Nasdaq-listed Akcea Therapeutics has hired Tracy Palmer Berns as chief compliance officer (CCO).
In her new position, Berns is responsible for Akcea’s compliance program, with a focus on policy development and training. She also works with other members of the executive team to offer strategic counsel regarding the development of business goals and compliance matters concerning the company’s commercial products and investigational therapies.
Boston-based Akcea is a majority-owned affiliate of Ionis Pharmaceuticals. The biopharmaceutical company focuses on developing and commercializing medicines designed to treat patients with serious and rare diseases.
Berns was previously CCO and vice president for legal affairs at AMAG Pharmaceuticals. In that role, she was responsible for the company’s compliance program and therapeutic product legal team, and provided counsel on regulatory, development, pharmacovigilance and quality matters. Between 2005 and 2017 she held roles at Medtronic (formerly Covidien), most recently as vice president for ethics and compliance in the minimally invasive therapies group.
During her career, Berns has also been regulatory manager with CR Bard, regulatory affairs manager and staff attorney at ABIOMED, senior consultant at EXPERTech and associate general counsel at Thermo Electron Corporation.
‘With Tracy’s extensive compliance and legal expertise, she will help inform and continually evolve our focus and commitment to ethical business practices,’ Akcea COO Alex Howarth says in a statement. ‘During this exciting time at Akcea, when we are building new levels of momentum with our commercialization strategies and development programs, Tracy is an important addition to the leadership team.’
Ben Maiden
Ben Maiden is the editor-at-large of Governance Intelligence, an IR Media publication, having joined the company in December 2016. He is based in New York. Ben was previously managing editor of Compliance Reporter, covering regulatory and compliance...
