Hyderabad, Telangana, India
An American Board Certified Toxicologist with >19 years of experience in non-clinical safety assessment, toxicology and pharmacology in drug discovery and development of New chemical and new molecular entities. Experienced in cross functional team co-ordination and execution of IND pipeline projects (Chemistry, formulation and non-clinical development). Monographs for occupational exposure limit (OEL) and permissible daily exposure (PDE) for API manufacturing. Designing the experimental studies, study conduct and monitoring, audit of in-life phase/data of various PK/Pharmacology/Toxicology studies, reporting and evaluating efficacy/safety data for new chemical entities, prodrugs, vaccines and impurities. Study conduct and monitoring of pharmacology (in vitro ADME, CYP interaction, metabolite profiling, in vitro cytotoxicity etc.) and toxicology studies (single dose, repeat dose, reproductive, teratology and genotoxicity studies) for 505(b)(1) and 505(b)(2) NDA submissions. Estimation of maximum safe human starting dose, preparation of investigator’s brochure, Toxicology summary for material safety data sheets. Experienced in audit of contract research organizations; writing non-clinical pharmacology and toxicology review for pre-IND and IND submissions.
Designing of experimental studies, study plan finalization and monitoring of Toxicology studies for REACH submission. Study Monitoring scientist for acute toxicity, repeat dose toxicity, reproductive and developmental toxicity and irritation and sensitization studies; and OECD 417 toxicokinetic studies (under Good Laboratory Practice). Evaluation of toxicokinetics and toxicology study data, review and finalization of study reports for existing and new chemical entities. Preparation of robust study summary and end point summary for toxicity studies, supporting ECHA dossier submissions using IUCLID platform. DNEL Derivation using ECHA guidance. Evaluation of product safety information to develop safety data sheets for global regulatory compliance with The Classification, Labelling and Packaging (CLP) Regulation and United Nations’ Globally Harmonised System (GHS).
Management of cross functional activities for studies conducted in the Contract research organizations (national and international CROs) for chemistry, analytical and formulation development, non-clinical operations for the drug substance and drug product development. Study monitoring scientist - Designing of experimental studies, study plan finalization and monitoring of Pharmacokinetics studies for novel active phytochemical compounds. Scientific/medical rationale writing and review for the new chemical entities, prodrugs and fixed dose combinations. Study protocol review, report writing and integrated summary preparation.
Identification of potential unmet needs in the current management and therapies for various diseases/ portfolios (Oncology, GI, CNS, Ophthalmic, Inflammation, etc). Preparation and review of Scientific /Medical rationale for fixed dose combination in various diseases, exploring unmet medical needs. Planning,conducting nonclinical toxicology studies (Single dose/MTD/ dose range finding toxicity, repeat dose toxicology studies) in line with global regulatory guidelines, and adequate requirement to initiate the First in Human or advanced stage of clinical studies. Evaluation of novel oncology therapeutic molecules: planning, conducting and monitoring of pharmacology studies (in vitro, in vivo PK and efficacy studies by in vitro cytotoxicity and various xenograft models). Audit of contract research organizations for the technical competence to perform non-clinical pharmacology, safety studies. Monitoring of projects of drug substance process RD, prototype drug product development and non-clinical studies. Study monitor for the efficacy studies for various new molecular conjugates (for the treatment of colorectal, pancreatic, breast cancer etc., inflammatory bowel disease and epilepsy). Estimation of maximum safe starting dose,preparation of investigator’s brochure, toxicology summary for material safety data sheets. Monographs preparation for the estimation of OEL and PDE for API manufacturing. Co-ordinating with various cross functional teams, preparation of non-clinical dossier and for submission to USFDA. Managed cross functional activities including chemistry, formulation development activities, non-clinical, regulatory and clinical teams. Broad knowledge in drug substance and drug product development; and interpretation of data. Negotiating with global CROs and service providers on the project costing to reduce and the operation cost. Nonclinical Data compilation and integrated summary preparation for regulatory pre-IND and IND submissions.
Protocol designing, review and monitoring of GLP regulatory toxicological studies (safety pharmacology, general toxicity, genotoxicity, reproductive toxicity studies etc; IND and NDA directed pre-clinical studies as per ICH/Schedule Y/USFDA/EMEA/WHO guidelines). Vaccine toxicological studies as per WHO, DCGI/DBT guidelines. Audit of various contract research organizations for the technical competence to perform IND/NDA directed various toxicological studies, and in-life phase of NCE and vaccines. Study monitor for various animal toxicity studies: Single dose toxicity and MTD study in rodents non-rodents, Sub acute toxicity studies, Reproductive, Prenatal and developmental toxicity studies in rats and rabbits. Animal House Veterinarian. Interpretation of gross and histopathological examination in pre-clinical toxicological studies. Correlation of inlife, clinical, gross and histopathological findings in pre-clinical toxicological studies. Compilation of integrated summary on preclinical toxicology studies for various regulatory submissions (USFDA, DCGI, BfArm).
Toxicology/Pathology Non-clinical toxicology and toxicokinetic studies in laboratory animals (rats, mice, dogs ). Study Director for various animal toxicity studies (Single dose toxicity and MTD study in rodents, Sub acute toxicity studies in rodents). Gross and histopathological examination of tissues from toxicological studies (mice, rats and dogs). Recording and interpretation of gross and histopathological examination in pre-clinical toxicological studies. Processing, sectioning and staining of tissues. Special staining for histopathology. Correlation of clinical, gross and histopathological findings in pre-clinical toxicological studies. Toxicology report review and preparation.