Throughout his career, Dr. Steele has led the nonclinical safety evaluation of a wide range of small molecule and biologic therapeutic candidates across multiple therapeutic areas, including oncology, metabolic disease, neuroscience, inflammation, virology, and diagnostic imaging. His work spans the full arc of nonclinical development—from early discovery strategy through IND-enabling programs and global regulatory submissions. He has authored or co-authored the nonclinical sections of numerous successful IND, NDA, and MAA submissions, and has contributed to peer-reviewed scientific publications. A defining strength of Dr. Steele’s approach is the ability to rapidly identify development-limiting safety risks, interpret complex or unexpected findings, and construct scientifically sound, regulator-defensible strategies to address them. His guidance is grounded in a deep understanding of how regulators evaluate nonclinical data and what distinguishes a strong safety narrative from one that invites questions or delay. While toxicology is his core expertise, Dr. Steele’s experience as both an FDA reviewer and a senior industry toxicology leader provides well-rounded perspective across related disciplines, including safety pharmacology, pharmacokinetics, and ADME. His written and verbal communication style emphasizes clarity, precision, and meaningful scientific context.

How NCSS Supports Clients

NCSS is frequently engaged to support complex or high-stakes nonclinical challenges, including:

• Nonclinical safety strategy and expert toxicology consulting
• Regulatory strategy, risk assessment, and gap resolution
• Authoring and review of nonclinical sections for regulatory submissions
• Preclinical study strategy and scientific oversight
• Due diligence reviews, impurity assessments, and safety liability evaluation

NCSS collaborates closely with internal development teams, external CROs, and global stakeholders to ensure nonclinical safety strategies remain aligned with overall program objectives and regulatory expectations.

Our Philosophy

NCSS was founded on the principle that effective nonclinical safety strategy requires more than data—it requires experienced scientific judgment. Every program presents unique challenges, and NCSS tailors its guidance to the specific biology, modality, and regulatory context of each asset. Whether supporting a single critical decision or serving as a long-term scientific advisor, NCSS provides clear, objective, and regulator-informed toxicology guidance designed to reduce uncertainty and support confident development decisions. Request a consultation to discuss how NCSS can support your nonclinical development strategy.