Vidya Sundararaman

- late phase and commercial readiness - LNPs, mRNA, ChAd virus, personalized vaccines for oncology and infectious diseases - CMC Core Team; Extended Leadership, - strategy, technical, financial decision making - regulatory strategy (IND, Type C, responses)

- support CAR-T, and gene therapy (AAV / LNP) - establish the vision for the AD group - collaborate with internal departments for seamless transitions - recommend AD roadmap for phase appropriate strategy - continue to grow the AD group with top tier talent - position Poseida as a leader in the cell and gene therapy space

- development optimization and establishment of in process and release assays for CAR-T products - establish critical raw material release for Mfg - grow the AD team with high caliber talent - IND and other regulatory filing

- cell-based potency assays for lot release and stability of GMP drug manufacturing - immunogenicity and NAb assay development - support PK, biomarkers and cytokine analysis - development, qualification and transfer to CROs (US and Europe) - lifecycle monitoring using statistical tools (JMP)

- development, qualification, bridging, and GMP/GLP sample testing - support IND filing and responses to both FDA and European regulators - SOPs, protocols, reports, technical guidance, and work instructions - trend charts and control limits - assay troubleshooting, NC and CAPAs

Developed new assays, platforms, and product verticals in the 'immune-monitoring" space generating increased sales revenue • Developed and optimized Cytotoxicity Assays, simplifying conventional methods, using Fluorescence Imaging • Validated cell-based assays to measure and quantitate ADCC activity and CD8 function • Developed new product portfolio for detecting and measuring cytokine secretion by different T cell lineages • Managed hardware and software (requirements to testing) for the development of high-throughput imaging and analysis of single-cell viability and functionality • Generated alternative applications for existing ELISPOT technology, including miniaturization and multi plexing Led dialogue with existing and potential clients for product optimization and new product initiation Supervised the work of junior researchers, including training, project design, optimization, and review Led and coordinated cross functional dialogue with various internal departments for technology transfers

Assisted Juventas Inc. (Ohio) with preclinical studies Gene therapy for delivering cardiac benefiting drug to infarcted myocardium • Designed a gene vector to express angiogenic proteins for a constitutive period of time • Optimized an imaging platform that can be used as a bioassay to detect the gene of interest • Delivered the gene of interest, non virally, and achieved significant improvement in cardiac function after chronic heart failure • Supported translation of this gene drug towards a clinical setting Identification of novel drugs for treating chronic heart failure • Identified pathways specific to improving cardiac function following stem cell therapy • Utilized microarray technology to identify proteins playing key roles in providing cardiac benefit Development of novel nanopaticle carriers for the delivery of therapeutic genes to the heart • Identified a homing peptide that targets cells in the failing heart • Designed a nanoparticulate delivery carrier to transport the drug/gene of choice to the ailing heart • Delivered a non viral plasmid, encapsulated within nanaoparticles tagged with homing peptides • Achieved significant cardiac benefit capable of translating to clinical settings

Clonal Analysis to determine the function of neural stem cells • Developed a method to obtain single clones of embryonic stem cells • Optimized various micro environments to allow for efficient growth and survival of clonal stem cells. Differentiation of neural stem cells • Differentiated rat cortical embryonic stem cells towards cells of a neural lineage • Optimized various extra cellular matrix compounds and identified an environment for maximal differentiation.

Quantification of collagen secreted by fibroblasts in vitro • Identified non-radioactive methods for collagen quantification • Cultured collagen secreting cardiac fibroblasts • Compared this technique to standard protocols and achieved significant similarity