NEW YORK, Sept. 11, 2019 /PRNewswire/ -- Elsevier, a
global information analytics business specializing in science and
health, is working together with a set of evaluation partners that
include industry leaders such as Boehringer Ingelheim, Eli Lilly
and Company, Pierre Fabre, Sanofi,
Servier, and others to develop a new and improved drug–drug
interaction risk calculator (DDIRC). The updated DDIRC will help
DMPK (Drug Metabolism-Pharmacokinetic) and clinical pharmacology
scientists improve patient safety and outcomes and reduce risk
during pharmaceutical development.
Adverse drug reactions (ADRs) are a serious problem worldwide.
In Europe, 197,000 deaths per year
are attributed to them, while the FDA estimates that over 106,000
people die every year due to ADRs. In the US alone, the cost to the
medical care system is an estimated $200
billion per year. One reason for the increase in ADRs is the
growth in prescription use—especially among aging populations where
drug–drug interactions (DDIs) are more likely. Currently, 9 percent
of Americans over age 55 take 10 or more prescription drugs, which
greatly increases the likelihood of DDIs and ADRs. As such,
pharmaceutical companies not only have to ensure that their drug is
safe for use and effective at treating its primary targets, but
must also ensure that the same drug is equally safe and effective
when interacting with potentially thousands of other drugs—an ever
more difficult task.
As DDIRC is a "mechanistic static" modeling calculator that can
be used to predict interactions early on—when information on the
drug candidate is limited—through to later stages of drug
development. It also allows fast predictions, for quick responses
to questions from regulatory bodies or physicians.
"Elsevier's team has collected the background data, and the
DDIRC can potentially help us put that data to work to broadly
understand DDI implications," said Jessica
Rehmel, MS, Consultant Scientist - ADME/Investigative Drug
Disposition, Eli Lilly and Company. "We look forward to quickly
evaluating and helping to develop this quantitative risk assessment
tool."
This joint project between Elsevier's PharmaPendium team and a
group of leading pharma companies will develop and test, for the
first time, a new DDIRC that can analyze both internal and external
data. It will include additional models that can, for example,
assess the risk of transporter-mediated DDIs or better assess the
risk of DDI due to polypharmacy, and will deliver accurate,
shareable and actionable insights.
"Because patient safety has always been a priority for Servier,
we want to make sure that our drugs are optimally co-administered.
Predicting pharmacokinetic Drug-Drug Interactions (DDI) with the
maximum of relevance, precision and reactivity is therefore
essential," said Yannick Parmentier,
Head of the Biopharmaceutical Research Department, Servier. "It
starts by anticipating the risk at the research stage, including it
in the decision process, to mastering the benefit risk ratio in
development phase, optimizing clinical DDI trials as well as
following up potential combinations with new drugs appearing on the
market in the clinical practice.
"DDIRC is therefore an essential tool in those perspectives and
enables rapid responses, hence decisions, on the interaction risks.
In addition, because the tool will be used by a large community of
users it will allow also to harmonize the way to predict DDI to the
benefit of the patient," said Parmentier.
By enabling pharmaceutical companies to upload internal data,
combined with the high-quality, public FDA/EMA data available in
PharmaPendium, the new DDIRC will feature increased predictive
power.
"The healthcare industry's ability to treat more and more
ailments has enabled people to live longer and more fruitful lives,
but with that benefit also comes the grave risk of complications
when those drugs interact," said Guenther
Kurapkat, Senior Vice President of Life Science Solutions,
Elsevier. "Researchers developing drugs need tools that can take
their valuable internal data and cross-reference it against what's
available in public regulatory filings to get a broader view into
how their drugs may interact with others. That's why we are
developing this new DDIRC alongside pharma companies who will
depend on it to ensure that key decisions are made with the most
predictive insights.
"For Elsevier, this is another important milestone towards a
portfolio which helps the Pharmaceutical industry in performing
better risk-management. With the power of our new versatile data
and analytics platform Entellect™, we enable insights across data
assets from customers, third-party or any of Elsevier's content in
a very flexible and reusable way."
PharmaPendium's updated DDIRC will continue to follow FDA
Guidelines for mechanistic static prediction of enzyme-mediated DDI
risk and could additionally provide information for other models of
DDI prediction, such as transporter-mediated DDI risk, based on
evaluation partner feedback and feasibility. This increased dataset
will allow for more reliable predictions. The new DDIRC is expected
to launch in 2020, leveraging the power of our data and analytics
platform.
About Elsevier
Elsevier is a global information analytics business that
helps scientists and clinicians to find new answers, reshape human
knowledge, and tackle the most urgent human crises. For 140 years,
we have partnered with the research world to curate and verify
scientific knowledge. Today, we're committed to bringing that rigor
to a new generation of platforms. Elsevier provides digital
solutions and tools in the areas of strategic research management,
R&D performance, clinical decision support, and professional
education; including ScienceDirect, Scopus, SciVal, ClinicalKey and
Sherpath. Elsevier publishes over 2,500 digitized journals,
including The Lancet and Cell, 39,000 e-book titles
and many iconic reference works, including Gray's Anatomy.
Elsevier is part of RELX, a global provider of information-based
analytics and decision tools for professional and business
customers. www.elsevier.com
Media contact
Christopher Capot, Global Communications
Elsevier
+1-917-704-5174
c.capot@elsevier.com
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SOURCE Elsevier