Challenges of Incorporating Non-Animal Preclinical Data into Drug Regulatory Applications
Date: Tuesday, December 8th 2020
Time: 8:00am PDT / 11:00am EDT
Duration: 45 minutes
Drug regulatory agencies including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) value human-based methods in drug discovery, and promote the inclusion of data from animal alternatives in new drug applications. Although accepted by regulatory agencies, sponsors submitting these applications are hesitant to include data from in vitro target-based or phenotypic screening assays as alternatives, in the absence of clear guidance from regulators on the use or interpretation of these data. A major challenge for regulators to develop guidelines is the lack of data standardization from these in vitro platforms. Fortunately, various initiatives to bring together constituencies from the regulatory agencies, drug developers, and service providers on this topic are beginning to coalesce. In this interactive roundtable, stakeholders from the FDA and global pharmaceutical companies will discuss the challenges of incorporating in vitro and phenotypic-based preclinical data into regulatory applications. We will discuss organizational, technical, scientific, and leadership barriers as well as possible solutions to the data problem, to improve the characterization and assessment of new drugs and products while concurrently eliminating the unnecessary use of animals in preclinical testing.
Learning Objectives:
- Learn the priorities and concerns of the FDA around accepting human-based in vitro target and phenotypic assay data in new drug applications
- Understand the challenges of standardizing electronic formats and metadata, including the potential for sharing and integration
- Discover opportunities to engage with stakeholders committed to developing standards for non-animal preclinical data
Moderator:
Ellen L Berg, PhD
Chief Scientific Officer, Translational Biology
Eurofins Discovery
Panelists:
Larry Callahan, PhD
Chemist & Lead Scientist
US Food and Drug Administration (FDA, HHS)
Dana Vanderwall, PhD
Director of Biology & Preclinical IT
Information Technology for R&D
Bristol-Myers Squibb
Sonia Roberts, MBA, PhD
Safety Pharmacology Outsourcing/Early Toxicology Project Leader
Roche Innovation Center