The Ivy Brain Tumor Center, the largest early-phase drug development program for brain cancer in the world, announced that its Pharmacodynamics (PD) Core and Pharmacokinetics (PK) Core laboratories passed their inspection and maintained accreditation by the Accreditation Committee of the College of American Pathologists (CAP). The results were determined from a recent on-site inspection conducted by CAP inspectors who are practicing pathology and laboratory medicine professionals.
The CAP’s Laboratory Accreditation Program ensures excellence in the quality, accuracy and consistency of laboratory testing. To maintain compliance, rigorous workflows, standard operating procedures, and personnel are tightly regulated which ensures that laboratories operate at the highest standards to deliver quality patient care. During the CAP accreditation process, inspectors examine the laboratory’s records from the previous two years, including the quality control of procedures, staff qualifications, equipment, facilities, safety program and record, and overall management.
“We’re thrilled to once again receive CAP accreditation for our core labs, which operate at an accelerated pace to discover new treatment options for brain tumor patients,” said Nader Sanai, MD, director of the Ivy Brain Tumor Center and director of neurosurgical oncology at Barrow Neurological Institute. “The results obtained in the PK Core within each ongoing clinical trial, along with the data received from the PD Core, enable our team to directly implement the most efficient regimens for brain tumor treatment.”
The Ivy Brain Tumor Center’s early-phase clinical trials program is designed to interrogate brain penetration and target modulation properties of new-in-class drugs or modalities. Based on personalized precision medicine, each patient participating in our Phase 0 studies has the unique prospect of advancing to an expansion phase and begin taking the drug therapeutically based on the results from our PK and PD labs.
“The Ivy Brain Tumor Center’s Pharmacodynamics and Pharmacokinetics Core Laboratories demonstrates leadership, innovation, and a passionate commitment to standards of excellence while providing the highest quality services, ultimately for patients,” said Richard M. Scanlan, MD, FCAP, chair of the CAP’s Council on Accreditation. “The CAP congratulates the Ivy Center on its recent CAP Accreditation.”
The CAP certified Pharmacokinetics (PK) Core laboratory, also referred to as the “Tovmasyan Laboratory,” under the leadership of Artak Tovmasyan, PhD, investigates if the drug agent can penetrate the blood-brain barrier and reach the brain tumor. To address that question, our PK lab utilizes its state-of-the-art analytical platform to develop and validate methods in accordance with CAP standards and requirements. The PK lab provides a broad range of services and pharmacological and pharmaceutical expertise critical in conducting clinical research. Numerous drugs and drug combinations are continuously screened in the lab for their brain penetration to enable their testing in clinical settings.
The CAP/CLIA-certified Pharmacodynamics (PD) Core laboratory, also referred to as the “Tien Laboratory,” under the leadership of An-Chi Tien, PhD, investigates if the drug agent had its intended effect on the tumor. The PD lab has developed and validated a next-generation sequencing panel (IvySeq) focused on identifying genetic mutations in brain tumors, allowing personalized recommendation for trial selection with individual patients. Our analytical assays and biosample collection are validated and carefully monitored to provide trustworthy clinical quality results with the long-term goal of understanding cellular and molecular mechanisms underlying glioma formation — to accelerate the current drug discovery processes for glioma treatment in patients.
For more information about our labs and clinical trials, visit https://www.ivybraintumorcenter.org/.