關於 toxicology in vitro ，我們在網路上蒐集到這些相關的討論、資訊與評價

2021/03/07 (日)【新藥開發系列】-藥毒理試驗在新藥開發扮演的角色與應用 🌟線上直播開放報名中🌟

✎主辦單位：台灣光鹽生物科技學苑
✎課程日期：110年3月7日 (日) 9:00至17:00 (8:30 開始報到)
✎課程地點：線上同步遠距教學

👨‍🏫授課師資：柯逢年 鑽石生技投資股份有限公司 副總裁

【授課大綱】
一、新藥研發流程簡介 (Introduction to the Process of New Drug Development)
二、藥/毒理在新藥研發中的角色與功能 (Role of Pharmacology/Toxicology in New Drug Development)
三、新藥探索階段藥/毒理試驗的角色與應用 (Role and Application of Pharmacology/Toxicology in Discovery Phase)
(1) 新藥標的研究/確效與案例分析 (Target Research/Validation and Case Study)
(2) 新藥標的選擇與策略 (Strategy for Drug Target Selection)
(3) 藥理活性篩選 (Pharmacological Screening)
(4) 體外模式與高效篩選 (In Vitro Model and High throughput Screening)
Hit-to-Lead ; Lead Optimization ; Candidate Generation
(5) 動物試驗模式的建立 (Establish an Animal Model)
動物模式介紹 (What’s an Animal Model)
動物模式的選擇及策略 (Selection of and Strategy for Animal Models)
動物模式的種類及應用實例分析 (Main Categories and Application Case Analysis of Animal Model)
(6) 抗體藥物的活性篩選 (Pharmacological Screening for Antibody)
四、新藥研發的藥/毒理試驗 (Non-clinical Studies)
五、新藥前臨床開發階段的藥理試驗 (Pre-clinical Pharmacological Studies)
(1) 主藥效學 (Primary Pharmacodynamics)
目的、項目、試驗設計及法規 (Objectives、Items Designs、Regulations)
(2) 次藥效學 (Secondary Pharmacodynamics)
目的、項目、試驗設計及法規 (Objectives、Items、
Designs、Regulations)
(3) 安全藥理 (Safety Pharmacology)
目的、項目、試驗設計及法規 (Objectives、Items、
Designs、Regulations)
(4) 藥政主管機關對藥理試驗的要求 (Authorities Expect)
六、新藥研發階段所需的毒理試驗 (Toxicology Studies)
(1) 新藥研發的毒理試驗介紹 (Introduction to Toxicology Study)
物種與選擇、人體關聯性及試驗設計 (Species and Species Selection、Concordance and Study Design)
(2) 基因毒 (Genotoxicity)
(3) 急毒 (Acute Toxicity)
(4) 重覆劑量毒性試驗 (Repeated Dose Toxicity)
人體起始劑量的計算與選擇 (Calculation and Selection of Human Recommended Starting Dose)
(5) 致癌性試驗 (Carcinogenicity)
(6) 生殖毒性試驗 (Reproductive Toxicity)
(7) 蛋白質藥物的毒理試驗與人體起始劑量 (Toxicology Studies and Human Recommended Starting Dose for Protein Drug)
(8) 藥政主管機關對毒理試驗的要求 (Authorities Expect)
(9) 毒理試驗對人體毒性的預測 (Prediction of Human Toxicity)
七、各研發階段所的各項藥毒理試驗 (Studies Should be Conducted in the IND and NDA Phases)
八、毒藥理試驗數據的解讀與使用 (Uses of Pharm/Tox Study Data)
九、藥/毒理學專家在藥物研發的角色 (Roles of Pharmacologist/Toxicologist in Drug Development)
十、總結 (Conclusion)

* 線上直播課程建議使用電腦觀看，因直播流量需求高，手機觀看不能保證上課品質，敬請見諒，謝謝！*

線上報名網址 👉 https://forms.gle/K9PRgcXUBG69hb9P8

🧑‍🎓學員對象：
(1)生命科學或毒藥理相關在學或在職者
(2)生技新藥公司/藥廠研發人員訓練
(3)從事新藥或臨床研發，需了解毒藥理試驗與臨床研究關聯性者

💸課程費用：每人2,100元；在學學生本學苑補助25%，每人1,600元 (在學學生報名時，需拍攝學生證或相關在學證明文件email至學苑)

*上課達滿時數六小時，核發本課程結業證書

~開放報名中~ 2019/09/27 (五)
【新藥開發系列】-轉譯醫學: 如何加速且有效推進藥物開發階段
Translational Medicine : the journey from research bench to preclinical development to clinical research

#Toxicology #ProteinTherapeutics #BiomarkerDevelopment #BioanalyticalMethod #Validation #PK #PD #ToxicologyStudyDesign

本學苑非常榮幸邀請到擁有二十餘年國際藥物開發實務經驗的龔曉嘉博士，本課程涵蓋轉譯醫學藥物開發，實驗室的候選藥物研發轉譯到動物實驗、臨床藥物研發，最後轉譯成在臨床上應用。透過轉譯醫學，能夠更有效地開發藥物。本課程將藉由講者豐富的實務經驗，可以詳細的逐月規畫，在十個月的期間內將藥物開發從實驗室推向前臨床及臨床階段。龔博士在本課程也將針對大分子與小分子在藥物開發過程進行比較與對比，並且講述一個藥物開發專案中前臨床、CMC及臨床試驗的相互關係及時程規劃,最後並講述毒理試驗設計(含大分子與小分子藥物)及在美台中等地區執行毒理試驗如何選擇一個合適CRO。
Large molecule protein therapeutics vs small molecule drugs. Different features in the drug development for small molecule drugs and protein therapeutics will be compared and contrasted. Furthermore, the presenter, Dr. Ada H.C. Kung will draw on her 20+ years of experience in the development of large molecule protein drugs and share this experience with the class. Detailed drug development planned will be presented month by month from research bench to preclinical development to the patients in clinical trials. The interrelationship and timing of preclinical, CMC, and clinical trials in a project will be described.

立即線上報名卡位🗓🚀 https://slbiotech.pse.is/L5F7P

主辦單位：台灣光鹽生物科技學苑

課程地點：光鹽會議中心

課程日期：108年9月27日 (五) 13:30至17:30

授課師資：龔曉嘉 博士 / 翼答生技顧問有限公司 董事長

學員對象：
(1)任職於大學學術單位、研究機構、新藥公司/藥廠，有藥物開發相關經驗者。
(2)曾從事藥物開發或臨床試驗工作者

【授課大綱】

PartⅠ:The role of toxicology in translational medicine:
Specific experiments and studies need to be done will be included in the lecture:
1). Drug discovery plan: biomarker development
2). Analytical and bioanalytical method development and validation
3). In vitro and in vivo efficacy models
4). PK, PD, and toxicology with protein therapeutics
5). Develop the project Gantt chart for the preclinical development to IND filing: how to carry out the preclinical development plan to file IND in 10 months. Month by month for a 10 months plan to bring a clinical candidate from preclinical stage to IND filing
6). Detailed timeline: correlating the CMC with the supply of materials for both GLP tox studies and clinical trial
Stage 1: Initiation
Stage 2: Pilot tox studies, preparation for pre-IND meeting
Stage 3: Pre-IND meeting submission package to FDA, design and initiation
Stage 4: Pre-IND meeting, GLP tox studies, and correlating CMC process
Stage 5: Complete the analytical and bioanalytical method validation, start clinical protocol and corresponding quality clinical material supply
Submit IND on the 10th month

PartⅡ: Toxicology study design (small molecule VS macromolecule)

PartⅢ: The selection of CROs for the conduct of tox studies in China, Taiwan and the USA

課程費用：每人2,000元

*上課達滿時數四小時，並完成案例演練者，核發本課程結業證書

【師資介紹】

龔曉嘉 博士

現職：
翼答生技顧問有限公司董事長

經歷：
翼陞生物科技股份有限公司 執行長
宣捷細胞生物製藥股份有限公司 執行長
太景生物科技股份有限公司 資深副總經理
康龍化成（北京）新藥技術股份有限公司 共同創辦人
SRI International 總監
Gryphon Therapeutics 副總
美國毒理學會認證毒理學家

學歷：
俄亥俄州立大學毒物學、生理學與營養學博士學位

【溫馨提醒】

本學苑採用線上繳費系統，請注意下列重要事項：
1.請學員報名務必先填寫Google報名表單後，再進入線上繳費系統。
2.本線上系統有下列兩種繳費方式
(1)信用卡繳費-需輸入卡號、有效月/年、卡片背面末三碼、手機驗證
(2)ATM櫃員機-產生虛擬帳號，由ATM轉帳
3.因繳費系統產生之帳單三日後即失效，敬請特別留意，如有任何問題，請來信或來電與學苑聯絡。
4.公司團體(三人以上)報名作業，如無法於本繳費系統作業者，再來信或來電本學苑洽詢。

若本梯次無法前來，可填寫預約報名連結：
http://www.biotech-edu.com/custom_cg9078.html

學苑信箱：bioschool@biotech-edu.com 學苑電話：02-2545-9721

Tin vui cho các bạn chuyên ngành Công Nghệ Sinh Học (CNSH) và Công Nghệ Thực Phẩm (CNTP). Bạn mình đang theo học chương trình thạc sĩ CNSH ở Hàn Quốc ( bạn í ở đấy gần 3 năm rồi) vừa mới gửi cho mình thông tin học bổng như sau: DU HỌC HÀN QUỐC 2014 CHUYÊN NGÀNH CÔNG NGHỆ SINH HỌC VÀ CÔNG NGHỆ THỰC PHẨM TẠI ĐẠI HỌC TỔNG HỢP SEJONG, HÀN QUỐC (MASTER AND DOCTORATE) Phỏng vấn (3hpm-5hpm tại Khoa Sinh học, ĐHKHTN, ĐHQG).... các chuyên ngành tham khảo dưới đây:
1.Dept. of Biotechnology Laboratory (Professor) : Molecular Pharmacology (Na Gyong Lee, Ph.D.)
Degree : Master/DoctorateIntegration program (1 person) Starting semester : 2014 spring or 2015 spring
Research area - Immune responses to human vaccines - Development of new vaccine adjuvants and human vaccines 2.Laboratory (Professor): Cancer and Stem cell biology (Chun JeihRyu, Ph.D.)
Degree: Doctorate (1 person)
Starting semester: 2014 spring
Research area Our lab is interested in studying various stem cells including human embryonic stem cells and cancer stem cells. Ongoing projects are the isolation and characterization of cell surface molecules on human embryonic stem cells and circulating tumor cells.
3.Laboratory (Professor):Cellular and Molecular Physiology (Eun-Yi Moon, Ph.D.)
Degree: Doctorate (1 person)
Starting semester: 2014 spring or 2014 Fall / 2015 spring or 2015 Fall
Research area Graduate students who study at the cellular and molecular physiology laboratory investigate ways to study cell migration of various cell types, tumor metastasis and inflammation, especially signal transduction, cytoskeletal reorganization and cytokine network using various in vitro and in vivo technologies. In addition, we develop anticancer drug and anti-inflammatory drug using various in vitro and in vivo assay methods.
4.Laboratory (Professor):Aging and Stem cell therapy lab (Changsung Kim, Ph.D.)
Degree: Master/Doctorate (1 person) Starting semester:2014 Fall
Research area Our lab focuses on a few sectors of research Area with modern stem cell technology. PI has deep knowledge in embryonic stem cell, iPSC, cardiac and neuronal disease pathology and physiology. Most of time we will use patient derived induced pluripotent stem cell to study human disease. Also we are increasing our research sector to use gene editing mediated stem cell therapy. 5.Laboratory (Professor): Cellular and Molecular Immunology Lab (Seokman Hong, Ph.D.)
Degree: Doctorate (1 person)
Starting semester: 2014 Fall / 2015 spring Research area We are interested in studying the function of immune regulatory cells such as natural killer T cells and regulatory T cells in autoimmune and allergic diseases (experimental autoimmune encephalomyelitis, inflammatory bowel diseases, atopic dermatitis) using various gene-modified murine models.
6. Laboratory (Professor) : Cell and Tissue Engineering Lab (Duk Jae Oh, Ph.D.)
Degree : Master(1 person) / Doctorate (1 person)
Starting semester: 2014 Fall / 2015 spring
Research area - Bioprocess development for animal cell technology including bioreactor operation, therapeutic protein production and collaboration with Korean industries - Gene therapy using non-viral gene delivery system Dept. of Food Science & Technology
7. Laboratory (Professor):Nano-Technology(Sang-HoonKo, Ph.D.) Degree : Master (1 person)
Starting semester: 2014 Spring or Fall / 2015 spring Research area Graduate students who study at the Food Nanotechnology Laboratory investigate ways to improve bioavailability and bioactivity of food ingredients, especially functional foods using nano and microencapsulation technology. In addition, we develop prototype food products using value-added technologies.
8. Laboratory (Professor):Food processing, Engineering, Rheology (Su-Yong Lee, Ph.D.)
Degree : Master (1 person)
Starting semester: 2014 Fall / 2015 spring or Fall
Research area - Environment-friendly cereal processing - Low-fat and low-calorie food applications - Novel food rheological technology
9. Laboratory (Professor): Food metabolism and Toxicology (Soon-Mi Shim, Ph.D.)
Degree : Master (1 person)/ Doctorate (1 person)
Starting semester: 2015 spring or Fall
Research area - Understanding aspects of absorption and metabolism of plant secondary metabolites. Particularly the flavonoids and phenolic acids, and how the metabolism influences biological effects. - Utilization of the systems of food processing to enhance bioavailability of plant secondary metabolites. Ultimately foremost to development of novel foods with enhanced health-related properties. - Understanding the impact of plant secondary metabolites on improving colon health. - Understanding how interactions between plant secondary metabolites con modify bioavailability and toxicity of toxic components found in food stuff, especially between flavonoids and heavy metals.

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