Larry Ereshefsky, PharmD, BCPP
Chief Scientific Officer and Owner
Follow the Molecule: CNS Consulting LLC
Marina del Rey, CA
Larry Ereshefsky over his 40 years’ career applies his experience as a clinician, 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 College of Psychiatric and Neurological Pharmacists (CPNP) 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 from the same institution. He is an elected Fellow in the American College of Clinical Pharmacy, and is Board Certified in Psychiatric Pharmacy by the Board of Pharmaceutical Specialties. 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. 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 several 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 80 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 insuring 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 is currently the Co-PI on Alzheimer’s Foundation and Part the Cloud Funding for M3-Biopharmaceutics’ novel therapy entering the clinic. He has particular 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 studies evaluating ethnicity and drug-drug interactions. He is a clinical scientist and clinical pharmacist having spent 26 years in Academia at the University of Texas Health Science Center and for 13 years as Chief Scientist/Global CNS Leader for Early Phase, California Clinical Trials/PAREXEL. Currently, he is Chief Scientific Officer for Follow the Molecule: CNS Consulting, providing services to pharma, CROs, and technology vendors. He is Chief Scientific Officer, Early Phase, for Hassman Research Institute, and a consultant for ProScience Research Group’s later phase psychiatry programs.
Uniquely, he was head of a laboratory applying the pharmacogenetics and pharmacokinetics of drugs to improve dosing and outcomes, served as sub-investigator on in vitro and animal neuropharmacology studies, is credentialed as a clinician caring for patients, and served as a Principal Investigator in over 50 (sub-I in an additional 70) clinical trials. Dr. Ereshefsky has a unique perspective having clinical investigator, Early/Late Phase research unit leadership, and more basic science applied research experience. 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 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 in Southern California. His PharmD and Residency in Psychopharmacology and Clinical Pharmacy were at the University of Southern California and LA County Medical Center. His first grant support, while an undergraduate at UCLA, was from the Atomic Energy Commission studying the kinetics of organic Cobalt compounds.