Ashley Newberry

Versatile certified clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities.

• Certified Clinical Research Professional, CCRP
• Basic Life Support, BLS
• Good Clinical Practice (GCP)
• Human Subject Protection
• Fundamentals of Clinical and Translational Science (FunCaTS)
• Nonviolent Crisis Intervention
• Bronze Mayo Quality Fellow

• Society of Clinical Research Associates (SOCRA)
• Florida Society of Clinical Oncology (FLASCO)

• Phases 1 Oncology Trials
• Hematology/Oncology
• CAR-T Cell Therapy
• Bone Marrow Transplant
• Infectious Diseases/Covid-19
• Inpatient/Hospital Trials
• Solid Tumor
• Neurology
• Breast Cancer
• Device Studies

CAR-T Studies

• P-BCMA-101-001: Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-101 in Subjects with Relapsed/Refractory Multiple Myeloma (MM) Followed by a Phase 2 Assessment of Response and Safety. Poseida Therapeutics
• P-BCMA-101-002: Open Label, Multicenter, Long-Term Follow-Up Study for Subjects Treated with P-BCMA-101. Poseida Therapeutics
• BELINDA: Tisagenlecleucel versus Standard of Care in Adult Patients with Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma; A Randomized, Open-Label, Phase 3 Trial. Novartis and Kymriah
• TRANSCEND: An Open-Label, Phase 1/2 Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. Juno Therapeutics
• TRANSFORM: A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas. Celgene
• UT-201502 Long-Term Follow-Up Study of Subjects Treated with an Autologous T Cell Product Expressing an Antibody Coupled T Cell Receptor (ACTR). Cogent Biosciences, Inc.
• ZUMA-14: A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination with Rituxamab in Subjects with Refractory Large B-Cell Lymphoma. Gilead and Yescarta

Hematology/Oncology Studies

• A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb@14045 in Patients with CD123-Expressing Hematological Malignancies..;21 Versus Standard ;Triplet Regimens in Subjects With Relapsed and Refractory Multiple Myeloma. KARMMA-3.
• A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb@14045 in Patients with CD123-Expressing Hematological Malignancies.
• A Multi Center, Pivotal Phase 3 Study of Iomab-B Prior to Allogenic Hematopoietic Cell Transplantation versus Conventional Care in Older Subjects with Active, Relapsed or Refractory Acute Myeloid Leukemia.
• An Open-Label, Multi Center Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 for Subjects with Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia.
• Beat AML: Study of Biomarker-Based Treatment of Acute Myeloid Leukemia.
• Managed Access Program (MAP) to Provide Access to CTL019, for Acute Lymphoblastic Leukemia (ALL) or Large B-cell Lymphoma patients without Specification Leukapheresis product and/or Manufactured Tisagenlecleucel out of Specification for Commercial Release.
• Evaluation of Skin Microbiome in Patients Undergoing Allogenic Hematopoietic Stem Cell Transplant. AlloHSCT.
• A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft Versus Host Disease in Adult and Pediatric Patients After Allogenic Hematopoietic Stem Cell Transplant. JZP963-201.
• A Phase 1/2 Study of INCB53914 in Subjects with Advanced Malignancies.
• A Phase 2, Multi Center, Open-Label Study to Evaluate the Efficacy and Safety of Luspatercept in Subjects with Myeloproliferative Neoplasm-Associated Myelofibrosis and Anemia with and without Red Blood Cell Transfusion Dependence. ACE-536-MF.
• A Phase 1/2, Open-Label, Dose-Escalation, Multi Center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered NS-018 in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis.

Solid Tumor Studies

• IMP7068-101: A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of the WEE1 Inhibitor IMP7068 Monotherapy in Patients with Advanced Solid Tumors. Impact Therapeutics
• TTI-621-01: A Phase 1a/1b Dose Escalation and Expansion Trial of TTI-621, a Novel Biologic Targeting CD47, in Subjects with Relapsed or Refractory Hematologic Malignancies and Selected Solid Tumors. Trillium Therapeutics Inc.

Breast Cancer Studies

• IMP321-P016-AIPAC-003: A randomized, double-blind, placebo-controlled Phase 3 trial testing eftilagimod alpha (soluble LAG-3) in HER2-neg/low metastatic breast cancer patients receiving paclitaxel, following an open-label dose optimization. Immutep

Device Studies

• LUNAR: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields) concurrent with standard of care therapies for treatment of stage 4 non-small cell lung cancer (NSCLC) following platinum failure. Novocure

Neurological Studies

• GBM AGILE/GCAR-7213: A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma. Phase 2 and 3. Global Coalition for Adaptive Research
• RAISE: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus. Phase 3. Marinus Pharmaceuticals

COVID 19 Studies