Former FDA Reviewer Joins Syntactx as Regulatory Strategist

Syntactx, a global, full-service clinical research organization (CRO) specializing in complex interventional medical device and pharmaceutical trials, has hired Dorothy Abel as vice president, Regulatory Strategy. In this newly established role, Abel oversees the development and execution of regulatory plans designed to help clients formulate their product development strategy to achieve market approvals and worldwide adoption.
 
Dorothy had a highly accomplished career with the U.S. Food and Drug Administration (FDA) in the Center for Devices and Radiological Health (CDRH) where she led the evaluation of vascular and endovascular surgical devices for over 30 years. Abel also fostered a collaborative approach between FDA, industry, and academia to advance modern approaches to pre-clinical, investigational, and post-market assessment of device performance.
 
“We are very proud to have Dorothy join the Syntactx leadership team,” said Dr. Kenneth Ouriel, Syntactx president and CEO. “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. We are excited for our clients worldwide to benefit from Dorothy’s involvement in their initiatives.” 
 
During her time at FDA, Abel pioneered approaches for the evaluation of vascular and endovascular surgical devices in collaboration with her colleagues, members of surgical societies, and international standards committees. Abel led FDA workshops on the preclinical testing of endovascular devices which inspired the Greenberg Stent Summits and she worked with surgical societies and device manufacturers to develop least burdensome clinical study designs. These approaches are now reflected in FDA initiatives such as the 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 post-market clinical evaluation.
 
Abel earned a bachelor of science degree in biomedical engineering from the University of Iowa and is a fellow of the American Institute for Medical and Biological Engineering. Abel has co-authored over 50 scientific articles, co-initiated the Greenberg Stent Summit, and is the recipient of several honors including the 2006 FDA Civil Service Civil Engineer of the Year and the 2017 CDRH Group Recognition Award for the Endovascular Devices Standards Team.

“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,” Abel said.