Dr. Michael Ropacki is the Chief Medical Officer (CMO) CNS Clinical Development and US Site Head for Oryzon Genomics, a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need. In addition, he serves as the Founder and President of Strategic Global Research and Development (SGR&D) originally based out of San Francisco, that collaborates with sponsors developing and executing Clinical Development Plans to maximize meaningful and productive regulatory interactions, as well as increase probability of technical and regulatory success. Through SGR&D, Dr. Ropacki serves various boards and committees including Scientific Advisory (SABs) and Data Safety Monitoring Boards/Data Monitoring Committees (DSMBs/DMCs), provides guidance on implementation of digital Drug Development Tools (dDDTs: eConsent, biometric wearables, digital biomarkers), patient recruitment and retention, as well as data review and scientific advice.
He was previously Senior Vice President of Psychiatry Clinical Development at MedAvante-ProPhase. Prior to that, he held roles of increasing responsibility at Johnson & Johnson (NYSE: JNJ), his last as Director, Clinical Research Neuroscience, Research and Development, for Janssen Research & Development where he was responsible for leading the Cognitive Health in Aging Registry: Investigational, Observational and Trial studies in dementia research – Prospective Readiness Cohort (CHARIOT-PRO) program. Prior to that role, Dr. Ropacki served as Global Medical Affairs Leader and Head of Late-Stage Development at Janssen Alzheimer’s Immunotherapy, LLC.
Dr. Ropacki also serves as Co-Chair of a Scientific Advisory Group for the Innovative Medicines Initiative-European Prevention of Alzheimer’s Dementia (IMI-EPAD) program and as a National Institute of Health (NIH) advisor. Previously, he was Co-Chair of the CAMD Preclinical Cognitive Outcome Assessment (pCOA) team working with the European Medicines Agency (EMA) and the Food and Drug Administration’s (FDA’s) Drug Development Tool, COA Qualification Program. Dr. Ropacki authored or co-authored of dozens of published manuscripts and abstracts and was an Assistant Clinical Professor of Neurology at the Loma Linda University School of Medicine.
Dr. Ropacki holds a bachelor’s degree Summa Cum Laude from University of Arizona and a master’s degree and doctorate from Texas Tech University. He completed his internship/residency at University of Oklahoma Health Sciences Center in Psychiatry and two post-doctoral fellowships at Brown University School of Medicine and UCLA School of Medicine in Psychiatry.