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

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Certara's QSTS division is actively involved in several international
partnerships, developing
novel modeling and simulation approaches
to solve toxicological issues

Certara®, the global leader in model-informed drug development,
regulatory science, market access and real-world evidence services,
today 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.

"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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