing in this area, although many reported that genetic tests they have ordered have benefited their patients. Half of the respondents agreed that genetic tests that would be useful in their practice are not readily available. A lack of practice guidelines, limited provider knowledge and lack of evidence-based clinical information were cited as the main barriers to practice. Differences across provinces were observed for measures relating to access to testing and the state of practice. Differences across specialties were observed for the state of practice, reported benefits and access to testing. Conclusions Canadian physicians recognise the benefits of genetic testing and PM; however, they lack the education, information and support needed to practice effectively in this area. Variability in practice and access to testing across specialties and across Canada was observed. These results support a need for national strategies and resources to facilitate physician knowledge, training and practice in PM.

An evaluation of multidimensional fingerprinting in the context of clinical proteomics.

Multidimensional fingerprinting (MDF) utilizes measurable peptide characteristics to identify proteins. In this study, 3-D fingerprinting, namely, parent protein molecular weight, peptide mass, and peptide retention time on RPLC, is used to identify 331 differentially expressed proteins between normal and human colon cancer plasma membrane samples. A false discovery rate (FDR) procedure is introduced to evaluate the performance of MDF on the colon cancer dataset. This evaluation establishes a false protein identification rate below 15% for this dataset. Western blot analysis is performed to validate the differential expression of the MDF-identified protein VDAC1 on the original tissue samples. The limits of MDF are further assessed by a simulation study where key parameters such as database size, query size, and mass accuracy are varied. The results of this simulation study demonstrate that fingerprinting with three dimensions yields low FDR values even for large queries on the complete human proteome without the need for prior peptide sequencing by tandem mass spectrometry. Specifically, when mass accuracy is 10 ppm or lower, full human proteome searches can achieve FDR values of 10% or less.