Farah Toullier-Garcia

Pangea Laboratory is diagnostics company specializing in the early detection of emerging diseases. The Bladder CARE™ Assay was granted FDA Breakthrough Device Designation in December 2023 as a non-invasive epigenetic assay intended for the quantitative detection of bladder cancer and Upper Tract Urothelial Carcinoma (UTUC)-DNA from urine specimens. • Reporting to the COO, manage study start-up operations of Bladder CARE™ oncology and rare disease clinical trial planning, protocol and case report form (CRF) development, IRB submissions, informed consent form (ICF) development and communication with clinical trial sites. • Serve as primary Sponsor contact for operational project-specific issues and study deliverables. • Maintain in depth knowledge of protocol, therapeutic areas, and indications. • Provide cross-functional oversight of internal project team members and deliverables. • Develop operational project plans. • Manage risk assessment and execution. • Manage site quality, including monitoring deliverables. • Prepare and compile all required documentation for FDA submissions. • Coordinate with internal stakeholders to gather necessary data, reports, and study results for inclusion in submissions. • Conduct thorough reviews of submission documents to ensure accuracy, completeness, and compliance with FDA requirements. • Manage timelines and milestones for FDA submissions to ensure timely and successful completion. • Stay updated on relevant FDA regulations, guidelines, and best practices for clinical trial management and submissions. • Proactively identify regulatory changes or updates that may impact clinical trial programs and develop strategies for compliance. • Conduct regular audits and quality checks to ensure adherence to regulatory requirements and internal standards.

• Conduct Biotech sponsored national, multi-year research study using a Class II Lancet 510(k)-Cleared blood collection device to study serology antibody biomarker immune response differences to the SARS-CoV-2 virus. • Manage enrollment of 2,000 participants nationwide ensuring quality control of Part 21 CFR 11 eConsents & eCRF’s. • Resource allocation, vendor management & project planning to manage 400 participants enrolled in 4 days. • Write IRB protocols, amendments & submit for WCG-IRB approval ensuring ICH-GCP FDA regulatory compliance. • Collaborate with Marketing to develop & implement NPS surveys to maintain study retention rates above 85%. • Stakeholder study metric reporting using CTMS system to track eConsents, eCRFs & hundreds of blood samples. • Cross functional stakeholder management with Marketing, Bioinformatics & Software Development teams. • Complete Good Laboratory Practice (GLP) training course and write GLP SOPs to prepare sponsor for GLP audit. • Develop cost saving measures for the management of DocuSign 21 CFR Part 11 e-consents. • Review & approve 250 SARS-CoV-2 Antibody Analysis subject reports per month. • Create & reconcile study supply purchase orders using Intuit QuickBooks.

The NIH Precision Medicine Initiative seeks to gather genomic biospecimens & health surveys from one million participants across the nation, with the goal of advancing clinical trials & fostering scientific collaborations, particularly focusing on underrepresented populations in clinical research. UCI co-leads the California Precision Medicine Consortium (CAPMC). • Hired, trained, supervised & grew the clinical operations team from 2 Clinical Research Coordinators at 2 sites to 36 team members across 8 sites in Orange County, CA. • Exceeded the site’s annual recruitment goal by 20%, enrolling 12,000 participants, in support of the California Precision Medicine Consortium (CAPMC)'s 20,000 participant yearly target. • Lead the large-scale research program recruiting 800 participants a month by developing & implementing KPI, retention strategies, high volume inventory & participant study compensation management. • Quality Control & Quality Assurance compliance of clinical data & biospecimen collections per NIH & Mayo Clinic Biobank SOPs. • Developed strategic contingency plans to identify and proactively resolve project risks. • Led cross-functional teams to achieve project objectives & deliverables within the specified timelines & budgets. • Protocol development approval from IRB NIH Office for Human Research Protections. • Weekly multidisciplinary leadership team meetings & budget planning with PI & Finance Department. • Collaborated with statisticians to analyze & interpret research data. • Study planning for continuous process improvement. • Facilitated communication & coordination between NIH Program stakeholders, academic researchers, clinicians, administrators & community partners. • Adhered to UC policies, GCP, NIH eCOA, California Bill of Rights, HIPAA, SOPs & confidentiality agreements.

• Created study start-up procedures, new hire training documents, workflows & operation manuals. • Collaborated with PI to develop internal & external stakeholder partnerships to open new study sites. • Conducted study start-up site visits to submit new site applications for NIH & Mayo Clinic Biobank onboarding approval. • Collaborated with Bioinformatics to develop appropriate REDCap EDC KPI metrics to collect vital research information & supervise team productivity across multiple sites. • Ordered & tracked hundreds of blood collection supplies from Mayo Clinic Biobank each month. • Coordinated with vendors to perform equipment calibrations & create marketing collateral for new study sites. • Managed constant communication with NIH, PI’s, co-investigators & CAPMC staff across the state of California. • Participated in weekly leadership team meetings & tracked project deliverables in Confluence.

• Managed 3-4, Phase II & Phase III neurodegenerative pharmaceutical clinical trials in Mild Cognitive Impairment, Alzheimer's Disease & Schizophrenia from study start up to close out sponsored by ADCS, Eisai, Eli Lilly, INC Research, Inventiv Health, Otsuka & vTv Therapeutics. • Maintained & updated Trial Master File (TMF) study start up FDA regulatory compliance documents - 1572s, Financial Disclosure Forms, CVs, medical licenses, signed IB page, protocol amendments & SAE reports. • Data entry & query resolution in Medidata RAVE, Inform, Oracle CTMS Systems & IP IXRS/IVRS. • Managed & prepared site for study start up, Pre-Site Selection Visits (PSSVs) and Site Initiation Visits (SIVs). • Independently managed all aspects of monthly study sponsor audits. • Study supply vendor management and forecasting with LabCorp, PPD & Covance. • Biological sample processing, storage & dry ice shipping. • Recruited & pre-screened more than 200 subjects. • Administered study scales, collected ECGs, vitals & assisted with biomarker lumbar puncture collections. • Coordinated with infusion center, hospital research pharmacy & in EPIC EMR for Alzheimer’s infusion IP. • Constant communication with PI, study physicians & director regarding study progress. • Scheduled research study MRI & PET-TAU scans. • Exercised GCP, followed IHC guidelines as adopted by the FDA, SOPs, hospital research policies, procedures, HIPAA & patient privacy laws. Certified Research MRI Technician • Conduct Pediatric neonatal fMRI protocol evaluating the impact of intrauterine environment on intraindividual variation in brain development outcomes & over the first two years of postnatal life • Follow MRI safety protocols

Dept. of Psychiatry & Human Behavior PI: Curt Sandman, Ph.D.; Elysia Poggi, Ph.D. UCI's Women and Children's Health and Well-Being Project funded by the National Institutes of Health (NIH) The study measures the effects of neonatal exposure to synthetic glucocorticoids, specifically betamethasone, on brain development. • Recruit & consent 50 pregnant English & Spanish speaking women in 12 months • Collect & process maternal biological samples: blood, saliva, & hair, per study protocol • Gross, & collect biopsy placental DNA methylation samples • Behavioral coding & processing of infant cortisol & blood spot samples • Perform standardized psychosocial interviews with 50 pregnant participants • Report generation and data audits using Epic EMR

Licensed CPT 1 Pharmacy Technician. Efficient and accurate typing of prescriptions. Knowledge of pharmaceutical drugs & their uses. Medication inventory and auditing. Administrative duties like answering telephone calls in a timely manner & resolving customer complaints. Submitting medication prior authorization approvals with insurance companies.

Conducted number learning research protocols with children 2 to 5 years old at preschools around UC Irvine. Coordinated weekly schedule with preschool director, teachers, maintained weekly communication with lab manager and attended weekly lab meetings. Guided and trained new research assistants in research protocols and procedures. Provided feedback on new protocols Data entry in database and finished three research papers a year. Presented poster at yearly Southern California Symposium on Cognitive and Language Development at UCLA (08-09) and UC Irvine (07-08).