【學員對象】
- 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。
- 曾從事藥物開發或臨床試驗工作者
【授課內容】
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.
PartⅠ:The role of toxicology in translational medicine:
Specific experiments and studies need to be done will be included in the lecture:
- Drug discovery plan: biomarker development
- Analytical and bioanalytical method development and validation
- In vitro and in vivo efficacy models
- PK, PD, and toxicology with protein therapeutics
- 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
- 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
【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
