BEDFORD, Mass.--(BUSINESS WIRE)--Kaleido Biosciences, a clinical-stage biotechnology company developing novel chemistries to unlock the power of the human microbiome, today announced the appointment of Stephen Sofen, Ph.D., as senior vice president of technical operations, and Susan Stewart, J.D., as senior vice president of regulatory affairs and quality.
“We are thrilled to have Steve and Sue join Kaleido,” said Alison Lawton, president and chief operating officer of Kaleido. “Their leadership and significant experience will be invaluable as we advance our innovative approach to the microbiome and develop products that address important patient needs and improve the management of human health.”
Dr. Sofen brings to Kaleido extensive experience in technical innovation, product development and manufacturing, including more than 15 years in the biotechnology industry. Most recently, he was a vice president of technical operations at CRISPR Therapeutics, where he built and led the company’s process development, analytical sciences and manufacturing capabilities. Dr. Sofen also held senior technology and operations positions at Biogen, Genzyme Corporation and the Novartis-MIT Center for Continuous Manufacturing. He received his Ph.D. in bioinorganic chemistry from the University of California, Berkeley and his B.A. from Reed College.
Ms. Stewart has worked for more than 25 years in biopharmaceutical regulatory affairs, with significant experience devising innovative strategies for novel therapeutics, overseeing regulatory submissions at various stages of product development and leading interactions with global health authorities. Previously, in addition to being an independent regulatory consultant for several years, she was senior vice president of regulatory affairs, quality, and compliance at Tokai Pharmaceuticals and vice president, regulatory affairs at TransMolecular. She also spent more than 10 years at Genzyme Corporation in regulatory and compliance roles, including serving as vice president, regulatory affairs. She received her J.D. from Concord Law School at Purdue University Global and her B.A. from the University of Massachusetts.
About Kaleido Biosciences
Kaleido Biosciences is a clinical-stage biotechnology company engaged in the development of novel chemistries that unlock the power of the microbiome to revolutionize health. The Company has built the first R&D engine to systematically create, discover, and develop interventions that activate metabolic processes in the microbiome to treat disease and maintain health. Since its founding in 2015 by Flagship VentureLabs, Kaleido has advanced candidate products into clinical studies across programs in rare genetic diseases, oncology and infectious disease, and has generated more than 3,000 days of human clinical data. The Company is also creating consumer products that optimize the microbiome's natural roles in promoting health. For more information, please visit: http://www.kaleido.com.