Subramanian Senthivinayagam Ph.D.

Led comprehensive preclinical drug discovery and development programs as Principal Investigator and Study Director, overseeing bioanalytical studies, facility establishment, and regulatory compliance to drive scientific innovation and business growth.

• Spearheaded the establishment of a GLP-compliant qRT-PCR facility, including IP/OQ/PQ equipment validation for 21 CFR Part 11 compliance, significantly enhancing in-house bioanalytical capabilities and enhanced revenue by 30%.
• Directed preclinical drug discovery and development programs across oncology, immunology, metabolism nd neuroscience, utilizing diverse bioanalytical platforms (ELISA, MSD, IVIS, qPCR, Flow Cytometry, LC-MS) for comprehensive drug candidate evaluation.
• Designed and oversaw critical DMPK and preclinical efficacy studies for novel investigational drugs, including cell and gene therapy candidates, across multiple disease models.
• Managed and mentored a team of 8-10 research scientists, overseeing in vivo and in vitro activities to ensure timely and on-budget project delivery.
• Authored, reviewed, and approved over 100 study-specific SOPs and related documents, ensuring stringent adherence to GLP, USDA, and FDA regulatory guidelines.
• Developed and implemented novel disease models, expanding service offerings and contributing to significant business revenue growth and client acquisition.
• Led scientific negotiations and provided critical scientific/operational insights for study budgeting and timeline evaluations, optimizing resource allocation and project advancements.
• Cultivated strong client relationships, serving as the primary scientific liaison and subject matter expert to analyze, interpret, and present complex data, driving continued project engagement and expansion.

Optimized downstream process scale-up for CAR-T lentivirus purification for a key client, ensuring efficient and compliant bioprocess development.

• Optimized downstream process scale-up for CAR-T lentivirus purification for Janssen Pharmaceuticals, significantly enhancing production efficiency leading to Carvykti, (Ciltacabtagene autoleucel) BCMA CART
• Executed large-scale lentivirus purification (20L and 50L cell culture suspension) using liquid chromatography (LC) and Tangential Flow Filtration (TFF), leveraging Millistak+ Pod and AKTA-ready systems for high yield.
• Managed comprehensive sample logistics (storage, shipping, tracking) for outsourcing sample testing at external CROs, ensuring accurate evaluation of critical process parameters.
• Authored and maintained essential documentation, including protocols, batch records, dPFDs, BOM, and PPURS, for seamless technology transfer.
• Precisely recorded process data in an electronic lab notebook (BioVia), ensuring data integrity and traceability for regulatory compliance.

Led and managed multiple research projects focused on therapeutic efficacy, disease mechanisms, and animal model development, while securing funding and publishing findings.

• Led research projects evaluating therapeutic efficacy of potential drug targets against immune modulators for MASH and hepatic fibrosis, advancing understanding of disease mechanisms.
• Directed a key project investigating Pannexin 1's role in regulating thermogenesis, obesity, and cardiovascular functions, contributing to novel scientific insights.
• Secured internal research funding by successfully writing and submitting grant proposals to UVA committees, supporting critical scientific endeavors.
• Authored and published multiple original research articles in top-tier peer-reviewed journals, disseminating key scientific findings to the broader community.
• Orchestrated cross-departmental collaborations (Radiology, Endocrinology, Cardiovascular Research Institute) to develop and implement innovative research techniques.
• Developed novel cell-type specific animal models (Cre-loxP system) for in vivo functional evaluation, accelerating research insights and capabilities.
• Mentored and trained 4 junior researchers (one summer research student, one undergraduate, two technicians) in experimental design, data interpretation, and presentation.

Managed and executed multiple research projects focused on protein interaction, cell line development, and biomarker analysis, contributing to significant scientific discoveries.

• Developed and optimized novel fluorescence resonance energy transfer (FRET)-based analysis, elucidating protein-protein interactions between Plin2 and SNAP23.
• Led projects to establish stable cell lines expressing fluorescent-tagged proteins, defining structure-function relationships related to lipid droplet targeting.
• Managed a collaborative study demonstrating Plin2's direct binding and transfer of lipids to/from lipid droplets, advancing lipid metabolism research.
• Designed and led studies using liver-specific Plin2 mice, demonstrating protection against high fructose and MCD-diet-induced MASH development.
• Led biomarker analysis studies, monitoring hepatic functions (ALT, AST, ALP) and assessing glucose intolerance/insulin resistance (GTT, ITT) to evaluate metabolic health.

Managed and executed multiple research projects focused on cancer cell biology, including mechanism of action studies, preclinical model development, and in vivo imaging.

• Managed and executed multiple concurrent research projects focused on cancer biology, ensuring efficient progress and impactful outcomes.
• Authored scientific manuscripts, leading to successful publication in peer-reviewed journals, disseminating key research findings.
• Led mechanism of action studies, validating small molecules/biologics to enhance TRAIL-mediated killing in drug-resistant prostate, gastric, and ovarian tumor cells.
• Validated a novel combination therapy (TRAIL + Troglitazone) as an effective in vitro tumor-killing strategy against drug-resistant prostate and cancer cells.
• Established robust in vivo preclinical models for gastric and prostate cancer metastasis in SCID/immunocompromised mice, enabling advanced disease modeling.
• Utilized whole animal bioluminescent imaging (BLI) for real-time visualization of metastatic tumors in live animal models, enhancing research capabilities.

Managed and contributed to a research project investigating the role of prostaglandins, supporting fundamental biological research.

• Managed and contributed to a research project investigating the role of prostaglandins, advancing understanding of their physiological functions.
• Managed ordering and supply of consumables and equipment for laboratory research, ensuring operational efficiency.

Executed research projects investigating urokinase-type plasminogen activator receptor (uPAR) in cancer, analyzing its role in cell survival and proliferation.

• Managed and executed a research project investigating uPAR's role in cancer cell survival and proliferation, contributing to cancer biology insights.
• Demonstrated that cancer cells with varying proliferative capacities exhibit differential uPAR expressions, identifying a key cellular characteristic.
• Analyzed the impact of RNAi-mediated uPAR knockdown on prostate cancer cell proliferation, providing insights into potential therapeutic targets.

Investigated oligomerization of reproductive hormones and engineered novel plasmid constructs for G-protein coupled receptor studies.

• Investigated the oligomerization of reproductive hormones (FSH, LH), advancing understanding of their functional mechanisms.
• Engineered novel tricistronic plasmid constructs for stable expression of differentially tagged receptors, verifying GPCR dimerization via co-immunoprecipitation.
• Conducted radioimmunoassays to quantify cAMP production in response to chimeric receptor ligand stimulation, validating receptor function.

Conducted extensive research on reproductive toxicology of heavy metal pollutants, optimized bioanalytical methods, and authored scientific publications.

• Investigated reproductive toxicity of the environmental heavy metal pollutant, chromium, using rodent, primate models, and clinical samples.
• Optimized bioanalytical methods for enzymatic and non-enzymatic antioxidants in primate tissues, improving analytical efficiency.
• Authored questionnaires and consent forms for ethical collection of samples from workers in the tanning industry.
• Analyzed and presented research data at national scientific meetings, contributing to scientific discourse.
• Authored and submitted original research articles for publication in peer-reviewed journals, disseminating findings.

Awarded for outstanding team care and collaboration during Q2 2022.

Recognized for exceeding client's expectations and providing superlative service.

Authored research on Pannexin-1 channels' role in adaptive thermogenesis in brown adipose tissue.

Co-authored research demonstrating Perilipin 2's role in alleviating hepatic steatosis.

Co-authored research on Disabled homolog 2's control over macrophage polarization and inflammation.

Co-authored research on structure-function relationship of lipid droplet protein, perilipin 2

Authored research on Plin2's inhibition of glucose uptake through SNAP23 interaction.

Co-authored research on Plin2's direct interaction with lipids on lipid droplets using FRET analysis.

Co-authored research on structural organization in lipid droplet membrane

Co-authored research on Mixed lineage kinase 3's modulation of β-catenin signaling in cancer.

Co-authored research on elucidating the mechanism(s) of gastrin mediated cancer cell metastasis.

Authored research on mechanism(s) of drug resistance underlying cancer cell survival.

Authored research on altered epididymal structure and function causing reproductive toxicity due to chromium exposure.

Authored research on oxidative stress mechanism(s) induced reproductive toxicity.

Authored research on structural changes in epididymis induced by chronic chromium exposure

Co-authored research on the development of a novel contraceptive candidate

Co-Authored research on prostatic functions with altered thyroid hormone status.

Co-authored research on the identification of a novel prostate-thyroid axis.