Magnetecs Engages Dr. Alexander Fleming for U.S. Regulatory Affairs
Dr. Alexander Fleming
Inglewood, CA – Magnetecs Corporation, a designer and manufacturer of robotic catheterization control systems for minimally invasive surgical procedures, today reported the engagement of Dr. Alexander Fleming, President and CEO of Kinexum LLC, to support the U.S. Food and Drug Administration (FDA) clearance of the Company’s Catheter Guidance Control and Imaging (CGCI) Robotic System.
Dr. Fleming has held senior positions in the U.S. healthcare industry and at the FDA. He is a leading authority on regulatory policy and communications and brings extensive experience and insight for successfully advancing regulatory clearance. He served as Chief Medical Officer, Boston Medical Technologies and Chief Scientific Officer, Ingenix Pharmaceutical Services – A UnitedHealth Group Company. He helped shape regulatory policy, review process, and reviewer professionalism for over a decade as a reviewer, leader, and innovator at the FDA. He is a board-certified endocrinologist with medical and research training at Emory, Vanderbilt, and the National Institutes of Health.
“As Magnetecs continues human clinical trials of our CGCI system at La Paz Hospital in Madrid, we have concurrent U.S. clinical trials planned in summer 2011 at Utah Valley Regional Medical Center and subsequently at Mount Sinai Medical Center in New York City for 510k submission,” said Josh Shachar, Chief Executive Officer and Chief Technology Officer of Magnetecs Corporation. “This key development stage of our Company necessitates an efficient U.S. regulatory process, and Dr. Fleming’s Kinexum organization clearly emerged as the best choice to effectively enable our U.S. regulatory clearance.”
Dr. Fleming’s regulatory and technical expertise has been requested in numerous international settings including the World Health Organization, where he was assigned from 1991 to 1992. He was a member of the expert working groups on Good Clinical Practices and General Considerations for Clinical Trials of the International Conference on Harmonization (ICH) and participated on other ICH committees including the Common Technical Document working group. While serving at FDA’s Center for Drug Evaluation and Research (CDER), Dr. Fleming was also the founder and editor in chief of the Virtual Journal of Drug Evaluation, a major contributor to FDA’s Good Review Practice (GRP) initiative, and chair of the committee responsible for education and training at CDER. He conceived and led the first FDA pilot project to utilize the internet for regulatory communication.”
Dr. Fleming is the lead author of the book, “Optimizing Development of Therapies for Diabetes.” He serves on numerous scientific advisory boards, expert committees, and corporate boards. He founded the Leigh Thompson Renaissance Conference, a forum for promoting dialogue and creativity within the community of therapeutic developers. Dr. Fleming has served as invited editorialist to The New England Journal of Medicine and as a commentator on National Public Radio.
ABOUT KINEXUM
Dr. Fleming founded Kinexum in 2003 to provide services to the healthcare industry to support cost-effective regulatory and clinical development strategies. Kinexum accelerates health product development and commercialization by supporting both new and mature companies with high-value scientific, clinical, regulatory, and business expertise. Involvement ranges across pharmaceuticals, medical devices, diagnostics, nutrition, and health informatics. Recognized for leadership in the Washington D.C. health and governmental policy arena and the Minnesota bio-business community, Kinexum is committed to innovative products and processes that improve the health of people and the companies that serve them.