Director - Clinical Science (Non-Md)
CurrentPHASE I & II CLINICAL STUDIES : • Well-versed in Clinical SOPs, ICH-GCP and good understanding of the drug discovery process• In-depth knowledge of Immunology and Pathophysiology of immune-related disorders at the clinical and molecular level.• Experienced user of various Databases (Oracle Clinical, INFORM, TranSMART), Tools (Oracle query tools such as BRIO, SpotFire, Excel & Macros, PREDICT, EndNote) and Resources used for conducting clinical research (CDISC, MEDRA) and ability to incorporate efficiencies for clinical data reviewCLINICAL PHARMACOGENOMICS:• Pharmacogenomics study in Alzheimer’s patients receiving an experimental therapeutic vaccine - Work was cited as a landmark publication (O'Toole et al., 2005, and link to editorial)• Insights into mechanism of action of Anti-MAdCAM Antibody in the Peripheral Blood of Patients With Crohn's Disease• Implementation of biomarker strategy for Phase I & Phase II studies in Ulcerative Colitis, Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus (SLE) and Healthy Volunteer studies for mechanism of action of study drug, patient stratification using IFN signatures etc• Published data to identify candidate biomarkers and deliver biomarker assays for the clinical development of a candidate therapeutic in asthma - responsible for leading team of scientists to generate the necessary internal data (link to patent application)• Biomarker characterization of animal disease models in pre-clinical drug efficacy studies with emphasis on models of lupus and RA - mapping mechanistic and biomarker similarities between animal models and human disease (Reddy et al. 2009)MEDICAL INFORMATION:• Experience in Medical Information to provide responses to medical inquiries, using resources such as data on file and published literature. This includes reviewing efficacy, Pharmacokinetics (PK), Pharmacodynamics (PD), safety results from clinical studies and pooled meta-analysis
