Deep-domain expertise meets patient-centric, safety-driven solutions to support your oncology product’s needs.
Oncology Sponsors choose UBC because of our depth and breadth of oncology expertise. We support your product’s entire lifecycle. Through clinical development, risk management strategies, and patient access and support, UBC has the streamlined, comprehensive service offerings you require.
UBC has worked with each of the top 50 oncology hospitals in the United States.
Oncology Experience (2011-2019):
Acute Lymphoblastic Leukemia
Acute Myelogenous leukemia
Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Peripheral T-Cell Lymphoma
Polycythemia Vera T cell lymphoma
Colorectal Liver Metastases
Hepatic-Dominant Ocular Melanoma
Medullary Thyroid Cancer
Non small cell lung cancer
Renal cell carcinoma
Small Cell Lung Cancer
Solid Tumor Malignancies
Head and neck
Febrile Neutropenia Chemotherapy
Cancer Associated Pain
We Follow the Latest Trends in Oncology
Development of small molecules and antibodies that block signal transduction pathways and their cell surface receptors remains a critical focus for new cancer therapeutics. In addition, Basket trials and big data strategies have been critically important in efficient identification of significant clinical activity for these new molecules.
UBC has demonstrated extensive experience in these areas as well as experience in signal-seeking trials design. UBC will continue participation in these traditional clinical development avenues, but is excited to address emerging advances in cancer treatment. Areas of particular interest include:
Inhibition of Immune Co-Stimulatory Molecules
Chimeric Antigen Receptor; CAR Tcells
Full Service Clinical Support to Meet Critical Needs
UBC was selected to work with the US Oncology division of a large pharmaceutical company to support a novel protocol-to-patient program. The goal of this program was to link targeted therapy to Patients with pathway activated tumors. There were 9 protocols in total managed by UBC in which full-service provided full service study support including: project management, regulatory, and site contracting support, site management, on site-monitoring, data management, statistics and medical writing. UBC successfully activated the first 5 protocols within 11 months.This was a patient-centric program requiring prior genomic profiling, done as part of usual care, in which Patients were directed by UBC into the appropriate oncology study protocols for randomization. Time from patient identification to dosing was critical. UBC achieved site initiation with an average of 5.9 weeks from the point of site approval to participate.In total, 1070 Patients were enrolled across these protocols. All of the protocols scheduled to have database lock, achieved this milestone on time per the project plan. To achieve this, UBC worked closely with the Sponsor to review data on an ongoing basis through a series of clean batch data reviews.
Post Approval and Safety Support to Meet Regulatory Needs
UBC is currently managing the Medullary Thyroid Carcinoma (MTC) Registry on behalf of four Sponsors with marketed long-acting GLP-1 receptor agonists (LA GLP-1 RA), a class of injectable drugs used to treat Type 2 Diabetes and weight management. There are 28 participating State Cancer Registries (sites) with the goal to capture 75% of US MTC Cases from the approval of the first LA GLP-1 RA medication in 2010 through the next 15+ years post final LA GLP-1RA approval. This currently equates to approximately 6,000 Patients.The MTC Registry is a unique model where Sponsors with marketing authorizations within the LA GLP-1 RA drug-class are collaborating in order to minimize burden to cancer registries, Patients, and physicians. In addition, the registry partners with the American Thyroid Association and the North American Association of Central Cancer Registries (NAACCR), a collaborative umbrella organization for cancer registries, governmental agencies, professional organizations, and private groups in North America interested in improving the quality and use of cancer registry data.
Our experts collaborate with Sponsors in customized design, conduct, and analysis of full-service oncology clinical development programs to make certain that safety and efficacy evidence needs are satisfied for regulatory review.
Because of the toxicities and adverse events that accompany therapy, oncology treatments are closely regulated. UBC has global expertise in managing risks associated with cancer treatments before, during, and after launch. We also have a team of skilled safety scientists, physicians, and medical writers who perform pharmacovigilance activities, and who recognize the unique challenges associated with oncology therapies.
For more information on our oncology experience, please contact us to connect with one of the experts below:
Don A. Gabriel, MD, PhD.
Sr. Director, Medical Oncology and Scientific Strategy
Don A. Gabriel, MD, PhD, joined UBC as Sr. Director, Medical Oncology and Scientific Strategy in 2015. In this role, Dr. Gabriel will support our operational team and support staff on oncology and medical issues and training. Dr. Gabriel was a Professor of Medicine at the University of North Carolina (UNC) at Chapel Hill, where he was a bone marrow transplant physician. He has previously served as Associate Chief of Staff, Assistant Dean for Clinical Services, Acting Chief of Medical Oncology, and Service Chief Liaison of the Division of Hematology/Oncology at UNC. His areas of expertise include oncology, hematology, and the application of physical methods such as light scattering to hemostasis, hematology and oncology. He has also served on NIH and FDA study sections and served on an IRB committee.
Dr. Gabriel completed an internal medicine residency at Massachusetts General Hospital and a Fellowship in Hematology at UNC. He is recognized as a leader in the fields of hematology and oncology, and is a recipient of the Lineberger Cancer Center Distinguished Achievement Award. Dr. Gabriel has served as co- or principal investigator on more than 100 clinical trials. He has published more than 250 research papers and abstracts and presented more than 400 invited lectures. He has served as an authority on oncology-focused topics such as chemotherapy-induced oral mucositis in bone marrow transplantation and hemostasis. Additionally, Dr. Gabriel has authored oncology books and chapters, a Dover monograph on laser light scattering theory and has presented numerous research papers at national and international forums. Lecture topics include a wide range of topics such as coagulation complications of cancer, intravenous therapies, multiple myeloma treatment and the use of various physical instrumentation such as light scattering in clinical medicine.
In addition, Dr. Gabriel has served as a clinical consultant to many leading pharmaceutical companies and is a founder of Invitrox, where he serves as President and Chairman of the Board of Directors. There, he is focused on the development of cell-based assays for diagnostic purposes and drug monitoring.
Don A. Gabriel, MD, PhD.
Sr. Director, Medical Oncology and Scientific Strategy
Dr. Annette Stemhagen
SVP & Chief Scientific Officer
Dr. Annette Stemhagen is an epidemiologist with more than 30 years of public health research experience, including 20 years in safety surveillance of pharmaceutical, biotechnology, and vaccine products. She is the Senior Vice President of Safety, Epidemiology, Registries and Risk Management within United BioSource, where she provides strategic consultative services to pharmaceutical, biotech, and medical device clients.
Dr. Stemhagen has specific expertise in safety surveillance and design, implementation, and analysis of epidemiologic studies, registries, large streamlined safety studies, and actual use and observational studies for products in Phase IIIb and post approval. She has designed and evaluated risk assessment studies, including more than 50 regulatory-mandated, long-term global safety studies. She has designed risk intervention programs, risk management evaluation studies, Risk Minimization Action Plans (RiskMAPs), Risk Evaluation and Mitigation Strategies (REMS), and risk minimization programs for EU Risk Management Plans for more than 120 products.
Dr. Stemhagen is active in the International Society for Pharmacoepidemiology and the Drug Information Association. She served on the Board of Directors for each of these organizations. Dr. Stemhagen has held adjunct faculty appointments at the University of Pennsylvania Center for Epidemiology and Biostatistics in the School of Medicine, the Temple University School of Pharmacy, and the Drexel University School of Public Health. In 2004, Dr. Stemhagen was appointed as the first Industry Representative to the FDA Drug Safety and Risk Management Advisory Committee.