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Rakesh Gollen

Rakesh Gollen
Associate Director, Clinical Pharmacokinetics
KinderPharm LLC Exton, PA, 19341, USA


• Trained pharmaceutical scientist having experience in both preclinical and clinical drug development with broad understanding of interpreting data. • Experience in modelling of drug compounds in clinical development (phase I, II, and III) to facilitate and design the clinical studies. • Experience in development and implementation of Physiologically-Based Pharmacokinetic (PBPK) models to simulate and predict Absorption, Distribution, Metabolism, and Excretion (ADME) properties of compounds in drug development to ensure safety and efficacy. • Proficient in working and interpreting the preclinical data to characterize human drug metabolism and pharmacokinetic (DMPK) parameters along with characterization of other ADME properties of drug candidates. • Adept at advanced analysis of PK/PD modeling (Phoenix, GastroPlus, SimCyp, NonMEM, etc.) and small animal PK study and hands on experiences on in vitro drug metabolism (metabolic stability, reaction phenotyping, metabolites identification). • Acquired proficiency in surgical and experimental expertise in animal models in isolated organ perfusions, along with ultrafiltration technique for protein binding determinations. • Hands-on experience with various bioanalytical tools including LCMS/MS, HPLC, and Fluorescence/UV-Vis spectrophotometers, DSC, TGA, HPLC, pH meter, KF, UV-VIS & Fluorescence spectrophotometer, Fluorescence microscope, FTIR, and IR. • Expert in extracting and summarizing the PK data for regulatory filings and adept at writing developmental & technical reports (PoC, IND, NDA, and IB), protocols and SOP’s. • Trained cGMP, statistical analysis and ICH guidelines proficient. • Trained in study design, execution, interpretation and management of continuous communication of study progress among various groups within pharmaceutical and CRO organizational setting. • Acquired significant knowledge and working experience related to Mass balance Studies of small molecules in both animals and humans, and in predictions for safe and efficacious first in human dosages, from varying source of data using allometric scaling, wajima method, reverse pharmacology approaches. • Excellent writing and oral communication skills. • Acquired good presentation and communications skills, along with leadership attitude. • Served as a student leader, represent LIU student chapter as chair, Newsletter committee as chair and AAPS blog committee as chair for PPB section at AAPS. EDUCATION Ph.D. in Pharmaceutics (2015) Long Island University, Brooklyn, NY Master of Science in Industrial Pharmacy (2010) Long Island University, Brooklyn, NY Bachelors in Pharmacy (2003) Guru Jambeshwar University, India

Research Interest

Advanced Pharmacokinetic and Pharmacodynamics, Advance Physical Pharmacy, Dosage form Design & Pharmaceutical Technology, Pharmacology and Medicinal Chemistry, Drug Stabilization