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.
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?
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, firstname.lastname@example.org
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, email@example.com
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.
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.
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