Poulami Datta PhD

• Led end-to-end translational biomarker and clinical assay strategies across global Phase 1–3 infectious disease and immunology programs, including pneumococcal, gonorrhea, and EBV vaccine initiatives. • Developed UAD assays supporting real-world evidence (RWE), serotype-specific surveillance, and clinical/public health insights. • Delivered fit-for-purpose, GxP-compliant biomarker assays generating high-quality clinical data for development and regulatory submissions. • Directed CRO partnerships, global sample logistics, and cross-functional operations to ensure timely, high-quality data delivery. • Managed and mentored scientific teams across global programs, driving execution, collaboration, and operational alignment. • Led development and optimization of high-throughput serological and neutralization assays across vaccine and immunology programs. • Drove automation strategies, platform transitions, and scalable workflows, improving throughput, efficiency, reproducibility, and delivery timelines. • Collaborated with data analytics teams to integrate biomarker, assay, and clinical datasets supporting translational insights and AI-enabled decision-making. • Partnered across R&D, Clinical, Regulatory, QA, Manufacturing, CROs, and external collaborators to support integrated program execution. • Directed vendor partnerships, contract negotiations, and multi-million-dollar budgets supporting operational scalability and program delivery. • Led assay tech transfer, qualification, validation, QC strategy, audit readiness, and GxP-compliant regulatory documentation. • Contributed to portfolio strategy, resource planning, risk mitigation, and budget allocation across global translational and clinical programs. Key Impact Accelerated global vaccine program timelines by 20–30%, improved assay throughput and operational efficiency, and delivered high-quality clinical data supporting regulatory submissions, portfolio decisions, and pipeline advancement.

•Led serological assay development (Luminex/MSD) for high-priority vaccine programs, including Pneumo Next Gen (AFX3772), Klebsiella pneumoniae, and Pseudomonas aeruginosa, driving timelines from early development to clinical readiness. •Spearheaded assay design and optimization, implementing high-throughput Luminex-based solutions that accelerated program milestones and strengthened pipeline readiness. •Managed and mentored a team of scientists, building technical expertise, fostering career growth, and ensuring delivery of high-quality, decision-enabling data. •Collaborated cross-functionally with R&D, Clinical, and Regulatory teams, reporting directly to the Executive Director to align assay strategies with organizational and program priorities. •Contributed to strategic acquisition activities, providing scientific and operational support that strengthened the company’s value proposition during the GSK acquisition and ensured seamless integration of critical vaccine programs. •Delivered measurable impact by improving assay throughput, shortening development timelines, and generating high-quality clinical data to support regulatory submissions and business decisions.

•Led translational research programs investigating adipose tissue and adipokines in scleroderma and skin fibrosis, leveraging patient samples, organoids, primary human cells, and mouse models to connect preclinical findings with clinical disease biology. •Translated preclinical discoveries into Phase 1 clinical studies, supporting IRB preparation, patient cohort selection, and enrollment to ensure smooth progression from bench to clinic. •Applied multi-omics platforms—including transcriptomics, genomics, proteomics, spatial genomics, and histopathology—to elucidate disease mechanisms and identify novel therapeutic targets. •Published high-impact scientific findings and mentored PhD, postdoctoral, and Master’s trainees, strengthening research capacity and fostering scientific development within the team. •Delivered measurable impact by generating actionable insights that informed clinical study design and advanced understanding of disease mechanisms.

•Led research programs identifying therapeutic targets and biomarkers for idiopathic pulmonary fibrosis (IPF), leveraging human primary lung fibroblasts and mouse models to support early-stage biotech development. •Developed and optimized a precision-cut lung slice (PCLS) model using human and murine tissue to evaluate antibody therapies in ex vivo systems, accelerating preclinical decision-making. •Investigated mechanistic effects of novel antifibrotic treatments at the genomic and single-cell level using Illumina NGS and single-cell sequencing, generating actionable translational insights. •Conducted industry-sponsored studies assessing pipeline therapeutics using human lung biopsy samples, ensuring data reliability and clinical relevance. •Collaborated with multidisciplinary teams—including pathologists, bioinformaticians, and clinicians—to integrate translational insights across research, preclinical, and clinical domains. •Managed day-to-day lab operations, scientific planning, and cross-team research efforts, ensuring timely program delivery within operational constraints. •Delivered measurable impact by generating preclinical evidence that informed early therapeutic strategies and supported the startup’s initial growth and strategic direction.

•Led translational research programs investigating the metabolic and molecular mechanisms of obesity-induced osteoarthritis (OA), integrating metabolomics, genomics, and preclinical models—including gene knockout mice—to drive therapeutic insights. •Identified novel metabolic biomarkers and obesity-driven signaling pathways, securing >$30K in research funding, publishing multiple peer-reviewed articles, and receiving media and conference recognition. •Directed NGS-based projects using in-house Illumina pipelines to uncover mechanisms of action for small-molecule inhibitors and discover novel miRNAs, advancing obesity-targeted translational therapeutics. •Independently managed multiple preclinical programs, designing and validating disease models, gene knockout studies, pharmacological assays, and biological experiments under tight timelines. •Oversaw animal study protocols (IACUC/IUPS) and clinical research activities, including IRB preparation, patient recruitment, and biofluid collection, ensuring regulatory compliance and translational relevance. •Collaborated with orthopedic surgeons, bioinformaticians, biostatisticians, and industry partners to enhance scientific rigor, translational impact, and data-driven decision-making. •Ensured GCP and GLP compliance across all experimental and clinical workflows. •Mentored PhD and Master’s trainees, fostering scientific growth and cross-functional team development. •Published high-impact manuscripts and presented at conferences, enhancing the visibility and influence of translational obesity and metabolic research programs.

• Showed the scientific background of using tea as a natural herbal treatment for curing inflammation, bone and joint disease • Used gold nanoparticles/gold nanoparticles tagged drugs and other herbal treatment for treatment of different human pathophysiological diseases • Collaborated and managed different interdisciplinary projects • Efficiently managed lab resources, leading to an increased productivity with high quality results • Efficiently published the result in journals

•In a team of 5 identified a pure bio active compound from venom by using protein purification, isolation technique •Played leading role in drug discovery for better treatment of inflammatory diseases •Managed the project single handed with minimal supervision and successfully completed the project with publication in top venom related journal •Successfully designed pharmacological experiments, mouse models of inflammatory disease and analysed the data

• Managed the project with leadership skills • Successfully developed the pre clinical models of different joint diseases and hepatic diseases and performed biochemical assays

• Delivered lectures in Human physiology, Immunology, Pharmacology and Anatomy at undergraduate and graduate level • Trained and supervised students with histology techniques, pharmacology in vivo models

During this time I learnt different molecular techniques, in vivo models that helped me in persuing my PhD program.