Dr. Ketan Variya

Results-driven bioanalytical and ADME scientist with over 9 years of experience in the drug discovery and development industry. Strong expertise in bioanalytical method development, DMPK strategies, and regulated bioanalysis. Proven ability to lead bioanalytical teams, oversee CRO collaborations, and support IND submissions. Skilled in designing and monitoring in-vitro and in-vivo DMPK studies, optimizing workflows, and contributing to strategic R&D initiatives.

• Actively contributed in developing clinical and regulatory strategies, securing FDA clearance for two IND candidates. • Secured an ICMR grant for a Phase 3 clinical trial in rare disease portfolio. • Initiated and led the modeling and simulation team for PBPK and pop-PK studies.

• Managed a team of 3 scientists to support ADME and PK evaluations of NCEs. • Presented ADME/PK findings to leadership, influencing key drug discovery decisions. • Conducted cost-benefit analyses for CRO selection and study execution.

• Monitor and review DMPK in-vitro & in-vivo bioanalytical activities outsourced to multiple CROs. • Design customized in-vitro ADME and PK studies as per the project need. • Interpret ADME and PK data and derive meaningful conclusions to support medicinal chemist for lead optimization. • Evaluation of ADME problems in the existing therapeutics, work closely with medicinal chemists, BD and IP personnel for quality target product profile and setting AMDE assay filters and cut-offs for screening of NCEs.

• Developed over 100 fit-for-purpose bioanalytical methods for rapid screening of NCEs. • Validation and PK/TK Study sample analysis of plasma and tissue homogenates for GLP-tox and regulatory submissions. • Analyzed samples of in vitro metabolic stability (microsomal, S9, hepatocytes, plasma), transporters, permeability experiments of NCEs. • Documentation as per GLP, report preparation its release through LIMS • Dose formulation analysis for GLP-Tox studies and Genotox studies.

Determination of Protodioscin in Rabbit Plasma by LC-MS/MS Method: Application to Preclinical Pharmacokinetics

Syllabus covering all types of intellectual properties - patent, trademark, copyright, design, trade secret, geographical indications, etc.

Simultaneous Determination of Ritonavir and Atazanavir in Combined Tablet Dosage Form by HPTLC

Pharmacy and Pharmaceutical Sciences