ClinPharm Dev Solutions

Consulting services for your Clinical and Preclinical Development needs. Strategic leader in drug development with over 17 years of industry experience, spanning the entire drug development spectrum from preclinical stages to life cycle management. Contributed to the development and approval of five commercially available drugs across various therapeutic areas, including oncology, rare diseases, anti-infectives, and CNS disorders. Expertise in diverse therapeutic modalities, such as small molecules, monoclonal antibodies, oligonucleotides and RNA-based therapies (including siRNAs), and ADCs, across multiple clinical indications. Extensive experience in regulatory interactions, including with FDA, EMA, and PMDA, and proficient in preparing and reviewing IND, NDA/ANDA, MAA, end-of-Phase-2, and pediatric investigational plans. Adept at resolving clinical/preclinical development challenges using state of the art Modeling and Simulation. Expertise in M&S techniques, including population pharmacokinetics-pharmacodynamics (PK-PD), exposure-response (ER) analyses, semi-mechanistic modeling, and physiologically based pharmacokinetic modeling (PBPK). Significant experience in designing Clinical Pharmacology and DMPK studies, covering a wide range of study types, such as SAD/MAD, drug-drug interaction, pediatric, special populations (renal and hepatic impairment), and bioavailability/bioequivalence studies.