By integrating trusted methods with innovative approaches, we aim to make drug development regulatory-ready and predictive through the use of in vitro tools and new approach methodologies (NAMs) in preclinical toxicology and translation.
90% of new drug candidates that enter clinical trials fail due to lack of efficacy and non-monitorable toxicity. In 2024 alone, seven clinical programs failed for safety or efficacy after promising preclinical results. The unbearable costs of drug development highlight the need for innovative solutions. The recent announcements from the FDA, EMA, and the UK to phase out animal testing requirements signal a shift towards using in vitro tools and NAMs (New Approach Methodologies). The FDA is committed to reducing and replacing animal testing by encouraging NAM-based nonclinical studies and sponsor engagement to optimize their use across diverse contexts, ultimately supporting drug safety and efficacy in toxicology and enhancing the translation of preclinical findings into clinical success.
SPECCRO is the architect of preclinical drug development strategy, guiding sponsors through every step of the process as a virtual extension of your internal team. Our use of in vitro tools and NAMs enhances the efficacy and safety profile of drug candidates, leading to reduced attrition and animal use, which materially improves the cost and speed of drug development. Industry-leading veterans with advanced degrees and specialty certifications bring decades of experience in building laboratories, leading regulatory interactions on novel toxicology tools, and solving complex pathology issues. Supported by therapeutic expertise, our Data Hub, and chip reproducibility testing lab, we provide curated capabilities that enhance translation beyond what larger organizations sustain or startups access.
Our Human‑Centric NAMs Platform integrates traditional paradigms with NAMs, in vitro tools, and computational models to deliver smarter, human-focused drug development aligned with 3R principles. With decades of experience in laboratory building, regulatory interactions, and complex programmatic challenges, our veteran team offers curated services and capabilities supported by therapeutic expertise in preclinical toxicology. We scale seamlessly to program needs, providing direct communication, personalized collaboration, and Therapeutic Execution Hub expertise that accelerates decisions and streamlines workflows. Acting as an extension of your research team, we define the right endpoints, co‑develop fit‑for‑purpose solutions, and drive IND‑enabling success through effective translation and partnership.
