Services and Capabilities Deep Dive: Substance Use Disorders Download
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DEEP DIVE A DEEPER DIVE INTO SUBSTANCE ABUSE DISORDERS AN INTEGRATED ADVANTAGE As a full-service and therapeutically-focused CRO, Medpace specializes in the design and conduct of global trials in substance use disorders 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 substance use disorder studies. • Highly relevant operational know-how and subject matter expertise in managing and executing substance use disorder studies • A well-profiled network of investigative sites enables timely enrollment and high-quality conduct of trials • End-to-end suite of global imaging services seamlessly integrated into the overall structure of the trial • A wide range of relevant biomarker assays through our wholly-owned central and bioanalytical lab network 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 from a team of therapeutic experts throughout the trial design and execution. Our highly experienced team of medical, regulatory, and operational experts work collaboratively to conduct clinical trials. We understand issues from the perspectives of Sponsors, clinical investigators, scientific leaders, and reviewers at regulatory agencies. With this insight, we successfully define and execute clear development plans from beginning to end. NEUROSCIENCE 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/neurologic neurology, plus more than 10 years of drug drug development experience to each study. Our development experience. medical leaders provide strategic direction for study design and planning, train operational staff, work Experience Summary with 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 NEUROSCIENCE 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 NEUROSCIENCE 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 University of 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 NEUROSCIENCE Page 4 of 6 EXPERIENCE Medpace Bioanalytical Laboratories has significant experience with small molecules, biologics, and biomarkers across a wide variety of technologies and Medpace has an in-house psychiatrist, neurologists, therapeutic areas including substance use disorders. imaging specialists, and operational teams with relevant We also have the capability to work with Sponsors to and recent experience in managing and executing create new assays and biomarkers to investigate novel substance use disorder studies. In addition, we have endpoints. experience overcoming the challenges associated Below are key biomarkers used in drugs of abuse. with regulations regarding controlled scheduled drugs –including getting sites up and running from a MEDPACE MEDPACE LAB regulatory perspective. TYPE BIOMARKER VALIDATED PARTNER ASSAYS NETWORK Our physicians and staff are experienced in the 6-ACETYLMORPHONE following areas: AMPHETAMINE AND • Opioid/narcotics METHAMPHETAMINE • Methamphetamines/cocaine BARBITURATES • Alcohol • Nicotine BENZODIAZEPINE RECRUITMENT AND SITE RELATIONSHIPS BUPRENORPHONE COCAINE Recruiting patients for substance use disorders can be challenging because patients need to be willing to COTININE get help for their addiction. Retaining patients is also difficult because high-dropout rates are associated