【BD系列-1】國際學名藥市場之挑戰與機會 – 成功與失敗案例探討

2018/07/16 (週一)09:00-17:00 (恭喜已結業)
(更新: 2018 / 06 /08 16:00)

【課程名稱】國際學名藥市場之挑戰與機會 – 成功與失敗關鍵探討!


1.Overview & Current State of the US Generic Drug Industry
2.China’s Role in the Global Generic Drug Industry: Present and Future
3.Recent Trends and Opportunities of Pharma Business in China
4.Case Histories of Recent US Generic Drug Approvals
5.US Drug Distribution Channels: Explanation & Evolution
6.Disruptive Forces and Future Scenarios in the US Generic Drug Industry
7.Overview of SE Asia market


  1. Dr. Jo Shen(馬海怡) Vivo Capital合資夥伴/ 本學院發起人
  2. Dr. Yon-Lian Wu(吳永連) 祥翊製藥執行長/本學院發起


  1. Margaret Hsiao(蕭巽媺) Harvest Moon Pharma 共同創辦人and CEO
  2. Da-Hai Guo(郭大海) 美國普克藥業公司創始人兼CEO
  3. Dr. Bill Liu(劉芳宇) 漢達生技醫藥(股)公司董事長&執行長
  4. Dr. Michael Zhang (張敏忠) 昆山龍燈-瑞迪製藥總經理
  5. Dr. Fang-Hsin Lee(李芳信) 永信東南亞控股有限公司集團總裁
【上課時間】2018/7/16,(週一) 9:30-12:30 / 13:30-16:30
【招生人數】 額滿為止。
【課程費用】定價NT :5,000元
預約早鳥價NT$ 3,600  7/9前,完成預約報名,一律享有早鳥優惠價!
【諮詢專線】(02)2655-8692 分機11 歡迎來電
1.認證字號: [臨藥繼字 第1070771號](藥事人員 7.2 積分)

9:00 to 9:10 Chairperson’s Opening Remarks – Dr. Jo Shen, Dr. Yon-Lian Wu
9:10 to 9:50 Overview & Current State of the US Generic Drug Industry – Margaret Hsiao
The US generic drug industry is very challenging today.  There are fewer customers, many more competitors, changing FDA regulations, stringent scientific requirements, different types of patent litigation, etc.  This presentation will give an update of the US generic drug industry, market trends, the internal and external forces, and will give attendees a flavor of the US generic drug industry. 
9:50 to 10:20 Case Histories of Recent US Generic Drug Approvals_ Margaret Hsiao
With Inputs from Dr. Bill Liu and Mr. Da-Hai Guo
We will review in Case Study format, a number of recent US generic drug approvals including its patent litigation history, the perceived complexities and why they are success or failure. 
This session will emphasize the importance of product selection.  We will also review a number of drug products that have no generic versions and the reasons why.
10:20 to 11:00 China’s Role in the Global Generic Drug Industry: Present and Future – Da-Hai Guo
The People’s Republic of China was the world’s second largest pharma market in 2017 – worth $122.6 Billion; while the USA pharma market was $466.6 billion and Japan’s was $84.8 billion.  But now China is exporting generic drugs to the USA.  In 2017, Chinese drug companies received US FDA approvals for 38 generic drugs, up from 22 approvals in 2016.  That is still very small compared to India, the world’s largest exporter of generic drugs and received 300 of the approved 927 ANDA approvals from US FDA in 2017.  This presentation will give an update on the important role which China will play in the international generic drug market, and how it can be an opportunity for cooperation with companies in Taiwan. 
11:00 to 11:10 Networking Coffee Break and Bio Break
(Announce to have people write their questions down for Keynote Panel)
11:10 to 11:50 Recent Trends and Opportunities of Pharma Business in China- Dr. Michael Zhang
  • China pharma market trends and population develop model
  • The changes of pharma policies and the opportunities: the drug registration, BE/GEA, public hospital renovation, classified diagnose and treatment, two-invoice policy, 3rd party drug logistics.
  • KRRP as an example: product structure, key therapeutic areas,  sales and marketing team strengths
11:50 to 12:40 Keynote Panel:  Reaction & Response to Morning Presentations
Moderator:  Margaret Hsiao
Panelists: Dr. Bill Liu, Mr. Da-Hai Guo, Dr. Michael Zhang, Dr. Jo Shen, Dr. Y.L Wu.
12:40 to 13:30 Networking Luncheon

13:30 to 14:00 US Drug Distribution Channels:  Explanation & Evolution _ Margaret Hsiao & Da-Hai Guo
The drug distribution system in the USA is very complicated and a complete mystery to people who live outside the USA.  There are retailers, wholesalers, PBMs, insurance companies, GPOs, state formularies which are all connected and part of the supply chain.  We will give a broad overview of the US drug channels and follow the product flow and more importantly, the money flow. 
We will emphasize why it is so difficult for generic drug companies to succeed if they choose the wrong products and the wrong partners. 
14:00 to 14:40
Disruptive Forces and Future Scenarios in the US Generic Drug Industry_ Margaret Hsiao & Da-Hai Guo
There are many potential disruptions in the US Generic Drug Industry.  We will look at future scenarios such as Amazon, digital health, new players from China & Korea, the positive US government policies, and how we see the US generic drug industry evolving in the years to come. 
New USA Drug Distribution Channels:  Amazon and others
New Health Networks:  JP Morgan, Amazon, Warren Buffet’s Berkshire venture
New Players in US Generic Drugs:  Korea, Japan, P.R. China!
US Government Policies:  positive regulatory and tax reform
New Manufacturing Technologies:  FDA is on board!
Digital Health, AI, and Block Chain:  Silicon Valley is converging with Drug Industry
14:40 to 15:00 Networking Refreshments & Bio Break
15:00 to 15:40 Overview of SE Asia market – Fang-Hsin Lee
With growing population in South East Asia, this region represents great market opportunities. Like in other areas, there are lots of challenges – distribution channels, local regulations, Halal requirement in some countries, to name a few. This presentation will give an overview of this emerging market by a veteran working in this area for decades.  
15:40 to 16:30
Last Burning Questions from Attendees, Then Summary & Key Takeaways
Moderator:  Margaret Hsiao
Panelists: Dr. Bill Liu, Mr. Da-Hai Guo, Dr. Michael Zhang, Dr. Fang-Hsin Lee, Dr. Jo Shen, Dr. Y.L Wu.
16:30~17:00 Networking Reception -


1.蕭巽媺/ Harvest Moon Pharma 共同創辦人and CEO
Margaret Hsiao has over 20 years of professional experience in the Pharmaceutical, Medical Device, and Consumer Products industries.  Margaret was born in Tainan, Taiwan, but moved overseas at the age of 2, and was raised and educated in the UK and the USA.   She has degrees in Chemical Engineering as well as a Master of Business Administration.  Additionally, she studied solid state chemistry specializing in electronics materials for the US defense industry.  Her healthcare background includes technical and commercial positions at Pfizer, Procter & Gamble, and Perrigo. 
 She is co-founder and CEO of Harvest Moon Pharma, a boutique firm that specializes in product development and regulatory strategy, M&A due diligence, and product distribution tactics in the global healthcare and consumer products industry. 
 In 2001, she was the COO and a founding member of Midas Pharma, the US division of Midas Pharmachemie, Germany where she licensed a number of branded healthcare products to Pfizer Consumer, Reckitt Benckiser, and other multinational companies.  Previously, Margaret worked as VP of Agvar and Aegis Pharma for the legendary Ms. Agnes Varis.   Margaret is an avid outdoor lover and loves to go fishing, hunting, skiing, fossil collecting. 

郭大海先生,是美國普克藥業公司創始人兼CEO, 同時他也是人福普克藥業公司董事長兼CEO, 普克國際公司CEO等職位。作為6家相關經營在中國及美國的醫藥企業CEO,管理過中國製藥行業在美國規模最大的企業,包括中美兩地多家美國FDA認證的生產、包裝、倉儲、配送分銷公司。
郭大海先生在製藥和生物技術領域擁有20多年廣泛的中國與美國的商業經歷,從跨國商業管理、新藥研發、市場銷售到製藥生產廠的建設與管理等各方面都擁有成功經驗。負責過全球6000多種藥品、保健品及健康用品的銷售。普克藥業公司在郭大海的領導下,從無到有,快速崛起,成功建設為一個集生產、研發、市場銷售為一體的跨國經營企業。公司業務涉及品牌處方藥、OTC藥和仿製藥多個市場領域,是第一家將“中國製造”的OTC藥品成功打入美國主流連鎖藥店及美國大型超市(如沃爾瑪)的企業,也是第一家中國製藥企業在美國銷售自主品牌處方藥的企業。普克藥業公司在美國和中國經營,依託人福醫藥集團,統一協調全球優質資源,創造了多項中國製藥企業在國際化方面的第一。人福普克藥業公司連續多年獲得中國醫藥工業協會頒發的“中國十大出口名牌企業”等多項國家級榮譽, 2017年更榮獲中國“瞪羚企業”高新區百強,是入選全國百強的唯一一家製藥企業。“郭大海及團隊”還曾獲得中央組織部頒發的第三屆“全球華人華僑重點創業大獎”。
郭大海先生早年間在中國科學院遺傳所工作,90年代赴美留學,獲得美國康奈爾大學MBA,羅格斯新澤西州立大學生物學碩士, 獲得美國品質協會頒發的6-西格瑪黑段。在職業生涯的早期,參與創立CMT公司,後進入跨國大型藥企“羅氏集團”(Hoffman-La Roche Group)工作,曾獲得羅氏公司全球性大獎“Roche MBA Fellow”榮譽。郭大海先生同時協助創立BioKatalyst協會,並任第一屆主席,該協會會員為在醫藥健康領域美國華人精英組織,會員全部為醫藥行業高管。

With over 20 years of experience, Dr. Liu is an accomplished scientist with a proven track record for commercializing technology-based pharmaceutical products.
Dr. Liu founded Handa Pharmaceuticals in November 2005. Prior to founding Handa, he served as Chief Operating Officer and Vice President of Product Development and Operations at Anchen Pharmaceuticals from September 2002 to August 2005. As its first employee, Dr. Liu helped to set up Anchen’s business operations including formulation development, analytical services, quality assurance, information technology, regulatory affairs and a cGMP facility. Under his direction, the team successfully developed a pipeline of Paragraph IV controlled-release generic products, two of which were first-to-file.
Prior to joining Anchen, Dr. Liu served in various management positions in product development and business development at Yamanouchi Pharma Technologies. From 1992 to 1997, Dr. Liu was employed by Impax Pharmaceuticals, Watson Pharmaceuticals, and Southern Research Institute, where he was credited with the development of several generic controlled-release products.
 Dr. Liu received a B.S. degree in Pharmacy from China Pharmaceutical University in 1983 and a Ph.D. degree in Industrial and Physical Pharmacy from Purdue University in 1992

4.Dr. Michael Zhang (張敏忠) 昆山龍燈-瑞迪製藥總經理
德國柏林自由大學臨床免疫研究所(1994年轉為柏林洪堡大學) Humboldt University of Berlin                    
獲得德國臨床免疫學會Clemens-von-Pirquet-Prize 1993
1993年4月2日獲得博士學位 (導師: Prof. Dr. Gert Kunkel)
在德留學期間在國際雜誌上發表40多篇文章;多次參加國際學術會議(Paris, Copenhagen, Stockholm, Mainz, Berlin and Poznan)

李博士經營東南亞市場三十年, 熟悉東協十國各地銷售據點,包含馬來西亞, 菲律賓, ....等地之製造廠,市場實戰經驗豐富。李博士從當初不到十人的小貿易公司,拓展到目前除了馬國內銷之外,印尼唯二外資藥廠之一,更主攻東協、非洲及中東等地市場。1987年隻身到馬來西亞闖天下,拼出了自己的藥品王國。2004年成立了永信東南亞控股公司,發揚臺灣製藥工業,進軍國際舞台,帶領該公司成為馬國前5大藥廠,並於當地掛牌上市。本次課程中,將分享豐富的東南亞開拓經驗。
1998  榮膺馬來西亞馬六甲元首頒發准拿督(DSM)勛銜
1998  榮獲第二屆中華民國中小企業專業經理人菁英獎
1998 榮獲海外華人第七屆創業青年楷模獎
2000 榮獲第十八屆中華傑出經理全球華商類傑出經理獎
2001 榮獲第三屆海外台商磐石獎
2007 榮膺 馬來西亞檳城洲元首頒發拿督(DSPN)勛銜
中華民國僑 務委員會           僑務委員
世界台灣商會聯合總會          名譽總會長
亞洲台灣商會聯合總會          榮譽總會長
馬來西亞台灣商會聯合總會   名譽總會長
中華民國工商建設研究會    理事
財團法人商業發展研究院   常務董事