Mapping the emerging field of genome editing

Targeted genetic modification (TagMo) technologies are being used for new approaches to genetic engineering often called 'genome editing'. These approaches are in the early stages of development, and basic understandings of what TagMo is, of its likely future, and how it should be governed are still being established. In order to inform these discussions and increase their transparency, we map the scientific landscape of TagMo using advances in tech mining and bibliometrics and in consultation with experts in the field. We assess the sub-topics and disciplines associated with TagMo research, and the actors, institutions, and nations involved, while making observations about the funding of research and the collaborative patterns among actors. The technology assessment approach used in this article has important implications for anticipatory governance of TagMo plant products. It is designed to help scientists, managers, and policy-makers understand trends in TagMo technological development in order to prepare for future governance. © 2013 © 2013 Taylor & Francis

Regulating animals with gene drive systems: lessons from the regulatory assessment of a genetically engineered mosquito

For the purposes of conservation or suppression of species, gene drive technology has significant potential. Theoretically speaking, with the release of even relatively few animals with gene drive systems in an ecosystem, beneficial or harmful genes could be introduced into the entire wild-type population of that species. Given the profound impact that gene drives could have on species and ecosystems, their use is a highly contentious issue. Communities and groups have differing beliefs about nature and its conservation or preservation, as well as concerns about the ecological safety of the eradication, replacement or enhancement of particular species of animals by means of genetic engineering. For all those reasons, the rigorous regulation of insects and other animals with gene drive systems is crucial. In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives

A decision analytic model to guide early‐stage government regulatory action: Applications for synthetic biology

Synthetic biology (SB) involves the alteration of living cells and biomolecules for specific purposes. Products developed using these approaches could have significant societal benefits, but also pose uncertain risks to human and environmental health. Policymakers currently face decisions regarding how stringently to regulate and monitor various SB applications. This is a complex task, in which policymakers must balance uncertain economic, political, social, and health‐related decision factors associated with SB use. We argue that formal decision analytical tools could serve as a method to integrate available evidence‐based information and expert judgment on the impacts associated with SB innovations, synthesize that information into quantitative indicators, and serve as the first step toward guiding governance of these emerging technologies. For this paper, we apply multi‐criteria decision analysis to a specific case of SB, a micro‐robot based on biological cells called “cyberplasm.” We use data from a Delphi study to assess cyberplasm governance options and demonstrate how such decision tools may be used for assessments of SB oversight.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/142416/1/rego12142.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/142416/2/rego12142_am.pd

Evidence review and experts’ opinion on consumer acceptance of agrifood nanotechnology

Nanotechnology is becoming increasingly important for the food sector, and advances and products are already being made in the areas of food packaging and food safety. However, there are several potential issues associated with the commercialization of agricultural and food (agrifood) nanotechnology that may limit its full potential, including uncertainty about whether consumers will accept or reject its products. Thus, this study aims to better understand key variables that are likely to affect consumer acceptance of agrifood nanotechnology, so that policies and programs can be better designed to address issues important to consumers prior to market entry. Factors that may influence consumer acceptance of agrifood nanotechnology were identified by examining historical experiences with other emerging technologies in food and agriculture and eliciting the opinions of experts and stakeholders. In this work, perceived risks and benefits and trust in regulatory agencies and industry were identified as the key factors influencing consumer acceptance. Our results compare favorably with other published studies in this area, and collectively they suggest that increasing consumer knowledge of agrifood nanotechnology products;ensuring high consumer benefits; minimizing risks; and increasing trust in decision makers and producers are important for consumer acceptance and the success of the emerging agrifood nanotechnology industry

Evidence review and experts’ opinion on consumer acceptance of agrifood nanotechnology

Nanotechnology is becoming increasingly important for the food sector, and advances and products are already being made in the areas of food packaging and food safety. However, there are several potential issues associated with the commercialization of agricultural and food (agrifood) nanotechnology that may limit its full potential, including uncertainty about whether consumers will accept or reject its products. Thus, this study aims to better understand key variables that are likely to affect consumer acceptance of agrifood nanotechnology, so that policies and programs can be better designed to address issues important to consumers prior to market entry. Factors that may influence consumer acceptance of agrifood nanotechnology were identified by examining historical experiences with other emerging technologies in food and agriculture and eliciting the opinions of experts and stakeholders. In this work, perceived risks and benefits and trust in regulatory agencies and industry were identified as the key factors influencing consumer acceptance. Our results compare favorably with other published studies in this area, and collectively they suggest that increasing consumer knowledge of agrifood nanotechnology products;ensuring high consumer benefits; minimizing risks; and increasing trust in decision makers and producers are important for consumer acceptance and the success of the emerging agrifood nanotechnology industry

Parameters, practices, and preferences for regulatory review of emerging biotechnology products in food and agriculture

This paper evaluates the U.S. regulatory review of three emerging biotechnology products according to parameters, practices, and endpoints of assessments that are important to stakeholders and publics. First, we present a summary of the literature on variables that are important to non-expert publics in governing biotech products, including ethical, social, policy process, and risk and benefit parameters. Second, we draw from our USDA-funded project results that surveyed stakeholders with subject matter expertise about their attitudes towards important risk, benefit, sustainability, and societal impact parameters for assessing novel agrifood technologies, including biotech. Third, we evaluate the regulatory assessments of three food and agricultural biotechnology case studies that have been reviewed under U.S. regulatory agencies and laws of the Coordinated Framework for the Regulation of Biotechnology, including gene-edited soybeans, beef cattle, and mustard greens. Evaluation of the regulatory review process was based on parameters identified in steps 1 and 2 which were deemed important to both publics and stakeholders. Based on this review, we then propose several policy options for U.S. federal agencies to strengthen their oversight processes to better align with a broader range of parameters to support sustainable agrifood products that rely on novel technologies. These policy options include 1) those that would not require new institutions or legal foundations (such as conducting Environmental Impact Statements and/or requiring a minimal level of safety data), 2) those that would require a novel institutional or cross-institutional framework (such as developing a publicly-available website and/or performing holistic sustainability assessments), and 3) those that would require the agencies to have additional legal authorities (such as requiring agencies to review biotech products according to a minimal set of health, environmental, and socio-economic parameters). Overall, the results of this analysis will be important for guiding policy practice and formulation in the regulatory assessment of emerging biotechnology products that challenge existing legal and institutional frameworks

Gene editing and agrifood systems

Gene-editing technologies represent a promising new tool for plant and animal breeding in low- and middle-income countries. They enhance precision and efficiency over current breeding methods and could lead to rapid development of improved plant varieties and animal breeds. However, as for any new technology, they have their merits and demerits. There is, as yet, no international consensus regarding if and how gene-edited organisms should be regulated, and whether their release would fall under the regulatory framework of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. This science- and evidence-based Issue Paper on gene editing and agrifood systems presents a balanced discussion of the most pertinent aspects of gene editing, including the consequences for human hunger, human health, food safety, effects on the environment, animal welfare, socioeconomic impact and distribution of benefits. Intrinsic ethical concerns and issues of governance and regulation are addressed, and the roles of the public and private sectors, alone and in partnership, are summarized. Various scenarios are also presented for how gene editing might be used in the future to help transform agrifood systems

Impact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance)

Purpose: One third of patients with triple-negative breast cancer (TNBC) achieve pathologic complete response (pCR) with standard neoadjuvant chemotherapy (NACT). CALGB 40603 (Alliance), a 2 x 2 factorial, open-label, randomized phase II trial, evaluated the impact of adding carboplatin and/or bevacizumab. Patients and Methods: Patients (N = 443) with stage II to III TNBC received paclitaxel 80 mg/m2 once per week (wP) for 12 weeks, followed by doxorubicin plus cyclophosphamide once every 2 weeks (ddAC) for four cycles, and were randomly assigned to concurrent carboplatin (area under curve 6) once every 3 weeks for four cycles and/or bevacizumab 10 mg/kg once every 2 weeks for nine cycles. Effects of adding these agents on pCR breast (ypT0/is), pCR breast/axilla (ypT0/isN0), treatment delivery, and toxicities were analyzed. Results: Patients assigned to either carboplatin or bevacizumab were less likely to complete wP and ddAC without skipped doses, dose modification, or early discontinuation resulting from toxicity. Grade 3 neutropenia and thrombocytopenia were more common with carboplatin, as were hypertension, infection, thromboembolic events, bleeding, and postoperative complications with bevacizumab. Employing one-sided P values, addition of either carboplatin (60% v 44%; P � .0018) or bevacizumab (59% v 48%; P =.0089) significantly increased pCR breast, whereas only carboplatin (54% v 41%; P = .0029) significantly raised pCR breast/axilla. More-than-additive interactions between the two agents could not be demonstrated. Conclusion: In stage II to III TNBC, addition of either carboplatin or bevacizumab to NACT increased pCR rates, but whether this will improve relapse-free or overall survival is unknown. Given results from recently reported adjuvant trials, further investigation of bevacizumab in this setting is unlikely, but the role of carboplatin could be evaluated in definitive studies, ideally limited to biologically defined patient subsets most likely to benefit from this agent

Impact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance)

One third of patients with triple-negative breast cancer (TNBC) achieve pathologic complete response (pCR) with standard neoadjuvant chemotherapy (NACT). CALGB 40603 (Alliance), a 2 × 2 factorial, open-label, randomized phase II trial, evaluated the impact of adding carboplatin and/or bevacizumab