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Syntactx Announces Expansion of Regulatory Affairs Leadership Team
Company Names Three Industry Veterans to Lead Regulatory Affairs Team: Marlene Barton, Vice President, Department Head; Chie Iwaishi, Senior Director; and Darlene Garner, Manager
Appointments Reflect Company’s Enhanced Commitment to Deliver Full-Scale Medical Research and Clinical Trial Services
NEW YORK, July 25, 2018 (GLOBE NEWSWIRE) -- Syntactx, a Contract Research Organization that specializes in medical device, pharmaceutical and genetics clinical trials, today announced the appointments of Marlene Barton to the position of Vice President, Department Head, Regulatory Affairs; Chie Iwaishi to the position of Senior Director, Regulatory Affairs; and Darlene Garner to the position of Manager, Regulatory Affairs. The expansion of the company’s regulatory affairs team reflects Syntactx’s commitment to serve its clients in navigating the complexities of the U.S. Food and Drug Administration (FDA) approval process for products undergoing clinical investigation.
"We are delighted to announce the addition to our Regulatory Affairs team of Marlene, Chie and Darlene, each of whom brings a unique skillset, a long list of accomplishments and wide-ranging expertise,” said Kenneth Ouriel, MD, MBA, President and CEO of Syntactx. “We are confident that Syntactx will benefit from this infusion of leadership. Together, we will strengthen our offerings to our clients, taking clinical trials from product inception through market introduction and post-market studies.”
Mrs. Barton is a renowned expert in regulatory affairs and has significant experience in global regulatory approvals and coordination of FDA panel meetings. Notably, she assisted in the first drug-eluting stent (Cypher) approval in Japan and the first brachytherapy system approval in the United States. Mrs. Barton has been an active participant in the AdvaMed PMA & 510(k) Working Groups since 1997, where she worked in conjunction with the FDA to streamline their systems and develop numerous guidance documents.
In addition, she has broad international experience, including her role as a representative for the Global Harmonization Task Force Study Group 1, and her work with Asia Pacific regulators. Prior to joining Syntactx, Marlene served as Vice President of Regulatory Affairs for Cordis Corporation (Cordis), where she spent nearly three decades focusing on endovascular, neurovascular and cardiology products. She left Cordis, a Cardinal Health Company, in 2010 to launch her own consulting company.
“I am excited to join Syntactx and look forward to building upon the company’s ability to bring high-quality products to the market,” said Mrs. Barton. “Beyond clinical trials, Syntactx is deeply rooted in helping the healthcare industry move new therapies from the bench to the bedside, enabling companies to improve patients’ quality of life.”
Ms. Iwaishi has extensive executive regulatory experience and a strong success record with U.S. class III/II medical devices, device-drug combination products and pharmaceuticals. She brings profound knowledge of U.S. and global regulatory processes and a demonstrated ability in guiding program development to optimize regulatory timelines. She also has experience with interpreting global policy, as well as FDA and global regulations, through her presentations, service on scientific working groups and think-tank projects. Ms. Iwaishi is fluent in Japanese and played the key role as the U.S regulatory contact in obtaining approval for the first drug-eluting stent in Japan.
Prior to Syntactx, she was WW Director at Cordis, a Johnson & Johnson company at that time. Most recently, she served at Abbot, in the Rapid Diagnostics Division, where Ms. Iwaishi was Vice President, Regulatory Affairs, Infectious Disease. In that role, she was responsible for regulatory strategy development and compliance for R&D and commercial sites in the Asia-Pacific region. Her other experiences include leading Bausch + Lomb’s RA/QA team supporting pharmaceuticals, medical devices and cosmetics businesses in Japan.
With more than 30 years of regulatory experience in the medical device industry, Ms. Garner’s career has involved various medical devices, including pacemakers, vagus nerve stimulators, intravascular radiotherapy systems, peripheral stents, TENS units, guide wires and catheters. She also successfully submitted multiple regulatory applications and has been involved in several FDA and Notified Body inspections. Prior to working at Syntactx, Ms. Garner was a regulatory consultant. She also worked for Sulzer Intermedics as a Regulatory Affairs Specialist and Cyberonics as Sr. Manager of Complaints and Medical Device Reporting.
Headquartered in New York City, Syntactx is a Contract Research Organization that specializes in full-service, innovative, technology-driven and customized clinical trial experiences. Leveraging long-standing relationships with clinicians, academic and non-academic institutions, and regulatory agencies, Syntactx partners with industry to develop and execute research plans.
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