Agenda:
Titles of Seminars:
1) ICH in China-a reality check and its impact on drug development
Dr. Dan Zhang, Executive Chairman of Fountain Medical Development. Ltd.
Contents:
a) One year has passed since CFDA became a member of ICH, what is the current status of ICH implementations in China?
b) What about derived new regulatory policies, patent consideration and reimbursement policies
c) What are the impacts of these changes on clinical development planning and regulatory strategy across Pacific Ocean?
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Dr. Dan Zhang is the Executive Chairman of Fountain Medical Development Ltd, a clinical CRO with 1700 employees operating in China, Hong Kong, Taiwan, South Korea, Japan, UK, India, Philippines, Armenia and USA.
Dr. Zhang was the Head of Clinical Development and was the Head of Safety Assessment at Sigma-Tau Research Inc-leading Italian Pharmaceutical Company. He was the Vice President at the Quintiles Transnational Corp., the world largest clinical CRO, and Chairman of Quintiles Medical Development (Shanghai) Company Ltd.,
Dr. Zhang is a member of grant review committee for National Drug Development Fund of China, and he is also consultant for the China Food and Drug Administration (CFDA). He is a member of ICH E19 Expert Working Group. He is also chairing the committee of Pharmaceutical R&D, China Pharmaceutical Industry Research and Development Association. Dr. Zhang is also a senior consultant for the Chinese Academy of Medical Sciences and Peking Union Medical College. He was a member of the Overseas Expert Committee on New Drug R&D for the Ministry of Science and Technology of China, and was the secretary-general of the Association of “Thousand Talent” Expert from 2011-2017. Dr. Zhang was the former board of directors for the Sino-American Pharmaceutical Association (SAPA) and was the former president of Chinese Biopharmaceutical Association-USA (CBA). Dr. Zhang is chairing the government relationship committee of BayHelix - an organization hosting senior executives from life science organizations in USA and China.
Dr. Zhang received his pre-med training from Peking University and received M.D. from Peking Union Medical College. He then went to the Harvard School of Public Health and received MPH in health policy and management. Then he went to the Wharton Business School of the University of Pennsylvania, where he obtained his master’s degree in healthcare management in 1998.
After received MPH in health policy and management from Harvard School of Public Health, he went to the Wharton Business School of the University of Pennsylvania, where he obtained his Master’s degree in healthcare management in 1998.
2) Legal consideration if you want to set up a company in China or in the US or both
Chuck Comey, Partner, Morrison & Foerster LLP
(650) 813-5723, ccomey@mofo.com
Chuck Comey is an M&A and corporate finance partner in the firm’s Palo Alto office. Mr. Comey’s practice experience includes working on the ground in China and Japan for 16 years. He advises clients on mergers and acquisitions, venture capital and private equity financings, and joint ventures and strategic alliances in the technology, consumer and life sciences sectors.
Beginning in 1994, Mr. Comey was seconded by the firm to the legal department of a major Japanese trading company, and thereafter was resident for nine years in Morrison & Foerster’s Tokyo office, where he specialized in cross-border mergers and acquisitions and strategic alliances. Before relocating to Silicon Valley in July 2010, Mr. Comey opened and served as managing partner of the firm’s Shanghai office from 2003 – 2010. He speaks and reads Mandarin.
3) Legal consideration for cross-border licensing deals, successful stories of cross-border licensing deals
Scott Carter, PhD, Of Counsel, Morrison & Foerster LLP
(415) 268-7884, scarter@mofo.com
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Scott Carter, Ph.D., J.D., focuses his practice on the life sciences industry, representing life sciences companies and investors in complex transactions relating to the development and commercialization of biotechnology, pharmaceutical, diagnostic, and medical-device products. He has extensive experience negotiating corporate partnership, licensing, research and development, clinical trial, manufacturing, and supply agreements. Dr. Carter also advises clients on the intellectual property aspects of mergers and acquisitions.
About Morrison & Foerster:
Morrison & Foerster was founded in San Francisco in 1883. Today, with approximately 1,000 lawyers in 16 offices across the U.S., Asia and Europe, Morrison & Foerster offers clients a comprehensive platform of global legal services, including extensive capabilities in the areas of corporate finance, mergers and acquisitions, tax, regulatory & compliance, litigation, and, intellectual property, among many others. We represent more than 550 life sciences companies, research institutions, and venture capital funds and investment banks that finance them. With more than 180 life sciences lawyers around the world, our fully-integrated team has the depth of practice and global reach that are critical in today’s global life sciences market.
4) Introduction of the Investment Environment of Bio-pharmaceutical Industry in Qidong City
Mr. Kangli Wang, Deputy Mayor of Qidong Municipal Committee
Mr. Kangli Wang is the Standing Committee and Deputy Mayor of Qidong Municipal Committee. From 1997 to 2017 Mr. Wang served as a member of the Party Working Committee of Nantong Economic and Technological Development Zone and deputy director of its management committee. Mr. Kangli Wang received his Bachelor Degree of Arts from the department of foreign languages of Fudan University and Master Degree of Public Administration from University of Maryland.
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About Qidong
Qidong is located on the north bank of the Yangtze River estuary, adjacent to the international metropolis Shanghai. The expressway G40, Ningqi Railway, Chongqi Bridge and the planned high-speed Railway along the Yangtze River connect Qidong with Shanghai closely. The advantage in time and space allows Qidong to emerge into the one-hour economic circle of Shanghai. Qidong is well-known as the hometown of electric tools, marine economy, architecture, education, longevity and printmaking. Qidong is in the first batch of coastal areas open to the outside in China. It ranks No.22 among national county-level economies, and 11 among small and medium-sized cities and towns across the country. In 2017, the city's GDP reached 14.467 billion dollars and its per capita GDP reached 15,197 dollars. Its research and development investment totaled 379 million dollars, accounting for 2.6% of the city's GDP, and the number of patent applications reached 7286. In addition, there are 152 high-tech enterprises in the city, accounting for 30% of the above-scale enterprises in Qidong.
Life & Health Science City is located at the north bank of the Yangtze River estuary, covering an area of 100 square kilometers. Mainly focusing on bio-medicine and health industry, it is devoted to develop genetic testing, bio-medicine, precision medicine, medical equipment, health and wellness industries, aiming to build the Yangtze River Delta innovation base of life science and technology, cluster of health Industries and a leisure and livable new city with a planned population of 1 million. By the end of 2017, there were 12 pharmaceutical manufacturers and 13 medical device manufacturers settled in the city. The leading companies include Bayer Pharmaceuticals, Gaitian Pharmaceutical, WuXi PharmaTech, ChemPartner, Xidi Pharmaceutical, Hotmed Sciences, Chengxin Pharmaceutical, Dongyue Pharmaceuticals and other well-known bio-pharmaceutical manufacturing companies both at home and abroad. 12 products produced in Qidong have been identified as national key new products, and 65 products have been identified as provincial high-tech products. In addition, there are 3 provincial-level enterprise academician workstations, 6 provincial engineering technology research centers, and 16 Nantong municipal engineering technology research centers in the biomedical field. In 2017, the output value of above-scale enterprises in new pharmaceutical industry in the city was nearly 2.2 billion dollars.
The Executive Deputy Mayor Mr. Kangli Wang and accompanying delegation of Qidong City, and other colleagues in the bio-pharmaceutical field will attend this event and share their experiences.
We sincerely invite you to register for this event. Limited places, please register as soon as possible! Dinner will be provided. RSVP is required for dinner reservation.
启东位于长江入海口北翼，毗邻国际大都市上海，高速公路G40、宁启铁路、崇启大桥及规划中的北沿江高铁将启东与上海紧密相连。时空的优势将启东纳入大上海一小时都市圈。启东是全国著名的电动工具之乡、海洋经济之乡、建筑之乡、教育之乡、长寿之乡、版画之乡。作为全国首批沿海对外开放地区之一，启东位列全国县域经济22位，全国中小城市创新创业百强县市11位。2017年全市GDP达到144.67亿美元，人均GDP达15197美元，研发投入总额3.79亿美元，专利申请7286项，研发投入占全市国内生产总值的2.6%。另外市内还有高新技术企业152家，占全市规模以上企业总数的30%。
启东生命科技健康城位于长江入海口北翼100平方公里内，围绕生物医药及大健康产业，大力发展基因检测、生物医药、精准医疗、医疗器械、健康养生等产业，建设长三角生命科技创新基地，健康产业集聚中心、滨江休闲宜居新城，规划人口达到100万。截至2017年底，全市现有药品生产企业12家，医疗器械生产企业13家，领军企业有拜耳药业、盖天力药业、药明康德、睿智化学、希迪制药、华拓药业、诚信药业、东岳药业等国内外知名的生物医药制造企业。全市有12个产品被认定为国家重点新产品，65个产品被认定为省高新技术产品。另外生物医药领域还有省级企业院士工作站3家、省级工程技术研究中心6家、南通市级工程技术研究中心16家。2017年全市新医药产业规模以上企业产值近22亿美元。
出席此次活动的主要人员有启东市常务副市长王康力先生及随行代表团及生物制药领域其他同行们。
我们诚挚邀请您注册参加此次活动，名额有限，报名从速! 会后提供晚餐，请尽早注册以便统计晚餐人数，谢谢!