Jaiprakash Bhelonde

Consultation on nonclinical development of pharmaceuticals, nonclinical regulatory writing/review & gap analyses of documents for regulatory submissions, toxicological risk assessments of excipients, impurities and extractables/leachable (E&L). Health Based Exposure Limits [HBELs - Acceptable Daily Exposure (ADE)/Permitted Daily Exposure (PDE)].

Successfully led toxicology and pathology teams and responsible for planning and conduct of all kind of toxicology (non clinical) studies for clients from diverse industries in accordance to various regulatory requirements. Planning and conduct of preclinical proof of concept (efficacy studies in various animal models). Preparation and review of health-based exposure limit for API [permitted daily exposure (PDE) or allowable daily exposure (ADE)] and Occupational Exposure Limits (OEL) for pharmaceuticals.

Planing and conduct of nonclinical toxicology studies including review of data. Preparation and review of toxicology and safety evaluation summaries and reports for non-clinical dossier for regulatory filings. Review of toxicity of individual chemical ingredients in the formulation or API used in the manufacture of pharmaceutical products for its hazard or "inherent" toxicity such as acute toxicity, skin/eye irritancy, potential for skin sensitization, reproductive, genotoxic, or carcinogenic activity.

Lead pathology team to support drug development. Standardized and validated various biomarkers and animal models of human diseases. Prepared and reviewed toxicology and safety evaluation summaries and reports for non-clinical dossier for regulatory filings. Safety assessment and review of in-licensing products and technologies as part of due diligence process. Conducted evaluation and qualification of Contract Research Organizations (CROs) and monitored outsourced non-clinical studies at CROs.

Overall planning and monitoring of clinical pathology and histopathology laboratories. Work assignment to team members and review of progress. Ensuring GLP compliance of various activities of necropsy, clinical pathology and histolopathology laboratories.

Lead pathology team to support early discovery and IND enabling toxicology studies. Planning and conduct of efficacy studies for new formulations/change in route and new indications. Preparation and review of IND and NDA documents.

As section head pathology was responsible for complete pathology support to non clinical studies for agrochemicals, industrial chemicals, cosmetics and pharmaceuticals in different laboratory animals.