Human Predictions Receives a Grant to Enhance Accessibility and Efficiency of Noncompartmental Analysis for Medical Regulatory Submissions

BOSTON – November 6, 2024

• Grant from the Bill & Melinda Gates Foundation will help facilitate enhanced usability and automation of PKNCA for regulatory review, especially in low-and-middle income countries.

BOSTON – Human Predictions, LLC, an innovator in efficient drug development, announced today it has received a grant from the Bill & Melinda Gates Foundation to enhance PKNCA – a widely-used Noncompartmental Analysis (NCA) program – by simplifying its use, automating key functions and expanding its graphical user interface. PKNCA is an open-source package based on the R programming language which allows NCA in a reproducible and validated manner.

PKNCA was developed by Human Predictions, LLC to support regulated submissions of NCA for clinical and nonclinical studies of pharmacokinetics. PKNCA has been used in multiple regulatory submissions for novel and generic medications and by academic investigators, industry scientists, and drug regulators throughout the world. Many researchers lack access to cost-prohibitive commercial NCA software, limiting their ability to conduct high-quality pharmacokinetic research. The grant hopes to reduce the cost burden and improve access to a regulatory-grade NCA program thereby facilitating more efficient and cost-effective research and regulatory processes. In addition, the work for this grant can be foundational in artificial intelligence support of NCA and generic drug approval support tools.

“We are excited to receive this grant from the Bill & Melinda Gates Foundation support efforts to improve access to NCA, especially in low-and-middle income countries. Starting in 2015, Human Predictions developed PKNCA with a goal of enabling pharmacokinetic scientists to have access to high-quality, regulatory-grade NCA tools,” said Bill Denney, CEO and Chief Scientific Officer, Human Predictions. “Currently, PKNCA supports analysis in academic, regulatory, and industry settings. With support from this grant, we’re excited to improve PKNCA automation and expand the audience for its use while helping make drug review more efficient.”

Human Predictions, LLC focuses on pharmacometrics and clinical pharmacology analysis. Its specialty is integrating many sources and types of data to increase the precision of client knowledge. Human Predictions has experience helping decision makers and clinical development teams with clinical development strategy, regulatory interactions and filings, in-licensing and out-licensing, clinical and nonclinical study design, and comparing standard of care to novel therapeutics. It collaborates with clients to focus drug development with efficient clinical trials, to perform novel analyses, and to convert unconnected data into actionable knowledge.