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【適合對象】對新藥開發想進一步了解或深入學習者。
歡迎有新藥開發或製藥相關背景或早期新藥開發人員、生技新藥公司、藥廠策略規劃人員等一同加入學習行列。
【上課時間】2019/5/11~6/29，每週六9:30-12:30 / 13:30-16:30
6/8 端午連假，順延一次
【課程時數】共7週(42小時)
【課程規劃專家】 黃文英博士
【專業師資】
- 黃文英/執行長暨總經理(安基生技新藥公司)
- 張子文/執行長(免疫功坊公司)
- 蕭世嘉/執行長(育世博生技) 新增講師
- 葉聖文/臨床前研發處經理(順天醫藥生技)
- 周志光/副總經理(順天醫藥生技)
- 溫國蘭/策略長(先驅生技) 新增講師
- 蕭嘉玲/副總經理(博晟生醫)
- 甘良生/執行長(逸達生技)
- 劉敏/醫務長(東曜藥業)
- 徐麗娟/副執行長(CDE)
- 莊欣怡/法規處暨專案管理處資深協理(順天醫藥生技)
【課程大綱】
| 5/11 | 1.0 | Course overview & 新藥開發及選題 (小分子) | 新藥開發課程目的與內容介紹: 新藥開發之概念及經驗分享;包括選題考量及研發的基本原則與步驟。 | Basic steps in asset evaluation, from drug candidate selection to IND and beyond; focusing on the discovery and critical success factors. |
| 5/11 | 2.0 | Emerging cell therapies, 免疫療法及細胞治療開發的基本概念及經驗分享 (2019新增) | 1. Latest update of immune cell therapy such as CART; 2. The challenge of CMC and percliniql cell therapy development; 3. Experience of an immune cell therapy start-up. | To be discussed with Sonny in the next few days |
| 5/11 | 3.0 | From Target to Candidate: 抗體新藥開發 |
抗體新藥基本概念及經驗分享 | From target validation to candidate selection - challenges and critical success factors in the development of protein new drugs; case studies with antibody drugs. |
| 5/18 | 6.0 | Design and conduct of preclinical drug development program | 臨床前體內及體外藥理與毒理試驗的考量與選擇 | Planning and executing pharmacology and Toxicology studies; IND-enabling and beyond IND; selecting and managing CROs; understanding regulatory requirements; supporting clinical development strategy. |
| 5/25 | 3.0 | CMC at pre-IND stage and planning for NDA; Points-for-consideration for small molecule drugs | 臨床前與臨床試驗供料的策略及如何準備CMC package for IND 並且為臨床二期之後做準備 | Requirements of test materials to support candidate selection, non-GLP, and GLP studies; how to supply for first-in-human clinical trial studies; IND-requirements for CMC; how and what to prepare for success in clinical studies, product registration and licensing. |
| 5/25 | 3.0 | 生物藥開發概論及進入IND的第一關 | 生物藥發展史; 細談CMC; Case studies | A general introduction about developing the biologics; challenges of filing an IND; discussion of specific examples encountered by the lecturer and the participants. |
| 6/1 | 6.0 | Bioanalysis for new drug development | 由技術面與策略面了解生物分析方法開發與應用，包括支持藥動與臨床劑量的選擇。How best integrate bioanalysis into preclinical and clincial development plans. | IND-enabling PK/TK studies; Development and application of bioanalytical methods; experimental design, data interpretation. Case studies; such as how bioanalysis saves or ruins the day; PK/PD (TK/TD) correlation, dose selection consideration for first-trial-in-human studies, etc. |
| 6/8 端午節連續假期 順延一次(週) | (休息/各小組分組作業準備) | |||
| 6/15 | 3.0 | DMPK for new drug development | 介紹藥物在體內之吸收分布與代謝追蹤；着重於如何運用藥物代謝與藥動學來支持新藥安全性及有效性預估，新藥開發計劃，及臨床試驗之風險管控。 用，包括支持藥動與臨床劑量的選擇。 | IND-enabling PK/TK studies; development and application of bioanalytical methods; experimental design, data interpretation; PK/PD (TK/TD) correlation, dose selection consideration for first-trial-in-human studies. |
| 6/15 | 3.0 | From Bench to Bed Part 1 | 如何規劃，準備，執行一個成功的首次臨床試驗及PoC臨床試驗。 | Development of a clinical plan from FIH trial to clinical investigation in patients; focusing on the preparation and updates of Investigator’s Brouchure; planning & executing first-in-man/ Proof-of-concept trials; Selection and the management of clincial CROs. |
| 6/22 | 3.0 | From Bench to Bed Part 2 | ||
| 6/22 | 3.0 | Principle of project management and Regulatory Requirements: IND and beyond | 新藥註册法規要求及專案計劃的配合: 從IND做起。 | 1. Introduction to regulatory strategy for new drug development 2. Data Requirement for Clinical Trial Applications (IND-enabling data package) 3. Proactive project management for IND submission and beyond |
| 6/29 | 6.0 | Project Management; integrating regulatory and development strategy through IND and beyond | 成功運用專案管理聚焦研發能量，執行法規策略，達成事業目標。 | Lecture & WORKSHOP |
【上課時間】2019/5/11~6/29，每週六9:30-12:30 / 13:30-16:30
6/8 端午連假，順延一次
【課程時數】共7週(42小時)
【上課地點】台北市大安區和平東路二段106號4樓(科技大樓)
【課程費用】非團體會員價NT$27,300，協會團體會員價NT$21,000
新春早鳥優惠: 4/5前完成報名及繳費者，只要NT$ :20,000元 (限額:10人)
【線上報名】我要報名/預約
6/8 端午連假，順延一次
【課程時數】共7週(42小時)
【上課地點】台北市大安區和平東路二段106號4樓(科技大樓)
【課程費用】非團體會員價NT$27,300，協會團體會員價NT$21,000
新春早鳥優惠: 4/5前完成報名及繳費者，只要NT$ :20,000元 (限額:10人)
【線上報名】我要報名/預約
日期 & 時間
2019.05.11 ~ 2019.06.29
地點 & 地址
主辦單位
聯絡資訊
