Holli Simpson RN, BSN, CCRP

Oversee CRO CRA team

Lead Clinical Research Associate/Monitoring ~ First in Human/Phase 1, 2&3 global clinical trials - Oncology/Immunology/Vaccine/CNS - Oversight Site Management (remote & on-site) Site Qualification, Site Initiation, Interim Monitoring, Close-out visits - CRA Mentor & trainer - Lead CRA/Oversight of CRAs - Vendor/CRO management - SME: EDC, EMR, IWRS, vTMF - Site Liaison Oncology Phase 2/3: Erdafitinib in Participants With Advanced Solid Tumors [Lung, Breast, Brain, Liver, prostrate] and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations • Immuno/Oncology: Phase 1: Safety/Immunogenicity of JNJ-64041757, Live Attenuated Listeria monocytogenes Immunotherapy, Subjects with Non-Small Cell Lung Cancer • Oncology Phase 1: Dose Escalation Study of JNJ-63709178, Humanized CD123 x CD3 DuoBody in Subjects with Relapsed or Refractory AML • Oncology [CAR-T] Phase 1b/2 of JNJ-68284528, a Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against BCMA in Subjects with Relapsed or Refractory Multiple Myeloma • CNS Phase 2; Multicenter Study for Efficacy/Safety of JNJ-63733657, Anti-tau Monoclonal Antibody, in Alzheimer's Disease • Vaccine [COVID] Phase 1 Study Safety, Reactogenicity, Immunogenicity of Ad26COVS1 in Adults 18 to 55yo and Adults 65yo+ (SARS-CoV-2) • Vaccine [COVID].Phase 2 Study: Safety, Reactogenicity, Immunogenicity of Ad26COVS1 in Adolescent Aged 12-17yo and Adults Aged 65+ SARS-CoV-2 • Vaccine PHASE 2: Study of Rilematovir in Adult with Respiratory Syncytial Virus (RSV) • Vaccine/Ebola PHASE 2: Study of 2-dose Vaccine Regimen Using Ad26.ZEBOV and MVA-BN-Filo in Adult Participants • Vaccine [COVID] Phase 2 Study: Safety, Reactogenicity/Immunogenicity of Ad26COVS1 in Adult Pregnant Women 18 to 40yo (SARS-CoV-2) • Vaccine [COVID]: Phase 2/3 Safety, Reactogenicity/Immunogenicity of Ad26COVS1 in Adults 18 to 55yo Inclusive and Adults 65 yo+ (SARS-CoV-2) • Rare Disease: Phase 2: Study of Guselkumab in Participants Familial Adenomatous Polyposis [FAP]

Lead Clinical Research Associate Oversight Project Management of the CRA team and all aspects of the day-to-day activities for Cardiac Device clinical trial projects: • INGEVITY [ImageReady™ MRI Conditional Pacing Implant - Leads] • SAMARI [ImageReady™ MRI Conditional Pacing Implant device] • ENABLE [MRI Conditional Defibrillation System] • NAVIGATE [quadripolar left ventricular (LV) pacing leads for CRT-D] • TRUE HD [safety for the mapping and ablation of various clinical arrhythmias] • ZERO [Airway Retrieval Basket - endoscopically remove foreign bodies in the airway] • LATITUDE™ [CRT & CRTD automatic monitoring system] • ASAP [Left Atrial Appendage Closure - WATCHMAN™] • CAPTIVATE & CAP2 [PaceSafe™ for LVHF] • ELITE [Everolimus-Eluting Platinum Chromium Coronary Stent System]

Oversight project Monitoring of the CRA team including all aspects of the day-to-day activities of clinical trial projects: • Oncology/Vaccine ~ Phase 2: Neoadjuvant Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT) With Algenpantucel-L Vaccine (HyperAcute®-Pancreas) Immunotherapy in Subjects with Borderline Resectable Pancreatic Cancer • Oncology/Vaccine ~ Phase I/II Study: Chemotherapy With or Without Algenpantucel-L Vaccine (HyperAcute®-Pancreas) Immunotherapy in Subjects with Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer • Oncology ~ Phase 2: Study of Docetaxel in Combination with 1-methyl-D-tryptophan (indoximod-IDO Pathway Inhibitor) in Metastatic Breast • Cardiology ~ Phase 2: Inhaled Nitric Oxide with Pulmonary Arterial Hypertension (PAH) • Cardiology ~ Phase 2: Vepoloxamer Injection, in Ambulatory Subjects with Chronic Heart Failure • Cardiology ~ Phase 3: Multicenter, Serelaxin when added to Standard Therapy in Acute Heart Failure Patients • Oncology ~ Phase 1/2 Multiple Myeloma Patients Undergoing Autologous Transplantation • GI ~ Phase 2: ASA for prevention of colon polyps • Immunology/Allergy ~ Phase 2: Pediatric Treatment of Peanut Allergy • Immunology/GI ~ Phase 2: Adalimumab Severe Ulcerative Colitis • CNS Phase 2, Study of Axillary Hyperhidrosis • Cardiology Phase 2, Stem Cells in Patients with a Myocardial Infarction and Ischemic Left Ventricular Dysfunction. • Infectious Disease: Post-market Registry: Sofosbuvir/Velpatasvir Fixed Dose Combination with Ribavirin in Chronic HCV Infected Adults who Participated in a prior Gilead Sponsored HCV Treatment Study [ARBM]

LeadCRA/ Monitor for Phase 2 thru Phase IV trials & Post-Market Registries. TA: Diagnostic Imaging Research (Mammography, MRI, CT), Cardiology (device & pharma)

Medtronics (Cardiology) Data Abstraction GE Healthcare (Device & Pharma) Pfizer (Endocrine, ID)

Lead Clinical Research Associate Oversight of the daily activities of Infectious Disease & CKD Registry studies: · CRA management, mentoring, co-monitoring - Report review - Project management activities Electronic Data Capture software implementation, deployment & utilization review

Monitoring of Clinical Trials - CNS Study start-up to Close-out activities

Clinical Reserach Study Coordinator: - Cardiology - Women's Health

Psychology