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| Dr. George C. Chou, Ph.D. |
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Dr. George C. Chou, Ph.D.
CEO and CSO AsiaGen Corporation Taiwan, ROC
Dr. Chou is the CEO & CSO of AsiaGen Corporation, a leading Taiwan-based company featuring multi-array technologies and DNA-labeling chemicals for molecular diagnosis of infectious diseases and genomic diagnosis of cancer. Dr. Chou was a senior manager at Aventis Pharmaceuticals and Senior Research Fellow at Novartis Pharmaceuticals prior to joining AsiaGen. As the head of the Department of Immunology of Preventive Medicine, NDMC, Taiwan for 12 years and with more than 29 years of R&D experiences in integration of large-scale research projects and specialized in cancer genetic therapy and virus molecular biology of HIV, Dr. Chou is a specialist in detection of infectious diseases, vaccine strategies and genetic therapy and has a wealth of experiences in international cooperation in strategic alliance and integration of technology. |
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Mr. Ed R. Kimmelman, JD.
Consultant Subcontractor, Quintiles Consulting, USA
Ed Kimmelman is globally known in quality system. He has participated in working groups and technical committees to develop guidance and other effective inputs to the FDA in forming regulatory standards for medical devices and medical diagnostics. Mr. Kimmelman joined DuPont's after graduating with a degree in mechanical engineering from Cornell University and earned a law degree from Seton Hall University. At DuPont he began working with medical device regulatory affairs and compliance. Starting as a regulatory affairs specialist, Mr. Kimmelman eventually headed up that activity at DuPont and then migrated into the quality systems field. After an early retirement, he joined Boehringer Mannheim as the Program Director of Regulatory Affairs and Regulatory Compliance. When the IVD manufacturing at Abbot was shut down by the FDA, Mr. Kimmelman was hired for the rescue and instrumental to obtaining FDA approval for their quality system in two years. As the convenor (chairholder) of the ISO TC 210 working group #1, he currently leads a team of international quality systems professionals who are developing standards and guidelines for the medical device industry. His working group developed ISO 13485 and ISO 13488, that include specific medical device quality system requirements. |
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| Mr. Ed R. Kimmelman, JD. |
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| Dr. Fred D. Lasky, Ph.D. |
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Dr. Fred D. Lasky, Ph.D
Senior Director, Regulatory Affairs, Diagnostics and Genetic Laboratory Divisions,
Genzyme Corporation, USA
Dr. Fred Lasky has been named by IVD board members as one of the 10 persons who have made a significant impact on the IVD industry. With more than 20 years of experience in regulatory affairs and quality systems compliance, Dr. Lasky is active in developing standards for the IVD industry. He is an expert in clinical standard development and has been key in the IVD industry for interpreting laboratory standards and in developing key FDA documents. He worked as director of regulatory affairs at Genzyme Diagnostics (Cambridge, MA) and has served on projects through the Clinical and Laboratory Standards Institute (Wayne, PA) on the linearity of quantitative methods, quality control, and alternate-site testing. He also contributes to the international standards arena by participating in ISO technical committee 212 and working on documents on quality management in the clinical laboratory, traceability, risk management, and device labeling. |
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Mr. Albert T.W. Li, LLM
Manager and Senior Administrator Office of Medical Device Evaluation Center for
Measurement Standards ITRI, Taiwan, ROC
Mr. Albert T.W. Li received his Bachelor of Engineering from National Cheng Kung University in 1984 and Master of Law in National Cheng Chi University in 1989. Mr. Li has been employed by Industrial Technology Research Institute (ITRI) since 1990 and became the Manager of Office of Medical Device Evaluation (OMDE) in 1999. OMDE is accredited by the US FDA as 510(k) third party review and QSR Inspection Accredited Person and is also designated by Taiwan Department of Health to conduct medical device GMP inspection, QSD review and Class II IVD pre-market review. Mr. Li was the Chairman of Asian Harmonization Working Party Technical Committee from 2000 to 2005. He is a member of GHTF SG 4 and is an experienced GMP/ISO 13485 assessor. He has been an invited speaker in numerous conferences in the GHTF, EU, US, HK, China and Taiwan. In 2006, he was listed on Who’s Who in Global Regulatory Affairs of the 10th GHTF Conference. |
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| Mr. Albert T.W. Li, LLM |
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| Dr. Yu Ping Maguire, Ph.D |
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Dr. Yu Ping Maguire, Ph.D
Vice President of Clinical Development, Transcept Pharmaceuticals, Inc., USA
Dr. Maguire has over 16 years of diverse industrial experience in the pharmaceutical and biotechnology industries in the US. Dr. Maguire earned her PhD from Rutgers University in Food Science and Technology and received post-doctoral fellowship training in Hematology and Oncology at the University of Washington, Seattle. A former Director of R&D with Baxter International, Dr. Maguire directed a team of scientists to generate five products from concept. She then went on to head up the Clinical and Regulatory functions for several diagnostics and therapeutic companies and contract research organizations in the San Francisco Bay Area and Seattle (Covance, Dendreon, and diaDexus) with a focus in oncology, infectious disease, cardiovascular disease, and immunotherapy. Dr. Maguire also served as Vice President of Clinical and Regulatory Affairs with Zila, Inc., a pharmaceutical/biotech company with products in oral cancer detection and dental care. She currently serves as Vice President of Clinical Development for Transcept Pharmaceuticals, Inc. in the Bay area where she is responsible for heading up Phase 1 to 3 trials and post-marketing studies in insomnia and depression. |
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Dr. Pauline Y. Lau, Ph.D.
President, Suntec Corporation, USA
Dr. Pauline Lau is the founder and president of Suntec Corporation, USA. She also serves on the advisory board and consultants for several major medical companies and research institutes including Roche Diagnostics and ITRI (Industrial Technology Research Institute). Prior to founding Suntec Corporation, Dr. Lau was head of Integrated Health Care Department at Hoffman La Roche Pharmaceutical Research Center in California, responsible for IVD development and validation. She is a recognized expert in personalized medicine. Dr. Lau also has over 15 years of experience in medical diagnostic research and product development. Dr. Lau has extensive experiences in managing FDA approval process of medical devices. She has successfully launched devices for physician’s office and other hospital-based products. Dr. Lau also has many years of successful records in market/business development between the drug and diagnostic industries. In 1996-2002, she successfully managed the cardiac and tumor markers with over 30% market growth each year. |
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| Dr. Pauline Y. Lau, Ph.D. |
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