US biotechnology firm Amicus Therapeutics has appointed Dr Andrew Mulberg as its vice president of regulatory strategy.
Serving as a member of Amicus’ executive team, Dr Mulberg will be responsible for overseeing the global regulatory strategies for all of the company’s rare disease therapy programmes.
He joins Amicus from the US Food and Drug Administration (FDA), where he most recently served as deputy director of the division of gastroenterology and inborn errors products.
Prior to this, Dr Mulberg worked at Johnson & Johnson’s pharmaceutical research and development division, serving as the portfolio leader for internal medicine and established products.
Dr Mulberg is a pediatric gastroenterologist, and was attending physician and fellowship director in gastroenterology and hepatology for The Children’s Hospital of Philadelphia between 1993 and 2001.
He is currently the board chairman and member of the medical advisory and research committees for the Go4theGoal Foundation, a pediatric cancer foundation.
Dr Jay Barth, chief medical officer at Amicus, said: “I am very pleased to welcome Andrew to our team.
“As we advance several programmes through global clinical development, his direct experience at the FDA within the gastroenterology and inborn errors division, as well as his successful track record in drug development and regulatory approvals within industry, will be very valuable for Amicus.
“Andrew will be instrumental in shaping our regulatory strategies from investigational new drug, or IND, applications and first-in-man studies through regulatory approvals.”