WATERTOWN, Mass.--(BUSINESS WIRE)--FORMA Therapeutics, a fully-integrated research and clinical development company, today announced the appointment of Frances Duffy-Warren, Ph.D., to the leadership team as Head of Regulatory Affairs. Frances brings more than 30 years of pharmaceutical and regulatory experience, having previously worked for several global and emerging pharmaceutical companies. In this role, Frances will report to FORMA’s President and Chief Executive Officer, Steven Tregay, and will oversee the company’s activities related to regulatory strategy, including upcoming interactions with regulatory authorities for a global development program.
“Frances brings a great depth of knowledge having managed internal and external resources involved in the global regulatory process. She has proven experience as both a strategist and team player in matrix environments,” said Steven Tregay, Ph.D., President and CEO, FORMA Therapeutics. “Frances will guide the path to registration for FORMA’s wholly-owned pipeline, ensuring a strong regulatory foundation for products from bench to bedside, and provide strategic insights for our partnered programs up to proof of concept. We are confident that her extensive regulatory expertise across multiple therapeutic disciplines, including oncology and rare diseases, will be instrumental to our success.”
“FORMA provides a unique opportunity to work in a collaborative environment to advance a best-in-class clinical portfolio through regulatory interactions. I am looking forward to working with FORMA’s talented team and be able to apply my expertise in regulatory to expedite the drug development process and advance FORMA’s pipeline to deliver critical medicines for patients in need,” said Frances Duffy-Warren.
Prior to joining FORMA, Frances served as Vice President and Head of U.S. Regulatory Affairs at Actelion Clinical Research. In addition to establishing and growing the US Regulatory Affairs group at Actelion, Frances built strong relationships with the FDA and was responsible for ensuring quality documents were submitted. As a member of senior management leadership teams, including the global regulatory management team, she ensured creation, discussion, agreement and implementation of global regulatory strategies to help optimize the development of a portfolio of drugs leading to successful approvals worldwide. Prior to Actelion, she held various leadership positions with increasing responsibilities in worldwide Regulatory Affairs at Novartis and AstraZeneca. Frances has experience across all phases of development and commercialization of drugs in cardiovascular, oncology, hematology, CNS, infectious diseases and pulmonary therapeutic areas. She has in-depth experience in drugs that are for rare, serious and life-threatening diseases. Frances earned both a Ph.D. in Biochemistry and a Bachelor of Science degree (Honors) from the University of Strathcylde in Glasgow, Scotland. She is a member of the Drug Information Association (DIA), Regulatory Affairs Professional Society (RAPS) and the Organisation for Professional Regulatory Affairs (TOPRA).
FORMA Therapeutics' scientists are passionate about discovering and developing medicines that will make a difference in oncology, inflammation & immunity, neurodegeneration, and other serious diseases. The Company’s fully integrated R&D team drives discovery and early clinical development of therapeutics for qualified targets in the areas of epigenetics, protein homeostasis and metabolism. Leveraging a world class network of academic investigators, clinical experts and partners, FORMA combines deep biology insight, chemistry expertise and early clinical development capabilities, to create drug candidates providing profound patient benefit.
FORMA is headquartered in Watertown, MA near the epicenter of the Cambridge Life Sciences cluster, with operations in Watertown, MA and Branford, CT. www.formatherapeutics.com
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