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2.
PLoS One ; 15(10): e0240515, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33048974

RESUMO

This paper explores the synergy effect of the government subsidies, tax incentives, and government procurement on innovation based on synergy theory, and further analyzes its path and mechanism in the process of innovation. We find that government subsidies, tax incentives, and government procurement exert positive synergy effect on innovation. Furthermore, in the process of innovation, government subsidies are shown to play strongest roles in the stages of innovation input and technological development, while government procurement is the most crucial in the transformation stage of technological innovation, and tax incentives play balanced roles. We also find that innovation resource input, innovation technology spillover, and innovation cooperation all play partial mediating roles in the synergy effect of science and technology policies on innovation. This paper applies the synergy theory to the field of innovation policies, which enriches and expands relevant researches, and provides micro-evidence for in-depth understanding of the effect of science and technology policies on innovation.


Assuntos
Biotecnologia/legislação & jurisprudência , Medicina Baseada em Evidências , Invenções/legislação & jurisprudência , Modelos Teóricos , Ciência/legislação & jurisprudência , China , Financiamento Governamental , Humanos
3.
Sheng Wu Gong Cheng Xue Bao ; 36(8): 1528-1535, 2020 Aug 25.
Artigo em Chinês | MEDLINE | ID: mdl-32924351

RESUMO

The advent of the bioeconomy era is triggers a new wave of technology and industrial revolution. Bioeconomy has become the commanding heights that major developed countries and emerging economies try to seize. This paper analyzes the spatiotemporal characteristics of global bioindustry development from four perspectives: biomedical industry, genetically modified crop planting industry, bioenergy industry, and bio-based chemical industry. Then it summarizes the main characteristics of the development of the global bioindustry, and further put forward policy recommendations for the bottleneck problems in the development of China's bioindustry, which can guide the future development of China's bioeconomy.


Assuntos
Biotecnologia , Indústrias , Políticas , Biotecnologia/legislação & jurisprudência , Biotecnologia/estatística & dados numéricos , Biotecnologia/tendências , China , Produtos Agrícolas , Indústrias/economia
5.
PLoS One ; 15(4): e0231733, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32339186

RESUMO

Genetically modified (GM) crops are one of the most valuable tools of modern biotechnology that secure yield potential needed to sustain the global agricultural demands for food, feed, fiber, and energy. Crossing single GM events through conventional breeding has proven to be an effective way to pyramid GM traits from individual events and increase yield protection in the resulting combined products. Even though years of research and commercialization of GM crops show that these organisms are safe and raise no additional biosafety concerns, some regulatory agencies still require risk assessments for these products. We sought out to investigate whether stacking single GM events would have a significant impact on agronomic and phenotypic plant characteristics in soybean, maize, and cotton. Several replicated field trials designed as randomized complete blocks were conducted by Monsanto Regulatory Department from 2008 to 2017 in field sites representative of cultivation regions in Brazil. In total, twenty-one single and stacked GM materials currently approved for in-country commercial use were grown with the corresponding conventional counterparts and commercially available GM/non-GM references. The generated data were presented to the Brazilian regulatory agency CTNBio (National Biosafety Technical Committee) over the years to request regulatory approvals for the single and stacked products, in compliance with the existing normatives. Data was submitted to analysis of variance and differences between GM and control materials were assessed using t-test with a 5% significance level. Data indicated the predominance of similarities and neglectable differences between single and stacked GM crops when compared to conventional counterpart. Our results support the conclusion that combining GM events through conventional breeding does not alter agronomic or phenotypic plant characteristics in these stacked crops. This is compatible with a growing weight of evidence that indicates this long-adopted strategy does not increase the risks associated with GM materials. It also provides evidence to support the review and modernization of the existing regulatory normatives to no longer require additional risk assessments of GM stacks comprised of previously approved single events for biotechnology-derived crops. The data analyzed confirms that the risk assessment of the individual events is sufficient to demonstrate the safety of the stacked products, which deliver significant benefits to growers and to the environment.


Assuntos
Gossypium/genética , Plantas Geneticamente Modificadas/genética , Soja/genética , Zea mays/genética , Biofortificação/legislação & jurisprudência , Biotecnologia/legislação & jurisprudência , Brasil , Fenótipo , Melhoramento Vegetal/métodos , Plantas Geneticamente Modificadas/efeitos adversos , Locos de Características Quantitativas , Distribuição Aleatória , Medição de Risco , Desenvolvimento Sustentável
7.
Recent Pat Biotechnol ; 14(1): 78-82, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31549958

RESUMO

BACKGROUND: The concept of biotechnology has gained wide popularity by the time. There is, of course, some anecdotal evidence as to what topics are currently considered the most prominent and how they can be compared to the common perception of which research topics were considered "trendy" years ago. OBJECTIVE: A thorough search of exact time frames can help us quantitatively determine the evolution of prominent biotechnology research topics since the turn of the century. METHODS: A text data mining approach has been followed to better identify the emerging trends and perspectives in biotechnology, taking a look back at how the focus of research and innovation in biotechnology has shifted, evolved and impacted the human race over the past three decades. RESULTS: The extent of biotechnology today is vast, however, the most important newly developed research themes and patents largely influence human healthcare, affecting hundreds of millions of people who use grafts, devices, diagnostics, treatment and delivery systems. Even if biotechnology is very much focused on healthcare, there is also focus on other specialized concepts, such as biofuel, biocatalyst, food, agriculture and water purification, which have a strong influence on the research topics studied today. CONCLUSION: We are in the process of developing the practice of medicine through pioneering advances in biotechnology research and innovation. As companies continue to develop emerging treatment strategies (involving gene therapy, stem cells, nanomedicine and new drug delivery systems) that address significant unmet needs, future innovations in biotechnology research will bring exciting new advancements to help millions of more people worldwide.


Assuntos
Biotecnologia , Pesquisa Biomédica/legislação & jurisprudência , Pesquisa Biomédica/tendências , Biotecnologia/legislação & jurisprudência , Biotecnologia/tendências , Humanos , Patentes como Assunto
8.
Plant Cell Rep ; 39(1): 163-167, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31754780

RESUMO

Innovations in plant breeding like genome editing methods raised questions about the adequacy of established regulatory policies for plant breeding and biotechnology in view of these new breeding methods and the resulting products. Most countries follow the principle approach that only those plants will be regulated under biotech regulations that include a novel combination of genetic material following the Cartagena protocol. In contrast to this, the European Court of Justice interpreted the current EU biotech regulations in a way that these also apply to plants resulting from new mutagenesis breeding, even if these plants are indistinguishable from conventionally bred plants. This ruling created strong reactions and concerns stating that recent technical developments have made the EU GMO Directive no longer fit for purpose. The article describes ongoing policy developments on EU level that might result in an update of current regulations.


Assuntos
Biotecnologia/legislação & jurisprudência , Produtos Agrícolas/genética , Edição de Genes/legislação & jurisprudência , Melhoramento Vegetal/legislação & jurisprudência , Plantas Geneticamente Modificadas/genética , União Europeia , Alimentos Geneticamente Modificados , Edição de Genes/métodos , Mutagênese
10.
Rev. bioét. derecho ; (47): 5-15, nov. 2019. ilus
Artigo em Inglês | IBECS | ID: ibc-184862

RESUMO

DNA read and write technologies have accelerated biotechnology at an unprecedented pace. This enhanced capacity to engineer living beings has accelerated not only scientific research, but also the translation into novel therapies. New approved medicinal products include the correction of the diseased genome and synthetic enhancement to fight diseases. These practices are widely supported socially and scientifically. Applications beyond therapy have also be attempted. In 2018, researcher He Jiankui reported on the edition of human germline during the Second International Summit on Human Genome Editing. On the other hand, during the last years, there have also been attempts at somatic genetic enhancement without the provision of detailed outcomes. Reading and writing DNA empowers us to change our world, even ourselves. The social benefits may be enormous. We need to accelerate the debate, including the stakeholders, to foster a responsible use of these technologies and maximize the positive impact on society


Las tecnologías de lectura y escritura de ADN han acelerado la biotecnología a un ritmo sin precedentes. Esta capacidad mejora para diseñar seres vivos no solo ha acelerado la investigación científica, sino también la translación a terapias novedosas. Nuevos medicamentos aprobados incluyen la corrección del genoma enfermo y la mejora sintética para combatir las enfermedades. Estas prácticas son ampliamente apoyadas social y científicamente. También se han intentado aplicaciones más allá de la terapia. En 2018, el investigador He Jiankui informó sobre la edición de la línea germinal humana durante la Segunda Cumbre Internacional sobre la Edición del Genoma Humano. Por otro lado, en los últimos años también se han producido intentos de mejora genética somática. Leer y escribir ADN nos permite cambiar nuestro planeta, incluso cambiarnos a nosotros mismos. Los beneficios sociales


Les tecnologies de lectura i escriptura d'ADN han accelerat la biotecnologia a un ritme sense precedents. Aquesta capacitat millorada per dissenyar éssers vius no només ha accelerat la recerca científica, sinó també la translació a teràpies noves. Nous medicaments aprovats inclouen la correcció del genoma malalt i la millora sintètica per a combatre les malalties. Aquestes pràctiques són àmpliament recolzades social i científicament. També s'han intentat aplicacions més enllà de la teràpia. El 2018, l'investigador He Jiankui va informar sobre l'edició de la línia germinal humana durant la Segona Cimera Internacional sobre l'Edició del Genoma Humà. D'altra banda, en els últims anys també s'han produït intents de millora genètica somàtica. Llegir i escriure ADN ens permet canviar el nostre planeta, fins i tot canviar-nos a nosaltres mateixos. Els beneficis socials poden ser enormes. Necessitem accelerar el debat, incloent-hi les parts interessades a fi de fomentar un ús responsable d'aquestes tecnologies i maximitzar-ne l'impacte positiu en la societat


Assuntos
Humanos , Edição de Genes , Pesquisa Médica Translacional , Biologia Sintética/ética , Biotecnologia/ética , Biotecnologia/instrumentação , Biotecnologia/legislação & jurisprudência , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
11.
Health Care Manag (Frederick) ; 38(4): 331-342, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31663872

RESUMO

Corporate espionage is a multifaceted problem causing hundreds of billions of dollars in losses to businesses each year. Health care managers have a wide variety of options available to prevent theft of their organizations' trade secrets and other proprietary information. Organizations should protect their confidential and trade secret information by taking various security measures to limit access to protected material and by using appropriate types of restrictive covenants such as nondisclosure, noncompetition, and nonsolicitation agreements. This article provides helpful guidance for managers to maximize protection against theft of proprietary information.


Assuntos
Biotecnologia/legislação & jurisprudência , Comércio/legislação & jurisprudência , Propriedade Intelectual , Roubo/legislação & jurisprudência , Roubo/prevenção & controle , Humanos
13.
Cytotherapy ; 21(7): 686-698, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31196821

RESUMO

We provide an overview of the regulatory framework, pathways and underlying regulatory authority for cell, gene and tissue-engineered therapies in Canada. Canada's regulatory approach uses three sets of regulations, namely, the Cells, Tissues and Organs Regulations, the Food and Drug Regulations and the Medical Devices Regulations. We provide an overview of each these sets of regulations as they apply to clinical investigation to post-market product lifecycle stages. Information is provided on the current sources of relevant Health Canada guidance documents. We highlight several regional success stories including Prochymal, a cell therapy product that achieved Canadian regulatory approval using the conditional marketing approval system. We also examine the perceived gaps in the Canadian regulations and how those gaps are being addressed by interactions between the government, stakeholders and international bodies. We conclude that the risk-benefit approach used by Health Canada for regulatory approval processes is sufficiently flexible to enable to development of novel cell and gene therapy products in Canada, yet stringent enough to protect patient safety.


Assuntos
Terapia Baseada em Transplante de Células e Tecidos , Terapia Genética/legislação & jurisprudência , Transplante Homólogo/legislação & jurisprudência , Biotecnologia/legislação & jurisprudência , Biotecnologia/métodos , Biotecnologia/normas , Canadá , Humanos , Marketing/legislação & jurisprudência , Turismo Médico , Segurança do Paciente , Transplante de Células-Tronco/legislação & jurisprudência , Engenharia Tecidual
15.
Hum Vaccin Immunother ; 15(11): 2706-2712, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30991887

RESUMO

The very recent US Supreme Court and Court of Appeals for Federal Circuit (CAFC) cases have dramatically changed the standard of patent eligibility. Several groundbreaking innovations were thus determined to be patent ineligible. The patent ineligibility would impact on the innovation s of the field of biomarkers, diagnostic methods and personalize cancer immunotherapy. To solve the thorny problem of eligibility, this study retrospectively analyzes all CAFC related cases and presents a flow chart determining patent eligibility based on the courts' decisions. Our analysis indicates the best way to avoid eligible rejection or invalidation is that an invention cannot fall within the categories of natural law, natural phenomenon or abstract idea. Thus, claiming non-natural cDNA, involving a step to grow a transformed cell or adding a means clause in a method claim would be some possible solutions. Moreover, based on the flow chart, even though a claim with substantive limitation but not well-understood, routine or conventional activities would be patent eligible; no one has successfully made the argument in the CAFC so far. We believe that this flow chart can serve as a set of guidelines for determining patent eligibility.


Assuntos
Biotecnologia/legislação & jurisprudência , Imunoterapia/legislação & jurisprudência , Patentes como Assunto , Projetos de Pesquisa/legislação & jurisprudência , Biotecnologia/métodos , Estudos Retrospectivos , Decisões da Suprema Corte , Estados Unidos
17.
Health Secur ; 17(2): 83-99, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30942632

RESUMO

Understanding the overall biosecurity and biodefense policy landscape, the relationships between policies and their effects on each other, and the mechanisms for leveraging advances in science and technology to enhance defensive capabilities is crucial for ensuring that policy strategies address long-standing gaps and challenges. To date, policy analyses have been conducted primarily on single issues, which limits analyses of broader effects of policies, particularly after implementation. Here we describe the first-ever systems-based analysis of the US biosecurity and biodefense policy landscape to analyze functional relationships between policies, including examination of the unintended positive or negative consequences of policy actions. This analysis revealed a striking bifurcation of the US policy landscape for countering biological threats, with one grouping of policies focused on prevention of theft, diversion, or deliberate malicious use of biological sciences knowledge, skills, materials, and technologies (ie, biosecurity) and a second grouping on development of capabilities and knowledge to assess, detect, monitor, respond to, and attribute biological threats (ie, biodefense). An analysis of indirect effects demonstrated that policies within groups may result in mutual benefit, but policies in different groups may counteract each other, limiting achievement of the policy objectives in either group. The current policy landscape predominantly focuses on pathogens and toxins, having limited focus on rapidly changing biotechnologies with potential to positively contribute to biodefense capabilities or introduce unknown and/or unacceptable security risk. Based on our analyses, we present actions for implementing biosecurity and biodefense policy in the United States that intends to harness the benefits of science and technology while also minimizing potential risks. This article synthesizes and highlights the major findings and conclusions from the detailed analyses, which can be found in the full report ( http://www.gryphonscientific.com/biosecurity-policy/ ).


Assuntos
Bioterrorismo/prevenção & controle , Formulação de Políticas , Medidas de Segurança/legislação & jurisprudência , Biotecnologia/legislação & jurisprudência , Bioterrorismo/legislação & jurisprudência , Humanos , Análise de Sistemas , Estados Unidos
20.
N Biotechnol ; 51: 49-56, 2019 Jul 25.
Artigo em Inglês | MEDLINE | ID: mdl-30779963

RESUMO

The comparatively low adoption rate of GMO products in the European Union (EU) market seems to be connected with the strictness of authorization regulations and inefficiency of the authorization process itself. These problems will apply to any product deemed to be a GMO that could potentially be marketable in the EU. Since modern methods of plant breeding involving oligonucleotide-directed mutagenesis (ODMs) or site-directed nucleases (SDNs), including Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), are becoming ever more popular, it is crucial to establish whether the products of such new breeding techniques (NBTs), in particular those which involve precise methods of mutagenesis, are exempted from the EU legislation on GMOs or not. Legal uncertainty as to their status may result in reluctance to invest in such methods and develop them further. Here, developments are presented in the legal classification of certain NBTs products in the context of recent decisions and jurisprudence. The socioeconomic aspects of GMO adoption in both global and European contexts are discussed. The legal and practical landscape of GMO regulation in the EU is presented and how it may pose an obstacle to investment and the development of new products. The latest jurisprudence (e.g., Case C-528/16) [1] on the interpretation of the legal concept of GMOs and the scope of the legislation are analyzed, with the conclusion that the strict regulations will probably also apply to products of the NBTs involving precise methods of mutagenesis. This in turn will probably result in the restriction of their application in the development of new plant varieties in the EU.


Assuntos
Biotecnologia/legislação & jurisprudência , Organismos Geneticamente Modificados/genética , Melhoramento Vegetal/legislação & jurisprudência , União Europeia
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