Certara Appoints Dr. Mark Holbrook to Lead Its Quantitative Systems Toxicology and Safety Division

“Global pharmaceutical companies and regulatory agencies are actively seeking ways to use modeling and simulation to expand their toxicology predictive capabilities, improve productivity and potentially reduce the use of animal testing in the drug development process,” said Certara’s Simcyp President and Managing Director Steve Toon, PhD.

“US Food and Drug Administration (FDA) described the approach that it plans to take in its ‘Predictive Toxicology Roadmap.’ FDA includes advances in systems biology and mathematical modeling among the breakthroughs that will help bring medical products to market faster or prevent products with increased toxicological risk from reaching the market,” added Dr. Toon.

Dr. Holbrook said, “I am excited to join Certara. This represents an unprecedented opportunity to partner with Certara’s Simcyp team, who are pioneers in physiologically-based pharmacokinetic modeling and simulation, and its rapidly-evolving, and very well-respected, quantitative systems pharmacology team, and really impact the toxicology and drug safety assessment fields. These three areas fit so naturally together in modern drug discovery and development.”

Prior to joining Certara, Dr. Holbrook was director and co-founder of VAST Pharma Solutions, a drug discovery and development consultancy serving biopharmaceutical clients in Europe, North America and Asia. Dr. Holbrook specialized in pharmacology, safety pharmacology and toxicology consulting from lead optimization through to filing.

Before that, Dr. Holbrook held several senior positions at Covance Laboratories Ltd., culminating in vice president, chief scientific officer for early development and head of Global Safety Pharmacology.

Dr. Holbrook joined Covance from Pfizer Global Research & Development, where he served as executive director, head of Global Safety Pharmacology.

Certara’s Simcyp business is playing an active role in several international toxicology research partnerships. They include Translational Quantitative Systems Toxicology (TransQST), a five-year project funded by the Innovative Medicines Initiative 2 Joint Undertaking (IMI 2), to improve the understanding of adverse drug reactions and develop and validate novel computational approaches to drug safety. TransQT is a partnership between 10 academic institutions, three small and medium-sized enterprises (SMEs), and eight pharmaceutical companies.

Simcyp is also participating in EU-ToxRisk project, a collaboration with 38 partners to accelerate toxicology’s shift toward a new mechanism-based chemical safety testing strategy. Simcyp is developing organ-specific mechanistic models, such as its Cardiac Safety Simulator™, to strengthen drug safety assessments. This work will enable the industry to move further away from animal testing toward mechanistic modeling of chemical adverse effects.

In addition, Simcyp is participating in Enhancing Translational Safety Assessment through Integrative Knowledge Management (eTRANSAFE), another five-year project funded by IMI 2. eTRANSAFE intends to develop an advanced data integration infrastructure, together with innovative computational methods, to improve security in the drug development process.

The eTRANSAFE consortium is a partnership between eight academic institutions, six SMEs and 12 pharmaceutical companies.

About Certara

Certara enables superior drug development and patient care decision-making through model-informed drug development, regulatory science, real-world evidence and knowledge integration. As a result, it optimizes R&D productivity, commercial value and patient outcomes. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.

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