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
The non-linear behavior of continuous fiber reinforced C/SiC ceramic matrix composites(CMCs)under tensile loading is modeled by three-dimensional representative volume element(RVE)models of the composite. The theoreti...The non-linear behavior of continuous fiber reinforced C/SiC ceramic matrix composites(CMCs)under tensile loading is modeled by three-dimensional representative volume element(RVE)models of the composite. The theoretical background of the multi-scale approach solved by the finite element method(FEM)is recalled firstly.Then the geometric characters of three kinds of damage mechanisms,i.e.micro matrix cracks,fiber/matrix interface debonding and fiber fracture,are studied.Three kinds of RVE are proposed to model the microstructure of C/SiC with above damage mechanisms respectively.The matrix cracking is modeled by critical matrix strain energy(CMSE)principle while a maximum shear stress criterion is used for modeling fiber/matrix interface debonding. The behavior of fiber fracture is modeled by the famous Weibull statistic theory.A numerical example of continuous fiber reinforced C/SiC composite under tensile loading is performed.The results show that the stress/strain curve predicted by the developed model agrees with experimental data.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Supported by the National Natural Science Foundation of China(51075204,51105195)the Aeronau-tical Science Foundation of China(2011ZB52024)
文摘The non-linear behavior of continuous fiber reinforced C/SiC ceramic matrix composites(CMCs)under tensile loading is modeled by three-dimensional representative volume element(RVE)models of the composite. The theoretical background of the multi-scale approach solved by the finite element method(FEM)is recalled firstly.Then the geometric characters of three kinds of damage mechanisms,i.e.micro matrix cracks,fiber/matrix interface debonding and fiber fracture,are studied.Three kinds of RVE are proposed to model the microstructure of C/SiC with above damage mechanisms respectively.The matrix cracking is modeled by critical matrix strain energy(CMSE)principle while a maximum shear stress criterion is used for modeling fiber/matrix interface debonding. The behavior of fiber fracture is modeled by the famous Weibull statistic theory.A numerical example of continuous fiber reinforced C/SiC composite under tensile loading is performed.The results show that the stress/strain curve predicted by the developed model agrees with experimental data.
