THE POWER OFxTM Experts. Experience. Execution. Medpace Neuroscience Expertise As a best-in-class strategic partner for sponsors in neuroscience drug and device development, Medpace utilizes key industry leaders, who have a deep knowledge of neurologic and psychiatric development best practices. Their knowledge of complex study design based on therapeutic depth, project management, regulatory issues, as well as noted relationships with key investigative sites, assure your projects are completed on time and on budget. With comprehensive capabilities, Medpace provides full-service programs and also selected startup, back-end, and regulatory services for these programs. Due to prior experience with a variety of neurologic indications, from multiple sclerosis to stroke, Medpace has developed relationships with neurologists in a wide variety of neurologic indications. Recent Expertise in Neurologic Disorders: Neuropathic pain Alzheimer s Disease Diabetic Neuropathy Migraines Parkinson s Disease Stroke Multiple Sclerosis Sleep-Wake disorder Psychiatric disorders This experience is a direct result of well-established Sponsor relationships, exceptional clinical operations, and committed study teams. Medpace has built a dedicated team, including board certified MDs in Neurology and Psychiatry, and PhD Neuroscience specialists, within dedicated project management groups. All team members are involved from project initiation to completion, producing truly seamless drug development.
Page 2 of 6 Therapeutic Expertise: Samer E. Kaba, MD, Vice President, Neuroscience With a wealth of experience in pharmaceutical product development, Dr. Kaba is responsible for formulating the overall regulatory and clinical development strategy, and providing strategic consulting on study design and execution, and managing the life cycle of products. Prior to joining Medpace, Dr. Kaba was the VP of Clinical Development and Chief Medical Officer at Camargo Pharmaceutical Services, and before that, VP of Medical Affairs and Strategic Product Development at Premier Research. Dr. Kaba is a board certified neurologist with additional training in neuro-immunology (MS) and neurooncology from the State University of New York (SUNY) at Buffalo and UT MD Anderson Cancer Center. Dr. Kaba has a large experience in neurology, psychiatry, and analgesia drug development, and regulatory interactions. In addition to his expertise in drug development, Dr. Kaba has over 20 years experience in neurology and oncology clinical care and clinical research in academic and private practice settings. Before joining the pharmaceutical industry, Dr. Kaba held multiple academic positions at the University of Texas MD Anderson Cancer center, The University of Arkansas for Medical Sciences, and the Shepherd MS Center. He continues to hold an adjunct faculty position in the department of neurology at Emory University. Dr. Kaba is well published on topics relating to multiple sclerosis and neuro-oncology. Dr. Kaba, as an industry opinion leader has wide expertise in multiple therapeutic areas: Multiple sclerosis Fellowship training in neuro-immunology - Multiple Sclerosis, and a focus on MS care in clinical practice for many years, resulting in an extensive experience in MS therapeutics. Direct involvement in the clinical development and/or life cycle management of several multiple sclerosis products including interferon beta 1b, Interferon beta 1a, glatiramer acetate, alemtuzumab, fampridine, daclizumab, and BHT-009, among others Analgesia experience Direct involvement in the clinical development of multiple analgesic products including combination products and abuse deterrent formulations of opioids (Embeda and Acrox, Vimovo ). Direct involvement in the developing the regulatory strategy, regulatory interaction, and preparation of NDAs of analgesia products for acute and chronic pain indications. Direct involvement in multiple products for neuropathic pain, diabetic neuropathy, and postherpetic neuralgia. Provided consulting in support of the early development of multiple analgesia products. Antiepileptics Direct involvement in the development of multiple antiepileptics including currently approved products (Topamax, Vmpat, Onfi ). Direct involvement in multiple NDAs for epilepsy indications, including submission strategy, regulatory agencies interaction, and drafting and reviewing NDA sections.
Page 3 of 6 Neurodegenerative diseases Represented Medpace on the Private Partners Scientific Board (PPSB) of ADNI Direct involvement in the development of multiple products for Alzheimer s disease, Parkinson s disease Associated Dementia, and brain imaging in Mild Cognitive Impairment. Stroke Direct involvement in numerous programs of stroke therapeutics, including acute stroke, neuroprotection agents, improving stroke functional outcome, and cell therapies for stroke. Cheri Lindberg, MD, Medical Director, Psychiatry Dr. Lindberg is a board certified psychiatrist based in Medpace s Cincinnati, Ohio office. Prior to joining Medpace, Dr. Lindberg served as medical reviewer at the U.S. Food and Drug Administration Center for Drug Evaluation and Research, Division of Psychiatry Products. Dr. Lindberg holds a Certificate in Public Health from Georgetown University in Washington, D.C. and completed all doctoral coursework toward a Ph.D. in Experimental and Clinical Pathology at Louisiana State University in New Orleans. Dr. Lindberg held an academic appointment as Assistant Professor of Psychiatry at Marshall University School of Medicine in Huntington, West Virginia. Dr. Lindberg has more than ten years of experience in clinical psychiatry providing psychiatric care in both the community mental health setting and private practice. She is a Fellow of the American Psychiatric Association and an active member of the American Medical Association. As a medical officer in the FDA Division of Psychiatry Products, Dr. Lindberg provided reviews and recommendations for clinical investigations and development programs related to the following indications: Major Depressive Disorder Novel mechanisms of action related to the treatment of MDD New molecular entity NDA Supplemental NDA reviews for new indications related to currently approved antidepressant medications Schizophrenia Novel compounds indicated for the cognitive impairment associated with Schizophrenia Autistic Disorder and Fragile X Syndrome Novel compounds intended to treat behavioral symptoms of associated with autistic disorder and Fragile X Syndrome Post Traumatic Stress Disorder Novel compounds intended to treat PTSD Attention Deficit Hyperactivity Disorder Clinical review of stimulant and non-stimulant medications for the treatment of ADHD in children, adolescents, and adults
Page 4 of 6 Dr. Lindberg also participated in FDA/Industry meetings (pre-ind, pre-nda, End of Phase I/II, Clinical Hold) and pre- and post-approval labeling negotiation meetings. She consulted with the Office of Prescription Drug Promotion (formerly DDMAC) regarding professional promotion and direct to consumer promotion of mood stabilizers, non-stimulant medication for the treatment of ADHD, and antidepressants. She was the Division representative to the Office of Scientific Investigation (OSI) to initiate the Risk Based Site Selection Tool. The clinical experience and regulatory knowledge Dr. Lindberg has gained is instrumental in her leadership of clinical trials in psychiatry. Medpace Clinical Leaders are well versed in conducting studies in Neuroscience Medpace is known for industry excellence hiring industry professionals with deep therapeutic experience. Thirty percent of Medpace clinical experts have deep experience in the following areas, having worked for some of the largest pharmaceutical companies, and CROs in the industry. Alzheimer s Disease Anxiety Attention Deficit Hyperactivity Disorder (ADHD) Insomnia - Sleep Disorders Amyotrophic Lateral Sclerosis (ALS) Migraine Mood Disorder Multiple Sclerosis (MS) Parkinson s Disease Post-Traumatic Stress Disorder Schizophrenia Seizure Disorder Stroke Traumatic Brain Injury Recent Medpace Neuroscience Experience Medpace distinguishes itself from other CROs by the medical knowledge and direct support that is brought to each study. Medpace has developed a strong neuroscience program and has continued to recruit key staff with significant neuroscience experience. This dedication results in higher success rates, better efficiencies, and lower costs in the long run. Medpace has been involved with multiple studies in the neuroscience area. With comprehensive capabilities, we have provided full-service programs and also selected start-up, back-end, and regulatory services for these programs. Due to our prior experience with a variety of neurologic indications, from multiple sclerosis to stroke, Medpace has developed relationships with neurologists in a wide variety of neurologic indications.
Page 5 of 6 Full Service Core Imaging: Medpace Imaging Core Lab Medpace Imaging Core Lab, a wholly owned subsidiary of Medpace, Inc., provides global imaging services to enhance and expedite bio-pharmaceutical and bio-device development. The Medpace Imaging teams bring a robust combination of imaging expertise and clinical trial experience to ensure that imaging components are seamlessly integrated into the complex structure of the overall clinical trial. Medpace Imaging uses state-of-the-art validated technologies that meet 21 CFR Part 11 criteria and adhere to all US and international regulatory requirements. Utilizing standard training and processes to conduct clinical trials with an imaging component, images are read by board certified subspecialitytrained physicians experienced in clinical trials from world renown tertiary medical centers using identical hardware and software and following identical standard operating procedures (SOP). Medpace Customized Reader Networks The majority of Medpace Imaging Core Lab readers are at major teaching hospitals in Boston. The large Boston medical centers have worked on numerous pharma and device-sponsored studies for many years and have integrated these activities into their daily work-flow to provide timely, expert readings. In addition to readers, the majority of our imaging trial medical experts are drawn from these institutions. The Medical Director of Medpace Imaging Core Lab, Dr. Daniel H. O Leary, did his Radiology and Neurology training at the Massachusetts General Hospital, was Director of Neuroradiology at the Brigham and Women s Hospital, and was Chairman of Radiology at Tufts Medical Center. Dr. O Leary is both well-respected and connected in the Boston imaging community. Our services include central reading of images, a network of imaging sites, access to our medical experts, and a coordinated data management system. Led by a team of imaging specialists with extensive clinical trial experience in the disciplined management of imaging services, Medpace Imaging Core Lab is headquartered in Cincinnati, Ohio, with regional offices in Rotterdam and Beijing. Full-Service CRO: The Medpace Advantage: Therapeutically focused expertise Medpace is a best-in-class strategic partner for late phase drug and device development programs. Staffed with the industry s most therapeutically focused leaders, Medpace s late phase clinical operations teams have expertise in development and trial design best practices, dedicated submissions team to accelerate startup, and noted relationships with key investigative sites, to assure the highest level of quality for outcomes research. Solid Site Relationships Medpace consistently delivers results. Medpace was recently named the top CRO by investigative sites, winning the Site Solutions Eagle Award two years running. The Eagle Award recognizes outstanding leadership, professionalism, integrity, passion and dedication to advancing the clinical research profession through strong site partnerships.
Page 6 of 6 Integrated Project Teams Medpace project teams including CTMs, CRAs, data managers, statisticians, safety managers, medical writers, and regulatory managers, specialize in conducting biopharmaceutical and medical device trials. All team members are involved from project initiation to completion, producing truly seamless drug development. Regulatory Know-How Led by industry experts, Medpace s regulatory staff can navigate your development program from IND to NDA. With central offices in Cincinnati, US and Munich, Germany, and staff throughout the world, our regulatory experts know the global climate and have built solid relationships with regulatory authorities worldwide to obtain appropriate licenses and approvals. Real-time System Support Fully integrated real-time information is supported with Clintrak, Medpace s proprietary web-based decision support system. Clintrak has the capabilities to serve IVRS, study drug management, data management, laboratory management, and image management needs for all studies. Who We Are Medpace is a full-service global CRO led by medical, regulatory, and operational experts with deep therapeutic experience. Our disciplined processes, site relationships, and technologies enable us to execute even the most complex global studies. Medpace also offers integrated imaging, central and bioanalytical lab capabilities, and clinical pharmacology through wholly-owned business units to provide cohesive, streamlined, and standardized trial management. For more information visit the Medpace website at: www.. FOCUSED. TRUSTED. GLOBAL. info@ North America Europe Latin America Asia Africa Middle East Australia