Achieving Success in Neuroscience Clinical Trials: An Integrated CRO Approach

James Vornov, MD, PhD, Vice President, Medical Department, Medpace

Dr. James Vornov is a board-certified neurologist and internationally known clinician-scientist with over 18 years of neurology and psychiatry clinical development experience. At Medpace, he provides hands-on medical leadership to sponsors and internal study teams engaged in neuroscience clinical research. He has worked in multiple neuroscience therapeutic areas having directed programs in depression, suicidal ideation, Parkinson’s disease, stroke, neuropathic pain, diabetic and chemotherapy-induced peripheral neuropathy, anesthesia and brain tumors.

He has particular expertise in the rapid transition of compounds from the laboratory to clinical proof of concept through the use of technologies such as biomarkers, PK/PD modeling, adaptive design and clinical trial simulation. Dr. Vornov received his BA in Biology from Columbia University and his MD and PhD from Emory University School of Medicine. He trained in Neurology at the Johns Hopkins Medical School where he served on the faculty for 10 years prior to transitioning to industry.

Danielle N. Caudell Stamper, MSN, AGACNP-BC Advanced Clinical Practitioner, Medpace

Ms. Danielle Caudell Stamper is a board-certified advanced practice registered nurse. She has over eight years of clinical and preclinical neurological research experience as a senior clinical research assistant specializing in hemorrhagic stroke, traumatic brain injury, aneurysm and ischemic stroke. As a clinical trial nurse coordinator and regulatory specialist, she was involved in the conduct of over 40 clinical trials.

Her clinical career includes over three years working as a nurse providing direct patient care on a medical-surgical unit. As a Nurse Practitioner, she has more than six years of experience at a large academic medical center in the pulmonary-critical care department, where in addition to clinical care, she served as a sub-investigator on multiple clinical trials.

Ms. Caudell Stamper is a well-published author, with articles printed in multiple peer-reviewed journals, she has presented at national conferences and has experience teaching and training others. In collaboration with the Medical Monitors, her role as a Medpace Advanced Clinical Practitioner (ACP) is to engage throughout the life of a clinical trial, providing scientific background, disease education, research rationale and protocol inclusion/exclusion criteria.

Scott K. Holland, PhD, Sr. Director, Scientific Affairs, Medpace Core Labs

Dr. Scott Holland is a physicist with PhD and MS degrees in Applied Physics from Yale University with post-doctoral training in image processing at Stanford Research Institute and in MRI physics at the Yale School of Medicine.  As a former faculty member at Yale University and the University of Cincinnati and Founding Scientific Director of the Imaging Research Center at Cincinnati Children’s Hospital, he has 30+ years of experience in medical imaging research with >250 peer-reviewed scientific publications.

His expertise is generally in advanced medical image acquisition and analysis methods, with a particular focus on advanced neuroimaging methods for quantitative analysis, including fMRI, DTI, MRI-PDFF, MRS, ASL, PET, SPECT and other specialized methods. At Medpace Core Labs since 2018, he oversees activity in biomarker imaging and software development across imaging modalities and applications in a wide range of clinical trials.

Serena Allen, PhD, Principal Scientist, Medpace Central Labs

Dr. Serena Allen is a principal scientist with a PhD in Pharmaceutical Sciences from East Tennessee State University and an MSc in Medicinal and Biological Chemistry from the University of Edinburgh, Scotland. She drove preclinical research projects to successfully characterize the in vivo neuropharmacology and neurotoxicology of synthetic drug compounds in animal models.

She is experienced in neuropharmacology, de novo assay development, clinical assay development, analytical method validation, HPLC/UPLC and ELISA/EIA methodologies with 10 years of combined experience in the preclinical and clinical research space. At Medpace Reference Labs since 2018, she oversees clinical testing and operations within the ELISA/EIA/UPLC and specialized biomarker areas.