NRPB長官蒞臨指導TADNI計畫

posted Mar 4, 2015, 8:08 AM by 林昆儒   [ updated Mar 4, 2015, 8:10 AM ]

經過了多年的努力,TADNI計畫終於獲得政府的生技醫藥國家型科技計畫經費補助執行,補助執行期程為2014年12月1日~2015年11月30日,為使計畫順利執行,2014-12-19 特別舉行了PI meeting ,由相關之研究團隊與林口長庚臨床試驗中心人員一同討論研究進程。
會中生技醫藥國家型科技計畫的謝桂貞博士也特別跟我們介紹了NRPB的相關業務,並期許我們的研究成果可以增進醫界對失智症的了解,以協助病患。

Tau PET 腦神經影像學術研討會

posted Nov 15, 2014, 10:02 AM by 林昆儒   [ updated Feb 1, 2015, 8:57 AM ]

這次 2014-11-14 開始為期兩天的台日腦神經影像新藥討論會,特別請到臨床試驗中心賴瓊慧教授開場,並由分子影像中心的閰紫宸教授,及東北大學(Tohoku University) 的 Nobuyuki 教授一同主持會議。會議有來自迴旋加速器製藥專家,高雄長庚,林口長庚,以及各醫學中心腦神經影像及臨床多位專家一同參與研習,了解目前腦神經影像在失智症上診斷的最新進展。

目前失智症的診斷工具由於分子影像醫學的大力進展,已經可以無需經由腦部穿刺,利用分子造影技術即可確認腦中有無內澱粉蛋白沉積,這類影像技術在美國以及歐洲都已經上市造福病友多年,台灣則因為法令的困擾,使得國外藥廠雖然得以在台灣進行臨床試驗(例如長庚醫院),但是卻遲遲未能引進上市,使得臨床診斷使用多有困難。但這些仍不能阻礙我們研發更新技術造福病友的初衷。

這次的會議除了回顧目前已經有的造影技術,以及各類類澱粉蛋白造影技術的比較,也初次介紹了新一類的Tau蛋白的影像研究進展。由Nobuyuki 教授以及該中心主任Kudo教授領軍的研發團隊特別應閰主任的邀請,來到台灣分享該團隊多年來研發Tau蛋白影像的最新成果,該新穎造影劑也在今年甫獲得美國核醫年會的最佳研究榮耀! 並正式邀請長庚團隊加入Tau影像的研究行列!

會議中我們也分享了改良該Tau PET造影劑合成效率的初步成果,並完成相關製程規劃成符合GMP規範的作業,這個步驟在日本當地雖然尚未有此要求,但未來對臨床使用的安全性將有所幫助。
這次除了在研討會上進行討論,該團隊也實地走訪長庚迴旋加速器中心,就要物合成技術充分交換意見,期待在不久的將來,可以在台灣進行相關的臨床試驗,來了解困擾國人的失智症成因,以及未來可以治療的方向。

更多會議影像請參閱 網路相簿

Tau PET 新藥合成學術研討會

posted Nov 4, 2014, 8:26 AM by 林昆儒

林口長庚與日本仙台東北大學將於 2014/11/14 (五)舉行「PET合成新藥學術研討會」議程如附檔,邀請大家一起參與學術交流,
  • 本會全天免費,無供應午餐(請自理) 
  • 學分認證:中華民國核醫學學會(申請中)

TADNI PI meeting

posted Aug 5, 2014, 8:19 AM by 林昆儒

今天 (2014-08-05) 在台北長庚小白宮邀集了T-ADNI第一階段五家醫院的主要PI商討後續研究作業。初步也確認了amyloid brain PET影像將可在北榮以及林口長庚兩處進行。以落實多研究中心的承諾,同時也可評估未來腦斑塊正子影像檢查普及的可行性。

會議中也就 TADNI 計畫在 NRBP 申請的進度跟大家做了簡單的報告,目前尚有第二次審查意見需要補充,也在今天送出回覆了,原則上審查委員對 TADNI 的計畫都表示支持,也咸認為在老化社會快速逼近的現實中,這樣的研究計畫在華人社會極為重要。但在審查意見也同時建議增加許多相關實驗,我們雖然都明瞭這些實驗的重要性,可惜的是目前 NRBP 僅能以"個別型計畫"來支持這個研究,在經費有限下,要納入完整的 TADNI 整合型規劃實在有其難度。團隊除了積極尋求其他可能的財務支持方案,目前暫時也僅能以各PI的熱誠來無償推動研究進行了....這次會議也就 case report form E 化的進度跟大家再次說明,希望能利用資訊的力量,協助大家後續統計研究便利性。目前尚未解決的是生物檢體儲存分析的研究經費,希望在不久的將來可以獲得解決。

劉景寬校長,王培寧,胡朝榮醫師,也在會議中分享了目前 WW-ADNI 的近況,提醒大家韓國,中國,甚至南美洲的國家都已經在 WW-ADNI 大會中報告研究進度了,我們的研究申請進展稍有落後。但PI也為大家打氣說明最困難的部分就快要過去了!! 希望能在近期獲得國家 NRBP 經費支持,於年底開始在五家醫院執行T-ADNI計畫。

生技醫藥國家型科技計畫衝刺

posted May 25, 2014, 4:38 AM by 林昆儒

為了提高研究的能見度,我們多次衝刺 生技醫藥國家型科技計畫 ,這 (2014-04-07) 已經是第三次獲得推薦進入複選了 (會是第三次就是前兩次都貢龜了)。但是閻醫師還是領著臨床試驗中心夥伴一同聽講學習,就是不想放棄任何一絲機會....

台上講的是國家支持本土新藥開發的遠大計畫,我們想的是如何爭取到國家支持,可以讓台灣學習到國外新藥開發的規矩及機會,來運用在解決本土的健康問題上...在這個世界分工的世界,我們除了深耕台灣,也該看清自己的優勢與國際接軌來競爭! 希望這次不會再陪榜了....

其中,台大腫瘤部的許駿醫師一張slide很有趣,他提到的為什麼IRB要審查計畫內容 (應該是IRB委員最常被質疑的問題吧!),他舉了Declaration of Helsinki 第17條的內容 "Medical research involving a disadvantaged population or community is only justified if the research is responsive to the health needs and priorities of this population or community and if there is a reasonable likelihood that this population or community stands to benefit from the results of the research." 當然這個論點還是有許多可以討論的地方。

此外,主持人也提到了國家計劃支持重點除了具產業價值的計劃外,也不排斥支持不具產業價值的計畫,例如計劃本身可能可以提升對疾病的認知,或研究平台建置(可供產業應用),或具公衛價值,學術價值...等。希望我們籌畫多年對失智症以及考神經退化疾病具有重要意義的腦神經影像平台 也能獲得評審的青睞!

更多講義請參見 google drive:

103年NRPB計劃書撰寫說明會

失智症防治照護政策綱領

posted Sep 1, 2013, 8:37 AM by 林昆儒   [ updated Sep 1, 2013, 8:38 AM ]

新成立的衛生福利部在上週 (2013-08-26) 公佈了「失智症防治照護政策綱領」。依據幾個月前政府委託台灣失智症協會所做的台灣首次大規模失智症盛行率調查,2012年台灣失智人口已經逼近十九萬多人,而且將隨著人口老化逐年增加。這份綱領的出爐也讓台灣在失智照護的領域向前再邁出一步!


這份文件裡頭列出七大綱領的施政重點
  1. 提高民眾對失智症防治及照護的認知
  2. 完善社區照護網絡
  3. 強化基層防治及醫療照護服務
  4. 發展人力資源強化服務知能
  5. 強化跨部門合作與資源整合
  6. 鼓勵失智症相關研究與國際合作
  7. 保障權益
其中針對第六項,將是我們團隊共同努力的目標!

CMS 同意有限度開放給付類澱粉蛋白正子掃描

posted Jul 6, 2013, 7:48 PM by 林昆儒   [ updated Jul 6, 2013, 7:50 PM ]

雖然美國 Center for Medicare & Medicaid Services 今年 2013-07-03 再次擋下針對失智症以及神經退化疾病患者全面給付 beta Amyloid positron emission tomography (類澱粉蛋白正子掃描)  


但該局同時也肯定並認為有一定證據顯示這項檢查 (類澱粉蛋白正子掃描) 在 
1) 排除阿茲海默失智症,以及 
2)  協助臨床試驗開發治療失智症藥物上的益處,
所以,該局提議每位病患可以給付一次類澱粉蛋白正子掃描,其條件如下:

Clinical study objectives must be to (1) develop better treatments or prevention strategies for AD, or, as a strategy to identify subpopulations at risk for developing AD, or (2) resolve clinically difficult differential diagnoses (e.g., frontotemporal dementia (FTD) versus AD) where the use of PET Aβ imaging appears to improve health outcomes.

Clinical studies must be approved by CMS, involve subjects from appropriate populations, be comparative, prospective and longitudinal, and use randomization and postmortem diagnosis as the endpoint where appropriate. Radiopharmaceuticals used in the PET Aβ scans must be FDA approved.  The studies must address one or more of the following questions. For Medicare beneficiaries with cognitive impairment suspicious for AD, or who may be at risk for developing AD:

  1. Do the results of PET Aβ imaging lead to improved health outcomes? Meaningful health outcomes of interest include: avoidance of futile treatment or tests; improving, or slowing the decline of, quality of life; and survival.


  2. Are there specific subpopulations, patient characteristics or differential diagnoses that are predicitive of improved health outcomes in patients whose management is guided by the PET Aβ imaging?


  3. Does using PET Aβ imaging in guiding patient management, to enrich clinical trials seeking better treatments or prevention strategies for AD, by selecting patients on the basis of biological as well as clinical and epidemiological factors, lead to improved health outcomes?

Any clinical study undertaken pursuant to this national coverage determination (NCD) must adhere to the timeframe designated in the approved clinical study protocol. Any approved clinical study must also adhere to the following standards of scientific integrity and relevance to the Medicare population.

  1. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants’ health outcomes.
  2. The research study is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
  3. The research study does not unjustifiably duplicate existing studies.
  4. The research study design is appropriate to answer the research question being asked in the study.
  5. The research study is sponsored by an organization or individual capable of executing the proposed study successfully.
  6. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it must be in compliance with 21 CFR parts 50 and 56.
  7. All aspects of the research study are conducted according to appropriate standards of scientific integrity (see http://www.icmje.org).
  8. The research study has a written protocol that clearly addresses, or incorporates by reference, the standards listed here as Medicare requirements.
  9. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals.  Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life threatening as defined in 21 CFR §312.81(a) and the patient has no other viable treatment options.
  10. The clinical research study is registered on the ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject.
  11. The research study protocol specifies the method and timing of public release of all pre-specified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early.  The results must be made public within 24 months of the end of data collection.  If a report is planned to be published in a peer reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors (http://www.icmje.org). However a full report of the outcomes must be made public no later than three (3) years after the end of data collection.
  12. The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial.  If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.
  13. The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention.  Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.

Frontier in Neurodegenerative diseases and beyond-from basic to translational

posted Jun 24, 2013, 11:25 PM by 林昆儒

中研院與長庚醫院共同舉辦的 Frontier in Neurodegenerative diseases and beyond-from basic to translational (神經退化疾病基礎與醫學新知國際研討會) (3-4, May 2013)

28th International conference of Alzheimer's disease international

posted Jun 24, 2013, 11:25 PM by 林昆儒

失智症協會舉辦的: 28th International conference of Alzheimer's disease international (18-20, Apr 2013) 

Most downloaded article

posted May 11, 2013, 1:36 AM by 林昆儒   [ updated May 11, 2013, 1:42 AM ]

過去本科也發了不少研究論文,除了改變醫療指引,評估影像力另一個指標便是下載次數了,前些日子收到了Nuclear Medicine Biology寄來的電郵,恭喜我們研究團隊一篇關於失智診斷藥物的文章,在過去一年 (2012) 成為下載次數最多的前三名!! 


更難得的是這篇文章是2010年發表的,直到2012年還是廣受學界的重視!

原始文章:

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