Regulatory Science Program

Overview

The Problem

Current tools and methodologies used by the pharmaceutical industry for drug development programs are outdated, inefficient, and non-informative. In 2021, the European Medicines Agency (EMA) published a report on Regulatory Science Research Needs which outlines the gaps in regulatory science to improve medicine development and evaluation. This EMA report identified over 100 topics with the intention of stimulating researchers and funding organizations to work towards addressing these challenges and accelerating medicines development.

The Solution

The Regulatory Science Program leads regulatory strategy development and brings together interdisciplinary scientific expertise from academia, industry, regulatory authorities, and patient perspectives to generate tangible tools and methodologies for adoption in clinical trials and drug development programs. In addition, the Regulatory Science Program provides cross-functional support of regulatory submissions to put forth actionable solutions for regulatory review and receive endorsements of new tools, standards, and methodologies that may be used to assess safety and efficacy of novel therapies. Regulatory Science is the science of developing novel tools, standards, and methodologies to assess safety, efficacy, quality, and performance of an approved medical product.

The Impact

Through cross-functional collaborations with the Data Collaboration Center, Rare Disease Cures Accelerator-Data and Analytics Platform, Quantitative Medicine, and Regulatory Science, C-Path develops novel tools and methodologies, based on science and data-sharing, that modernize clinical trial design, increase efficiency of drug development, and inform regulatory decision making.

Since its inception in 2005, C-Path has demonstrated itself to be a global leader in developing novel tools and methodologies that have been adopted by the pharmaceutical industry in the development of new medical therapies. Through collaborative efforts with regulatory authorities, pharmaceutical companies, and patients/patient groups, C-Path Consortia and Programs have led the development of novel trial simulation tools, disease progression models, novel biomarkers, endpoints, and outcome assessments.