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. 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.
Dr. Deniz brings more than 20 years of clinical experience spanning both academia and industry. He has worked extensively in global drug development and regulatory affairs and was instrumental in the filing and approval of multiple drugs and diagnostic agents across a variety of therapeutic areas. Before joining Flexion, Dr. Deniz served as Vice President & Global Head of Rare Diseases Medical Affairs at Sanofi-Genzyme, and prior to that, he held the position of Chief Medical Officer and Global Head of Development at GE Healthcare Medical Diagnostics. Dr. Deniz also held numerous senior clinical development and leadership positions of increasing responsibilities in the Respiratory and Inflammation groups at Genentech and Roche respectively. Prior to transitioning from academic medicine to biotech in 2001, Dr. Deniz worked in the Division of Pediatric Allergy and Immunology at the Karolinska Institute Children’s Hospital in Stockholm, Sweden.
Dr. Deniz earned a BA in chemistry from The College of the Holy Cross and an MD from the University of Massachusetts Medical School. Following an internship and residency in Pediatrics at Long Island Jewish Medical Center, Dr. Deniz completed a clinical fellowship in Pediatric Allergy & Immunology at Duke University Medical Center.
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.
Mark Levine has more than twenty years of experience counseling companies on general corporate matters, including: strategic corporate development; complex commercial transactions; mergers, acquisitions and divestitures; licensing agreements and corporate partnerships; financings; securities law; corporate governance; and regulatory compliance. Prior to joining Flexion, Mr. Levine served as Senior Vice President, General Counsel and Corporate Secretary and a member of the executive management team of Minerva Neurosciences, Inc., a publicly traded biotechnology company. Mr. Levine has also served in senior legal positions at athenahealth, Inc., a network-based health internet technology company; Clinical Data, Inc., a biopharmaceutical company acquired by Forest Laboratories, Inc.; Wheelabrator Technologies Inc., a renewable energy company; and Xpedior Incorporated, an internet consulting company.
Mr. Levine holds a bachelor of arts degree from Binghamton University, SUNY, and a juris doctor degree from Washington University School of Law in St. Louis.
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. Magee has more than 35 years of experience as a sales professional and brings extensive experience in successfully recruiting and managing pharmaceutical sales organizations. Prior to joining Flexion, he was head of U.S. sales for the rare disease unit of Shire Pharmaceuticals, where he also served as U.S. sales director for its renal business. During his time in the rare disease unit of Shire, he helped to achieve revenue growth of more than $1 billion. Previously, he held senior sales positions at Esprit Pharma and Bayer Corporation. He has a Bachelor’s degree in biology and anthropology from Hamilton College, and completed MBA courses at the Rochester Institute of Technology.
Dr. Muzikant joins Flexion with 18 years of hands-on leadership experience in biotechnology and specialty pharmaceuticals companies, and consulting firms. Most recently, he was Vice President, Business Development at Synta Pharmaceuticals, where he led the strategic transaction process culminating in a merger with Madrigal Pharmaceuticals, and subsequently negotiated out-licensing agreements for Synta’s oncology programs. Prior to Synta, Dr. Muzikant held business development leadership positions at AMAG Pharmaceuticals, Inotek Pharmaceuticals, EPIX Pharmaceuticals, and Predix Pharmaceuticals, and also performed transaction/strategic advisory work for biotechnology and pharmaceutical clients with Locust Walk Partners. Prior to moving into business development, Dr. Muzikant led an anti-arrhythmia drug discovery program at Predix targeting ion channels. He received his PhD in biomedical engineering from Duke University, and a BS in bioengineering from the University of California, San Diego.
Ms. Scimemi has more than a decade of experience working with legal and contractual matters for publicly traded biopharmaceutical companies in both pre-approval and in commercial stages of product development. She joined Dyax in 2009 and most recently served as Vice President, Associate General Counsel & Chief Compliance Officer. Previously, she was Associate Director of Legal Affairs and Compliance for Oscient Pharmaceuticals in Waltham, MA, an associate attorney at Palmer and Dodge LLP in Boston, and a contracts administrator at the Massachusetts Institute of Technology. She earned her J.D. and Bachelors of Science degrees from Suffolk Law School in Boston.
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.
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.