Dennis Fenton was granted a PhD in Microbiology from Rutgers University.  He joined Pfizer Central research, working in New Product Development from 1977 – 1981.  He joined Amgen at its inception in 1982 as a Research Scientist.  During his 26 year career, he held positions of increasing responsibility, including Vice President of Research, Senior Vice President of Sales and Marketing, and Senior Vice President of Operations.  He was Amgen’s first Executive Vice President.  He holds 5 US patents in microbiology and published over 50 papers and abstracts.  He retired from Amgen in 2008 and is currently an independent consultant and a member of the boards of Amira, Kythera, CytomX, Xenoport ,Rugters University, the Keck graduate Institute and the Biotechnology Institute.

Dr. Herman has over 30 years in the biopharmaceutical industry. He has been a pioneer in the biotechnology field beginning with Heptavax development while at Merck. From Merck, Dr. Herman moved to Genentech where he was actively involved with the development of several early bio-tech products while in the Process Development Department and, later, in Pharmaceutical R&D. He eventually went to Amgen where he served as Director of Analytical Research and Development. His department was responsible for the development of all protein analytical assays as well as product characterization. Following Amgen, Dr. Herman was Senior Director of Quality Control at Tercica. Most recently, Dr. Herman was the founder and president of WindRose Analytica, Inc., a contract analytical laboratory specializing in protein analysis and characterization. Dr. Herman has been involved in the establishment of the specified biologics concept since its inception and is often invited to speak on this and related topics at international meetings. He received his Ph.D. in protein chemistry from the microbiology department at Duke University Medical Center and remained at Duke for his post-doctoral work studying RNA tumor viruses.

Dr. Steve Kay is currently the Dean of the Division of Biological Sciences and holds the Richard C. Atkinson Chair in the Biological Sciences at the University of California, San Diego, and Distinguished Professor of Cell and Developmental Biology. Previously, he was Chairman, Department of Biochemistry, Professor of Cell Biology and Director of the Institute for Childhood and Neglected Diseases at The Scripps Research Institute (TSRI) in La Jolla where he was a faculty member from 1996 to 2007. His academic research concerns the molecular genetic basis of circadian rhythms in plants, animals and humans. He was also recently the Director of Discovery Research at the Genomics Institute of the Novartis Research Foundation (GNF), where he built a large Department of applying human genome science to biomedical research and drug discovery. Dr. Kay was also the founder, former Chief Technology Officer and Senior Vice President of Phenomix Corporation, a drug discovery and development company based in San Diego.

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Daniel I.C. Wang received his B.S. degree in Chemical Engineering in 1959 from MIT.  He obtained his M.S. degree in Biochemical Engineering in 1961 also from MIT.  He continued his studies at the University of Pennsylvania and received his Ph.D. degree in Chemical Engineering in 1963.  He served two years in the U.S. Army and returned to MIT as an Assistant Professor in 1965.  Professor Wang founded the Biotechnology Process Engineering Center through the NSF Engineering Research Center Initiative and acted as its Director from 1985 to 1998. He held the Chevron Professorship from 1985 to 1996. He was subsequently named as an Institute Professor of Chemical Engineering at MIT in 1996.  In 2000, Professor Wang was given the Temasek Professorship at the National University of Singapore where he will devote part of his time to help Singapore in their biomedical science research and development. He received an Honorary Doctorate in Engineering from the Hong Kong University of Science and Technology in 2000 and an Honorary Doctorate in Engineering from the Catholic University Valparaiso, Chile in 2002.

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Jeff Yuen is a well-respected domestic and international speaker with over 20 years of compliance and regulatory experience; Jeff was a peace officer/investigator with the State of California, Food and Drug Branch and a Consumer Safety Officer for and the US FDA.  During his tenure with the US FDA, he was rapidly promoted to the rank of Commander in the US Public Health Service while serving as a member of the following teams:

• FDA’s Pacific Regional Biotech Team (pre-cursor to ORA Team Biologics);
• Los Angeles District Pre-Approval Manager and Drug Team Leader; and
• Foreign Inspection Cadre.

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