Benjamin Neter

Detail-oriented Regulatory Coordinator offering 8 years of expertise in research risk management, institutional policy development and research regulations. Advanced knowledge of regulatory compliance with proven track record of partnering with clinical teams and management to ensure all studies are following appropriate guidance as well as identifying vulnerabilities and creating corrective actions when needed. Collaborative and team-oriented with excellent communication and interpersonal skills to foster strategic partnerships and promote company reputation. Experience working with many of the major IRB's, and all phases of trials, including Phase 1 trials and Expanded Access Protocol (EAP) Trials.

• Coursera Course - Google Data Analytics
• Coursera Course - Python For Everybody

Phase 1 Trials

• "A Phase I/II Randomized, Double-blind, Placebo-controlled Trial (1-BETTER) Examining XB2001 (Anti-IL-1a; True Human Antibody) in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer"
• "A Phase 1b/2 Placebo Controlled, Double Blinded Study on the Efficacy and Safety of BXQ-350 in Combination with mFOLFOX7 and Bevacizumab in Newly Diagnosed Metastatic Colorectal Carcinoma"
• "A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 in Patients with Locally Advanced or Metastatic Solid Tumors"
• "A Phase I/IIa First-in-Human Study of [212Pb]VMT-a-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors"
• "Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematologic Malignancies or Solid Tumors"
• "A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Cancer With FGFR2b Overexpression"

Sponsored Trials (non-phase 1)

• "An Open-Label Phase 2 Study of Surufatinib in Patients with Neuroendocrine Tumors in Europe"
• "TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy in Subjects with Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line has an Immune Checkpoint Inhibitor"
• "A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects with Carcinoid Syndrome"
• "A Randomized, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-Fluorouracil/Leucovorin Versus Nab-Paclitaxel plus Gemcitabine in Subjects who have not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas. "
• "A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in combination with Gemcitabine Plus Nab-paclitaxel as Neoadjuvant Treatment in Patients with Locally Advanced, Unresectable Pancreatic Cancer"
• "A Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/PD-L1 Based Immunotherapy"
• "A Pivotal Longitudinal Study of the URO17 Bladder Cancer Recurrence Test as an Indicator of Tumor Recurrence in Patients Previously Diagnosed and Treated for Bladder Cancer"
• "MK7902-002 A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination with Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants with Unresectable Hepatocellular Carcinoma (LEAP-002)"
• "A Phase II Randomized Controlled Trial of Stereotactic Ablative Body Radiotherapy (SAbR) With or Without Neurovascular Sparing for Erectile Function Preservation in Localized Prostate Cancer"
• "Prospective Validation of Prostate Biomarkers for Repeat Biopsy: The PRIORITY Study"
• "A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 Tablet in Adult Patients with Advanced Cholangiocarcinoma"

Expanded Access Protocol (EAP) Studies

• "Expanded Access To Ulixertinib (BVD-523) In Patients With Advanced MAPK Pathway-Altered Malignancies"

National Cancer Institute (NCI) Trials

• "Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)"
• "Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma (AMBASSADOR) Versus Observation"
• "PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab vs. VEGF TKI Cabozantinib with Nivolumab: a Phase III Trial in Metastatic Untreated Renal Cell Cancer [PDIGREE]"
• "MAIN-CAV: Phase 3 Randomized Trial of Maintenance Cabozantinib And Avelumab VS Maintenance Avelumab After First- Line Platinum-Based Chemotherapy in Patients With Metastatic Urothelial Cancer "
• "Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs"
• "A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer (GIANT)"
• "Optimal Perioperative Therapy For Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial"
• "Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate Cancer"
• "A Phase II, Double-Blinded, Placebo Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-androgen Therapy With Apalutamide in Recurrent Prostate Cancer"
• "A Phase II/III Trial of Neoadjuvant FOLFOX With Selective Use of Combined Modality Chemoradiation Versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection With Total Mesorectal Excision (PROSPECT)"
• "Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)"
• "Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease"
• "Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation (PREDICT-RT*)"
• "Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)"
• "Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)"
• "Androgen Deprivation Therapy and High Dose Radiotherapy with or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial"
• "Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer"
• "Randomized Phase II/III Trial of First Line Platinum/Etoposide with or without Atezolizumab (NSC #783608) in Patients with Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)"
• "Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide versus Observation in High-Risk Pancreatic Neuroendocrine Tumors"