全球醫(yī)藥產(chǎn)業(yè)研究與發(fā)展的最新趨勢-資料下載頁
2024-12-31 14:21本頁面
【正文】 ? Outsourcing 29 ) Outsourcing 為什么要 Outsourcing? 1. Capacity Management 人力資源的調(diào)控 2. Technology/Specific expertise 新技術(shù) 3. Strategic 戰(zhàn)略上的考慮 4. Cost control 控制成本 5. Deadline 時間 30 ) D i sco v e r y2 6 . 9 %N o n cl i n i ca l1 9 . 5 %R e g u l a t o r y4 . 1 %O t h e r1 1 . 3 %P h a se 16 . 7 %P o st m a r ke t i n g6 . 0 %T o t a l C l i n i ca l3 8 . 2 %P h a se 2 32 5 . 5 %新藥研發(fā)的費(fèi)用分布 2023 31 ) 0 10 20 30 40 50 60 1997 1998 1999 2023 2023 USA Noncore markets Germany UK France Japan Source of patients for clinical trials 19972023 Year enrolment pleted Percentage of total patients recruited 32 ) Respiratory (151) Antiinfectives (222) Cardiovascular system (174) Nervous system (383) Anticancer (342) Median duration of enrolment period (months) Impact of therapeutic area on enrolment period (n) = number of clinical studies 33 ) 22% 0% 5% 10% 15% 20% 25% 30% CMC outsourcing expenditure as a percentage of total CMC expenditure (average) 18% 0% 5% 10% 15% 20% 25% 30% Average percentage of RD FTEs working in CMC Outsourcing of CMC 12% 0% 5% 10% 15% 20% 25% 30% Average percentage of RD expenditure invested in CMC Proportion of RD expenditure spent on CMC activities in 2023 Proportion of RD Full Time Equivalents allocated to CMC in 2023 CMC outsourcing expenditure as a percentage of total CMC expenditure 34 ) Conclusions 結(jié)語 ? 開發(fā)具有國內(nèi)或國外水平的新藥不僅要依靠企業(yè)本身的實(shí)力 , 還要眼光向外 . 有效的引進(jìn)新項(xiàng)目及專利是目前國際上流行做法 . ? 對已有的上市產(chǎn)品， 要利用新技術(shù)進(jìn)行多次開發(fā)和產(chǎn)品周期管理 (LCM)，以維持和延續(xù)產(chǎn)品的壽命和市場份額。 ? 一旦中國的產(chǎn)品質(zhì)量，技術(shù)及 GMP得已保證， Outsourcing, Generic chemical drug and biotech strategy 中國的制藥企業(yè)對上述所提的問題都得到加強(qiáng)時，那么中國制藥企業(yè)的崛起將為時不遠(yuǎn) … 35 ) Questions??? ??? 謝謝 ! 36 ) 謝謝觀看 /歡迎下載 BY FAITH I MEAN A VISION OF GOOD ONE CHERISHES AND THE ENTHUSIASM THAT PUSHES ONE TO SEEK ITS FULFILLMENT REGARDLESS OF OBSTACLES. BY FAITH I BY FAITH
教學(xué)課件相關(guān)推薦
鄂ICP備17016276號-1