Monday, July 23, 2012

繼中國後 荷蘭也核准基因治療 !!! 欧盟教一體適用


Glybera有望成为欧洲首个基因治疗药物 发布时间:2012-7-23 来源:爱唯医学 荷兰生物技术公司uniQure研发的Glybera(alipogene tiparvovec)成为了欧洲首个被推荐上市的基因治疗药物。欧洲药品管理局(EMA)上周五宣布,其人用药品委员会(CHMP)建议在欧盟范围内批准Glybera上市。这一授权将涵盖所有27个欧盟成员国。Glybera为单次注射剂,适用于严格限制脂肪饮食却仍然发生严重或反复胰腺炎发作的脂蛋白脂酶缺乏症(LPLD)患者。CHMP虽然建议批准Glybera上市,但强调这属于“特殊情况”,因此uniQure将需要开展上市后监测,必须建立登记库,监测接受该治疗者的结局,并将数据提交给EMA审查。这项批准令还有待欧盟委员会的最终裁决,但后者通常会采纳CHMP的建议。UniQure期待欧盟委员会在3个月内给出定论。LPLD是一种罕见的严重遗传性疾病,而且目前无法治疗。其发病率约为1~2/百万人。该病是由LP基因突变引起的,后者会使LPL蛋白的活性严重下降或丧失。LPL蛋白是一种分解乳糜微粒的酶,如果乳糜微粒不被分解,就会在血液中积聚而堵塞小血管,从而可能导致复发性或严重急性胰腺炎。目前,唯一对LPLD患者有帮助的是采取严格限制脂肪饮食,使每日通过脂肪获得的热量不超过总热量的20%。但要坚持这样的饮食习惯并不容易,因此许多患者因危及生命的胰腺炎而住院。基因治疗通过以有活性的基因取代患者DNA中有缺陷的基因而发挥疗效。Glybera利用一种腺相关病毒将有活性的LPL基因插入肌细胞中,从而使这些细胞能产生正常数量的酶。由于LPLD非常罕见,2004年欧盟委员会批准将Glybera列为孤儿药。孤儿药上市申请通常会被更快受理,生产商还会获得经济方面的激励,例如税收优惠和延长市场独占期(在美国为7年,在欧洲为10)等。不过,Glybera在欧盟的上市之路并非一帆风顺。Glybera的首次申请是在2009年提交的。20116月,CHMP和先进治疗委员会(CAT)均表示不赞成该药上市,原因是“他们采纳了关于采用Glybera治疗LPLD的负面意见”。然后Glybera接受了重新审查,CAT表示只要生产商同意开展进一步上市后研究,就有可能批准Glybera批准上市,但CHMP仍坚持其否定意见,直至201110月。在20121CHMP召开成员国常务会议之后,欧盟要求EMA重新评估Glybera申请,并且严格限制在严重或反复胰腺炎发作的患者中。在经过详细的学术探讨之后,CAT改变其立场,“于20126月采纳了积极的草案意见”,CHMP随后也对此表示支持。CHMP代理主席Tomas Salmonson博士解释称,CHMP的结论是:通过分析符合限制条件的患者的数据,认为Glybera的益处大于已知风险。CAT主席Christian Schneider博士表示,两个委员会虽然存在分歧,但在整个过程中开展了紧密协作。uniQure首席执行官Aldag表示:“CHMP的的支持态度对于LPLD患者和这种药物而言是重大突破。Glybera即将为欧洲治疗孤儿病的首个基因疗法。LPLD患者不敢吃正常的食物以免引起急性胰腺炎和导致急诊入院。如今,这些患者第一次有了治疗方法,不仅能降低出现严重病情的风险,而且只需单次注射即可多年受益。基因治疗将赋予这些患者分解血液中脂肪的能力。”

並不是愛滋病 所有骨人 都可用髓移植 根除HIV病毒!!


治療愛滋病 科學家趨樂觀【中央社╱華盛頓22日綜合外電報導】 2012.07.23 04:25 pm 19屆國際愛滋病研討會今天在華府揭幕,會期6天,到27日為止。科學家呼籲各界投入資源,進一步尋求治癒愛滋病的良方,並表示愛滋病流行可能在40年內控制住。因罹患後天免疫不全症(AIDS)而在2011年死亡的有150萬人,專家呼籲全球加緊採取行動,對抗這個發現了30年的傳染病。這項世界最大的愛滋病會議預期會吸引政治人物、科學家、運動人士等25000人與會,若干愛滋病患也會親自講述自己的故事。全球估計有3400萬人罹患愛滋病。其中一名是美國人布朗(Timothy Brown),他經由骨髓移植成為世界第一個達到「功能性治癒」的愛滋病患。布朗將於24日發表演說,希望宣揚治療愛滋病的新努力。布朗在柏林接受治療,醫療人員先破壞他的免疫系統,再讓他接受幹細胞移植,捐贈者帶有罕見基因變異,對愛滋病毒免疫。但這項手術所費不貲,且難以複製、大規模施行。自從布朗在2007年功能性治癒後,他的病例讓科學家認為,現在正是找出愛滋病解藥的時機。這項愛滋病會議每兩年召開一次,這是1990年以後首度回到美國召開,因為美國2009年取消了禁止愛滋病患入境美國的法令。這屆會議的主題是「力挽狂瀾」。諾貝爾醫學獎得主巴瑞-西諾希(FrancoiseBarre-Sinoussi)指出,科學家正盡全力找出愛滋治癒之道。巴瑞-西諾希因所屬團隊發現導致愛滋病的人類免疫不全病毒(HIV),2008年獲頒諾貝爾醫學獎。她以「柏林病患」布朗似乎透過骨髓移植而痊癒來說:「這證明確實有可能找到根除病毒之道。」她指出,藥物普及度的障礙若能去除,愛滋流行「原則上」可能於2050年前絕跡。慈善家比爾‧蓋茲(Bill Gates)承諾捐獻25億美元愛滋病基金給世界各地相關組織。他說:「我們有許多進展,可能扭轉大局,讓我們一步步趨近愛滋病的終結。」他指的是新疫苗、抗反轉錄病毒藥物等協助愛滋病患對抗疾病的進展。「我很樂觀…我們會發展出新工具…將使愛滋病成為陳跡。攜手合作,我曉得我們能達成目標。」國際科學家數日前在英國「自然」(Nature)期刊發表一項計畫,推動新一波愛滋病治癒方法。這項7步驟的科學策略著重在關鍵領域,像是愛滋病毒在人體的藏身處,以及全球各地似乎對愛滋病毒有天然抵抗力的少數人。聯合國呼籲,2015年以前每年投入220億至240億美元協助抑制愛滋病,其中70%的經費會用在最嚴重地區的抗反轉錄病毒治療上。2012/07/23 中央社】

TFDA: 奈米化粧保養品法規研討會


2012國際化粧保養品法規暨奈米管理研討會 (發布日期2012-07-23) 2012 International Forum on Cosmetic & Nano-related Regulations 全球美容產業蓬勃發展,化粧保養品市場蘊藏著無限的商機,國內外各廠商無不卯足全力,不斷的開發新產品來吸引消費者的目光並藉以擴大商機,因此健全管理制度,確保化粧品法規能符合時代潮流且能與國際接軌,以加強維繫民眾使用安全,就成為化粧品生產管理上的重要課題。有鑑於此,行政院衛生署食品藥物管理局於本年度委託工研院生醫所辦理2012國際化粧保養品法規暨奈米管理研討會,特邀請歐盟、東協、美國、日本、中國大陸及台灣之化粧品法規管理之官方代表或技術專家,共同研討全球化粧保養品管理現況及未來趨勢,會中將針對國際間實施之GMP(優良製造規範)、PIF(產品資訊檔案),以及對於產品上市前後之管理作業及方法,藉由交流以瞭解各國實施現況或因應對策,並針對化粧保養品奈米相關技術及其對應法規規範之考量進行探討。透過此次研討會的舉行,將有助國內產、官、研多方代表正視法規相關議題,共同研擬符合國際潮流的對策,促使產業提升及增加國際競爭力。
主辦單位:行政院衛生署食品藥物管理局 執行單位:工研院生醫所協辦單位:工研院量測中心、國際業務中心、行銷傳播處 台灣化粧品工業同業公會、台北市化粧品商業同業公會、中華民國化粧品科技學會 
一、時間:1010724(星期二) 二、地點:台北福華國際文教會館2F卓越堂(臺北市新生南路三段30) 三、費用:完全免費!(若需租用同步翻譯耳機者,請於現場另行繳納300/人之租用費)四、報名日期:即日起至1010723日止,恕不接受現場報名。因場地關係,名額以250人為限,若先額滿將提前截止報名,請多見諒。大會將於1010723日前以電話或e-mail通知您報名是否成功,未收到者逕請來電洽詢。

五、議    程:
2012國際化粧保養品法規暨奈米管理研討會
2012 International Forum on Cosmetic& Nano-related Regulations
Program Agenda (Tentative)
07/24 (Howard International House, Taipei)
Schedule
Topics
Speakers (依照優先順序排列)
Moderators
0830~0900
Registration
0900~0915
Opening Ceremony

Chairperson:  Dr. Jaw-Jou Kang, Director-General, Taiwan Food and Drug Administration, Department of Health, Executive Yuan
(行政院衛生署食品藥物管理局康照洲局長)
Co-chairperson:   Dr. Yio-Wha Shau, President & General Director, Biomedical Techno logy and Device Research Laboratories, ITRI
(工研院生醫與醫材研究所邵耀華所長)
0915~1015
Regulatory Updates for Cosmetic Products


Mr. Roman Mokry
Policy Officer, Health Technology and Cosmetics Unit, DG SANCO (歐盟)
Ms. Li-Ling Liu, Director, Division of Medical Devices and Cosmetics, Taiwan Food and Drug Administration
(食品藥物管理局醫療器材及化粧品組 劉麗玲組長)

1015~1030
Coffee Break
1030~1130
Overview of the ASEAN Cosmetic Regulation
Ms. Zuraida Abdullah,
Head of Cosmetic Section, National Pharmaceutical Control Bureau, Malaysia (馬來西亞)
1130~1230
Regulatory Updates and Trends in the USA Cosmetic Regulation and International Harmonization
Ms. Glenda Williams,
Director of International Regulatory Affairs,Global Strategies,
Personal Care Products Council (PCPC, formerly CTFA)
U. S. A. (美國)
1230~1330
Lunch
1330~1430
Outlines of Regulation for Cosmetics/Quasi-drugs and GMP Implementation in Japan
Mr. Katsuhiro Takano,
Director of Technical Division,
Japan Cosmetic Industry Association
Japan (日本)
Dr. Yio-Wha Shau, President & General Director, Biomedical Techno logy and Device Research Laboratories, ITRI
(工研院生醫與醫材研究所
邵耀華所長)
1430~1530
大陸化粧品管理法規發展趨勢
Cosmetic Regulation and  Administration Prospect in Mainland China
Mr. 鄭慶光 副處長
Deputy Director of Dept. of Cosmetics, GuangDong Food and Drug Administration,
China (中國大陸)
1530~1545
Coffee Break
1545~1645
Current and Recent Development of Cosmetic Regulations in Taiwan
Ms. Cheng-chin Lin
Section Chief, Division of Medical Devices and Cosmetics, Taiwan FDA
(食品藥物管理局醫療器材及化粧品組林澄琴科長)
1645~1715
Panel Discussion (All Speakers)
Moderators:
Ms. Li-Ling Liu (劉麗玲組長), Director, Div. of Medical Devices and Cosmetics, Taiwan FDA; and
Dr. Yio-Wha Shau(邵耀華所長) President & General Director, of Biomedical Technology and Device Research Laboratories, ITRI
1830
Banquet (Grand Hyatt Hotel, Taipei)
承辦單位保留議題更動之權利

Gut Microbes Might Reflect Health !!!!


Diet of Older Adults Study found intestinal species varied depending on seniors' health, residence Friday, July 13, 2012 FRIDAY, July 13 (HealthDay News) -- The health of elderly people appears closely linked with their diet and the type of microorganisms living in their gut, suggesting that what you eat may affect how well you age, according to new research. "Our findings indicate that any two given older people, independent of [their] starting health status and genetic makeup, could experience very different rates of health loss upon aging due to dietary choices that impact on their gut bacterial ecosystem," said Paul O'Toole, senior author of the study appearing July 13 in the journal Nature. "You can think of [diet] as another controllable environmental factor that we can act upon to promote healthier aging," O'Toole added. Numerous studies have indicated a link between the "microbiota" that live in the human gut and health, including obesity and perhaps even brain health. More recent studies have noted greater variation in the microbiota of elderly people than younger people. To study the potential meaning of this greater variation, these authors looked at the gut microbiota of 178 elderly individuals (average age 78). None was being treated with antibiotics, which can alter the composition of your gut. The researchers discovered that intestinal flora (microbes) varied depending on where the participants lived and also with their health. For instance, people living independently in the community had more varied flora and were the healthiest. On the other hand, people living in long-term, assisted-living situations had less diverse flora and tended to be frailer. The differences in flora were associated with differences in diet, although it's unclear if the diet was responsible for the number and type of flora and health status or the other way around. It does seem likely that it's diet that ultimately determines a person's health status, the authors stated. "The diet of older people changes quickly when they move from community to long-term care (in a couple of weeks), but the microbiota changes more slowly -- up to a year for full change from community type to long-term residential type," O'Toole explained. "One would not expect that the rate of heath decline in this time could be responsible for the change in microbiota composition. It's more plausible to be driven by diet." A September 2011 study in the journal Science found that people who ate a diet high in fats and animal proteins had a different assortment of bacteria in their digestive tracts than people who ate a diet with more plant-based foods and higher carbohydrates. Identifying exactly what lives in our guts could point to dietary interventions that might lead to longer and healthier lives, authors of the new study stated. "To combat frailty, it makes sense if our microbiota is helping our bodies to be as effective and efficient as possible," said O'Toole, a senior lecturer in genetics at University College Cork, in Ireland. Gut microbiota synthesizes vitamins, helps metabolism and appears also to profoundly affect how our immune systems work. "[Some studies] have shown that gut bacteria can 'talk' to the brain by synthesizing compounds that affect the brain-gut axis," O'Toole said. "An exciting theory is that altered gut bacteria in older subjects could impact on cognitive function or mood." Gastroenterologist Dr. Ilseung Cho commented on the findings. "This is one of the first studies that correlates differences in the gut microbiome to disease in the elderly. It remains to be seen whether the observed differences are a result or cause of infirmity in this particular population," said Cho, an assistant professor of medicine at NYU Langone Medical Center, in New York City. "Regardless, these findings add to the growing body of evidence that shows that the gut microbiome can affect human health and disease at all stages of life," Cho added. Dr. David Bernstein, a gastroenterologist and chief of hepatology at North Shore-LIJ Healthcare System, in Manhasset, N.Y., considers the findings preliminary. "We know that there are millions or billions of bacteria throughout the gut, and how we manipulate those certainly affects health," said Bernstein, who is also a professor of medicine at Hofstra-North Shore LIJ School of Medicine. "This is an important topic [but] it requires a lot more research," Bernstein said. SOURCES: Paul O'Toole, Ph.D., senior lecturer in genetics, University College Cork, Ireland; Ilseung Cho, M.D., gastroenterologist and assistant professor of medicine, NYU Langone Medical Center, New York City; David Bernstein, M.D., gastroenterologist and chief, hepatology, North Shore-LIJ Healthcare System, Manhasset, N.Y., and professor of medicine, Hofstra-North Shore LIJ School of Medicine, Hempstead, N.Y.; July 13, 2012, Nature HealthDay

李鍾熙 希望 政府 "推一把" !!


共用管理階層 生技論壇聚焦【經濟日報╱記者黃文奇/台北報導】 2012.07.23 05:24 am2012生技大展 / 黃文奇 2012台灣生技大展26日登場,生物產業發展協會理事長李鍾熙表示,今年生技大展參展廠商已突破600家,攤位數也達1,000個。創歷史新高。今年展前兩天「亞太生技商機高峰論壇(BBA)」提前登場,邀請美、日、星、韓、港澳等地專家與談。台灣生技展邁入第10屆,由原本的數十個攤位,到目前的上千個展出單位,顯見台灣生技產業已經邁入成長期。李鍾熙強調,目前台灣生技產值已達2,400億元,若政府能夠「推一把」,並協助打開國際(大陸)市場,要再翻倍不是問題。論壇方面,李鍾熙表示,今年探討主軸是共用「管理階層」,讓新創生技公司的成長更有爆發性。此外,各國生技訪問團前來,將探討生技投資議題,生技整合育成中心首席顧問蘇懷仁將主持其中1場討論。今年論壇主軸談的「共用管理階層」,意指當前的生技新創公司可以共用執行長、財務長,以加強執行效能,加速產品商品化時間。2012/07/22 經濟日報】

Biosimilar regulations and CMOs


 WEBINAR: JUNE 26 | 11AM ET/8 AM PT Biosimilar legislation passed in 2010 guaranteed 12 years of patent protection to biotechs from biosimilar competition. But passing the law was the easy part. As FDA hashes out regulations to implement the law, we help CMOs understand the significance of the legislation to their businesses and how the new legislation may help, or hurt, contract manufacturing for biologics. Register Now! Sign up for our FREE newsletter for more news like this sent to your inbox! Roche comes to the game in fairly different position. The Swiss drug giant, which currently lacks a big cardio business, seeks its first multibillion-dollar seller in this category. In May the drugmaker wrote off its experimental dalcetrapib after the drug for increasing good cholesterol bombed in a late-stage study. As Bloomberg reports, Roche has kept details about its PCSK9 drug from U.S. unit Genentech under wraps because of the intense competition in the field. Yet that will rapidly change as Roche unveils data on the program and builds its case with docs to enroll their patients in its studies. Behind Roche's and Sanofi's PCSK9 programs are several more. Amgen ($AMGN) and Pfizer are in mid-stage studies with their own candidates aimed at the hot target. Also, Bristol-Myers Squibb ($BMY), Merck ($MRK) and Alnylam ($ALNY) have research underway in the field. "These drugs allow us to go where no one has gone before," Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic in Ohio, said in an interview with Bloomberg. "There's a tremendous amount of interest among a broad range of makers of pharmaceuticals to get involved." 

中国十二五 加速 生医产业重组!


生物医药优势企业重组获政策支持 发布时间:2012-7-23 来源:药品资讯网信息中心 《“十二五”国家战略性新兴产业发展规划》将生物产业划分为生物医药产业、生物医学工程产业、生物农业产业和生物制造产业四大板块,力争“十二五”期间实现产业规模年均增长20%以上。《规划》提出,在生物医药产业结构方面,将全面推进药品生产质量管理体系和产品质量标准体系升级,推动制剂产品进入国际主流市场。优化产业布局,鼓励优势企业兼并重组,促进品种、技术等资源向优势企业集中。到2015,形成基因工程药物、新型疫苗、抗体药物、化学新药、现代中药等为代表的一批具有国际水平的新药开发平台,制药技术和装备研制水平大幅提升。30个以上自主知识产权新药投放市场,200个以上药品制剂进入国际主流市场,产业集中度大幅提升。此外,在生物医学工程领域,将研究开发预防、诊断、治疗、康复、卫生应急装备和新型生物医药材料的关键技术与核心部件,形成一批适合大中型医院使用、具有自主知识产权的高端诊疗产品等。并将推动生物农业产业到2015年形成一批现代生物育种和农用生物产品创新平台。培育动物新品种()20,培育高产优质多抗高效农作物新品种180,累计推广5亿亩;一批新型绿色农用生物产品实现产业化。到2015,生物制造技术能力将显著提升,生物基产品在工业化学品中的比重大幅提高。聚乳酸、聚丁二酸丁二醇酯等有机化工原料与工业生物材料等品种实现十万吨级规模化生产。生物新工艺在印染、制浆、漂白、脱胶等工艺过程中达到规模化应用,污染物排放和能耗总量明显降低。制定生物基产品认定机制与财政补贴、税收优惠政策。

Placenta-derived endothelial colony-forming cells are more vasculogenic


 Published on July 20, 2012 at 1:14 PM · No Comments A study comparing whether endothelial colony-forming cells (ECFCs) derived from human placenta or those derived from human umbilical cord blood are more proliferative and better for forming new blood vessels has found that ECFCs derived from human placenta are more vasculogenic. The study, carried out by researchers at the Indiana School of Medicine, is published in a recent issue of Cell Medicine [2(3)] and is freely available on-line at: http://www.ingentaconnect.com/content/cog/cm. "Circulating ECFCs isolated from umbilical cord blood and those isolated from human placenta are phenotypically identical and have equivalent proliferative potential," said study lead author Michael P. Murphy, MD of the Indiana University's Department of Surgery. "After transplantation, the circulating placenta-derived ECFCs formed significantly more blood vessels in vivo than the ECFCs derived from umbilical cord blood, indicating not only that there are inherent functional differences between resident and circulating ECFC populations, but that the placenta-derived cells are more vasculogenic." Umbilical cord blood and the extra-embryonic membranes of placenta are ideal sources of progenitor cells, said the researchers, because the tissues are discarded as medical waste and ethical concerns facing embryonic stem cells are avoided. The quantity of cells that can be derived from placenta, however, is much greater than the amount that can be derived from umbilical cord blood, making the placenta the more abundant source. 

胚胎篩檢晶片: Genesis-24 鎖定"特殊"客源 !


創源8月底開法說 9月中掛牌 全年營收衝倍增 鉅亨網記者張旭宏 台北2012-07-2311:55訊聯生技(1784-TW)旗下專攻基因檢測的創源生物科技(4160-TW),順利通過櫃買中心上櫃董事會審議,據了解,公司將於8月底召開上櫃前法人說明會,9月中旬掛牌交易。公司上半年在接單火熱帶動下,業績暴增,營收達1.53億元,年增達1.54倍,隨著基因治療逐步進入爆發階段,加上日本及大陸市場開花結果,法人推估全年營收衝上3億元大關,倍數成長。創源成立於2008年,是由國內首家幹細胞上櫃公司訊聯生物科技(1784-TW)與美國Genesis Genetics Institution(GGI)合資成立,目前創源業務範圍包含基因檢測、分子診斷、生物技術服務、個人化醫療相關檢測及、生物資訊服務等,其中試劑銷售佔營收佔營收比重34.92%、檢測服務58.57%創源以基因檢測技術為核心能力,取得GGI「胚胎著床前基因診斷」PGD技術於亞洲的獨家授權及Genesis-24胚胎著床前晶片篩檢技術,在台灣即可與國際同步擁有先進篩檢技術,目前可檢測300種以上單一基因遺傳疾病。此外目前尚有全球首創脊髓性肌肉萎縮症(SMA)產前基因檢測服務,持續推出胚胎著床前晶片篩檢(Genesis 24)、產前羊水晶片篩檢(array CGH)等各項產前檢驗服務,另更開發各種預防性基因檢測,搶攻大陸與亞洲市場。另外,去年5月推出的「羊水染色體晶片檢測」是利用生物晶片,檢測最小的基因單位並篩檢100種以上與染色體相關的遺傳疾病,透過訊聯在產前及孕前檢測的通路平台優勢,深耕國內產婦市場,挹注今年新成長動能。創源2009年營收1594萬元,稅後淨利32萬元,每股稅後純益0.62元;2010年營收1.39億元,稅後淨利625萬元,每股稅後純益0.81元;2011年營收1.7億元,稅後淨利1493萬元,每股稅後純益0.86元。

Music has big brain benefits compared to other leisure pursuits


 July 20, 2012 in Neuroscience Musical instrumental training, when compared to other activities, may reduce the effects of memory decline and cognitive aging (Medical Xpress) -- It turns out mom was right. Music lessons are good for you, and those benefits may last a lifetime. A recent study conducted by Brenda Hanna-Pladdy, PhD, a clinical neuropsychologist in Emory University School of Medicine’s Department of Neurology, offers additional evidence that musical instrumental training, when compared to other activities, may reduce the effects of memory decline and cognitive aging. This is the second study published by Hanna-Pladdy, which confirms and refines findings from an original study published in Neuropsychology in 2011 that revealed that musicians with at least 10 years of instrumental musical training remained cognitively sharp in advanced age. The findings were published in the July issue of Frontiers in Human Neuroscience. “The study confirms that musical activity preserves cognition as we age, by comparing variability in cognitive outcomes of older adults active in musical instrumental and other leisure activities,” says Hanna-Pladdy. “A range of cognitive benefits, including memory, was sustained for musicians between the ages of 60-80 if they played for at least 10 years throughout their life, confirming that maintenance of advantages is not reliant on continued activity. In other words, you don’t use it or lose it. Nonetheless, the study highlighted the critical importance of the timing of musical activity, which may optimize cognitive benefits.” The cognitive enhancements in older musicians included a range of verbal and nonverbal functions, as well as memory, which is the hallmark of Alzhemier’s pathology. The study evaluated the timing of musical engagement to determine whether there is a critical period of musical training for optimal cognitive advantages in advanced age. While years of playing music were the best indication of enhanced cognition in advanced age, the results revealed different sensitive periods for cognitive development across the lifespan. Early age of acquisition, before age nine, predicted verbal working memory functions such as remembering and reorganizing digits in your head, consistent with early sensitive periods in brain development. Sustained musical activity in advanced age predicted other non-verbal abilities involving visuospatial judgment, suggesting it is never too late to be musically active. Continued musical activity in advanced age also appeared to buffer lower educational levels. This is an exciting finding in light of recent evidence suggesting that high educational levels are likely to yield cognitive reserve that may potentially delay the onset of Alzheimer’s symptoms or cognitive decline,” says Hanna-Pladdy. “This also highlights the promising role of musical activity as a form of cognitive enrichment across the lifespan, and it raises the question of whether musical training should eventually be considered an alternative form of educational training.” According to Hanna-Pladdy, to obtain optimal results, individuals should start musical training before age nine, play at least 10 years or more and if possible, keep playing for as long as possible over the age of 60. Music rocks. Musical activity was found to preserve cognition, including memory, as you age, when comparing variability in cognitive outcomes of older adults active in musical instrumental and other leisure activities. You won’t lose it if you don’t use it. A range of cognitive benefits including memory were sustained for musicians between the ages of 60-80 if they played for at least 10 years throughout their life, confirming the maintenance of advantages is not reliant on continued activity. Start young. Timing of musical instrumental acquisition, before age nine, is important in optimizing cognitive benefits and was associated with enhanced verbal working memory functions. It’s never too late, so keep at it. Sustained musical activity over the age of 60 was associated with other nonverbal cognitive benefits, and appeared to compensate for low educational attainment, which is possibly the greatest protection against age-related cognitive declines. This suggests that musical training should be considered an alternative form of education. Journal reference: Frontiers in Human Neuroscience Provided by Emory University

台灣生醫業界如何從中國十二五 獲ECFA 中取得優勢?????


王榮旭:生技股 醞釀大爆發【經濟日報╱】 2012.07.23 04:46 am 歐洲消費緊縮,全球經濟跟著降溫,各國央行降息救市,提振經濟還需時間發酵,此時景氣打底階段,各產業都受到波及,上周電子股受創嚴重,除生活必須品外,就屬生技最強。事實上,生技向來與景氣連動性低,國際大藥廠如製造銷售醫療保健產品的嬌生(JNJ)與全球最大製藥公司輝瑞(PFE)上周股價皆創近4年來新高,國際大型製藥、新藥研發公司必治妥(BMY)上周更是創下10年來新高股價,不僅如此,中國的廣州藥業(6003327月以來大漲35%,股價改寫歷史新高。要不是台股太弱,台灣生技股應該不止漲這樣。台灣生技產業坐擁「天時、地利、人和」,過去研發的新藥在未來2~3年內就會有成功上市的機會,地理位置與14億人口的中國市場緊鄰,在語言上比歐美亞洲鄰國更具有優勢,因此,更能掌握到中國十二五生醫升級的商機。此外,生技鑽石起飛計畫重新啟動,顯示政府的積極態度,若能更進一步擴大ECFA的加乘效果,把進入中國市場的時間縮短及降低門檻,那肯定會讓台灣生技大爆發,生技股已經朝這個方向前進,如新藥股基亞,去年底剛掛牌沒沒無聞,經過一段時間後,股價從不到30元飆漲到70元,跌破大家眼鏡。到現在我看好基亞的立場沒變,因為其新藥價值高,才能獲選成為兩岸新藥合作試範廠商,跳過臨床12期,直接到大陸進行3期臨床,完成3期臨床後就可申請藥證上市銷售,股價維持高姿態整理,後勢不要小看。至於已經先到中國搶占市場的F-金可則已經開花結果,穩居中國隱形眼鏡市場龍頭,如今回攻台灣市場,進入暑假旺季與精華大力促銷,第3季營收可望改寫歷史新高。本周生技展前,生技股王精華股價愈走愈高,比價效應又再展開,東洋微脂體可望獲國際大廠代工訂單,營運大有轉機,轉投資新藥股智擎預計8月掛牌,潛在投資利益可觀。進軍中國原料藥市場的神隆,下半年業績也很有看頭,台灣兩條新產線即將完工,估可增加三成新產能,在中國擁有符合新版GMP規範的藥廠,未來可望成為中國癌症原料藥龍頭,其美國客戶Vivus減肥新藥獲FDA藥證,這是13年以來FDA「唯二」被核准有關調整體重的新藥,預估第4季上市銷售量將很可觀,其原料藥由神隆獨家供應,第3季出貨量就會增溫,股價完成中期頭肩底,上周突破所有均線,法人大買,為一檔下有撐、上無壓的生技潛力股。(作者是萬寶投顧證券期貨雙證分析師)【2012/07/23 經濟日報】

中國及國際生物藥企將從政策和市場契機中獲益


 2012/07/23 07:14上海2012723 /美通社亞洲/ -- 中國《生物醫藥「十二五」規劃》為生物藥行業發展帶來巨大潛力。據統計,「十二五」期間生物醫藥總產值年均增長20%,到2015年將突破達到3萬億元。生物藥及生物仿製藥生物技術、藥物分析和臨床研究領域正在歐美和中國等其他醫藥新興市場穩步增長,快速發展的行業為生物仿製藥帶來巨大的發展空間,然而藥企進入這個市場機遇與挑戰並存:
--全球生物仿製藥法規有待完善:歐盟是當前最完善的關於生物仿製藥法規政策體系;美國FDA已頒布生物仿製藥批准指導意見草案;中國等醫藥新興市場政策制訂嚴重落後於製藥行業的發展。
-- 「重磅炸彈」藥物專利紛紛到期,專利糾紛上升。
-- 小分子化合物藥物審批持續下降。
-- 各國藥企研發成本上升。
-- 跨國藥企正在從大分子領域尋求潛在高利潤的產品線。
-- 經濟危機、法規環境的不明確使生物藥發展和化學小分子藥物發展趨勢截然不同。 2012中國生物藥峰會關注生物藥企共同關注的熱點問題,120位來自政府機構、國內藥企、跨國藥企等決策者將共同深入探討區域性法律法規更新、專利到期、高利潤市場及產品、抗體類生物仿製藥、臨床試驗、工藝流程等熱點內容。為期兩天的會議將幫助中國及在華跨國藥企了解全球生物藥的法規和申報程序、對藥品研發程序與質量體系建設要求等內容。各演講嘉賓將現場解答企業在實際註冊申請和生產中遇到的問題。來自葛蘭素史克公司,麗珠醫藥集團、惠生集團、上海嘉和生物藥業等藥企的高層演講嘉賓將介紹全球生物藥及生物仿製藥市場的最新動態及對中國藥企的發展機會,並介紹如何選擇高利潤市場與生物藥品種,最大化投資回報。 關於如何優化技術與開發策略的議題也將幫助生物藥企了解自身差距與改進策略,從當前政策和市場發展契機中脫穎而出。深入探討的話題將主要包括單抗、臨床前、臨床、CMC、分析檢測、生產工藝等領域。參與演講與案例分析的領先藥企包括:江蘇恆瑞醫藥的醫學執行總監蔣皓媛女士,賽諾菲安萬特的中國研發中心臨床前主管和全球臨床前藥物安全評價總監楊毅,安進公司大中華區執行醫學總監黑永疆等。 該會議將於913-14日在上海舉行。如欲獲得更多有關2012中國生物藥峰會信息,請參見www.nextbio-china.com 或致電:021-6157391961573930 CPhI中國生物藥峰會(Nextbio China)是CPhI(世界製藥原料展)定期在醫藥領域舉辦的專業會議活動之一,並已被醫藥行業高端專業人士廣泛熟知。其他相關活動還包括了CPhI中國仿製藥峰會(Nextgen China)、CPhI醫藥中國峰會(CPhI Onsite Module Conferences)、新型給藥系統中國峰會 (NDDS China) 等。消息來源CPhI Conferences 

3-D tumor models improve drug discovery success rate


 July 20, 2012 in Medications Imagine millions of cancer cells organized in thousands of small divots. Hit these cells with drugs and when some cells die, you have a candidate for a cancer drug. But a review published this week in the journal Expert Opinion on Drug Discovery argues that these 2D models in fact offer very little information about a potential drug's effects in the body and may often give researchers misleading results. "Up until the 1980s animal models were the standard for cancer drug discovery. However, with the increase in the number of compounds available for testing and the advent of high-throughput screening (HTS), the use of animals to discover cancer drugs became too costly and unethical. Consequently, 2D cell culture models have become the mainstay for drug discovery or to explore a drug's mechanism of action," says Dan LaBarbera, PhD, investigator at the University of Colorado Cancer Center and the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. LaBarbera is principal investigator of the recent review, on which he collaborated with Skaggs colleagues Brian Reid, PhD, and Byong Hoon Yoo, PhD. LaBarbera cites the gap between results in 2D cells and effects in tumors themselves as a contributing factor for the declining rate of drugs passing FDA approval. In particular, only 5 percent of investigational new drugs targeting cancer make it through clinical trials, at a cost of about $800 million per drug. When you factor in the inevitable failures at various points in development, each approved drug costs an average $1.5 billion. To increase the drug success rate, LaBarbera suggests something called the multicellular tumor spheroid (MCTS) model. In these models, instead of 2D monolayers, cancer cells are cultured as 3D spheroids. One of the advantages of the MCTS model is that when spheroids reach a critical diameter, they begin to form an outer proliferating zone, an inner quiescent zone, and a central necrotic core – more faithfully mimicking the microenvironments of human tumors. Additionally, spheroids can be grown in the presence of compounds that mimic extra cellular matrix – the environment that surrounds and very much affects the growth and behaviors of human tumors. Why pay more? Save on Quality Monoclonal Antibodies & much more! - www.anogen.ca Instead of indiscriminately killing cells, modern cancer drugs tend to target cells with very specific genetic mutations that turn on and off very specific growth and survival mechanisms that in turn very frequently depend on everything else going on in and around the cells. Using MCTS models, researchers can ask questions about how a drug will penetrate a tumor's heterogeneous 3D structure and how a drug will interact with the environment surrounding these tiny tumors. "Though these MCTS models have been around since the 1970s, only recently has technology made it possible to use them in place of 2D models for the high-throughput screening used in drug discovery," LaBarbera says. Remember those millions of cancer cells organized in independent divots that researchers hit with drugs? We're fairly tied to the technology that reads the results of these divots. But micro-technologies now allow multicellular tumor spheroids to be cultured in place of 2D cell cultures using high-throughput micro-well plates – we can use the same drug testing machinery on these new models. Likewise, materials science technology now exists to grow cells within semipermeable membranes, helping researchers define the shape of the eventual spheres. And as futuristic as it undoubtedly sounds, magnetic cell levitation can help alleviate the problem of cells sticking to the plastic well surface, which limits spheroid growth. The recent practicality of high-throughput MCTS screening leads LaBarbera to call today a "renaissance" for the technique. Of course, this 3D testing is initially more expensive and more challenging. "A lot of researchers try to get cost down to pennies per well – you can see how screening millions of compounds equals millions of dollars – but this often leads to a higher cost down the road due to a lower success rate. Yes, it may cost more to do HTS with 3D models, but in the long run it may lead to higher success rates and so decreased costs," LaBarbera says. LaBarbera suggests that another use of the systems biology approach made possible by 3D models like MCTS is to bridge the gap between high-volume, low-accuracy screens and more involved testing in animal models. "We envision a future in which MCTS arrays enable a convergence of systems biology and chemical biology, improving the success rate of drugs in the pipeline of discovery," LaBarbera says. Provided by University of Colorado Denver
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