- Simulations Plus (SLP, Financial) supports the FDA's new roadmap for reducing animal testing in preclinical studies using new approach methodologies (NAMs).
- The company introduces NAMVantage™, combining PBPK and QSP professional services with regulatory strategy and training to aid in the transition.
- The software platforms like GastroPlus, MonolixSuite™, ADMET Predictor®, DILIsym®, and OBESITYsym™ are designed to support this initiative by enabling researchers to reduce or eliminate animal testing.
Simulations Plus, Inc. (SLP), a prominent player in biosimulation and cheminformatics, has announced its support for the FDA's newly introduced roadmap aimed at reducing animal testing in preclinical safety studies. This aligns with the FDA's innovative science approach, featuring new methodologies such as organ-on-a-chip and computational modeling. Simulations Plus's commitment is encapsulated in their NAMVantage™ package, which integrates PBPK and QSP professional services with regulatory strategy, coaching, and training.
SLP's established software platforms, including GastroPlus, MonolixSuite™, ADMET Predictor®, DILIsym®, and OBESITYsym™, are tailored to facilitate the reduction of animal testing. These platforms employ modeling, simulation, and AI/ML technologies to provide human-relevant insights that aid in predicting drug efficacy and safety, underscoring the roadmap's focus on transitioning from traditional animal studies.
The company has successfully collaborated with the FDA on over 15 projects in the past decade, providing them with a deep understanding of regulatory expectations. By leveraging advanced methodologies and computational capabilities, Simulations Plus is strategically positioned to support pharmaceutical companies in aligning with the FDA's roadmap and expediting drug development timelines.
Furthermore, the introduction of NAMVantage™ underscores SLP’s comprehensive offering, encapsulating software, consulting, and regulatory guidance. This positions the company as a pivotal partner for the biopharma sector, particularly as the industry embraces non-animal methodologies to enhance drug discovery and development processes.
