DEEP DIVE
A DEEPER DIVE INTO PSYCHIATRY
AN INTEGRATED ADVANTAGE As a full-service and therapeutically-focused CRO, Medpace specializes in the design and conduct of global trials in neuroscience clinical research, including psychiatry. We bring a global footprint, strategic medical, regulatory, and operational leadership as well as fully integrated Central Labs and Core Imaging services to accelerate psychiatric studies. • Highly relevant operational know-how and subject matter expertise in psychiatry and neurology drug development • A well-profiled network of investigative sites enables timely enrollment and high-quality conduct of trials • A team of Clinical Research Associates and Clinical Trial Managers experienced in psychiatric research • Integrated imaging and central laboratory services, ensuring seamless logistics, review, and testing THERAPEUTICALLY-FOCUSED TEAM Medpace is unique in its scientifically-driven approach to clinical research. Our model gives Sponsors the advantage of early and ongoing insight and guidance Accelerate your psychiatric studies from a team of therapeutic experts throughout the with Medpace’s full-service team trial design and execution. Our highly experienced of medical and regulatory experts, team of medical, regulatory, and operational experts highly-experienced clinical trial work collaboratively to conduct clinical trials. We understand issues from the perspectives of management teams, central labs, Sponsors, clinical investigators, scientific leaders, and and core imaging labs. reviewers at regulatory agencies. With this insight, we successfully define and execute clear development plans from beginning to end.
NEUROLOGY AND PSYCHIATRY Page 1 of 6 EXPERTS Sarah DeRossett, MD, PhD Senior Medical Director, Medical Department, Neurology, Psychopharmacology, Analgesia
EXPERT INSIGHT Dr. Sarah DeRossett is a board-certified neurologist Serving as therapeutic team leaders, our in-house with 15 years of experience in clinical and academic medical doctors apply years of psychiatric drug neurology, plus more than 10 years of drug development experience to each study. Our medical development experience. leaders provide strategic direction for study design and planning, train operational staff, work with Experience Summary Investigators, provide medical monitoring, and • Drug development expertise in neuropsychiatric meet with regulatory agencies as well as our global disorders, dementia, opioid use disorder, sleep, regulatory affairs experts to provide strategic guidance and other CNS disorders into the best pathways to accelerate approvals. • Clinical and drug development experience in Medpace MDs are embedded throughout every study, pain and analgesia providing greater depth of expertise and the ability to • Extensive research experience in tackle complex and challenging diseases. psychopharmacology with special focus on opioids • Leadership of clinical development programs in Parkinson’s disease, Alzheimer’s disease, Migraine, Restless Leg Syndrome (RLS), Neuropathic pain, Epilepsy, and Opioid Use Disorder • Broad experience in pharmaceutical R&D, Sarah DeRossett, MD, PhD Toshihiro Hokonohara, MD Richard D. Scheyer, MD Senior Medical Director, Medical Director, Vice President, including single point of accountability for Medical Department Medical Department Medical Department clinical development plans, medical governance, and support of regulatory submissions • Well-published in the peer-reviewed medical and scientific literature
Education Summary • Doctor of Medicine, cum laude, Emory Thomas R. Thompson, MD James Vornov, MD, PhD Vice President, Vice President, University School of Medicine Medical Department Medical Department • Postdoctoral Fellowship, Pharmacology, Emory University School of Medicine • Residency in Neurology, The Johns Hopkins Hospital
NEUROLOGY AND PSYCHIATRY Page 2 of 6 Toshihiro Hokonohara, MD Thomas R. Thompson, MD Medical Director, Medical Department, Vice President, Medical Department, Neurology, Psychiatry Neurology, Psychiatry
Dr. Toshihiro Hokonohara is a board-certified Dr. Thompson is board certified in both Psychiatry and neurologist with over 15 years of clinical practice and Geriatric Psychiatry and has over 20 years of phases academic neurology including experience in leadership I-IV clinical development experience. roles at pharmaceutical and global contract research organizations. Experience Summary • Experience in numerous indications including Experience Summary major depression, substance use disorders, • Drug development expertise in neuropsychiatric bipolar disorders, schizophrenia, anxiety disorders, dementia, autoimmune disease, disorders, Parkinson's disease, dementia, oncology and other CNS and Internal Medicine epilepsy, headache and pain disease • Industry leadership roles with responsibility • Clinical and drug development experience in for clinical development plans, medical affairs, neuro-immunological disease regulatory submissions, medical governance, • Extensive research experience in some and medical monitoring neurological hereditary disease • Leadership and single point of accountability • Pharmacovigilance Leader of clinical for numerous programs as a previous Director development programs in Epilepsy of Neurosciences and Clinical Development for • Broad experience in pharmacovigilance medical 12 years at a large pharmaceutical company governance and support of regulatory • Well-published in the peer-reviewed medical submissions and scientific literature
Education Summary Education Summary • Doctor of Medicine, Kyushu University – • Bachelor of Science, Biology, University of Fukuoka, Japan Central Florida • Residency in Neurology, Kyushu University • Doctor of Medicine, Temple University, School Hospital – Fukuoka, Japan of Medicine • Diplomate, American Board of Neurology and Psychiatry • Residency in Psychiatry, Emory University School of Medicine • Fellowship in Geriatric, Emory University School of Medicine
NEUROLOGY AND PSYCHIATRY Page 3 of 6 Richard D. Scheyer, MD James Vornov, MD, PhD Vice President, Medical Department, Vice President, Medical Department, Neurology, Pharmacology Neurology, Analgesia, Psychiatry
Dr. Richard Scheyer is a board-certified neurologist Dr. James Vornov is a board-certified neurologist with with over 30 years of professional medical experience over 18 years of director level clinical development which includes 18 years dedicated to clinical experience. drug development. Experience Summary Experience Summary • Brought multiple compounds into first-in- • Pioneer in translational medicine and Phase I/IIa man to proof-of-concept and successful drug development with special interest in early NDA submission. Provided broad clinical trial demonstration of clinical efficacy design expertise, clinical pharmacology • Led a team that designed and executed an early experience, operational excellence and global development program for next-generation regulatory strategy development across a alpha-2 delta ligand, including capsaicin broad range of CNS diagnostics and challenge, and crafting Proof of Concept therapeutics strategy for novel ion channel blockers • Expertise in the rapid transition of compounds • Highly-regarded author with over 60 from the laboratory to clinical proof of concept manuscripts and abstracts, with a focus on using Critical Path technologies such as clinical pharmacology and therapeutic activity in biomarkers, PK/PD modeling and clinical trial areas ranging from diabetes to oncology simulation • Launched first controlled trial natural product- • Worked in multiple CNS therapeutic areas derived protein kinase C activator in Alzheimer’s having directed programs in Depression, at previous company Suicidal Ideation, Parkinson’s disease treatment and diagnosis, stroke, neuropathic Education Summary pain, diabetic and chemotherapy-induced • Bachelor of Science, Physics, Stanford University peripheral neuropathies, anesthesia and • Doctor of Medicine, The State Universityof New York, Upstate Medical University brain tumors • Residency in Neurology, Yale University Education Summary • Fellowship Training in Epilepsy, Yale University • Bachelor of Arts, Biology & Psychology, Columbia University • Doctor of Medicine, Emory University, School of Medicine • Doctor of Philosophy, Anatomy, Emory University, School of Medicine
NEUROLOGY AND PSYCHIATRY Page 4 of 6 EXPERIENCE
Developing effective treatments for psychiatric disorders such as depression, bipolar disorder, anxiety disorders, and schizophrenia requires unique expertise. Medpace medical, regulatory, and operational experts bring a broad range of experience in designing and conducting psychiatric studies for psychiatric clinical development across adult, geriatric, and pediatric populations.
Indication expertise: • Addictive Disorders • Anxiety Disorders • Attention-Deficit/Hyperactivity Disorder • Bipolar Disorder • Cognition Disorders • Depression • Developmental Disorders • Eating Disorders • Schizophrenia • Sleep Disorders • Neuropsychiatric Disorders RECRUITMENT AND SITE RELATIONSHIPS With broad neuroscience experience and relationships with Investigators and Key Opinion Leaders (KOLs) worldwide, we can select the best sites for your specific program. We provide in-depth knowledge of screening tools and rating scales and will provide oversight for rater services including subjective assessments, inter- rater reliability, and scale validation.
SPECIALIZED MEDICAL DEVICE EXPERTISE There is a growing number of neurologic and psychiatric devices and diagnostics in various stages of research and development. With a dedicated Medical Device division, Medpace brings together medical and regulatory experts into a collaborative team that understands the nuances from both the drug and device perspectives. Medpace is experienced in helping clients meet regulatory compliance and ensuring patient safety while accelerating their medical device or product to market.
NEUROLOGY AND PSYCHIATRY Page 5 of 6 EXECUTION SPECIALIZED NEURO-IMAGING High-quality image acquisition and interpretation is crucial for the success of trials relying on neuroimaging CENTRAL LABS for patient selection or as a primary or secondary Medpace Central Labs provide consistency in methods endpoint. Medpace Imaging Core Lab provides an and instrumentation across four wholly-owned and end to-end suite of imaging services to enhance and purpose-built laboratories located in the US, Europe, expedite biopharmaceutical and imaging contrast China, and Singapore. We provide safety and efficacy agent development, including consultation on imaging testing to support psychiatric trials. Central labs biomarker strategies, image acquisition protocols, offer a wide range of relevant biomarker assays and image collection/archiving services, and image analysis can rapidly establish and validate novel assays as across imaging modalities. needed. Over the past several years, Medpace has validated hundreds of new biomarker assays based on FULL-SERVICE CLINICAL DEVELOPMENT guidelines from the Clinical and Laboratory Standards Medpace is a scientifically-driven, global, full- Institute (CLSI) and in accordance with CAP and CLIA service clinical contract research organization (CRO) regulations. With hundreds of thousands of patients providing Phase I-IV clinical development services screened, Medpace central labs has supported some to the biotechnology, pharmaceutical and medical of the world’s largest and most complex clinical trials. 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.
ClinTrak®, Medpace’s proprietary study management platform, facilitates team coordination and decision support for Sponsors and sites, and ensures global teams can collaborate and maximize efficiency. It supports eDiary/ ePROs, an increasingly important requirement for psychiatric studies while providing real-time global tracking and tracing of specimens.
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