Arindam Pal

Background

About Arindam Pal

With a strong background in clinical development (study designing, PK/PD analysis, modelling & simulations & applied biostatistics) of over 18 years, I work right from concepts’ ideation, validation, clinical development, leading them to regulatory submissions. This involves in-vivo transitions from drug development involving PoC (preclinical, ex-vivo, in-silico models and clinical) to clinical phases (2-3). I worked in toxicology program to FIH (sentinel dose) studies. My role also involves KoL engagements and external/internal collaborations. I have good hands-on experience in Phoenix NLME, Winnonlin & IVIVC toolkit. Basic experience in NONMEM. Fair experience in GastroPlus. Working with R and still learning. Well equipped with scientific and regulatory writing; have lots of experience in controlled correspondences and scientific advice meetings. Worked in: Therapeutic areas: Urooncology, Gastroenterology, Reproductive medicine and maternal healthcare, Respiratory, Dermatology, Neurology and Pain management - Dosage forms: Solid and liquid orals (IR, MR), parenterals (with and without auto-injectors), inhalation (DPI, MDI), intranasal, topical, transdermal- Clinical efficacy phases: 2-3 (superiority, non-inferiority, equivalence), organoleptic studies, device robustness studies- Study types: RCT and observational studies (RWE)- Skill sets: study designing through statistical principles, data analysis & investigations, PK modelling and simulations and exposure-response analyses, IVIVC/R, preclinical-clinical translational analysis. Exposure in RWE and survival analysis.