Material Transfer Agreements Research Articles

DBT Propelled National Effort in Creating Mutant Resource for Functional Genomics in Rice

In 2007, with the help of DBT, a research project to create mutant resources for functional genomics in rice was launched through a national initiative involving ICAR-National Research Centre on Plant Biotechnology, New Delhi; ICAR-Indian Agricultural Research Institute, New Delhi; Tamil Nadu Agricultural University, Coimbatore; ICAR-Indian Institute of Rice Research, Hyderabad; University of Agricultural Sciences, Bangalore and Punjab Agricultural University, Ludhiana. Genetically well-defined material is a prerequisite for functional genomics. Thus, the project aimed to generate EMS mutants in the background of an upland and short duration aus genotype, Nagina22, characterize the mutants and use them in crop improvement. As of now, nearly 85,000 rice M2 mutant populations have been created under the project. Based on field phenotyping, gain and or loss of function mutants for tolerance to herbicide spray, drought, salinity and resistance to rice leaf and panicle blast, sheath blight and high phosphorus (P) use efficiency under low P field have been identified. Notably, the herbicide-tolerant mutant identified is under the process of registration for distribution to public and private rice breeders under appropriate material transfer agreement. Besides this, the project also aims to serve as a 'National Repository of rice EMS mutant resource' for the researchers involved in rice biology and improvement in the country.

Abstract S1-08: High risk premenopausal luminal A breast cancer patients derive no benefit from adjuvant chemotherapy: Results from DBCG77B randomized trial

Abstract Aim: To determine the predictive value of intrinsic subtypes for response to adjuvant chemotherapy using specimens from a randomized clinical trial. Background: Several studies have shown distinct clinical profiles of intrinsic breast cancer subtypes. The Luminal A subtype has a favorable prognosis with higher survival rate and lower recurrence in comparison to other breast cancer subtypes (luminal B, HER2 and basal-like). In addition, there is mounting evidence suggesting that intrinsic breast cancer subtypes differ in their responsiveness to adjuvant chemotherapy. Based on these data, we hypothesized that Luminal A breast cancer patients derive no benefit from adjuvant chemotherapy whereas other intrinsic subtypes do. Randomized breast cancer trials with a no chemotherapy arm and available tissues are rare, but represent the best materials to test for markers predicting chemotherapy benefit. The 77B clinical trial from the Danish Breast Cancer Cooperative Group (DBCG) offers a unique opportunity to test such hypotheses as it randomized 1146 premenopausal women, who had positive axillary lymph nodes or tumors >5 cm, to two chemotherapy arms (single-agent oral cyclophosphamide, or cyclophosphamide-methotrexate-fluorouracil (CMF)), and two no chemotherapy arms (levamisole, or no agent). All arms included radiotherapy but no endocrine therapy. Methods: We performed a full intrinsic subtype analysis on the 709 breast cancers available from DBCG77B on tissue microarrays using previously published, locked-down immunohistochemical (IHC) methods and intrinsic subtype definitions based on ER, PR, HER2, Ki67 and basal markers (Prat et al. JCO 2014). Biomarker scoring was performed in Vancouver by researchers with no access to the clinical database. A full statistical plan was prespecified in the Material Transfer Agreement and executed accordingly by the DBCG Statistical Office. 10-year invasive disease-free survival (IDFS) was the primary end point in DBCG77B; overall survival was also a predefined endpoint. The primary hypothesis was to assess interaction between benefit of chemotherapy (chemotherapy yes vs no) and subtype (Luminal A vs non-luminal A). This was analyzed in multivariate Cox proportional hazards models using the Wald test for interaction. Results: 709 patients had tissue available and completed IHC intrinsic subtyping. The effect of chemotherapy in this subset of patients was similar to the original trial: hazard ratio 0.56, favoring chemotherapy for 10-yr IDFS. IHC classified 165 as luminal A, 319 luminal B, 58 HER2E and 91 as triple negative (including 82 core basal). Patients with luminal A breast tumors did not benefit from chemotherapy (HR = 1.07, 95% CI = 0.53-2.14, p = 0.86), whereas patients with non-luminal A subtypes did (HR = 0.50, 95% CI = 0.38-0.66, p < 0.001). This heterogeneity was statistically significant (p=0.048). A similar trend for 25-yr OS was seen, although not significant. Conclusions: In a formal prospective-retrospective analysis of the DBCG 77B study randomizing women to adjuvant cyclophosphamide-based chemotherapy vs. no chemotherapy arms, patients with non-luminal A breast tumors (defined by IHC), but not luminal A tumors, benefit from adjuvant chemotherapy. Citation Format: Nielsen TO, Jensen [lrm] M-B, Gao D, Leung S, Burugu S, Liu S, Tykjær Jørgensen CL, Balslev E, Ejlertsen B. High risk premenopausal luminal A breast cancer patients derive no benefit from adjuvant chemotherapy: Results from DBCG77B randomized trial. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr S1-08.

Current modalities and concepts on access and use of biospecimen samples and associated data for research from human biobanks

It is accepted worldwide that biospecimen and data sharing (BDS) play an essential role for the future of medical research to improve diagnostics and prognostics, e.g. by validated biomarkers. BDS is also pivotal to the development of new therapeutic treatments and for the improvement of population health. Human biobanks can generate an added value to this need by providing biospecimens and/or associated data to researchers. An inspection of several examples of epidemiological as well as clinical/disease-oriented biobanks in Germany shows that best practice procedures (BPP) that are internationally agreed on are being installed for biospecimen and/or data access. In general, fair access is aimed at requiring a written application by the requesting scientist, which is then peer-reviewed for scientific and ethical validity by the Biobank. Applied BPP take into account (i) patient education/agreement according to the informed consent model, (ii) privacy protection, (iii) intellectual property rights, the (iv) notification obligation of health-related findings (including incidental findings), the (v) use of material (MTA) and data transfer agreements (DTA) for mutual legal security, the avoidance of conflicts of interests, as well as for cost recovery/fee for service as a basis for sustainability of the biobank. BPP are rooted in the self-regulation efforts of life sciences and are supported by parent ethics committees in Germany. Central biobank registries displaying aggregated information on biospecimens stored and the research foci constitute an important tool to make biobanks that are scattered across the country visible to each other, and, can thus promote access to hitherto unknown biospecimen and data resources.

University Licensing and the Flow of Scientific Knowledge

As university involvement in technology transfer and entrepreneurship has increased, concerns over the patenting and licensing of scientific discoveries have grown. This paper examines the effect that the licensing of academic patents has on journal citations to academic publications covering the same scientific research. We analyze data on invention disclosures, patents, and licenses from the University of California, a leading U.S. academic patenter and licensor, between 1997 and 2007. We also develop a novel “inventor–based” maximum–likelihood matching technique to automate and generalize Murray’s (2002) “patent–paper pairs” methodology. We use this methodology to identify the scientific publications associated with University of California patents and licenses.Based on a “difference–in–differences” analysis, we find that for patented academic discoveries in general, licensing appears to have little effect on journal citations to related scientific publications. When we examine the subset of discoveries that are not inputs to further research, however, licensing has a positive effect on journal citations to related scientific publications, suggesting that the successful negotiation of a license may demonstrate that a particular area of research has scientific value. In contrast, we find that licensing of research inputs (which we identify through the use of material transfer agreements, or MTAs) depresses citations to related scientific publications, raising the possibility that licensing may restrict the flow of inputs to “follow–on” scientific research.

Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi.

BackgroundThis paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi.DiscussionThe current research ethics regulations and guidelines in Malawi do not allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes.SummaryIn conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi.

From Bench to Worldwide: How Addgene Built a Global Resource for Material Sharing

While advancements in informational technologies have provided nearly instant access to scientific data and information, ready and available access to research materials remains a problem for many in the research community. Issues such as a lack of lab resources or the loss of published materials can create practical impediments to sharing, while in other cases, prolonged legal negotiations over the sharing terms can create administrative ones. Addgene’s founders set out to create an effective platform that would address these issues to make sharing easier between scientists. Like many startups and nonprofit organizations, Addgene faced many hurdles such as community adoption and financial stability. However, Addgene’s commitment to its mission and its perseverance eventually led to the widespread adoption of Addgene’s services by the research community. By delivering an efficient, streamlined process for scientists and their technology transfer offices, the research community has since come to view Addgene as a trusted and vital research resource and one that continues to hone its efforts in making it easier for scientists to share their research materials. Keywords: material transfer agreements, MTA, plasmids, sharing, repository, nonprofit, self sustainable, efficient systems, uniform biological material transfer agreement, UBMTA.

Can Plant Breeding Go Open Source?

Can Plant Breeding Go Open Source?

Benefit sharing in health research

The necessity of benefit sharing may be questioned when research activities are funded by international sources within a developing country. Benefit sharing is a topic which remains uncertain in the context of genetic research, particularly with regard to how and with whom benefits should be shared. A Material Transfer Agreement (MTA) is one way (and in some instances the only way) in which the transfer of human biological materials is regulated. With biobank research increasing and the historical exploitation of research participants in Africa a reality, it is essential that the transfer of human tissues across national boundaries is regulated with specific regard to the sharing of benefits and the respect and protection of traditional values. This paper will debate the requirement of benefit sharing when research is undertaken; discuss its meaning in the context of genetic research; and outline some South African and international perspectives on the sharing of benefits. While this paper emphasises benefit sharing in the context of genetic research, the principles apply to all human participant research.

The International Society of Biological and Environmental Repositories presents Abstracts from their Annual MeetingBridging the Canyon – Connecting Biobank Communities through Innovations in Global Health, Research and Environmental PreservationMay 5–9, 2015Phoenix, Arizona

The International Society of Biological and Environmental Repositories presents Abstracts from their Annual MeetingBridging the Canyon – Connecting Biobank Communities through Innovations in Global Health, Research and Environmental PreservationMay 5–9, 2015Phoenix, Arizona

Understanding the Implications of Mitochondrial DNA Variation in the Health of Black Southern African Populations: The 2014 Workshop.

Understanding the Implications of Mitochondrial DNA Variation in the Health of Black Southern African Populations: The 2014 Workshop.

Intersubgeneric hybridization between Glycine max and G. tomentella: production of F₁, amphidiploid, BC₁, BC₂, BC₃, and fertile soybean plants.

This paper describes methods for unlocking genetic treasure from wild perennial Glycine species of Australia for soybean improvement. The genetic resources of the ca. 26 species of the genus Glycine subgenus Glycine have not been exploited to broaden the genetic base of soybean (Glycine max; 2n = 40). The objectives of this study were to develop methods for producing F1, amphidiploid, BC1, BC2, BC3, and fertile soybean plants from crosses of soybean and the genus Glycine subgenus Glycine species, in order to utilize the subgenus Glycine germplasm in soybean breeding. Soybean cultivars were hybridized with six accessions of 78-chromosome G. tomentella as well as one accession each of 40-chromosome G. tomentella, G. argyrea and G. latifolia. They were chosen because they exhibit resistance to soybean rust. We were successful in producing fertile soybean from soybean cv. 'Dwight' and 78-chromosome G. tomentella accession PI 441001, while other hybrids were discontinued either at F1 or amphidiploid stage. The F1 seeds aborted prior to reaching maturity, so developing seeds from 19 to 21 day old pods were cultured aseptically in various media formulations. Seed maturation and multiple embryo generation media were developed. F1 plants with shoots and roots (2n = 59) were transplanted to pots in greenhouse. Amphidiploid (2n = 118) plants were backcrossed to 'Dwight'. BC1 (2n = 79) plants were propagated through in vitro and 43 mature BC2F1 seeds were harvested. Fifteen surviving BC2F1 plants were morphologically distinct, sterile, and had chromosome numbers ranging 2n = 56-59. Chromosome numbers of the BC3F1 plants ranged 2n = 40-49. Derived fertile soybeans were first planted in the field in 2008 and are being evaluated for yield, resistance to pathogens and pests and tolerance to salt through material transfer agreement.

An access and benefit-sharing awareness survey for botanic gardens: Are they prepared for the Nagoya Protocol?

Botanic gardens acquire, use and exchange plants for a range of scientific, conservation, economic and cultural purposes, and these activities are affected by the Convention on Biological Diversity's provisions on access to genetic resources and benefit-sharing and related national laws and policies. The new Nagoya Protocol on access to genetic resources and benefit-sharing, a supplementary agreement to the Convention on Biological Diversity, adds new requirements for compliance with national laws and providers' terms, including the monitoring of utilisation of genetic resources. A global survey of botanic gardens was conducted to assess awareness of access and benefit-sharing and potential preparedness for Nagoya Protocol requirements, using an online Qualtrics questionnaire distributed via Botanic Gardens Conservation International and American Public Gardens Association. Data were collected on gardens' location, governance, size, international involvement, network membership, familiarity with access and benefit-sharing, collections policies and extent to which gardens track material and permit terms. Representatives of 222 gardens from 46 countries responded. Results indicate that many respondents are not yet familiar with access and benefit-sharing or the Nagoya Protocol. Exchange of plant material is common, but many gardens do not track transfers to third parties, use material transfer agreements, or link permits or restrictions to collection records. Global socio-economic region and international involvement were significantly related to several measures of familiarity and preparedness. The survey demonstrates a need for more effective communication with government authorities and within institutions. Capacity-building initiatives and practical tools are needed to enable gardens and their networks to understand access and benefit-sharing, comply with new legislation, build trust and safeguard their role in conservation.

Innovative Contracting for Better Material Transfers

Empirical studies find that contrary to expected outcomes, it is not patents that most often impede research. Instead, it is access to tangible research inputs that is more likely to cause the delay or abandonment of promising research. Difficulty in the negotiation and execution of material transfer agreements (MTAs), the contractual agreements governing the transfer of materials, research tools, and data, is the cause. This Article addresses a new trend in MTA practice that is both exciting and problematic. In the past, MTAs largely functioned as a recording mechanism to track who had what materials and to set expectations in case of a laboratory accident or infringement lawsuit involving the transferred material. Now, however, some industry parties are using MTAs to gain more than just a record of the transfer and basic representations and warranties. These industry parties are using MTAs to develop and build relationships. This, in turn, is leading to more shared innovative activity, a key factor in moving scientific fields forward. Yet this progress towards more shared innovative activity is not without cost. Most notably, this modern MTA practice is increasing transaction costs and the likelihood of bargaining breakdowns because not all parties are using MTAs in this way. In order to facilitate access to materials, tools, and data while also furthering shared innovative activity, non-industry parties, most notably academic institutions, should join the modern MTA regime. Lawyers have an opportunity to improve the material transfer process through innovative contracting practices. This Article provides suggestions on how to accomplish this by overcoming contested terms and using a modern MTA to give access to materials and help develop collaborative relationships.

Managing Human Tissue Transfer Across National Boundaries - An Approach from an Institution in South Africa.

With biobank research on the increase and the history of exploitation in Africa, it has become necessary to manage the transfer of human tissues across national boundaries. There are many accepted templates of Material Transfer Agreements (MTAs) that currently exist internationally. However, these templates do not address the specific concerns of South Africa and even of Africa as a continent. This article will examine three significantly important ethico-legal concepts that were deliberated and carefully adapted by a South African Institution to suit the transfer of Human Biological Materials (HBMs) and associated data for biobank research, namely: informed consent; benefit sharing arrangements; and ownership together with intellectual property rights in human tissues. The discussion includes an analysis of current practice; the ethico-legal challenges in the South African/African context; the decisions made with regard to how the related ethico-legal challenges were addressed in the MTA; and justifications for implementing these decisions. The processes considered could be of benefit to other developing world countries who consider it necessary to manage the transfer of HBMs across national boundaries.

Use and misuse of material transfer agreements: lessons in proportionality from research, repositories, and litigation.

Material transfer agreements exist to facilitate the exchange of materials and associated data between researchers as well as to protect the interests of the researchers and their institutions. But this dual mandate can be a source of frustration for researchers, creating administrative burdens and slowing down collaborations. We argue here that in most cases in pre-competitive research, a simple agreement would suffice; the more complex agreements and mechanisms for their negotiation should be reserved for cases where the risks posed to the institution and the potential commercial value of the research reagents is high.

International standardization and classification of human papillomavirus types

Established Human Papillomavirus (HPV) types, up to HPV202, belong to 49 species in five genera. International standardization in classification and quality standards for HPV type designation and detection is ensured by the International HPV Reference Center. The center i) receives clones of potentially novel HPV types, re-clones and re-sequences them. If confirmed, an HPV type number is assigned and posted on www.hpvcenter.se. ii) distributes reference clone samples, for academic research, under Material Transfer Agreements agreed with the originator. iii) provides preliminary checking of whether new sequences represent novel types iv) issues international proficiency panels for HPV genotyping.The rate of HPV type discovery is increasing, probably because of metagenomic sequencing. γ-genus today contains 79HPV types and 27 species, surpassing ∝ and β genera with 65 and 51HPV types, respectively. Regular issuing of proficiency panels based on HPV reference clones has resulted in global improvement of HPV genotyping services.

Meeting report: 2nd workshop of the United States culture collection network (May 19–21, 2014, State College, PA, USA)

This report summarizes the activities and outcomes of the second workshop of the US Culture Collection Network, formally an activity of the US National Science Foundation sponsored Research Coordination Network for a Community of ex situ Microbial Germplasm Repositories. The workshop included presentations on topics as diverse as permitting for genetically engineered plant pest organisms to facilitating strain exchange via formal material transfer agreement systems and codes of conduct. Short talks introduced diverse collections held by government, university, and private entities. Participants visited living microbe collections as well as active research and production facilities.

Who Owns the Intellectual Property Rights to Chinese Genetically Modified Rice? Evidence from Patent Portfolio Analysis.

Who Owns the Intellectual Property Rights to Chinese Genetically Modified Rice? Evidence from Patent Portfolio Analysis.

Comments on FAO’s Achievements toward a Public Domain in Plant Genetic Resources for Food and Agriculture

Acronyms: ABS Access and Benefit Sharing CBD Convention on Biological Diversity FAO Food and Agriculture Organisation of the United Nations IPR(s) Intellectual Property Right(s) ITPGRFA International Treaty on Plant Genetic Resources for Food and Agriculture IUPGR International Undertaking on Plant Genetic Resources MLS Multilateral System under ITPGRFA MTAs Material Transfer Agreements PGRs Plant Genetic Resources PGFRAs Plant Genetic Resources for Food and Agriculture PVP Plant Variety Protection TRIPS Agreement on Trade Related Aspects of Intellectual Property Rights UPOV International Convention for the Protection of New Varieties of Plants WTO World Trade Organization

Material transfer agreements: An economic and econometric analysis

This paper uses econometric analysis for understanding the determinants that affect the payment mechanism in material transfer agreements (MTAs). These contracts regulate the exchange of peculiar ecosystem services (genetic and biological materials) between a provider and a recipient of the service. The paper uses a set of “model” contracts from the late 2000s, gathered from the U.N. World Intellectual Property Organization (WIPO) and the Convention of Biological Diversity (CBD). Empirical results show that the probability that a payment scheme is included in the contract negatively depends on the presence of an acknowledgment obligation to the provider of the material. Probably aware of the complexity and uncertainty of the recipient's research activity, the provider (and the CBD) requires to be compensated through the recognition of his/her important input to the research venture. In economics, this can be interpreted as payment in terms of moral satisfaction.