RAPS today announced the names of its 2018 class of RAPS Fellows. Daniel Mannix, PhD, FRAPS, vice president, regulatory affairs, MacroGenics Inc.; Sandra Matsumoto, PhD, RAC, FRAPS, vice president, regulatory affairs, Sebela Pharmaceuticals; and Frank Pokrop, CPGP, CQA, CQE, CSQE, RAC, FRAPS, senior director, regulatory affairs and quality assurance, Sotera Wireless, are the latest to join this elite group of accomplished regulatory professionals, the RAPS Fellows. They will be recognized at the RAPS Regulatory Convergence conference next week in Vancouver.
“To be chosen as a RAPS Fellows is great honor because of what it represents—years of tireless dedication to regulatory excellence,” said Fellows Selection Committee Chair Nancy J. Gertlar, principal, Crossroads Regulatory Consulting and Mentoring. “Daniel Mannix, Sandra Matsumoto and Frank Pokrop could not be more appropriate choices for this distinction. They are regulatory experts, leaders, mentors, writers and speakers, committed to the regulatory profession, sharing their knowledge and giving back to the community.”
Daniel Mannix has more than 25 years of regulatory affairs experience in the pharmaceutical industry in both the US and EU. He has worked in positions of increasing responsibility at Kyowa Hakko Kirin, EMD Serono, Bristol-Myers Squibb, Amersham Health and Pharmacia. He is a past chair of the board of editors for RAPS’ Regulatory Focus and was a RAPS board member for six years. After earning his PhD from the University of Notre Dame, Mannix completed an NIH postdoctoral fellowship in molecular oncology at The Ohio State University Comprehensive Cancer Center.
Sandra Matsumoto has more than 17 years of experience in the biotechnology and pharmaceutical industries, at companies including Vital Therapies, Shire Regenerative Medicine, Advanced BioHealing, Amylin Pharmaceuticals, Sequenom and Illumina. She is an expert in leading and implementing global regulatory strategies, and shares her knowledge as a mentor and volunteer leader with local professional organizations. Matsumoto has chaired and participated on multiple committees for the San Diego Regulatory Affairs Network and the Association for Women in Science. She also served as co-leader of the Women in Bio mentor-advisor-peer group. She holds the RAC (US and EU).
Frank Pokrop has worked in the medical device arena for more than 20 years. In his current role, he oversees staff and budget, global submissions, worldwide regulatory intelligence, project management, auditing and compliance, recall management and training. He has expertise as a liaison with regulators around the world working with pharmaceuticals, medical devices, IVDs and infant formula. Throughout his career, he has been an ardent supporter of training and personnel development, as well as a frequent volunteer, contributor and speaker with ASQ, RAPS and the San Diego Regulatory Affairs Network, where he served as president.
RAPS Fellows serve as important resources for knowledge and guidance to RAPS and to the global regulatory community. Fellows may use the FRAPS designation among their degrees and other professional credentials.