Martha A. Brumfield, PhD – Chairman of the Board
Martha A. Brumfield is president and chief executive officer of Critical Path Institute, an Arizona based non-profit (501(c)3). She also has her own consulting practice, Martha A. Brumfield LLC, focusing on concordance in global regulatory initiatives and regulatory science qualification programs. Brumfield brings 20 years of experience from Pfizer Inc., most recently, as senior vice president of worldwide regulatory affairs and quality assurance. In addition to her role on the RAPS board of directors, she participates in an advisory capacity to the Harvard Global Health Institute's Multi-Regional Clinical Trial Center. She also is active with global nonprofits, including the Regulatory Harmonization Institute and GlobalMD, where she delivers educational workshops on regulatory and clinical trial topics in Asia.
Todd Chermak, RPh, PhD – President
Todd Chermak is divisional vice president of Innovation & Development, Abbott Established Pharmaceuticals. He has more than 20 years of combined experience in the biopharmaceutical and food/nutrition industries, and has held a variety of technical and leadership roles in R&D, manufacturing, QA and regulatory affairs. He serves on the board of trustees for the International Life Sciences Institute, on the dean’s advisory board for the School of Pharmacy at Purdue University, and is a Ford Scholar at the Kellogg Business School at Northwestern University. Chermak holds an MS in engineering and management sciences from Northwestern University and a PhD in pharmacy from the University of Illinois.
Susumu Nozawa, RAC, FRAPS – President-Elect
Susumu Nozawa is director of corporate regulatory affairs for the Japan region at BD, responsible for establishing and maintaining effective communication between BD Japan and the US business headquarters in regulatory affairs and compliance issues, and facilitating BD’s global development and advocacy initiatives for regulatory policies and standards. Nozawa is an active member of the AdvaMed Japan Subcommittee Working Group on Japan regulatory affairs and compliance, and a leadership team member of the American Medical Devices and Diagnostics Manufacturers’ Association regulatory affairs/quality assurance (AMDD RAQA) Group in Tokyo, Japan.
Salma Michor, PhD, MSc, MBA, CMgr, RAC – Treasurer
Salma Michor is founder and CEO of Michor Consulting e.U, serving such clients as Johnson & Johnson, Novartis, Valeant Pharma and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. Michor is a member of the RAPS European Advisory Committee. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU).
Don Boyer, BSc, RAC, FRAPS – Director
Don Boyer recently retired from his position as director, establishment licensing, billing and invoicing unit of the Health Products and Food Branch Inspectorate at Health Canada in 2014. He has more than 25 years of regulatory affairs experience with Health Canada and has been director of national regulatory programs for medical devices and natural health products covering all aspects of a product’s regulatory lifecycle including premarket review and authorizations, quality systems and compliance, verification and enforcement activities. He has also been active in initiatives such as the GHTF, IMDRF and cooperative agreements with other international regulatory authorities. He has been a member of the Canadian RAC exam committee since 2004 and served as its chair from 2009 to 2013.
Paul Brooks – Executive Director
Paul Brooks has more than 25 years of work experience within the medical device regulatory affairs environment during his 35-year career with the British Standards Institution (BSI), where he served most recently as senior vice president, BSI Americas Healthcare and previously was head of the medical device EU Notified Body responsible for review and clearance of medical devices against European regulations. He also led BSI in achieving formal recognition as a recognized third party under FDA’s Center for Devices and Radiological Health (CDRH) and Health Canada’s Canadian Medical Devices Conformity Assessment System (CMDCAS) programs, and he is known both domestically and internationally as an expert on medical device regulations and regulatory issues.
Glenn N. Byrd, MBA, RAC – Director
Glenn N. Byrd is a senior director, promotional regulatory affairs, at AstraZeneca. He has more than 21 years of regulatory experience including 10 years at the US Food and Drug Administration. Byrd’s industry experience has focused on advertising and promotional compliance, regulatory strategy, clinical trial design and management of consulting firms and CROs, combination products, and medical devices. He holds an MBA from Hood College.
Edward Tabor, MD – Director
Edward Tabor is vice president, regulatory affairs North America, at Fresenius Kabi, a leading manufacturer of intravenous nutrition products. Previously, he was vice president, strategic drug development, and vice president, global regulatory affairs at Quintiles and had been a division director of two FDA divisions. Tabor is the author of more than 300 publications on viral hepatitis, other infections transmitted by blood, liver cancer and regulatory affairs, including Risk Evaluation and Mitigation Strategies for US Drug Development published by RAPS in 2012. He holds an MD from Columbia University.
Robert Yocher, MS, RAC, CQA, FRAPS – Director
Robert Yocher is senior vice president, regulatory affairs and quality assurance, HeartWare Inc., an adjunct faculty for regulatory and clinical research management at Regis College Graduate School of Nursing and a guest lecturer at the Massachusetts School of Pharmacy and Northeastern University. He has more than 38 years of experience in the medical products business holding many senior executive management positions in QA, regulatory affairs and clinical affairs. Yocher has served as chairman of the RAPS Boston Chapter, chairman of the RAPS Fellows Selection Committee, and is a senior member of ASQ. He holds an MS in health science in public health microbiology and epidemiology from the School of Allied Health, Quinnipiac University.
Raina Dauria, MS, RAC – Director
Raina Dauria is vice president of regulatory affairs for Ethicon Biosurgery, a platform within Ethicon Inc. Prior to joining Ethicon in 2011, Dauria worked for Advanced Technologies and Regenerative Therapeutics LLC., part of the Johnson & Johnson family of companies, with experience spanning from pre-approval regulatory submissions for device, biological and combination products to oversight of clinical research, field scientific affairs and quality assurance. Dauria received her master’s of science in drug regulatory affairs and health policy from Massachusetts College of Pharmacy, Boston.
Judith Smith, MS, MT (ASCP) – Director
Judith Smith is vice president of in vitro diagnostics and quality within Precision for Medicine’s translational and regulatory sciences practice. She has worked in the medical products regulatory, quality and clinical trial areas for more than 30 years. Smith has served as president of the Association of Medical Diagnostics Manufacturers (AMDM) since 2006 and was awarded the FDA Group Recognition Award for her work on the FDA/Industry Roundtable. She received her BS from Temple University and her MS from the Medical College of Pennsylvania.
Laila Gurney, MSc, RAC – Director
Laila Gurney is executive, regulatory affairs at GE Healthcare, where she leads a team of regulatory professionals responsible for global submissions of GE Healthcare’s “dose” modalities. She also has experience in both quality and clinical affairs, and served on the Global Harmonization Task Force Study Group 3 – Quality Systems as secretary from 2009 to 2012. Gurney received both her BSc. and MSc. in biochemistry at McGill University, and holds both the US and EU RAC credentials.
David E. Chadwick, PhD, RAC, FRAPS – Director
David E. Chadwick is director of regulatory affairs and regulatory science for Cook Inc. In this role, he provides high-level regulatory and clinical advice on pre- and postmarket safety, quality, performance testing, compliance and marketing issues pertaining to the manufacture and supply of medical devices globally. Dr. Chadwick has more than 25 years of experience in the medical device industry, including many years in research and development functions and managing clinical trials prior to transitioning into regulatory affairs. He is an adjunct professor of biology at Bethel College in St. Paul, MN, USA, and adjunct faculty at Ivy Tech College in Bloomington, IN, USA.
Jethro Ekuta, DVM, PhD, RAC, FRAPS – Director
Jethro Ekuta is vice president and head of regulatory affairs North America, Johnson & Johnson Consumer Inc. In this role, he drives regulatory innovation and develops regulatory strategies and their execution for the R&D pipeline across the entire consumer product portfolio encompassing all need states and product classifications (drugs, medical devices, cosmetics and commodities) in North America. Ekuta has also served in executive-level regulatory affairs positions at Genzyme, Bristol Myers Squibb Company, Wyeth Research, Pfizer Global Research and Development and Procter & Gamble Pharmaceuticals. Prior to that, he was special government employee and fellow in clinical pharmacology in the US Food and Drug Administration’s Office of Clinical Pharmacology and Biopharmaceutics.