Certara and Paidion Research Form Partnership Focused on Improving Pediatric Drug Development

PRINCETON, N.J. & DURHAM, N.C.–(BUSINESS WIRE)–Certara®, the global biosimulation technology-enabled drug development
company, and Paidion Research, Inc., a pediatric clinical research
organization (CRO), today announced a new partnership dedicated to
promoting more efficient and reliable drug development for pediatric
patients. The partnership harnesses Certara’s unmatched biosimulation
(modeling and simulation) and regulatory writing capabilities, with
Paidion’s regulatory strategy and pediatric clinical trial management
expertise to address the critical challenges of bringing new therapies
to children.

“The US Food and Drug Administration (FDA) reports that pediatric
product development initiatives have resulted in improved product
labeling, increased identification of adverse events, and the
development of new pediatric formulations. However, 42 percent of recent
pediatric trials have failed to establish either safety or efficacy,”
said Certara Chief Executive Officer (CEO) Edmundo Muniz, MD, PhD. “Both
Certara and Paidion are passionate in their scientific commitment to
developing safer medicines for children, as they are our most precious

Paidion CEO Barry Mangum, PharmD, FCP, added, “Sick children represent
the most vulnerable population in the world. As our understanding of
pediatric patients has grown, we recognize that they manifest many
diseases and side effects of the related medical treatments differently
than adults. Combining Certara’s expertise in both
pharmacokinetic/pharmacodynamic (PK/PD) and physiologically-based PK
(PBPK) modeling with Paidion’s success rate in conducting pediatric
clinical trials will be transformative.”

Both FDA and the European Medicines Agency (EMA) have legislated that
pharmaceutical companies must develop label guidelines for pediatric
drug development. This requirement has resulted in an increased need for
new scientific approaches, a clear aim of the Certara/Paidion

One of the greatest challenges in pediatric clinical research is
defining a safe and effective dose or dose range for this patient
population that can span premature neonates to adolescents. There are
significant physiological differences between children and adults that
can affect the absorption, distribution, metabolism, and elimination
(ADME) of medications. Certara has developed specific technologies and
strategies to inform proper dose selection, including PK/PD simulations
using sparse data analysis and its Simcyp® Pediatric PBPK simulator. The
simulator captures changes in physiology and enzyme/transporter
development that are particularly prominent in children from birth to
two years of age. The Simcyp Simulator is used by most leading
pharmaceutical companies and international regulatory agencies. In 2012,
FDA voted unanimously in support of extending the use of PBPK modeling
for pediatric drug development.

In addition to physiological differences between pediatric populations,
there are sizeable challenges in conducting pediatric clinical trials,
which include study design, patient identification, recruitment and
retention, and determining clinical benchmarks. The available pool of
pediatric populations for many target indications is much smaller than
adults, and ethical constraints significantly limit the number of
participants. Paidion’s pediatric focus, as well as its formation of
sustainable neonatal and pediatric intensive care unit and pediatric
clinical site networks will help resolve those challenges.

Current FDA and EMA guidelines recommend that dose selection for
pediatric studies be based on all available prior information, starting
with what has been learned in adult populations. This guidance
translates into an ethical imperative to use biosimulation to inform
pediatric drug development whenever possible, minimizing the impact on
children that must enroll in clinical trials. At the same time, clinical
trials are still a necessary part of drug development and they must be
organized with a pediatric patient-centric focus. By combining expertise
in biosimulation, pediatric clinical trial management, and regulatory
strategy and writing, the Certara/Paidion partnership intends to greatly
expand the number of new medications available to children.

About Certara

Certara is a global biosimulation technology-enabled drug development
company. Its customers include hundreds of biopharmaceutical companies
around the globe, together with several regulatory agencies. Certara’s
solutions, which span the discovery, preclinical and clinical stages of
drug development, enable superior drug development and regulatory
decision-making through biosimulation, thus increasing R&D productivity
and commercial value. For more information, visit www.certara.com.

About Paidion

Paidion Research, Inc. is a clinical research organization (CRO) focused
solely on pediatrics and specializing in NICU and PICU populations
(neonatal and pediatric intensive care). Headquartered in Durham, NC,
they combine pediatric clinical pharmacology expertise with innovative
pediatric regulatory strategies and trial methodologies to provide
best-in-class service to drug and device development partners in
industry, government, academia and nonprofits. For more about the
company, visit their website www.paidion.com
or email info@paidion.com.


Ellen Leinfuss, 609-216-9586
Chief Marketing
Betsy Reid, 919-433-2000
Operating Officer
Rana Healthcare Solutions
Osborne, 206-992-5245