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Wednesday, May 18, 2011

反海外腐敗法(Foreign Corrupt Practices Act)監控美國藥廠國外賄絡行為

藥業新藍海 臨床試驗問題多(下)

立報2011-05-17羅氏藥廠(Roche Holding AG)執行長舒萬(Severin Schwan)前陣子走訪巴西及中國的醫院後表示,好幾年前在國外的新興市場進行藥物試驗時,確實會引起不少人擔憂,但現在已經改善許多。舒萬肯定國外的藥物臨床試驗,讓更多病患參與是好事一件,而且人種變得更多元。瑞士的羅氏藥廠是全世界最大的肺癌藥物製造者,舒萬表示:「如果我們的全球試驗中,沒有將某一部分的人給納進來,部分國家可能就會暫緩對某些藥物的同意。」人種議題在藥物測試中相當重要,科學家可藉此發現細微的基因差異,並瞭解藥物是否適合某一特定族群。阿斯特捷利康的肺癌藥物艾瑞莎(Iressa)便是一例,整體說來艾瑞莎對西方病患無效,但對亞洲人卻有效,這類的發現對於解決全球疾病問題而言相當重要。歐洲癌症學會主席克爾(David Kerr)表示,全球性的藥物試驗有助於進行不同人種之間的比對,藉由基因差異的瞭解來辨識不同的生物標記。藥廠公司之所以追求臨床試驗的全球化,主要因素可歸納成兩點:時間及金錢。在時間上,製藥產業有藥品專利到期問題,如果藥廠能減少6個月的時間在藥品發展,改將心力放在銷售時,可額外多賺取數億美元。在金錢上,藥廠在遙遠國度進行試驗的原因是為了降低成本。葛蘭素史克藥廠前執行長加尼耶(Jean-Pierre Garnier)曾在《哈佛商業評論》(Harvard Business Review)中進行估算,中型公司如果需要6萬名病患來進行臨床試驗,將其中半數試驗移至低成本國家(如印度及拉丁美洲)進行時,一年可省下6億美元。在印度頂級的醫療中心內,需投注1,5002,000 美元在每名病患身上;但在美國的二等醫療中心內,一個人要花費2萬美元。塔夫斯藥品開發研究中心(Tufts Center for the Study of Drug Development)的蓋茲(Kenneth Getz)卻有不同計算結果,他認為海外試驗約可減少一半成本,而如果在許多國家同時進行研究,成本還會再增加許多,所以藥廠的獲利情形沒有加尼耶所說的如此龐大。

藥價將加強監控  除了顧慮公眾形象及保持廠牌信譽,藥廠必須兼顧到法律問題。美國司法部加緊調查藥廠在國外是否涉及《反海外腐敗法》(Foreign Corrupt Practices Act)所禁止的賄絡行為,醫生在許多國家中屬於政府雇員,若支付給醫生的款項高出公平市價,將被視為是賄絡。英國今年7月也將引進新的《反賄賂法案》(Bribery Act),英國政府將監控海外的藥價支付金額是否合理。倫敦的歐盟藥物管理署(EMA)及華盛頓的美國食品暨藥物管理局(FDA)目前也加緊監督,避免在海外所進行的醫療試驗有遵守法規,蓋茲期待EMAFDA在今年能稽核更多試驗場所。但EMAFDA的團隊規模太小,調查行動成果將相當有限。面對成千上萬種正在進行的試驗,他們無法全面監控。在EMA負責執法及督察的史威尼(Fergus Sweeney)表示,他現在必須花費更多時間處理外國臨床測試問題,但他承認,EMAFDA所能監督到的臨床研究只是冰山一角。

中國設置 臺灣農民創業園

招商引資促農民就業 石林鎮勞務經濟或增2000

 2011-05-18  (昆明日報)臺灣農民創業園的落地建設,促進了全鎮經濟的快速發展,大量的農村富餘勞動力從第一產業到第二、三產業轉變。今年石林鎮要實現新增農民轉移就業3184人,勞務經濟收入超過2474萬元。"現在已經在石林本地招了257人了,占公司總招聘人數的52.7%,還需要水電工、服務員、草坪養護等工作人員100多人。等會所建設結束後,還有用工的需求。"在石林鎮及台創園2011年農民就業工作會議上,石林太和公司這樣表態。

全鎮無零就業家庭  近年來,石林鎮招商引資企業不斷增多,臺灣農民創業園的落地建設,促進了全鎮經濟的快速發展,大量的農村富餘勞動力從第一產業到第二、三產業轉變。石林鎮社保所相關負責人表示,去年該鎮與企業溝通,組織了"送水就崗"及落戶企業3場專場招聘會,為當地農民提供了球童、綠化工、康樂服務、家政府服務等就業崗位350多個,錄用人員共達263人。同時收集了上海富士通將軍有限公司、上海巨騰電子有限公司、江蘇無錫松下能源有限公司、江蘇富士康科技集團富益電子科技有限公司等多家外地企業600多就業崗位。組織了20多人到江蘇洪澤、無錫,廣東佛山等地務工。2010年,石林鎮共完成各種培訓5337人,其中,滇東現代煙草農業示範區技能培訓245人,滇東現代煙草農業示範區引導性培訓890人,農村勞動力技能培訓935人,農村勞動力引導性培訓3654人。農村勞動力轉移就業3554人,實現城鎮新增就業240人,全鎮無零就業家庭。

今年新增轉移就業3184  由於有很多農民不願意離開石林到外地打工,石林鎮積極研究制定失地農民、貧困農民、台創園及招商引資落地企業所在地農民轉移就業等方面的政策措施。據介紹,今年石林鎮將開展農民轉移就業培訓4110人,其中,完成農民轉移就業技能培訓750人,引導性培訓3360人;實現新增農民轉移就業3184人;農民勞務經濟總收入達到9188萬元,其中,新增農民轉移就業勞務經濟收入超過2474萬元。

訂單式培訓促進就業  石林太和、春喜集團、石林統一千州農業科技公司、聖火藥業杏林國際度假村等落地企業紛紛表態,將建立起對當地農民的優先錄用的機制,同時提出了"組織農民前期培訓,招收後能儘快上手"、"訂單式服務"、"用工方面多給予支持"等要求。石林統一千州農業科技公司負責人表示,該公司以種植煙草和香草為主,長期管理人員達到了150人,還有季節性用工需要300人左右,目前大部分員工均來自石林本地。"有部分員工招收以後需要進一步的培訓,如果之前做過培訓,能直接上崗就更好了。"石林鎮副鎮長畢志峰介紹,由於石林氣候宜人,本地人大都不願意到外地務工,勞動力就地轉移就成為了工作的重點。因為大部分企業都希望招收能直接上崗的人員,因此現在石林鎮正積極組織失地農民進行培訓,"我們先去企業瞭解需要什麼樣的人才,再回來按需培訓農民,實現訂單式服務。企業對此十分歡迎,農民也很高興,擁有了技術就有了選擇的權利。"

中國養生園區: Shenghuo Pharmaceutical(昆明聖火藥業) building Xinglin International Health Care Resort

Yunnan Shilin To Build Health Care Resort

May 19, 2011  Shilin in Yunnan province is making CNY1.06 billion available for building the Xinglin International Health Care Resort in Shilin Imbark Park for Taiwan Farmers. This program is invested in by China Shenghuo Pharmaceutical Holdings Inc, and will develop the leisure and health care market based on Shilin's tourism resources, the company's advantages and traditional Chinese medicine. The whole program will include one park and four areas: a Chinese medicine expo park, a plantation area, a health care and leisure area, a health care and holiday area, and a hotel area. All these functions will reflect the culture of traditional Chinese medicine.

比較中國眾多生技高新園區戰略 思考台灣生醫的藍海機會??

馬總統 歡喜替生醫園區剪綵

2011/05/19 聯合報】新竹縣竹北市「新竹生物醫學園區」昨天再度剪綵,總統馬英九高興地說「生物科技有家了!」總統表示,政府已決定不在彰化蓋國光石化,希望生醫園區不僅「多一個科學園區」,要「多一個生技產業」。新竹生醫園區在2003年就經行政院核定。馬英九坦言,生醫園區在建與不建之間「有一點延宕、有一點反覆」,昨天終於成立「生醫科技與與產品研發中心籌備處」,也同時啟用生技大樓。行政院院長吳敦義指出,生醫研發、生物科技「現在很夯、最夯」,在這個世紀是繼續帶領台灣航向世界的原動力。新竹生醫園區佔地卅八公頃,規畫三大中心:由國家科學委員會主導生醫科技與產品研發中心、衛生署主管園區醫院、經濟部設立產業及育成中心。目前有十家廠商申請進駐新竹生醫園區,聯合骨科器材、百丹特生醫、國璽幹細胞、竟天生技、紅電醫學和暐正生技等六家已獲准。總統馬英九昨天主持新竹生醫園區研發中心暨生技大樓啟用典禮時,與生物醫學園區(設在高鐵特定區內)相連的璞玉開發計畫的地主們,贊成與反對的各據一方喊話。

杏輝(杏國生技) 的”菜花策略”!! 影響深遠 !!

杏輝集團獲德國MediGene植物新藥在台獨家製造與銷售權

2011518 杏輝醫藥集團子公司杏國生技公司18日獲得德國MediGene公司研發上市的處方新藥Veregen的技術授權與原料供應合約,取得技術移轉和在台獨家製造與銷售。該產品的主要組成來自於綠茶萃取物,用以治療人類乳突病毒 (human papilloma virus, HPV)所引起的生殖器疣(俗稱菜花)的外用軟膏,是美國FDA第一張核准植物新藥,且為唯一中草藥新藥執照在台銷售。杏輝指出,這項合作議定,預計將對杏國生技在新藥開發的經驗植入與市場開發、營收帶來重大影響。杏輝說,生殖器疣(俗稱菜花)是一種具感染性且不易治癒的常見性病,據統計,國人每10萬人就有1871人罹患,是性病中盛行率最高的。治療此病的外用藥膏,目前健保不給付需自費,平均每兩天要花350元,必須使用3個月,因此很多病患未治療完全即放棄。 Veregen在歐美等多國進行臨床試驗,發現治療期間至16週或全部治癒為止,其治癒效果都高於市售品,藥效明確且幾乎無副作用,因而在2006年獲FDA全球第一個核准上市的植物新藥,至今仍為唯一核准中草藥新藥。杏輝表示,其象徵意義為以中草藥或天然植物開發出植物性醫藥品,已漸成國際發展趨勢,而本項目在台授權杏國生產製造,對中草藥新藥的開發及台灣醫藥產業未來的發展也有指標作用。杏國生技是杏輝醫藥集團旗下的研發型子公司,所研發的抗癌新藥SCB01A已通過美國FDA及台灣衛生署核准第一期人體臨床試驗,預估兩年後完成;杏國另有其它多項研究計劃將陸續向美國FDA及衛生署申請新藥臨床。杏國在簽下本項生產與銷售授權契約後,預估兩年內在台上市,將一躍成為新藥開發與銷售並重的生技公司。

用一棟生技大樓 區分陳水扁與馬英九??

馬:生技替代石化

2011-05-19 工商時報   馬英九總統昨(18)日參加新竹生物醫學園區生醫研發中心成立暨生技大樓啟用典禮時表示,政府已決定不再開發國光石化,期望生物科技成為一項替代的重大產業,更期許生醫園區的啟用,不只是多一個科技園區,而是多一個科技新產業。馬總統表示,2年前金融海嘯期間,全球都意識到金融海嘯後的世界,產業一定會重新洗牌,其中生物科技更是不能放棄,一定要大力推動的產業。因此在政府推動的6大新興產業之中,生物科技產業排名一向都名列前矛。馬總統指出,政院正推動「台灣生技起飛鑽石行動方案」,投入240億預算開發新藥、創投,積極建立生技上游到下游整合產業鏈。另外,衛生署也成立食品藥物管理局專責管理,另有生技創投及超級育成中心的設立開發新藥和醫材。馬總統並表示,政府已經決定不在彰化開發國光石化了,很多人會問,未來產業投資怎麼辦,他希望生物科技能成為一項替代的重大產業。雖然生物科技產業的特色是投資大、風險高、獲利遲,但另一個特點是爆發力強,可以3年不開張,但開張後不只吃3年,是一項值得我們投入的新產業。馬總統也強調,台灣的生技產業,在研發方面有中研院與國衛院的投入,創投方面,台大、榮總也和全球前5大藥廠合作,加上政府投資200多億在生物科技產業,一步一步朝準備好了的目標邁進。新竹生醫園區的生醫科技大樓,主要提供以研發為主(非量產)廠商、研究中心或實驗室進駐,目前已核准10家生醫廠商,並有國璽幹細胞、聯合骨科器材等6家廠商正式進駐。科管局指出,研發中心未來將引進國家實驗研究院、工研院等團隊進駐,其中國研院致力於整合所屬動物、儀科、晶片、奈米、國網及政策等研究中心能量,可望創造下一波生技產業契機。

不法醫美醫療行為 應加強消費者認知與教育!

醫美診所 檢舉困難

2011/05/18 聯合報】醫美診所雇用護士違法施打雷射踢爆事件,顯示了現行法律與制度下,醫美診所不法醫療行為檢舉的困難。北市衛生局醫護管理處副處長陳青梅表示,去年衛生局曾大規模普查北市133家雷射及微整型診所。但依造行政罰法第33條,公務人員在執行職務前,需先出示證明文件及表明來意。「往往我們一出示證件後,對方東西收的收,動作變得變,很難抓到什麼」

杏國與MediGene合作 技轉授權金將轉嫁於原料藥

杏輝植物新藥 商機2

2011/05/19 經濟日報】 杏輝(1734)昨(18)日宣布,其子公司杏國已獲得德國MediGene公司處方新藥Veregen技術授權與原料供應合約,這項藥品是美國食品藥物管理局(FDA)唯一核准上市的植物新藥,預期可搶攻每年2億元以上市場商場。杏輝昨日股價以33.5元作收,上漲0.2元。杏輝今年第一季稅後純益約2,100萬元,每股稅後純益為0.81元,較去年同期衰退。法人表示,杏輝今年整體營收可望成長一成。杏輝表示,這項治療藥品主要是用來治療俗稱菜花的「人類乳突病毒」,由德國MediGene公司獨家授權杏國在台生產、銷售,技轉授權金將轉嫁於原料藥中,約一年後將開始買進原料。杏輝表示,昨日簽約完畢後,已經向我衛生單位申請藥證,最快在一年半後將可上市銷售,目前,杏輝積極通路布局,未來將在醫院、診所及藥局等通路銷售。據統計,在台灣每10萬人就有1,871人罹患乳突病毒,為性病中罹患率最高的類別,該產品目前健保並不給付,平均每兩天須花費350元,必須連續使用三個月,杏國將產品推到市場後,推估每年市場銷售額2億元以上。專家指出,Veregen藥效明確且幾乎無副作用,在2006年獲得美國FDA核准上市,為全世界唯一通過FDA許可的植物新藥,該新藥在全球市場規模達100億元,杏國獲此代理權,在市場具有指標性意義。

Taiwanese beauty products win recognition in China

2011/05/18 Taipei, May 18 (CNA) Cosmetics distributors in China said Wednesday they are huge fans of Taiwan-made beauty products because of the quality. At the China Beauty Expo that opened in Shanghai Wednesday, procurers said Taiwanese products are more attractive than other foreign brands because the quality is guaranteed and the products are designed exclusively for Asians. A Chinese buyer surnamed Wang said he was also impressed by Taiwan's frequent use of brand spokespersons in its sale campaigns. For example, a Taiwan-made tooth powder attracted much attention at the expo because Taiwanese superstar Barbie Hsu, better known as "Big S," had recommended it in her book, he noted. Some 30 Taiwanese brands, including Maywufa Company, Allied Industrial Corp. and China Chemical & Pharmaceutical Co., are displaying a variety of products such as medical cosmetics, makeup and beauty equipment at the expo that will run through May 20.

化妝品警察? 另一種噱頭 ?

眼霜=較貴面霜 美作家新書破除迷思 

2011/05/18台北報導〕暢銷書「美麗聖經」作者、素有化妝品警察之稱的寶拉培岡,昨日在台舉行新書發表會。她這回又直指,眼霜只是「容量少了一半、價格卻變成兩倍」的面霜,是「化妝品公司想出來的搶錢奇招」。

批化妝品公司的搶錢奇招  眼霜常是保養品中最昂貴的品項,多數女性相信,眼霜是專為眼周肌膚所調配。不過,寶拉培岡表示,有些眼霜甚至沒有防曬成分,白天單獨使用,反而可能因紫外線傷害,長出細紋。寶拉培岡說,沒有任何證據或文獻能證明眼霜具有特殊配方、必須要從面霜獨立出來。雖然有些專家會說︰「眼周肌膚較為敏感,不能使用含有刺激的成分。」其實不管臉部或身體其他皮膚,也都該用成分好的保養品。至於該怎麼保養皮膚才對?她表示,要保護皮膚外在的防護層,一定要戒菸、避免非必要的直接日曬。不過眼霜究竟是不是化妝品公司的行銷手法?皮膚科醫師則有不同意見。

台大醫師:眼霜抗菌需求高 台大皮膚科教授蔡呈芳認為,單從有效成分來看,或許眼霜成分真的跟面霜沒有太大差別,但眼睛仍有其特殊性,眼霜跟面霜還是有些不同要求。例如,眼睛附近皮膚吸收性比較好、易刺激、易過敏,眼霜產品需要比較濃稠,以免流動滲到眼睛裡面去,抗菌需求也更高。長庚醫院皮膚科鐘文宏醫師指出,從有效成分含量來看,眼霜跟一般面霜的定價確實不成比例,甚至有些成分可能還比保養品低。「如果你問我,面霜可不可以擦在眼睛周圍?我覺得,當然可以。」

醫美業者:精華液也可塗眼周  醫美品牌保養品DR.WU的創辦人吳英俊醫師則表示,眼周肌膚彈性、角質厚度、吸收度等,都與臉上其他區域不同。眼霜是另一種服務的概念,其效果比不上醫學美容,但也不能說沒有存在價值。不過「消費者要將精華液用在眼周保養,我們也不會反對。」

Taiwan Hsinchu Biomedical Science Park: NSC, DOH, MOEA participate in organization

President voices hope for biotech industry

2011/05/18 Taipei, May 18 (CNA) President Ma Ying-jeou expressed hope Wednesday that the biotech industry will become the nation's next high-tech industry following the recent scrapping of a controversial petrochemical project. Speaking while presiding over the inauguration of a biomedical research and development center at the under-construction Hsinchu Biomedical Science Park, Ma was referring to the multi-billion dollar Kuokuang Petrochemical Project, originally scheduled to be built in a wetland area of central Taiwan's Changhua County, but later scrapped because of stiff opposition by environmentalists. "We hope the inauguration will represent the start of another major high-tech industry," Ma said. The science park's plan is for three centers to be established. Wednesday's inauguration was for a biomedical technology and product R&D center planned by the National Science Council. The other two centers -- a hospital to be set up by the Department of Health that will be in charge of clinical experiments and serious disease care, and an incubation center to be set up by the Ministry of Economic Affairs -- have yet to be completed. The government has been planning the park since 2003, but has suffered delays and setbacks for many years. Ma noted that when he visited the planned park as recently as October 2008, it was still just a vacant lot, and he expressed happiness that the project has finally got off the ground. "Biotech is the star industry of the 21st century. With the recent scrapping of the Kuokuang investment project, biotech will have to step in to take the place of petrochemicals as a leading industry," Ma said. He said that Academia Sinica, Taiwan's highest academic institute, and National Health Research Institutes, have already achieved good results in basic research of biomedicine and medical equipment development. In addition, Taiwan National University Hospital and Veterans General Hospital introduced French technology as early as 1984 to develop hepatitis vaccines, he went on. The two hospitals have also been in cooperation with the world's five top pharmaceutical companies, the president noted. These, coupled with government investment of more than NT$20 billion in biotechnology, have made the biotech field an ideal one for the nation, Ma said. Meanwhile that same day, supporters of the park and those opposed confronted each other. Those opposed to the biotech park said that the world has entered a period in which there is insufficient food and that the government should not requisition more farmland for urban development. One protest banner proclaimed that "the government has become a bandit." The supporters, on the other hand, carried banners reading "no development, no progress." Police were mobilized to keep order, but due to prior coordination, the two camps restrained themselves from shouting at each other while the president was speaking.

竹北生醫園區生技大樓落成 成就未來台灣生技醫藥?

總統盼生技產業大步起飛

2011-05-18 【中央社】 國科會新竹生物醫學園區今天舉行生醫研發中心成立暨生技大樓啟用典禮。馬總統表示,期待生物科技替代國光石化成為新產業,今天的啟用不只多一個園區,而是多一個科技產業。 國科會指出,「新竹生物醫學園區計畫」為「愛台十二建設」中產業創新走廊計畫之一,並列入「台灣生技起飛鑽石行動方案」中,是馬英九總統上任後關切的重要新興產業。 生醫園區內共規劃三大中心,今天啟用的生技大樓為國科會統籌設置的生醫科技與產品研發中心,同時宣布該中心成立。今天包括行政院長吳敦義、政務委員朱敬一、新竹縣長邱鏡淳及公共工程委員會主委李鴻源等人都與會。 衛生署的新竹生醫園區醫院負責臨床實驗與重症醫療,經濟部設置的產業及育成中心負責商品化工作,這兩個中心尚未落成。 馬總統致詞時表示,民國971025他到現場時,還是一片平地,當時他特別要求要儘速興建,後來進度上是有延宕;然而生物科技是21世紀的明星產業,台灣也早在1984年就由科技政委李國鼎找來台大與榮總引進法國技術,開發肝癌疫苗。 他並說,生物科技也是政府推動的六大新興產業中名列前茅的產業,行政院還推動「台灣生技起飛鑽石行動方案」,包含投資新台幣 240億元開發新藥、創投等,要從上游到下游整合產業鍊,衛生署也成立食品藥物管理局專責管理,還有生物科技創投及超級育成中心的設立。 為推動生技產業,他說,甚至調降營利事業所得稅,打造與鄰國媲美的投資環境;投注的研發經費也以占GDP(國內生產毛額)3%為目標,每年並要成長8%10%馬總統說,國光石化已不再開發,希望生物科技成為替代產業,而台灣的研發已有中研院與國衛院的投入。創投方面,台大與榮總也與世界前5大藥廠合作,加上政府已投資200多億元在生物科技上,相關條件已具備。他強調,雖然此產業投資大、風險高、獲利遲,但爆發力強,而洛桑管理學院最新競爭力排名,台灣已進步2名,來到世界第6名,如今透過人才與產業的結合,期望今天大樓的啟用,不只多了一個科技園區,而是要多一個科技產業,帶領台灣再進步。

鄭誠功出任”生醫科技與產品研發中心籌備處”主任

生醫園區啟用 新竹璞玉居民陳情

新頭殼newtalk 2011.05.18   新竹生物醫學園區今(18)日舉行生醫研發中心成立暨生技大樓啟用典禮,邀請總統馬英九及行政院長吳敦義等人到場剪綵及揭牌,由於現場出現新竹縣璞玉計畫支持與反對兩派民眾較勁,讓活動添增緊張氣氛。新竹縣反對璞玉計畫 (新竹縣台灣知識經濟旗艦園區開發案)的民眾今早前往陳情,在生醫園區旁,頭戴綁著「圈地惡法立即停止」黃絲帶的斗笠,拉白布條抗議,並高喊「官商勾結,踐踏農地」、「政府變強盜」、「馬總統縱容邱鏡淳」、「搶民地逼民反」等。據竹北璞玉自救會陳請指出,根據新竹縣政府網站9日所公告的新聞稿指出,「台灣知識經濟旗艦園區特定區計畫」已於427召開之新竹縣都委會決議,報請送內政部都委會接續審議。此舉公然違背馬英九於去年1010國慶的政策宣言:「…今後對於土地開發或徵收,政府必須多傾聽民意…」。竹北璞玉自救會表示,由於國立交通大學與中央及新竹縣府官員任意曲解法令,強取農田,因此,竹北璞玉田居民堅決反對「台灣知識經濟旗艦園區特定區計畫」的區段徵收,堅持「維持現狀,永續務農」。並請馬英九重視中華民國憲法第15條所賦予當地居民:「人民之生存權、工作權及財產權,應予保障。」要求相關政府單位立即撤銷該案,立即停止「交通大學竹北園區」與「IC/SOC研發設計園區」等設立與規劃。但吊詭的是,今天另有一群支持璞玉計畫的民眾在旁搭棚子,並懸掛「支持生醫園區璞玉整體開發」、「開發璞玉就有選票」、「要求盡速開發璞玉」及「璞玉若再延宕選票就不漂亮」等紅布條,表達支持的意見。由於新竹縣支持與反對璞玉計畫兩派民眾同時在生醫園區旁較勁,警方出動多名警力維持秩序,讓該啟用活動增添緊張氣氛。新竹生醫園區由竹科管理局負責營運,今天啟用的生技大樓預定包括工研院、竟天生物科技園區分公司、國璽幹細胞應用技術–新竹生醫園區分公司和紅電醫學科技等進駐。 另隸屬國研院的「生醫科技與產品研發中心籌備處」,也於今天成立,籌備處主任由陽明大學教授鄭誠功出任,將配合政府發展生技產業政策,整合院內動物、儀科、晶片、奈米、國網及政策等研究中心能量,建構數項生醫研發服務平台。

馬英九意識到台灣生技醫藥”產業人才”侷限

生醫研發中心成立 馬期許生技替代石化業

 2011/05/18 聯合晚報】延宕多年的新竹生物醫學園區,今天再度舉行剪綵典禮,總統馬英九上午出席生醫研發中心成立暨生技大樓啟用典禮時表示,期待生物科技替代國光石化成為新產業,從今天開始,我國將不只多一個科技園區,更多了一個科技產業,科技產業也將帶領我國經濟前進21世紀的全球競爭場域。新竹生物醫學園區早在民國92年就開始籌設,但過程風波不斷,光是為了要由哪個機構主導,就花了很長一段時間。民進黨執政期間,園區雖仍是一片荒煙蔓草,但當時陳水扁總統就曾前往剪綵過;如今過了34年,馬總統又到場剪綵,不同的是多了一棟生技大樓。儘管如此,馬總統今天還是表示欣慰,他坦言當年為了建與不建,就有很多不同聲音,開發時程也出現延宕,但從他民國9710月視察現場後,即加速趕工,如今終有成果。他強調,生物科技是21世紀的明星產業,不久前政府決定不在彰化大城鄉投資國光石化後,生物科技將成為替代的產業。他說,翁啟惠及伍焜玉領軍的中央研究院、國家衛生研究院,在生物醫學基礎研究及醫材開發都有很好的成果,而我國的創投能量又高居全球第二位,僅次於美國,台灣生技產業將有很好的機會。更何況,台大醫院及台北榮民總醫院近年來又積極和全球五大藥廠合作,不斷創造臨床研究條件,未來將可一步一步往目標邁進,讓我國生技產業發光發熱。但他也說,較讓人擔心的是,我國目前每年有38000多名生物科技相關科系的學生畢業,但只有10分之1投入生技產業,其餘都分散到其他產業發展,相當可惜。他期望新竹生物醫學園區開始運作後,專業人才可以回到這個領域,帶領我國生技產業往前衝。對於這個新興的明星產業,馬總統也說「既愛又怕」,因為這是個投資大、回收慢卻又獲利高、爆發力強的產業,「三年不開張,開張吃三年」,只要人才到位了,一定可以大放異彩。他也說,期許國內出現一位生技界的李國鼎,帶領生技產業大步邁前,把生技產業打造成為台灣競爭力最重要的一環。

竹北生醫園區將如何整合署立新竹及竹東醫院資源??

新竹生醫園區 等十年終啟用  

2011/05/18 聯合晚報】新竹生物醫學園區的生醫研發中心及生技大樓,今天分別舉行成立及啟用典禮,這個延宕近十年、一度被看衰差點胎死腹中的園區,終於邁出第一步。「新竹生物醫學園區計畫」是國家「愛台十二建設」中產業創新走廊計畫之一,後來更列名「台灣生技起飛鑽石行動方案」的一環,園區位於新竹縣竹北市,剛好位於高鐵新竹站旁,交通相當方便。園區佔地38公頃目前規畫三大中心,分別是國科會主導的生醫科技與產品研發中心、衛生署負責的新竹生醫園區醫院、經濟部運作的產業及育成中心。今天揭幕的生技大樓,規畫有50100200的標準廠房共36個單元,提供以研發為主的廠商、研究中心或實驗室進駐,至今已有10家廠商提出申請,其中6家獲准進駐,分別是製造人工關節的聯合骨科器材、研發人工植牙植體的百丹特生醫、研發肝病治療藥物的國璽幹細胞基因技術、竟天生物科技、紅電醫學及暐正生物科技等。至於國人相當關切的新竹生醫園區醫院,已確定由台大醫院接手。今年71起,台大將把署立新竹及竹東醫院納入,全力運作。

Quantitative Fecal Hemoglobin May Predict Colon Cancer Risk

May 17, 2011 — Quantitative fecal hemoglobin concentration at first screening predicts the subsequent risk for incident colorectal cancer, according to the results of a prospective cohort study reported May 17 Online First in Lancet Oncology. "Despite widespread use of the immunochemical faecal occult blood test (iFOBT), little is known about the subsequent risk of developing colorectal neoplasia for participants with negative iFOBT results," write Li-Sheng Chen, PhD, from the School of Oral Hygiene, College of Oral Medicine, Taipei Medical University in Taipei, Taiwan, and colleagues. "We investigated whether the concentration of faecal haemoglobin at the first screen is predictive of the subsequent incidence of colorectal neoplasia in those with a negative screening result." Within the Keelung community-based iFOBT screening program for residents who were aged 40 to 69 years between 2001 and 2007, the investigators used a cutoff fecal hemoglobin concentration of 100 ng/mL to define groups with negative and positive results for additional clinical testing. To identify cases of colorectal cancer, the investigators followed up on 44,324 participants with negative iFOBT results and 1668 with positive iFOBT results at the first screen, including 854 who refused colonoscopy and 814 with a false-positive iFOBT result as determined at colonoscopy. The association between baseline fecal hemoglobin concentration and the risk for incident colorectal cancer was determined after adjustment for possible confounders. During follow-up (median duration, 4.39 years; interquartile range, 2.53 - 6.12), the incidence of colorectal cancer increased from 1.74 per 1000 person-years for those with baseline fecal hemoglobin concentration of 1 to 19 ng/mL, to 7.08 per 1000 person-years for those with a baseline concentration of 80 to 99 ng/mL. Compared with baseline fecal hemoglobin concentration of 1 to 19 ng/mL, adjusted hazard ratios (HRs) increased from 1.43 (95% confidence interval [CI], 1.08 - 1.88) for baseline fecal hemoglobin concentration of 20 to 39 ng/mL, to 3.41 (95% CI, 2.02 - 5.75) for a baseline concentration of 80 - 99 ng/mL (P for trend < .0001). Inclusion of repeated iFOBT measurements did not affect these findings. The risk for incident colorectal cancer was highest for those who initially refused colonoscopy (adjusted HR, 8.46; 95% CI, 6.08 - 11.76). "Quantitative faecal haemoglobin concentration at first screening predicts subsequent risk of incident colorectal neoplasia," the study authors write. "During follow-up, risk stratification based on faecal haemoglobin could help clinicians, with particular attention being paid to those with higher initial faecal haemoglobin concentrations, especially those just under the threshold taken to indicate presence of colorectal neoplasia." Limitations of this study include fecal hemoglobin concentration unknown in 17.3% of the cohort, small number of false-positive cases, and difficulty comparing the findings vs those of previous studies. In an accompanying comment, Callum G. Fraser, from the University of Dundee, Scotland, United Kingdom, notes that these findings have important implications for the design of future screening programs. "Faecal haemoglobin concentration at baseline could provide a means for determining risk; low, intermediate, high-risk, and extremely high-risk groups could be defined, which would allow for individually tailored screening strategies," Dr. Fraser writes. "With modern information technology, flair, and imagination, risk-adapted strategies could be adopted in future screening programmes. New data on associations between faecal haemoglobin concentration and demographic characteristics should also affect programme design." This study has received no funding. The study authors have disclosed no relevant financial relationships. Dr. Fraser has received payment for consultancy work from Immunostics Inc and Alpha Labs Ltd. Lancet Oncol. Published online May 17, 2011. Abstract Extract

世基(Pharmigene) cooperates/competes with University of Washington

The University of Washington and Pharmigene Announce Licensing Agreement for Personalized Medicine Technology that Predicts Patients' Sensitivity to Warfarin

May 17, 2011 10:03 AM Eastern Daylight Time   SEATTLE & PALO ALTO, Calif.--(EON: Enhanced Online News)--The University of Washington Center for Commercialization (UW C4C) and Pharmigene, a leader in advancing personalized medicine and reducing severe adverse reactions to drugs through genetic-based diagnostic solutions, today announced the execution of a licensing agreement between the parties. The agreement settles a U.S. patent interference concerning previously competing applications that describe methods to determine proper dosing of the popular anti-coagulant drug, warfarin. Pharmigene is now the global licensee of VKORC1-1639 SNP related patents and application from both the University of Washington and Academia Sinica, Taiwan. Pharmigene now offers the most complete VKORC1-1639 SNP patent portfolio to drive development and commercialization of genetic tests that reduce warfarin-related adverse drug events. "The agreement between the University of Washington and Pharmigene will clear the path to providing technology that will improve the health and well-being of patients the world over" Previous studies have shown that leveraging patient genetic information, such as the variances in the VKORC1-1639 gene, can reduce hospitalization rates by almost one-third for patients taking the anti-coagulant drug. Each year, with several million people worldwide starting on an anti-coagulant therapy, the combination of warfarin with genetic testing promises improvements in patient care and represents enormous savings for healthcare systems. "The agreement between the University of Washington and Pharmigene will clear the path to providing technology that will improve the health and well-being of patients the world over," commented Dr. Luke Chen, CEO of Pharmigene. "Assisting doctors in quickly determining the proper dosage of warfarin for their patients will prevent a number of dangerous outcomes, improve the patient's care, and minimize risks for doctors," he added. "This deal between Pharmigene and UW C4C represents a positive outcome for both parties, resolving a complex IP rights situation, and allows for the further development of the market for this valuable diagnostic test. The wide adoption of this test will undoubtedly help physicians better manage a very real problem with a useful but potentially dangerous therapy," stated Dennis A. Hanson, PhD, technology manager at UW C4C.  Warfarin, an anti-coagulant (blood thinner), is prescribed for the prevention of blood clots, atrial fibrillation, or prosthetic heart valve replacement. The drug has a narrow therapeutic window, with the optimum dose for each patient varying widely. Warfarin can cause massive internal bleeding if too much is taken, but if too little is given during treatment, the drug may not have the desirable therapeutic effect. With the aid of the VKOR genetic testing technology, covered by patents and patent applications from the University of Washington and Pharmigene, a proper dosage for each specific patient can be determined quickly, and thus the likelihood of serious complications can be greatly reduced.

About the University of Washington Center for Commercialization (UW C4C)  UW researchers in hundreds of labs are making extraordinary innovations. As one of America's leading federally funded public research universities, UW is producing innovations that have the power to change the world—from biofuel alternatives, to more effective treatments for Alzheimer's disease and brain cancer, to purification technology for drinking water in the developing world. The Center for Commercialization (C4C) is committed to getting these research outcomes into products, services, therapies, diagnostics, and cures to where they can impact millions of people.

About Pharmigene  Pharmigene's mission (www.pharmigene.com) is to improve personal health and advance personalized medicine by providing genetic-based diagnostic solutions that enable individuals to become more informed about their genetic makeup and allow them and their healthcare professionals to make better health decisions. An example is a study involving executives of Pharmigene that was recently published in The New England Journal of Medicine related to detection of the HLA-B*1502 allele and patient treatment with carbamazepine, an anticonvulsant and mood-stabilizing drug. Pharmigene was founded in 2005 with exclusive worldwide intellectual property rights related to warfarin sensitivity and other adverse drug reactions from Academia Sinica in Taiwan. Currently Pharmigene has offices in Palo Alto, California, as well as offices and a research and GMP/ISO manufacturing facility in Taiwan.