Adarsh Kumar Ray

WORK HISTORY

EDUCATION

ABOUT ADARSH KUMAR RAY

Medical writing toxicologist skilled in translating complex toxicology and pharmacology data into clear, regulatory-compliant scientific content.I specialize in:•Authoring and designing pre-clinical study protocols, study reports, Investigator Brochure (IB), Section C (Non-clinical data), Module 2 and Module 4 for Phase trials.•Authoring regulatory dossiers like Summary of Product Characteristics (SmPC), Prescribing Information (PI), Patient information leaflets (PILs) for MAA in Europe, UK and India regions.•Regulatory guidelines (EMA, FDA, CDSCO, WHO) for biologicals and biosimilar development.•Biosimilarity assessment, including comparability studies (bio-characterization, analytical, non-clinical, and clinical).•Design and execution of in vitro and in vivo pharmacology and toxicology studies and experience with animal models, especially relevant for immune-oncology.•Pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and toxicity assessment and translation to first-in-human trials.•Familiarity with endpoints for biosimilar trials, including PK/PD comparability and equivalence testing.•Scientific writing, data presentation and statistical analysis of non-clinical and clinical data.•Preparing scientific reports of health-based exposure limits including permitted daily exposure (PDE) and occupational exposure limit (OEL) for active pharmaceutical ingredients, Biosimilars, impurities and chemicals in accordance with EMA and ICH guidelines.•Data retrieval from Scientific databases like AusPARs, ECHA, EMA, EMC, EPA, FDA, HSDB, PubChem, etc.•Evaluating toxicological data to support drug development and safety assessments.I hold a Master’s degree in Pharmacology and Toxicology from National Institute of Pharmaceutical Education and Research (NIPER) with a strong foundation in preclinical research and laboratory expertise.My professional experience spans a wide range of research activities, including:Skilled animal handling and dosing, with proficiency in creating animal disease models for diabetes and cancer studies.Conducting toxicity studies, behavioral experiments, and performing animal sacrifices with precision to collect organs for biochemical and histological assays. Experience in cell culture techniques and working with various cell lines. Proficient in operating advanced laboratory equipment and ensuring accurate experimental outcomes.With a passion for research and a commitment to scientific excellence, I am dedicated to advancing knowledge in pharmacology and toxicology while contributing to impactful projects.