ACCP Annual Meeting

Co-Chair, Faculty, and Presenter: Amy SY Cheung, PhD, VP, Certara Drug Development Solutions

Presenter: Karen Yeo, PhD, SVP, Client & Regulatory Strategy, Certara

Presenters: Carrie Malinczak, PhD, Director of Toxicology, Certara | David Wesche, MD, PhD, Vice President, Clinical Pharmacology

Drug development is moving from traditional scaling to advanced modeling that integrates pharmacology, biomarkers, and disease biology. Certara’s framework supports preclinical-to-clinical translation with study design, modeling, and iterative data-driven refinement.

With the FDA encouraging New Approach Methodologies (NAMs) to reduce animal testing, Certara’s Non-Animal Navigator™ helps sponsors implement NAMs through program analysis, tailored development plans, regulatory support, and AI-enabled modeling tools, accelerating development while minimizing animal use.

In this learning lab, we will present case studies highlighting the applications of model-informed translational techniques and applications of NAMs to reduce and even replace the need for animal studies.

Presenters: Piet van der Graaf, PharmD, PhD, SVP and Head of Quantitative Systems Pharmacology, Certara

Presenters: Amin Rostami, PhD, SVP of R&D and Chief Scientific Officer, Certara