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:

Martha Feldman, R.A.C.
President, Drug and Device Development Co.; Affiliated Associate Professor, Bioengineering; Instructor, UW Extension Certificate Program in Biomedical Regulatory Affairs
Feldman leads Drug and Device Development Co., where she assists companies in bringing drugs and 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 Affairs Manager, Calypso Medical Technologies, Inc.
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—a global provider of central laboratory services to the biopharmaceutical industry—and has spent more than 14 years in the clinical trials industry. Prior to LabConnect, Hayashi was vice president, corporate development, for Radiant Research, the world's largest Site Management Organization (SMO), where he continuously served on the company's three-person executive team and held responsibility for sales, marketing, site acquisitions, strategic corporate alliances and patient recruitment. Hayashi joined Radiant near its inception, and was instrumental in its growth to nearly 1,000 employees over six years. Radiant was recognized as one of the nation's 500 fastest growing privately held companies by Inc. magazine. Hayashi holds an MBA from the Wharton School of the University of Pennsylvania.

Erica Jonlin, Ph.D.
Research Scientist, Hematology
Jonlin is clinical research administrator for the Program of Excellence in Gene Therapy NHLBI grant at the University of Washington. Her responsibilities include coordinating and managing clinical gene therapy trials, ensuring regulatory compliance, and training investigators in regulatory issues. For five years, Jonlin was a human subjects review coordinator for one of the University of Washington's Institutional Review Boards. Jonlin is a former AAAS Science and Diplomacy Fellow, in which capacity she worked at the U.S. Agency for International Development, Office of Research. As a Fellow, she was involved in 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.

William Pitlick, Ph.D.
President, Ocularis
Pitlick left his position as vice president and acting head of regulatory affairs at Chiron Corp. to start a new drug company, Ocularis. He spent nine years with the National Institutes of Health, and three years with the Food and Drug Administration's Division of Biopharmaceutics. Pitlick holds a Ph.D. in pharmacokinetics from the University of Washington, and has completed advanced studies at the Harvard University School of Public Health.