Generation Bio, a company developing the first genetic medicines that can be titrated to effect and re-dosed for a lifetime of benefit, today announced the appointment of Antoinette Paone as head of regulatory affairs. Paone was formerly head of North American regulatory affairs strategy at Vertex Pharmaceuticals.
“Antoinette brings crucial experience in clinical regulatory strategy, CMC, and pediatric product development, having led regulatory teams responsible for multiple U.S. IND and global clinical trial submissions, and the marketing application approvals for four novel drugs,” said Geoff McDonough, M.D., president and chief executive officer of Generation Bio. “We are so pleased to welcome her to Generation Bio, and look forward to drawing on her expertise as we move our portfolio of ceDNA-based genetic medicines for liver and eye diseases into clinical development.”
Paone brings nearly two decades of pharmaceutical industry experience, including twelve years at Vertex where she provided regulatory leadership on the marketing application submissions and approvals for Incivek®, Kalydeco®, Orkambi® and Symdeko®. She most recently served as vice president and head of North American regulatory affairs strategy. Prior to that, Paone led the global regulatory affairs chemistry, manufacturing and controls (CMC) team at Vertex, and also held positions in chemical research and development and regulatory affairs CMC at Millennium Pharmaceuticals, and served as a research chemist at Merck & Co., Inc. She earned a Bachelor of Science degree in chemistry from Fordham University, a Master of Science in organic chemistry at Yale University and a Master of Business Administration from Bentley College.
“Generation Bio is creating an exciting new class of genetic medicines with drug-like properties, with strong potential to transform the way genetic diseases are treated,” said Paone. “I am thrilled to provide regulatory leadership and guide the company as it works to bring these exciting new medicines to patients who need them.”
Generation Bio is a biotechnology company developing a breakthrough class of genetic medicines to enable a new generation of people unaffected by inherited disease. The company’s therapies are based on its proprietary ceDNA technology, which delivers durable, high levels of gene expression and can be re-dosed to titrate to effect and to sustain impact over a lifetime. Generation Bio was founded and launched by Atlas Venture and is headquartered in Cambridge, Mass. For more information, please visit www.generationbio.com or follow @generationbio.
Ten Bridge Communications