Many of the instructors for the Master of Science in Biomedical Regulatory Affairs program are leading regulatory affairs practitioners in the Seattle area. The participation of industry professionals is vital to our program, helping ensure you develop the competencies you need to be successful and serving as important contacts in your professional network.
Tom Hazlet – Director
Tom Hazlet is an associate professor in the Department of Pharmacy and director of the Master of Science in Biomedical Regulatory Affairs program. Hazlet was a food and drug scientist with the Food and Drug Branch of the California Department of Health Services from 1988 to 1996 and a member of the FDA's Pacific Regional Biotechnology Team from 1996 to 2003. His regulatory activities included reviewing investigational new drug applications and acting as technical liaison with field investigator staff, clinical sponsors, industry representatives and legislators. Hazlet's research interests include drug regulation, pharmaceutical policy, bioethics and technology assessment, including drug formularies. He earned a DrPH in health policy and administration at the University of California, Berkeley.
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Maria Agapova, a lecturer in the Department of Pharmacy, has helped teach the Medical Risk Analysis & Management course since 2013. A medical outcomes liaison for Teva Pharmaceuticals, she presents clinical, economic and health outcomes data to managed care organizations to demonstrate the value of Teva products. She is also involved in health outcomes and economics research relating to migraines, movement disorders and asthma. Previously at PATH, Agapova used modeling to show value in integrating human milk banks with breastfeeding promotion programs. Agapova’s policy work has been used to inform FDA guidance recommendations in blood donor screening for Trypanosoma cruzi and benefit-risk assessment in medical devices.
Keith Bower is a principal CMC statistician at Seattle Genetics and an affiliate assistant professor in the Department of Pharmacy. He has worked in the biotechnology industry for over 10 years, specializing in non-clinical statistical techniques. Before joining Seattle Genetics, Bower worked as a statistical trainer for Minitab and was a principal quality engineer at Amgen and Juno Therapeutics. Bower has a master’s in quality management and productivity from the University of Iowa.
Allene Dodge is an independent regulatory affairs consultant and a lecturer in the Department of Pharmacy. She has worked in the development and regulation of health care products for 30 years, with an emphasis on U.S. pharmaceutical product development and commercialization. Before founding her own consulting company in 2004, she served in senior regulatory affairs and quality assurance positions at Cell Therapeutics, CV Therapeutics and Genentech. Dodge earned a BS in cellular and molecular biology at the University of Washington.
Daina Graham is an independent regulatory consultant and an affiliate associate professor in the Department of Pharmacy. She has more than 30 years of experience in U.S. and international medical device and biotechnology regulatory affairs, including experience with sterile products, disposables, pacing devices, implantables and radiological equipment. Her specialties include FDA and ISO quality system compliance assessments and regulatory crisis management. Graham has a MS in public affairs from the University of Oregon.
Tracie Granger, an affiliate assistant professor in the Department of Pharmacy, is the research director for the Heart & Vascular and Neuroscience Research Departments at Swedish Medical Center. She has been working in clinical research management for more than a decade, specializing in site management and research compliance. She also has experience as a clinical research associate and a clinical trial coordinator. Before transitioning to clinical research, Granger worked in pre-clinical research, including stints as an imaging specialist for a local biotech company and in quality assurance at a local CRO. A member of the Health Care Compliance Association, she’s working towards her clinical research compliance certification. Granger has also been affiliated with research organizations such as the Association of Clinical Research Professionals, the Society of Clinical Research Associates and the Society of Research Administration. She earned a MHS in clinical research administration at George Washington University.
David Hammond is the principal consultant of Hammond Clinical Trial Consulting and a lecturer in the Department of Pharmacy. A former clinical director, clinical study monitor and site coordinator, Hammond specializes in developing clinical strategies for medical devices and implementing the clinical and regulatory pathways required for their approval. His experience also includes the design and implementation of standard operating procedures for clinical research organizations and international clinical trial operations in Canada, the United Kingdom, New Zealand and China. Hammond has served as a board member and president of the Organization of Regulatory and Clinical Associates and a member of the national committee overseeing the educational and certification programs of the Association of Clinical Research Professionals. He has a MS in biomedical regulatory affairs from the University of Washington.
Eric Hayashi, an affiliate instructor in the Department of Pharmacy, is president and CEO of LabConnect, a global provider of centralized laboratory testing services for the biopharmaceutical industry. He has more than 15 years of experience in the clinical trials industry, including experience at clinical outsourcing services startup companies. Prior working at LabConnect, he was vice president of corporate development for Radiant Research, where he was responsible for sales, marketing and acquisition activities. Hayashi has also served as vice president of site management and director of North American operations at MDS Harris, now MDS Pharma Services, and as senior consultant with Accenture. He has a MBA from the University of Pennsylvania.
Floyd Karp is a scientific advisor at Gesea Biosciences and a lecturer in the Department of Pharmacy. At Gesea Biosciences, he works on the technical championing of implantable sustained drug release device targeted for distribution in the developing world. Karp has experience in testing and evaluating medical devices and systems and determining strategy for regulatory agency submissions and applications. He earned a PhD in bioengineering at the University of Washington.
Lynn Rose is the director of scientific administration at the Benaroya Research Institute at Virginia Mason and an affiliate associate professor in the Department of Pharmacy. Rose has extensive experience in biomedical research, clinical research administration and medical product development gained in both corporate and academic settings. She has more than two decades of drug development experience, including oversight of manufacturing, preclinical and clinical programs. Before joining the Benaroya Institute, Rose was a senior administrative director of clinical operations at Seattle Children's Research Institute. As a faculty member at the Institute of Translational Health Sciences, she works with academic investigators to develop regulatory strategies for product development teams, facilitates development and submission of investigational new drug applications and investigational device exemption applications to the FDA. Rose has a PhD in immunology from the University of Geneva in Switzerland.
Stefan Shipman is an associate director of planning and strategy at Juno Therapeutics, where he focuses on manufacturing planning, strategy and commercialization. An affiliate assistant professor in the Department of Pharmacy, he has more than 15 years of pharmaceutical, biotech and clinical research experience, and he serves as an adviser to medical device and diagnostic start-ups. Shipman is a graduate of the UW Master of Science in Biomedical Regulatory Affairs program.
Karen Kurt Teal
Karen Teal is an affiliate assistant professor in the Department of Pharmacy. She has taught technical and scientific writing at the UW since 2001. She earned a PhD in English at the University of Massachusetts, Amherst.