Certara ®, a leader in model-informed drug development, regulatory science, market access and real-world evidence services, has announced that it has appointed Mark Holbrook, PhD, to the newly-created position of vice president of quantitative systems toxicology and safety (QSTS). Dr. Holbrook will lead Certara’s QSTS division from the company’s Simcyp offices in Sheffield, UK.
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 specialised in pharmacology, safety pharmacology and toxicology consulting from lead optimisation 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.
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.”