Bilva Nitin Burkule

• Supported and advanced in vivo studies for drug candidate development targeting eye-related diseases, as part of the Ophthalmology program.
• Evaluated various pre-clinical models to test the efficacy, safety, and toxicity of ophthalmic AAV-based prime editor drug candidates to treat Inherited Retinal Indications.
• Independently developed and performed assays to assess Prime Editing component expression, and the expression of inflammatory markers in murine and human retinal tissues, as per GLP regulations.
• Conducted QC testing, wrote SOPs, analyzed, and compiled data sets for ocular AAV-based prime editor drug products, as per FDA guidelines.
• Assisted in generating a comprehensive data package for IND-enabling studies and FDA review of the drug candidate for Retinitis Pigmentosa.
• Managed interactions with CROs for imaging-based projects for the Ophthalmology program.
• Analyzed data sets using specialized software, presented findings to the scientific team, maintained contemporaneous, accurate experimental records, and wrote scientific protocols in Benchling ELN.
• Trained colleagues and interns on experimental protocols.

• Assisted in the development of a novel drug discovery platform to identify and test 'gene rewriter' therapeutic candidates for rare and genetic disorders, as part of the R&D team.
• Designed and wrote protocols for high-throughput screens performed to test gene 'gene rewriter' molecules in-vitro, and validated results through lead finding and hit validation.
• Performed cell and molecular biology experiments according to GLP standards.
• Independently managed projects for multiple rare and genetic indications by conducting pooled screens, identifying lead candidates, analyzing, and compiling data sets to advance candidates for drug product development, and IND-enabling activities.
• Worked on reviewing scientific protocols for data quality and accuracy in Benchling ELN entries supplied by scientists.
• Communicated experimental findings in team meetings, and maintained contemporaneous and accurate records in Benchling ELN.

• Aims of graduate research dissertation projects on colorectal cancer (CRC):

1. To determine the biodistribution profile of modified exosomes using a murine CRC model

• Demonstrated biodistribution of modified EVs in relevant organs in CRC, including spleen, liver, and lung

2. To evaluate the metabolic profile of modified colorectal cancer cells and cancer cell-derived exosomes using the Seahorse Extracellular Flux Analyzer

• Demonstrated that there is an altered mitochondrial respiratory and glycolytic profile in modified CRC cells and in the EVs derived from these cells

· Developed a bioanalytical method for testing the phytoconstituents levels in preclinical brain samples.

· Optimized different parameters including type of solvent, ratios of the solvent system, and columns used for bioanalysis of the phytoconstituents utilizing HPLC.

Department: Formulation and Analytical R&D

• Performed tablet compression, in-process quality control tests (weight variation, hardness, friability), and coating for oral solid dosage forms.
• Performed calibration of dissolution apparatus and dissolution study of oral solid dosage forms.