Shamim Ruff — Senior Vice President of Regulatory Affairs & Quality at Sarepta Therapeutics

Ms. Shamim Ruff has been Senior Vice President of Regulatory Affairs and Quality at Sarepta Therapeutics, Inc. since December 2015 and served as its Vice President of Regulatory Affairs and Quality from January 2013 to December 2015. Ms. Ruff joined Sarepta in January 2013. She experience includes more than twenty-five 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, including Rare Diseases, Oncology, Hematology, Antivirals and Bone Therapy Areas and includes extensive interaction with multiple regulatory agencies globally, including FDA (CDER/CBER/CDRH), EMA/CHMP, Health Canada and PMDA. Prior to joining Sarepta, Ms. Ruff served as Vice President of Regulatory Affairs at Sanofi from April 2011 to December 2012, where she was Head of Oncology Regulatory Affairs, responsible for leading Global, European and CMC Regulatory Affairs teams. She held senior positions at Amgen, Abbott and AstraZeneca where she had global oversight for the development and filings of multiple compounds, some of which had companion diagnostics. In addition, Ms. Ruff has significant experience leading the preparations for FDA Advisory Committee Meetings. She is a Chartered Chemist and Member of the Royal Society of Chemistry (CChem MRSC), and is also an active member of DIA, RAPS and ASCO. Ms. Ruff holds a Bachelor's degree in Chemistry & Biology from the University of Leicester, UK and a Master's degree in Analytical Chemistry from the University of Loughborough, UK.