Regulatory Operations/ Regulatory Strategy at 9:00 am – 10:00 am Dr. Manal Morsy joined Athersys in 2013 as Vice President and Head of Global Regulatory Affairs and has served as their Senior Vice President and Head of Global Regulatory Affairs since September 2016. She is responsible for the global regulatory activities for the Company’s therapeutic programs, including its MultiStem® cell therapy. Prior to joining Athersys, Dr. Morsy served as Vice President at PTC Therapeutics, Inc. since 2007 where she led global regulatory affairs, developed the company’s regulatory capabilities and was responsible for regulatory activities for multiple programs in several therapeutic areas, including the programs for treatment of Duchene muscular dystrophy and cystic fibrosis using Ataluren, the company’s lead product candidate. Prior to joining PTC, Dr. Morsy spent three years at Tibotec / J&J, serving as Senior Director, Global Regulatory Affairs, where she was responsible for global regulatory activities for the company’s pediatric development programs, tuberculosis and the HIV (Prezista) programs. Previous to her tenure at Tibotec, Dr. Morsy served as Director of Worldwide Regulatory Affairs for Merck & Co., where she led and supported new regulatory filings in the US and abroad, as well as supplemental filings for previously approved products. Dr. Morsy received her MD degree from the University of Alexandria, Faculty of Medicine, Egypt; her PhD from the Eastern Virginia Medical School/Old Dominion University in Norfolk, VA; and her MBA from the LeBow Business School, Drexel University in Philadelphia, PA. Dr. Morsy has several scientific publications and reviews in peer-reviewed journals, including Nature Biotechnology, The Journal of Clinical Investigation (JCI), Proceedings of the National Academy of Sciences (PNAS), The Journal of the American Medical Association (JAMA), and Annual Review of Medicine (ARM).