TRANSLATIONAL MEDICINE / CLINICAL DEVELOPMENT
- 18 years of in biotech/pharma ranging from drug target discovery through clinical drug development.
- 10 years in academic medicine and research.
Translational Medicine and Strategy; Drug Research and Development; Clinical Development Planning; Trial Design; Medical Management of Phase 1-2 Clinical Trials; Development of Biomarker Strategies; PK/PD Assessments; Pharmacogenomics and Multi-omics Profiling.
Specialties: Pediatrics, Clinical Genetics, Molecular Biology, Obesity, Diabetes, Autoimmunity, Cardiovascular, Infectious Diseases, Metabolism, Neurology, Oncology, and “Omics” Methods.
Co-inventor on 18 filed patents, with over 40 publications and presentations.
Vice President, Translational Medicine, Rexahn Pharmaceuticals
Develops translational strategies implemented for patient selection, PD monitoring, plus dose and schedule selection in traditional and adaptive clinical trials (FIH – POC). Liaises with PIs, KOLs, and scientific contractors.
Senior Director, Translational Medicine, Acorda Therapeutics
Simplified the dosing regimen of a small molecule for spinal cord injury in Phase 2. Restructured trial designs and safety evaluations for a biologic in Phase 1 for heart failure. Broadened development plans and added unique PD assessments of an antibody in Phase 1 to treat MS. Refined clinical development plans and safety evaluations for an inhaled triptan in Phase 1 for migraine. Medically managed six Phase 1 and one Phase 2 clinical trials.
Translational Strategies Consulting
Provided scientific guidance for a gene-targeting biotech start-up, as well as biomarker consultation services for a multi-function, preclinical CRO.
Senior Director, Clinical Pharmacology & Translational Medicine, Eisai Oncology Product Creation Systems
Developed novel biomarker strategies for assessing PK / PD in multiple oncology agents. Initiated the use of CTCs for dynamic PK / PD monitoring for a multi-RTK inhibitor. Broadened the clinical development plans for a PARP inhibitor and a multi-RTKi with new potential indications. Implemented multi-omics profiling program for biomarker discovery in oncology drug development. Received Distinguished Role Model Award.
Director, Clinical Pharmacology & Experimental Medicine, Daiichi-Sankyo Pharma Development
Utilized pharmacogenomics to provide a go / no-go decision for a novel CV drug. Developed an adaptive, healthy volunteer study to assess transition from warfarin to an FXa inhibitor, a PD biomarker strategy for an agonistic anti-cancer antibody, and a unique strategy for patient selection and PK / PD assessments for an
Head, Metabolic Diseases Program, CuraGen Corporation
Led and managed drug target discovery and development activities in obesity and diabetes that relied upon functional genomics and proteomics profiling. Managed collaboration with BAYER, A.G. Built and supervised a team of five to ten PhD scientists, developed laboratory and clinical investigations for new drug target discovery, and initiated over 40 HTS for obesity and diabetes with Bayer, leading to an IND for BAY 76-7171.
Assistant Professor, Pediatrics & Molecular Genetics, Albert Einstein College Of Medicine
Attending physician in Pediatrics and Medical Genetics. Taught medical students and fellows. Conducted sponsored research on homologous recombination with gene therapy applications.