Alex Rodriguez, DABT, ERT

Scientific Leadership: Provide strategic scientific and regulatory leadership for all nonclinical toxicology activities, overseeing safety package while ensuring adherence to global regulatory guidelines Regulatory Expertise: Serve as the nonclinical safety representative in global regulatory interactions (EMA, FDA, NMPA PMDA) and lead the preparation of nonclinical sections in regulatory submissions (INDs, CTAs, NDAs, MAAs) and related documentation (e.g., briefing books, IBs, PIPs/PSPs, labelling) CRO Management: Manage Contract Research Organizations (CROs), consultants, and research institutions, including procurement, contract negotiations, and GLP study oversight Due Diligence and Gap Analysis: Evaluate nonclinical aspects of in-licensing compounds and conduct due diligence and gap analyses on nonclinical data packages Data Analysis and Interpretation: Conduct in-depth analysis and interpretation of nonclinical data to support regulatory decision-making and human risk assessment evaluations Client and Team Collaboration: Serve as subject matter expert (SME) in cross-functional teams, informing portfolio prioritization and representing the function in discussions with regulatory bodies and external partners

Same responsibilities as described in role above

• Led the development of regulatory and scientific strategies to support nonclinical development, registration, and market licensure of GSK-Vaccines' product portfolio ( Live-Attenuated, Inactivated, Toxoid, subunit, viral vector, conjugate, and mRNA (LNPs) vaccines). • Led the preparation, coordination, and sign-off of nonclinical toxicology regulatory sections for INDs, CTAs, BLAs, and MAAs. • Authored nonclinical content and reviewed regulatory documents for new registrations and life-cycle products. • Led face-to-face meetings and communications with regulatory authorities worldwide (EMA, FDA, PMDA, CDE) on nonclinical toxicology matters. • Served as an advisory member of GSK's Toxicology Working Group, defining and approving nonclinical scientific and regulatory strategies. • Evaluated, implemented, and managed strategic business opportunities and outsourcing of nonclinical regulatory activities to CROs. • Provided Toxicological Risk Assessment (TRA) and Extractable & Leachable (L&E) evaluations for vaccine portfolio

• Designed and established clinical genomics laboratories. • Provided operational, strategic, and managerial leadership to Genomics and Toxicology departments. • Spearheaded the selection, clinical validation, and market release of 64 pharmacogenetics biomarker variants. • Directed bioinformatics pipeline development for genomic variant profiling, interpretation, and reporting. • Managed laboratory and bioinformatics staff, vendor selections, and laboratory operations.

• Led in-vivo toxicity IND enabling studies as Principal Investigator and Project Manager. • Directed the design, conduct, and reporting of in-vitro toxicity studies. • Analyzed and reported clinical pathology and safety biomarker toxicology data to support regulatory filings. • Represented GSK on C-PATH's PSTC, validating and qualifying translational biomarkers of cardiac hypertrophy. • Led global genomics teams and cross-functional projects focused on developing biomarker safety strategies.