臨終病人死亡品質調查：台灣亞洲第一，躍升全球第六 資料來源：醫事司 英國「經濟學人資訊社」（Economist Intelligence Unit）公布臨終病人死亡品質（Quality of Death）全球性調查，台灣在五年前(2010年)全球40個受調查國家裡排名第14，亞洲排名第1，今（2015）年受調查國家增加為80個，排名第6，大幅躍升8名，亞洲排名仍維持第1，落後排名前5的英國、澳洲、紐西蘭、愛爾蘭及比利時。本次計調查5個大類項目，即分別是末期照護的環境（Palliative and Healthcare Environment），名次由2010年排名15進步至排名5；末期照護的人力資源（Human Resources），名次排名10（2015年新增項目）；末期照護的品質（Quality of Care），名次由2010年排名10進步至排名7；末期照護的負擔（Affordability of Care），名次由2010年排名10進步至排名6；末期照護的可近性（Community Engagement），名次由2010年排名19進步至排名5。 目前先進國家都在推動安寧社區化，讓老人可以在地安老，這是安寧緩和醫療未來的趨勢，也一直是本部重要政策，為落實安寧緩和醫療照護普及化到各級醫院、社區及居家，推動建構整合性安寧緩和醫療體系，本部前於101年4月9日發布修正醫療機構設置標準，其中增訂安寧病房設置標準，作為醫院設置安寧病床之依據。又因應國內安寧緩和醫療照護需求及政策推動，本部自100年將「安寧緩和醫療照護議題」列為醫院評鑑研修重點，經檢討及研修後，本（104）年度醫院評鑑基準計188條，其中與安寧緩和醫療相關之基準計5條，以促使醫院重視安寧緩和醫療。 為強化臨床醫護人員對安寧緩和醫療的正確觀念，本部自102年起請各縣市政府衛生局協同醫療網區域網絡，辦理生命末期臨終照護意願徵詢相關訓練課程，讓醫療機構臨床醫護人員獲得正確概念，以保障末期病人醫療品質，統計至103年度共辦理55場醫事人員教育訓練，共5萬4,378人次參加，總共有89家醫院參與。復為促進本土性社區安寧緩和醫療服務模式發展，本部已於本（104）年度補助4區4家醫院（臺北市立聯合醫院忠孝院區、奇美醫療財團法人奇美醫院、衛生福利部花蓮醫院及戴德森醫療財團法人嘉義基督教醫院）辦理試辦計畫，由受補助之醫院為核心醫院，提供一定範圍之基層診所、衛生所、社區護理機構，專業諮詢及後援，並由在地醫療基層診所、衛生所、居家護理所提供居家安寧緩和醫療服務，共同建構以病人為中心之安寧緩和醫療照護網絡。另本部於本（104）年度補助3家醫院（國立臺灣大學醫學院附設醫院、奇美醫療財團法人奇美醫院及佛教慈濟醫療財團法人花蓮慈濟醫院）辦理安寧緩和醫療之末期病人評估指引計畫，依腎臟疾病（台大）、失智症（奇美）及腦神經損傷（慈濟）等類別，建立末期病人疾病嚴重度評估指標及末期照護措施，並將安寧緩和醫療列入該疾病類科醫學會辦理之繼續訓練課程。本部自95年起，即推廣民眾簽立「預立安寧緩和醫療暨維生醫療抉擇」意願書，並註記於健保IC卡上。當時民眾對安寧緩和醫療認知不足，申請人數每月僅平均678人申請，累計至99年止僅有55,887人註記於健保IC卡上。經各界大力宣導，傳遞民眾正確安寧緩和醫療認知後，民眾已逐漸接受安寧療護之觀念，迄今每月平均申辦數已超過4,800人以上，統計至104年10月6日止，計有31萬1,604位民眾簽署「預立安寧緩和醫療暨維生醫療抉擇」意願書並註記於健保IC卡上，預計105年可達成40萬人簽署目標。 為增進民眾對安寧緩和醫療照護的認知，本部委託台灣安寧照顧協會設立免付費安寧緩和醫療諮詢服務專線0800-220-927（愛安寧，就安心），為民眾解答關於安寧緩和醫療之相關問題。基於對生命尊嚴的重視，當病人已步入人生終曲之時，若能尊重病人的意願，善加利用安寧緩和醫療，無論是進住醫院的安寧病房，或是選擇留在自己家中接受安寧居家療護，都可以讓他們有尊嚴且安詳的離世，讓生命有尊嚴，臨終有品質。
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Saturday, November 7, 2015
TFDA 辦法規論壇 加速台灣生技產業起飛 !!
國際生醫論壇精彩接力：生技醫藥法規科學週(Regulatory Science BIO Week) 11月開跑 【發布日期：2015-11-03】 ：藥品組 食品藥物管理署(以下簡稱食藥署)因應行政院今(104)年推出「生物經濟產業發展方案」將於11月16日至20日盛大舉辦「生技醫藥法規科學週 (Regulatory Science BIO Week)」，藉由一系列國際論壇接力，帶動我國生醫科技發展，打造國際接軌優良法規環境，以新興技術深耕台灣、創新產品佈局全球，加速生技產業起飛。首先，11月16日及17日「前瞻生物藥品國際法規科學論壇」於交通部集思國際會議廳舉行揭開Regulatory Science BIO Week的序幕，主題涵蓋全球生物藥品及疫苗的最新發展及審查法規，講者包括美國、歐盟、日本、韓國等法規官員、國際大藥廠以及國內生物新藥公司的代表，介紹法規科學審查並分享最近創新生物藥品及疫苗的研發與突破。緊接著為18日「再生醫學科技、倫理與法規交流研討會」於台灣研發型生技新藥發展協會(TRPMA)演講廳登場，期望聚集國內人體試驗審查委員會(IRB)成員對於日益月新的細胞治療、基因治療及組織工程等高科技發展產品，就其倫理審查的重要性及科學發展基本面達成共識，促進國內再生醫學治療發展。Regulatory Science BIO Week壓軸為19日及20日「細胞治療國際法規科學論壇」，將於張榮發基金會國際會議中心舉行。由於台灣細胞治療研發蓬勃發展，為與國際法規科學協和，使國內自行研發細胞治療產品早日核准上市，食藥署邀請美國、歐盟、日本、韓國、新加坡與中國法規官員來台，介紹各國細胞治療管理；美國、日本及韓國著名的細胞治療公司也將分享產品核准及上市使用經驗。同時針對日益受重視的癌症免疫療法(cancer immunotherapy)將邀請國際專家及抗癌新藥研發廠商，分享研發及臨床使用經驗，期望國內對免疫療法有嶄新且正確的認識。因應全球朝向以生物經濟解決人口老化及促進民眾健康的期許，各國衛生機關陸續制定前瞻生物製劑及再生醫學產品審查規範，以滿足更多醫療的迫切需求。Regulatory Science BIO Week系列活動議程及報名資訊請至食藥署藥品相關研討會資訊(http://www.fda.gov.tw/TC/siteList.aspx?sid=4577)查詢。系列論壇接力傳遞，精采可期，歡迎各界踴躍參
翁啟惠: Taiwan Biobank 進展緩慢
基因解密 台灣Taiwan Biobank加入世紀對決 2015年11月03日 04:10 記者杜蕙蓉／台北報導 精準醫療掀起風潮，在美、英、中等國政府陸續宣布斥資近百億美元參戰下，由中研院建置的「臺灣人體生物資料庫」（Taiwan Biobank），也結合台大、北榮等指標性醫院進行解密肺癌、乳癌等12種華人疾病基因，加入此場世紀大對決。中研院院長翁啟惠表示，台灣華人人種豐富，代表性高，是漢族的縮影，Taiwan Biobank的建置，對了解華人疾病基因有助，未來更可聯手生醫產業，開發適合華人疾病的治療方法。翁啟惠說，Taiwan Biobank預計10年內收集30萬筆國人生物基因數據，其中20萬筆為健康人，另10萬筆由台大、北榮、三總及北醫等國內大醫院，蒐集病患檢體，進行肺癌、乳癌、大腸直腸癌、腦中風、阿茲海默症等12種國人常見疾病研究。Taiwan Biobank目前已集結超過5萬3千名臺灣民眾，日前也公布找到41個與糖尿病相關的基因體位置和罹患糖尿病的風險，由於預測準確度高達八成八，也讓產業界對於台灣加入基因解密的世紀對決充滿信心。不過翁啟惠認為，Taiwan Biobank是生命發展的最基礎研究，目前進展速度太緩慢，政府應該要有全盤性規畫，讓產官學研能快速接軌。為了能在這場世紀精準醫療對決中取得主導權，根據環球生技月刊調查，美國國家衛生研究院（NIH）已規畫10年內建立百萬人志願者基因資訊庫，並自明年起啟動收案。另外，中國大陸也把精準醫療納入國家「十三五規劃」，計畫到2030年將投入600億人民幣，其中，中央財政包辦200億人民幣。至於較早啟動的英國政府，則是繼2013年推動為期4年「十萬基因體計畫」後，今年4月，再成立「精準醫療推進器」，預計2015～2021年投入93億美元預算。(工商時報)
協和新藥 2項 PD-1藥物 (肺癌) phase I__2017 !!
迎戰基因檢測 30家廠商卡位 2015年11月03日 04:10 記者杜蕙蓉／台北報導 精準醫療引爆新商機，預期全球基因檢測產值約200億美元，因而吸引生醫廠商瘋卡位，賽亞、行動基因、創源、大江、基亞、世基、基龍米克斯等近30家基因檢測相關公司，正奮力上游。生物產業協會名譽理事長李鍾熙表示，精準醫學個人化概念會從癌症治療出發，擴及至基因組學、數據科學及病患合作等，台灣的醫療環境具有國際水平，若結合生醫產業將有發展優勢。初步統計，目前國內已有不少廠商搶攻精準醫學商機，除了大江、 行動基因、賽亞和基龍米克斯投入基因檢測外，世基是搭配癲癇藥物、創源都鎖定新生兒篩檢，另外，康聯、基亞等公司都則開發診斷試劑。賽亞基因是由擁有「基因定序之父」之稱的陳奕雄創立，該公司是大中華區唯一與跨國大藥廠合作，執行臨床實驗藥物基因組委外合同服務（CRO）的廠商。賽亞總經理謝春成表示，賽亞目標是成為台灣最大醫檢集團，目前已整併的醫學檢驗市場，包含大華、益揚等醫事檢驗所，也成功架構醫療通路達2,000家以上的診所及醫院。基龍米克斯則已建構國內業界規模最大的基因體核心實驗室，備有尖端高精密的第三代基因定序儀，每台每次能跑10個人的全基因定序，需連續7天作業，由於去年全基因定序產能超過已1,000人，今年營運十分樂觀另外，備受關注的是由鑽石生技主導投資的醣基生醫，以及由台大校長楊泮池團隊領軍的協和新藥。醣基專攻醣類平台技術，應用於高療效低副作用的新藥開發以及與醣類相關精確的疾病治療和檢測。協和新藥則是開發新一代免疫療法檢查點PD-1藥物，目標是2年內有2項新藥進入人體臨床一期試驗，目前最具焦的是肺癌新藥。根據統計，全球基因檢測產值約200億美元，最大宗為癌症檢測（50％），其次是科研服務（25％），其他還有產前檢測（10％～15％）及傳染病檢測（5％～10％）等。(工商時報)
(2015台灣) 40億 拼民生有感政策 ! 生醫 拼小確信 !
跨世代降眼壓藥 Roclatan (Rhopressa+ latanoprost) 將攻占既有單一藥物市場!!!
ROCK inhibitors show promise in glaucoma treatment By Michelle Dalton, ELS; Reviewed by Richard A. Lewis, MDTop-line results from Rocket 2 show once daily Rhopressa's non-inferiority to timolol November 01, 2015 By Michelle Dalton ELS, Richard A. Lewis MD Take-home message: A novel class of drugs ‒ rho-kinase, or ROCK inhibitors ‒ appears to lower IOP by relaxing the trabecular meshwork.Sacramento, CA—Topical therapy remains the first-line treatment for patients with primary open-angle glaucoma, but these treatment options are not perfect, nor are they "one size fits all," and most patients require multiple medications to control their IOP. Further, some patients require IOP to be lowered to "low normal (e.g. below 15mm Hg)" to prevent visual field loss.To date, there are no commercially available treatments that are able to target the diseased trabecular meshwork (TM) and lower episcleral venous pressure (EVP) to show consistent efficacy across all pressure ranges, and maintain minimal daily dosing. However, a novel class of drugs (rho-kinase, or ROCK inhibitors) appears to lower IOP by relaxing the TM. Several published studies in the U.S., Europe, and Japan have shown that ROCK inhibitors relax pre-contracted TM tissue ex vivo and increase outflow of aqueous humor in animal and human eyes.The ROCK inhibitor furthest along in clinical development is Rhopressa (Aerie Pharmaceuticals, Bedminster, NJ), a novel triple-action eye drop that inhibits both ROCK and the norepinephrine transporter (NET). Preclinical studies have indicated that Rhopressa lowers IOP by improving outflow via the TM, lowering EVP, and reducing the production of aqueous humor through NET inhibition."Doctors want to get the IOP as low as possible quickly with the least amount of medications," said Richard A. Lewis, MD, (Sacramento, Calif.) a world-renowned leader in ophthalmology, particularly in glaucoma, and the newly appointed Chief Medical Officer for Aerie Pharmaceuticals. "We used to start off with a single drug and then kept adding. Now when a patient presents with moderately advanced glaucoma, we want maximal pressure reduction as soon as we can get it."
Rhopressa Phase 3 ProgramPhase 3 Rhopressa studies commenced in July 2014, with Rocket 1. That trial enrolled 411 subjects at 36 sites with untreated baseline IOP > 20 mm Hg and < 27 mm Hg. The primary goal of this trial was to demonstrate non-inferiority of Rhopressa 0.02%, dosed QD, compared to timolol 0.5% dosed BID. Rhopressa did not meet the primary endpoint, however, it did meet the non-inferiority to timolol in subjects with baseline IOPs analyzed below 27 mm Hg. The Rocket 2 Phase 3 study enrolled 756 patients with baseline IOPs between 20 mm Hg and 27 mm Hg at 62 sites. Patients were randomly assigned 1:1:1 to receive Rhopressa 0.02% QD, Rhopressa 0.02% BID, or timolol 0.5% BID; the primary endpoint was non-inferiority to timolol with subjects with baseline IOP > 20 mm Hg and < 25 mm Hg. In this trial, Rhopressa demonstrated non-inferiority to timolol in the primary endpoint analysis range at all time points evaluated (8am, 10am, 4pm, at weeks 2 and 6, and at month 3). Ocular and systemic safety measures are being evaluated through 12 months.
Baseline demographics were similar in all three treatment groups, Dr. Lewis said."The really interesting question was whether this drug has potential beyond lowering IOP, meaning could this drug perhaps cause some element of disease modification? We haven't had a new compound in glaucoma since latanoprost was introduced 20 years ago. The opportunity to see what happens with this drug, in terms of what its effect is, how it remodels the trabecular meshwork ‒ that is very exciting," Dr. Lewis said.He said the majority of patients who are diagnosed with confirmed glaucoma in his practice tend to be below 25 mm Hg initially."Most of the drugs have been studied in patients with higher IOPs, and the prostaglandins are very effective in treating those pressure levels. But as you get down in the low 20s, they are less effective and that creates a gap in efficacy at lower IOPs. There also are patients who achieve low IOPs with medication, but need to get IOP even lower to prevent vision loss. Rhopressa may be able to fill that gap, once all the data is analyzed," he said.In Rocket 2, timolol was "slightly more efficacious than Rhopressa, but similarly showed loss of efficacy at lower baseline IOPs, same as it had in Rocket 1," Dr. Lewis said.The most common adverse events (AEs) in either Rhopressa arm were conjunctival hyperemia and the majority of AEs in each arm were considered mild. Based on these new Rocket 2 results, Aerie expects to file Rhopressa for U.S. regulatory approval in mid-2016."There's a good likelihood that, if approved, Rhopressa will be additive to other IOP lowering agents. It's a different mechanism of action, so you are attacking the pressure issues from three sides," Dr. Lewis said. "ROCK inhibitors also may have benefits above and beyond treating pressure. Some preliminary animal studies are looking at neuroprotection, anti-fibrotic effects, and increased TM perfusion. There are hints from Dr. Kinoshita's group in Kyoto of a potential supportive role of ROCK inhibitors on corneal endothelium."
Roclatan Roclatan is a combination of Rhopressa and latanoprost. Positive results of a phase 2b study of Roclatan were also reported in 2014."Combination products have been particularly challenging to get approved in the U.S.," Dr. Lewis said. "There has never been a combination prostaglandin product approved here, even though 50% of our patients on a prostaglandin are taking a second medication."In the Roclatan phase 2b trial of about 300 patients, Roclatan lowered mean diurnal IOP from 25.1 mm Hg at baseline to 16.5 mm Hg on day 29, about 2 mm Hg greater than monotherapy with latanoprost.Aerie Pharmaceuticals recently commenced Mercury 1, the first phase 3, 12-month, 3-arm study evaluating Roclatan vs. Rhopressa QD and latanoprost monotherapy. If the phase 3 clinical trials prove successful, Roclatan would be the first topical glaucoma medication with four distinct mechanisms of action to lower IOP.If Mercury 1 bears out the earlier results, "it would be a great opportunity for patients because it would ease the compliance adherence problem inherent in taking more than one medication each day," Dr. Lewis said.Topline results from Mercury 1 are expected during the first half of mid-2016."We are just scratching the surface of the potential of this drug class. It offers an exciting opportunity for ophthalmology," Dr. Lewis said. Richard A. Lewis, MDP: 916/649-1515E: rlewiseyemd@yahoo.comDr. Lewis is the medical monitor for Aerie Pharmaceuticals, and recently became the company's part-time chief medical officer.