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
Objective:To achieve the effective construction of NICU nursing quality evaluation indes and promote the necessany inprovement of the success rate of treatment of citially ill newborns.Methods:The "structure-proc...Objective:To achieve the effective construction of NICU nursing quality evaluation indes and promote the necessany inprovement of the success rate of treatment of citially ill newborns.Methods:The "structure-process-outcome"mnodel was used to constuct the necessary logical relationship for NICU ursing quality evaluation icators.Then the NICU rursing qality evaluation indeses were initilly establisbed and defined accordingly.After that,the consultation scoring method was used to cary out the two rouds of questionnaire consultation,which was divided,deleted,and modified in the process.The second round of quality assessment indicators for critical neooatal care were used as research results.The establishment of the corresponding judgment matrix and the determination of the weighting relationship of each ervaluation indes were realized Resulis:Forty-eight experts from 12 tertiary care children's hospitals in 9 provinces and cities in China participated in the questiomaire consultation Aifter the work.the resulting quality asessment indicators for crical neonatal care were ageed upo by all the eaperts Sixty-seven quality indicators for cntical neonatal care(18 process indicators)were evaluated based on the Structure Process-Outcome(SPO)model.The necessary definitional work was achieved for the first round of questionnaire comsulations(1 evaluation indicator,19 structural indicators,30 outcome idicators).In the first round of questionnaire consultations,eight evaluation indicators were deleted,one evaluation indicator was split,four ervaluatiom indicators were aded,and four indicators were added.Iwo evaluation indicators were combined In the second round of questiornaine consultation,5 evalunion indicators were removed,resulting in a more complete quality of care for critially ill Dewbons.Conchusion:Based on the"sucuerprces-ouatone"model the 58 indiators for evaluating the quality of tertiary NICU care were fully obtained The unanimous approval of the consaling egets provides a solid foundiation for the later stages oflreatmnent of citically i neonates.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.
文摘Objective:To achieve the effective construction of NICU nursing quality evaluation indes and promote the necessany inprovement of the success rate of treatment of citially ill newborns.Methods:The "structure-process-outcome"mnodel was used to constuct the necessary logical relationship for NICU ursing quality evaluation icators.Then the NICU rursing qality evaluation indeses were initilly establisbed and defined accordingly.After that,the consultation scoring method was used to cary out the two rouds of questionnaire consultation,which was divided,deleted,and modified in the process.The second round of quality assessment indicators for critical neooatal care were used as research results.The establishment of the corresponding judgment matrix and the determination of the weighting relationship of each ervaluation indes were realized Resulis:Forty-eight experts from 12 tertiary care children's hospitals in 9 provinces and cities in China participated in the questiomaire consultation Aifter the work.the resulting quality asessment indicators for crical neonatal care were ageed upo by all the eaperts Sixty-seven quality indicators for cntical neonatal care(18 process indicators)were evaluated based on the Structure Process-Outcome(SPO)model.The necessary definitional work was achieved for the first round of questionnaire comsulations(1 evaluation indicator,19 structural indicators,30 outcome idicators).In the first round of questionnaire consultations,eight evaluation indicators were deleted,one evaluation indicator was split,four ervaluatiom indicators were aded,and four indicators were added.Iwo evaluation indicators were combined In the second round of questiornaine consultation,5 evalunion indicators were removed,resulting in a more complete quality of care for critially ill Dewbons.Conchusion:Based on the"sucuerprces-ouatone"model the 58 indiators for evaluating the quality of tertiary NICU care were fully obtained The unanimous approval of the consaling egets provides a solid foundiation for the later stages oflreatmnent of citically i neonates.
