IMMUNOLOGY IMMUNOLOGY PRA Health Sciences’ signiﬁcant experience in the clinical development of autoimmune drugs affords us a thorough understanding of the treatment communities and patient populations of many key immunology disorders. We have experience across more than 14 indications and have participated in the successful market approval of 4 immunology drugs. EXPERIENCE EXPERTISE N o. OF A PP ROVE D DRU GS 4 100 2,500+ 19,200+ More than one-third of our medical staff have have experience in supporting trials that involved immunology indications. Additionally, more than half of our key clinical development directors are experienced in the planning and conduct of clinical trials for immunology related diseases. 38 50 51 54 N o . OF CLINICAL STUDIES * N o . O F CLI NI CA L SI TE S* N o . O F CL INIC A L PATIE NTS * * O VER TH E PA S T 5 YEA R S OUR IMMUNOLOGY EXPERTS MAKE THE COMPLEX, SIMPLE. MEDICAL DIRECTORS CRAs =10% CLINICAL TEAM MANAGERS WITH IMMUNOLOGY EXPERIENCE I N N O VAT I O N Autoimmune disorders affect an estimated 23.5 million Americans. That’s more than the number afﬂicted with cancer (9 million) or heart disease (22 million). With the prevalence rising, patients, now more than ever, need innovative solutions to safely advance better treatments to market. While there are more than 80-100 autoimmune diseases, PRA has substantial experience in many of the more common indications. MORE THAN 21M 3.6 M WORLDWIDE RHEUMATOID ARTHRITIS WORLDWIDE INFLAMMATORY BOWEL DISEASE 125M 5M WORLDWIDE PSORIASIS WORLDWIDE Working on a novel RA compound, PRA leveraged our investigator relationships and attained FPI by the sponsor’s target date – something the sponsor had never achieved with this drug before. LUPUS (including Crohn’s and ulcerative colitis) Lupus Central Review Services In 2008, PRA established the Central Review Services unit to provide design and operational expertise as well as physician–led review and grading of SLE efﬁcacy indices for our clients. SLE studies utilize a unique set of complex efﬁcacy endpoints that require a strong understanding of the operational implications of the data on clinical trial results. PRA has developed an innovative training program for our internal study staff, investigators, and CRAs on the use and accurate application of SLE indices and tools being used in each unique clinical trial. “As incidence rates of autoimmune disease continue to rise globally, PRA is committed to partnering with our clients to understand and cure these debilitating illnesses.” MICHAEL KIRCHENGAST, PHD Sr. Vice President, Scientiﬁc Affairs PROJECT DIRECTORS AND MANAGERS To date, PRA has supported over 19 global SLE clinical studies, enrolled over 3,000 subjects, and accurately graded over 150,000+ assessments. PRA's global investigator network provides preferred access to established investigative sites that accrue patients and deliver high-quality clinical trial data. We never forget that every global immunology study is executed locally. With global ofﬁces providing service in 80+ countries, our team harnesses practical knowledge of local regulations, standards of care, and cultural customs to maximize safety and efﬁciency for your immunology trials. The challenge of discovering safe, meaningful treatments for autoimmune diseases seems daunting. Their prevalence continues to rise, inflicting millions of people each year. Moreover, many immunosuppressant treatments often lead to devastating long-term side effects. But while some may turn away from this research challenge, we press forward, convinced that innovation and tireless commitment will lead to better outcomes and industry-changing discoveries. To improve the drug development process for autoimmune research, we employ highly dedicated and passionate people and deliver unmatched scientific expertise. More than that,we share the commitment to achieving life-changing drug discoveries with patients and clients, because it motivates and inspires them to bravely face the struggles of tomorrow. By getting better medicines for autoimmune diseases to market sooner, we can make a difference in the quality of life for countless patients worldwide. PRA PRA Health Health Sciences Sciences conducts conducts comprehensive comprehensive Phase phase I-IV I-IV biopharmaceutical biopharmaceutical drug drug development. development. To To learn learn more more about about our our solutions, solutions, please please visit visit us us at at prahs.com prahs.com or or email email us us at at [email protected]. [email protected].