New PRO measure being developed in conjunction with the FNIH
Biomarkers Consortium
DUBLIN--(BUSINESS WIRE)--
ICON
plc, (NASDAQ: ICLR) a global provider of outsourced
development services to the pharmaceutical, biotechnology and medical
device industries, today announced that it has been awarded a project by
the US
Food & Drug Administration (FDA) to develop an industry-standard
Patient Reported Outcome (PRO) measure that can be used in
anti-bacterial drug development trials for hospital-acquired bacterial
pneumonia (HABP).
HABP is the second most common hospital-acquired infection and is the
primary cause of death in intensive care units. ICON's
Commercialisation and Outcomes group, in collaboration with the Biomarkers
Consortium of the Foundation
for the National Institutes of Health (FNIH), aims to address an
unmet need for a well-defined, reliable endpoint that can measure the
effects of antibacterial drugs on HABP patients. The project involves
creating a HABP PRO instrument with established content validity in
accordance with the FDA Drug Development Tool qualification process. The
new PRO would assess the symptoms of HABP at various time points over
the course of the infection.
The collaboration brings together scientists from ICON, the FDA, the National
Institute of Allergy and Infectious Diseases, the Infectious
Diseases Society of America, pharmaceutical and biotechnology
companies, and the academic research community to develop new approaches
to evaluating the efficacy of antibiotics in future clinical trials of
therapies for HABP.
"We are proud to be working with FDA and the FNIH to develop a PRO
measure that will enable a better understanding of the effects of
anti-bacterial drugs on HABP patients," commented Elizabeth Thiele,
President, ICON Commercialisation & Outcomes. "This project is
particularly important given the need for new medicines to treat
emerging drug-resistant strains of HABP pathogens which are on the
increase. ICON's PRO group offers the right blend of knowledge and
industry expertise in all areas of outcomes research to develop a
reliable endpoint for HABP trials which will help deliver new
antibacterial drugs to patients faster."
About ICON plc
ICON plc is a global provider of outsourced development services to the
pharmaceutical, biotechnology and medical device industries. The company
specialises in the strategic development, management and analysis of
programs that support clinical development - from compound selection to
Phase I-IV clinical studies. ICON currently has approximately 10,700
employees, operating from 83 locations in 38 countries.
Further information is available at www.iconplc.com
About the FNIH
The Foundation for the National Institutes of Health creates and manages
alliances with public and private institutions in support of the mission
of the NIH, the world's premier medical research agency. The Foundation,
also known as the FNIH, works with its partners to accelerate key issues
of scientific study and strategies against diseases and health concerns
in the United States and across the globe. The FNIH organizes and
administers research projects; supports education and training of new
researchers; organizes educational events and symposia; and administers
a series of funds supporting a wide range of health issues. Established
by Congress in 1996, the FNIH is a not-for-profit 501(c)(3) charitable
organization.
Further information is available at www.fnih.org
About the Biomarkers Consortium
The Biomarkers Consortium is a public-private biomedical research
partnership managed by the Foundation for the National Institutes of
Health (FNIH) that endeavors to develop, validate, and/or qualify
biological markers (biomarkers) to speed the development of medicines
and therapies for detection, prevention, diagnosis and treatment of
disease and improve patient care.
Further information is available at www.biomarkersconsortium.org
This press release contains forward-looking statements. These
statements are based on management's current expectations and
information currently available, including current economic and industry
conditions. These statements are not guarantees of future performance or
actual results, and actual results, developments and business decisions
may differ from those stated in this press release. The forward-looking
statements are subject to future events, risks, uncertainties and other
factors that could cause actual results to differ materially from those
projected in the statements, including, but not limited to, the ability
to enter into new contracts, maintain client relationships, manage the
opening of new offices and offering of new services, the integration of
new business mergers and acquisitions, as well as economic and global
market conditions and other risks and uncertainties detailed from time
to time in SEC reports filed by ICON, all of which are difficult to
predict and some of which are beyond our control. For these reasons, you
should not place undue reliance on these forward-looking statements when
making investment decisions. The word "expected" and variations of such
words and similar expressions are intended to identify forward-looking
statements. Forward-looking statements are only as of the date they are
made and we do not undertake any obligation to update publicly any
forward-looking statement, either as a result of new information, future
events or otherwise. More information about the risks and uncertainties
relating to these forward-looking statements may be found in SEC reports
filed by ICON, including its Form 20-F, F-1, S-8 and F-3, which are
available on the SEC's website at http://www.sec.gov.
ICON/ICLR-G
ICON
Rebecca Power
Weber Shandwick
Tel: +44 (0)
207 067 0866
Email: RPower@webershandwick.com
Source: ICON plc
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