【課程介紹】
提高藥物生物利用率及穩定性， 以及創造更優異的新藥整體表現，是推動創新配方科學研發之基礎。本課程擬探討從小分子、大分子、 創新藥物產品(AMPs)等配方及劑型所需之工業藥學產品知識，例如配方開發對產品之影響、預測模擬以精準評估各種性質的表現、由根源問題以提出產品解決問題、結合前臨床生物或臨床資訊反饋產品設計等，同時應用至產品品質及文件的建立。我們也會透過案例分析、小組討論、實作練習等以加強學員的學以致用的能力。
 
【上課日期與時間】

• 學科：04/22、29、5/6、5/13每周六 (09:30~12:30 / 13:30~16:30))
• 術科：5/12(週五)術科操作及實體交流與座談 (09:30~12:30 / 13:30~16:30)

(5/1 勞動節連假未排課)

【上課時數】30小時 (全修包括: 學科24小時/術課6小時)
【上課地點】
週六_學科教學: 線上課程(ZOOM 系統連線)
5/12(週五)術科操作: 新竹市光復路二段321號1館
(可只參加學科,惟結訓證書會加註參加科別)

【報名方式】 截止報名

 【課程費用】
1. 非團體會員每人:21,000元
2. 本會團體會員每人:19,500元
3. 早鳥優惠價 (4/10前完成報名及繳費) 每人: 18,500元
4 同公司或機關;2人以上同時報名,即享有優惠價: 每人: 17,000 元  

如只參加學科可扣抵:3,000元(EX:學科早鳥優惠價: 15,500)
為課程完整度建議全程參加(學/術科);結業證書上會加註科別(學科/術科)
 
【課程預排表】
 

日期	授課單元	講師	時數(hr)	課程大綱
4月22日 (週六)	Design and development of dermatological formulations	蔡瑞真	3小時	經皮吸收原理、配方設計、法規送件注意事項
4月22日 (週六)	CMC Consideration For Drug Product Development	曾宓	3小時	Parenteral lecture 1. Type of dosage form and delivery 2. Consideration of Excipient and formulation 3. Consideration of manufacturing 4. Examples
4月29日 (週六)	難溶性藥物製劑技術	楊智強	3小時	難溶性藥物製劑開發基礎 新藥開發與難溶性藥物 藥物溶離與口服吸收 提高藥物溶離速度的方法 固態分散及相關檢測技術介紹 固體分散技術-混合造粒技術 固體分散技術-噴霧造粒技術 固體分散技術-熱熔擠出技術 奈米研磨技術 自乳化傳輸技術 藥物溶離與藥物動力學檢測 仿單練習 選擇以上技術所開發的藥品，共6項，分組討論練習，報告講評與問題討論
4月29日 (週六)	Materials Science and Engineering Perspectives of Pharmaceutical Research and Development	王宏仁	3小時	課程重點&大綱 Introduction to materials science and engineering perspective for pharmaceutical research and development Case studies with real world data with interactive discussions Amorphous pharmaceutical materials physical stability considerations at different development stages Physical form control during dissolution and processing
5月6日 (週六)	脂質奈米粒開發與應用	蔡翠敏	3小時	課程重點： mRNA疫苗的上市使得LNP成為藥物遞送載體熱門的選擇，本次課程介紹目前LNP的歷史、特性及挑戰，使學員了解LNP劑型及其應用。   課程大綱： LBDDS (lipid-base drug delivery system) LNP development and application Characterization of LNP Challenge of LNP
5月6日 (週六)	Injectable formulation and manufacture what you should know	曾雲龍	3小時	課程重點： Liposome及Lipid-based 奈米微粒是重要的藥物傳輸遞送載體，本次課程介紹這兩種載體的技術特性、賦形劑選擇及產品開發的選擇，特別是生產製造及法規所需要注意的事項。   課程大綱 The Concept and history of liposomes Introduction of the liposome technology The excipients of liposomal formulations From Molecules to Assembly  Lipid based nano-drug, from bench to market Global Trends of Lipid-based drug delivery platform Regulatory Considerations Specific to Liposome Drug Development  Manufacturing Considerations for the Development of Lipid-based formulation Case study ANDA of liposome products NDA of liposome products
5月12日 (週五)	The R&D considerations of injectable PLGA-based microspheres   術科操作: 新竹市光復路二段321號1館	羅友文	6小時	課程重點：長效微米球注射針劑技術已成功應用於眾多藥物產品開發。 此課程將介紹長效微米球配方設計以及製程開發於產品端的主要考量，並透過實作課程累積學員的實務經驗，學員可從中習得微米球技術以及評估潛力藥物之產品開發方向。 上課地點:新竹 課程大綱 General introduction of long-acting injectables development PLGA-based microspheres and application Formulation development and main considerations from regulation aspect Novel fabrication method Case study Practical class (learn by doing) 講師群交流及座談
5月13日 (週六)	Biologics and the considerations for drug process and product development	葉秉陽	3小時	課程重點&大綱： • General Overview • Biologic is the future, which plays a much more important role; it is commercially validated, can tackle different targets • Difference between small vs large molecules • Nature of protein modality • mAb • Bispecific • BITE • Biologic development paradigm • Phase-based development from discovery to commercial • Molecule Assessment – a critical step to ensure process development success • Importance in TPP, QTPP, CoG and Regulatory considerations • Drug Product Development • Process, Manufacturing, Container Closure, Transportation • Attributes (Analytical) Sciences and Development • QTPP, CQA, Phase-Appropriate • Formulation Development and drug delivery • High dose SC product development • Low concentration potent protein therapeutic – BITE as example • Challenges with next generation biological protein development
5月13日 (週六)	講題：吸入途徑投藥系統及產品開發導論	甘霈	3小時	課程重點：吸入產品有別於其他給藥途徑，本次講授內容對於有興趣吸入產品開發者， 提供初步了解和認識，學員可藉此評估產品項目的優缺點， 和未來可能切入的方向。   課程大綱： 1. 為何選擇吸入途徑給藥 2. 吸入投藥系統的分類 3. 藥械合一產品的特色 4. 吸入途徑藥械合一產品開發的考慮 5. Case Study + Open Discussion

 
 【講師介紹】

講師	講師介紹
蔡瑞真	經歷： Professor Emeritus at School of Pharmacy, and Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University (NCKU), Taiwan, after retirement in 2022. Her work experiences include hospital pharmacist, and drug administrator in both Bureau of Drugs and Food Analysis, and Bureau of Drugs, Department of Health. She has been devoted to pharmacy education in Taiwan, and was appointed as Director of Department of Pharmacy in NCKU Hospital.   學歷：Ph.D. degree in Pharmaceutics in 1992 from University of Michigan, and worked under Dr. Peter Elias in Dermatology as a postdoctoral fellow at University of California, San Francisco.   專長：Her research interests focused on percutaneous absorption, drug delivery systems, skin pharmacokinetics and pharmacodynamics, skin barrier functions, cosmeceuticals, and regulatory aspects of pharmaceutical nanotechnology, in collaboration with dermatology, environmental medicine, TFDA, and pharmaceutical companies. Dr. Tsai published more than 50 papers in scientific journals and more than 80 abstracts in conferences. She also co-authored several book chapters. _____________________________________________________________________________________________________________________
曾  宓	現職：美國藥廠劑型CMC主管   專長：小分子(small molecules, 大分子 (peptide, protein, enzyme)。核酸 (therapeutic nucleotide acid), Biosimilar, 從研發到上市和超過 100案 NDA/CTA/IND 經驗。   學歷：國立臺灣大學(NTU)藥學系學士, 美國康州州立大學 (University of Connecticut)藥學碩士博士, 美國哈佛大學(Harvard University)管理碩士。   經歷： 康州州立大學藥學系的客串教授。具有20年以上的美國藥物製劑產品開發(Formulation, drug product development) 和CMC (Chemistry, Manufacturing and Controls) 藥廠工作經驗, 包括 Alnylam, Momenta, Shire, Baxter, Celltech, UCB and Lavipharm。 _________________________________________________________________________________________________________________
楊智強	現職：財團法人醫藥工業技術發展中心藥品製劑研發處資深研究員   學歷：英國倫敦大學藥學院藥物傳輸研究中心博士   經歷： 財團法人製藥工業技術發展中心副研究員、藥物研究組組長、產品開發組組長、藥品製劑研發處副處長、藥品製劑研發處處長、企劃處處長、藥品製劑研發處資深研究員 2012-Now台灣大學藥學系開授『製藥技術』課程 ___________________________________________________________________________________________________________________-
王宏仁	現職：智擎生技總經理   專長：Highly accomplished and effective Pharmaceutical Product Development, Materials Science & Engineering executive leader with an exceptional record of success in early-to-late-phase pharmaceutical drug development with multiple NDA experience. Scientific expertise includes pharmaceutical formulation design of low solubility compounds, solid-state analytical development, materials science and engineering, solid-state characterization, imaging/spectroscopy, surface/colloidal chemistry, and glass/optical materials. Collaborative and respected scientific leader, team builder and mentor with excellent communication, critical thinking, relationship management and problem solving abilities.   學歷：Ph.D., Materials Science & Engineering, Massachusetts Institute of Technology.   經歷： PROTEOSTASIS THERAPEUTICS, INC., September 2017 – November 2020 Vice President, Product Development/ Senior Director, Formulation   MICROCHIPS BIOTECH, January 2016 – September 2017 Director of Formulation Science   VERTEX PHARMACEUTICALS, February 2010 – December 2015 Materials Discovery & Characterization, Director/ Associate Director/ Senior Scientist   TRANSFORM PHARMACEUTICALS June 2005 – January 2010 A Johnson & Johnson Company, Senior Scientist/ Scientist   MASSACHUSETTS INSTITUTE OF TECHNOLOGY, June 2000 – June 2006 Department of Materials Science & Engineering, Lecturer (January 2005-June 2005) Microstructural Evolution in Materials (Undergrad Level); and Kinetic Processes in Materials (Graduate Level) Research Assistant (June 2000-January 2005)   NATIONAL TSING-HUA UNIVERSITY, September 1995 – June 1997, Department of Materials Science and Engineering Thermal Analysis Laboratory Manger _____________________________________________________________________________________________________________________
蔡翠敏	現職：FormuRx Pharmaceuticals, Founder/President/Chair   專長：Drug Delivery System, Formulation Design   學歷：University of Kentucky, Ph.D.   經歷： RuenHuei Biopharmaceuticals, 2018-2019, Formulation Development Director RuenHong Biopharmaceutical, 2016-2018, President Taipei Medical University, 1994-2016, Professor Taiwan Drug Relief Foundation & National ADR Reporting System, 2013-2015, Executive Director ____________________________________________________________________________________________________________________
曾雲龍	現職：Vice President, R&D, Taiwan Liposome Co., Ltd., Taipei, Taiwan.   專長： Immunoliposomes for targeted delivery Animal experiments (Drug metabolism, Pharmacokinetics, Tumor model in mouse, Liver perfusion) Molecular biology (Plasmid Construction, cDNA Cloning, Fusion Protein Expression, Non-viral Gene Delivery, Phage Display-Based Specific Peptide Ligands Screening) Antiangiogenesis studies; Anticancer Drug development Formulation development for drug control release Preparing an IND Application, Chemistry, Manufacturing, and Control (CMC) Information, ANDA Submission   學歷： Ph.D., Biochemistry, College of Medicine, National Taiwan University   經歷： 2002-2013: Director, R&D, Taiwan Liposome Co., Ltd., Taipei, Taiwan. 2001-2002: Consultant, TTY Biopharm, Taipei, Taiwan. 1999-2002: Postdoctoral Fellow, Department of Oncology, National Taiwan University Hospital 1997-2000: Project Manager, Taiwan Liposome Co., Ltd., Taipei, Taiwan. 1999: Scientist, Taiwan Liposome Co. Ltd., Taipei, Taiwan. 1995, 1996: Visiting Researcher, Liposome Research Laboratory of Demetrios Papahadjopoulos at the University of California, San Francisco (UCSF), CA, US ________________________________________________________________________________________________________________-
羅友文	現職：工研院生醫所標靶藥物技術部門副理兼任廠長   專長： His research focuses on polymeric microspheres-based sustained release technology, injectable hydrogel-based drug delivery technology, formulation for water-insoluble drugs, manufacturing process development and pharmacokinetics.   學歷：PhD, School of Pharmacy, Taipei Medical University   經歷：Over 15 years of experience in the field of advanced drug delivery technology. ___________________________________________________________________________________________________________________
葉秉陽	現職：全心醫藥生技台灣子公司- AltruBio Taiwan, 總經理(President)   經歷： 台康生技(EirGenix, Inc.), 2019 – 2021, 技術長暨副總經理(CTO & VP) Amgen (2011 – 2019) Thousand Oaks, CA; Seattle, WA; Boston, MA Executive Director and Head, Drug Product Development and Technologies, Process Development, Operation, Biogen (2006 - 2011) San Diego, CA & Boston, MA Director and Head, Protein Pharmaceutical Development, Pharmaceutical Operation and Technology, GlaxoSmithKline (1995 - 2006), Upper Merion, PA Associate Director, BioPharm CEDD, and Global Pharmaceutical Development ____________________________________________________________________________________________________________________
甘霈	現職：co-founder and president of Pharmosa Biopharm Inc..   學歷：PhD, National Tsinghua University in Taiwan and completed post-doctoral research at Tsukuba University in Japan.   專長：He has worked in pharmaceutical industry for more than 25 years, focused on formulation technology and product development, published over 50 papers and more than 20 patents related to drug delivery. He has led the development of several new formulation-based drug projects and completed filing and listing of IND, BioIND, and ANDA products in Taiwan, China, United States, Japan, and Europe.   經歷：He served as a researcher at Industrial Technology Research Institute (ITRI), then an associate director of Taiwan Liposomal Company.

【上課地點】
週六_學科教學: 線上課程(ZOOM 系統連線)
5/12(週五)術科操作: 新竹市光復路二段321號1館
(可只參加學科,惟結訓證書會加註參加科別)

※機構及企業包班歡迎與我們聯繫
以上費用包含:講義及證書費用
【諮詢專線】02-2783 6028 分機11或分機12 歡迎來電
(注意事項:以上課綱及開課日期/授課師資/場地..等; 本協會保有異動權，如有變動將會提前通知)