ROADMAP FOR BIOLOGICS DRUG DEVELOPMENT

September 13th, 2013 | Categories: 2013 | Tags:

ROADMAP FOR BIOLOGICS DRUG DEVELOPMENT

Biotherapeutic Training Workshop

Date:     Oct. 1, 2013 (Tue)

Venue:    1st Conference Rm, H.S.S. Building, Academia Sinica, Taipei

 

The focus of this workshop is to provide the attendees with an overview of the drug development process for Biologic Therapeutics. Experts in the field who themselves have had several years of experience both in developing such drugs and having them approved, will present their perspectives on the general considerations of drug development at various stages of the process including, preclinical, translation, FIH and late stage trials and also cover aspects of challenges involved in the commercialization of biologics in upstream process development and contract manufacturing. All these aspects will be highlighted by specific examples relevant to that stage of development, so that the audience can appreciate the significance of the process and use the examples to define the relevance to their own drug development scenario. Finally, the speakers will be available to address any specific questions that the attendees may have at the panel discussion.

 

財團法人生物技術開發中心主辦的“ROADMAP FOR BIOLOGICS DRUG DEVELOPMENT”研討會,將於2013年10月1日(二)假中央研究院人文館第一會議室舉行。其主旨在於對生物新藥的開發過程做一深入講解,以利參與者應用於工作或研究。幾位主講者均於國際大藥廠有多年新藥開發經驗,其中多項開發之新藥已獲准上市。

講師們將就其專業領域,依不同研發階段如:臨床前試驗、轉譯研究、首例人體臨床試驗、及後期臨床開發做整體性的介紹,繼以介紹商業化過程中不可忽視之上游製程開發及委託製造的考量。全程佐以實例講解,俾使產學研界均可學以致用。

對於參加者於工作上遭遇的問題,特別設計了專家座談,由生技中心紀威光副執行長主持,全體講師及李文機博士、簡海珊博士參與討論,針對參加者的問題提出解答及建議,以期為其工作釋疑,並達到參與研討會的具體效益。

 

Program

Time

Topics

Speakers

09:00-09:15 Opening Remarks Dr. Chia-Lin Jeff Wang, President, Development Center for Biotechnology

(財團法人生物技術開發中心

汪嘉林執行長)

Dr. Haishan Jang, CEO, BRIM Biotech

(全福生物科技 簡海珊總經理)

09:15-10:15 Overview on Bioanalytical Considerations for Biotherapeutics Dr. Uma Prabhakar, Consultant,

National Cancer Institute(NCI)

10:15-10:30 Break
10:30-11:30 Overview of Early Trials in Human Subjects and Associated Regulatory Requirements. Dr. Hugh Davis, Vice President,

Janssen Research and Development, LLC., J&J

11:30-12:10 Q&A Dr. Uma Prabhakar,

Dr. Hugh Davis

12:10-13:30 Lunch
13:30-14:10 Upstream Process Development for Biologics- An Overview Dr. David Jan, Director ,

Vaccine Research Center, NIAID/NIH

14:10-14:50 CMO Management Dr. David Jan
14:50-15:20 Break
15:20-16:30 Panel Discussion Moderator:

Dr. Wei-Kung Chi, Vice President, Development Center for Biotechnology

(財團法人生物技術開發中心

紀威光副執行長)

Dr. Hugh Davis,

Dr. Uma Prabhakar,

Dr. David Jan,

Dr. Haishan Jang

Dr. Frank Lee, Chairman, BRIM Biotech

 

Event Organizer:  National Research Program for Biopharmaceuticals(NRPB)

Development Center for Biotechnology(DCB)

 

 

報名網址: http://www.dcb.org.tw/en_msg.aspx?a=2&i=761

報名日期: 即日起至額滿為止

 

備註: 全場以英文進行。另因名額有限,若報名人數過多,將以報名先後順序安排。

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