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
- Gene Editing
- Microparticle (MP)
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.