2012-06-22 02:04 工商時報 【記者杜蕙蓉／台北報導】台灣浩鼎（4174）研發乳癌末期標靶藥OPT-822，高達200億美元（約5,920億元台幣）商機，引爆台美股東大戰，由於本案戰火延燒，原本預計六月上興櫃掛牌的日期被迫延後，這也凸顯台灣發展新藥之路確實坎坷。 乳癌末期標靶藥OPT-822，的龐大商機，是引爆美商身兼台灣浩鼎、美國OPTIMER董事長張念慈下台的導火線，戰火從搶藥風波延燒至股權之爭，戰線從美國打到台灣。 據了解，為捍衛可能是華人研發的第一個新藥OPT-822，目前潤泰集團董事長尹衍樑已結合永豐金、富邦金、玉山金等股東以台灣股東持有約58％股權對抗OPTIMER持有台灣浩鼎的42％股權。 一名不願具名的台灣浩鼎董事表示，此起戰火，基本上就是OPTIMER覬覦OPT-822/821而使出的小手段。 OPTIMER和台灣浩鼎都是張念慈創辦，OPTIMER研發用於治療偽膜性結腸炎的新型抗生素Dificid，去年順利在美國FDA拿到上市藥證，而且也成功以2.24億美元授權日本藥廠安斯泰來（ASTELLAS），銷售歐洲市場權利。為順利行銷Dificid，張念慈引進曾經任職於輝瑞藥廠的行銷團隊到OPTIMER，並讓他們擔任董事長和CEO等要職，詎料，由於台灣浩鼎投入研發治療乳癌藥的822，完成台、美二期臨床後，雙盲測試效果頗佳，被生醫界認為成功率極高，為此，OPTIMER新團隊對822興趣濃厚，於是趁著台灣浩鼎正準備推動在台灣上市下，先搶下「優先授權」權利，但OPTIMER也同意由原本持有60％股權降至42％。 不過，OPTIMER雖有優先授權權利，但822光是乳癌藥潛在商機即高達200億美元，更何況它還有8個適應症，因此未來若有國際大藥廠來談海外授權，以OPTIMER目前規模，根本無法與國際大藥廠競爭，優先授權只能流於紙上作業。為此，OPTIMER希望直接把台灣浩鼎納入可掌控的公司，但這與張念慈和台灣股東想要在台灣建立一個由台灣成功開發新藥的理念不合，於是OPTIMER的董事在美國時間4月9日 以張念慈要拿150萬技術股送給對822開發有功的「疑似利益輸送」為由，一口氣撤換張念慈在台灣浩鼎董事長的職位，同時也解任研發副總許友恭和財務長等老臣，上演一場逼宮和美國人打台灣人戲碼。 只是後來事實證明台灣浩鼎在申請公開發行和上興櫃過程中，並未執行技術股，蒙受不白之冤的張念慈，也狀告OPTIMER還其信譽，成為前董事長告自己公司的窘狀。
Sunday, June 24, 2012
Shanghai Institutes of Preventative Medicine, Gentris sign MOU to advance personalized medicine
Published on June 22, 2012Gentris® Corporation (www.gentris.com), a
global leader in the application of genomic biomarkers to clinical studies,
announced today that it has signed a Memorandum of Understanding with the
Shanghai Institutes of Preventative Medicine to advance global personalized
medicine. The goal of this USA-China collaboration is to create translational
research and epidemiological projects, as well as training and education
programs, focused on pharmacogenomics and clinical sample banking, which will
drive innovation in drug development and improvements in patient care.Through
this collaboration, Gentris and the Shanghai Institutes of Preventative
Medicine will work together to launch cutting-edge research projects to
discover, develop, and validate new genomic biomarkers. Gentris will take the
lead to identify sponsors in the United States Shanghai United States and China China
to begin establishing a satellite laboratory for Gentris in Shanghai
that complies with U.S. Shanghai
Municipal Center
for Disease Control and Prevention (Shanghai CDC),and Dr. Howard McLeod from
the University of
North Carolina United
States and China
北榮院長林芳郁…健保局應腳踏實地…!
醫療困境 林芳郁：看不到未來 2012/06/24 20:03:00（中央社記者龍瑞雲台北24日電）台北榮民總醫院院長林芳郁今天表示，整體醫療制度與環境都面臨困難，醫療人員如廉價勞工。他說，若不立即重建醫療制度，「醫療體制將在5年到10年內瓦解。」中華醫學會今天舉辦「101年度會員大會暨聯合學術研討會」，議程安排除針對內、外、牙科進行專題研討會，也增加醫學人文教育與中西醫整合治療的討論。中華醫學會理事長暨台北榮民總醫院長林芳郁在會後受訪時表示，內、外、婦、兒、急診五大皆空是已知的，還有急重症醫療、癌症治療等方面醫護人力都因整體醫療制度與環境，面臨危機，可以說是「看不到未來」。林芳郁表示，醫療占GDP（國內生產毛額）不到6%，醫護人力被當成便宜勞工或外勞運作，所以就只好跑了，因為還有其他的選擇。他說，整體制度需要重新檢討，大家一起來討論如何建立好的制度，現在重建還來得及；若沒有想辦法解決，在可預見的5年到10年間，醫療體制將會瓦解。林芳郁指出，健保局為解決五大皆空問題加碼健保給付與相關費用，但健保費用是固定的，加碼是拿別科別的來補，「這是揩別人的油，非腳踏實地的方法，這種做事方法屬便宜行事。」他說，醫療強調團隊合作，加碼是拿別的科的錢來補給另一科別，建議健保局腳踏實地，另編預算。他指出，健保不能全包，社會福利應該是由政府編列預算，例如罕見疾病可由社會福利支付、車禍是由商業保險支付，「健保是社會福利還是社會保險，這個要先釐清楚」。
Just a blood test....predict improper growth of fetus
Published on June 22,
2012Researchers from the Ottawa Hospital Research Institute (OHRI) and the University of Ottawa Ottawa and Kingston
東洋開發特殊抗生素用藥Lipo-AB TFDA藥證到手 歐洲藥證努力中 !
東洋 歐洲藥證 將到手【經濟日報╱黃文奇】 2012.06.24 03:24 am 產業評析：東洋（4105）為台灣前3大學名藥廠，近年致力發展高階學名藥，也切入蛋白質藥物市場；以一般學名藥及高階學名藥為公司營運成長的雙引擎。看好理由：東洋開發特殊抗生素用藥Lipo-AB，順利取得衛生署核發藥證，並申請歐洲藥證，公司規劃明年中前可望拿下歐洲藥證。投資策略：東洋22日股價上漲1.00元，以117.50元作收，日線呈多頭排列，6月12日 以後量增價揚，KD開口向上，投信近5日連續買超共1,800多張，外資連四日賣超近700張。【2012/06/24 經濟日報】
東洋 建構亞洲癌症最大針劑供應中心 !!!!!
東洋線型多頭排列，續航力道佳 2012-06-24 【時報-台北電】 東洋（4105）挾著微脂體可望獲國際代工大廠訂單，激勵營運大舉成長外，轉投資事業以治療胰臟癌新劑型藥的智擎生技，預計8月可望上櫃掛牌，近日股價表現突出，上周五股價收117.5元、上漲1元，創近2個月收盤價新高。由於技術線型和KD指標呈現多頭排列，使後市應有續航力道。東洋今年起將主打用於治療抗感染的Lipo-AB和抗癌用的Lipo-Dox，目前已規劃中壢廠專責癌症針劑的生產，預估第3季微脂體批次量將達6,000支，整體癌症針劑量2013年將上看100萬支，挑戰亞洲最大針劑供應中心。(新聞來源：工商時報─記者杜蕙蓉／綜合報導)
America’s biotech future needs political support
06-22-2012 17:41 By Fareed Zakaria NEW YORK ― It's hard to find any good economic news these days. Europe is teetering on the brink, emerging markets such as China, Brazil and India are slowing down, and the United States is in a slump. There is one bright spot on the American landscape: technology, particularly biotechnology. The cost of sequencing a human genome is down to $1,000, and the process now takes two hours ― a pace that is much faster than ``Moore's Law," which says that computing power doubles while its costs drop by half every 18 months. This technology revolution is already transforming whole industries. It is a reminder that, as we confront difficulties across the economic landscape, one area where the United States can still grow stronger is science and technology ― if we make the right decisions. Take, for instance, the decision to map the human genome. The federal government funded that project at a whopping $3.8 billion cost, over a 15-year period. But consider the payback. One study ― funded by the industry ― calculates that the Human Genome Project has helped drive $796 billion in economic activity and raised $244 billion in personal income; it supported 310,000 jobs in 2010 alone. These numbers may be exaggerated, but the scale of the impact is clear across such vast fields as agriculture and medicine and new areas such as gene therapy. A lot has been said about the government's $535 million loan to Solyndra, which was indeed a bust. But how often do you hear about the Human Genome Project? ``From a simple return on investment, the financial stake made in mapping the entire human genome is clearly one of the best uses of taxpayer dollars the U.S. government has ever made," says Greg Lucier, chief executive officer of Life Technologies, whose foundation sponsored the study cited above and whose company produces the $1,000 gene-sequencing technology. Lucier, and many scientists, argue that we're at the beginning of a new wave of biotechnologies that could be applied to produce food, fuels and medicines, and to counteract problems such as pollution and climate change. Federal funding for research and development ― a drop in the bucket compared with farm subsidies ― has long been in decline. From 1970 to 1995, it fell as a percentage of gross domestic product by 54 percent in physical sciences and 51 percent in engineering. Federal R&D funding increased slightly in recent years but has resumed its long-term slump ― just as China and South Korea are increasing their funding 10 percent year over year. The budget for Turkey's government agency for science and technology is slated to grow 15-fold over the next 15 years. In a knowledge economy, American jobs will depend more on scientific research than they did in the 1950s, yet we spend much less as a share of GDP.Government investment in basic science has had huge commercial payoffs. For example, 13 Nobel laureates had devoted major parts of their careers to cholesterol research before cholesterol-reducing statins came to market. Now it is the largest-selling class of drugs in the world. Funding existing technologies is more complicated. Sometimes it works. The Air Force and NASA were the only buyers of semiconductor chips when they were first manufactured in the 1950s and through the early 1960s ― when costs started plummeting and private industry got interested. Or consider ``fracking," a technology that was developed using Energy Department grants and loans starting in the late 1970s. On the other hand, there are Solyndra and many flops like it. Even here, however, the case for funding basic science is unimpeachable. If solar panels are to become a subsidy-free form of energy, the breakthrough will come at the level of basic science, in cheaply producing highly efficient alternatives to silicon. Several companies have started using compounds that are now expensive, one of which, Alta Devices, occupies an office building that once served as the headquarters for Solyndra. There is more to encouraging science and technology than simply funding. Government rules and regulations play a large role. Kiran Mazumdar-Shaw, the dynamic founder of one of India's powerhouse pharmaceutical companies, Biocon, argues that the entire American-style set of regulations, clinical trials and lengthy waiting periods is a serious deterrent to innovation in drugs and in pharmaceuticals more generally. ``It takes 12 years to get a drug from conception to market," she says, ``while it took six years to get the Airbus A380 from the drawing board to flying in the skies." The science and economics of large-scale increases in support of science and technology are clear. As usual, the politics is the problem. Fareed Zakaria's email address is comments@fareedzakaria.com.
智擎上櫃案
櫃買中心董事會通過智擎、瓦城、鮮活上櫃案 2012/06/22 17:46 精實新聞 2012-06-22 17:45:41 記者 林詩茵 報導 櫃檯買賣中心於今(22)日召開第6屆第36次董事、監察人聯席會議，會中討論通過「證券商營業處所買賣有價證券業務規則」等修正條文；另討論通過智擎生技製藥(4162)、瓦城泰統(2729)及外國發行人Sunjuice Holdings Co., Limited(鮮活控股股份有限公司)申請股票上櫃案。
FDA tracks rising impact of the 'placebo effect' in antipsychotic trials
June 22, 2012 | By John Carroll One of the big conundrums in the neurosciences branch of drug discovery is the ever-present threat that a therapy that delivered sterling proof-of-concept data in Phase II will go down to defeat in late-stage studies, often because the placebo response suddenly spikes. That placebo wild card helped drive GlaxoSmithKline ($GSK) and others out of CNS. And now a study by the FDA underscores how rising placebo responses have been eroding the treatment benefits that have been recorded in schizophrenia studies over the past two decades.The investigators set out to see how the second-generation antipsychotics compared to some of the breakthrough medications studied in the early '90s. Dr. Thomas P. Laughren, who runs the agency's division of psychiatry products, concluded that the rising placebo response made it appear that the more expensive second-gen therapies--like Risperdal and Zyprexa--had a smaller effect on patients.The rising placebo response has had a definite impact on the odds of success in clinical studies, says Laughren, according to a Reuters report. Theoretically, the placebo response could be due to the better relative health of patients being recruited for the studies. But frankly, the FDA doesn't know exactly what caused it. And now Laughren plans to dig deeper, studying the individuals included in trials.
Many psoriasis patients undertreated for CV risk factors
June 22, 2012 in Diseases, A large proportion of patients with moderate-to-severe plaque psoriasis are underdiagnosed and undertreated for cardiovascular risk factors, according to a study published in the July issue of the Journal of the American Academy of Dermatology. (HealthDay) -- A large proportion of patients with moderate-to-severe plaque psoriasis are underdiagnosed and undertreated for cardiovascular (CV) risk factors, according to a study published in the July issue of the Journal of the American Academy of Dermatology. Alexa B. Kimball, M.D., from Harvard Medical School in Boston, and colleagues reviewed the medical histories, including glucose, lipid, and blood pressure levels, of 2,899 patients with moderate-to-severe psoriasis participating in three phase III ustekinumab trials. The researchers found that there were significant risk factors in patients with moderate-to-severe psoriasis, with 58.6 and 28.8 percent of patients, respectively, having two or more and three or more CV risk factors. The risk of CV events, based on Framingham risk score, was high for 18.6 percent of patients and intermediate for 12.3 percent of patients. A small proportion of patients with diabetes, hypertension, or hyperlipidemia were undiagnosed at baseline (2.3, 9.1, and 4.9 percent, respectively). A higher proportion were untreated at baseline (19.1, 21.8, and 38.6 percent, respectively), and the proportion achieving the treatment goal was not ideal (36.7, 59.6, and 69.7 percent, respectively). "In summary, study findings highlight the fact that despite a growing recognition of the association between psoriasis and CV risk, a high proportion of patients with psoriasis severe enough to qualify for clinical trial participation have unrecognized or inadequately treated CV risk factors," the authors write. Several authors disclosed financial ties to the pharmaceutical industry.
How the FDA regulates pharmaceutical apps
By: admin | Jun 20, 2012 By Bradley Merrill ThompsonMobile apps seem all the rage in the pharmaceutical industry.According to the website InPharm, there are presently over 100 of them publicly available. Based on what I'm hearing from pharmaceutical companies directly, that's only a small number compared to the apps in development.Recently there's been a debate going on in the UK about whether pharmaceutical apps are medical devices under EU law. Consulting firms Bluelight & d4 suggested in a January report that many health-related apps are indeed medical devices in the UK. Specific to pharmaceutical apps, the report suggests that at least in the UK "if your app will be associated with, contributes to or makes a clinical decision, assume that it will be classified as a medical device…." The report stirred quite a controversy among champions of innovation and free speech.In the US, there've been a couple of events recently that have caused pharmaceutical companies to focus on these issues. First, FDA held a public hearing in March to take testimony on whether greater reliance on patient decision support software could allow certain drugs to be switched from prescription status to over-the-counter. That prompted companies to wonder how such software would be regulated. Further, on May 18, in an issue briefing for congressional staff, Dr. Jeff Shuren, the director of the center at FDA that regulates devices, spoke plainly about the agency's intention to deregulate certain apps used for low-risk pharmaceutical management.In my series of posts on this website 2 years ago, I laid out the basics of FDA regulation of mHealth. Now I'd like to expand that to address FDA regulation of pharmaceutical apps.
Regulatory CategoriesThe starting point is to understand the four different possible regulatory categories into which pharmaceutical apps might fit. Those four categories are:
1. Heaven on Earth, a.k.a. Apps not Actively Regulated by FDA.Just about everyone wants their app to be unregulated. And Utopia it nearly is. But, not to be a Debbie Downer, I need to be clear this just means unregulated by FDA (and even that status may change in the future).Most apps would still be regulated by the Federal Trade Commission, and indeed it was FTC that brought one of the first enforcement actions against a mobile app developer. Further, nearly all apps would be subject to state regulators, Lanham Act challenges by competitors, and tort law if they hurt somebody.So it's probably still a good idea if app developers exempt from FDA regulation nonetheless test their apps to make sure they work.
2. Drug labeling. FDA law makes it clear that information provided by a pharmaceutical company in support of its drugs qualifies as a regulated drug labeling even if it is not physically near the drug itself. Generally there are two kinds of labeling:Prescribing information—also sometimes referred to as product labeling or a package insert—provides carefully crafted information regarding instructions for use.This information is highly regulated and, for new prescription drugs, is the subject of much negotiation between the manufacturer and the agency. Promotional labeling—is used to help sell the drug. This kind of labeling comes in all different shapes and sizes from brochures and booklets, videotapes, refrigerator magnets, cups and other giveaways to virtually anything else where a pharmaceutical company tries to convey a message about its drugs.There are different levels of promotional labeling; for example, a reminder advertisement is intended merely to convey the brand name. A full discussion of the contours and scope of promotional labeling is well beyond this post, but suffice it to say that apps and other software used to convey information about a prescription drug will typically be regulated at least as drug labeling. As such, the labeling must include (at a minimum) full prescribing information, and perhaps need to be filed with FDA at time of first use.
3. Medical device. Yes, I said a medical device. In my previous posts, I explained the medical device definition ad nauseum, and I don't want to bore you with the details of that again. Basically software, if intended for a medical purpose in the treatment or diagnosis of disease, can be a medical device.In the guidance document FDA published last summer on mobile medical apps (MMA), FDA outlined its thinking on when mobile medical apps would constitute a medical device. A specific category mentioned in that guidance is standalone clinical decision support (CDS) software, or software that is not connected to any medical device but provides information used in the treatment or diagnosis of disease. The agency explained that it was beginning a process to refine its definition of the scope of regulated CDS, and then they held a public workshop on the topic in September of 2011. At that workshop, FDA suggested that there were three primary elements to CDS, including:
Data taken from any source, for example, a medical device, environmental data or demographic data; A conversion, by which the FDA seemed to be referring to the use of algorithms, formulas, database lookups or other analytic steps to produce; An actionable result, which I understood to have two key defining characteristics: (i) a specific patient and (ii) a specific recommendation, not a list of possibilities. The agency then gave some examples of what they would consider CDS, and offered up BMI calculators, trending algorithms, medication reminders and drug/drug interaction software to be examples of low-risk CDS. On the high-risk side, the agency mentioned radiation dose calculators, medical imaging analyzers, cancer treatment software and complex analyzers for untrained users.The agency is working on a CDS guidance, but in the MMA guidance the agency made it clear that it does not plan to regulate:
Electronic copies of medical textbooks; Apps that are simply used to provide clinicians with training; Apps that are used for general health and wellness, and not disease; or The traditional electronic health record apps used as an electronic health record. FDA also indicated that they would use enforcement discretion to hold back on regulating certain apps they consider to be medical devices, but that are low-risk. The draft guidance wasn't very specific, and hopefully the final guidance will elaborate more, but in a footnote (#13) FDA mentioned apps "that may meet the definition of a medical device [and] have functionality either to automate common medical knowledge available in the medical literature or to allow individuals to self-manage their disease or condition." Remember, always read the footnotes!As I mentioned above, on May 18, 2012 Dr. Shuren spoke at a Capitol Hill briefing where he revealed a little bit of the agency's thinking. He explained that the items listed above are low-risk CDS and would likely not be actively regulated. Putting the pieces together, it would seem that although FDA might say that they qualify as medical devices, they plan to exercise enforcement discretion and not regulate them presently. Dr. Shuren specifically mentioned not regulating:Educational tools (e.g., apps that provide a list of questions to ask physicians); Medication reminders for therapy adherence; Simple, common calculators (e.g., for tabulating an apgar score);
BMI calculators; Drug-drug interaction formulae; Diabetes management guides (e.g., nutritional guides or pre-diabetes risk assessments); and Substance abuse behavior guides. Because it was part of an informal panel discussion, we don't have much detail on specifically the scope of each of those categories.
4. Combination products.This category only applies if the app first is a medical device. If that's true and the app cross-references a drug to be used with the app, and if likewise the drug cross-references the app to be used together, that creates what is called a combination product. Below I'll give some examples of combination products, but for the moment it's simply important to understand that if an app and a drug together constitute a combination product, it means the FDA regulatory process gets a bit more complex. Literally it means that two different centers at FDA—the drug people and the device people—get actively involved in regulating the product. FDA has put in place some procedures for improving the coordination of the reviews between those two centers, but it is not without its challenges.Okay, that's the background. Now let's get to the interesting stuff: the apps.The easiest way to organize this part of the discussion is to divide the apps between those for professionals and those for patients.Apps for Healthcare Professionals
There are a ton of different apps for professionals that relate to pharmaceuticals, so I thought I would just pick a few of the more common categories to discuss.
1. Drug labeling.I'll go out on a limb and say that a drug labeling app ordinarily would be regulated as "drug labeling."If an app is an electronic version of the approved drug labeling, then the FDA requirements for drug labeling apply, including, for certain products, submission to FDA at the time of first use and all the other rules around the content itself. For the most part, FDA doesn't allow manufacturers to mess around with the package insert, and there are many, many restrictions on promotional labeling. The good news is they should not be medical devices. The draft MMA guidance says FDA does not regulate "Mobile apps that are electronic 'copies' of medical textbooks, teaching aids or reference materials…. These types of apps do not contain any patient-specific information…." So as long as the app doesn't add functionality like a dosage calculator or decision support, it's just labeling.
2. Drug dosage calculators.Here I wish I had better insight to offer you. The only thing I really know is that not all drug dosage calculators are created equally. On the one hand, Dr. Shuren in his recent comments called out simple calculators as likely to be unregulated. That's terrific. On the other hand, in September 2011, in a speech on clinical decision support software, the agency identified radiation dose calculators and software used to determine chemotherapy as very high-risk CDS. Further, as stated in the draft MMA guidance, "the FDA has previously classified software that calculates a drug dose based on a patients height, weight, mass, and other patient-specific information as a 'Drug Dose Calculator' under 21 CFR 868.1890." That classification includes mostly insulin calculators, and places them in class II, which is for moderate risk devices that typically require premarket clearance from FDA.So basically I don't know what to tell you except some are regulated and some aren't.Hopefully we will learn more soon.
3. Drug/drug interactions.Here Dr. Shuren's recent remarks would suggest that most apps or other software that look for drug/drug interactions will not be regulated. While his comments were very general, we didn't hear any particular limitation on that, so presumably that functionality, even if found in electronic health record software, would be unregulated. But again, it will be nice to see that in writing.
4. Decision support apps.Above I gave an explanation of the category called CDS software, and everything I said would apply equally if the software constitutes an app on a mobile platform.So basically we need to wait to see what FDA publishes here. All indications point to FDA taking a similar approach to the one they took with mobile apps where they stratified the types of software based on risk and proposed only to regulate the riskiest. As to where they draw the line, that will be the interesting part.
5. Clinical trial management.As I understand it, there's a whole slew of apps being developed for many different functionalities that will be useful as a part of drug clinical trials. To create the chart below, I borrowed the categorization of these apps that was developed in, "Opportunities: Advancing The Pharmaceutical Industry Through Mobile Technologies," an ArcStream Solutions Whitepaper.Frankly, all of the functionalities have potential FDA requirements that apply.
6. Adverse event data management.Frankly, no one should accuse FDA of not being hip. Not only are they making major forays into social media—you can look at their Flickr page and see pictures of all the lovely items that are being recalled—but they're also developing their own app. On June 6, the agency provided an update on its plans to develop an app that will allow doctors to directly report to the FDA adverse events associated with regulated articles. This app—which will be a suped up version of the already available MedWatcher app— will allow for portable, instantaneous reporting of drug reactions.The ultimate goal is to allow collecting video and images of patient reactions; recording audio of medical histories; and displaying geographic trends and mapping clusters of incidents using GPS data.Actually that sounds pretty cool. I wonder if it's a medical device, and who would regulate it?
7. EHR functionality.FDA has said over and over again that it does not actively regulate the EHR. For example, in the draft MMA guidance, FDA explains that it does not plan to regulate "Mobile apps that perform the functionality of an electronic health record system or personal health record system."That seems clear. The ambiguities arise when an app goes beyond the functionality of merely storing and retrieving data entered manually based on a healthcare professional's observations.For example, a software app that stores data from a medical device is itself a medical device, and goes under the name of medical device data system, or MDDS.Functionality that goes beyond mere storage and retrieval to add an analytical piece can be CDS. So in the future it will be interesting how broadly or narrowly FDA interprets what is an electronic health record.It's hard to make any generalities regarding these apps to be used by healthcare professionals, but certainly some of them address uses that carry with them risk.This area should be significantly clarified when FDA publishes its guidance on CDS, perhaps later this year.
Apps for PatientsUsually apps for patients address less important subjects, but on the other hand involve people who may have very little training or expertise in the task at hand.Balancing those out, it seems as though these apps present a wide range of risk.Some of the apps discussed above can be targeted at patients (e.g., CDS apps that help patients make self-diagnosis or therapeutic decisions). I won't repeat any of those topics here. Instead, I'll go through a few apps that are uniquely tailored to patients.
1. Public toilet finders.I'm over 50, so I really like the sound of this app.Pfizer cleverly developed this app with which the user community can note the location of bathrooms and rate them based on cleanliness and other factors. Pfizer launched the app for Israel, where I understand it can be difficult to find a public restroom.Why Pfizer? I suppose it might have something to do with the fact that they have a drug for overactive bladder. If this app were introduced into the United States, which it was not, the question would be whether the app constituted promotional labeling for the associated drug. Sometimes the connection between the drug and the supposed labeling can be pretty remote.
2. Drug reminders.As I understand it, there are many different apps that provide drug reminder functionality, and the functionality can be based on different technologies. Some can be just a manual programming of an app to alarm at a given time, while others might be reminders sent by the health professional.In any event, if they're like an alarm clock that simply reminds you that it's time to do something, that's pretty low risk, and according to Dr. Shuren it won't be regulated as a medical device.Further, the Draft MMA guidance says certain reminders are medical devices but FDA will defer regulating "mobile medical apps that: log, track, and graph manually-entered (keyed in) data that lead to reminders or alarms." If the app is branded to work with a particular drug, it might fall into the drug labeling category.
3. Drug tracking logs.Compliance with medication regimens is a big issue for many patients, and doctors want as much objective evidence as they can obtain. So it can be quite useful for patients to keep track of what drugs they take and when. In its draft MMA guidance, FDA elects to defer regulating "Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment or mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. Examples of these apps include dietary tracking logs [and] appointment reminders…."So I have to point out that the language very clearly does not exclude from regulation apps that track drug usage. That language, which I've seen misapplied by some commentators, is expressly limited to functionality related to wellness, not the treatment of disease. Drugs, by their very definition, are used to treat disease. So are drug tracking logs regulated as medical devices? I have no idea.
4. Smart pill apps.By now most people are well aware of the ability to use technology to measure very precisely the exact time the pill is ingested, for purposes of tracking drug compliance. It should come as no surprise that the software used to manage that technology will at least be a medical device, if not also in some cases a combination product.
5. Apps that are a condition of drug sale. Public health officials have long been trying to figure out ways to improve medication adherence.For a variety of reasons, people just don't take their medicine. Sometimes it's because the regimen for taking the medicine is pretty darn complicated, and sometimes it's because people just don't want the hassle and the cost of getting the prescription in the first place. FDA thinks apps can help with that. Apps that use what would amount to CDS functionality can help people decide whether they need medications for certain common and chronic diseases such as high cholesterol or high blood pressure. Further, as discussed above, apps can help instruct people on how to properly take their medications.There is so much potential here that FDA is actually thinking about switching certain common medications for chronic diseases from prescription status to over-the-counter, but on the condition that the patient makes use of the software. In FDA's early thinking, the software might be available at the pharmacy or through some other means. FDA held a hearing on this topic on March 22 of this year, and sought comments. From a regulatory standpoint, software used in this manner may very well constitute either drug labeling or a medical device, for example, CDS. If it is CDS, it's quite likely that the drug and device pair would be considered a combination product.I covered a lot, so I thought I would summarize this post in the following chart showing the possible regulatory categories for these types of patient apps.
ConclusionThis is an exciting time to be in healthcare. There is so much innovation going on that offers much potential.I truly believe FDA appreciates that and wants to be part of the solution.We in industry all have to recognize FDA's role in protecting patients from stuff that doesn't work.In healthcare, we can't put a piece of software on the market in beta form, see if it hiccups, and then fix it. So several of these apps will be FDA regulated. Fortunately, though, many of them are very low-risk and I suspect FDA has no interest in slowing down the incredible possibilities.We will simply have to wait to see how FDA draws the lines.At the same time, FDA can't develop thoughtful approaches without public input, so I would encourage you to get involved in the ongoing public discussion with FDA.
TFDA與大陸中檢院 醫藥品檢驗技術交流 !
(發布日期2012-06-22)延續去(100)年8月15日衛生署食品藥物管理局(TFDA)康照洲局長與前大陸食品藥品監督管理局(SFDA)邵明立局長會談後，所建立兩岸醫藥品業務主管部門制度性的工作框架平台，雙方將共同舉辦醫藥品檢驗技術交流研討會，以就醫藥品(包括藥品、醫療器材、健康食品及化粧品)的檢驗檢測規範、認證認可標準及實驗室量能進行交流。故TFDA、中國大陸食品藥品檢定研究院(簡稱中檢院)以及福建省藥檢所共同主辦之「第一屆海峽兩岸醫藥品檢驗技術交流研討會」，於101年6月6-7日在中國大陸福建省福州市舉辦，研討會由雙方學者專家針對藥品(包括中藥)、醫療器材、健康食品及化粧品等之檢驗體系、品質監管方式、檢驗檢測機構認定等進行報告，以促進雙方對彼此的了解。TFDA吳秀英副局長及SFDA國際合作司徐幼軍司長均蒞會於開幕式中致詞，臺灣方面演講的專家學者包括：胡幼圃特聘教授、何國榮教授、鍾柄泓顧問、徐照程教授、溫國慶教授、蔡敬民教授、鄭誠功教授、蘇振隆教授及李元鳳博士等人。陸方則包括有中檢院多位專家，如任德權先生、金少鴻、李冠民、周來生等研究員；以及楊化新、白東庭、林瑞超、沈琦、張慶生等幾位中檢院所長、李靜莉主任等人進行醫藥品監管、檢驗檢測體系與認證認可規範的說明。臺方赴陸參加此一研討會人員包括TFDA、中醫藥委員會、財團法人醫藥品查驗中心、國內醫藥品研發、生產業者，以及檢驗檢測機構等相關人員；陸方參加人員則包括中檢院、大陸各省監局及藥檢所等人員，與會人員突破兩百人。藉由此次研討會，兩岸對彼此的醫藥品檢驗體系及檢驗檢測機構有了更進一步的相互瞭解，有助於兩岸在醫藥品事務合作的推展、醫藥品檢驗技術的交流，並作為未來落實協議內容，以國際標準為原則，積極推動雙方技術標準的協調性，進行醫藥品檢驗合作的基礎，共同為保障兩岸民眾之健康而努力。原出處：TFDA
2012 觀光精英盃全國遊程設計競賽
2012-06-21 15:55:21蘇松濤/報導由中華民國遊程規劃設計協會所主辦的全國「2012 觀光精英盃全國遊程設計競賽」，目的在於提升國內遊程設計規劃的實務技能，並帶動大專院校與高中職相關科系師生學以致用與激發創意的效益。此次比賽受到產官學界的關注，包括交通部觀光局、長榮航空、台糖長榮飯店、溪頭米堤飯店、立榮航空、康福旅行社等蒞臨現場擔任評審與贊助，報名隊伍更高達近百組，競爭相當激烈，學生作品充滿創意與巧思。此次比賽一共來自全國大專院校與高中職93組學生報名參賽，分為大專組－國內旅遊組與來台旅客組，以及高中職組－國內旅遊組與來台旅客組。一路從初賽就競爭激烈，首先必需獲得北中南三區各分區的前2名，始得晉級決賽，總計24組進入全國總決賽。德明財經科技大學行銷管理系二組同學在北區初賽旗開得勝，由會展三甲鄭芝涵、陳慧靈、陳建嘉晉級北區大專組－國內旅遊組決賽，會展三甲季航如、楊雅婷、呂宜臻、陶羽柔、朱芳儀、潘佳綺、張庭雅晉級北區大專組－來台旅客組決賽。6月11日在大同技術學院舉辦全國總決賽，來自各分區的前兩名隊伍果然實力堅強，各隊所設計的旅遊行程也都規畫縝密，揮灑無限創意，有與寵物同遊、台灣農村深度體驗、深度賞鳥行、婚紗之旅、視障家庭旅遊等等。經過一整天的激戰，會展三甲鄭芝涵、陳慧靈、陳建嘉勇奪大專組－國內旅遊組第三名，會展三甲季航如、楊雅婷、呂宜臻、陶羽柔、朱芳儀、潘佳綺、張庭雅獲得大專組－來台旅客組第四名。此次得獎實屬不易，傳統上都是觀光科系學生參加遊程設計競賽，這次也不例外，在觀光系學生的夾擊下，該校行銷系學生以行銷角度力戰群雄，展現出不同凡響之企劃能力及創意火花，在所有參賽隊伍中表現令人為之一亮。感謝行銷系鮑慧文老師及王高樑老師用心的指導，他們是這些同學們成就的幕後推手，不斷累積能力並開花結果，同時也勉勵學生能繼續提升實力，這項競賽對未來學生進入旅行業專業能力之培養具有正向助益。 聯絡人：行銷管理系鮑慧文老師及王高樑老師 電話：（02）26585801ext:5721【中央網路報】
豐苗健身器材享特價
2012/06/22 【桃園訊】豐苗機械專業生產各式運動器材，將內外銷口碑最熱門的三款「M8241PU吸震電動跑步機」、「MS16扭腰轉身機」、「M6500媽媽樂泰式頂級按摩椅」，推出優惠活動。 「M8241PU吸震電動跑步機」，專利的多重避震設計，減少運動傷害的專利Q-跑道，運動可以兼具舒適感。電動坡度超寬跑台44x130cm、大面板LED藍色背光顯示（時間/速度/距離/消耗熱量/心跳顯示）原價29,800元，寵愛價26,800元，跑出好健康。「MS16扭腰轉身機」，自動計算運動資訊（次數\卡路里\時間\輪流顯示）、超大型踏板吸收強裂運動衝擊/減少機械噪音/防滑底座不傷地板，原價4,800元，寵愛價3,800元，幫助雕塑魔鬼好身材。「M6500媽媽樂泰式頂級按摩椅」，人體脊椎呈S型曲線，讓您的背腰和按摩滾輪合成一體符合人體工學設計，偵測背部弧度和肩頸位置，確保不會打到頭，更不會按不到肩頸，大幅改善一般按摩椅的缺失。臀部/大腿/小腿/腳底/氣囊擠壓功能，讓下半身舒暢，可輕鬆按摩到大腿及臀部，擁有10個氣囊表現最為突出的部分，對久站造成的痠痛有舒緩的效果，超大面板，明顯易操作。實木扶手、美觀大方/特大顯示字幕，明顯易操作，原價60,000元，寵愛價39,800元，有如身在泰國皇宮般的高級享受。
醫學院老師 健保中載浮載沉
【聯合報╱王任賢／中華民國防疫學會理事長（台中市）】 2012.06.24 02:02 am 台大醫院院長陳明豐痛批健保齊頭式的給付，是造成內、外、婦、兒、急診五大皆空的加劇原因；更會造成醫療教育、生態嚴重變形，影響整個醫學教育「從根爛起」。其實，醫學生在學校受教育時，根本沒有碰到健保，影響學生價值觀最劇的是老師。若要強說健保會影響到醫學教育，那一定是要先影響到老師，這才是整個問題的關鍵。醫學院老師，都是在醫院中打滾多年的人，也在健保中載浮載沉許久，自己受不了利益的誘惑，進而影響到後輩的學生，這才是醫學教育從根爛起的根源。要把這些完全歸因到健保制度，未免太過牽強。但若因健保制度設計不當，經由影響老師，到影響醫學教育，間接有關當然是脫不了關係的。
健保的齊頭式給付到底對不對？不論哪一科的醫師，在面對病人時，都是要做整體評估的，肯定不能頭痛看頭，腳痛看腳。所以五官科及皮膚科也不例外，這些都是老師教的。所以齊頭式給付是合理的，也是應該做的。病人的整體評估可快可慢，端看看診醫師的聰明程度而定。有些醫師就是龜毛，該自己問兩句就能判定的不敢判，非得靠昂貴的檢查才敢說是或否；該摸摸肚皮就能知道的，也非得抽一大堆血，驗個電腦斷層才敢說。這樣的醫師，人家看十個，他才看一個，還嚷著說齊頭式給付不公平，你說這像話嗎？所以，若要說健保制度設計不良，應該是設計了鼓勵這種醫師的制度。其實醫院的院長，是爽在心裡口難開，因為靠這些醫師作為，讓他賺了更多的檢驗費，還可以有事沒事把醫師抓來罵一頓，說你怎麼耗用了這麼多的資源。那麼健保該如何改，才能減少這些這些醫師呢？最好的制度就是ＤＲＧ（住院診斷關聯群）支付制度，讓每個疾病有統一的給付。這些醫師要做再多的檢查都隨便他，因為超過限度的費用會由這些醫師埋單。此時就會逼得醫師減少非必要的檢查，多用腦筋去思考，多關心病人，避免院內感染。把醫師都強迫變成聰明的傢伙，此時齊頭式的給付方式就不會再被視為不公平了。非常可笑的是，這麼好的ＤＲＧ制度，我國原本要五年內全面到位的，反對最力的就是醫院資方。希望台大醫院能帶頭倡議此制度，拯救從根爛起的醫學教育吧！【2012/06/24 聯合報】
Human antibody for dengue virus isolated
June 22, 2012 by Lin Edwards in Diseases, Conditions, Syndromes(Phys.org) -- A group of scientists in Singapore and the UK have isolated a human antibody capable of effectively neutralizing the mosquito-borne dengue virus. Dengue fever is currently incurable and infects an estimated 100,000 people a year, mostly in the tropics. The only treatment is alleviating the symptoms, which can include intense joint and muscle pain, nausea, vomiting, high fever, and death in severe cases. Dengue virus (DENV) has four strains or serotypes (1 to 4), and a person infected by one serotype produces antibodies that make them immune for life to infection from that serotype, but that usually only give limited or transient immunity to the other three. The newly isolated antibody is extremely effective for serotype 1. The researchers isolated the human antibody, HM14c10, which was formed in the body of a patient in Singapore who had recovered from a DENV1 infection. The antibody turned out to be extremely fast-acting and gave powerful immunity to the virus. The group recruited around 100 recovered dengue patients and found over 200,000 antibodies in total. The HM14c10 antibody turned out to be so powerful that it kills the virus before it is able to infect the cells, according to lead researcher, Professor Lok of the National University of Singapore. After isolating the antibody the researchers carried out experiments on mice and discovered that it functions by stretching across the virus surface, preventing the changes to its surface proteins that must take place for the virus to be able to infect cells. The paper was published in the journal Science Translational Medicine, and the findings may help researchers develop new therapies to treat or prevent infection by the dengue virus. The research showed the antibody to be far more effective at neutralizing viruses than the anti-dengue chemicals now in development. The next phase of the research on DENV1 will be clinical trials to test the antibody on patients infected with DENV1. The team will also continue to check the remaining antibodies in their library to determine if any are as effective against the other serotypes, and they have already found a likely candidate against serotype 2. Another lead author of the paper, Dr Paul A. MacAry of the National University of Singapore said that in Singapore around 90% of dengue fever cases were either DENV1 or 2, and their research should lead to an antibody for each of these strains within about six months. More information: The Structural Basis for Serotype-Specific Neutralization of Dengue Virus by a Human Antibody, Sci Transl Med 20 June 2012:Vol. 4, Issue 139, p. 139ra83. DOI: 10.1126/scitranslmed.3003888
ABSTRACTDengue virus (DENV) is a mosquito-borne flavivirus that affects 2.5 billion people worldwide. There are four dengue serotypes (DENV1 to DENV4), and infection with one elicits lifelong immunity to that serotype but offers only transient protection against the other serotypes. Identification of the protective determinants of the human antibody response to DENV is a vital requirement for the design and evaluation of future preventative therapies and treatments. Here, we describe the isolation of a neutralizing antibody from a DENV1-infected patient. The human antibody 14c10 (HM14c10) binds specifically to DENV1. HM14c10 neutralizes the virus principally by blocking virus attachment; at higher concentrations, a post-attachment step can also be inhibited. In vivo studies show that the HM14c10 antibody has antiviral activity at picomolar concentrations. A 7 Å resolution cryoelectron microscopy map of Fab fragments of HM14c10 in a complex with DENV1 shows targeting of a discontinuous epitope that spans the adjacent surface of envelope protein dimers. As found previously, a human antibody specific for the related West Nile virus binds to a similar quaternary structure, suggesting that this could be an immunodominant epitope. These findings provide a structural and molecular context for durable, serotype-specific immunity to DENV infection. Journal reference: Science Translational Medicine
First study to link risk of cognitive decline to severity of diabetes
Published on June 23, 2012Preventing diabetes or delaying its onset has been thought to stave off cognitive decline -- a connection strongly supported by the results of a 9-year study led by researchers at the University of California, San Francisco (UCSF) and the San Francisco VA Medical Center.Earlier studies have looked at cognitive decline in people who already had diabetes. The new study is the first to demonstrate that the greater risk of cognitive decline is also present among people who develop diabetes later in life. It is also the first study to link the risk of cognitive decline to the severity of diabetes.The result is the latest finding to emerge from the Health, Aging, and Body Composition (Health ABC) Study, which enrolled 3,069 adults over 70 at two community clinics in Memphis, TN and Pittsburgh, PA beginning in 1997. All the patients provided periodic blood samples and took regular cognitive tests over time.When the study began, hundreds of those patients already had diabetes. A decade later, many more of them had developed diabetes, and many also suffered cognitive decline. As described this week in Archives of Neurology, those two health outcomes were closely linked.People who had diabetes at the beginning of the study showed a faster cognitive decline than people who developed it during the course of the study-and these people, in turn, tended to be worse off than people who never developed diabetes at all. The study also showed that patients with more severe diabetes who did not control their blood sugar levels as well suffered faster cognitive declines."Both the duration and the severity of diabetes are very important factors," said Kristine Yaffe, MD, the lead author of the study. "It's another piece of the puzzle in terms of linking diabetes to accelerated cognitive aging."An important question for future studies, she added, would be to ask if interventions that would effectively prevent, delay or better control diabetes would also lower people's risk of cognitive impairment later in life.Yaffe is the Roy and Marie Scola Endowed Chair of Psychiatry; professor in the UCSF departments of Psychiatry, Neurology and Epidemiology and Biostatistics; and Chief of Geriatric Psychiatry and Director of the Memory Disorders Clinic at the San Francisco VA Medical Center.
Diabetes and Cognitive Decline Diabetes is a chronic and complex disease marked by high levels of sugar in the blood that arise due to problems with the hormone insulin, which regulates blood sugar levels. It is caused by an inability to produce insulin (type 1) or an inability to respond correctly to insulin (type 2).
兩岸生技展，中低價生醫股衝
2012-06-23 【時報-台北電】 生醫類股利多不斷，在全球第二大規模的原料藥展26日將在上海開幕，台灣一年一度的7月生技月亦登場，加上太景下周一宣布奈諾沙星授權案，激勵族群掀起暖身行情，有機會扮演多頭指標。有機會成為資金避風港的生醫族群，昨（22）日是由中低價股以小兵立大功姿態聚焦，加捷（4109）、紅電醫（1799）、天良（4127）、優盛（4121）、晶宇（4131）、盛弘（8403）、訊聯（1784）和（（又又））美（478）都直奔漲停。另外，健喬（4114）、濟生（4111）、美時（1795）表現也十分突出。法人認為，由於目前是醫材業的旺季，加上F-金可（8406）7月起將全面大作海昌品牌隱形眼鏡的廣告，預計也將激勵產業洗牌。營運表現不錯的生醫業，精華光、葡萄王、杏輝、太醫和聯合5月營收都同步改寫歷史新高紀錄，而基亞、中化生、南光、懷特、泰博的年增率也都由5成起跳。另外，F-金可也是同期的新高，而必翔則是4年來單月新高，由於目前各家公司的訂單展望頗佳，法人預期生醫族群未來題材性頗佳。生醫族群目前除了上海生技展可望帶動原料藥族群有接單利多外，台灣的生技展也可能有媒合利多。另外，東洋、健喬、友華、盛弘和訊聯等，也都有子公司上櫃和上興櫃利多，中化生、神隆、金可、葡萄王和杏輝等，則都擴建新產能，使未來營運頗有想像空間。至於最受矚目的是精華光和F-金可的股王之爭。目前精華光的單月營收已突破3億元大關，預期因日本第二家客戶彩色片訂單挹注之下，該公司未來的營運，將可續保成長力道，今年營收和獲利都將同步改寫歷史新高，因此，第4季繼續擴建產能是可以預期的。F-金可的隱形眼鏡6月已經開始在國內鋪貨，7月則要開始大打廣告戰之下，將讓未來營運添加力道，法人估計，F-金可6月有機會再創高，第2季將是淡季不淡。法人表示，F-金可的品牌效應是激勵股價走高的原因，在該公司雙品牌提供了將近400個規格，且二級以下市場市占遙遙領先下，該公司今年積極擴充產線，並將再創第三個高價位品牌，將讓F-金可的未來營運更有想像空間。 (新聞來源：工商時報─記者杜蕙蓉／台北報導)
衛生署發12萬獎勵金 鼓勵醫師投入
因為工時長、暴力事件頻傳，台灣急診人力嚴重流失，根據統計，目前全台至少還缺1200位急診醫師，即使醫院開出高月薪的條件，還是找不到醫生。現在衛生署打算編列預算，讓包括急診在內的五大科的住院醫師，每年可多領12萬元的獎勵金，希望增加誘因。不論白天或是晚上，醫院的急診室裡總是擠滿大大小小等候看診的民眾，一旁的病床更躺著一個個吊著點滴等待住院的病患，在台灣急診室經常人滿為患，根據統計，國內10年前一年急診人次為320萬人次，現在增加為650萬人次，至少需2000多位急診醫師才夠，但目前實際急診醫師卻只有800人。
==急診醫學會秘書長 顏瑞昇== 醫學生有可能是個人興趣的問題 或者是我們更擔心的是 整個外在的環境並不太理想 導致他們在選科上 不願意從事像這樣 以救人為第一職志的專科急診暴力、醫療環境持續惡化，是導致年輕醫師不願投入的主因，根據急診醫師分析健保資料庫及醫師執業登記資料後發現，服務滿10年時，急診醫師退出職場的比率是一般外科的4倍、更是放射、病理科的十倍。
==聲音來源 衛生署醫事處長 石崇良== 把過去專科醫師的員額 重新做調整 特別保障內.外.婦產.兒跟急診 五大科的人力 完成訓練的 每人每年給予12萬元的獎金面對衛生署提出的改善方案，醫改會認為，編列五大科住院醫師獎勵金只是短期誘因，政府應該工作環境去做改善，否則未來還是無法留住年輕醫師，民眾的醫療品質還是無法獲得保障。
Oxytocin hormone plays an important role in Williams syndrome
Published on June 23, 2012 at 4:17 AMThe hormone oxytocin - often referred to as the "trust" hormone or "love hormone" for its role in stimulating emotional responses - plays an important role in Williams syndrome (WS), according to a study published June 12, 2012, in PLoS One. The study, a collaboration between scientists at the Salk Institute for Biological Studies and the University of Utah, found that people with WS flushed with the hormones oxytocin and arginine vasopressin (AVP) when exposed to emotional triggers.The findings may help in understanding human emotional and behavioral systems and lead to new treatments for devastating illnesses such as WS, post-traumatic stress disorder, anxiety and possibly even autism."Williams syndrome results from a very clear genetic deletion, allowing us to explore the genetic and neuronal basis of social behavior," says Ursula Bellugi, the director of Salk's Laboratory for Cognitive Neuroscience and a co-author on the paper. "This study provides us with crucial information about genes and brain regions involved in the control of oxytocin and vasopressin, hormones that may play important roles in other disorders."WS arises from a faulty recombination event during the development of sperm or egg cells. As a result, virtually everyone with WS has exactly the same set of genes missing (25 to 28 genes are missing from one of two copies of chromosome 7). There also are rare cases of individuals who retain one or more genes that most people with the disorder have lost.To children with WS, people are much more comprehensible than inanimate objects. Despite myriad health problems they are extremely gregarious, irresistibly drawn to strangers, and insist on making eye contact. They have an affinity for music. But they also experience heightened anxiety, have an average IQ of 60, experience severe spatial-visual problems, and suffer from cardiovascular and other health issues. Despite their desire to befriend people, they have difficulty creating and maintaining social relationships, something that is not at all understood but can afflict many people without WS.In the new study, led by Dr. Julie R. Korenberg, a University of Utah professor and Salk adjunct professor, the scientists conducted a trial with 21 participants, 13 who have WS and a control group of eight people without the disorder. The participants were evaluated at the Cedars-Sinai Medical Center in Los Angeles. Because music is a known strong emotional stimulus, the researchers asked participants to listen to music.Before the music was played, the participants' blood was drawn to determine a baseline level for oxytocin, and those with WS had three times as much of the hormone as those without the syndrome. Blood also was drawn at regular intervals while the music played and was analyzed afterward to check for real-time, rapid changes in the levels of oxytocin and AVP. Other studies have examined how oxytocin affects emotion when artificially introduced into people, such as through nasal sprays, but this is one of the first significant studies to measure naturally occurring changes in oxytocin levels in rapid, real time as people undergo an emotional response.There was little outward response to the music, but when the blood samples were analyzed, the researchers were happily surprised. The analyses showed that the oxytocin levels, and to a lesser degree AVP, had not only increased but begun to bounce among WS participants while among those without WS, both the oxytocin and AVP levels remained largely unchanged as they listened to music.Korenberg believes the blood analyses strongly indicate that oxytocin and AVP are not regulated correctly in people with WS, and that the behavioral characteristics unique to people with WS are related to this problem."This shows that oxytocin quite likely is very involved in emotional response," Korenberg says.
SIIC整合生技業獲初步進展
中央商情網-2012年06月18日 下午23:20(中央社記者羅秀文台北2012年6月18日電)由生技專家蘇懷仁博士領軍的「台灣生技整合育成中心」成立滿半年，已完成肺癌、肝癌與TB/MDR-TB新藥開發的價值鏈能量評估及藍圖建置。台灣生技整合育成中心(Supra Integration and Incubation Center, SIIC)」2011年11月1日正式成立，主要在提供生技製藥及醫材產業發展所需的資金、法務、智權、技術等協助，並提升生技產業轉譯研究的能力。台灣生技整合育成中心成立滿半年，包括營運長簡海珊、首席顧問蘇懷仁、行政院政務委員張善政、行政院科技會報執行秘書江惠華、工研院生醫所所長邵耀華等人，17日在美國波士頓參加北美生技大展前夕舉辦記者會，說明生技整合育成中心成立至今運作情況。在首度召開的新藥開發盤點委員會議中，台灣生技整合育成中心針對國內新藥研發價值鏈藍圖及潛力案源進行審議。委員們對於SIIC團隊已完成的肺癌、肝癌與TB／MDR-TB新藥開發的價值鏈能量評估及藍圖建置表示認可。並建議國內加強針對台灣、大陸、以及其他亞洲地區具高度醫療需求疾病領域的藥物開發能力。此外，在7件具潛力的候選案源中，SIIC目前已選出1件，將進行深入評估及後續可行的資金募集及育成輔導。另外，SIIC醫材開發盤點委員會議規劃於7月份召開。並將於7月24日「亞洲生技商機高峰會議BioBusiness Asia」期間主辦一場論壇，研討新藥開發生技育成模式，與來自日本、韓國、新加坡、美國的育成中心領導人，分享各國生技創新育成機制，並探詢合作機會。
兩岸醫藥協定 空轉
2012-06-22 02:04 工商時報 【記者杜蕙蓉／台北報導】兩岸醫藥衛生合作協議自2010簽訂以來，迄今依然紋風不動，眼見新加坡、韓國、印度和大陸都已急速成長，政府扶持生技產業不力，TFDA（食品藥物管理局）持續空轉，均讓台灣生醫業界感到憂心。 據了解，為今（22）日起生策會和生策中心將登場的系列政策總體檢，立法院長王金平於6月3日特別宴請重要與談人、政府相關部門主管、環評委員等進行環境、體制、資源、法規等四面向的探討，席間中研院長翁啟惠即對TFDA沒有進度和推委責任表達高度不滿。 生策會執行長吳明發認為，兩岸生醫藥產業合作應該回到當初簽署的以ICH和GHTF的國際規格為基準的共識下進行，TFDA、SFDA應該互相成立ICH辦公室，欽選彼此考核通過的臨床實驗中心，而非一味在評選案件或一些枝節上做文章，因為如果沒有回到當初簽署的架構取得共識，兩岸醫藥衛生合作協定終究還是空轉，也無法為華人而戰。 事實上，當年政府在制定台灣生醫產業發展方向時，究竟是要以符合美國FDA或是大陸SFDA（藥監局）認證標準時，有針鋒相對的論述。當時Vivo創投創辦人孔繁建即力倡要以中國為目標市場，建議生醫廠商應以大陸的法規為標準。 孔繁建表示，大陸終究會成為全球前三大的醫療消費市場，只要能在大陸佔有一席之地，台灣生醫廠商就有躋身國際舞台的機會。 吳明發表示，台灣生醫產業目前產值佔不到全球1％，2011年總產值僅2,100億元、成長率平均僅7％，相較已奠定國際研發、製造基地地位的新加坡、生物技術排名晉身全球10大的韓國、全球生技服務與學名藥產製重心的印度及每年以20％以上成長率快速發展的大陸，已無先驅優勢。 為此，除了持續和大陸積極搭橋外，政府應聚焦掌握產業困境瓶頸，大刀闊斧投入政策變革。在預算編制上，過去70％以上預算經費幾乎都投入前段研發，第二棒和產品市場行銷的比例則不到3成，其實，產品能夠商業化才有價值，因此，未來應該前段的研發經費比重應不超過10％，第二棒的臨床約佔24％，比較多的經費應投入後段商品和市場行銷。
翁啟惠...台灣研究主題和產業脫鉤 !!!
翁啟惠：補斷鏈 串人才、科技、經濟【聯合晚報╱翁啟惠(中央研究院院長)／記者林進修／整理】 2012.06.24 04:55 pm 台灣快轉／台人才流失 /瑞士洛桑國際管理學院 (IMD)最近公布的世界競爭力年報顯示，台灣的經濟表現已由第8名跌到第13名，跌幅既深且大，其關鍵因素大都與政府有關，值得我們深思。台灣目前所面臨的困境，我覺得有三個主要面向，一是人才供需失衡，一是產業結構過度集中，另一則是科研發展並未顧及產業需求。換句話說，就是人才、科技與經濟這三個層面的鏈結斷裂，進而導致競爭力下滑。就人才培育來說，台灣目前的大學多達160幾所，同質性太高，不管研究型大學或技職型大學，都以研究為優先導向，也都以產出研究論文並刊登在國際期刊為主要訴求，進而出現為了研究而研究的奇怪現象。長期下來，各大學的研究和產業需求出現斷裂，教育出來的人才，不一定符合國家發展及產業需求。這個失衡現象，我覺得和長期以來太追求論文發表的評鑑制度有關。評鑑指標單一化，研究型大學和技職型大學沒有太大差異性，加上研究主題又常和經濟產業發展脫鉤，當然會影響到國家整體的經濟發展。面臨這個困境，重新設計一套可長可久、兼顧各種發展的評鑑制度，已刻不容緩。研究型大學當然仍以學術研究及發表研究論文為主，但技職型大學或藝術大學，就不一定要以發表論文為首要任務，而應以特色、創新及多元發展為重點，才能培育出多元人才，也才能滿足產業發展及國家需求，提升國家整體競爭力。在這個大前提下，我深深覺得，唯有人才培育和科技發展、產業創新相連結，再加上政府建立一套可兼顧經濟發展、環境保護及確保社會公平正義的決策模式，才有可能走出競爭力逐漸下滑的困境，重新站上國際舞台。就我的觀察，政府以前在做決策時，不僅忽略了環境保護及社會公平正義的聲音，而且決策過程太快了，缺少多元參與和討論所形成的共識，無法獲得社會大眾的廣泛認同與支持，使得行政部門在施政時，遭遇很多困難，做得很辛苦。縱觀近來的大型公共政策，中科二林園區的開發如此，美牛案的食品安全如此，稅制改革政策及核電能源政策也是如此。台灣要向前走，經濟發展是關鍵，未來的經濟發展更要從降低成本、薄利多銷的效率導向，轉型為有前瞻規畫且高附加價值的創新導向才行。面對這個挑戰，除了人才培育外，問題導向研究的提案機制也要重新設計，並重新界定科技研發預算的先後次序。目前我國每年約有3000億元的科技研發預算，其中三分之一來自政府，另三分之二則來自民間。由於預算有限，必須要有完整的規畫，政府的經費運用應該具有前瞻性，找出優勢領域的上游基礎研發項目、長期投資，才能繼續維持原有的競爭力。至於民間的研發則以追求經濟效益為導向，不妨集中在研發鏈的中、下游。一旦上、中、下游的研發鏈結串起來，才能帶動創新產業，我國的經濟發展才有未來。所謂的創新，指的是能改變及帶來社會、經濟的全新價值，除了科技外，舉凡設計、營運模式、體制、環境、思維及文化，只要能帶來價值都算，範圍相當廣泛。就拿思維來說，包括對失敗的認知和容忍度，以及對不同意見的包容態度，都要有所改變，才能鼓勵並帶動創新發展。以此為基礎，再回推到人才培育的原點，就相當多元且海闊天空，毫無涯際。‧ 【2012/06/22 聯合晚報】
翁啟惠：無法創造好環境 難留人才
談到台灣的人才危機，中央研究院院長翁啟惠表示，造成危機的原因由來已久，今天看到的只是日積月累後的嚴重後果，而新加坡副總理尚達曼舉台灣為例的說法實是倒果為因。 聯合報22日新聞報導，「台灣並非不歡迎境外人才，以致今天實質所得降低、工作機會減少，」翁啟惠說，事實剛好相反，是因為台灣無法創造良好的工作環境與條件，才會導致人才出走或境外人才不進來；實質所得偏低，也是因為台灣的產業競爭力撐不起高薪資。他認為，假如台灣擁有自主品牌、研發能力及關鍵技術，台灣的薪資所得不會是現在這種水準。 翁啟惠說，台灣若要解除當前的人才危機，必須從制度面與環境面改善。現階段最迫切需要處理的問題有二，一是落實公教研分軌，不要再以公務體系的齊頭式平等模式，限制教研體系的人才晉用；二是正視當前高等教育發展失衡問題，調整大學評鑑方式，依據學校特色與發展方向，訂定不同評鑑標準。 在科技基本法完成修訂及彈性工資實施後，目前公教研分軌問題已獲得一些改善。但法規調整只是第一步，社會對於薪資差異拉大、研發創新的高失敗率等看法，也會影響人才的養成與去留。 在高等教育上，過去多年來，台灣技職學校紛紛升格為大學，導致大學院校多達一百六十餘所。但學校的評鑑標準大同小異，並將發表論文當成是最重要的評鑑指標。翁啟惠說，這導致今天台灣高等教育培育出來的人才同質性太高，都是一批批的「論文製造機」，卻未必符合社會或產業界需求。 翁啟惠說，學校定位及目標會影響學生的就業取向及能力，對從事基礎研究的高等院校，論文是很重要的評鑑指標；但對以技能為導向的學校，專利、技術轉移及產業合作成果、產品研發創新能力與學生出路，可能遠比論文重要。 【中央網路報】
張善政：醫院管理 應納入輔導
【經濟日報╱記者黃文奇／台北報導】 2012.06.23 04:04 am 行政院政務委員張善政昨（22）日表示，醫院管理為台灣強項，政府可將「醫院管理」納入產業輔導標的、並輔導成立公司，藉由技術輸出，建立新的產業規模。張善政昨天出席參與生策會主辦的「生技醫療產業政策總體檢系列論壇」，擔任第1天「環境面論壇」首場研討會主持人，同場主持人還有衛生署長邱文達。張善政表示，生技產業中過去以製藥產業為核心，後來加入醫材產業，成為該領域兩大強項，卻忽略台灣在醫院管理這部分，具有專業的經驗與知識；且這種獨門知識，若成為大量的營運模式，將聚合成一個產業。他認為，目前台灣和大陸交流頻繁，且大陸醫院林立必然有管理需求，因此台灣醫院管理技術可供輸出。政府在其中可扮演輔導角色，鼓勵民間成立醫院管理顧問公司，並將技術輸出大陸，將是一個值得期待的營運模式。但業界也有不同聲音，部分人士認為，委託管理型態多種，即使將之視為一個產業，效能也不大；此外，輸出大陸的醫院管理知識與經驗，若被對方取得後，合作也將終止，沒有關鍵的技術可永續輸出。【2012/06/23 經濟日報】
CARHY announces comprehensive hematopoietic stem cell transplant service
Published on June 23, 2012 ting image of Bangalore being a healthcare destination of India, Columbia Asia Referral Hospital, Yeshwanthpur (CARHY), announced comprehensive bone marrow transplant (stem cell transplant) service on Thursday. This facility will give hope to many cancer patients in and around Bangalore as there are very few hospitals in South India providing allogeneic transplant, which involves using stem cells from a donor with a similar genetic makeup.The bone marrow transplant (BMT) service will have a team of medical experts including clinical hematologist, oncologist, and other qualified doctors from allied specialties like pediatrics, infectious disease specialist and trained nurses for stem cell transplant, state-of-the-art HEPA filtered room, ICU, 24 hrs blood bank services and radiology services for providing comprehensive care during stem cell transplant.Addressing the media, Dr. Nandakumar Jairam, Chairman and Group Medical Director, Columbia Asia Hospitals,said, "We are happy to announce allogenic bone marrow transplant service at our hospital in Yeshwanthpur, over and above the existing autologous transplant service. This will enhance comprehensive bone marrow transplant treatment delivery; a dire need for the people of Karnataka and neighbouring states. This will also help many international patients who look for such a treatment in India.""This facility is dedicated to providing end-to-end services including expert counsel from a clinical hematologist and an entire team of doctors and nurses providing the latest in medical advances to those suffering from blood cancer and some non-cancerous conditions affecting the bone marrow," said Dr. Satish, Consultant in Clinical Hematology, Columbia Asia Hospitals.
Perjeta helps people with HER2-positive metastatic breast cancer live longer
Published on June 23, 2012Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that people with HER2-positive metastatic breast cancer (mBC) lived significantly longer (overall survival) when treated with the combination of Perjeta™ (pertuzumab), Herceptin® (trastuzumab) and docetaxel chemotherapy, compared to Herceptin and docetaxel chemotherapy alone in the Phase III CLEOPATRA study. These data will be submitted for presentation at an upcoming medical meeting."We are pleased that Perjeta helped people with HER2-positive metastatic breast cancer live longer and lengthened the time they lived without their disease worsening," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "The improvement in survival seen in the CLEOPATRA study is great news for patients and doctors, and reinforces our belief that Perjeta will improve the outlook for people with this devastating disease."Perjeta is a personalized medicine that targets the HER2 receptor, a protein found in high quantities on the outside of cancer cells in HER2-positive cancers. Perjeta is believed to work in a way that is complementary to Herceptin, as the two medicines target different places on the HER2 receptor.The FDA recently approved Perjeta in combination with Herceptin and docetaxel chemotherapy for the treatment of people with HER2-positive mBC who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease, based on the results of the CLEOPATRA study. Roche has also submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for Perjeta for people with previously untreated HER2-positive mBC.
vNew paper discusses potential of tumor-derived microvesicles
Published on June 23, 2012A new paper by Crislyn D'Souza-Schorey, professor of biological sciences at the University of Notre Dame, discusses the biology of tumor-derived microvesicles and their clinical application as circulating biomarkers. Microvesicles are membrane-bound sacs released by tumor cells and can be detected in the body fluids of cancer patients.The World Health Organization (WHO) estimates that the incidence of cancer will reach approximately 9 million deaths in 2015. The rising prevalence of the disease is a major factor that drives the growth of the oncology biomarkers market. Biomarkers can be defined as any biological, chemical or physical parameter that can be utilized as an indicator of physiological or disease status. Thus, biomarkers are useful in cancer screening and detection, drug design and also to boost the effectiveness of cancer care by allowing physicians to tailor therapies for individual patients-an approach known as personalized medicine.The new paper discusses the potential of microvesicles to present a combination of disease and tissue-specific markers that would constitute a unique, specific and identifiable biosignature for individual cancers."As such, it would make their sampling over time a preferred method to monitor changes to the tumor in response to treatment, especially for tissues such as the ovary or pancreas, where repeated biopsies of these organs is impractical," D'Souza-Schorey said.Profiling of microvesicles could form the basis of personalized, targeted cancer therapies, especially as more reliable and rapid profiling technologies become available."For example, certain markers like HER2/neu, in addition to being elevated in breast cancer, is also increased in a relatively smaller subset of other cancers such as ovarian cancer," D'Souza-Schorey said. "This latter group of patients would benefit from existing treatment strategies that target the HER2 receptor."The approach could be advantageous over currently used approaches of profiling whole tissue or un-fractionated body fluid particularly if circulating microvesicles indeed concentrate molecular changes that occur in the tumor, as it would increase the sensitivity of detecting critical markers of cancer progression.
Testosterone makes women want to pleasure themselves rather than have sex
By DAILY MAIL REPORTER PUBLISHED: 16:00 GMT, 22 June 2012Libido lift? Women who had higher levels of testosterone were more likely to pleasure themselves It has long been assumed that men typically want to have sex more often than women because they have higher levels of testosterone. But a team from the University of Michigan found that women with high testosterone had a greater desire to masturbate compared to their peers. However, they were surprised to discover that women with higher testosterone levels were less likely to want to have sex with a partner. It suggests that behind the finding is a complex web of factors including anxiety. Lead author Sara M Van Anders from the University of Michigan, told LiveScience.com: 'People have argued that sex research focuses too much on dysfunction and pharmaceutical treatment as opposed to questions like pleasure or relationships or stress. 'There is a whole scope of factors that go unstudied.' Living near loud traffic increases your risk of having a heart attack Why men are less moral than women: When masculinity is at stake, males are more likely to ditch the ethics The study was one of the few to study healthy adults. Most other research into sexual desire has relied on animal models or people being treated for abnormal hormonal levels. They recruited 105 men and 91 women who completed questionnaires about their sex lives, answering questions such as 'Are you self-conscious of your body during sex?' They also provided a saliva sample which was tested for both testosterone and the stress hormone cortisol. Testosterone is a steroid hormone that is released by the ovaries in women and testes in men as well as in the adrenal gland in both sexes. Van Anders found that levels of testosterone had nothing to do with how often men thought about masturbation or sex.However, women with higher testosterone were less likely to want sex with someone. Although it may seem counter-intuitive it fits with previous studies that have found women in long-term relationships have lower testosterone. It could be that the hormone drives them to find a partner to be close to rather than just have sex with, van Anders said. Or it may be that higher testosterone reflects higher stress in women rather than a higher sexual drive. She told LiveScience.com: 'When you're saying you desire sexuality with another person, what are you desiring and are people desiring different things sometimes? 'Are some people more desiring to be with their partner, to give their partner pleasure, to have a routine, or for their own pleasure?' The one link van Anders did find was between masturbation and sexual desire. Men were more likely to masturbate than women and also reported a greater desire to have sex. It is not yet known whether desire triggers masturbation or vice versa. The research has been published online in the journal Archives of Sexual Behaviour
近視雷射手術市場落谷底‧亞洲眼科醫師齊聚商討對策
2012/06/23 ■王慰祖／撰稿■ 由於今年二月知名眼科醫師對於近視雷射手術的言論，使得國內近視雷射手術市場如同經歷一場「大海嘯」，至今海嘯的威力仍在持續醱酵，這場海嘯不僅重創國內醫院與眼科診所，甚至連大陸眼科市場也無法幸免。兩岸眼科人士甚至預言至少要兩年時間才有可能回春，這場眼科界的大浩劫何時結束，還有待後續的觀察。甫落幕的「第七屆白內障屈光手術國際學術研討會暨海峽兩岸論壇」，兩岸眼科醫師以及來自日本、創下全球雷射近視手術量第一的品川眼科中心副院長暨手術總監富田實Tomita ，針對目前台灣近視雷射手術的現況，以及如何提振民眾對Lasik手術的信心，進行廣泛討論。根據眼科界人士透露，從今年二月至今，國內近視雷射手術市場可以用「一厥不振」來形容，知名連鎖眼科診所-諾貝爾眼科執行長張朝凱醫師不諱言的說：「我們的業績掉了七成，相信其它眼科診所業績更慘。」的確，這場近視雷射手術界的大浩劫，帶來的衝擊超出想像，不少醫院的近視雷射手術乏人問津，甚至還有醫學中心連著兩個月做不到一台刀，已經不能用一個「慘」字來形容這場海嘯造成的傷害。來自大陸的知名眼科醫師趙家良也表示，大陸眼科市場也受到波及，平均業績掉了三成五到四成之間。富田實指出，他有聽聞此事，但實地了解才知道事態如此嚴重。此次來台，富田實分享他在近視雷射手術方面的心得與成功經驗，希望能為台灣眼科市場提供更多的貢獻。從醫美起家的品川診所，過去20年醫學美容項目營業收入為全日本第一，2005年才開始涉足準分子雷射近視治療領域，目前品川眼科共開設東京銀座總店，以及橫濱、福岡、大阪、名古屋共五個店，其中，東京銀座總店一年手術量占絕大多數，光是飛秒雷射手術一年就超過10萬例。雖然品川眼科才進入近視雷射7年時間，但是以獨特的經營方式，可以用「席捲」日本近視雷射手術市場來形容。近視飛秒手術量占日本近視雷射手術市場逾六成。在2009年，僅東京銀座總店的手術量就達到15萬多雙眼睛，每個月超過一萬人的近視手術，而且是全面性接受飛秒雷射手術，比2005 年成立之初，業績成長了10倍。品川眼科近視手術量占全日本准分子手術量的60%。截止到2010年2月的短短5年間，品川眼科共實施近視雷射手術超過70萬例，目前已突破百萬例，其中絕大多數是飛秒雷射手術，目前品川眼科飛秒雷射手術量位居世界第一。富田實表示，近視雷射手術最關鍵的兩個要點就是「手術過程」與「術後品質」。從2005年品川眼科中心成立以來，陸續引進全球各種最新式的雷射手術儀器，就一直思索如何讓術後品質及手術過程都能不斷提升，直到最新的達芬奇LDV 飛秒雷射問市後，他的觀念開始徹底改變。富田實以手機為例，手機主要的功能還是不變，就是聽與撥打，但是多數人一定不能滿足現況，所以有能力有需要的人一定會用智慧型手機。他強調，手術儀器也一樣，科技一直進步當然手術的方法也隨之進步，尤其是攸關雙眼的術後滿意度，富田實認為一定要做到比病人的期望值更高，才能獲得顧客的認同，首要是從手術基本的儀器開始。富田實表示，新一代的雷射近視手術儀器的特點，就是彌補醫師在手術過程中的不方便與患者的不便，尤其是做飛秒雷射時，一般的情況需要等待與換床，但是新一代的儀器貼心的為醫師及患者思索手術中的可變因素，提升術後的滿意度。這一點讓許多開過刀的民眾都覺得感覺才剛開始要進行手術，卻已經完成了。他強調，近視雷射手術其實是一項非常安全的手術，會有問題都是出現在醫師在術前評估沒有做好病人的滿意度與適合度的評估。舉例來說，如果一位民眾角膜太薄，或是合併有其他的疾病，醫師都應該審慎的建議病患不要貿然進行，做好為病患把關的角色。國內眼科醫師也表示，儀器已經發展如此精進，若還是用傳統的儀器在動手術，風險係數當然會增加。趙家良說，雖然大陸近視雷射手術市場也掃到颱風尾，但是有一個現象值得觀察，就是民眾擔心近視雷射手術的安全問題，但若是眼科診所採用的是飛秒雷射，而不是傳統的板層刀切削角膜，業績不但沒有下降，反而有微幅成長。國內眼科醫師也認為使用傳統板層刀的雷射儀器已經在這場海嘯中，宣告「壽終正寢」。至於國內近視雷射手術市場何時才能「回春」，就有待後續的發展了。
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