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In an increasingly complex food regulatory environment, the new Swiss unit will centralize the company's global clinical trial work. By Joanna Cosgrove, Online EditorPublished June 14, 2012 It's been three years since Nestlé found itself on the losing end a 2009 decision by the U.S. FDA when it was deemed that the company's drinks for children were labeled with misleading health claims. In a show of carefully executed planning, the company had bounced back with the creation of a new Clinical Development Unit (CDU) in Lausanne, Switzerland, proving it's ready to meet not only the science-based requirements of the U.S. FDA but also the increasingly tough health claim challenges of European food regulatory system. The company's Clinical Development Unit (CDU) was created to manage its clinical trial endeavors, affording the company a more centralized workspace to "effectively and efficiently evaluate the impact of its foods and ingredients on human biology and health, as well as on taste and pleasure." Nestlé has a long history of clinical trial work and publication. Last year alone the company had more than 100 ongoing clinical trials and said it expected to carry out even more in the future. The CDU marks the first time Nestlé has consolidated the management of its global clinical trials program under one roof. "Our clinical development work ultimately provides the scientific evidence as to whether our ingredients, new products, and product reformulations are effective in delivering consumer benefits," commented Nestlé's Chief Technology Officer Werner Bauer via press release. "The new CDU is a strategic fit with our research and development commitment to provide innovative solutions for nutrition, health and wellness." Mr. Bauer went on to add that the CDU was a "strategic fit" to the Nestlé's research and development commitment in the areas of nutrition, health and wellness. The CDU will provide medical expertise in different therapeutic areas. It will also offer specialist knowhow in project management, data management and biostatistics – the use of statistics in the analysis of biological data. In an interview with Nutraceuticals World, Dr. Rafael Crabbé, the head of the new unit, said that given the difficulty associated with proving food health claims, Nestlé's CDU lays the groundwork for a more cohesive and unified approach to clinical trials. "Until now our clinical trials were managed by several different functions including the Nestlé Research Centre, Strategic Business Units (e.g. Dairy), Nestlé Nutrition, and locally by the markets," he said. "Our new CDU brings the management of these clinical trials under one roof, and streamlines the managerial process making it both more efficient and more effective." He also underscored the great importance of the clinical work he plans to oversee at the new unit. "We want to communicate the health benefits of our products, and clinical trials are a robust way of evaluating the impact of food and beverages on human health," he said. "In addition to our clinical trials, we constantly review the scientific literature to ensure that our claims are always science-based and meet the regulatory requirements." Because food health claims are often more complex to prove, Dr. Crabbé will no doubt draw on his past experience in the pharmaceutical industry as he leads the new unit. He told a Reuter's reporter Nestle scientists planned to follow the same standards and methodologies for trials as drug companies. "When it comes to showing specific health benefits, food is a complex environment. The benefits of food are more subtle, more complicated," he said. When asked by Nutraceuticals World which health claims and/or foods studies might be among the unit's top research priorities, Dr. Crabbé was mum on details. "Our top priority for the Clinical Development Unit is to strengthen the management of Nestlé's global portfolio of clinical trials. The Clinical Development Unit oversees many different types of clinical trials, including randomized controlled trials (double-blind and crossover)," he said. "In our trials, we include measurements of clinical biochemistry or physiological function, as well as tolerance and acceptability of diets and dietary compliance." Nestlé's CDU also houses a Metabolic Unit for metabolic studies in healthy people, as well in those with health conditions such as obesity, diabetes and osteoporosis.The unit has exercise equipment to test strength, speed and endurance, and specialist scanners for measuring bone density and body composition. It also has "indirect calorimetry" equipment for scientists to measure the energy people expend at rest and during exercise. It includes sensory booths, a kitchen and a dining area, and a clinical observation space for metabolic studies. 
Published August 1, 2012 NSF International has developed a new global protocol to assess whether an over-the-counter (OTC) pharmaceutical or prescription drug manufacturer complies with current Good Manufacturing Practices (cGMPs) as outlined in the Code of Federal Regulations (21 CFR 210 & 211).The new protocol, titled NSF P414-201x, Auditing Practices for the Assessment of the Manufacture of Over the Counter Drugs against Established GMP Standards, helps manufacturers understand which requirements must be met in order to produce OTC drugs, including pain relievers, nasal decongestant sprays, cough syrups, antacids and allergy medications. The protocol outlines requirements for personnel, building and facility maintenance, equipment, production/process controls, holding/distribution, laboratory controls, recordkeeping and packaging and labeling.Regulators and industry representatives, including the nation's largest drugstore chain, Walgreens, have championed the development of the NSF protocol. The OTC and prescription drug protocol is intended to be developed into an NSF American National Standard for OTC and prescription pharmaceuticals by NSF International, an independent organization that writes standards, and tests and certifies products for the food, water, nutritional, health and wellness industries, as well as consumer goods. NSF is currently forming a Joint Committee to develop the protocol."Customers and patients need to have complete trust in the safety of all medicine, whether prescription or over-the-counter," said Alain Turenne, director, product integrity, at Walgreen Co. "If there are industry gaps of any kind in monitoring, standard setting and quality control, we need to fill them. We are proud to be working with NSF International to continuously elevate our already strong standards for product safety and integrity."The new NSF regulatory-based protocol focuses on quality management and provides companies outsourcing manufacturing of drug products, including pharmacy retailers and others, with a means to qualify their pharmaceutical vendors and suppliers. Using a standardized auditing approach, the protocol establishes a grading scheme to ensure OTC manufacturers meet global GMP drug requirements through the inclusion of principles and guidance from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) as well as 21 CFR 210 & 211."The new NSF protocol for over-the-counter and prescription drugs builds on NSF's significant expertise in pharmaceuticals and dietary supplements and furthers our mission to protect public health," said Casey Coy of NSF International's pharmaceutical consulting arm NSF-DBA. "Vendor qualification is a crucial component for pharmacy retailers to ensure they receive high quality OTC and prescription drugs from their vendors and avoid potential recalls. The significant costs involved in a product recall are not only absorbed by the drug manufacturer but the retailer as well."
治癌因性疲憊新藥 在台上市 2012-08-06 01:00 旺報 【記者李蜚鴻／台北報導】 全球唯一專治癌因性疲憊症的懷特血寶注射劑新藥上市，懷特生技研發14年，從中醫典籍記載的補氣上藥黃耆，運用獨有的現代科技，加以萃取、分離及部分純化研製成懷特血寶注射劑，是全球唯一抗「癌因性疲憊」的處方藥，目前已在台上市，成為癌友抗癌新選擇。中央研究院彭汪嘉康院士說，癌因性疲憊是指癌症病人在治療過程中，生理、情緒與認知功能的持續耗竭，這類疲憊無法藉由休息而改善，據調查，它對患者的影響更甚於疼痛、暈眩與憂鬱。
投資12億 建新廠供需求 由於血寶注射劑市場成長動能強，需要一座新藥廠來滿足後續市場需求。美吾華集團懷特董事長李成家31日宣布，因應未來懷特新藥生產所需，懷特將於今年底前斥資10億到12億元，展開新藥製藥廠併購或自建新廠。血寶注射劑於2010年正式取得衛生署所核發台灣首張植物新藥藥證，今年4月進軍各大醫學中心。目前每針售價約1.2萬元，一次療程建議使用20支；未來會繼續開發2到3個新適應症，如「缺血性腦中風」治療，目前已經和中國醫藥大學合作，並進入「先導性臨床」，預估將收300名病患，目前收案率已逾6成。
西藥規格 雙向免疫調節 為何血寶注射劑可抗癌因性疲憊？主要是血寶提煉自上藥黃耆，不是科學中藥，而是完全採用西藥規格，經過安全、毒理及臨床人體試驗，藥理顯示該藥可有雙向免疫調節作用，以調整癌病患體內的抗發炎反應。中央研究院李國雄院士說，血寶注射劑已為國內新藥研發找到新方向。研發天然藥物30年有成，為國際推崇的專家，美國北卡大學藥學教授、中央研究院李國雄院士指出，新藥研發時間漫長，尋找新藥愈來愈困難，惟從已有千百年使用經驗的中藥著手實為一大捷徑。2004年美國FDA公布植物新藥指南，宣布開始接受植物新藥的審批，是一突破性進展，世界大廠近年來也紛紛投入植物新藥研發工作，顯示植物新藥已成為國際趨勢。一生從事癌症研究有成、享譽國際的知名癌症專家、中央研究院彭汪嘉康院士指出，75至80%癌症病患有疲憊症狀，高達3分之2的患者認為疲憊症狀比疼痛更加困擾；由於醫界對「癌因性疲憊」的致病機轉仍不十分清楚，目前研究團隊發現癌症患者體內多種發炎細胞激素標記偏高，正積極尋找導致癌症疲憊的「疲憊生物指標」（CRF biomarker），進一步探討疲憊的奧祕，徹底解決癌症病人難以回復的疲憊症。
繼續研發將擴大適應症 懷特血寶注射劑為獲准上市的全球第一個專治癌因性疲憊症的處方新藥，總裁陳寬墀說，繼續投入後續研發，極可能擴大適應症範圍。現已取得美國FDA用於原發性血小板低下紫斑症的孤兒藥資格認證，將有機會進入美國FDA快速審查機制。懷特公司開創植物新藥注射劑製造技術，並掌握原料藥自主性及關鍵技術，依國際標準建置完成我第一座無菌植物新藥精製廠，為我國生技界創舉。
「借殼」養病毒！台清團隊成功研發新一代腸病毒疫苗 鉅亨網新聞中心(來源：NOWnews)2012-08-0312:30兒童恐怖殺手腸病毒71型，國內疫苗研發有大突破！台大醫院和清華大學的研究團隊花了4年時間，成功研發出新一代腸病毒71型「類病毒顆粒疫苗」，利用昆蟲夜蛾的細胞「借殼」培養，不但動物試驗讓彌猴產生抗體濃度，還沒有傳統死毒疫苗會感染腸病毒遺傳物質的疑慮，且生產速度更快，只要8天就可完成。 腸病毒71型一直是國內5歲以下嬰幼兒的恐怖殺手，1998年第一次在台灣大流行時，當年就有450例感染個案、78人死亡；亞洲一直是腸病毒熱區，今年柬埔寨就傳出60多個孩子因此死亡，目前台灣、大陸、新加坡都在競相開發疫苗。不同於傳統直接把腸病毒病毒去活化的疫苗做法，台大醫院醫學研究部和清華大學化工研究所合作的新型腸病毒疫苗，利用分子生物技術，改用夜蛾（T.ni）細胞來培養疫苗，發現同樣可以得到相當好的抗體濃度。清華大學化工研究所教授胡育誠形容，研究團隊利用基因重組技術，把昆蟲細胞當「工廠」，組裝形成一個病毒空殼，使之具有腸病毒的外殼結構，卻不含病毒基因體DNA、RNA等遺傳物質，因此不會傳染，但仍可誘發免疫反應的產生，像子宮頸癌疫苗也是類病毒顆粒疫苗。這項新疫苗日前已完成彌猴動物試驗，12彌猴在注射3劑疫苗之後，體內皆誘發相當好的抗體濃度，且可有效中和腸病毒71型病毒，形成保護力，證實有用。台大醫院醫研部教授江伯倫說，這一種類顆粒病毒，除了可以跟一般的腸病毒疫苗一樣誘發好抗體反應之外，更重要的是，類病毒顆粒疫苗較不會有副作用，已經是未來全球研發疫苗的主要發展方向。量產速度也比較快！胡育誠強調，比起一般腸病毒疫苗的5周，只要培養出足量的類顆粒病毒疫苗，8天就可以生產，以每10公升培養液含3000毫克為例，至少就可以生產1萬5000劑疫苗，一旦爆發大流行時，能夠及時應付大量需求。此一研究結果也已經發表在報告各種疫苗製備的國際期刊「疫苗」之上，讓台灣目前在腸病毒新一代疫苗的研發上領先國際；研究團隊也正尋求生技業者合作，開發商業量產。
Published July 25, 2012 Despite the amount of information available on weight management, a new study by HealthFocus® International shows that a wide disconnect continues to hamper weight loss efforts. The study, titled "Actionable Solutions for Overweight Segments of the Population," found that although the amount of information continues to reach mainstream consumers through traditional media, social networks, and websites, 76% of consumers still admitted that they don't know how to eat to lose weight. For instance, 68% of Americans said "drinking more water" is the step they are most likely to take when trying to lose weight. In contrast, only 20% of them followed any structured diet plan.The study suggested that a better understanding of the obesity crisis lies in a different kind of understanding of the consumer. This study examined consumer emotional and lifestyle needs going well beyond diet and exercise, and focused on understanding how consumers are different from one another. "New approaches to combatting obesity are essential, so we wanted to provide actionable information in this study," said Barbara Katz, president of HealthFocus International. "This is especially important in light of recent estimates from the Duke University study putting obesity rates at 42% by 2030. One way to be more effective at addressing this issue may be to individualize the approach to weight management." Five different consumer segments were identified, each unique and different in their needs and their approach to weight management:
1. Active Maintainers are mostly moderately overweight, in control and fairly consistent about taking steps to maintain their weight.
2. Emotional Seekers are very unsatisfied with their bodies, and emotion plays a huge part in weight loss for this group. They have a strong desire for change, and they are more willing to try different approaches.
3. Practical Reducers are also highly unsatisfied with how they look but they are more empowered.
4. Health Driven consumers usually have a high body mass index (BMI) and lots of health issues, which drives them to find solutions.
5. Nonchalants are just that - nonchalant about managing their weight. They often feel they are at the right weight already, or just need to lose a few pounds but they don't feel they need to focus on their weight. The study revealed interesting information about attitudes toward weight management as well. Seventy-six percent of the respondents in the study admitted that they simply love to eat. In fact, 37% blame the fact that they "love to eat and don't want to give it up" as one reason why they can't lose weight. Other key reasons cited for excess weight were lack of exercise and too much stress. One-third of consumers believe that they often deal with "overwhelming" stress levels. The largest segment of consumers, comprising over one-third of the population, is a "very emotional group." More than half of this group claims to be "disgusted with themselves." This level of disillusionment in the largest segment of the population suggests that for many, increasing knowledge is only part of the challenge, and the focus needs to shift to the psychological side of weight management.To obtain a copy of this study, follow this link.
Published July 25, 2012Increasing dietary intake of the antioxidant vitamins C, E, and selenium could help cut the risk of developing pancreatic cancer by up to two thirds. In fact, if the association turns out to be causal, one in 12 of these cancers might be prevented, according to researchers who are leading the Norfolk arm of the European Prospective Investigation of Cancer (EPIC) and have published their findings online in the journal Gut.Cancer of the pancreas kills more than a quarter of a million people every year around the world. And 7,500 people are diagnosed with the disease every year in the UK, where it is the sixth most common cause of cancer death. The disease has the worst prognosis of any cancer, with just 3% of people surviving beyond five years. Genes, smoking, and type 2 diabetes are all risk factors, but diet is also thought to have a role, and may explain why rates vary so much from country to country, the authors said.The researchers tracked the health of more than 23,500 40 to 74 year olds, who had entered the Norfolk arm of the EPIC study between 1993 and 1997.Each participant filled in a comprehensive food diary, detailing the types and amount of every food they ate for 7 days, as well as the methods they used to prepare it. Each entry in the food diary was matched to one of 11,000 food items, and the nutrient values calculated using a specially designed computer program (DINER).Forty nine people (55% men) developed pancreatic cancer within ten years of entering the study. This increased to 86 (44% men) by 2010. On average, they survived six months after diagnosis.The nutrient intakes of those diagnosed with the disease within ten years of entering EPIC were compared with those of almost 4000 healthy people to see if there were any differences. The analysis showed that a weekly intake of selenium in the top 25% of consumption roughly halved their risk of developing pancreatic cancer compared with those whose intake was in the bottom 25%.And those whose vitamins C, E, and selenium intake was in the top 25% of consumption were 67% less likely to develop pancreatic cancer than those who were in the bottom 25%. If the link turns out to be causal, that would add up to the prevention of more than one in 12 (8%) of pancreatic cancers, calculate the authors.Antioxidants may neutralize the harmful by-products of metabolism and normal cell activity—free radicals—and curb genetically programmed influences, as well as stimulating the immune system response, explained the authors.Other trials using antioxidant supplements have not produced such encouraging results, but this may be because food sources of these nutrients may behave differently from those found in supplements, they said. "If a causal association is confirmed by reporting consistent findings from other epidemiological studies, then population based dietary recommendations may help to prevent pancreatic cancer," they concluded.
2012年08月01日 14:36 來源：新華網 傅雲威 專訪："借船出海"將助力中醫融入西方主流醫療行業——訪澳大利亞康平國際醫療集團董事長陳星惠新華網雪梨8月1日電(記者 傅雲威)今年7月，澳大利亞政府正式對中醫行業實行註冊管理，這標誌著西方國家首次以立法方式承認中醫療效及合法性。日前，就如何促進中醫更好"走出去"問題，澳大利亞康平國際醫療集團董事長、著名華人醫生陳星惠接受新華社記者專訪時指出，在海外特定環境下，中醫通過與當地主流醫學相結合，在行業標準、資質認證、教育培訓等領域實現"借船出海"，便於贏得更為有利的發展機遇。陳星惠多年來為促進澳洲主流社會接納中醫以及中西醫結合事業作出了突出貢獻。目前，他所領銜的相關項目已成為中澳兩國政府部門的扶持重點。而中澳兩國近年來在中西醫結合領域已邁出重要步伐。早在2010年5月，中國國家中醫藥管理局與澳大利亞新南威爾士政府就簽訂了在雪梨設立"康平高水準中西醫結合醫療中心"的諒解備忘錄。該中心已于2011年1月破土動工。2011年10月，由中澳兩國政府部門主辦、康平國際醫療集團承辦的"2011年首屆澳大利亞中西醫結合國際研討會暨展會"在雪梨隆重舉行。會上，新南威爾士州政府、科研院校和企業以及中國政府有關部門簽署了《中澳中醫藥科技創新合作聯盟》等11個推進中西醫結合發展的協議。作為上述項目的重要參與方和見證者，陳星惠特別指出，建設中的"康平高水準中西醫結合醫療中心"是中外政府合作在海外設立的第一家中西醫結合的現代醫療中心，"高水準"特指中西醫結合的程度。談及中西醫結合的程度，陳星惠說，中西醫結合從低到高大致可分為三個層次：第一，中西醫科合署辦公，但各自收治患者，少有溝通；第二，中西醫科在合署辦公基礎上互相溝通與交流，甚至就具體病例實施會診；第三，建立專業化中西醫結合醫院實體，使中西醫科在臨床、科研和教育方面實現高度融通。陳星惠認為，像康平高水準中西醫結合醫療中心這樣由雙方政府支援、民間投資、中西醫結合、本土化運作的模式是順應大勢的明智之舉，有利於積極引導中醫"人、財、物"走出國門，有利於中西醫結合走上正規化、體制化、現代化軌道。據悉，康平國際醫療集團目前已與雪梨科技大學、西雪梨大學、北京中醫藥大學、培力健康產品有限公司、天士力集團等方面達成書面合作意向，為中西醫結合事業發展預留了充分資源和空間。陳星惠說，在澳洲實行中醫註冊管理的大背景下，澳洲中西醫結合將迎來更多機會。在中澳兩國政府部門和產學研機構支援下，康平高水準中西醫結合醫療中心投入運營後，有望成為澳洲中西醫臨床交流和溝通的重要平臺，並促使兩國醫學和產業界在教育、研發、投資等廣闊領域實現緊密對接。在陳星惠看來，澳洲中西醫結合事業前景廣闊，中西醫實現高水準結合，無疑有利於中醫"借船出海"，適應澳洲國情和行業標準，並推動業界在尊重中醫發展規律基礎上，構築本土化的中醫藥管理、培訓、研發和品質控制體系。（責任編輯：林秀敏）
醫美Q&A／纖纖玉腿非妄想！4大絕招向蘿蔔腿說掰掰 方齡 2012年8月3日 15:18 分享 記者方齡／專題報導 一雙穠纖合度、緊實修長的美腿，不但令男性怦然心動，連女性自己看了也羨慕不已。但可惜的是，並非所有人生來就擁有美腿基因，有些人甚至依靠後天努力也無法踏上「美腿殿堂」一步，難道就只能一輩子望著圓滾滾的「蘿蔔腿」唉聲嘆氣嗎？ 嘉仕美整形外科診所張格彰醫師表示，這是一個比較棘手的問題，因為粗壯小腿多半不是脂肪囤積所造成的，而是結實的肌肉所組成。但儘管如此，市面上依然有4種辦法得以解決亞洲女性常有的「蘿蔔腿」煩惱。 張格彰醫師首先提出俗稱「拔蘿蔔」的小腿手術，是4個方法中最有效也最複雜的。「拔蘿蔔」手術是從膝蓋後方動刀，全部或部分切除小腿後方上端的腓腸肌，達到縮減小腿目的。而此方式的缺點是術後留下的疤痕較為明顯，且往後無法從事劇烈運動。 第2種辦法是「切神經」手術，藉由切斷腓腸肌神經的方式讓腓腸肌萎縮，小腿也會因此而消瘦，且不會影響正常行走。但張格彰醫師表示，此方法有可能導致小腿其他肌肉變得粗壯，或是出現O型腿的問題。第3種方式也和神經有關，不過是以「電燒」部分神經，減弱腓腸肌的組成，但效果不如「切神經」手術來的好。 最後一種辦法也是最廣為人知的小手術，就是在小腿上注射「肉毒桿菌」幫助雕塑和削減小腿尺寸；但張醫師表示，雖然注射肉毒桿菌要價較便宜，但效果只能維持6個月至8個月，且注射量大，和前3種方法相比之下較不符合經濟效益。
By Lee I-chia The National Science Council (NSC) is to hold its first science and technology development consultation meeting on Monday and Tuesday, inviting top academics and specialists from the business sectors to discuss three main issues. As the council will be become the Ministry of Science and Technology next year, National Science Council Minister Cyrus Chu (朱敬一) yesterday said the meeting will mark the first step of its transformation. The Executive Yuan's Science and Technology Advisory Group, which consists of academics and specialists and holds annual meetings to provide professional advice, is to be transformed into the Executive Yuan's Board of Science and Technology, with the heads of ministries for making policy decisions, after the government reform that sees the council upgraded, Chu said. The council decided to hold the science and technology development consultation meetings in order to make up for the lack of a professional consultation role in next year's government reform, he said. Chu said the first meeting will focus on three main issues: How to improve the linkage between the upstream of learning and research with the downstream of industrial production; how to drive top-bottom science and technology programs and how to solve the problem of insufficient high-technology talent in Taiwan. "Academics have suggested that National Science and Technology Programs should have very clear visions of their goals, and also create deep and long-term impacts," Chu said, adding the programs will be re-evaluated on Monday and Tuesday in addition to discussions on how they should be enforced after the government reform. Among the 17 committee members invited to the meeting are Academia Sinica President Wong Chi-huey (翁啟惠), Academia Sinica's academician Michael Lai (賴明詔), former Academia Sinica vice president Chen Chien-jen (陳建仁), dean of National Taiwan University's College of Medicine Yang Pan-chyr (楊泮池) and other academics from Taiwan and overseas. Taiwan Semiconductor Manufacturing Co chairman Morris Chang (張忠謀) and Stan Shih (施振榮), chairman of iD SoftCapital and the founder of Acer Group will also attend the meeting. Chu said decisions made at the meeting will become strategy reference for the council and will also be included for further discussion at the 9th annual National Science and Technology Conference, scheduled for December this year.
2012/07/20 【聯合報╱記者蔡永彬／台北報導】 多位大學教師、研究人員涉嫌詐領研究經費，有學者批評經費核銷制度僵化，讓他們「被迫」浮報或虛報。國家科學委員會從8月起放寬大項目經費流用比例至50％、授權學校自行查核細項，但也新增查獲不法就扣學校管理費的「懲罰條款」。中央研究院院長翁啟惠、台灣大學校長李嗣涔、清華大學校長陳力俊曾對假發票案發表聲明，指出是許多助理便宜行事，並呼籲檢討科研會計與出納的彈性不足；台灣師範大學校長張國恩則強調，假發票案可能引發學者出走潮；本月初中研院院士會議也建議政府補助經費應該具有充分彈性。國科會昨天修正部分補助規定。國科會主任委員朱敬一表示，從8月起，研究計畫的業務費、研究設備費和國外差旅費這3大項目間，流用比例增加到50％，超過才要報國科會核准，與歐、美國家大致相當。此外，未來國科會將只管理主經費項目的新增和流用，耗材、人力等內容細項則由校方認定。學校權力增加，國科會也訂出配套措施。國科會綜合業務處處長陳宗權指出，未來個人浮報、虛報被查到，國科會將從學校管理費中扣除浮報金額的1至3倍當作懲罰；若學校未落實查核，國科會也將扣減管理費比率。朱敬一認為，學術研究和公務行政不一樣，學術是「探索未知」，事前寫不出絕對的方向，「愛迪生要試幾百種材料，才知道鎢絲做電燈泡最好。」他舉例，研究人員做實驗做到半夜，只好搭計程車回家；國科會副主委孫以瀚研究果蠅，要買化妝用的眉筆，因為要在果蠅翅膀上標記。帳面上看來，研究人員搭計程車、買眉筆的確很奇怪，但現實是合理的。國科會每年將抽驗一定比率的研究計畫，總金額約占每年補助總經費的6％多。「我們是勇敢的！」朱敬一希望讓學、研界有更多的自由，但各校也應建立良好的內控機制。
教育廣播電台 (2012-08-03 17:43)行政院國家科學委員會「第一次科學技術發展諮議會議」，將於6、7號舉行，這可說是代表國科會轉型科技部的第一步。國科會主委朱敬一表示，國科會「第一次科學技術發展諮議會議」將邀請國內外諮議委員、部會首長、立法委員、國科會業務主管及學者專家60多人參加，會中將討論3大議題「如何銜接上游學研與下游產業」、「如何推動由上而下的科技計畫」與「如何面對台灣的科技人才危機」。其中教育部、陸委會、勞委會、經建會都將參加第三場「面對人才危機」的討論。朱敬一說，國科會轉型為科技部後，將專注於國家科技研究發展業務，包含學術性基礎研究補助、科技發展政策規劃、重大與應用科技研究等，為了建立常態諮詢機制，提供專業建議與討論國家科技發展政策、重大研發推動等，國科會今年3月先行設置「科學技術發展諮議會」，聘請國內外委員共17位，包括中研院院長翁啟惠、院士賴明詔、陳建仁、朱經武等人，並邀請久未擔任政府顧問的台積電創辦人張忠謀、宏碁集團創辦人施振榮及國外學者擔任。這次諮議會議結論將作為未來國科會訂定發展策略參考。
「ＡＬＳ＝筋萎縮性側索硬化症」の患者から ｉＰＳ細胞を作り、発症のメカニズムの一部を解明することに、 京都大学の研究グループが成功したそうで。研究を行ったのは、京都大学ｉＰＳ細胞研究所の井上治久准教授らの研究グループ。これまでの研究で、ＡＬＳ患者の約９割は、脳からの指令を筋肉に伝える運動神経の細胞内で、 遺伝子の働きの強弱を調節するたんぱく質「ＴＤＰ―４３」が変性し、蓄積することがわかっていたとのこと。井上准教授らは、全身の筋肉が萎縮し動かなくなるＡＬＳ＝筋萎縮性側索硬化症の患者の皮膚から ｉＰＳ細胞を作り、脳の指令を筋肉に伝える運動神経に変化させたところ、 変性したＴＤＰ―４３が大量に蓄積しているのを確認。その影響で、運動神経の突起部分が、健康な人より短くなっていたことを解明。このＡＬＳ患者の細胞に、ＴＤＰ―４３の正常な働きを補うことで知られる４種類の化合物を加えたところ、 そのうちカシューナッツの殻から抽出した「アナカルジン酸」によって、 変性したＴＤＰ―４３が減少、突起の長さも２倍になり、健康な人の細胞と同じ長さになったとのことで。ＡＬＳは運動神経が働かなくなることで発症することが分かっていますが、 これまで病態を再現することは難しく、新薬の開発は進んでいませんでした。井上准教授曰く「アナカルジン酸を治療薬に応用できるか、 今後、安全性や人への効果について慎重に調べていきたい」とのこと。
※筋萎縮性側索硬化症（ＡＬＳ）とは→運動神経が徐々に機能を失い、全身の筋肉が動かなくなる病気。これまで有効な治療法はない。難病情報センターによると、５０～６０歳代で発症することが多く、 国内には、約８５００人の患者がいる。米国では大リーガーのルー・ゲーリッグ選手が発症したことから 「ゲーリッグ病」とも呼ばれる。
「ヒッグス粒子」の続報。 欧州合同原子核研究機関（ＣＥＲＮ）が７月に発表した新粒子について、 実験グループの一つ「ＡＴＬＡＳ」が新たな反応を確認し、 「ヒッグス粒子である可能性がさらに強まった」とする論文を３１日に発表。新粒子がヒッグス粒子であれば、それが壊れる反応は５通りが観測可能で、 それぞれ頻度が異なると予測されており、このうち２通りの壊れ方が既に確認されていましたが、 今回、別の壊れ方一つを、ほぼ予測通りの頻度で検出。今後、残り２通りの反応についても分析し、最終確認を目指すとのこと。今度こそ本当に間違いがないのか。注目です。
時間：2012/8/5 13:27 新聞引據： 中央社衛生署食品藥物管理局長康照洲指出，兩岸藥品管理展開實質合作，以中藥材為例，今年8月1日起，展開進口中藥材品質衛生的邊境把關，兩岸攜手合作。由台灣財團法人醫藥品查驗中心、大陸中華醫學會共同舉辦，台灣臨床藥學會、北京藥學會協辦的海峽兩岸藥事服務交流研討會，日前北京召開，康照洲是在致詞時，做以上表示。康照洲指出，兩岸已多次會談藥品管理，直到最近實質展開輸入中藥材管理，這次交流議題包括兩岸健保藥品給付政策、藥師養成教育到執業體制、藥局與藥物供應管理體系等，兩岸彼此了解差異，有助於建立適合華人的用藥照護體系。中國大陸方面「十二五計畫」中，納入藥師執業改革，大陸當局粗估60萬藥事人員，其中約20萬領有執業執照，預計2015年將全面要求執業藥師專業管理並提供合理用藥的諮詢服務，同時訂定藥師執業法。台北市藥師公會前理事長劉宏志認為，大陸藥事人力雖仍有很大缺口，但是，除了藥事法規不熟悉外，重要的是，藥師執業收入並不高，短期內台灣藥師人力要流向大陸執業，仍缺乏誘因。
朱敬一：台灣人才斷層再無作為 死狀甚慘【聯合報╱記者蔡永彬／台北報導】 2012.08.06 08:31 am 國家科學委員會設置「科學技術發展諮議會」後，今天開第一次會議，討論產學合作、國家型計畫和人才問題。國科會主委朱敬一在會議前夕指出，台灣已經進入「人才斷層」期，如果再無作為，早年的優勢也會流失掉，與他國競爭將「死狀甚慘」。朱敬一表示，台灣出國留學的年輕人越來越少，數量上「後繼無力」，向外找人也很困難。台灣找來的外籍人士多是藍領，白領階級也多半是外語教師；還有中國大陸乘虛而入，挖我們的本土人才。朱敬一表示，工研院高層向他透露，中國大陸有許多省級之下類似工研院的單位，挖台灣工研院的所長去當副院長；薪水數字從新台幣變人民幣，已經有人被挖走，目前情勢岌岌可危。至於如何解決人才問題，朱敬一說，社會觀念裡應該把「人才」和「勞工」清楚切割，例如公營事業或某些重要研發機構如工研院、國家實驗研究院院長等要職就需要人才來擔任，才能以他的經驗、人脈或眼界帶動整體發展。金融海嘯後，社會上看到高薪的高階主管就說是「肥貓」，「這就是民粹、平頭主義！」朱敬一痛批這種想法「愚蠢」。他舉例，國研院以前曾經規定「院長薪水不能超過國科會主委、其他主管薪水不能超過副主委」；好不容易找到人放棄國外工作返國服務，結果一算，薪水等於他之前的「打對折再打對折」，這股社會氛圍也讓許多單位找不到人任高階主管。另一方面，他認為台灣應該扭轉錯誤的保護觀念，不能把所有的外籍人士都看成要搶大學畢業生的飯碗。他批評現在外籍畢業生就業條件嚴格、限制多，他們畢業後找不到工作，當然會離開台灣，看起來好像是「訓練出來請他走路」。「我們要攬才、留才、育才。」朱敬一說，目前的「彈薪計畫」、消除政府財團法人主管的薪資上限，可以算是「稍微有點突破」，近年社會上提供的就業條件和行政協助也變得友善，有助於讓國外人才願意留下。但他認為培育人才也很重要，才能趕快把「海外人才庫」和「人才斷層」補起來。【2012/08/06 聯合報】
泰格医药新股发行与上市定价报告:快速崛起的CRO行业民营翘楚 贺菊颖 广发证券
快速崛起:成为引导CRO服务的龙头民营企业之一 泰格医药是一家以临床试验CRO服务为主营的公司,是为数不多有能力进行国际多中心试验的本土CRO企业之一,构筑了覆盖临床研究产业链各个环节的完整服务体系。公司实际控制人为叶小平先生和曹晓春女士;叶小平先生现任公司董事长和总经理,曹晓春女士现任公司董事和副总经理。公司本次拟发行1340万股人民币普通股,占发行后总股本5340万股的25.09%。
CRO行业历经15年,大步迈入成长期,后市可期 我国CRO服务是近十五年来发展起来的新兴行业,市场化较高,主要由临床前试验CRO和临床试验CRO两个细分行业构成。CRO行业整体有望保持较快增速,但服务较为单一,缺乏实验室、临床、产品一体化运作。行业的未来发展趋势将体现在:①国际制药企业向中国转移研发业务使国内临床研究逐年递增;②产业链专业化与综合化发展趋势并存。
重视人才与创新,与临床试验机构和制药企业形成战略合作关系 公司重视人才培养与创新研发积累,以丰富的医药专业知识和药物临床研究经验为客户提供专业规范的医药临床研究服务奠定扎实的基础。公司积极推进数据管理平台和SMO管理平台建设,完善公司CRO产业链。公司已与390家临床试验机构开展合作,服务网络能够满足国内外医药客户在全国开展临床研究的需要;同时,公司与国内的先声药业等以研发创新为主的制药企业签订了战略协议,共同推动创新药的研究工作。
计划募集2.06亿元,抓住市场机遇,巩固自身竞争优势 公司本次募集资金预计2.06亿元,其中:①0.78亿元投向临床试验综合管理平台建设项目;②1.16亿元募集资金亦投向数据管理平台建设项目,通过推动离岸外包业务和完善CRO产业链来巩固自身竞争优势的;③0.17亿元用于建设SMO管理中心项目建设,用以辅助公司的CRO核心业务。建议询价区间:30.28-39.97元我们预测公司2012-2014年EPS分别为1.21/1.60/2.11元,未来三年公司净利润复合增速33%左右。考虑到CRO行业增速较快、公司标的的稀缺性,公司也是CRO服务的龙头民营企业之一,我们认为公司合理估值为2012年的25-33倍,建议询价区间为30.28-39.97元。
风险提示人员成本及人力资源危险,细分市场竞争激烈,因临床试验服务面临诉讼的风险以及因监管政策变化导致经营受到影响的风险等。