Prashant Kshirsagar

Led the preparation, critical review, and submission of high-quality regulatory dossiers (Modules 1–3) in compliance with EMA, US FDA, ANVISA, MFDS for biosimilar products. Developed and compiled Scientific Advice (SA) and Pre-IND/Type B meeting packages, ensuring clear articulation of development strategies and alignment with regulatory expectations. Successfully submitted IMPDs and CTAs for clinical trial approvals in the EU, coordinating closely with clinical and CMC teams. Drafted and reviewed core regulatory documents including CMC summaries, quality overall summaries (QOS), and regional information for EU and US submissions. Collaborated with cross-functional teams (CFTs) to integrate regulatory perspectives during product development, addressing technical challenges early in the lifecycle. Managed gap assessments and regulatory risk evaluations to support decision-making and optimize development timelines. Provided strategic regulatory input for biosimilarity demonstration, including analytical comparability. Maintained up-to-date knowledge of EMA guidelines (CHMP, CMDh, etc.) and US FDA biosimilar guidance documents, incorporating evolving requirements into submission planning. Actively involved in internal reviews and regulatory process optimization, promoting consistency and regulatory excellence across teams Supporting licensing activity by providing appropriate information in due diligence.

Led the preparation, critical review, and submission of high-quality regulatory dossiers (Modules 1–3) in compliance with EMA for biosimilar products. Developed and compiled Scientific Advice (SA) and Pre-IND/Type B meeting packages, ensuring clear articulation of development strategies and alignment with regulatory expectations. Successfully submitted IMPDs and CTAs for clinical trial approvals in the EU, coordinating closely with clinical and CMC teams. Drafted and reviewed core regulatory documents including CMC summaries, quality overall summaries (QOS), and regional information for EU and US submissions. Collaborated with cross-functional teams (CFTs) to integrate regulatory perspectives during product development, addressing technical challenges early in the lifecycle. Managed gap assessments and regulatory risk evaluations to support decision-making and optimize development timelines. Provided strategic regulatory input for biosimilarity demonstration, including analytical comparability. Maintained up-to-date knowledge of EMA guidelines (CHMP, CMDh, etc.) and US FDA biosimilar guidance documents, incorporating evolving requirements into submission planning. Actively involved in internal reviews and regulatory process optimization, promoting consistency and regulatory excellence across teams

Bioassay Specialist in Biosimilars CMC Development As a Bioassay Specialist in biosimilars CMC development, I played a crucial role in ensuring the quality and efficacy of biosimilar products. My expertise includes: Bioassay Development and Validation: Developed and validated bioassays, including cell-based and ligand-binding assays, using platforms such as ELISAs and HTRF. Designed assays for lot release and stability testing, ensuring functional properties were equivalent to reference products. Conducted immunogenicity assessments (ADA and NAb assays) and pharmacokinetic (PK) studies to demonstrate biosimilarity with innovator products. Method Development and Transfer: Planned and supported method development at R&D. Facilitated method transfer and oversaw method validation activities at QC. Reviewed data and reports for regulatory compliance and effectively communicated findings with stakeholders. Collaboration and Troubleshooting: Worked closely with cross-functional teams, including analytical development, quality control, and regulatory affairs, to ensure seamless integration of bioassay data into the overall CMC strategy. Contributed to troubleshooting and resolving technical issues, ensuring the robustness and reliability of bioassay methods.

Researcher in Metabolic Disorders As a dedicated researcher in the metabolic disorder group, I specialized in developing protocols for islet isolation and assay development. My key responsibilities included: Protocol Development and Training: Developed protocols for islet isolation and assay development. Trained colleagues in these protocols and techniques. Compound Screening and Assay Development: Screened compounds for activity, specificity, and selectivity. Conducted in vitro screening of new chemical entities (NCEs) to assess their potency and efficacy. Focused on specificity studies of compounds on prioritized targets and investigated signaling events related to receptor activation. High-Throughput Screening (HTS) Campaigns: Led HTS campaigns for compound library screening on prioritized targets. Utilized various platforms such as fluorescence, luminescence, TR-FRET, FLIPR, and AlphaLISA. Analyzed data from these campaigns and identified promising compounds for further development. Collaboration and Target Evaluation: Collaborated with team members to evaluate potential new targets across different therapeutic areas by mining scientific literature. Actively participated in team meetings, journal clubs, and new target evaluations, contributing to the advancement of therapeutic research.

Actively involved in in vitro screening of the NCE (Primary and secondary screening) with respect to their potency as well as efficacy. Specificity study of the compounds on prioritized targets. Functional assay development and compound screening on same platform. High through put screening (HTS) compaigns for compound library screening on prioritized target. Analysis of the data from the campaign, sorting of compounds to be a starting point for the chemist.

Biotech Research Specialist In my role within the Biotech research department, I was responsible for a variety of tasks aimed at achieving departmental goals. My key responsibilities included: Cell Line Maintenance and Assays: Maintained mammalian cell lines. Conducted cell-based assays, including cell cytotoxicity and anti-inflammatory assays, as part of the drug discovery process. Cell Biology Techniques: Elucidated cellular signaling using ELISA and flow cytometry. Detected proteins (e.g., Insulin, GLP-1) through functional assays in the drug discovery process. Developed ELISA methods. Performed ELISPOT assays as reporter assays for IFN gamma secretion by T cells. Assessed granzyme function of splenocytes (anti-tumor activity) in vaccines. Developed syngeneic mice tumor models by inducing tumors in immunocompetent mice. Conducted in vivo efficacy studies of cancer therapeutic vaccines in these models. Performed stability studies of vaccines and other antigenic proteins as potential vaccine candidates. Proteomics Techniques: Conducted protein estimation, SDS PAGE, gradient gel electrophoresis, and Western blotting (WB). Performed immunization and antibody titer detection (Dot Blot). Conducted SRID and flow cytometry studies for protein expression (both surface and intracellular). Assessed target cell lysis by T lymphocytes.