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.
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.
Ali Bouge is the director of the BRAMS practicum, a senior lecturer in the Department of Pharmacy and a graduate of BRAMS. She is a Certified IRB Professional (CIP) and has earned the Regulatory Affairs Certification (RAC). Since graduating from BRAMS, Bouge has gained extensive experience in the field of biomedical regulatory affairs, in particularly with Institutional Review Boards (IRBs). She has worked for IRBs at Stanford University, the University of Michigan and the Quorum Review. Today, Bouge is the senior manager of regulatory affairs and quality assurance for the Department of Pediatrics, Stem Cell and Gene Therapy Clinical Trials Program at Stanford. Bouge's work puts her at the forefront of new developments in regulatory affairs and clinical trials.
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.
Thomas Hazlet is the founding director of BRAMS and is now a retired, active associate professor. 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 his Doctor of Pharmacy from the University of California, San Francisco, and his Doctor of Public Health in Health Policy and Administration from the University of California, Berkeley.
Joshua Kim is a BRAMS alum and affiliate assistant professor. He has a diverse background in quality systems and regulatory affairs in the medical device and pharmaceutical industries. He is the senior regulatory affairs specialist in Boston Scientific's Peripheral Intervention Division as well as a regulatory representative for the Emerging Therapies Group. In his spare time, he provides consulting services for regulatory affairs and quality system matters through V Scale Consulting, LLC.
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.
Andy Stergachis is a professor of pharmacy and global health, associate dean of the School of Pharmacy and the interim director of BRAMS. He is an elected member of the National Academy of Medicine. His research focuses on global post-marketing safety and use of medicines and vaccines. His current research projects include a pharmacovigilance project funded by the Bill & Melinda Gates Foundation; activities with the USAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program; and a project with the Institute for Health Metrics and Evaluation (IHME) on the global burden of antimicrobial resistance. Previously, he was senior advisor in the Safety Surveillance Working Group at the Bill & Melinda Gates Foundation, a member of the FDA Drug Safety and Risk Management Advisory Committee, member of the Access & Product Management Advisory Committee for Medicines for Malaria Venture, and chair of the Malaria in Pregnancy Consortium Safety Working Group. He earned his PhD and masters from the University of Minnesota and his bachelor’s in pharmacy from Washington State University. He is a fellow of the International Society for Pharmacoepidemiology and a fellow of the American Pharmacists Association.
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.
Tracie Van Etten
Tracie Van Etten, 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, Van Etten 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. Van Etten 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.