The Congenital and Perinatal Infections Consortium (CPIC) advances research on rare congenital and perinatal viral infections by building on existing relationships with longstanding partners. We welcome collaboration with Rare Diseases Clinical Research Network (RDCRN) consortia and with sites currently outside of the network. In addition to our disease expertise, the CPIC offers both a time-tested research model and advanced pharmacometric expertise.
Through collaboration with the University of Alabama at Birmingham’s Pediatric Pharmacometrics Laboratory led by Edward Acosta, PharmD, we have made strides in understanding antiviral drugs in rare disease populations.
The Pediatric Pharmacometrics Laboratory offers access to mass spectrometry assay development and state-of-the-art pharmacokinetic and pharmacodynamic (PK/PD) data analysis services, assessing both how drugs move within the body and what drugs do to the body. Dr. Acosta and his team are able to quantitatively measure specific analytes in over 110 different compounds. In order to support innovative study designs, novel assay methods are developed under Good Clinical Laboratory Practice (GCLP) conditions and in compliance with current U.S. Food and Drug Administration (FDA) regulations and standards.
The laboratory has undergone five separate FDA audits leading to new or supplemental pediatric drug indications. Additionally, the laboratory conducts noncompartmental pharmacokinetic analyses and applies complex state-of-the-art individual and population-level pharmacokinetics, pharmacodynamics, and drug-disease models to concentration-time and response data.
This collaboration has enhanced our understanding of the development pathways of absorption, distribution, metabolism, and excretion of drugs in children. The Pediatric Pharmacometrics Laboratory and Dr. Acosta’s expertise may also assist other rare disease groups in conducting Phase I and II investigations of drugs for potential treatments.
To discuss opportunities for collaboration, please contact:
David W. Kimberlin, MD
University of Alabama at Birmingham
1600 7th Ave. S.
Children's Harbor Suite 303
Birmingham, AL 35233