New members join Novartis, Janssen, and Eli Lilly to develop adaptive
design and execution methodologies for improved decision-making in
exploratory studies
DUBLIN--(BUSINESS WIRE)--
ICON plc (NASDAQ: ICLR), today announced that Pfizer and Roche
have joined the ADDPLAN® DF Consortium. The consortium was
founded in 2013 by Novartis Pharma AG, Janssen Pharmaceuticals Inc., Eli
Lilly, and Aptiv Solutions, which is an ICON plc company leading the
design and implementation of adaptive trials. The goal of the ADDPLAN DF
Consortium is to develop methodologies and execution technologies that
improve dose-selection, which remains a major barrier to resolving high
failure rates in Phase III trials. Both Pfizer's and Roche's decision to
join the Consortium comes as more companies recognise the value of
adaptive design in improving decision making in exploratory development.
The ADDPLAN DF Consortium statisticians are currently collaborating to
expand the utility of the Multiple Comparison Procedure and Modeling
(MCP-Mod) approach, specifically by developing robust methodology for
incorporating adaptive functionality. The current MCP-Mod procedure
enables Proof of Concept (PoC) and dose selection to be established in a
single trial. The ability to go beyond the current approach and
include interim decision making into the MCP-Mod procedure will build in
additional efficiency and flexibility.
"The membership of Pfizer and Roche, long time proponents of adaptive
design, significantly strengthens the Consortium's ability to develop
validated, regulatory-compliant software for the design and execution of
adaptive trials," says Reinhard Eisebitt, Executive Vice President and
Head of ICON's Adaptive Trial Innovation Center. "Since its formation
last year, the ADDPLAN DF Consortium has provided invaluable insight to
further enhance the software, including the addition of adaptive
dose-escalation functionality and more simulation metrics, improved
plotting functionalities for simulation results, and an extension to
documentation."
ICON will hold an ADDPLAN User Group meeting on August 4, 2014 from 4:30
to 6:30 PM, at the Seaport Hotel, Boston, MA. Jose Pinheiro, Ph.D.,
Senior Director, Quantitative Decision Strategies at Janssen, and
co-developer of MCP-Mod, will give a talk on the basics of MCP-Mod;
David Ohlssen, Ph.D., Senior Expert Methodologist at Novartis, will
present a case study on the use of adaptive MCP-Mod for a multiple
sclerosis trial; and Tobias Mielke, Ph.D., Statistical Consultant at
Aptiv Solutions, will speak about the use and development of ADDPLAN DF.
An open Q&A will take place following the presentations. Registration is
limited to 20 attendees and can be completed by emailing inquiry@aptivsolutions.com.
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 plc currently has approximately 11,000
employees in 38 countries.
Further information is available at www.iconplc.com
About ADDPLAN®
ADDPLAN is the leading fully validated statistical design, simulation
and analysis software for adaptive clinical trials and is widely used by
regulatory agencies and the pharmaceutical and medical device
industries. It is available in the following modules:
-
ADDPLAN Base: Adaptive group sequential designs and sample size
re‐estimation
-
ADDPLAN MC: Adaptive multiple comparison procedures
-
ADDPLAN PE: Adaptive population enrichment designs
-
ADDPLAN DF: Adaptive dose finding designs (including MCP-Mod)
For additional details about ADDPLAN software, including eLearning
modules, pricing and ordering information, visit http://www.aptivsolutions.com/addplan-software/.
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 plc
Ryan Ferrell
Tel: +1 312.506.5202
Email: ryan.ferrell@hdmz.com
or
Niamh
Murphy
Tel: +353-1-2912000
Email: Niamh.murphy@iconplc.com
Source: ICON
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