New executives bring cross-disciplinary expertise and diversity to the company’s premier global Integrated Drug Development team
PRINCETON, N.J.—May 17, 2021. Certara, Inc, (Nasdaq: CERT), the global leader in biosimulation, announced the appointments of four executives to its growing model-informed drug development team: Dr. Matt Zierhut as Vice President, Model-Based Meta-Analysis, Dr. James Dunyak as Senior Director, Biostatistics and Data Programming, Susan Potts as Senior Director, Biostatistics and Data Programming, and Dr. Josh Xie as Director, Clinical Pharmacology and Translational Medicine.
The Certara Integrated Drug Development (iDD™) team provides drug program stewardship, regulatory strategy, and multi-disciplinary competencies to accelerate and improve the drug development process across therapeutic areas, modalities, and regulatory pathways. By designing and implementing strategies using quantitative science such as pharmacometrics, clinical pharmacology modeling, and model-based meta-analysis, the iDD team partners with drug developers to advance the process of bringing new, safe, and efficacious medications to market faster and more efficiently. Certara’s iDD team continues to grow, with nearly 40 new hires in the past 6 months.
“We are excited to have this experienced and accomplished group join Certara as we continue to build our integrated drug development capabilities to help our customers advance new therapies and target unmet medical needs,” said Dr. Craig Rayner, president of integrated drug development at Certara. “These impressive additions to the team signal continued growth in Certara’s quantitative bench strength and our unparalleled experience in model-informed drug development.”
Dr. Matt Zierhut joins Certara as a Vice President, Model-Based Meta-Analysis (MBMA), a vital area of pharmacometrics, where Certara plays a leading role globally. In this position, Dr. Zierhut will be responsible for driving the continued growth of Certara’s MBMA service offerings, capabilities, and business in the context of the company’s broader data science strategy. He comes to Certara from Janssen Pharmaceuticals, where over the past five years he led the development of its global MBMA capabilities.
Susan Potts joins Certara as U.S. Head and Senior Director of Biostatistics and Data Programming. Potts brings to Certara 30 years of experience in successful regulatory submissions for drugs, biologics, and medical devices. Most recently, Ms. Potts was a senior director of biostatistics at Aeglea BioTherapeutics in Austin, Texas. During her tenure there, she built the biometrics department from the ground up, which consisted of biostatistics, statistical programming, medical writing, and data management.
Dr. James Dunyak brings more than 35 years of experience as statistician, modeler, engineer, and mathematical scientist to his role at Certara as Senior Director of Biostatistics and Data Programming. He was most recently the Senior Director of Clinical Pharmacometrics at AstraZeneca where he led the development of viral dynamics models to support dosing regimen decisions in developing an antibody treatment for COVID-19.
Based in Shanghai, China, Dr. Josh Xie joins Certara as Director of Clinical Pharmacology and Translational Medicine where he will be responsible for further growing collaborations with China-based and multi-national biopharmaceutical companies. Dr. Xie brings more than ten years of experience in clinical pharmacology, including experience in planning, authorship, execution of complex projects, and regulatory interactions in China. Prior to Certara, he held positions at the U.S. Food & Drug Administration, Pfizer, and Frontage Laboratories.
To learn more about Certara’s Integrated Drug Development team, please visit https://www.certara.com/services/drug-development-and-regulatory-strategy/.
Certara accelerates medicines using biosimulation software and technology to transform traditional drug discovery and development. Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.
Jieun W. Choe