Instructors for the Master of Science in Biomedical Regulatory Affairs program include academic, affiliate and adjunct faculty who 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 in the field and serving as important contacts in your professional network.
Maria has assisted in teaching Medial Risk Analysis and Management for the Master of Science in Biomedical Regulatory Affairs program since 2013. Maria has worked in biotech, diagnostics and blood safety industries. Her dissertation project, A Decision Framework for Quantifying Benefits and Risks of Diagnostic Imaging Tests, focused on matching quantitative methods for benefit-risk assessment to decision problems in radiology. Maria’s passion is policy writing and analysis. At PATH Maria is leading a cost-effectiveness analysis using modeling to show value in integrating human milk banks with breastfeeding promotion programs. Maria’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, Keith worked as a statistical trainer for Minitab and was a principal quality engineer at Amgen and Juno Therapeutics.
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 in 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.
Jean Feagin, a senior lecturer in the Department of Pharmacy, is a researcher and the practicum director for the MS in Biomedical Regulatory Affairs program. She has served as a principal investigator and then consultant at Seattle Biomed, where she studied the human malaria parasite and related organisms for potential novel targets for therapeutic development. Feagin has extensive experience in preclinical regulatory affairs, having served on committees regulating the use of biohazards and animals in research and the use of recombinant DNA products in clinical trials. Feagin received a teaching award from the Department of Pathobiology (now the Pathobiology Graduate Program in the Department of Global Health) in 2006.
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Daina Graham is an independent regulatory consultant and lecturer 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.
Tracie Granger is the research director for the Heart & Vascular and Neuroscience Research departments at Swedish Medical Center and an Affiliate Assistant Professor in the Department of Pharmacy. She has been working in clinical research management for over 13 years, where she specializes in clinical research site management and research compliance. She also has experience as a Clinical Research Associate and a Clinical Trial Coordinator. Prior to transitioning to clinical research, Granger worked in pre-clinical research including working as an imaging specialist for a local biotech company and in quality assurance at a local CRO. As a current member of Health Care Compliance Association she is working towards her clinical research compliance certification. Granger has also been affiliated with research organizations such as Association of Clinical Research Professionals, Society of Clinical Research Associates and Society of Research Administration.
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.
Eric Hayashi is president and CEO of LabConnect, a global provider of centralized laboratory testing services for the biopharmaceutical industry, and an instructor in the Department of Pharmacy. 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.
Tom Hazlet is an associate professor in the Department of Pharmacy and director of the MS 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.
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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.
Lynn Rose is the director of scientific administration at the Benaroya Research Institute at Virginia Mason. 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.
Karen Teal is an affiliate assistant professor in the Department of Pharmacy. She has taught technical and scientific writing at the UW since 2001.