Neuroscience trials increasingly depend on non-clinical measures from early-stage development through pivotal trials. The introduction of diagnosis is done by gene, blood, cerebrospinal fluid (CSF) and imaging measures as well as accelerated approval with biomarker surrogate endpoints. Navigating this new landscape requires an integrated contract research organization (CRO) strategy for the development program and trials at each stage of the process.
In this webinar, the featured speakers discuss new key measures relevant to neuroscience trials. They explore how to integrate and manage imaging and liquid biomarkers in neuroscience therapeutic product development. Collaboration and cooperation between the CRO and laboratories providing specialized services for imaging and biochemical assays are critical to delivering high-quality, regulatory-compliant endpoints within the clinical trial timeline.
Medpace Imaging Core Lab provides the full spectrum of medical imaging services needed for neuroscience clinical trials, routinely collaborating with Medpace CRO and Medpace Central Labs. Harmonization of data acquisition protocols across global sites is supported by study-specific, customized manuals. Standardized site education and central reviewer training are also important elements of data harmonization. Advanced quantitative neuroimaging analysis pipelines are fully integrated into our clinical trial management system for imaging and provide a seamless and efficient analysis of imaging data to produce high-quality safety and disease endpoint. These systems provide easy access for sites, lab staff and the sponsor to view raw image data, results and metrics within a CFR Part 11 compliant system that is fully validated for clinical trials according to industry standards, to ensure regulatory compliance.
As new biomarker assessments are performed during clinical trials, study management is complicated by the decision to allow real-time release of study results. Can unblinding and bias be prevented while giving providers data to use in treatment decisions?
Register for this webinar to learn key strategies to successfully conduct neuroscience clinical trials through lessons learned from how Medpace works to integrate clinical operations, medical monitoring, central lab and core lab experts.
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.
Who Should Attend?
This webinar will appeal to VPs, Directors, Managers and Department Heads working within:
- Clinical Affairs
- Clinical Research
- Clinical Pharmacology
- Clinical Outsourcing
- Project Management
- Regulatory Affairs
- Medical Affairs
What You Will Learn
Attendees will learn how to:
- Deliver high-quality regulatory-compliant endpoints in neuroscience clinical trials
- Integrate and manage imaging and liquid biomarkers in neuroscience therapeutic product development
- Apply lessons learned in conducting neuroscience clinical trials with an integrated CRO approach, including core labs and central labs
Medpace is a scientifically driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical 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.