FDA extends its Cooperative Research and Development Agreement with
Certara until 2020
PRINCETON, N.J.–(BUSINESS WIRE)–Certara®, the global biosimulation technology-enabled drug development
company, today announced that the US Food and Drug Administration’s
(FDA’s) Center for Veterinary Medicine has extended its five-year
Cooperative Research and Development Agreement (CRADA) with the company
until 2020. Certara is partnering with the FDA to create additional
Simcyp® physiologically-based pharmacokinetic (PBPK) canine models to
help streamline veterinary drug development and evaluation.
“The FDA values the additional insight and increased predictability
provided by PBPK modeling when evaluating new drug candidates for
animals and humans,” said Certara Chief Executive Officer Edmundo Muniz,
MD, PhD. “Our Simcyp Simulator models can assess the effect of drug
formulation and food on drug exposure in animals. These predictions can
then be integrated with safety and effectiveness data to create more
informative product labels.”
FDA and Certara will now focus their research efforts on exploring how
drug absorption through the canine gastrointestinal tract is impacted by
the presence or absence of food. They will also use the Simcyp Simulator
to examine critical quality attributes that a drug formulation must
possess to enable oral absorption by dogs. In addition, they will
develop and test PBPK models for two more dog breeds.
“Our sophisticated canine computer models can help to improve the safety
and efficacy of veterinary drugs. They can also reduce the need to
include animals in the drug development process for human medications,”
added Steve Toon, BPharm, PhD, President of Simcyp, a Certara company.
In addition to their importance as a companion animal species, dogs are
frequently used as a preclinical species to support human drug
development or as a toxicological species when evaluating the human
safety of drug residues in food-producing animal species. In these
situations, the Simcyp canine PBPK models can prove invaluable for
assessing the potential impact of genetic variations between species on
the resulting study data.
PK principles can also be used to address complex questions related to
the design and interpretation of target animal safety studies and
clinical field studies.
Certara is a global biosimulation and regulatory writing company,
committed to optimizing drug development decisions. Its clients include
hundreds of international biopharmaceutical companies, leading academic
institutions, and key regulatory agencies. Certara’s solutions, which
span drug discovery through patient care, increase the probability of
regulatory and commercial success by using the most
scientifically-advanced modeling and simulation technologies and
regulatory strategies. For more information, visit www.certara.com.
Ellen Leinfuss, 609-216-9586
Lisa Osborne, 206-992-5245