THE POWER OFx SUBSTANCE USE DISORDERS Experts. Experience. Execution. Deep Dive: Substance Use Disorder Clinical Research Accelerate your next substance use disorder study with Medpace s noted medical and regulatory experts, highly experienced clinical trial management teams, central labs, and core imaging labs. As a therapeutically-focused CRO, Medpace specializes in the design and conduct of global trials in psychiatry, including substance use disorders. We bring a global footprint, strategic medical, regulatory and operational leadership as well as fully integrated Central Labs and Core Imaging Services to enhance and expedite development. Highly relevant operational know-how and subject matter expertise in managing and executing substance use disorder studies OUR INTEGRATED APPROACH End-to-end suite of global imaging services seamlessly integrated into the overall structure of the trial Experience Core Imaging A well-profiled network of experienced sites conducting substance use disorder studies enabling timely enrollment and high-quality conduct of trials. Recruitment & Site Relationships Global Labs A wide range of relevant biomarker assays through our wholly-owned central & bioanalytical lab network
Page 2 of 6 Experience Medpace has an in-house psychiatrist, neurologists, imaging specialists, and operational teams with relevant and recent experience in managing and executing substance use disorder studies. In addition, we have experience overcoming the challenges associated with regulations regarding controlled scheduled drugs including getting sites up and running from a regulatory perspective. Our physicians and staff are experienced in the following areas: Opioid/narcotics Methamphetamines/cocaine Alcohol Nicotine Recruitment and Global Site Relationships Recruiting patients for substance use disorders can be challenging because patients need to be willing to get help for their addiction. Retaining patients is also difficult because high-dropout rates are associated with this patient population. Medpace is able to navigate the complex world of patient recruitment and retention by employing our multi-dimensional recruitment model that enables us to implement customized strategies that identify, recruit, and retain members of specific patient populations. Medpace has also established a productive network of key clinical sites and KOLs who specialize in substance use disorders ensuring study timelines and key milestones are achieved. Our physicians and professional staff have in-depth knowledge of screening tools and rater scales and will provide oversight for rater services including subjective assessments, inter-rater reliability, and scale validation. Scientifically-Driven Clinical Research Medpace is unique in its approach to clinical research. The Medpace model gives you the advantage of early and ongoing insight and guidance from therapeutic experts throughout trial design and execution. Our highly experienced medical doctors provide strategic direction for study design and planning, train operational staff, work with Investigators, provide medical monitoring, and meet with regulatory agencies. In addition, our medical monitors work collaboratively with our global regulatory affairs experts to provide strategic guidance into the best pathways to accelerate approval.
Page 3 of 6 Meet our Experts Thomas Thompson, MD Vice President, Medical Affairs, Psychiatry, Neurology Sarah DeRossett, MD, PhD Senior Medical Director, Neurology Michael Oldham, MD, MPH Medical Director, Neuroscience Richard Scheyer, MD Vice President, Medical Affairs, Neurology, Pharmacology James Vornov, MD, PhD Vice President, Medical Affairs, Neurology, Analgesia, Psychiatry Psychiatry Thomas Thompson, MD Vice President, Medical Affairs, Psychiatry, Neurology Dr. Thompson has over 18 years of clinical, academic, and drug development experience in Psychiatry and Neurology across Phases I-IV. He is board certified in Psychiatry and Geriatric Psychiatry and is a distinguished fellow of the APA with clinical development experience in numerous indications, including substance use disorders. Dr. Thompson has led clinical studies in opioid use disorders as well as developing and writing substance use disorder protocols and clinical development plans. Dr. Thompson has worked closely with addictionologists and addiction treatment sites and is experienced in the nuances related to recruiting and conducting substance use disorder studies. He also has clinical experience treating a wide variety of substance use disorders including benzodiazepines, alcohol, cocaine, opioids, amphetamines, and nicotine. Neurology Sarah DeRossett, MD, PhD Senior Medical Director, Neurology Dr. DeRossett has a long-standing involvement in opioid analgesia and substance use disorder, complemented by extensive related drug-development experience. She completed a post-doctoral fellowship in opioid pharmacology, including studies of the discriminative stimulus properties of the partial agonist buprenorphine, now a cornerstone of treatment for opioid use disorder. Prior to joining Medpace, Dr. DeRossett served as VP of Clinical Research and Medical Affairs at a specialty pharmaceutical company with a focus in pain and addiction.
Page 4 of 6 Meet our Experts Michael Oldham, MD, MPH Medical Director, Neuroscience Dr. Michael Oldham is a board-certified neurologist, with Special Qualification in Child Neurology and Epilepsy. He has many years of clinical and research experience in Neurology, holding positions in both Academia and Industry and supporting clinical development in a wide range of neurologic diseases, including epilepsy, movement, neurodegenerative, neurometabolic, and neuromuscular. Prior to joining Medpace, he was the Senior Medical Director for a specialty pharmaceutical company in Louisville, Kentucky, overseeing several compounds for various indications: a subcutaneous injection for the treatment of off episodes in Parkinson s disease; a currently-marketed botulinum toxin used for cervical dystonia and pain and for the development program of use of this toxin for treatment of sialorrhea (pediatric and adult); and the pediatric development program for a compound to treat opioid withdrawal symptoms. He served as Assistant Professor and Director of Neonatal Neurology in the Division of Child Neurology at the University of Louisville where he established the multidisciplinary neonatal neurology program, was involved in several industry-sponsored clinical trials, and focused his clinical efforts on the treatment of children with various disorders such as epilepsy, neuromuscular disorders, and rare genetic diseases. He has won numerous awards for his work in neurology and has been published in various peer-reviewed journals. Richard Scheyer, MD Vice President, Medical Affairs, Neurology, Pharmacology Dr. Richard Scheyer has extensive experience managing alcohol use and withdrawal. He has led programs using PET imaging to assess binding to dopamine and other receptors, supported programs for cocaine abuse and opiate abuse, and served as ethics committee reviewer overseeing a substance abuse research center. James Vornov, MD, PhD Vice President, Medical Affairs, Neurology, Analgesia, Psychiatry Dr. Vornov has previous experience in the development of drug abuse treatments based on glutamate and kappa opiate receptor antagonists. Clinically, he was responsible for recruitment strategy and operational supervision of a large study of currently marketed buprenorphine-based therapy.
Page 5 of 6 Medpace Global Labs Provide Safety and Biomarker Analysis Medpace Labs provide consistency in methods and instrumentation across wholly-owned and purpose built laboratories located in the US, Europe, China and Singapore. Medpace s frontline testing for drugs of abuse is immunoassay based screening tests that identify drugs of abuse by class. The central lab performs 14 common drugs of abuse screening tests on the Beckman Coulter chemistry analyzer. If there are requirements (e.g. determination of specific metabolite, possible cross-reactivity) they are followed by confirmatory testing (typically GC/MS or LC/MS) which Medpace offers through our partner lab network. Medpace Bioanalytical Laboratories has significant experience with small molecules, biologics, and biomarkers across a wide variety of technologies and therapeutic areas including substance use disorders. We also have the capability to work with Sponsors to create new assays and biomarkers to investigate novel endpoints. Below are key biomarkers used in drugs of abuse: Type Biomarker Medpace Validated Assays Medpace Lab Partner Network Drugs of abuse Confirmation tests medpace.com
Page 6 of 6 Core Imaging Expertise for Substance Use Studies Neuroimaging plays a crucial role in determining how substance use disorders affect changes in brain structure, function, and neurochemistry. Medpace Imaging Core Lab has experience in the primary imaging techniques that are used to reveal different structures of the brain. The primary techniques are: Structural Magnetic Resonance Imaging (MRI) Functional MRI Magnetic Resonance Spectroscopy (MRS) Positron Emission Tomography Single Photon Emission Computed Tomography (SPECT) Cardiovascular Core Lab The potential cardiac side effects of drugs in development and the long-term cardiovascular effects of substance abuse are quantified in the identification of the cardiovascular status of the patient at baseline right through the treatment phases of the clinical development program. State of the art surface ECG and Holter monitoring for potential arrhythmia assessment as well as changes in blood pressure through the use of centralized ambulatory blood pressure monitoring are utilized by the Medpace Cardiovascular Core Laboratory team consisting of board certified cardiologists and highly trained and experienced electrocardiographic analysts, biostatisticians, pharmacometricians, data mangers and medical writers. A Full-Service Approach to Clinical Research Driven by a full-service CRO model that coordinates and integrates all services for our clients, Medpace provides an accountable, seamless, integrated and efficient platform for executing clinical research increasing quality and speed while significantly reducing the need for duplicate management oversight. Our disciplined processes, site relationships, and technologies enable us to execute even the most complex global studies, from first-in-human through post-approval. Medical Affairs Regulatory Affairs and Medical Writing Clinical Monitoring Clinical Trial Management Biometrics and Data Sciences Safety and Pharmacovigilance Quality Assurance Global Labs, Imaging & Cardiovascular Core Labs medpace.com info@medpace.com North America Latin America Europe Asia Pacific Middle East Africa