膝の軟骨再生、治験へ 細胞培養し移植 神大など

 (2012/05/09) 先端医療センター病院（神戸市中央区）と神戸大医学部付属病院（同）は９日、激しいスポーツや交通事故などによる膝関節軟骨損傷の患者を対象に、本人から採取した膝の軟骨細胞を培養し、損傷部に移植する臨床試験（治験）を近く始めると発表した。欧州では２５００例以上の実績がある治療法で、来年３月までに１０例の実施を予定。民間企業による治験を経て、２０１５年中の国内承認を目指す。膝の軟骨は大腿骨と脛骨の端の表面にあり、関節をスムーズに動かす役割がある。損傷で痛みや動きにくさが生じ、進行すれば生活に支障が出たり、変形性膝関節症の原因になったりする。関節軟骨には血管がないため自然には元に戻らず、損傷部の周辺を刺激して組織再生を促す治療法などがあるが、十分な回復は難しいという。治験では、体重の負担がかかりにくい部位にある正常な軟骨細胞を採取し、タンパク質の一種であるコラーゲンのゲル（ゼリー状の粘質）を"足場"にして培養。損傷部に合わせ、生体素材ののりで接着する。縫合が不要なため手術時間が短縮され、従来より大きな部位を治療できる利点がある。移植後１カ月半～２カ月程度で自力歩行が可能になるといい、計１年半ほどかけて損傷部の回復を目指す。治験の対象は２０歳以上５０歳以下で、希望者は受診中の主治医からの紹介が必要。将来的には初期の変形性膝関節症への適用拡大も目指す。先端医療振興財団細胞療法開発事業部門の川真田伸副事業統括は「海外では既に有効性が確認されている治療法なので、できるだけ早く国内で広げたい」と話す。  

翁啟惠…學術單位應加強”人”的合作!!

翁啟惠：學術單位忽視人才    2012/05/10  【聯合報】  中研院長翁啟惠昨天在立法院表示，學術研究應為社會提出建言，因此評鑑制度不應該只考慮論文發表，而是納入社會貢獻等指標。建議教育部、國科會應打破現有評鑑方式。   他指出，研究分為兩種，一種是問題導向，為創造知識而投入研究，另也有對公共事務的研究，這類題目可能對社會、產業、就業機會等有關，兩者的衡量標準是不同的，應固守單一評鑑方式。   他表示，國內學術單位大都是「先爭取（資源）再說」，少談和人合作，人才問題亦然；「教育部、國科會、經濟部有經常坐下來談人才問題嗎？」   他強調，這個時代面對的往往是跨領域問題，若大家都不太願意表達意見，「先照顧自己再說」，是走不出世界的。   國科會副主委張清風說，近幾年國科會的評鑑方式已經在轉型；在評鑑論文或報告時，不會只看發表量、有沒有登在ＳＣＩ等資料庫的期刊，「那個階段性任務已經完成了。」會更著重於對社會的貢獻和影響，或對產業、知識的突破。

吸引人才 薪水是誘因之一!!

港大學月薪80萬挖角 學者王汎森仍留台灣 【2012/05/09 聯合晚報】    台灣人才流失問題有多嚴重？可從中研院副院長王汎森被香港某大學挖角這事看出來，所幸他未被台幣80萬元的月薪誘惑，仍堅持留下來，讓台灣擁有一個國際級的歷史研究學者。   立法院教育及文化委員今天安排中研院院長翁啟惠業務報告，台灣人才流失問題成為立委關切焦點。國民黨籍立委呂玉玲強調，台灣人才失衡嚴重，如何留住本土優秀人才，並讓國外專業人才進來，更顯重要。   她透露，王汎森年前被國外學術機構鎖定，高薪挖角，可見國內人才外流問題的嚴重性。王汎森隨即證實確有此事，他說，曾有香港某大學以每月80萬元的高薪聘他接任該校文學院長，後來甚至要安排他出任副校長。   王汎森半開玩笑地說，當時居中牽線的一位大老級學者透露，那所大學的文學院長「待遇高」、「非常忙」，但「工作簡單」，可說是很多人求之不得的好工作，要他好好考慮一下。   幾經思考，王汎森最後回絕了邀請，因為他的專長領域在社會、文化及歷史，留在台灣發展才有意義。不過他也直言，「愛我們這塊土地很重要，但薪水也相當重要！」話一說完，立即引來哄堂大笑。   國民黨籍立委陳學聖表示，聽到他的同學被80萬元高薪挖角，「很開心，卻也很擔心。」因為王汎森若真被挖走，台灣就少了一個相當有活力的學者。王汎森也私下透露，他被挖角時，在台月薪是10幾萬元，80萬元確實很具誘惑力。   台灣面臨人才流失的危機，總統馬英九和行政院長陳?都指示相關部門積極研議解決。立委何欣純質詢時也要求翁啟惠在去年8月提出「人才宣言」後，應繼續關注台灣人才的未來發展。   翁啟惠表示，自從立法院通過「科技基本法」後，法制面有相當大的突破，有比較大的彈性可留住優秀人才。不過他強調，人才來來去去是國際間常見的現象，只要能吸引更多、也更優秀的人才來台灣奉獻心力，我們就不必太擔心短期的人才外流現象。   在此前提下，他認為薪水只是吸引人才的誘因之一，提供更優質的工作環境才重要。只要台灣擁有很好的工作環境，就不怕找不到好人才。

翁啟惠…人才供需失衡代表產、學沒有合作!!

人才供需仍失衡 翁啟惠：加強產學合作   時間：2012/5/9 11:15  撰稿‧編輯：李憶璇 　中研院院長翁啟惠等學術界人士為提醒政府重視人才外流問題，曾提出「人才宣言」。翁啟惠今天(9日)再度表示，雖然宣言已小有作用，但仍顯得不夠積極，要解決人才外流問題，除了需要跨部會合作，更重要的是如何改變根本觀念，加強產學合作，以解決人才供需失衡現象。　中央研究院院長翁啟惠去年發表「人才宣言」，指近年台灣出現嚴重人才供需失衡問題，並研擬因應對策，但到目前為止，只有科技基本法有實質進展。  　翁啟惠9日在立法院教育文化委員會坦言，目前成績勉強及格，但政府應更積極努力。他指出，這個問題需要跨部會共同解決，從制度及環境方面著手，並改變文化與觀念，以符合國際潮流。  翁啟惠並舉例表示，人才供需失衡代表產、學界沒有相互連結，台灣如果要發展創新經濟，還是要加強產學合作。翁啟惠說：『(原音)我想既然要走創新知識經濟，就是要有產、學之間的合作。產業界面臨的問題很多是學術界沒有在做的，怎麼從問題導向研究去扭轉情況，就是現在產業面臨可能是關鍵技術問題、設計的問題，假如產業沒辦法自己提昇競爭力，就可以跟學術界合作，委託學術界做問題解決的研究工作。』  　　另外，曾有香港某大學挖角中研院副院長王汎森，不但每月提供超過新台幣80萬元的薪水，還提供宿舍，但王汎森沒有接受。王汎森表示，薪水不是他唯一的考量，而且相關領域在台灣比較有發展。

翁啟惠…. 人才問題 政府部會 各做各的!!

翁啟惠：政府攬才留才勉強及格 2012-05-10  中國時報 中央研究院長翁啟惠昨日在立法院答詢時表示，政府針對人才供需失衡雖有因應對策，但不夠積極，距離理想還很遠，目前僅是勉強及格！  去年八月，翁啟惠與國內十八位產官學研及媒體重要領導人共同連署發表《人才宣言》，指出我國人才流失及供需失衡問題。而新加坡副總理尚達曼在上個月初引用《人才宣言》指出，新加坡如果也阻止外國人才進入，將會重演「台灣故事」，喪失全球競爭優勢。  翁啟惠昨日赴立法院教育及文化委員會進行業務報告並備詢，人才問題成為朝野立委質詢焦點。翁啟惠表示，尚達曼完全誤解《人才宣言》內容、倒因為果。中研院的目的是用這種方式，讓大家重視人才問題可能對國家發展的影響，台灣現在的人才其實比新加坡好很多。  他說，《人才宣言》發表後，已發揮作用，政府也採取行動，但還不夠積極。尤其是從教育到產業，如何人才培育並與經濟發展連結起來，還有很多問題。目前政府所做的努力僅勉強及格，但這個問題不是靠政府就可以解決，「人才供需已失衡，培養出來的人才找不到出路，產學之間必須密切合作！」  翁啟惠會後受訪時加重語氣強調：「對於人才問題，教育部、國科會和經濟部有經常坐下來談嗎？」大家還是各做各的，看不出整體走向。最主要的癥結在於，學術界跟產業界沒有互動。  他直言，尤其是在現行大學評鑑制度下，各大學爭相做研究、發表論文，現有一百六十幾所大學院校，就像是一個模子刻出來、同質性太高，造成培育的人才不符合產業界需求，只能拚命擠進學校或研究機構。  「這個問題我在《人才宣言》講得很痛心，可是到現在好像都沒有反應！」翁啟惠直言，相關部會要認真面對國內高等教育人才供需失衡問題。「不然，我們只能蓋更多學校容納這些人！」但現在的大學院校已經太多了！

翁啟惠…..台灣人才工作環境: 勉強及格

翁啟惠：台灣人才 比新加坡好多了 世界新聞網 北美華文新聞May 09, 2012 新加坡副總理日前把台灣人才問題當成負面教材，中研院長翁啟惠昨天說，台灣人才比新加坡好多了，不過若要他替台灣人才環境工作評分，只是「勉強及格」。  翁啟惠昨天至立法院報告年度預算解凍計畫，人才問題成了立委質詢重點。國民黨立委呂玉玲提到，翁啟惠曾於去年八月發起「人才宣言」，但新加坡副總理日前說，台灣阻止國外人才進入，星國不能重演「台灣故事」，問翁如何看待台灣人才危機。   翁啟惠表示，新國副總理說台灣不歡迎人才進來、讓好的人才流失，所以薪資低迷，是倒因為果，其實「台灣人才比新加坡好多了，」新加坡就不像台灣擁有研發與電子業的人才。   翁啟惠說，去年八月發布人才宣言後，已引起政府重視，但行動上必須更積極。推動科技基本法修法是其一，不過台灣文化、觀念上都需要改變。   中研院副院長王汎森曾在日前受訪時曾表示，香港想挖他過去，昨天也被立委追問「行情」。王汎森說，他擔任史語所所長時，香港某大學找他去當校長，待遇是月薪八十萬元加宿舍。他說，沒去是因為「在台灣研究人文社會領域比較有意思」，立委再問，是否因為愛國才不去？他委婉表示，愛這片土地很重要，不過薪水也不能太差。   據了解，王汎森被香港某大學挖角，是四、五年前的事，當時他在台月薪至少十幾萬，他認為以他的專長，在台灣的學術環境較好，故回絕邀請。翁啟惠表示，薪水只是吸引人才的誘因之一，更重要的是人才有沒有發展機會。

美國進行漸凍症 幹細胞治療試驗!!

Neuralstem 發佈肌萎縮性側索硬化症幹細胞試驗進展的最新情況 鉅亨網　2012-05-09    馬里蘭州洛克維爾, 2012年5月8日 /美通社-PR Newswire/ -- Neuralstem, Inc. 今天宣佈，美國食品及藥物管理局（Federal Drug Administration，以下簡稱「FDA」）批准正在進行第一階段安全試驗的早期同齡組3位患者可以再次利用其脊髓幹細胞 (spinal cord stem cells, HSSC s) 治療肌萎縮性側索硬化症（amyotrophic lateral sclerosis，以下簡稱「ALS」或「盧格裡克氏病」）。只要他們在規定時間達到參加實驗的相關要求，這些患者便獲許作為下一批同齡階段患者進入第二次治療的實驗。他們將成為沿著脊髓接受幹細胞移植的首批患者。    這次實驗將在佐治亞州亞特蘭大的埃默里大學醫學院 (Emory University Hospital) 進行，其中首批12位患者將只在脊髓的腰椎（下背部）區域接受了幹細胞移植。同齡組最後的3位患者於4月完成試驗，在脊髓的頸部（上背部）區域接受了幹細胞移植手術，這將有助於增強 ALS 惡化中所喪失的呼吸這項重要功能。同齡的下一組3位患者將分別在腰椎和頸部區域注射10次和5次 HSSC，在脊髓處總計注射15次。對於重新加入試驗並在腰椎注射10次的患者，他們將在頸部注射5次。他們是首次接受注射的15至17個月患者，並且第一次療程效果良好。   此外，Neuralstem 向 FDA 提交了一份試驗修正方案，旨在增加未來同齡組受治患者的人數和劑量。此項修正方案還將為此次實驗增加部分療效的終點。該實驗最初是作為治療18位患者的安全試驗。   Neuralstem 董事長兼首席科學官 Karl Johe（哲學博士）表示：「這些患者重新參加二次治療的實驗，這不斷證明了該實驗具有安全性。一般而言，第一階段實驗不會重新收治實驗者，因為這會增加他們有可能接受有害治療的風險。治療這些已經在脊柱部分區域接受過注射的患者使我們能為每位患者增加整體劑量，並在脊柱沒有接受過注射的區域進行幹細胞移植。下一組同齡患者將成為全球首批在脊髓頸部和腰椎區域都接受幹細胞移植的患者。例如，對於腰椎接受過注射的患者，他們將接受頸部注射，我們還將為其呼吸這維持生活品質的至關重要功能提供潛在支援。」   這項 FDA 批准的修正方案在實施前，需要獲得 Emory Institutional Review Board 的批准。   消息來源 Neuralstem, Inc.  

日本用幹細胞 開發漸凍症藥物平台!!

日研究人員利用胚胎幹細胞研究漸凍症   2012年05月09日   新華社東京５月９日電（記者藍建中）日本京都大學一個研究小組在美國《幹細胞轉化醫學》雜誌上發表論文說，他們利用人類胚胎幹細胞成功製作出具有肌萎縮側索硬化症（漸凍症）特徵的細胞，這將有助於弄清該病的機制並開發治療藥物。  肌萎縮側索硬化症俗稱漸凍症，是由於運動神經出現障礙，導致全身肌肉逐漸變得無力的一種疾病。漸凍症患者約有１０％屬於遺傳性患病。由於不清楚詳細的致病原因，醫學界一直沒有找到根治此病的方法。  在遺傳性漸凍症患者中，約有２０％是由於"ＳＯＤ１"基因變異所致。研究小組將變異"ＳＯＤ１"基因導入人類胚胎幹細胞，使其分化成運動神經細胞等。結果在這些分化後的運動神經細胞中再現了漸凍症患者細胞的一些形狀、性質特徵，比如神經突形狀大小多變、細胞易壞死等。  研究小組負責人中?憲夫說，有報告顯示，非遺傳性的漸凍症也與"ＳＯＤ１"基因有關，期待本次開發的細胞模型在漸凍症治療中發揮重大作用。

國家型科技計畫轉型或退場機制小組??

國科會力行改革 合理分配學界資源  台灣醒報2012-05-07   國科會執行效率不彰長年惹人詬病，主委朱敬一甫上任便大力改革，包括限制主管的申請案件數、成立轉型和退場機制小組等。長庚大學教授周成功日前投書媒體指出，國科會本有「補助經費集中少數對象」和「計畫施行管理不彰」的弊病，朱敬一的改革方向正確。  台大教授季瑋珠和中山大學教授張學文受訪時都認為，此舉的確能改善學界的「大老壟斷多個研究案」情況。不過，台大教授蕭寧馨則認為，改革是否真能改善先前的困境，仍有待時間證明。  在過去，國科會經常會出現超大型的研究計畫，而其補助經費卻只集中少數對象，造成計畫的形成、徵求到審查的過程幾乎都是黑箱作業。長庚大學生命科學系教授周成功說，中研院院長翁啟惠主持為期3年、總經費高達2億元的生質能源計畫就是一個例子，且此類計畫成果卻多為無關緊要的學術論文，浪費許多資源。  為此，國科會主委朱敬一上個月明確規範，未來主委不得申請或執行任何國科會研究案，副主委和各處處長則以1件為限；如果目前手頭上仍有多餘的研究案，也該在3個月內結束；此外，申請經費不得超過任職前3年平均，所申請的專題研究計畫由專案小組審查，副主委和主管人員全程不得參與。  周成功肯定此項改革，並希望朱敬一能堅持公開和透明的施政風格。台灣大學公衛學系教授季瑋珠也表示，此新措施的確能稍改善學界的「學霸」情況，她提出建議，國家不應該主導學術研究方向，國家型計畫應該少一點，讓學者自由發展。  「其次，針對國家型計畫，朱敬一也提出轉型機制。」周成功表示，過去國家型計畫總主持人多半由學界大老兼任，但卻缺少監督機關督促整體計畫的實行，造成該計畫最後成敗無人負責，或是某些大老肩負許多研究案，讓人懷疑其是否真有時間參與。  為應付此狀況，國科會成立「國家型科技計畫轉型或退場機制小組」，並提出5項改進重點，包括未來每個主軸計畫將由「統包」改為「分包」，亦即從以往由國科會選定總主持人，再讓他自行尋找個計畫的主持人的模式，改為每個主軸計畫都將對外公開徵求執行者，且總主持人或執行長都得全程參與。  另外，將組成改進指導小組，強化指導功能；訂定國家型科技計畫退場原則和程序，每個計畫應於期程結束前一年提出退場計畫；強化績效評估機制，不拘限於論文或是專利形式，並落實按期追蹤。  朱敬一日前接受媒體採訪時曾強調，為確保補助專題研究計畫的公正客觀性，並有效推動國家科技發展，主管執行專題研究計畫將嚴加自律，建立相關迴避機制。周成功表示，國科會的施政和國內學術界的關係密切，每次的改革都是牽一髮而動全身，希望朱敬一趁勝追擊，為台灣的科技發展創造健全的發展空間。  「國科會的改革案提供研究人員更多機會實踐其計畫。」中山大學生物科學系副教授張學文表示，國科會所提的研究計畫多具任務導向，因此會內仍把持研究的主要方向；但改革後將釋出更多主導權，讓其他研究人員有更多機會發揮所長，有益於國家發展。  台灣大學農化系教授蕭寧馨則認為，政府常常提出許多制度性的改革，但就如同近日火熱的教改議題，是否真能改變先前遭遇的困境，仍待日後證明。

餵母乳降低新生兒打針痛….母乳內褪黑激素前驅物 !!

打針新法寶 母乳能止痛    ‧聯合新聞網2012/05/08  母乳能止痛？台北榮總以60名新生兒進行試驗，半數嬰兒在扎足跟採血前先餵食2c.c.母乳，結果這些小朋友因恐懼、疼痛而哭泣的時間縮短一半，心跳、呼吸也較為平穩，連臉部表情都比較放鬆。   國際護士節（5月12日）前夕，台北榮總昨天展示實證照護運用，包括採血、打針前先餵母乳，減少嬰兒疼痛反應，還以衛生棉幫早產的「巴掌仙子」製作小尿褲，充分展現護理專業。   新生兒一出生就要接受一連串疼痛處置，包括足跟採血、肌肉注射維他K1及接種疫苗等。   北榮嬰兒室副護理長李延慧說，多數人以為嬰兒那麼小，不會痛，但事實上，若醫護人員未能察覺，或誤解新生兒對疼痛的因應能力，恐留下不愉快經驗。   北榮護士翻閱文獻後發現，靜脈抽血前先餵新生兒喝母乳，能有效降低哭泣時間、減緩疼痛，使嬰兒出現疼痛生理反應及行為變化的時間較少。北榮以60位新生兒進行試驗，半數在採血前餵哺母乳，半數則無，得到與文獻相同的結果。前年年底開始，北榮護理人員在採新生兒腳跟血前，已例行性餵哺母乳。   李延慧說，有的新生兒在採血前1小時，媽媽就先親自餵哺母乳，無法親餵者，由護理人員兒收集2c.c.母乳，在採血前2分鐘先餵食，新生兒疼痛反應明顯減緩，哭泣時間縮短一半，有些寶寶甚至扎完後很快睡著。   母乳為何能止痛？李延慧說，母乳裡的褪黑激素前驅物與腦內啡有關，能刺激腦內啡分泌，達到止痛效果。「打疫苗之前也有效。」   不過，李延慧提醒，孩子吃進母乳量較多，最好提前一小時餵哺，並間隔半小時再讓孩子接種疫苗，以免吃太飽哭鬧，導致吐奶。

友華羊奶 前進新疆卡位!!

友華、訊聯卡位「龍寶寶」商機成功 營運邁入收成期！   2012/5/9  鉅亨網   兩岸都掀起龍年生子潮，龍寶寶商機俏，友華(4120)、訊聯(1784)分別佈局羊奶粉、臍帶血商機，首季起已明顯感受到熱度，友華大陸羊奶粉銷售創下佳績，並調漲售價，讓海外營收在營養品部分占比衝上3成新高，訊聯則是去年已服務台灣45%新生兒，今年市占率持續攀高，轉投資創源生技晶片檢測試劑並已供不應求。      友華首季每股稅後盈餘1.19元，訊聯首季每股稅後盈餘0.45元，都是近幾年來的單季新高數字，今年營運將邁入收成期。   友華旗下自有品牌羊奶粉卡洛塔妮，去年起開始進入大陸銷售，目前在大陸371家大賣場及2493家銷售據點銷售，不僅強攻華南、華中市場，友華也計畫前往新疆設立據點。  也由於龍年商機俏，羊奶粉乳源供應吃緊，紐西蘭羊奶期貨價格也攀高，海外羊奶粉銷售價格已調漲3%，台灣部分成本上漲仍自行吸收。   友華首季稅後淨利1.03億元中，來自海外貢獻達5000萬元，大陸羊奶粉熱銷功不可沒。  而友華首季每股稅後盈餘1.19元，已達去年每股稅後盈餘2.09元6成，友華內部也以今年營運獲利逐季成長為努力目標。   訊聯部分，國內首季新生兒達5.2萬人，年成長17％，但訊聯的臍帶血儲存業務年增率達34％，訊聯市占率持續攀升，仍穩坐臍帶血市占率龍頭，也推升訊聯首季每股稅後盈餘0.45元，年增逾5倍。   預估今年第2、3季新生兒人數將可持續攀高，訊聯業績與獲利也有機會同步攀高。

台灣進入腸病毒高峰期!!

腸病毒肆虐 233班停課 急診人數增7倍  〔2012-5-10記者何玉華／新北報導〕腸病毒增溫，新北市今年累計已有兩百卅三班停課，感染腸病毒急診的人數增加近七倍，衛生局疾病管制科長李佳琪說，監測資料顯示，腸病毒進入流行高峰期，民眾除了勤洗手，還要注意幼童是否出現重症症狀，盡速送大醫院治療。  李佳琪說，新北市五月第一週因腸病毒就診約兩千人次，停課卅一班，比四月同期就診約一千八百人次、停課十幾班增加不少，至八日止，全國已出現卅四起腸病毒感染併發重症案例，新北市有四例，分佈在人口密集的都會區，目前都已痊癒出院。  李佳琪強調，腸病毒重症病程發展快速，只有短短數小時的黃金治療時間，嬰幼童若出現嗜睡、意識不清、活力不佳、手腳無力、無故驚嚇或突然間全身肌肉收縮、持續嘔吐、呼吸急促、心跳加快等重症前兆病徵，就不要到診所，直接去大醫院治療。  

延遲通報罰學校、幼托  李佳琪解釋，區域內出現重症確診個案或監測到腸病毒七十一型，就列入高危險區，新北市已有十五區，包括中和、永和、鶯歌、蘆洲、樹林、林口、淡水、新莊、土城、板橋、三重、八里、汐止、新店、泰山，區域內的學校及幼托，一週內有兩人感染腸病毒，全班必須停課七天。  學校或幼托機構必須在四十八小時內通報腸病毒個案，延遲通報將處三千元至一萬五千元罰鍰，今年五股一處私立幼稚園被開罰。

永信藥品：公告通過解除董事競業禁止限制

鉅亨網　2012-05-09    第七條　第9款  1.股東會決議日:101/05/09    2.許可從事競業行為之董事姓名及職稱:  (1)李芳裕/董事長  (2)李玲津/董事  (3)李芳信/董事  3.許可從事競業行為之項目:投資或經理其他與本公司營業範圍相同或類似之公司   並擔任董事或經理人之行為  4.許可從事競業行為之期間:101/04/01~102/06/08  5.決議情形（請依公司法第209條說明表決結果）:經董事會主席徵詢全體出席董事   無異議照案通過(董事會代行   股東會職權)  6.所許可之競業行為如屬大陸地區事業之營業者，董事姓名及職稱（非屬大陸地區事業  之營業者，以下欄位請輸不適用）:  (1)李芳裕/董事長  (2)李玲津/董事  (3)李芳信/董事  7.所擔任該大陸地區事業之公司名稱及職務:  (1)李芳裕/董事長  (A)永信藥品工業(昆山)有限公司/董事  (B)上海永日藥品貿易有限公司/董事  (C)佑康貿易(上海)有限公司/董事  (D)江蘇德芳醫藥科研有限公司/董事  (2)李玲津/董事  (A)江蘇德芳醫藥科研有限公司/董事  (3)李芳信/董事  (A)永信藥品工業(昆山)有限公司/董事  (B)上海永日藥品貿易有限公司/董事  (C)佑康貿易(上海)有限公司/董事  (D)江蘇德芳醫藥科研有限公司/董事  8.所擔任該大陸地區事業地址:昆山市、上海市  9.所擔任該大陸地區事業營業項目:  (1)永信藥品工業(昆山)有限公司：生產銷售西藥、成藥、原料藥及化學中間體等  (2)上海永日藥品貿易有限公司：國際貿易、區內貿易代理、倉儲及商業性簡單加工等  (3)佑康貿易(上海)有限公司：藥用中間體、化妝品、保健食品及其化學原料等  (4)江蘇德芳醫藥科研有限公司：醫藥產品的研發及研發成果之轉讓、授權等  10.對本公司財務業務之影響程度:無  11.董事如有對該大陸地區事業從事投資者，其投資金額及持股比例:不適用  12.其他應敘明事項:依公司法第128-1法人股東一人所組織之股份有限公司   其股東會職權由董事會行使  

健亞代工大廠旗艦藥品??

健亞獲國際大廠代工訂單 陳正：Q4起業績爆發性成長   2012/5/9  鉅亨網  健亞生技(4130)今天應邀參加櫃買中心舉辦的業績發表會，健亞總經理陳正透露，健亞已於8日獲得衛生署核發製造藥證，可正式為國際大廠代工。     而此一藥品，預定第4季起帶來業績貢獻，並可望使健亞的業績呈現「爆發性成長」，而健亞明年的代工比重將可突破5成。   據了解，健亞爭取這項國際大廠「旗艦藥品」的代工訂單，已長達2年半，而衛生署正式核發製造藥證，可望讓健亞的營運邁入新里程。  而健亞後續將繼續爭取其他亞洲地區的代工訂單，成為國際大廠的「發貨中心」。   陳正表示，健亞的營運，主要成長動能在於上市3年內的旗艦藥品，這部分每年約有5-20%的成長。  以全球前15大暢銷藥中，9項為小分子藥物，而健亞生產達8項，且其中一半以上，正在同步申請中國藥證，而中國的市場為台灣10-20倍，透過這些旗艦藥品，健亞可以擺脫健保調降藥價影響，成為未來3年的主要成長動能。    陳正規劃健亞的獲利模式，代工部分約可穩定貢獻每股盈餘1元左右，但如果處方新藥有較大突破，未來光是處方新藥部分，每年就有機會貢獻健亞每股3-5元的獲利貢獻。   另外健亞與武田藥廠的侵權損害賠償勝訴，武田賠償金可望於第2季入帳，而健亞5月1日起，並獲得優脂持續釋放錠(Nidadd Susttained-Release Tablets)的健保藥價給付，用於高血脂症飲食控制，初估台灣約200萬名病患，市場規模超過2億元，均將為健亞後續的營運與獲利表現增添助力。

綠色空間+ 體內細菌較多樣性= 舒緩氣喘和過敏症

研究：接觸綠色空間　氣喘、過敏病患不藥而癒   NOWnews.com 今日新聞網 2012年5月9日  到戶外走走、接觸大自然好處多！芬蘭科學家研究發現，現代人長期身處城市中，缺乏與大自然接觸，反導致過敏病症增多，研究建議多接觸大自然、綠色空間，有助舒緩氣喘和過敏症。  據芬蘭科學家漢斯基(Ilkka Hanski)在美國「國家科學院學報(PNAS)」刊登的一項研究，針對118名居住於芬蘭東部地區的青少年進行生物樣本分析，發現常與大自然接觸，住在農場或森林的青少年，體內細菌較多樣性，也較少有過敏困擾。  漢斯基表示，人類所居住的環境，不管是城市或鄉村都擁有微生物，只是在森林或農村地帶，一種對於抗炎成效最佳的「變形菌（Gammaproteo bacteria）」菌種特別多，也較為有用，在鞏固增強人類免疫系統上扮演著重要角色。  因為一般預防過敏症狀的治療方法，多半都是打針或是吃含有類固醇的藥劑，但事實上患有過敏病症者，應該多接觸自然環境、多做體能活動，才是最佳的治療方法。

Human dental cells analyzed for telomere length, telomerase activity

A research team from the Republic of Korea has isolated a population of stem cells derived from dental tissues of third molars and found that human dental papilla stem cells (DPaSCs; dental papilla develops into dentin and dental pulp) have biological features similar to bone marrow-derived mesenchymal stem cells (MSCs) in terms of telomere length, telomerase activity and reverse transcriptase (Rtase) activity.   MSCs, one of the most studied and clinically important populations of adult stem cells, do have shortcomings associated with their isolation and expansion from bone marrow, said study lead author Dr. Gyu-Jin Rho of the College of Veterinary Medicine, Gyeongsang National University, Republic of Korea.   "The role of telomere and telomerase are critical biological features of normal tissue stem and progenitor cells," said Dr. Rho. "Telomeres are a specialized region of repetitive DNA, and telomere shortening is related to cellular life span. Lack of telomerase indicates cellular aging. We compared the telomere length and telomerase activity in DPaSCs with those in MSCs and found that DPaSCs possessed ideal characteristics on telomere length, telomerase activity and reverse transcriptase activity, making DPaSCs suitable alternative candidates for regenerative medicine."   The researchers concluded that DPaSCs could provide a source of stem cells for tooth regeneration and repair as well as a wide range of regenerative medicine applications in humans.   "These two studies highlight the potential value of two populations of stem cells that can be derived from the immature dental pulp and papilla of teeth" said Dr. Shinn-Zong Lin, professor of Neurosurgery and superintendent at the China Medical University Hospital, Beigang, Taiwan. "Their MSC-like abilities, ease of transformation to induced pluripotent stem cells, and ease of availability make them a potentially valuable cell therapy".

2 Cell Transplantation studies impact dental stem cell research for therapeutic purposes

 Posted On: May 8, 2012   Tampa, Fla. (May. 8, 2012) – Two studies appearing in a recent issue of Cell Transplantation (20:11-12), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/, evaluate stem cells derived from dental tissues for characteristics that may make them therapeutically useful and appropriate for transplantation purposes.     

Induced pluripotent stem cells from immature dental pulp stem cells  A Brazilian and American team of researchers used human immature dental pulp stem cells (IDPSCs) as an alternative source for creating induced pluripotent stem cells (iPSCs), stem cells that can be derived from several kinds of adult tissues. According to the study authors, production of iPSCs "opens new opportunities for increased understanding of human genetic diseases and embryogenesis" and will likely have a "great impact on future drug screening and toxicology tests."   The authors note, however, that the reprogramming methodology for making iPSCs is relatively new and "needs refining" in terms of technique, efficiency and cell type choice.   The researchers report that they easily, and in a short time frame, programmed human immature dental pulp stem cells into iPSCs with the hallmarks of pluripotent stem cells.   "Human IDPSCs can be easily derived from dental pulp extracted from adult or 'baby teeth' during routine dental visits," said study lead author Dr. Patricia C.B. Beltrao-Braga of the highly ranked National Institute of Science and Technology in Stem and Cell Therapy in Ribeirao Preto, Brazil. "hIDPSCs are immunologically privileged and can be used in the absence of any immune suppression protocol and have valuable cell therapy applications, including reconstruction of large cranial defects."   Contact: Dr. Patricia C.B. Beltrao-Braga, National Institute of Science and Technology in Stem Cell and Cell Therapy, 2051 Tenente Catao Roxo St. Ribeirao Preto, Brazil. Tel. 55 (11) 3091-7690 Email patriciacbbbraga@usp.br   Citation: Beltrao-Braga, P. C. B.; Pignatari, G. C.; Maiorka, P. C.; Oliveira, N. A. J.; Lizier, N. F.; Wenceslau, C. V.; Miglino, M. A.; Muotri, A. R.; Kerkis, I. Feeder-free derivation of induced pluripotent stem cells from human immature dental pulp stem cells. Cell Transplant. 20(11-12):1707-1719;2011.

Pfizer starts biosimilar rituximab Phase I/II trial

 May 9, 2012     Pfizer Inc. has recently started the clinical trials of its biosimilar rituximab program. The Phase I/II trial will be conducted in rheumatoid arthritis patients comparing the pharmacokinetics, pharmacodynamics and safety to that of different versions of rituximab sold in the EU and US.    The trial, REFLECTIONS B328-01, which started in March this year will be conducted globally in 210 patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate. The patients will receive two intravenous treatments with either PF-05280586 or Rituxan or MabThera. Pfizer expects the study to be finished in December 2013.   Rituximab, sold under different brand names in the US and other parts of the world is a blockbuster biologic of Biogen Idec and Genentech (Roche). The product is approved to treat Non-Hodgkin's lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis in the EU and US, plus it is approved to treat diffuse large B cell lymphoma in the EU. Rituximab is also used for other types of lymphoma (e.g. Mantle Cell lymphoma) in certain parts of the world.   Rituximab, like many other blockbuster monoclonal antibodies, is under the attack of several biosimilar manufacturers. Celltrion of South Korea, Sandoz, the generics unit of Novartis, Teva of Israel and Merck has also started clinical trials of their own rituximab biosimilars.

Sandoz testimony at FDA hearing on biosimilars will emphasize need for consistent regulatory standards

 May 9, 2012    Sandoz announced today that Dr. Mark McCamish, Head of Global Biopharmaceutical Development, will present on behalf of the Novartis Group of companies at the May 11 FDA public hearing on draft guidances related to the development of biosimilar products.    

■Sandoz will testify on behalf of the Novartis Group  

■Sandoz supports FDA in its efforts to improve access to safe, efficacious, affordable biologics and agrees with the flexible, step-by-step approach outlined in draft guidances  

■Sandoz is committed to bringing biosimilars to patients in the US, just as it has done in the EU and other markets around the world   The central message in the Novartis Group testimony will focus on the need for a single science-based regulatory standard that FDA should apply across all biologics, irrespective of the business model of the sponsor.   "Sandoz is pleased that FDA has taken another step toward increasing patient access to affordable, high-quality biologics," says Dr. McCamish. "We support the flexibility of the draft guidances and hope that FDA will provide similar science-based, pragmatic approaches in its final guidelines."   Based on its global experience developing and commercializing three biosimilars, and as part of a company that produces both biosimilars and originator biologics, Sandoz has already submitted written comment on the draft guidances. With patient access to biologics becoming increasingly limited by high costs and growing demand, the company's input is aimed at ensuring US patients receive safe, effective and affordable biosimilars in a timely and efficient manner.   The key areas that Sandoz will address in their testimony include:  

  ■One science-based standard for all biologics: It is important that regulatory standards across all biologics are consistent. Several originator biologics have undergone manufacturing changes since their commercialization. Sandoz uses these data to create a "highly similar" biologic that overlaps with the originator's product attributes. Such a highly similar product should justify an abbreviated clinical trial program as is outlined in the draft guidance documents. "Highly similar quality attributes" is the established standard for manufacturing changes1 and "highly similar" is the biosimilars statutory standard.  

■Biosimilar clinical studies are only confirmatory: Biotechnology has advanced significantly and a biosimilar sponsor is able to use highly sophisticated and sensitive analytical technologies and bioassays to pick up differences from the originator compound more effectively and efficiently than any reasonably sized clinical trial. This allows a sponsor to fully characterize and understand a biosimilar and its reference product. Once high similarity is established early in development, all subsequent tests are confirmatory. Sandoz agrees that if a high degree of similarity isn't demonstrated, then more extensive preclinical and clinical data will be necessary.  

■Interchangeability: Comparability is the extrapolation/interchangeability standard applied by FDA to currently approved biologics that have undergone a manufacturing change. Therefore, interchangeability is inevitable when a manufacturing change has been approved using comparability. FDA can, and should, require that biosimilars sponsors comply with the same rules and standards as originator biologics, and vice versa. Sandoz will anticipate receiving guidance from FDA on biosimilar interchangeability requirements, as interchangeability is critical to maximizing access to affordable biosimilars for patients.   In his presentation, Dr. McCamish will also provide examples of how the use of biosimilars can increase patient access and reduce expenditures on biologics. He will highlight a recent study conducted by IGES Institute in Berlin, which showed that by 2020, eight countries in the European Union could save a cumulative total of between EUR 11.8 billion and 33.4 billion through the use of biosimilar medicines. This is in line with the results of a 2008 Congressional Budget Office study that estimated the biosimilar pathway implementation could reduce total expenditures on biologics in the US by USD 25 billion over 10 years (2009-2018).   "Sandoz is focused on ensuring that US patients receive timely access to high-quality biosimilars and believes these factors are critical to achieving this," says Dr. McCamish. "We look forward to continuing to work with FDA in bringing these high-quality, safe and effective products to the US market."  

New Research Report Wireless Health Market Forecasts to 2016

Published By MarketsandMarkets     Dallas, TX (PRWEB) May 09, 2012   The report "Wireless Health Market (WLAN, WMAN, WPAN, Sensors, Smartphone, Tablet, PC, Mobile APPS) - Global Trends, Opportunities, Competitive Landscape and Forecasts Till 2016" as the name suggests, analyzes and studies the major market drivers, restraints, and opportunities in North America (U.S. and Canada), Europe (U.K., Germany, France, Italy, Spain, ROE), APAC (China, Japan, India, South Korea, Australia) and Rest of the World.   Browse market data tables and in-depth TOC on "Wireless Health Market (WLAN, WMAN, WPAN, Sensors, Smartphone, Tablet, PC, Mobile APPS) - Global Trends, Opportunities, Competitive Landscape and Forecasts Till 2016".    Wireless health comprises of advanced sensor technologies, wireless communications, and information technologies which aims at providing a better healthcare delivery. With affordable wireless information and communication technology and availability of inexpensive wireless-based laptops, portables and CD-ROM-based problem resolution and diagnostic technology, the value of wireless technology is clearly seen in improving service productivity, efficiency and profitability. Though healthcare organizations have been slow to embrace wireless technology, more and more organizations are finding that they can save money and improve care with this technology, and as it eliminates the need for wired connections, it increases mobility of the patients and healthcare professionals, invariably improving treatment outcomes. The global wireless health market is estimated to grow at a CAGR of 19.43% during the study period (2011-2016).   In this report, the wireless health market is segmented on the basis of wireless technologies, handheld devices and mobile apps across their applications in healthcare amenities (hospitals, nursing homes), pharmaceuticals, medical and diagnostic laboratories, home care, telehealth and by physicians; through various geographies. North America led the global wireless health market with around 45% share in 2011;rising cost of healthcare and increasing demand for better healthcare services has lead to the adoption of advanced wireless solutions. In addition, American Recovery and Reinvestment Act and U.S. healthcare reforms are boosting the adoption of healthcare IT systems.   The U.S. captures the largest market share of North America, and shows a remarkable growth opportunity. The second largest market is Europe, and Asia-Pacific is the fastest growing region with China capturing the largest market share of APAC region.

Hematech Biotherapeutics: hematology drug development in Taiwan

ProMetic and Hematech Biotherapeutics Close $10 Million Orphan Drug License and Strategic Manufacturing Deal  Press Release: ProMetic Life Sciences Inc. – Mon, May 7, 2012   ProMetic Life Sciences Inc. (PLI.TO - News) ("ProMetic" or the "Corporation") and Hematech Biotherapeutics Inc. ("HBI") announced today the signature of definitive agreements for the co-development and co-exclusive commercialization, on a world-wide basis (excluding China), of a plasma-derived biopharmaceutical product targeting a rare medical condition ("Orphan Drug"). The deal includes the granting of manufacturing rights by ProMetic to HBI of plasma-derived biopharmaceuticals using ProMetic's proprietary PPPS(TM).   The $10 million from HBI will fund the Orphan Drug's development program up to regulatory approval; a $1 million upfront payment followed by $9 million staged payments to ProMetic related to defined development milestones. $5 million of the development fees are expected over the course of the next 15 to 18 months leading to the filing of an IND in the second half of 2013. Following the completion of clinical trials and regulatory approval, the Orphan Drug will be commercialized jointly by ProMetic and HBI on a global basis (excluding China), with both parties sharing profits equally. The Orphan Drug will be manufactured by ProMetic in its Laval facility and in HBI's planned facility in Taiwan.   The deal includes a strategic alliance providing HBI rights to ProMetic's proprietary PPPS(TM) as well as training and technical support to manufacture plasma-derived biopharmaceuticals in a Taiwanese facility to be built and operated by HBI. Under this strategic alliance, HBI will fully fund the construction and operating costs of the new cGMP plant dedicated to manufacture plasma-derived therapeutics for ProMetic and its licensees. The core cGMP manufacturing area of the facility in Taiwan will be based on the same design as ProMetic's own Laval facility. Pursuant to this alliance, the two companies will synchronize the construction of this Taiwanese manufacturing facility along with the advancement of other plasma-derived therapeutics currently under development by ProMetic and its other licensees.  "This strategic relationship will provide Hematech and ProMetic with a valuable biopharmaceutical product with excellent market potential as well as a world class manufacturing facility implementing ProMetic's proven manufacturing platform," stated Dr Chan, M.D., Chairman of HBI. "We are pleased to see our financial resources and extensive experience in the manufacturing of biopharmaceuticals contributing to leverage the strategic fit between our two companies. The competitive advantage provided by ProMetic's manufacturing platform will certainly create value for Hematech as it pursues its goal of marketing high-value, niche products targeting unmet medical needs", added Dr. Chan.  "We are privileged to have access to the wealth of experience brought on board by Dr Chan and his colleagues at Hematech. Under Dr Chan's leadership as Chairman, Adimmune Corporation in Taiwan successfully built the first commercial vaccine facility in Asia meeting European Medecines Agency ("EMA") standards", mentioned Dr Tom Chen, ProMetic's Senior Vice President Product and Asia/Pacific Development. "Both parties will mutually benefit from their respective extensive industry expertise", added Dr Chen.   "The combination of our sizeable investments to develop our manufacturing platform, our strategic decision to set up our own plasma manufacturing facility as well as the recent successful scale up of our process in China were all instrumental in securing this strategic partnership with HBI" mentioned Mr. Pierre Laurin, ProMetic's President and Chief Executing Officer. "This transaction capitalizes on our mutual synergies and common commercial visions", added Mr. Laurin.   

About Orphan Drug  An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public policy in many countries, and has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development. Orphan drugs generally follow the same regulatory development path as any other pharmaceutical product, in which testing focuses on pharmacokinetics and pharmacodynamics, dosing, stability, safety and efficacy. However, some statistical burdens are lessened in an effort to maintain development momentum.   

About the Plasma Protein Purification System  The Plasma Protein Purification System (PPPS(TM)) allows for the targeting and removal of multiple high-value proteins from a single plasma sample at unprecedented activity levels using ProMetic's Mimetic Ligand(TM) adsorbent technology. This system also provides for the recovery of new biotherapeutics as they are discovered and identified. The effect of this process is to reduce the significant losses incurred when using the more conventional Cohn precipitation process. 

About Hematech Botherapeutics Inc.   Hematech Biotherapeutics Inc. is a privately held biotechnology company with headquarters located in Taipei, Taiwan. Hematech Biotherapeutics Inc. is extensively involved in the sponsorship, development and production of therapeutic drug particularly in the area of hematology. Hematech Biotherapeutics Inc. maintains an extensive collaborative network with industrial partners and is committed to the development of safe, high-quality, and low cost therapeutics drug. Major shareholders of Hematech Biotherapeutics Inc. include a key supplier of vaccines and a medical service and logistics company in Taiwan. Both companies are publicly listed in Taiwan. 

About ProMetic Life Sciences Inc.   ProMetic Life Sciences Inc. (www.prometic.com) is a biopharmaceutical company specializing in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand(TM) technology. This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in therapeutic drug development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of hematology and cancer. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic "drug-like" protein mimetics. Headquartered in Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and business development activities in the U.S., Europe, Asia and in the Middle-East.