THE POWER OFx MEDPACE ADVANTAGE FOR LIPID STUDIES Experts. Experience. Execution. Medpace, a pioneer in the development of therapeutics to treat metabolic disorders, is your first stop for compound development in lipid studies. Medpace full service specialty teams have conducted over 150 lipid studies over the past 20 years. Medpace noted medical experts, highly experienced clinical trial management teams, central labs, imaging and cardiovascular core labs can bring sponsors one stop solutions for conducting effective and efficient lipid studies. Since its inception in 1992, the advancement of novel therapies for metabolic and endocrine disorders has been a primary therapeutic focus for Medpace. Led by an international team of medical and regulatory experts, our company has helped pioneer mainstay therapies that have revolutionized the care and quality of life for patients. This experience spans a broad array of trial designs, drug classes, and disease endpoints and includes all phases of clinical research. The Medpace team s years of experience conducting metabolic and endocrine studies is unmatched by any other Clinical Research Organization. Highlights Unsurpassed regulatory experience in chronic metabolic and endocrine disorders Operational staff with proven track record of rapid study start-up, successful recruitment and retention, high quality site monitoring and oversight, and proactive risk mitigation One of the most extensive selections of metabolic biomarkers for clinical trials via Medpace Central Laboratories (US, Europe, China and Singapore) Existing investigative site relationships with local KOLs who specialize in recruiting patients with lipid disorders
Page 2 of 5 Medpace Experience in Lipid Studies Pioneer in the development of key statins over the past 25 years including: atorvastatin (Lipitor) fluvastatin (Lescol) rosuvastatin (Crestor) simvastatin (Zocor) Over 150 lipid trials involving more than 34,000 patients at more than 2,500 sites Closely involved with the development of most of the lipid agents that have received marketing approval over the last 20 years Statins, fibrates, niacin, bile-acid sequestrants, ezetimibe, omega 3 fatty acid products, RNA targeted therapies, PCSK9, as well as numerous other experimental compounds 30 NDAs- 7 have been related to lipids Additional FH experience Conducted over 20 studies in FH 9 involving HoFH patients involving pediatric populations Provided full service for most of these studies on a global scale Collaboration with opinion leaders in the lipid field and longstanding relationships with key Investigators worldwide Specifically, Medpace has relationships with Investigators at specialized lipid sites that utilize up-to-date databases of their FH patients Ability to leverage these relationships, contributing to accurate feasibility assessments that determine whether the objectives of a particular study can be met within proposed timelines Medpace Central Labs Robust experience supporting key global lipid studies Medpace Central Laboratories delivers key support for fully integrated studies on a global stage by providing consistency in methods and instrumentation across wholly owned and purpose built laboratories around the world. Medpace Central Laboratories has provided core laboratory support to trial sites in 6 continents with truly stellar performance. Medpace Central Labs has conducted some of the largest lipid studies over the past 30 years directed by industry KOLs in Lipidology.
Page 3 of 5 Scientific Leadership Traci Turner, MD Executive Director, Central Labs and Metabolic Atherosclerosis Research Center (MARC) Dr. Traci Turner is in Internal Medicine, is a Diplomate with the American Board of Clinical Lipidology, and serves as the Executive Director of Medpace Central Laboratory Operations and the Metabolic and Atherosclerosis Research Center. A native of Cincinnati, OH, she attended the University of Cincinnati and graduated with a BS in Medical Technology, where she also earned her medical degree. Dr. Turner completed her residency at University Hospital in Cincinnati, Ohio. Prior to joining Medpace, Dr. Turner s experience includes 15 years in central laboratory operations supporting the pharmaceutical industry and 7 years in practice specializing in Internal Medicine. KOL Leadership: Evan Stein, MD, PhD, Sr. Consultant Medpace Central Labs, was originally founded by Evan Stein, MD, PhD in 1987 as Medical Research Laboratories. Dr. Stein is considered a foremost expert on the study of lipids. Dr. Stein has held a number of appointments to the NIH, including the National Cholesterol Education Program. He served on the Data and Safety Advisory Board of the NHLBI Program on Genetics in Hypertension. From 2006-2010, he was appointed to the FDA Clinical Chemistry and Clinical Toxicology Advisory Panel. Dr. Stein is an accomplished researcher in the of lipid metabolism with extensive publications in this He is an authority on the clinical treatment of hyperlipidemia, as well as on the laboratory measurements of lipid parameters. Dr. Stein consults with many pharmaceutical companies on the development programs for lipid-lowering drugs and participates in many Advisory Boards for these companies. Global Laboratory Studies in Lipidology With laboratories in the US, Europe, China and Singapore, Medpace Labs has the global reach and capabilities to conduct a wide variety of lipid studies in concert with Medpace CRO or as a standalone service. Medpace Central Laboratories has experience in conducting large Phase II-III global studies. Select Medpace Central Lab Lipid studies include: Phase Indication III Dyslipidemia 48 II Hypercholesterolemia 37 III Hyperlipidemia 26 III Hypercholesterolemia 18 II Hypercholesterolemia 10 III Hypercholesterolemia 10 # Of Countries # Sites # Randomized 1,279 189 364 199 91 132 26,737 1,290 3,666 1,901 901 722 Medpace Lab Locations BE, CN, SG, & US BE & US BE & US
Page 4 of 5 Phillippa Miranda, MD Senior Medical Director Dr. Miranda received her M.D. from Duke University School of Medicine and completed her residency in Internal Medicine and her fellowship in Endocrinology at Duke. She served on the faculty in the Division of Endocrinology at Duke University Health System for five years prior to transitioning to industry. Dr. Miranda is board certified in Endocrinology, Diabetes, and Metabolism. Her therapeutic expertise covers a wide range of metabolic indications with significant medical monitoring experience in the areas of type 2 diabetes, type 1 diabetes, obesity, and hyperlipidemia. Dr. Miranda has over nine years of experience conducting clinical research studies and is well versed in the conduct of Phase 2 and 3 studies in endocrinology. Alicia Weeks, MD Medical Director Alicia Weeks is an experienced Clinical Endocrinologist with a former academic clinical practice and translational research experience in Type 2 Diabetes. As a Medical Director at Medpace, she provides medical management and expertise to all phases of studies and clinical trials, as well as assists with new business development through participation in proposal and Sponsor meetings. Dr. Weeks gained experience from a dual appointment as a clinical instructor at the University of Wisconsin Hospital & Clinics and as a Research Fellow at the William S. Middleton Memorial Veterans Hospital after earning her medical degree from the Wright State University Boonshoft School of Medicine. Dr. Weeks completed her residency at the Kettering Medical Center and an endocrinology fellowship at the University of Wisconsin. There she was awarded the Dickie Research Award for her significant research contribution toward advancing the field of medicine. Prior to entering the field of medicine, Dr. Weeks worked in the pharmaceutical industry within validation after earning a Bachelor s of Science in Chemical Engineering (BSChE) from the University of Cincinnati. Dr. Weeks is board certified in both Internal Medicine and Endocrinology.
Page 5 of 5 Gretchen Williamson, MD, FAAP Medical Director Dr. Williamson completed residency training at Penn State Hershey Medical Center and has post-graduate experience in pediatric endocrinology from Cincinnati Children s Hospital. She has clinical research experience in diabetes, hypercholesterolemia, hypertriglyceridemia, and multiple orphan indications (including familial chylomicronemia). She also has protocol development experience for numerous therapeutic areas, including rheumatoid arthritis, hypogonadism, pancreatic insufficiency, growth hormone deficiency, and stem cell therapies. About Medpace Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,500 people across 35 countries. FOCUSED. TRUSTED. GLOBAL. medpace.com info@medpace.com North America Europe Latin America Asia Africa Middle East Australia