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Master of Science in Biomedical Regulatory Affairs


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.

Core Faculty

Maria Agapova

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's 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. She earned her doctorate in pharmaceutical outcomes research and policy at the University of Washington.

Ali Bouge

Ali Bouge is a teaching associate professor in the Department of Pharmacy, an associate director of the BRAMS program and director of the BRAMS practicum. She's earned the Regulatory Affairs Certification (RAC), and since graduating from BRAMS, Bouge has gained extensive experience in the field of biomedical regulatory affairs, particularly with Investigational New Drug applications and Institutional Review Boards (IRBs). She has worked for IRBs at Stanford University, the University of Michigan and the Quorum Review, and co-directed the Clinical Trials Program at Stanford University within the Department of Pediatrics, Stem Cell and Gene Therapy. Bouge is senior director of regulatory affairs for Exegenesis Bio. Her work puts her at the forefront of new developments in regulatory affairs and clinical trials. She earned her master's degree is biomedical regulatory affairs at the University of Washington.

David Hammond

David Hammond is a teaching associate professor in the Department of Pharmacy, an associate director of the BRAMS program and the lead for the Clinical Trials Certificate. He holds a Regulatory Affairs Certification in Medical Devices (RAC), the Certified IRB Professional (CIP), the Certified Clinical Research Professional (CCRP) and a number of other industry certifications. Hammond is the chair of an institutional review board and serves as a consultant to several biotechnology companies, providing guidance on regulatory strategy, clinical trial design and operations, and compliance with the FDA and other regulatory bodies around the world. He currently serves on the board of the Organization of Regulatory and Clinical Associates (ORCA) and was the inaugural recipient of the Martha Feldman Award for service and education to the regulatory community. Hammond is an alumnus of the UW BRAMS program, with a master’s degree in biomedical regulatory affairs.

Thomas Hazlet

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.

Teddy Johnson

Teddy Johnson is a clinical associate professor in the Department of Pharmacy, the director of technology development at the UW’s Institute of Translational Health Sciences and a licensed professional engineer in California. He joined the health care community over 25 years ago after graduating from Stanford University’s mechanical engineering program. Since then he's served startup and Fortune 500 companies in research, design, clinical, marketing and sales leadership roles and has developed imaging, interventional, surgical and digital health products. Along the way, Johnson earned his MBA from the University of Michigan’s Ross Business School. He has celebrated two initial public offerings and four acquisitions, and has earned numerous patents while commercializing dozens of new products worldwide. In addition to BRAMS, Johnson teaches for the UW’s Creative Destruction Lab program and advises startup CEOs in Vancouver, Seattle and Silicon Valley.

Joshua Kim

Joshua Kim is an affiliate assistant professor in the Department of Pharmacy and a graduate of BRAMS. He has a diverse background in quality systems and regulatory affairs in the medical device and pharmaceutical industries. He's 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.

Mary Lessig

Mary Lessig is an affiliate assistant professor in the Department of Pharmacy and a senior clinical research associate for a Seattle-area immuno-oncology biotechnology company. A graduate of BRAMS, she has over 20 years of experience in clinical research. Lessig started her career in a nonclinical research laboratory, where she submitted institutional review board and institutional animal care and use committee applications. After graduating from the University of Florida with a degree in biological psychology, she worked in clinical research coordinator and research quality assurance specialist roles at the University of Washington and then at a community-based hospital. Lessig serves on the board of directors of the Junior League of Seattle and volunteers with several STEM nonprofit organizations.

Brent Lewis 

Brent Lewis is an affiliate assistant professor in the Department of Pharmacy. He began his career in biotechnology, establishing and overseeing the quality control labs for biotechnology products where he wrote the chemistry, manufacturing and control (CMC) sections of several investigational new drug (IND) applications. Lewis went on to become a vice president of quality and regulatory affairs at several global medical device companies where he managed complex 510k submissions; led routine and for-cause FDA inspections; resolved FDA warning letters; oversaw mergers, acquisitions and integrations; and established quality systems for various companies. Today, as an IT leader responsible for quality, regulatory, R&D and commercial IT solutions at a global medical device company, he's at the intersection of quality, regulatory and business operations, and focused on solutions to harmonize them. He has a bachelor's degree in biology from Seattle University.

Lori Martell

Lori Martell is an affiliate assistant professor in the Department of Pharmacy and the senior director of medical writing for a Seattle-area immuno-oncology biotechnology company. Martell began her research career in neurotransmitter-mediated cell signaling at The University of Michigan Medical School, and after completing a doctorate in pharmacology she collaborated with neurosurgery colleagues to establish the Brain Tumor Research Laboratory. She has worked for over 20 years in the biopharmaceutical industry for both startup and global pharmaceutical companies, supporting regulatory and clinical document development for novel therapies in oncology.

Lynn Rose

Lynn Rose is an affiliate associate professor in the UW School of Pharmacy and a founding member of the UW Institute of Translational Health Sciences, Drug and Device Advisory Committee, which advises academic investigators on the regulatory requirements for product development. She was previously a senior executive in the biomedical industry, where she was responsible for preclinical, clinical and regulatory programs. This experience included participation on multiple drug development teams, two of which resulted in marketed products for the treatment of cystic fibrosis and two for hemostasis. Rose has expertise in biomedical products, clinical protocols, the development of regulatory strategies and the management of regulatory submissions to federal authorities. Her research experience is in the field of immunology, with an emphasis on autoimmunity, infectious disease and immune-oncology. Rose earned her doctorate in immunology from the University of Geneva, Switzerland.

Andy Stergachis

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 doctorate and master's degrees in pharmacy from the University of Minnesota and his bachelor’s degree in pharmacy from Washington State University. He is a fellow of the International Society for Pharmacoepidemiology and a fellow of the American Pharmacists Association.

Jessica Urban

Jessica Urban is a consultant with more than 25 years of experience as an executive, project manager and quality engineer in the product development of medical devices and drug/device combinations, supporting startup and multinational companies. She's served on the UW Institute of Translational Health Sciences Drug & Device Advisory Committee since 2018 and has been a New Ventures Mentor at UW’s CoMotion since 2016, guiding early-stage innovators on regulatory, product development and business development strategy. Urban earned her master's degree in medical engineering at the University of Washington and a certificate from the UW Foster School of Business Executive Development Program.