In the emerging world of biotech innovation, the fast-to-clinic/market strategy has emerged as a critical “mantra” for biotech, investors, and CDMOs. This approach addresses the escalating costs and complexities of ...In the emerging world of biotech innovation, the fast-to-clinic/market strategy has emerged as a critical “mantra” for biotech, investors, and CDMOs. This approach addresses the escalating costs and complexities of research and development by streamlining the path from concept to clinical trials and, ultimately, to market. The article delves into the intricacies of implementing a fast-to-clinic/market strategy, underlining the empowering role of strategic decision-making in preclinical and commercial stages. The plan advocates for a phase-appropriate approach, where the development decision is tailored to each phase of the product’s lifecycle. This ensures that resources are allocated efficiently, risks are managed effectively, and the product can move through the development pipeline accelerated without compromising quality or regulatory compliance. The article also discusses the role of CDMOs in facilitating rapid product development and the essential factors biotech companies must consider when selecting a partner for outsourcing. These factors include the CDMO’s expertise in navigating regulatory landscapes, technological capabilities, and ability to scale processes efficiently. Moreover, the article stresses the importance of agility and flexibility in the fast-to-clinic/market approach. Biotech companies are encouraged to adopt adaptable strategies that respond to the fast-evolving regulatory and market landscapes.展开更多
We describe the sol-gel synthesis of a new family of organic-inorganic hybrid materials, in which various vinyl polymers are covalently bonded to and uniformly distributed in inorganic oxide matrices. The materials ca...We describe the sol-gel synthesis of a new family of organic-inorganic hybrid materials, in which various vinyl polymers are covalently bonded to and uniformly distributed in inorganic oxide matrices. The materials can be tailored to have both good toughness and hardness while maintaining excellent optical transparency. Doping the sol-gel metal oxides with optically active compounds such as D-glucose results in new optical rotatory composite materials. Removal of the dopant compounds from the composites affords mesoporous oxide materials; which represents a new, nonsurfactant-templated route to mesoporous molecular sieves. We have successfully immobilized a series of enzymes and other bioactive agents in mesoporous materials. Catalytical activities of the enzyme encapsulated in mesoporous materials were found to be much higher than those encapsulated in microporous materials.展开更多
China is the leading importer of soybeans in the world. If China adopts high yield biotech soybean varieties, China＇s soybean production would increase significantly and this would impact global soybean markets. This...China is the leading importer of soybeans in the world. If China adopts high yield biotech soybean varieties, China＇s soybean production would increase significantly and this would impact global soybean markets. This paper assesses the possible effects of adoption of herbicide-tolerant, biotech soybeans in China and its impact on the world soybean trade. Results indicate that under a low technology fee and high adoption rate, China would be able to satisfy its soybean food demand. Urban consumers＇ strong preference for non-biotech soybean oil may lead to increase in imports of non-biotech soybeans.展开更多
Modern biotechnology booms in the molecular life science. It brings about a promising future for improving human health, foodstuff, environment and energy and is of significance to improve traditional agriculture, dru...Modern biotechnology booms in the molecular life science. It brings about a promising future for improving human health, foodstuff, environment and energy and is of significance to improve traditional agriculture, druamakins and other展开更多
This paper estimates and decomposes the output-oriented three-stage cost Malmquist productivity index of the Taiwan region of China biotech and biopharmaceutical(B&BP)industry in 2004-2007 periods.The empirical es...This paper estimates and decomposes the output-oriented three-stage cost Malmquist productivity index of the Taiwan region of China biotech and biopharmaceutical(B&BP)industry in 2004-2007 periods.The empirical estimations proceed in three stages.Following the methodology of Yang and Huang(2009)with the assumption of variable return to scale(VRS)in the first stage,the original cost Malmquist productivity index(CM)is decomposed into five sources of productivity change:pure technical efficiency change,technical change,allocative efficiency change(AEC),input-price effect,and cost scale efficiency change.The method of Yang and Huang(2009)is an excellent contribution,but it did not deal with the exogenous environmental variables and noises.In the second stage,the original input variables are adjusted by the exogenous environmental variables.Finally,adjusted input variables produced by the second stage are reused for obtaining the reality of CM in the third stage.展开更多
In environmental biosafety assessments of glyphosate-tolerant crops,it is essential to evaluate the effects of cultivating these crops and applying glyphosate on the microbial community in the rhizosphere soil,which p...In environmental biosafety assessments of glyphosate-tolerant crops,it is essential to evaluate the effects of cultivating these crops and applying glyphosate on the microbial community in the rhizosphere soil,which play a critical role in maintaining soil health,plant growth,and crop productivity.Maize(Zea mays)line GG2 was previously generated by transforming wild-type maize with the gat and gr79-epsps genes,endowing GG2 with both active and passive resistance to glyphosate.However,the ecological risk of introducing these two new glyphosate-tolerance genes into maize,as well as glyphosate treatment,to rhizosphere microorganisms remain unclear.In this study,we used high-throughput sequencing to analyze the diversity and composition of the bacterial and fungal communities in the rhizosphere soil around biotech maize GG2,with(GG2-H)and without glyphosate treatment(GG2-N),compared with the near-isogenic,non-biotech maize line ZD958 at seven stages of growth.The structure and diversity of the bacterial and fungal communities of GG2-H were similar to those of ZD958,whereas glyphosate treatment had temporary effects on bacterial and fungal diversity and richness.The differences in the bacterial and fungal communities were associated with changes in soil properties such as pH,available phosphorus and organic matter,and seasonal changes.These factors,rather than maize lines,made the greatest contributions to the shifts in bacterial and fungal community structure.This study provides a comprehensive analysis of the effects of biotech crop cultivation,glyphosate treatment,soil physicochemical properties of soil,and maize growth stages on soil microbial communities,offering valuable insights for the large-scale adoption of biotech crops in China.展开更多
Currently,biological drugs such as gene,protein,and monoclonal antibody are widely applied in the clinic due to their excellent effectiveness.However,they still have some problems,including poor solubility,instability...Currently,biological drugs such as gene,protein,and monoclonal antibody are widely applied in the clinic due to their excellent effectiveness.However,they still have some problems,including poor solubility,instability,toxicity,and weak capability to cross cell membranes.Owing to the specific structure of cyclodextrins(CDs)and the advantage of polymeric backbones,various cyclodextrin polymers(CDPs)have been designed as delivery systems for biotech drugs.In this review,after a brief introduction on CDPs and discussion of their physicochemical and biological properties,we will focus on recent advances in the use of CDPs for the delivery of biotech drugs.This review highlights the structure-function relationship of CDPs to their performance in biotech drug delivery.Finally,an outlook will be proposed on the developing trends and challenge in this field.展开更多
夜读此文,既兴奋,又悲凉。兴奋,是因为千百年来,人们靠天吃饭,地里的活,种瓜得瓜,种豆得豆。得多少,并非“大跃进”可以吹出来的,而是有一个常规,种地能手,能超出常规亩产20％,已有登天之难。而如今,植物的遗传工程(genetic engineering...夜读此文,既兴奋,又悲凉。兴奋,是因为千百年来,人们靠天吃饭,地里的活,种瓜得瓜,种豆得豆。得多少,并非“大跃进”可以吹出来的,而是有一个常规,种地能手,能超出常规亩产20％,已有登天之难。而如今,植物的遗传工程(genetic engineering of plants)令世人一惊:It can improve crop yields and develop resis-tance to drought(干旱),salinity(盐份)and pests(害虫)。Biotechnology is also used todevelop drugs to treat diseases such as diabetes and hepatitis(肝炎);悲凉的是,这些专利正紧锁于富国的保险柜中待价而沽:The big biotech companies are locking uppatents at an incredible(难以置信的)rate！其另一个借口是:The full impact of thesenew life sciences on health and the environment is not known。 本文末尾的一句话又让我们另有想法: Biotechnology is by no means the only answer to the problem of hunger as the words already producing more food than it needs。】展开更多
基因,转基因,基因工程……与“基因”有关的这几个词,几乎成了上世纪末以来的热门词语。这似乎印证了“21世纪属于生物学世纪”这一著名预言。“genetically modified(GM)crops”也成了一个英语热门词汇。本文详细介绍了上世纪六、七十...基因,转基因,基因工程……与“基因”有关的这几个词,几乎成了上世纪末以来的热门词语。这似乎印证了“21世纪属于生物学世纪”这一著名预言。“genetically modified(GM)crops”也成了一个英语热门词汇。本文详细介绍了上世纪六、七十年代所谓绿色革命之父,诺贝尔奖获得者Norman Borlaug对(GM)crops这场新革命的观点。他的观点有两点值得我们关注: 1/为什么当今世界有人反对这场崭新意义的绿色革命?Borlaug的观点非常犀利: If we sit in Europe or North America and decide that because we don't need that scientific approach for our food supply, therefore they can't have it either, that is grossly (非常) unethical (不道德的). 2/凡是革命。那就必然会有风险:no agricultural advance is risk-free. Borlaug称,当年的绿色革命也同样遭受了人们的反对:Critics(批评家们)in the past accused the Green Revolution of popularizing (普及) chemical fertilizers, pesticides and irrigation that jeopardized (危害) the environment in developing countries.】展开更多
文摘In the emerging world of biotech innovation, the fast-to-clinic/market strategy has emerged as a critical “mantra” for biotech, investors, and CDMOs. This approach addresses the escalating costs and complexities of research and development by streamlining the path from concept to clinical trials and, ultimately, to market. The article delves into the intricacies of implementing a fast-to-clinic/market strategy, underlining the empowering role of strategic decision-making in preclinical and commercial stages. The plan advocates for a phase-appropriate approach, where the development decision is tailored to each phase of the product’s lifecycle. This ensures that resources are allocated efficiently, risks are managed effectively, and the product can move through the development pipeline accelerated without compromising quality or regulatory compliance. The article also discusses the role of CDMOs in facilitating rapid product development and the essential factors biotech companies must consider when selecting a partner for outsourcing. These factors include the CDMO’s expertise in navigating regulatory landscapes, technological capabilities, and ability to scale processes efficiently. Moreover, the article stresses the importance of agility and flexibility in the fast-to-clinic/market approach. Biotech companies are encouraged to adopt adaptable strategies that respond to the fast-evolving regulatory and market landscapes.
基金This work has been supported by the US National Institutes of Health (No. RO1-DE09848 to YW) and Natural Science Foundation of China (NSFC Nos. 29674001 and 19810760343 to KYQ and YW).
文摘We describe the sol-gel synthesis of a new family of organic-inorganic hybrid materials, in which various vinyl polymers are covalently bonded to and uniformly distributed in inorganic oxide matrices. The materials can be tailored to have both good toughness and hardness while maintaining excellent optical transparency. Doping the sol-gel metal oxides with optically active compounds such as D-glucose results in new optical rotatory composite materials. Removal of the dopant compounds from the composites affords mesoporous oxide materials; which represents a new, nonsurfactant-templated route to mesoporous molecular sieves. We have successfully immobilized a series of enzymes and other bioactive agents in mesoporous materials. Catalytical activities of the enzyme encapsulated in mesoporous materials were found to be much higher than those encapsulated in microporous materials.
文摘China is the leading importer of soybeans in the world. If China adopts high yield biotech soybean varieties, China＇s soybean production would increase significantly and this would impact global soybean markets. This paper assesses the possible effects of adoption of herbicide-tolerant, biotech soybeans in China and its impact on the world soybean trade. Results indicate that under a low technology fee and high adoption rate, China would be able to satisfy its soybean food demand. Urban consumers＇ strong preference for non-biotech soybean oil may lead to increase in imports of non-biotech soybeans.
文摘Modern biotechnology booms in the molecular life science. It brings about a promising future for improving human health, foodstuff, environment and energy and is of significance to improve traditional agriculture, druamakins and other
文摘This paper estimates and decomposes the output-oriented three-stage cost Malmquist productivity index of the Taiwan region of China biotech and biopharmaceutical(B&BP)industry in 2004-2007 periods.The empirical estimations proceed in three stages.Following the methodology of Yang and Huang(2009)with the assumption of variable return to scale(VRS)in the first stage,the original cost Malmquist productivity index(CM)is decomposed into five sources of productivity change:pure technical efficiency change,technical change,allocative efficiency change(AEC),input-price effect,and cost scale efficiency change.The method of Yang and Huang(2009)is an excellent contribution,but it did not deal with the exogenous environmental variables and noises.In the second stage,the original input variables are adjusted by the exogenous environmental variables.Finally,adjusted input variables produced by the second stage are reused for obtaining the reality of CM in the third stage.
基金supported by the Nanfan Special Project(Grant No.YBXM2318)the Agricultural Science and Technology Innovation Program of the Chinese Academy of Agricultural Sciences(CAAS-ZDRW202402)the Biological Breeding-National Science and Technology Major Project(2022ZD0400602).
文摘In environmental biosafety assessments of glyphosate-tolerant crops,it is essential to evaluate the effects of cultivating these crops and applying glyphosate on the microbial community in the rhizosphere soil,which play a critical role in maintaining soil health,plant growth,and crop productivity.Maize(Zea mays)line GG2 was previously generated by transforming wild-type maize with the gat and gr79-epsps genes,endowing GG2 with both active and passive resistance to glyphosate.However,the ecological risk of introducing these two new glyphosate-tolerance genes into maize,as well as glyphosate treatment,to rhizosphere microorganisms remain unclear.In this study,we used high-throughput sequencing to analyze the diversity and composition of the bacterial and fungal communities in the rhizosphere soil around biotech maize GG2,with(GG2-H)and without glyphosate treatment(GG2-N),compared with the near-isogenic,non-biotech maize line ZD958 at seven stages of growth.The structure and diversity of the bacterial and fungal communities of GG2-H were similar to those of ZD958,whereas glyphosate treatment had temporary effects on bacterial and fungal diversity and richness.The differences in the bacterial and fungal communities were associated with changes in soil properties such as pH,available phosphorus and organic matter,and seasonal changes.These factors,rather than maize lines,made the greatest contributions to the shifts in bacterial and fungal community structure.This study provides a comprehensive analysis of the effects of biotech crop cultivation,glyphosate treatment,soil physicochemical properties of soil,and maize growth stages on soil microbial communities,offering valuable insights for the large-scale adoption of biotech crops in China.
基金Financial support from the National Natural Science Foundation of China(Grant No.21534008,51322303,and 51573110)State Key Laboratory of Polymer Materials Engineering(sklpme2014-3-01)are gratefully acknowledged.
文摘Currently,biological drugs such as gene,protein,and monoclonal antibody are widely applied in the clinic due to their excellent effectiveness.However,they still have some problems,including poor solubility,instability,toxicity,and weak capability to cross cell membranes.Owing to the specific structure of cyclodextrins(CDs)and the advantage of polymeric backbones,various cyclodextrin polymers(CDPs)have been designed as delivery systems for biotech drugs.In this review,after a brief introduction on CDPs and discussion of their physicochemical and biological properties,we will focus on recent advances in the use of CDPs for the delivery of biotech drugs.This review highlights the structure-function relationship of CDPs to their performance in biotech drug delivery.Finally,an outlook will be proposed on the developing trends and challenge in this field.
文摘夜读此文,既兴奋,又悲凉。兴奋,是因为千百年来,人们靠天吃饭,地里的活,种瓜得瓜,种豆得豆。得多少,并非“大跃进”可以吹出来的,而是有一个常规,种地能手,能超出常规亩产20％,已有登天之难。而如今,植物的遗传工程(genetic engineering of plants)令世人一惊:It can improve crop yields and develop resis-tance to drought(干旱),salinity(盐份)and pests(害虫)。Biotechnology is also used todevelop drugs to treat diseases such as diabetes and hepatitis(肝炎);悲凉的是,这些专利正紧锁于富国的保险柜中待价而沽:The big biotech companies are locking uppatents at an incredible(难以置信的)rate！其另一个借口是:The full impact of thesenew life sciences on health and the environment is not known。 本文末尾的一句话又让我们另有想法: Biotechnology is by no means the only answer to the problem of hunger as the words already producing more food than it needs。】
文摘基因,转基因,基因工程……与“基因”有关的这几个词,几乎成了上世纪末以来的热门词语。这似乎印证了“21世纪属于生物学世纪”这一著名预言。“genetically modified(GM)crops”也成了一个英语热门词汇。本文详细介绍了上世纪六、七十年代所谓绿色革命之父,诺贝尔奖获得者Norman Borlaug对(GM)crops这场新革命的观点。他的观点有两点值得我们关注: 1/为什么当今世界有人反对这场崭新意义的绿色革命?Borlaug的观点非常犀利: If we sit in Europe or North America and decide that because we don't need that scientific approach for our food supply, therefore they can't have it either, that is grossly (非常) unethical (不道德的). 2/凡是革命。那就必然会有风险:no agricultural advance is risk-free. Borlaug称,当年的绿色革命也同样遭受了人们的反对:Critics(批评家们)in the past accused the Green Revolution of popularizing (普及) chemical fertilizers, pesticides and irrigation that jeopardized (危害) the environment in developing countries.】
