Considerations for Neuroscience Trials with Direct Administration to the CNS

The blood-brain barrier limits central nervous system (CNS) exposure of systemically administered investigational products. Direct local administration to the CNS is not new. However, there continues to be debate around routes of delivery, safety profiles and distribution characteristics. The utilization and accrued knowledge of direct CNS administration techniques is increasing, and these approaches are important for CNS targets. The modern-day application of intraparenchymal, intracerebroventricular and intrathecal delivery in neuroscience trials comes with many clinical, operational and regulatory challenges.

To overcome these challenges and mitigate risks, it is essential to understand common site and operational considerations associated with these methods of drug delivery. Challenges include study set-up, site and investigator-specific training requirements, vendor selection, recruitment considerations and a unique regulatory environment.

Join neuroscience experts from Medpace as they look at the history of direct CNS administration and how it has led to modern day applications. The featured speakers will discuss unique challenges from the investigative site perspective with strategies to mitigate them. The speakers will also share key operational and regulatory considerations for neuroscience trials with direct CNS administration.

Speakers

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

Dr. 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.

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Filipe Rodrigues, MD/MSc, Medical Director, Medpace

Dr. Filipe Rodrigues is a Medical Director at Medpace and provides clinical and scientific expertise and hands-on experience within neurosciences programs. Dr. Rodrigues provides ongoing training, particularly focused on the operations group, supporting the Medpace team during complex neurology and psychiatry trials. He has over six years’ experience in drug development, from first-in-human through dose finding and early efficacy, to pivotal trials. Immediately prior to joining Medpace, Dr. Rodrigues served as an academic at University College London Queen Square Institute of Neurology and as a clinician at the National Hospital for Neurology & Neurosurgery in London, UK. Dr. Rodrigues remains active in academia with honorary positions at University College London and University of Lisbon. He continues to serve on international committees and societies.

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Kelsey Carter, Clinical Trial Manager, Medpace

Since joining Medpace in 2014, Kelsey Carter has applied her background in clinical pharmacology/ pharmacogenomics as a Lead CRA and CTM across many diverse Phase I-III trial designs. Ms. Carter has significant experience in cultivating a strong rapport with sites and KOLs. As a Medpace CTM, Ms. Carter’s experience in clinical operations has optimized processes and timelines throughout the entirety of her studies. Her adaptive oversight and leadership help empower team members to successfully meet study milestones. Ms. Carter has strong therapeutic experience in CNS, rare disease and advanced therapy medicinal products. Ms. Carter earned a BS in Pharmaceutical Science and MS in Clinical Pharmacology degrees from Ohio State University College(s) of Pharmacy/Medicine.

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