Larry Ereshefsky, PharmD, BCPP
Chief Scientific Officer and Owner
Follow the Molecule: CNS Consulting LLC
Marina del Rey, CA
Larry Ereshefsky over his 45 years’ career applies his experience as a clinical scientist and investigator, to develop treatments and clinical methodologies to make a difference in the lives of patients with Neurodegenerative and Psychiatric Disorders. He is a past President of the American Association of Psychiatric Pharmacists (AAPP) and a founding member. He is a Past Chair, for the Section of Clinical Specialists, of the American Society of Health-System Pharmacists and served on the Board of Regents of the American College of Clinical Pharmacy. Dr. Ereshefsky completed his Pharm.D. from the University of Southern California in 1976, and a specialty practice residency in psychiatric pharmacy (with additional training in psychopharmacology) from the same institution. His first grant support, while an undergraduate at UCLA, was from the Atomic Energy Commission studying the kinetics of organic Cobalt compounds. He made significant contributions to the study of the pharmacokinetics and pharmacodynamics of lithium therapy and LAIs (fluphenazine and haloperidol decanoate). He was the first Pharm.D. Principal Investigator for clinical trials of psychiatric medications, including many antidepressants and atypical antipsychotics, including the registration trials for clozapine.
He is an elected Fellow in the American College of Clinical Pharmacy and is Board Certified in Psychiatric Pharmacy by the BPS. He is recognized as an innovator in the pharmacotherapy of psychiatric disorders and provision of clinical pharmacy services. He was instrumental in the development and implementation of evidence-based care and therapeutic drug monitoring programs for the Texas Department of Mental Health and Mental Retardation, leading to the creation of clinical psychopharmacologist positions. He was previously Associate Director, Clinical Research, San Antonio State Hospital, co-Directed the Applied Psychopharmacology and Evaluation Laboratory, and was the Director of the Psychiatric Pharmacy Program at the University of Texas.
He has contributed significantly to many CNS drug approvals spanning neurology and psychiatry, including clinical drug development planning and methodological innovation in support of biomarker and relevant cognitive/behavioral endpoints. He has designed, implemented, supervised, and conducted more than 120 CNS clinical trials ranging from first into patient, proof of concept, Asian Bridging strategies, through to large global Phase III registration trials. He is a leader in the use of signal detection strategies to minimize placebo response while ‘maximizing the delta’ of active therapies, developing and using strategies such as patient adjudication, improving inter-rater reliability, managing expectation bias, and ensuring study designs preserve statistical power while preserving the blinding. Similarly, in early development Larry has a proven track record as an investigator, translational CNS scientist, and clinical advisor in designing and performing Phase I and clinical pharmacology studies. He has expertise and skill in supporting complex, integrated (umbrella) and adaptive Phase I-II studies, including extensive experience using enriched population strategies. These trials designs include healthy volunteers as well as Japanese, Chinese, and Korean Single Ascending and Multiple Ascending Dose components. He was an early investigator of CYP drug metabolism, evaluating ethnicity and drug-drug interactions.
He served as sub-investigator on in vitro and animal neuropharmacology studies and is credentialed as a clinician caring for patients. He has been a leader in the application of translational drug development tools including neurocircuitry/biomarker based (RDoC) strategies (i.e., continuous CSF sampling, QEEG, ERP, PSG, sMRI, fMRI, PET, and cognitive and behavioral paradigms), and pain models for many CNS disorders. He guides analyses exploring toxicokinetic, PK/PD modeling, and guides clinical drug development plans informed by pre-clinical data, animal behavioral markers, and safety signals. He incorporates the preclinical and available clinical study data into design strategies to efficiently de-risk early phase drug development.
He has been honored for accomplishments in his field by the ISCTM (Andrew Leon Distinguished Career Award, 2023) and AAPP (Judy J Saklad Memorial Career accomplishment award 2009). He served twice on the FDA Psychopharmacological Drugs Advisory Committee. He is a retired Regents Professor of Pharmacy, Psychiatry, and Pharmacology from The University of Texas System. Subsequently, he was the CSO and Exec VP for California Clinical Trials, acquired by PAREXEL International where his role was VP, Principal Pharmacologist and Therapeutic Area Leader for CNS Early Phase with Global responsibilities. Throughout he continued as a clinical investigator actively involved in supporting the study teams at CCT and PAREXEL research facilities. Currently, he is Chief Scientific Officer for Follow the Molecule: CNS Consulting, providing clinical and translational science services to pharma, CROs, and technology vendors. He is also Chief Scientific Officer at CenExel Research, heading up their Clinical Sciences, Early Phase business unit. He also supports ProScience Research Group’s later phase psychiatry programs.
