Dr. Vashi has 29 years’ Clinical Pharmacology experience in Pharma, CRO and Biotech industry in the US. As a Clinical Pharmacologist he has worked both as an individual contributor as well as in management. He is very experienced in all aspects of Clinical Pharmacology including developing strategic clinical development plans for Early Development as well as Late Development compounds. Dr. Vashi also has experience in DMPK, TK, bioanalysis and clinical operations in all aspects of Clin Pharm-including design of studies/programs.
Most recently Dr. Vashi was a Senior Director Clinical Pharmacology and Head Clinical Operations at Asana BioSciences LLC/Prolong Pharma (joint appointment) where is the Clinical Pharmacology Lead for three clinical stage portfolio assets for Atopic Dermatitis, Chronic Hand Eczema and Acute Ischemic Stroke with responsibilities for Clinical Pharmacology Plans, Bioanalysis, DMPK and Clinical Operations.
In his career, Dr. Vashi has supported 40+ assets from Phase 1 through Phase 4, NMEs-small molecule as well as biologicals in many non-oncology and oncology therapeutic areas. He has experience in authoring/reviewing various eCTDs modules; 2.7.1 and 2.7.2, Biologics License Applications (BLA), New Drug Application (NDA), Investigational New Drug (IND), Breakthrough Therapy Designations application, and briefing books as well as interactions with regulatory agencies globally.
Dr. Vashi has authored/co-authored 35+ peer-reviewed publications. He has a PhD, in pharmaceutical sciences specializing in Pharmacokinetics/Biopharmaceutics from the University of Tennessee, Health Science Center, Memphis, TN.
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