Accelerating Pharmaceutical Growth through Open Innovation and Global Collaborations

Transcription

1 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 1 20 th SAPA Annual Conference

2 August 3, 2012 PM Program (Friday) Pines Manor, 2085 Lincoln Highway, Edison, NJ 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 Overview of Global Drug Master File Systems and Where China s DMF May Fit in Chih-duen Tse, PhD, Director, Global CMC, Pfizer 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 (A group of experts from Regulatory, Clinical Programming, Project Management, Patent, Business Development will lead the discussions) Kim DeWoody, PhD, Global Head, Biostatistics & Programming, Janssen Research & Development Leigh Shultz, PhD, Executive Director, Global Project Management, Merck 2

3 Kathy Ku, PhD, Director, Global Regulatory Science and Safety, BMS Mingde Xia, PhD, Sr. Director, Corporate Office of Sciences & Technology, Johnson & Johnson Shahnam Sharareh, JD, PharmD, RAC, Partner, Fox Rothschild LLP Hui Cai, PhD, MBA, VP, WuXi AppTec Many Pharma, Biotech & CRO companies will participate in job fair including Wuxi AppTec, GeneWiz, Luye, GenScript, ChemPartner, Pharmaron, etc Chris Peck, VP, Expert Services, YourEncore, Inc. 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 IND and Clinic Trials in China and US: Luye s Experiences Youxin Li, PhD, VP, R&D, Luye Pharma Group BIOasis Brief Introduction Sammy Jiang, Vice General Manger, Shandong International Biotechnology Park Development Co. 6:40 7: 10 pm Innovation, Sustainability and Purpose-Personal Thoughts from an Internist in our Industry Richard K. Murray, MD, FACP, VP, Head of Global Center for Scientific Affairs, Merck 7:10 7:40 pm SAPA Annual Event Summary ( ) Excellent Service Award Presentations 7:40 9:00 pm Dinner and Entertainment (Live Band, Open Bar, Stage Performances and networking with speakers & colleagues) 3

4 August 4, 2012 Program (Saturday) Busch Campus Center, Rutgers University, 604 Bartholomew Road, Piscataway, NJ 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 Challenges and Opportunities in the Pharmaceutical Industry: Working Together to Meet Unmet Medical Needs Joanne Waldstreicher, MD, Chief Medical Officer and Head, Asia Pacific Medical Sciences, Janssen Pharmaceutical Research & Development 9:30 10:15 am Achieving Global Success via Strategic Position and Open Innovation Dianbo Liu, CEO, Luye Pharma Group 10:15 10:30 am Ambassador Guoxiang Sun, Consulate General of the People s Republic of China in New York 10:30 10:45 am Coffee Break SAPA Corporate Excellence Awards 10:45 11:30 am Graham Burton, MD, SVP, Regulatory Affairs PHRMCV/COMPL, Celgene Corporation 11:30 12:15 pm Science-based Regulatory Decision Making Recent Efforts in the Clinical Pharmacology Area Shiew-Mei Huang, PhD, Deputy Director, Office of Clinical Pharmacology, FDA 12:15-12:30 pm SAPA Scholarships/SAPA EC election results 12:30 1:30 pm Lunch Break Dr. Baoguo Huang, SAPA President ( ) Dr. Handan He, SAPA President-elect ( ) 4

5 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 Biostatistics and Programming Perspective on Global Drug Development: Strategic and Operational Considerations Surya Mohanty, PhD, VP, Clinical Biostatistics, Cardiovascular & Metabolism, Janssen R& D 2:00 2:30 pm Opportunities and Challenges in Global Biosimilar Development W. David Shen, PhD, VP, Global Head of Biologics Development, TEVA 2:30 3:00 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 3:00 3:30 pm Innovative Thinking for Innovative Drugs - Lessons Learned from the Development of Telaprevir, a First Generation HCV Protease Inhibitor 3:30 3:45 pm Coffee Break 3:45 5:30 pm Panel discussion Chao Lin, PhD, Director, Vertex Pharmaceuticals 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 Perspectives of Global Partnerships for Drug Discovery and Development Richard Soll, PhD, SVP, Integrated Services, 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