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亞太生技醫藥研發中心
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iing
November 02, 2015
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亞太生技醫藥研發中心
iing
November 02, 2015
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Transcript
❎㣕欰䪮ꄲ谒灇涭欳噟⚥䗰 륝僇Ꚙ 㜠デ➂ 䎃剢傈 㜠デ儗
Ⰻ椔莃〴抒欰䪮ꄲ谒欳噟植屣莃馸 知㜠㣐符 1 2 〴抒欰䪮ꄲ谒欳噟涭㾜湡垥ծ瘻殛⿹ 遤⹛倯周 2
1 Ⰻ椔莃〴抒欰䪮ꄲ谒欳噟 植屣莃馸 3
0 750 1,500 2,250 3,000 2002 2004 2006 2008 2010
2012 䥯欽欰䪮 醡谒 ꄲ洽㐻勞 项俱⢵彁欰䪮欳噟涯淼剅%$#欳项穈*5*4鎘殥 1,109 2013 2,886 倜荨䍣⭙⯋ 2014 應⽤⽣技 28% 製藥 29% 醫材 43% ▪ 䎃涸Ⰻ椔欰䪮醡谒䋐㜥谒ㅷ⯐繟⯋䎃䧭ꞿꄲ洽㐻勞 ⭙繟 ⯋䎃䧭ꞿ欰暟醡ⷬ ⭙繟⯋䎃䧭ꞿկ ▪ 䎃〴抒欰ꄲ欳噟斈噟겘⠮鎘捀倜荨䍣 ⭙⯋鯰♧䎃䏝䧭ꞿկ湡 Ⱏ剣 㹺欰䪮Ⱅ せ䖰噟➂㆞կ Ⰻ椔莃〴抒欰䪮ꄲ谒欳噟馸莃植屣 4
▪ 䎂㖱♧⦐倜谒灇涭竣顤馄麓⭙繟⯋署儗馄麓䎃 荈荅䎮鑐뀾ꥡ媮饯鎘皾 ▪ Ⰻ椔剣 ⟝荅䎮鑐뀾周 ⦐鑐뀾럊⿹馄麓蠜せ涸「鑐罏 20%
50% 死亡之谷 项ꆃ㺘꧊ծ䪮遭㺘꧊ծ㼠噟㺘꧊涸欳噟 騖걄㚖ծ騖㕰ծⰋ椔畸是 資料來源:BrightFocus Foundation, 2010 Ⰻ椔欰䪮ꄲ谒欳噟⭆⧩ꕔ ⭆⧩然钠ꥡ媮 ⭆⧩ⶼ鸡ꥡ媮 ⭆⧩介䓸ꥡ媮 5
▪ 鸐麓չ⸇䓼欰 暟䪮遭欳噟䱿 ⹛倯周պ ▪ 䧭甧遤佟ꤍչ欰 暟䪮遭欳噟䭷 㼪㼭穈պ
▪ 鸐麓չ猰㷷䪮 遭㛇劤岀պ ▪ 䱿⹛㛁遤չ醡 谒莃欰暟䪮遭 㕜㹺㘗鎘殥պ ▪ 䱿⹛չ欰ꄲ猰 䪮䃊鎘殥պ ▪ 〮痥如欰䪮 欳噟瘻殛镨陽 㨻㆞剙 #5$ 剙 陽 遤佟ꤍ㼝欰暟䪮 遭捀Ⱂ㣐ꅾ럊 猰䪮⛒♧ Ⱅ䋒չ欰䪮倜谒 欳噟涭㾜哫⢽պ ▪ 荨抒欰䪮 饯굲ꚼ瀖遤⹛ 倯周 ▪ 䎃饯䱿⹛ 㛁遤չ欰䪮ꄲ 谒㕜㹺㘗猰䪮 鎘殥պ " # $ 䧮㕜欰䪮ꄲ谒欳噟涭㾜佟瘻 6
荨抒欰䪮ꄲ谒灇涭⛒4805ⴓ匿 4 4USFOHUI ⮚ 8 8FBLOFTT ⸋ ▪ 㕜Ⰹ㷷灇歲灇涭腉ꆀ䓼➂⸂稆颵⮚葺կ ▪
鯰ꁅ鵚㕜㹺㥴⽂ꯑծ倜⸇梯ծ⚥㕜㣐ꤵ刿傍䫎Ⰵ㛇 㔓넑ꄲ㷷⿹欰䪮ꄲ谒灇涭鏣倵⛒䒉縧鏣⪒⿹䪮遭 㕰㖱剣⾨㻛涸颵莃ꆀկ ▪ Ⱗ⮚颵ꄲ洽넑禸㼠噟涸ꄲ洽➂㆞莃㸣㊣涸鏣倵 駈⟃䖰✲倜谒⛒荅䎮鑐뀾կ ▪ 捀չ㕜ꥷꄲ谒ㅷ珫叅⼿秈穈籼1*$4պ涸剙㆞ 谒ㅷ鋉眔㓂阋剣⸔倳醡谒欳噟䬪㾜㢩ꌺ䋐㜥⿹莃 㕜ꥷ谒䑕さ⡲կ ▪ 倜ꄲ谒ㅷ灇涭⛒䧭劤鯰ꁅ鵚㕜㹺倜⸇㗗ծ傈劤ծ 態崍⡚眍満谒暟涭佄⳿կ ▪ 㕜Ⰹ噟罏㖱㿁⚥㼭㘗⟰噟劤魦緂⛗㸣侭谒暟涭 麓玎涸JOGSBTUSVDUVSF罜㕜Ⰹ䋐㜥鋉垷⛲㼭կ ▪ 谒暟涭䧭劤넝傰♶锷僽㷷灇堣圓䧴Ⱅ㖱搀 岀栬⸂頾亊կ ▪ Ⱗ倜谒涭㻛⿹㕜ꥷ竣뀾⛒➂䩝♶駈կ ▪ 㷷灇歲㼨㼠ⵃ兰頿⥂隊♶欧✪鍑䌢㔓㼠ⵃ⺪醘♶ Ⰻ罜㋨㣟噰㣐涸䋐㜥⭆⧩կ ▪ 㕜Ⰹ㛁遤傍劍荅䎮鑐뀾涸㜥䨽♶駈կ 0 0QQPSUVOJUZ 堣剙 5 5ISFBU 㪬腘 ▪ 佟䏍剙琎噰䱿⹛项劤䋐㜥攦窃孖⿹䑕㉀䫎项 䠐격䲿⼮կ ▪ 㕜ꥷ㣐谒䑕QJQFMJOF緂⛗琎噰ぢⰋ椔㼥実周彁䪮 鱲կ ▪ 暴㹀氫氺荅䎮鑐뀾さ⡲耠湅涸䧭甧剣⸔倳ェ䒷㢳 㕜㢳⚥䗰鑐뀾կ ▪ 㕜ꥷ畸是慧捗❎㣕㖑⼤㥴⚥㕜㣐ꤵծ⽂ꯑծ傈ծ 瘝㕜⛒佟䏍㖱琎噰䱿⹛ぐ갪剣ⵃ欰䪮欳噟涭㾜⛒ 佟瘻是《❎㣕㖑⼤걄㼪奘կ ▪ ⚥㕜㣐ꤵծ껺庥ծ倜⸇㗗是湱䒉甧荅䎮鑐뀾⚥䗰 ⚛䲿⣘㢳갪⮚䟃կ ▪ 讎项鯰ꁅ鵚㕜㹺⡚♶僒䬸莃殅⟣Ⱗ倜谒灇涭竣 뀾⛒ぐꥡ媮넝ꥡ㼠噟莃盖椚➂䩝կ 7
2 〴抒欰䪮ꄲ谒欳噟涭㾜湡垥ծ 瘻殛⿹遤⹛倯周 8
Lead Discovery Preclinical Pharm, Tox IND NDA Validation Optimization Phase
I, II, III Clinical Trials Market 䩧鸡չ❎㣕欰䪮ꄲ谒灇涭欳噟⚥䗰պ 涭㾜湡垥ծ瘻殛莃遤⹛倯周 湡垥 瘻殛 䲿⼮չ➂䩝ծ项ꆃծ兰䢳頿欳ծ岀鋉橆㞮ծ 侭さ项彁ծ䢅鼅⚺겗պ佩腉 遤⹛倯周 䓼⻉Ⰻ椔鸬穠⟃⿹侭さ㖈㖑ⶼ倜纇翷 9
〴抒欰䪮ꄲ谒涸Ⰻ椔鸬穠 暴럊 〴抒 ⚅歲欰䪮ꄲ谒灇涭ꅾꔨ 繟㕜 岚㡦갽ծ⸇䊜抒⼤ծ翯㖑暃ㆤ 嫰ⵃ儗 榰㡦 榰Ⱙ 蚚費
➂ 䩝 䪮 遭 项 ꆃ 岀 鋉 ⼾馉ꄲ㷷灇瑔堣圓⿹ꡟ꒲䪮遭灇涭腉ꆀ ⮚猕ꄲ㷷⚥䗰ꄲꤍ腉㛁遤㢳㕜㢳⚥䗰荅䎮灇瑔莃鑐뀾 项劤䋐㜥攦窃乨剣兰頿䪮鱲涸㼠噟➂䩝莃ⶼ䫎㛇ꆃ 滝㢳騖噟侭さ涭倜谒涸倜ⶼⰕ ⤑䰦涸❛鸐笨窃莃莝黝涸欰崞堣腉 10
〴抒欰䪮ꄲ谒㖈㖑ⶼ倜纇翷鋉ⷔ ˖ ⽂庥捀鯥䗰⟃欰䪮猰䪮ⶼ倜灇涭⟃ ⿹肪䧭欰䪮倜谒倜ⶼⰕ捀ꅾ럊䒉 甧鱲陻ꄲ㷷灇瑔⿹欳噟ⶼ倜灇涭饥䐣 䖰✲倜谒倜氊蕐倜鑐ⷬ涸鱲陻ꄲ㷷灇 瑔⼿⸔肪䧭倜ⶼⰕ倜欳ㅷ涭կ 〴⻌ 倜畾 〴⚥
〴⽂ ˖ 畾⻌ꄲ勞灇瑔㕦⼤衼ꅾ倳넝ꥡꄲ 勞涸ⶼ倜灇涭⟃⿹欰暟醡ⷬ涸醡鸡կ ˖ ⚥鿇猰㷷㕦⼤⟃灇涭礵㺘⭑㐻⿹ 墝뀾ꄲ勞捀ꅾ럊կ ˖ ⽂鿇猰㷷㕦⼤⟃灇涭낦猰 莃暃猰涸礵㺘ꄲ勞捀ꅾ럊կ 㕜㹺欰䪮灇瑔㕦⼤ ⽂庥欰䪮㕦⼤ Ⰹ廩猰䪮㕦⼤ 倜⻌欳噟㕦⼤ 11
國家⽣技研究園區 中研院與研究⼤學 新藥/新疫苗/新試劑研究 灇涭ꅾ럊 浒氾 聽浒ծ✋浒ծ肼浒ծ脧浒瘝 䠬厩氾 呓費孑ꤣ䚍蝑 䫑谒䚍穠呌蝑ծ崧遤䚍䠬ⱍծ聽拦氺 嫩ծ涫ꬠ攦ծ倜莆⫄厩氺瘝
牞竣鷌⻉氫氺 㣟兰氾ծ䋪ꆃ孑氺瘝 ⱄ欰ꄲ㷷 浒氾䎌稢脄ծ钷涭㢳悲腉䎌稢脄 J14$ 瘝 肪䧭⚥䗰秈㹺倜ⶼⰕ 鱲陻ⶼ倜灇瑔⿹肪䧭⚥䗰 Discovery Invention 基礎研究 Curiosity or Problem Driven Innovation 轉譯研發 產品 Usable Technology or Early Product Candidate Value Creation from Innovation, Manufacturing , & Marketing 12
➂䩝 岀鋉 橆㞮 项ꆃ 䢅鼅 ⚺겗 兰䢳 頿欳 侭さ 项彁
遤⹛倯周 㣐 13
㛅肪ⶼ倜灇涭莃欳噟竣斈넝ꥡ걄㼪➂䩝 ➂䩝 ˖ 琎噰㛅鎮鱲陻ꄲ㷷灇瑔➂䩝 ˖ 렼⺐㷷灇➂䩝莃倜ⶼⰕ ˖ 䎂邁欳㷷➂䩝⛒琻㹀⣘ ˖ ⼿⸔⟰噟畸鷵Ⰻ椔欰ꄲ灇涭➂䩝
˖ ⤛䧭㛇燉莃荅䎮㼠㹺⛒さ⡲㕰 14
˖ 介㣐չ猰㷷䪮遭㛇劤岀պ黝欽眔㕞 ˖ 介㣐չ欰䪮倜谒欳噟涭㾜哫⢽պ黝欽眔㕞 ˖ ⵖ㹀չ㷷灇歲灇涭➂䩝䪮遭Ⰵ肄պ柿⺐鳴岀 ˖ 何㊣麓儗岀鋉⟃⤛鹌欰䪮䫎项⿹Ⱅ顠颪さ⢘ 鹌♧姾ⶼ鸡⚅歲秷欰䪮欳噟Ⱅ ˖
何鸡⫄窟錘䙀歋竣憗鿇莃頿佟鿇⸇䓼㼨欰ꄲ欳 噟⛒荅䎮鑐뀾⿹荅䎮鑐뀾涸灇涭酡⸔莃柿⺐ 项ꆃ 斈鸡㊣项劤䋐㜥ծ꣬⡚欰䪮项壉 15
䓼⻉兰䢳頿欳⥂隊ծ䲿⼮䪮遭獳鱲佩腉 兰䢳頿欳 ˖ ⸇鸞兰䢳欳噟⼮秷 ˖ 䓼⻉欰ꄲ倜ⶼⰕ肪䧭⚥䗰 ˖ 䒉鏣⽂庥欰ꄲ灇涭翷衅 ˖ 䲿傻欰ꄲ欳噟ⶼ倜⹛腉
˖ ⸇䓼堀䱸䧴4*$鳴Ⱅ㹓⛒欳㷷鰊㼪⸆腉 ˖ 䖰✲㕜ꥷ㼠ⵃ⡑㽷⟃䲿넝㕜ꥷ䋐㜥畸是⸂ 16
䱿⹛㕜ꥷ岀鋉垥彊⼿さծ衅㻛Ⰽ䁘ꄲ谒 遹欰さ⡲⼿陽 ˖ 遹欰状ⵃ鿇琎噰㻛植ꄲ谒ㅷ岀鋉盖椚⛒䪮遭㼠噟 ㋲⡘奘顑湱痗 ˖ ꄲ谒ㅷ叅뀾⚥䗰 $%& 遤佟岀➂⻉⟃㟝鹌ꄲ谒ㅷ 㻢叅佩桦ծ䲿⼮镨鑈鰊㼪欰ꄲ欳噟涸⸆腉
˖ 何㊣荅䎮鑐뀾橆㞮렼⺐灇瑔罏涭饯⛒荅䎮鑐뀾 ˖ 衅㻛Ⰽ䁘ꄲ谒さ⡲⼿陽 ˖ 䱿⹛㢳㕜㢳⚥䗰荅䎮鑐뀾 ˖ ⸇鸞鎍㹀շꄲ洽㐻勞盖椚岀ո 莃繟㕜岀鋉垥彊⼿ㄤ 岀鋉橆㞮 17
侭さ欰ꄲ呌䗰鏣倵莃项彁⚥䗰ծ佄䴂欰䪮 欳噟ⶼ倜灇涭 ˖ 䒉圓〴抒⨳䏿䊬ꆀ项俱䏧 ˖ ⯍㻛〴抒欰暟项俱䏧 ˖ ⸇䓼灇瑔岀➂⛒䪮遭佄䴂䎂〴 ˖ 㟝鹌荅䎮鑐뀾⛒佩桦莃佩腉
˖ 䲿⼮5$5$⛒荅䎮鑐뀾侶ㅷ颵莃侶ꆀ⚛⸇䓼㼨 劤㕼灇涭周⛒⼿⸔ ˖ 翷搊欰䪮⮚걄㚖ⶼ倜㕜ꥷ畸是⸂ 侭さ项彁 18
1SFWFOUJWF 갸ꄲ㷷 1SFEJDUJWF 갸庠ꄲ㷷 1FSTPOBMJ[FE ⦐➂⻉ꄲ㷷 1BSUJDJQBUPSZ 莃ꄲ㷷 4USBUFHZPGGVUVSF IFBMUIDBSF
Health Data Cloud Big Data Analysis 䊬ꆀ⨳䏿项俱莃1ꄲ㷷 侭さ项彁 19
荨抒荅䎮鑐뀾さ⡲耠湅 5$5$ Taiwan Clinical Trial Consortium (TCTC): http://tc2.ntu.edu.tw/ 肺癌臨床試驗聯盟 Lung
Cancer Consortium 癌症早期臨床試驗聯盟 Oncology Phase I Consortium 婦科癌症研究聯盟 GYN Oncology Group 乳癌臨床試驗聯盟 Breast Cancer Consortium 心血管關疾病臨床試驗聯盟 Cardiovascular Disease Consortium 小兒疾病臨床試驗聯盟 Pediatric Diseases Alliance 肺臟疾病臨床試驗聯盟 Lung Disease Consortium 胃腸疾病合作聯盟 Gastrointestinal Disease Consortium 精神疾病臨床試驗聯盟 Mental Disorders Consortium 肝臟疾病臨床試驗聯盟 Liver Disease Consortium 成人感染症臨床試驗聯盟 Adult Infectious Diseases 中風臨床試驗聯盟 Stroke Consortium 腎臟疾病臨床試驗聯盟 Renal Diseases Consortium 侭さ项彁 20
䢅鼅ꄲ谒欳ㅷ灇涭⚺겗ծ翷搊⿹䱍䳢 匌❎氫氺⛒暴婊⨳䏿撑隊 ˖ 렼⺐涭㾜欰䪮ꄲ谒ꡟ꒲䪮遭 ˖ 灇涭騖*$5⿹欰䪮ꄲ谒걄㚖涸欳ㅷ ˖ 帾Ⰵ✪鍑匌❎氫氺⛒䧭㔓莃屚 ˖ 麊欽䊬ꆀ⨳䏿项俱䬪⦐➂⻉礵彊ꄲ洽欳ㅷ
䢅鼅⚺겗 21
Lead Discovery Preclinical Pharm, Tox IND NDA Validation Optimization Phase
I, II, III Clinical Trials Market 籍穠 鷲麓Ⰻ椔鸬穠⟃⿹侭さ㖈㖑ⶼ倜纇翷䲿⼮չ➂䩝ծ 项ꆃծ兰䢳頿欳ծ岀鋉橆㞮ծ侭さ项彁ծ䢅鼅⚺겗պ 佩腉䩧鸡⟃灇涭ⶼ倜捀劤⛒չ❎㣕欰䪮ꄲ谒灇涭欳 噟⚥䗰պկ 22
㢳闐翓聁価锜䭷侄