GI Dynamics Appoints Chief Compliance Officer
LEXINGTON, Mass & SYDNEY, Australia – 10 May 2016 AEST – GI Dynamics, Inc. (ASX: GID) (the Company), a medical device company that provides an innovative treatment for type 2 diabetes and obesity, today announces the appointment of Brian Callahan to the position of chief compliance officer and executive vice president clinical, regulatory and quality.
Callahan will be responsible for overseeing the Company’s clinical, regulatory and quality affairs and will ensure the Company is engaged in an effective dialogue with regulatory bodies in Europe, Australia and the United States. He has extensive experience working as a consultant with the FDA in remediating serious issues across multiple companies.
GI Dynamics’ CEO Scott Schorer said, “On behalf of the board of directors, I am pleased to announce the appointment of Brian Callahan as GI Dynamics’ chief compliance officer. He is a vital addition to the senior management team as we work to reboot GI Dynamics.”
“Brian and I have worked together extensively in the past. Together, we have supported multiple FDA inspections, received a CE mark certification and multiple CE mark product approvals. GI Dynamics must immediately focus on engaging with its regulatory bodies in a more open and constructive manner. Brian has a long history of working across multiple companies and technologies to remediate clinical, regulatory and quality issues. I asked Brian to join GI Dynamics and help us solve the execution issues that led to stopping the ENDO Trial in the United States.”
“I joined GI Dynamics after speaking with Scott about the issues and the potential for EndoBarrier Therapy,” Callahan said. “GI Dynamics’ technology meets a critical need, providing an effective nonsurgical alternative treatment for a large and growing patient population. I look forward to enhancing our relationships with our European notified body, with the TGA and the FDA.”
Callahan is an accomplished senior compliance executive with more than 25 years of experience in the medical device, pharmaceutical and biologics industries. He began his career in the United States Army as a nuclear weapons specialist and has experience working for Johnson & Johnson, Covidien and Quintiles. In 2002, Callahan founded EEC & Associates, a global compliance consulting company providing clinical, regulatory and quality services to domestic and international life science companies. More recently, Callahan was executive vice president of clinical, quality and regulatory affairs at Histogenics Corporation (HSGX) and was instrumental in raising $49 million while working with the FDA to restart the NeoCart pivotal phase III study.