Dr. Clayman is a co-founder of Flexion Therapeutics and has served as our President, Chief Executive Officer, and as one of our directors since our inception in 2007. Dr. Clayman also serves on the Board of Directors of Akebia Therapeutics and Anokion, both biopharmaceutical companies. Previously, Dr. Clayman had a lengthy career at Eli Lilly and Company, a global pharmaceutical company, where he was most recently Vice President, Lilly Research Laboratories, and General Manager of Chorus, Lilly’s early-phase development accelerator. During his career at Lilly, Dr. Clayman also led its Global Regulatory Affairs division; the Cardiovascular Discovery Research and Clinical Investigation, Research and Development at Advanced Cardiovascular Systems, a medical device subsidiary of Lilly; the Internal Medicine Division; the Lilly Clinic, Lilly’s dedicated Phase 1 unit; and served as Chair of Lilly’s Bioethics Committee. Prior to his tenure at Lilly, Dr. Clayman was an Assistant Professor in the School of Medicine at the University of Pennsylvania, where his research centered on the immunopathogenesis of renal disease. Dr. Clayman is the recipient of the Physician Scientist Award from the National Institutes of Health. He earned a BA, cum laude, from Yale University and an MD from the University of California, San Diego School of Medicine. Following an internship and residency in Internal Medicine at the University of California, San Francisco Moffitt Hospitals, Dr. Clayman completed clinical and research fellowships in Nephrology at the University of Pennsylvania.
Dr. Bodick is a co-founder and has served as our Chief Medical Officer since our inception in 2007. Previously, Dr. Bodick was at Eli Lilly and Company, where he founded Chorus and served as Chief Medical Officer and Chief Operating Officer. Prior to that, Dr. Bodick was responsible for early-phase clinical investigation at Lilly Research Laboratories. Dr. Bodick also was Assistant Professor in the School of Medicine at the University of Pennsylvania, where his research centered on the development of computer-based systems to support image-intensive diagnosis. Dr. Bodick holds 14 patents in the areas of neuroscience and computer science and is the recipient of the Biomedical Research Service Award and the New Investigator Research Award from the National Institutes of Health. Dr. Bodick earned an AB from Cornell University, a PhD in neuroscience from Columbia University, an MD from the Albert Einstein College of Medicine and an MBA from the Wharton School of the University of Pennsylvania.
Mr. Driscoll has served as our Chief Financial Officer since May 2013. Mr. Driscoll also serves on the Board of Directors of OXiGENE, Inc. and Cynapsus Therapeutics Inc., both biopharmaceutical companies. Prior to joining us, Mr. Driscoll was Chief Financial Officer at Novavax, Inc., a publicly traded biopharmaceutical company since 2009. Previously, Mr. Driscoll also served as Chief Financial Officer from 2007 to 2008, and subsequently Chief Executive Officer from 2008 to 2009, at Genelabs Technologies, Inc., a publicly traded biopharmaceutical and diagnostics company; and Chief Executive Officer at OXiGENE, Inc., a biopharmaceutical company, from 2002 to 2006. Mr. Driscoll earned a Bachelor’s degree in accounting and finance from Bentley University.
Mr. Deardorf has more than 18 years of commercial biopharmaceutical experience encompassing marketing, business development, market development, program management and sales. Most recently, he provided strategic commercial guidance to biopharmaceutical start-up companies as an independent consultant. Prior to that, he spent 14 years at Genzyme Corp. working on a variety of biomaterial, cell-based, and small molecule products in the orthopaedic market. Most notably, Mr. Deardorf was Vice President of Marketing for the Synvisc® franchise and led the extremely successful launch of Synvisc-One, an injectable product for osteoarthritis of the knee. He holds a BS in Biochemistry from California Polytechnic State University and an MBA from the Wharton School at the University of Pennsylvania.
Ms. Wentworth brings more than 20 years of experience in both domestic and international Regulatory Affairs that spans early and late development across multiple therapeutic areas. Prior to joining Flexion, Ms. Wentworth served as Vice President, Clinical, Regulatory and Quality at Agenus, Inc., where she was responsible for leading all global regulatory and clinical development efforts for nearly 10 years. Previously, Ms. Wentworth led the Regulatory and Quality function for Genelabs Technologies, Inc., where she was responsible for advancing their lead program through Phase 3 development and into the registration phase with FDA and EMA. Ms. Wentworth also held positions of increasing responsibility within Regulatory Affairs at Genzyme. Ms. Wentworth holds a BS in pre-veterinary medicine from the University of New Hampshire.
Ms. Willwerth has more than 20 years of experience in pharmaceutical development. She joined Flexion Therapeutics from Viacell, where she was a member of the company’s Executive Management team and served as Vice President, Product Development, with management responsibility for the company’s interdisciplinary cellular therapy and fertility preservation development programs. Ms. Willwerth previously served as Senior Director, Product Development at The Medicines Company, where she focused on cardiovascular therapy clinical and product development. Prior to that, she held a number of ascendant clinical operations positions at Astra Pharmaceuticals and Biopure Corporation. Ms. Willwerth holds a BS in Biology, with high distinction, from Worcester Polytechnic Institute.
Dr. Doyle has over 20 years of clinical, academic and biopharmaceutical experience. She has held faculty positions at Harvard Medical School, Tulane University School of Medicine and the University of Pennsylvania School of Medicine. Prior to joining Flexion, Dr. Doyle served as Senior Medical Director in Translational Medicine at Alexion Pharmaceuticals focusing on First in Human and Proof of Concept studies in orphan diseases. Prior to her tenure at Alexion, Dr. Doyle held positions of increasing responsibility at Centocor and Janssen R&D where she worked on the successful BLA filing for Golimumab in Rheumatoid Arthritis and served as Clinical lead for the Phase III Ustekinumab Psoriatic arthritis program. She earned her BA, magna cum laude, from Princeton University and her MD, cum laude, from Yale University School of Medicine. Following an internship and residency in Internal Medicine at Massachusetts General Hospital, Dr. Doyle completed clinical and research fellowships in Rheumatology and Immunology at Brigham and Women’s Hospital and Harvard Medical School. She is board certified in Rheumatology and maintains a clinical practice at the Veterans Administration Hospital.
Mr. Fraga has a broad background including marketing leadership roles for both global and US organizations in bio-pharma and medical device companies. Before joining Flexion, Mr. Fraga served as Head of Global Marketing for Sanofi Biosurgery with responsibility for the SYNVISC franchise (an injectable treatment for osteoarthritis of the knee) as well as surgical device businesses. Prior to joining Sanofi, he held a variety of global, commercial and strategic marketing roles at Codman Neuro, a neurosurgery device subsidiary of Johnson & Johnson’s DePuy Synthes franchise. Before Codman, Mr. Fraga built a European commercial team for Centocor, now part of J&J’s Janssen Pharmaceuticals business, focusing on REMICADE and SIMPONI. Mr. Fraga holds an MBA from the Wharton School of the University of Pennsylvania, an M. Phil. from the University of Oxford, and a BA from the University of Pennsylvania.
Dr. Kelley has over 25 years of clinical, academic and industry medical affairs experience. Most recently, Dr. Kelley served as Vice President, Global Medical Affairs at Sanofi where he oversaw global data generation, data dissemination and KOL engagement strategy for the Biosurgery portfolio including Synvisc®, an injectable product for osteoarthritis of the knee. Prior to Sanofi, Dr. Kelley led medical affairs functions at Covidien Respiratory & Monitoring Solutions and at Aspect Medical Systems. Dr. Kelley earned his BS and MS from Stanford University and his MD from University of California, San Francisco. He completed his residency and fellowship in Anesthesiology at UCSF and obtained board certifications in Anesthesiology and Pain Management. Dr. Kelley maintains a clinical practice at Brigham & Women’s Hospital.
Mr. Leblanc has extensive experience in pharmaceutical development and operations with an emphasis on novel drug delivery systems. Most recently, Mr. Leblanc spent over 4 years as the Director of Pharmaceutical Development at Merck Serono in Geneva, Switzerland, where he was globally responsible for drug product and process development of all large molecule programs throughout the development life cycle. Prior to this, he spent 11 years at Alkermes, Inc. in various positions, specializing in the characterization and development of manufacturing processes for PLGA based drug delivery programs as well as the start-up and operation of Alkermes’ internal manufacturing processes for Nutropin Depot® , Vivitrol® , as well as Risperdal Consta® . He holds a BS degree from Syracuse University in Chemical Engineering and a joint MS from University of Pennsylvania School of Engineering and the Wharton School in Technology Management.
Ms. Lufkin joined Flexion in May 2011 and brings more than 15 years of experience in Clinical Operation including global studies across multiple therapeutic areas. Prior to joining Flexion, Ms. Lufkin served as Director Clinical Operations at Synta Pharmaceuticals where she was responsible for leading two global oncology programs during her 7 year tenure. Previously, she was responsible for overseeing a Phase 3 infectious disease program at Cubist Pharmaceuticals which received regulatory approval by the FDA and also held positions within Clinical Operations at Genetics Institute (currently Pfizer) and Ergo Science. Ms. Lufkin holds a BS in Biology from the University of Massachusetts, Amherst and a Master’s in Public Health with a concentration in Epidemiology and Biostatistics from Boston University.
Mr. Mahlowitz has over 18 years of legal and transactional experience, including over 10 years in the life sciences industry. Prior to joining Flexion, Mr. Mahlowitz served as Senior Corporate Counsel at ARIAD Pharmaceuticals, where he was responsible for SEC reporting, corporate governance and strategic transactions. Before that, he worked on a wide variety of legal matters in positions of increasing responsibility during his 10 years at Cubist Pharmaceuticals, most recently as Senior Corporate Counsel. Before Cubist, he worked as a corporate attorney at a global fire safety company and prior to that as a corporate associate at a large Boston law firm. Mr. Mahlowitz earned a JD from Boston College Law School and a BA from the University of Rochester.
Mr. Thornton has had leadership roles for nearly 20 years in patient and market access, pricing and distribution, and market development for a number of biotechnology and pharmaceutical firms. Most recently, he was VP of market access and patient services at Chiasma, where he built a comprehensive patient services and market access organization for the launch of an oral product for the treatment of acromegaly. He has also built and executed market access strategies at a number of companies including Shire Pharmaceuticals, Santhera Pharmaceuticals and Targanta Therapeutics. Mr. Thornton earned his BA from Duke University and his MBA from the Wharton School at the University of Pennsylvania.
Ms. Villandry brings more than 20 years of experience in the Life Sciences industry where she held increasing roles of responsibility in the early stage start-up phases of high growth companies and has been responsible for creating and developing Human Resources organizations while supporting both the long and short term strategic business needs of these companies. Prior to joining Flexion, Ms. Villandry served as a member of the Leadership Team at Interleukin Genetics in the capacity of Vice President, Human Resources. Previously Ms. Villandry served as Head of Human Resources for RainDance Technologies; Sr. Director of Human Resources at Altus Pharmaceuticals, where she was responsible for creating and developing the Human Resources function in a pre-and post IPO environment; Director of Human Resources with iMarket, Inc. until its merger with D&B where she then served as Human Resources Director; and Corporate Director of Human Resources at MediSense, Inc., with global responsibility for Human Resources. Ms. Villandry holds a Bachelor of Science Degree from Northeastern University and received her Human Resources Certificate from the Northeast Human Resources Association.