Key Points
Drug discovery and development are crucial components of biomedical research aimed at combating diseases. The preclinical phase is foundational but often hampered by inconsistent data replication, leading to a less than 10 percent approval rate for potential pipeline drugs moving from preclinical to Phase 1. This challenge has created a pressing need for alternatives to traditional animal and culture models.
The approval of the FDA Modernization Act 2.0 in December 2022, as part of the broader Consolidated Appropriations Act, has marked a significant shift in biological research. Among the promising new alternatives are Human Biology-inspired Microphysiological Systems (HMS), also known as miniaturized physiological environments. These systems, engineered with microscale precision, offer more physiologically relevant insights for drug development and testing.
Mounting evidence suggests that Microphysiological Systems (MPS) can better predict human tissue responses to drugs compared to animal models and traditional 2D cultures. These systems have empowered the preclinical drug development process by closely emulating human biology. MPS encompasses human organ-on-chips, organoids, tissue explants and 3D cell cultures. Various MPS are being tested across therapeutic areas and regulatory bodies are working proactively to integrate these models into standard testing workflows. The vision for MPS is to be central to preclinical R&D.
Several pharmaceutical companies are already developing and utilizing MPS model systems. To navigate this rapidly evolving area, competitive intelligence consulting and monitoring services are essential for pharma players to stay informed about competitor activities. Strategic collaborations with subject matter experts in competitive intelligence and preclinical research are necessary to generate actionable insights and drive innovation.