Biography
Tony Yang is a part-time lecturer in the University of Washington (UW) Department of Pharmacy and contributes to the UW BRAMS Practicum Program. He began his career in biopharmaceutical sector, specializing in quality assurance (QA). In this role, he supported quality management systems (QMS) and led cleanroom environmental monitoring initiatives. Tony later transitioned to the in vitro diagnostics (IVD) sector, where he continued advancing QMS practices and managed regulatory submissions, including 510(k) clearances and EU Technical Files. His expertise expanded into regulatory affairs (RA), guiding medical device compliance during the COVID-19 enforcement policy period. Currently, Tony serves as a Senior Regulatory Coordinator at Fred Hutchinson Cancer Center in Seattle, focusing on Research IND management and providing regulatory guidance to physicians and study teams. Yang is a graduate of the UW BRAMS program.
Biography
Amanda Olson is an affiliate assistant professor in the UW’s School of Pharmacy, where she co-teaches the Technical Writing courses. She brings ten years of experience in oncology medical writing, with a primary focus on regulatory submissions, clinical study documentation, and plain language communication. In her industry role, Olson serves as a senior manager leading content strategy and development, supporting cross functional teams, and mentoring early career writers. Olson values and strives for audience aware writing, clear structure, and collaborative processes that help teams translate complex data into concise, actionable documents for regulators, clinicians, and patients. Olson is a graduate of the UW BRAMS program.
Courses taught
- PHARM 516: Introduction to Biomedical Regulatory Affairs
- PHARM 517: Introduction to Biomedical Regulatory Affairs
- PHARM 518: Product Testing, Evaluation & Post-Market Issues
Biography
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.
Courses taught
- PHRMRA 536 Skills for the Regulatory Affairs Professional
- PHARM 516: Introduction to Biomedical Regulatory Affairs
- PHARM 517: Introduction to Biomedical Regulatory Affairs
- PHARM 518: Product Testing, Evaluation & Post-Market Issues
Biography
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.
Courses taught
- PHARM 516: Introduction to Biomedical Regulatory Affairs
- PHARM 517: Introduction to Biomedical Regulatory Affairs
- PHARM 518: Product Testing, Evaluation & Post-Market Issues
Biography
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.
Course taught
- PHRMRA 528 Medical Risk Analysis & Management
- PHRMRA 548 Practicum
Biography
Jessica Urban is an affiliate assistant professor in the 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 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 bachelor’s degree in mechanical engineering at Northern Arizona University, master’s degree in medical engineering at the University of Washington and a certificate from the UW Foster School of Business Executive Development Program.
Course taught
- PHRMRA 536 Skills for the Regulatory Affairs Professional
Biography
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.
Courses taught
- PHRMRA 525: Implementation & Conduct of Clinical Trials
- PHRMRA 526: Project Management & the Business of Clinical Trials
- PHRMRA 548: Practicum
- PHRMRA 554: Advanced Medical Products Regulation I
Biography
Sonal Jain is a lecturer in the Department of Pharmacy and assists with the Clinical Trials Certificate and Regulatory Affairs Certificate. She began her career in the medical device industry, where she managed complex 510k submissions, regulatory strategies for AI/ML based product features, and international regulatory submissions to federal authorities. Jain is an alumnus of the UW BRAMS program. She also holds a master’s degree in applied microbiology and biotechnology from India.
Courses taught
- PHRMRA 546 Technical Writing for Biomedical Regulatory Affairs
- PHRMRA 548 Practicum
- PHRMRA 550 Advanced Technical Writing for Biomedical Regulatory Affairs
Biography
Lori Martell is an affiliate assistant professor in the 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 over 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.
Biography
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 Institute of Translational Health Sciences, and a licensed professional engineer in the state of California. He joined the healthcare community 30 years ago and has served start-up and Fortune 500 companies in research, design, clinical, marketing, and sales leadership roles; developing imaging, interventional, surgical, and digital health products. Over the years, Teddy has celebrated 2 IPO’s and 4 acquisitions, while earning numerous patents and commercializing dozens of new products worldwide. To foster the next generation of innovators, Teddy teaches in the Biomedical Regulatory Affairs Master of Science (BRAMS) program at the University of Washington and advises startup CEOs in Seattle, Vancouver, and Silicon Valley.
Courses taught
- PHRMRA 524: Introduction to Clinical Trials
- PHRMRA 525: Implementation & Conduct of Clinical Trials
- PHRMRA 526: Project Management & the Business of Clinical Trials
Biography
Mary Lessig is an affiliate assistant professor in the Department of Pharmacy and works in Clinical Operations for a Seattle-area immuno-oncology biotechnology company. She has over 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 an alumnus of the UW BRAMS program.
Course taught
Biography
Ali Bouge is a teaching associate professor in the Department of Pharmacy and Director of the BRAMS Practicum. She’s earned the Regulatory Affairs Certification (RAC) and 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. Ali Bouge is Executive Director of regulatory affairs for Exegenesis Bio. Her work puts her at the forefront of new developments in regulatory affairs and clinical trials in the area of gene therapy. Bouge is an alumnus of the UW BRAMS program.
Courses taught:
- PHRMRA 528 Medical Risk Analysis & Management
- PHRMRA 548 Practicum
Biography
Maria Agapova is an affiliate assistant professor in the Department of Pharmacy, she has helped teach the Medical Risk Analysis & Management course since 2013 and is a faculty advisor for Practicum. As a health economics and outcomes research medical affairs professional, Maria currently works at Gilead Sciences. She previously held similar roles at AbbVie and Teva Pharmaceuticals. Maria is also an affiliate faculty at the UW CHOICE Institute.
Education
- MS in Biomedical Regulatory Affairs, University of Washington
Courses taught
- PHRMRA 524: Introduction to Clinical Trials
- PHRMRA 525: Implementation & Conduct of Clinical Trials
- PHRMRA 526: Project Management & the Business of Clinical Trials
- PHRMRA 527: International Regulatory Affairs
- PHRMRA 548: Practicum
- PHRMRA 554: Advanced Medical Products Regulation I
Biography
David Hammond is the Director of the BRAMS program, teaching associate professor in the Department of Pharmacy, 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.
Education
- DrPH in Health Policy & Administration, University of California, Berkeley
- PharmD, University of California, San Francisco
- Bachelor of Science in Biology, University of Redlands
Research Interests
- Regulation of medical products
Courses Taught
- Pharm 516-518 Biomedical Regulatory Affairs
- Pharm 532 Medical Products Policy Analysis
- Pharm 543 Pharmacy Law & Ethics
- Phrmra 548 BRAMS Practicum
Biography
1968-72 — Industrial microbiologist for a biologics manufacturer
1973-77 — University of California San Francisco — PharmD
1977-78 — Yale-New Haven Hospital — residency
1978-84 — UCLA Hospital — parenteral nutrition
1984-96 — Sutter Solano Hospital (part time after 1986)
1986-91 — University of California Berkeley — DrPH
1998-96 — California Department of Health Services; seconded to US Food and Drug Administration
1996-present — University of Washington School of Pharmacy
2007-present — Director, Biomedical Regulatory Affairs MS (BRAMS)
Selected Publications
- Karwaki TE & Hazlet TK. A qualitative analysis of student-written law and ethics cases: A snapshot of PY2 student experience. CPTL. 2017
- Hazlet TK, Karwaki TE, Downing DF. Pathway to pharmacist medical provider status in Washington State. J Am Pharm Assoc (2003). 2017 Jan – Feb;57(1):116-119.
- Chan LN, Soltani H, Hazlet TK. Probiotics for neonates: safety for prime time questioned without regulatory changes. J Pediatr. 2015 Feb;166(2):502
- Austin SC, Hammer D, Hazlet T, et al. An educational technology student and faculty needs assessment. PHARMACOTHERAPY 2012; 32(10): E287-E287