Faculty
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 is an affiliate assistant professor in the UW Department of Pharmacy. She’s helped teach the Medical Risk Analysis & Management course since 2013 and is a faculty adviser for the Practicum. Agapova is also an affiliate faculty member of the Comparative Health Outcomes, Policy and Economics (CHOICE) Institute at the UW School of Pharmacy. As a health economics and outcomes research medical affairs professional, she currently works at Gilead Sciences. She previously held similar roles at AbbVie and Teva Pharmaceuticals. Agapova earned a doctorate in pharmaceutical outcomes research and policy at the UW.
Aasthaa Bansal
Aasthaa Bansal is an associate professor in the UW Department of Pharmacy and the Comparative Health Outcomes, Policy and Economics (CHOICE) Institute at the UW School of Pharmacy. Within the UW BRAMS program, she co-teaches the course on Statistical Topics for Biomedical Regulatory Affairs Professionals. Bansal's research focuses on sequential decision-making using longitudinal data, prediction modeling, decision theoretic methods including value of information analysis, and comparative effectiveness and outcomes research using large health care claims databases and electronic health records data. She is the principal investigator of a study to develop methods for cost-effective personalized risk-adaptive surveillance in cancer. Bansal earned a master's degree and doctorate in biostatistics at the UW.
Ali Bouge
Ali Bouge is a teaching associate professor in the UW Department of Pharmacy and director of the BRAMS Practicum. She most recently served as executive director of regulatory affairs for Exegenesis Bio, where her work put her at the forefront of new developments in regulatory affairs and clinical trials in the area of gene therapy. Bouge earned a Regulatory Affairs Certification (RAC) — the leading credential for regulatory professionals in the health care sector. She has extensive experience in the field of biomedical regulatory affairs, particularly with investigational new drug (IND) 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 in the Department of Pediatrics, Stem Cell and Gene Therapy at Stanford University. Bouge earned a master’s degree from the UW BRAMS program.
Alexander Cutler
Alexander N. Cutler is an affiliate assistant professor in the UW’s School of Pharmacy, where he teaches the Regulatory Skills course and the year-long Regulatory Affairs sequence. He brings over a decade of consulting experience as principal of Cutler Consulting, with a primary focus on medical devices containing software, software as a medical device (SaMD) and combination products. Cutler has also advised on pharmaceuticals, biologics, dietary supplements and cosmetics. Cutler’s clientele increasingly includes companies developing artificial intelligence for use in regulated industries. He has served in executive leadership and advisory board roles throughout the industry. Cutler earned his bachelor’s degree in biochemistry from Western Washington University and his master’s degree from the UW BRAMS program.
David Hammond
David Hammond is the director of the UW BRAMS program, teaching associate professor in the UW Department of Pharmacy and the lead for the Certificate in Clinical Trials. He holds a Regulatory Affairs Certification in Medical Devices, the Certified IRB Professional credential, the Certified Clinical Research Professional certification 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 Food and Drug Administration and other regulatory bodies around the world. He currently serves on the board of the Organization of Regulatory and Clinical Associates and was the inaugural recipient of the Martha Feldman Award for service and education to the regulatory community. Hammond is a graduate of the UW BRAMS program.
Thomas Hazlet
Thomas Hazlet is the founding director of the UW BRAMS program and is now a retired associate professor emeritus with the Comparative Health Outcomes, Policy and Economics (CHOICE) Institute at the UW School of Pharmacy. Hazlet was a food and drug scientist with the California Department of Health Services Food and Drug Branch from 1988 to 1996 and a member of the Food and Drug Administration'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. He earned his doctorate of pharmacy from the University of California, San Francisco, and his doctorate of public health in health policy and administration from the University of California, Berkeley.
Sonal Jain
Sonal Jain is an affiliate assistant professor in the UW Department of Pharmacy, assists with the Certificate in Clinical Trials and is a co-teacher for the Advanced Medical Products Regulation course. She began her career in the medical device industry, where she managed complex FDA 510(k) submissions (premarket device clearance filings), regulatory strategies for artificial intelligence and machine learning based product features, and international regulatory submissions to federal authorities. Jain is a graduate of the UW BRAMS program. She also holds a master’s degree in applied microbiology and biotechnology from Banasthali University in India.
Teddy Johnson
Teddy Johnson is a clinical associate professor in the UW School of Pharmacy, the director of technology development and co-director of the Pilot Awards Program at the UW Institute of Translational Health Sciences, and a licensed professional engineer in the state of California. He joined the health care community 30 years ago and has served startup and Fortune 500 companies in research, design, clinical, marketing and sales leadership roles, as well as developing imaging, interventional, surgical and digital health products. Over the years, Johnson has celebrated two initial public offerings and four acquisitions, while earning numerous patents and commercializing dozens of new products worldwide. To foster the next generation of innovators, he teaches in the UW BRAMS program and advises startup CEOs in Seattle, Vancouver and Silicon Valley. He earned a bachelor’s degree in mechanical engineering at Stanford University and an MBA at the University of Michigan.
Mary Lessig
Mary Lessig is an affiliate assistant professor in the UW Department of Pharmacy and works in clinical operations for a Seattle-area immuno-oncology biotechnology company. She has more than 20 years of experience in clinical research. Lessig started her career in a nonclinical research laboratory and then moved to work in an academic clinical research office. 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 UF, the University of Washington and a community-based hospital before joining industry. Lessig is a graduate of the UW BRAMS program.
Brent Lewis
Brent Lewis is an affiliate assistant professor in the UW 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 sections of several investigational new drug applications. Lewis went on to become a vice president of quality and regulatory affairs at several global medical device companies. He has managed complex FDA 510(k) submissions (premarket device clearance filings); 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 vice president of global regulatory affairs and quality assurance at Advanced Sterilization Products, his work spans product development, manufacturing, market access and post-market surveillance, ensuring alignment with evolving regulatory landscapes and harmonization across international markets. He has a bachelor's degree in biology from Seattle University.
Lori Martell
Lori Martell is an affiliate assistant professor in the UW Department of Pharmacy and has been the senior director of medical writing for several Seattle-area immuno-oncology biotechnology companies. She 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. Martell has worked for more than 20 years in the biopharmaceutical industry for both startup biotechnology and global pharmaceutical companies, supporting regulatory and clinical document development primarily for novel therapies in oncology.
Laurie Mendelson
Laurie Mendelson is an affiliate assistant professor in the UW Department of Pharmacy, where she co-teaches the courses for the Certificate in Biomedical Regulatory Affairs. She is the former director of the Division of Health Communication at FDA’s Center for Devices and Radiological Health. After leaving the FDA, Mendelson joined Bigfoot Biomedical, where she helped the company gain its first FDA 510(k) clearances (premarket submissions for regulatory approval) and implement post-market surveillance for a novel diabetes product. Currently, Mendelson consults with several medical device companies, providing guidance and hands-on support for pre- and post-market FDA regulatory compliance. She has a special interest in mentoring early-stage start-ups that are just beginning their regulatory journeys. Mendelson has a master’s degree in biomedical engineering from Case Western Reserve University.
Mohammad Shawish
Mohammad Shawish is an affiliate assistant professor in the UW Department of Pharmacy. He is an accomplished medical affairs professional in the pharmaceutical industry, currently working at Jazz Pharmaceuticals as a senior medical science liaison in the epilepsy division. Throughout his career, Shawish has been instrumental in supporting product launches, conducting medical education initiatives and fostering strong relationships with the medical community. His contributions have significantly impacted the successful implementation of medical strategies and the advancement of patient care. He has demonstrated success in supporting product launches and overseeing products throughout their life cycle. Shawish is a pharmacist by training, and holds a doctorate in pharmacy from the Massachusetts College of Pharmacy and Health Sciences. He's also a graduate of the UW BRAMS program.
Jessica Urban
Jessica Urban is an affiliate assistant professor in the UW Department of Pharmacy. She is a consultant with more than 25 years of experience in the product development of medical devices and drug/device combinations in quality, engineering, program management and business development roles. She’s served on the Drug & Device Advisory Committee at the UW Institute of Translational Health Sciences 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 a bachelor’s degree in mechanical engineering at Northern Arizona University, a master's degree in medical engineering at the UW and a certificate from the UW Foster School of Business Executive Development Program.