BEDFORD, Mass.--(BUSINESS WIRE)--Stoke Therapeutics today announced the addition of two senior leaders who bring substantial experience guiding regulatory strategy and managing clinical development and operations.
Shamim Ruff, previously Chief Regulatory Affairs Officer and SVP, Head of Quality at Sarepta Therapeutics, joins as Senior Vice President of Regulatory Affairs and Quality. Nancy Wyant, an independent consultant, comes on board as Vice President, Head of Clinical Operations.
With the team growing and research accelerating on a deep pipeline of programs, the Stoke team recently moved to new R&D facilities at 45 Wiggins Avenue in Bedford, Mass. The new space is four times larger than Stoke’s current facilities and includes expanded in vivo, biology and medicinal chemistry laboratories where the team is advancing its lead candidate, an oligonucleotide therapy for Dravet Syndrome, along with other precision medicines.
“We are moving quickly to bring our lead program into the clinic as the first disease-modifying medicine for a genetic epilepsy,” said Ed Kaye, M.D., Stoke’s Chief Executive Officer. “Shamim and Nancy have the experience and insight we need to ensure that our path is smooth and successful. We’re delighted to have them on board.”
Shamim Ruff joins Stoke as Senior Vice President of Regulatory Affairs and Quality. Ruff has extensive knowledge of drug development with more than 25 years in the biopharmaceutical industry, working with a diverse range of therapeutics including small molecules, monoclonal antibodies, oncolytic viruses and oligonucleotides. Her expertise in both domestic and international regulatory affairs spans early and late development across multiple therapeutic areas. Prior to joining Stoke, she was at Sarepta Therapeutics, where she built the company’s regulatory affairs and quality organizations and was responsible for leading and defining the regulatory strategy for their rare and infectious disease pipelines. Prior to joining Sarepta, Ruff served as Vice President, Head of Regulatory Affairs Oncology at Sanofi-Genzyme, where she was responsible for leading the Global, European and CMC Regulatory Affairs teams. She previously held senior positions at Amgen, Abbott and AstraZeneca where she had global oversight for the development and filings of multiple successful regulatory approvals. Ruff holds a BSc. in chemistry & biology from the University of Leicester, UK, and an MSc. in analytical chemistry from the University of Loughborough, UK. Additionally, she is a Chartered Chemist and Member of the Royal Society of Chemistry (CChem MRSC), and is also a member of DIA, RAPS, ASCO and ASGCT.
Nancy Wyant has been an independent consultant since February 2018 and during that time has collaborated with Stoke on several key projects. Previously, she was Vice President, Clinical Operations at BeiGene USA, Inc, where she helped build the global clinical operations organization, implemented compliance standards and oversaw global clinical trial execution. Throughout her career, Wyant has led clinical trial development operations across the biotechnology industry, including as Vice President, Clinical Operations at Idera Pharmaceuticals, as Head of Clinical Operations at Sarepta Therapeutics and as Head of Global Clinical Operations at Shire Human Genetic Therapies. She also facilitated clinical operations and clinical compliance programs at EMD Serono, Therion Biologics Corporation and Vertex Pharmaceuticals. Wyant began her career at Massachusetts General Hospital as a Clinical Research and Program Coordinator. She is a member of Linking Leaders Boston and the American Epilepsy Society as well as the Society for Clinical Oncology and has a B.A. in psychology from Hartwick College.
About Stoke Therapeutics
Launched in 2018, Stoke Therapeutics is a biotechnology company working to increase gene expression to treat a wide array of severe genetic diseases, including genetic conditions affecting the central nervous system, eye, liver and kidney. Stoke has raised $130 million in funding from two rounds of financing; investors include RTW Investments, RA Capital Management, Cormorant Asset Management, Perceptive Advisors, funds managed by Janus Henderson Investors, Redmile Group, Sphera Funds Management, and Alexandria Venture Investments, as well as founding investor Apple Tree Partners. For more information, visit www.StokeTherapeutics.com and follow Stoke on Twitter @StokeTx.
