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Jesse M. Cedarbaum, MD, FAAN (Neurology), FANA

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About

Titles

Medical School Recruit - Professor

Biography

A 1978 YSM graduate, I am a neurologist/clinical trialist with sub-specialty in Movement Disorders. After 7 years heading the Parkinson and Movement Disorders program at New York-Hospital Cornell, I have spent the majority of his career as an executive in the pharmaceutical industry, leading teams in the areas of neurodegenerative, neuropsychiatric and retinal disorders at Regeneron, Elan, Cytokinetics and Bristol-Myers Squibb. Most recently I led a team at Biogen that advanced 3 new compounds into the clinic for potential treatment of Parkinson’s disease. At Biogen I also established a clinical research program in inherited ataxias. My research activities have encompassed efforts to develop novel clinical outcome measures and biomarkers, including digital health technologies for clinical trials. I have served as chair of the ADNI Private Partner Scientific Board, the Industry Scientific Advisory Board of the Michael J. Fox Foundation-sponsored Parkinson Progression Markers Initiative, and as industry co-chair of the Critical Path for Parkinson’s consortium. I have authored or-co-authored over 100 papers and book chapters, mostly in the area of neurological and opthalmological therapeutics , especially therapeutic development for Movement Disorders

Appointments

Other Departments & Organizations

Education & Training

Resident
New York Hospital-Cornell Medical Center (1983)
Intern and Resident
University of Chicago Hospitals and Clinics (1980)
MD
Yale University School of Medicine (1978)
MA
Stanford University, Biology
AB
Stanford University, Human Biology

Board Certifications

  • Neurology

    Certification Organization
    AB of Psychiatry & Neurology
    Original Certification Date
    1985

Research

Overview

The early focus of my work was on using neuroanatomical and neurophysiological tools to understand the pharmacology of drugs acting on the noradrenergic system of the brain, and the contribution of the locus coeruleus (LC) noradrenergic system to brain function. These efforts helped lay the groundwork for a theory of locus coeruleus function that is still widely supported – that the LC is involved in novelty detection and selective attention. Subsequent understanding of pathological changes in the LC and the correlation of loss of noradrenergic function in dementia are in keeping with this hypothesis.

My interest in the pharmacology of catecholaminergic systems in the brain led to a clinical interest in Parkinson’s disease. Significant novel clinical observations from work carried out at Cornell and the Burke Rehabilitation Center included the (at that time) novel understanding that the timing emergence of MRF and dyskinesia in the treatment of PD was related to age of onset and severity of disease, not the duration of levodopa administration. In addition, our group was among the first to report on the near-universal prevalence of dementia in advanced PD. Our group also was among the early pioneers in the utilization of enteral levodopa infusions to attempt to control MRFs, and we established the basis for the use of peripheral COMT inhibitors in PD through a combination of clinical observations and studies using novel COMT inhibitors in nonhuman primates. And finally, we described the relationship between plasma and brain pharmacokinetics levodopa and dopamine by sampling CSF from PD patients who had Ommaya reservoirs left in place following neurosurgical procedures.

Prior to initiation of clinical trials for ALS at Regeneron Pharmaceuticals, it became apparent to us that there was a need for a comprehensive clinical rating scale to be used as a clinical trial outcome measure. This work resulted in the development and validation of the ALS Functional Rating Scale (ALSFRS) and its revised, expanded version, the ALSFRS-R. Unfortunately, none of our ALS clinical trials were successful, but the ALSFRS-R continues to be the most-used outcome measure for ALS trials, and is endorsed by FDA for this use.

The neurotrophic factor trail led us to studies for treatment of retinal disorders, since the eye, after all, is a part of, and a window into, the brain. Subsequent to the completion of the ALS program, I led a series of clinical trials of an anti-VEGF agent, aflibercept, for treatment of neovascular Age Related Macular Degeneration (“wet”) AMD. This program resulted in the eventual approval of the drug, known commercially as Eyelea, for wet AMD and a variety of other retinal vascular diseases.

After leaving Regeneron, I joined Elan Pharmaceuticals. There my focus shifted back to neurodegenerative disease, in particular Alzheimer’s disease. Three publications from this period helped lay the groundwork for acceptance by both FDA and EMA of the Clinical Dementia Rating Sum of Boxes (CDR-SB), developed at Washington University in St. Louis, as a sole clinical outcome measure for trials in the MCI-early AD space, and its adoption as the outcome measure for most contemporary MCI-mild AD clinical trials.

Most recently, as we prepared for the development of novel therapeutic agents for the treatment of PD at Biogen, I established a number of external collaborative projects that resulted in the identification and preliminary validation of novel or pre-existing biomarkers for PD clinical trials, and helped lead pre-competitive collaborative efforts to secure regulatory support for the use of dopamine transporter (DaT) imaging as an enrichment biomarker for PD clinical trials.




Medical Subject Headings (MeSH)

Cerebellar Ataxia; Lewy Body Disease; Motor Neuron Disease; Multiple System Atrophy; Parkinson Disease; Supranuclear Palsy, Progressive

Research at a Glance

Yale Co-Authors

Frequent collaborators of Jesse M. Cedarbaum's published research.

Publications

2024

2023

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