INSTRUCTORS

Instructors for this professional master's degree include research and teaching faculty, as well as affiliate faculty who are practitioners in the industry. The participation of industry professionals is essential to the success of this program, because it ensures that students achieve competencies needed by the industry and that they can be connected to key people and resources.

Led by Dr. Tom Hazlet, Associate Professor, UW Pharmacy, the instructional team includes:

Jean Feagin
Senior Lecturer, Pharmacy, University of Washington; Affiliate Associate Professor, Global Health, University of Washington; Affiliate Member, Seattle Biomedical Research Institute
Feagin brings extensive experience with teaching and mentoring of graduate students to the program, as well as connections to the biomedical community, expertise in grant and paper writing, and broad knowledge in global health that will broaden and enrich students' frames of reference. She has been a UW faculty member since 1995 and received the UW Pathobiology Department teaching award in 2006. Feagin has 20 years experience in basic research, studying the human malaria parasite for potential novel targets for therapeutic development. She has been awarded research grants from NIH and NSF, and has published numerous research papers in peer-reviewed scientific journals. She has served on journal editorial boards and NIH grant review panels. Feagin chaired NIH-mandated committees regulating the use of biohazards and animals in research at Seattle Biomedical Research Institute. She is also a Core Member for Institutional Biosafety Committee Services at Western Institutional Review Board, reviewing proposals for the use of recombinant DNA products in clinical trials. Feagin earned her Ph.D. in Biological Sciences at Stanford University, focusing on molecular biology.

Martha A. Feldman, R.A.C.
President and CEO, Drug & Device Development Co.; Affiliated Associate Professor, Bioengineering; Instructor, UW Extension Certificate Program in Biomedical Regulatory Affairs
Feldman leads Drug & Device Development Co., where she and her team assist companies in bringing drugs, biologics, biotechnology products and medical devices through the development process to market. Her expertise is in developing and implementing regulatory and clinical strategies, and in troubleshooting regulatory impediments and clinical trial activities. An instructor in the University of Washington Certificate Program in Biomedical Regulatory Affairs, the Certificate Program in Clinical Trials, and the Medical Engineering Program, Feldman is the founding past president of the Organization of Regulatory and Clinical Associates, a major professional organization in the Puget Sound region. She holds an Affiliate Faculty appointment in the UW Department of Bioengineering.

David Hammond, CCRC, CCRA
Clinical & Regulatory Consultant, Hammond Clinical Trial Consulting, LLC
Hammond is a former site coordinator, study monitor, project manager and clinical director with an expertise 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 UK, New Zealand and China.

An annual lecturer on clinical research activities for the UW Extension Certificate Program in Biomedical Regulatory Affairs, he is also a former member of the national committee overseeing the educational and certification programs for the Association of Clinical Research Professionals.

Tom Hazlet, Pharm.D., Dr.P.H.
Associate Professor, Pharmacy, University of Washington
Hazlet completed a doctorate in pharmacy at the University of California, San Francisco and a residency in hospital pharmacy at Yale-New Haven Hospital. He earned a doctorate in health at the University of California, Berkeley. His prior professional experiences include industrial microbiology, parenteral nutrition research, and pharmacy practice in a community hospital. Most recently, Hazlet has been a Food and Drug Scientist with the California Department of Health Services' Food and Drug Branch and a member of the Food and Drug Administration's Pacific Region Biotechnology Team. His regulatory activities included reviewing investigational new drug applications and acting as technical liaison with field investigator staff, clinical sponsors, industry representatives and legislators. His research interests include drug regulation, pharmaceutical policy, bioethics and technology assessment (including drug formularies).

Eric Hayashi, M.B.A
President and CEO, LabConnect
Hayashi is president and CEO of LabConnect, LLC, a global provider of centralized laboratory testing services for the biopharmaceutical industry. His experience includes more than 16 years in the clinical trials industry including four clinical outsourcing services start-up companies. He holds an MBA from the Wharton School of the University of Pennsylvania and a BA from Whitman College. Prior to LabConnect, he was Vice President, Corporate Development for Radiant Research, where he continuously served on the company's three-person executive team and was responsible for sales, marketing and acquisition activities and was instrumental in its growth to 1,000 employees over six years. Prior to Radiant, Hayashi served as Vice President, Site Management and Director of North American Operations at MDS Harris (now MDS Pharma Services), as President and CEO of a regional site management organization, and as a Senior Consultant with Accenture. He and his family reside in Seattle, Wash.

Erica Jonlin, Ph.D.
Clinical Research Administrator and Regulatory Manager, University of Washington, Department of Medicine
Jonlin is the clinical research administrator and regulatory manager for gene transfer clinical trials conducted in the Divisions of Medical Genetics and Hematology, and for clinical research activities in the Institute for Stem Cell and Regenerative Medicine. Her responsibilities include clinical protocol design, human subjects protection, and coordinating and managing the regulatory submission and review processes for clinical trials involving gene transfer and stem cells. Jonlin regularly lectures on good clinical practice guidelines. For five years, Jonlin was a human subjects review administrator for one of the University of Washington's Institutional Review Boards, serving as a member and facilitator of the committee, and documenting committee reviews and decisions. Jonlin is a former AAAS Science and Diplomacy Fellow, in which capacity she worked at the U.S. Agency for International Development, administering research funding programs and facilitating the review of grant proposals in the areas of immunology, tropical medicine and biotechnology. Jonlin earned her Ph.D. in biochemistry at the University of California, Los Angeles.

Raisa Loboda
Quality Assurance Manager, Bio-Rad Laboratories, Clinical Diagnostics Group
Loboda is a Quality Assurance Manager for Bio-Rad Laboratories, a world-leading provider of diverse products for the life science and diagnostic markets. She and her team are responsible for promoting and applying risk management principles and processes for the safe development, manufacture, and use of in vitro diagnostic systems. With this responsibility, she and her team are highly involved in both validation and corrective action for final products and their associated production processes. With over 10 years of experience as a quality engineer in multiple industries (pulp and paper, information management, biotechnology, and clinical diagnostics), she has implemented and maintained cGMP and ISO compliant quality management systems as well as employed various process improvement methodologies including Lean, Six Sigma, and Kaizen. Loboda holds a bachelor’s degree in Paper Science and Engineering from Miami University in Oxford, Ohio. She is an active senior member of American Society for Quality (ASQ), a member of the Organization for Regulatory and Clinical Associates (ORCA), an ASQ certified Six Sigma Black Belt (CSSBB), and an ASQ certified Quality Engineer (CQE).

Sara Magee
Affiliate Assistant Professor, Pharmacy, University of Washington
Magee retired from the position of Head of Quality Assurance for Amgen, Washington. Her expertise is in biopharmaceutical manufacturing and quality. She and her team provided the quality systems and support for a block buster biomolecule, and later for technology transfer and First-in-Human production for bulk drug substances. She has taught classes in regulatory compliance and was a subject matter expert for the annual Web-based GMP compliance training program. Magee worked for the conventional pharmaceutical industry as an industrial engineer. Other experience includes excursions into pre-clinical and clinical research.

Karen Kurt Teal
Affiliate Assistant Professor, Department of Human Centered Design and Engineering, University of Washington
Teal has taught technical writing for engineers in the Department of Human Centered Design and Engineering at the University of Washington since 2001. Additionally, since 2003 she has taught the graduate course entitled Writing the Scientific Paper, a course which is open to students in all the sciences and divisions of engineering. In Spring 2009, she lectured at the annual meeting of the American Association of Immunologists on the subject of excellence in scientific writing. Teal was awarded her doctorate in English from the University of Massachusetts, Amherst, in 2000.