Marlene Barton has been appointed vice president, department head, Regulatory Affairs, Syntactx. Also Chie Iwaishi was named senior director, Regulatory Affairs, and Darlene Garner was appointed manager, Regulatory Affairs.
 
“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 chief executive officer 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 an 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 U.S. 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.
 
Prior to joining Syntactx, she served as vice president of Regulatory Affairs for Cordis Corp., 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.
  
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.
 
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 she was vice president, Regulatory Affairs, Infectious Disease.
 
Ms. Garner has more than 30 years of regulatory experience in the medical device industry and has been involved with 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.