SYS-CON MEDIA Authors: Michael Bushong, Eric Brown, Gilad Parann-Nissany, Kevin Benedict, PR.com Newswire

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Aptiv Solutions Reaches First Milestone in Delivering New Platform for Model-Based Dose-Finding Trials (ADDPLAN® DF)

Aptiv Solutions, a biopharmaceutical and medical device development services company, and the leader in adaptive clinical trial design, simulation and execution, announces the completion of a key milestone in the development of a new platform for phase Ib and II adaptive design clinical trials.

Both regulatory agencies and the pharmaceutical industry agree that poor understanding of dose response is a major cause of late phase product attrition, and recognize that they need to improve critical decision-making in early stage clinical development so that appropriate doses are progressed to pivotal studies.

Aptiv Solutions has now completed the first phase of development of ADDPLAN® DF for dose finding trials and has successfully delivered this software platform to a major pharma company. ADDPLAN® DF is based on MCPmod methodology and covers model-based dose-finding designs for proof-of-concept testing and estimation of target doses in phase II clinical trials. MCPmod methodology is a preferred tool for dose-finding studies although until now fully validated design and analysis software has not been available. ADDPLAN® DF will allow researchers to establish a dose response signal based on a set of candidate models while strongly controlling the type I error, an important step in maintaining trial validity.

ADDPLAN® DF is linked to AptivAdvantage™, the proprietary Aptiv Solutions technology for implementation of adaptive trials, delivering the first integrated design and execution platform for exploratory trials to the market. This will enable the design and execution of proof-of-concept and phase II trials that more accurately determine the effective dose to take forward to phase III studies, leading to increased success in pivotal trials at the same time as improving the efficiency of the product development process.

“Fixing the dose selection problem in phase II is a crucial step in increasing the approval rate of novel treatments,” said Professor Andy Grieve, senior vice president clinical trial methodology, at Aptiv Solutions. “ADDPLAN® DF coupled with AptivAdvantageTM provides a key technology to address this issue.”

Pat Donnelly, chairman and chief executive officer of Aptiv Solutions commented “We are very excited about the benefits that an integrated design and execution platform for exploratory phase adaptive trials will bring to our clients.”

About ADDPLAN® and AptivAdvantageTM

ADDPLAN® is the leading fully validated design software for adaptive clinical trials and is in use at both US and European regulatory agencies. Four products are currently available for confirmatory trials: ADDPLAN® Base, ADDPLAN® MC (Multiple Comparisons), ADDPLAN® PE (Population Enrichment) and ADDPLAN® DF (Dose Finding).

AptivAdvantageTM is the only integrated technology platform specifically designed for adaptive clinical trials and comprises electronic data capture, randomization and drug supply management.

About Aptiv Solutions

Aptiv Solutions is a global development services company focused on enhancing clinical trial decision-making, efficiency and productivity in the pharmaceutical, biotech and medical device markets. The company offers clients an extensive portfolio of innovative services including adaptive clinical trials, translational research services, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. Aptiv Solutions has over 850 professionals in North America, Eastern & Western Europe, Israel, and Japan. Visit the website at www.aptivsolutions.com.

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