Therapeutic Areas

Oncology Clinical Development Expertise

Cancer Clinical Development is Complex, Our Experts Can Help

Veristat has extensive experience supporting 700 oncology projects and marketing applications in the United States, Europe, and Japan. We help oncology developers navigate the complexities of designing and executing their cancer trials in the most highly competitive and complicated market. Our extensive expertise includes traditional cancer treatments, devices/diagnostics as well as specialized therapies including vaccines, gene therapies, cell therapies, and immunotherapies.

Oncology Experience

With cancer being the second* leading cause of death today, it’s no wonder that Veristat’s clients are prioritizing their pipelines to develop life-extending cancer therapies. 

Veristat's teams work on a spectrum of amazing cancer treatments including drugs, vaccines, and diagnostics.

  • Cancer clinical development comprises >35% of the work we do
  • Cancer treatments account for 50% of the marketing applications that our teams have prepared, 
  • In the past 5 years, 10 oncology products were approved for NDAs and jNDAs that we prepared

*Source: http://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm

oncology-graphic

 

Experience in Blood Cancers & Solid Tumors

Hematologic Malignancies/Blood Cancers
Acute Myeloid Leukemia (AML) Metastatic Non-Hematologic Malignancies
B-Cell Lymphoma Multiple Myeloma (MM)
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Myelodysplastic Syndromes (MDS)
Chronic Lymphocytic Leukemia (CLL) Myeloid Leukemia
Cutaneous T-Cell Lymphoma (CTCL) Myeloproliferative Neoplasm
Diffuse Large B-Cell Lymphoma (DLBCL) Non-Hodgkin's Lymphoma (NHL)
Essential Thrombocythemia Peripheral T-cell Lymphoma (PTCL)
Follicular Lymphoma Richter's Transformation (RT)
Hodgkin’s Lymphoma Systemic Mastocytosis (SM)
Mantle Cell Lymphoma T Cell Lymphoma
Mantle Cell NHL Waldenstrom's Macroglobulinemia
Solid Tumor Indications
Advanced/Metastatic Solid Tumors Melanoma
Biliary Cancer Non-Small Cell Lung Cancer (NSCLC)
Bladder Cancer Ovarian Cancer
Brain Cancer Pancreatic Cancer
Breast Cancer Prostate Cancer
Cervical Cancer / Dysplasia Rectal Cancer
Cholangiocarcinoma/Bile Duct Renal Cell Carcinoma (RCC)
Colorectal Cancer Small Cell Lung Cancer (SCLC)
Gastric Cancer Synovial Tumors
Head & Neck Tumors Thyroid Cancer
Hepatocellular Carcinoma (HCC) Urothelial Carcinoma
Human Papilloma Virus (HPV) Cancers Vulva Cancer

Customized Oncology Solutions

Cancer Diagnostic Imaging
Lymph Node Imaging - MRI Contract Agent Mammography for Breast Cancer Diagnosis
Lymph Node Imaging for Prostate Cancer
Chemotherapy Side Effects
Chemotherapy-induced Alopecia Chemotherapy Induced Pain Management
Chemotherapy-induced nausea and vomiting (CINV) Chemotherapy Induced Peripheral Neuropathy

Solutions Span Early to Late Phase

Our solutions span the entire clinical development life-cycle - and are offered as a comprehensive, all-inclusive solution or as functional support. We offer strategic guidance for informed decision-making, operational support to mitigate trial risks, the statistical knowledge to prove safety and efficacy, the medical oversight to ensure patient safety, and the regulatory expertise to achieve approval success.

early_to_late_phase_experience

 

Case Study

Approvals for an Ultra-Rare Hematologic Malignancy

Conference Presentation

The Role of Natural History Studies in Ultra-Rare Disease ...

Infographic

Marketing Applications Approval Record