Tuesday April 25, 2017
時間 Time	議程內容 Topics	講者 Speakers
8:30~9:00	報到 Registration
9:00~9:30	開幕致詞 Opening Remarks Room 301	蘇芳慶政務次長科技部 Dr. Fong-Chin Su, Deputy Minister Ministry of Science and Technology 莊裕澤主任財團法人國家實驗研究院科技政策研究與資訊中心 Dr. Yuh-Jzer Joung, Director General STPI, NARLabs 張鴻仁副理事長台灣研發型生技新藥展協會 Dr. Hong-Jen Chang, Vice Chairman TRPMA
9:30~10:40	綜合討論 Discussion Forum Today's New Business Trend for Drug Development – Funding and the Collaboration Room 301	主持人 Moderator：張鴻仁副理事長台灣研發型生技新藥發展協會 Dr. Hong-Jen Chang, Vice Chairman TRPMA 與談人 Panelist：何正宏總經理圓祥生命科技股份有限公司 Dr. Jeng Her, Founder and CEO AP Biosciences 顧曼芹董事會主席 & 執行長展旺生命科技股份有限公司 Dr. Sherry Ku, Chairperson of Board & CEO Savior Lifetech Corporation 溫國蘭總經理永昕生物醫藥股份有限公司 Dr. Karen Wen, President Mycenax Biotech Inc. 葉志鴻總經理台灣微脂體股份有限公司 George Yeh, President Taiwan Liposome Company, Ltd. (TLC)
10:40~11:00	茶敘 Coffee Break 3F Lobby
11:00~12:20	Track1: Drug Development Lecture: Late Stage CMC Development for Biologics Room 402AB	李文豐博士 Dr. Frank Lee, Director of Upstream Development and Operations Eisai Inc.
	Track 2: Regulatory Lecture: TPP continuation - Regulatory Strategy for Labeling and Packaging from Ph I, II, and III to HA submission Room 402CD	林舒悦 Su-Yueh Lin, Sr. Regulatory Labeling Consultant SYL Regulatory Labeling Consulting Group
	Track 3: Business Development Lecture: 2016 Class of New Drug Trend and Strategy Room 301	顧曼芹董事會主席 & 執行長展旺生命科技股份有限公司 Dr. Sherry Ku, Chairperson of Board & CEO Savior Lifetech Corporation
12:20~14:00	午餐 Lunch Box & Social
12:20~14:00	Vendor Workshop Session A (1:00-1:40pm) Presentation: Room 301, 402AB, and 402CD Booth: 3F Lobby
14:00~15:20	Track1: Drug Development Lecture: Portfolio Prioritization & Methodology Review Room 402AB	莊蕾潔 Lei Chuang, Global Drug Development Advisory Consultant LCKC Consulting
	Track 2: Regulatory Workshop: US Prescription Drug Labeling Room 402CD (名額有限，需事先勾選場次報名) (名額已滿，停止開放報名，現場視報到情況候補)	林舒悦 Su-Yueh Lin, Sr. Regulatory Labeling Consultant SYL Regulatory Labeling Consulting Group
	Track 3: Business Development Lecture: Deal Term Structure and Valuation Room 301	Dr. Carl Firth, Founder and Chief Executive Officer ASLAN Pharmaceuticals Yen Zhao Yi, Finance and Business Development Analyst ASLAN Pharmaceuticals
15:20~15:40	茶敘 Coffee Break 3F Lobby
15:40~17:00	Track 1: Drug Development Workshop: CMC Development for Biologics Workshop & Q/A Room 402AB	李文豐博士 Dr. Frank Lee, Director of Upstream Development and Operations Eisai Inc.
	Track 2: Regulatory Writing Workshop: How to Prepare an Initial Investigator's Brochure (IB) for a Large/Small Molecule IND/CTA Room 402CD (名額有限，需事先勾選場次報名) (名額已滿，停止開放報名，現場視報到情況候補)	Kent Cochran, Director, Regulatory Medical Writing Janssen Research and Development, LLC (Johnson & Johnson)
	Track 3: Business Development Lecture: Forecasting & Market Analysis ,Presenting Your Pitch & Negotiating the Deal Room 301	Dr. Carl Firth, Founder and Chief Executive Officer ASLAN Pharmaceuticals Yen Zhao Yi, Finance and Business Development Analyst ASLAN Pharmaceuticals
17:00~18:00	開幕茶會 Opening Reception 3F Lobby

Wednesday, April 26, 2017
時間 Time	議程內容 Topics	講者 Speakers
8:30~9:00	報到 Registration
9:00~10:20	Track1: Drug Development Lecture: Clinical Development Strategy – Final Countdown from Preclinical Development to IND Submission Room 402AB	莊蕾潔 Lei Chuang, Global Drug Development Advisory Consultant LCKC Consulting 林舒悦 Su-Yueh Lin, Sr. Regulatory Labeling Consultant SYL Regulatory Labeling Consulting Group Kent Cochran, Director, Regulatory Medical Writing Janssen Research and Development, LLC (Johnson & Johnson)
	Track2: Regulatory Lecture: Global Medical Device Regulatory Strategy Room 202 (名額有限，需事先勾選場次報名) (名額已滿，停止開放報名，現場視報到情況候補)	洪哲章資深主任稽核員 Dr. Tim Hung, Senior Lead Auditor/ Medical device Specialist DNV GL
	Track 3: Business Development From a Technology Startup to an Antibody Drug Company on NASDAQ Room 301	何正宏總經理圓祥生命科技股份有限公司 Dr. Jeng Her, Founder and CEO AP Biosciences
10:20~10:40	茶敘 Coffee Break 3F Lobby
10:40~12:00	Track 1: Drug Development Lecture: Patent Strategy: Challenges of Pharmaceutical Companies Room 402AB	林宗緯專利副理萬國法律事務所 Wade Lin, Vice Manager Formosa Transnational Attorneys at Law
	Track 2: Regulatory Writing Workshop: How to Prepare a Clinical Protocol for Large/Small Molecule IND/CTA Room 202	Kent Cochran, Director, Regulatory Medical Writing Janssen Research and Development, LLC (Johnson & Johnson)
	Track 3: Business Development Lecture: Taiwan Company Setup Experience and the Fund Raising and Business Models Room 301	溫國蘭總經理永昕生物醫藥股份有限公司 Dr. Karen Wen, President Mycenax Biotech Inc.
12:00~14:00	午餐 Lunch Box & Social
12:00~14:00	Vendor Workshop Session A (12:20-1:00pm) Session B (1:10-1:50pm) Booth: 3F Lobby Presentation: Room 202, 301 and 402AB
14:00~15:20	Track1: Drug Development Lecture: The Role of Toxicology in the Translational Medicine Room 402AB	龔曉嘉博士 Dr. Ada Kung, President and Managing Director Expedient Solutions International
	Track2: Regulatory Lecture: Case Study for Some Medical Device Companies RA Strategy Room 202 (名額有限，需事先勾選場次報名) (名額已滿，停止開放報名，現場視報到情況候補)	洪哲章資深主任稽核員 Dr. Tim Hung, Senior Lead Auditor/ Medical device Specialist DNV GL
	Track2: Regulatory Lecture: Regulatory Project Management for IND Submission – Planning, Dossier Preparation and Tools use Room 301	莊蕾潔 Lei Chuang, Global Drug Development Advisory Consultant LCKC Consulting
15:20~15:40	茶敘 Coffee Break 3F Lobby
15:40~17:00	Track 1: Drug Development Lecture: Practical considerations and strategies in filing and prosecuting U.S. patent applications Room 301	徐基峰客座專家中央研究院 Dr. Jeff Hsu, Visiting Expert Academia Sinica
	Track 2: Regulatory Lecture: FDA Meetings Room 402AB	龔曉嘉博士 Dr. Ada Kung, President and Managing Director Expedient Solutions International
	Track 3: Business Development Workshop: BD Project Management – BD Activity preparation, BD Meeting Management, and Alliance Management Room 202 (名額有限，需事先勾選場次報名) (名額已滿，停止開放報名，現場視報到情況候補)	莊蕾潔 Lei Chuang, Global Drug Development Advisory Consultant LCKC Consulting

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