February 6, 2020
Dorothy Abel Joins Syntactx as Vice President, Regulatory Strategy
February 6, 2020—Syntactx announced that Ms. Dorothy Abel has joined the company as Vice President, Regulatory Strategy. At Syntactx, a global, full-service clinical research organization specializing in complex interventional medical device and pharmaceutical trials, Ms. Abel oversees the development and execution of regulatory plans to help clients formulate product development strategies to achieve market approvals and worldwide adoption.
Ms. Abel previously served in the FDA’s Center for Devices and Radiological Health, leading the evaluation of vascular and endovascular surgical devices for more than 30 years and fostering collaboration between FDA, industry, and academia to advance preclinical, investigational, and postmarket assessment of device performance.
According to Syntactx, Ms. Abel's work is now reflected in FDA initiatives, including device evaluation strategy documentation for early feasibility study applications, the use of real-world evidence to develop performance goals, and the application of the appropriate balance of pre- and postmarket clinical evaluation.
“We are very proud to have Dorothy join the Syntactx leadership team,” remarked President and CEO Kenneth Ouriel, MD, in the company’s announcement. “With the evolving clinical and regulatory complexities faced by manufacturers with innovative therapies and devices, Dorothy will play a critical role in strengthening our ability to assist our clients with the design and execution of sound strategies to support product introduction and clinical acceptance. Dorothy is highly respected for her ability to bring together physician thought leaders, medical societies, and industry in a manner that has transformed the way in which medical devices are evaluated.”
Ms. Abel holds a Bachelor of Science in biomedical engineering from the University of Iowa and is a fellow of the American Institute for Medical and Biological Engineering. She has coauthored more than 50 scientific articles, coinitiated the Greenberg Stent Summit, and is the recipient of several honors. In the company’s announcement, she shared, “I look forward to working together with my Syntactx colleagues and our clients in continuing to develop and communicate least burdensome evaluation strategies, helping to efficiently get beneficial technologies to patients.”