FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation Announce a Workshop Entitled “Assessing Changes in Pharmacokinetics of Drugs in Liver Disease”

FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation Announce a Workshop Entitled “Assessing Changes in Pharmacokinetics of Drugs in Liver Disease”

The U.S. Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will host a virtual public workshop entitled “Assessing Changes in Pharmacokinetics of Drugs in Liver Disease” on October 8, 2020. This workshop will bring together stakeholders from FDA, academia, and industry in a virtual setting to discuss advances to improve assessing the impact of hepatic function on the pharmacokinetics and pharmacodynamics of a drug. Drug development for a target population includes patients with various comorbidities, including liver disease. Patients with liver disease can have a decreased capacity to eliminate drugs via the liver and may require dosage adjustments. Dosage adjustment is typically based on bridging pharmacokinetic parameters between a hepatically impaired population to a population with normal hepatic function and requires reliable biomarkers that identify and classify the underlying hepatic dysfunction and also reflect the trajectory of changes in biotransformation capacity due to liver disease. While current FDA guidance has been the standard for evaluating the impact of impaired hepatic function on the pharmacokinetics of new drugs, challenges in implementation include difficulties in enrolling patients, delays in hepatic impairment studies until late in drug development, and the fact that current markers of hepatic function are more relevant for patients with cirrhosis. Key topics of discussion include: Relevant biomarkers and their predictive ability to identify changes in biotransformation and transport capacity of the liver Classification of degree of impairment in biotransformation and transport capacity of the diseased liver to aid drug development and dosing recommendations Research on potential differences in pharmacokinetics in different underlying liver diseases Research on the potential to utilize modelling and simulation approaches to obtain dosing recommendations in patients with impaired hepatic function. The date, time, and location of the workshop are as follows: Date: October 8, 2020 Time: 10:00 am - 4:00 pm Location: This is a virtual public workshop For more information on this workshop, please visit: https://cersi.umd.edu/event/15266/m-cersi-workshop-assessing-changes-in-pharmacokinetics-of-drugs-in-liver-disease. To register, visit https://bioeumd.wufoo.com/forms/z1x9mzfe0iic6gi/. If you have any additional questions about this workshop, please contact Ann Anonsen at aanonsen@umd.edu.