Accelerating Pharmaceutical Growth through Open Innovation and Global Collaborations

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Sino American Pharmaceutical Professionals Association 美中醫藥開發協會 Accelerating Pharmaceutical Growth through Open Innovation and Global Collaborations August 3-4, 2012 New Jersey, USA PRELIMINARY PROGRAM www.sapaweb.org 1 20 th SAPA Annual Conference

August 3, 2012 PM Program (Friday) Pines Manor, Edison, New Jersey Session 1: Path to the Regulatory Understanding Connect, Communicate and Collaborate Co-Chairs: Drs. Jane Xiang, Zak Huang 1:00-1:10 pm Baoguo Huang, PhD, SAPA President (Welcome remarks) 1:10-1:20 pm Zhen Wu, Deputy Commissioner of SFDA 1:20-1:40 pm Ji Zhang, PhD, VP, Global Head of Scientific Core Platform, SANOFI (Clinical study) 1:40-2:00 pm Sharon Olmstead, VP, Global Head Regulatory Policy & Intelligence DRA FDA Liaison Novartis Pharmaceuticals Corporation (Innovations) 2:00-2:20 pm Lee Kang, PhD, Director, Asia-Pacific, Perrigon (Regulation of pharmaceutical materials & GMP) 2:20-2:40 pm Chih-duen Tse, Director, Pharmaceutical Science/Global CMC, Pfizer Inc (GMP) 2:40-3:00 pm Overview on Chinese Drug Regulatory System Xiaoling Qin, Deputy Director-General, Department of International Cooperation, SFDA Break 3:00 3:30 pm Session 2: Pharma Career Transition & Job Fair Co-Chairs: Drs. Ning Yan, Xin Du, Su-Fen Pu, Frank Gan 3:30 3:50 pm Change: Survive and Thrive James Boyd, PhD, VP, Global Regulatory Affairs, SANOFI 3: 50 5:30 pm Panel discussion: Kim DeWoody, PhD, Global Head, Biostatistics & Programming, Janssen Research & Development, Johnson & Johnson Kathy Ku, PhD, Director, Global Regulatory Science and Safety, CMC, BMS Mingde Xia, PhD, Sr. Director, Corporate Office of Sciences & Technology, Johnson & Johnson Chris Peck, VP, Expert Services, YourEncore, Inc 2

August 3 Dinner Banquet Program (Luye Night, 绿叶之夜 ) Co-Chairs: Ms. Helena Feng, Dr. Xiaole Shen 6:00 6:10 pm Counselor Dongbai Ye, Science & Technology Affairs, Consulate General of the People s Republic of China in New York 6:10 6:40 pm BIOasis Brief Introduction Sammy Jiang, Director, International Business Development, Shandong International Biotechnology Park Development Co., Ltd. IND and clinic trials in China and US, Luye s experiences Youxin Li, PhD, Executive VP, R&D, Luye Pharma Group 6:40 7: 10 pm Richard K. Murray, MD, VP, Head of Global Center for Scientific Affairs, Merck 7:10 7:40 pm SAPA Annual Event Summary (2011-2012) Excellent Service Award Presentations 7:40 9:00 pm Dinner and Entertainment 3

August 4, 2012 Program (Saturday) Busch Campus Center, Rutgers University, Piscataway, New Jersey Plenary Session: Accelerating Pharmaceutical Growth through Open Innovation & Global Collaborations (8:45 12:00 pm) Co-Chairs: Drs. Baoguo Huang, Handan He 8:30 8:45 am Baoguo Huang, PhD, SAPA President, Opening Remarks 8:45 9:30 am Joanne Waldstreicher, MD, Chief Medical Officer, Janssen Research & Development, Johnson & Johnson 9:30 10:15 am Achieving Global Success via Strategic Position and Open Innovation Dianbo Liu, President and CEO, Luye Pharma Group 10:15 10:30 am Coffee Break 10:30 11:15 am Graham Burton, MD, SVP, Regulatory Affairs PHRMCV/COMPL, Celgene Corporation 11:15 12:00 pm Impact and Consideration of Ethnic Factors in Global Drug Development, Regulatory Review, and Clinical Practice Shiew-Mei Huang, PhD, Deputy Director, FDA 12:00-12:30 pm SAPA Scholarships/SAPA EC election results 12:30 1:30 pm Lunch Break Ambassador Guoxiang Sun, Consulate General of the People s Republic of China in New York, Dr. Baoguo Huang, SAPA President (2011-2012) Dr. Handan He, SAPA President-elect (2011-2012) 4

Parallel Symposia (1:30-5:30 pm) Session 1: Established Markets - Strategies for Thriving Co-Chairs: Drs. Jiwen Chen, Wansheng Jerry Liu, Wei Ding 1:30 2:00 pm David Shen, PhD, VP, Global Head of Biologics Development, Teva Pharmaceuticals 2:00 2:30 pm Maximizing the Value of Corporate Intellectual Property Assets Following Enactment of America Invents Act & Mayo v. Prometheus Bringing Fire to Medical Diagnostics and Personalized Medicine or Distinguishing It? Gerard P. Norton, PhD, JD, Partner, Chairman of Intellectual Property Department, Fox Rothschild LLP 2:30 3:00 pm Chao Lin, PhD, Director, Vertex Pharmaceuticals 3:00 3:45 pm Coffee Break 3:45 5:30 pm Panel discussion Session 2: Emerging Market - A Driver for Growth Co-Chairs: Drs. Ning Yan, John Tan, Charles Bao 1:30 2:00 pm Merck's R&D Strategy in China Ming-Qiang Zhang, VP, Asia Pacific Regional R & D and GM in China, Merck 2:00 2:30 pm Richard Soll, PhD, SVP, Global Alliances, Wuxi AppTec 2:30 3:00 pm Icotinib for Lung Cancer: a Small Molecule in a large Market Don Zhang, President & CEO, BetaPharma, Inc. 3:00-3:30 pm Capturing the Growing Market in China, the Hengrui Approach Minsheng Zhang, PhD, VP and Site Head, Hengrui Pharma Group 3:30 3:45 pm Coffee Break 3:45 5:30 pm Panel discussion 5