ICON Selected by the FDA to Develop New Patient-Reported Outcome Measure for Hospital-Acquired Bacterial Pneumonia Trials
06 Novembro 2014 - 9:11AM
Business Wire
New PRO measure being developed in
conjunction with the FNIH Biomarkers Consortium
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
ICONRebecca PowerWeber ShandwickTel: +44 (0) 207 067
0866Email: RPower@webershandwick.com
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