ERT Announces Inaugural Seminar for Effective Strategies in Early Phase Clinical Trials – Focus on Cardiac Safety and Biomarkers

ERT, the leading provider of best-in-class technology and services for the successful execution of clinical trials, will be offering a free seminar on effective strategies for early phase clinical trials.

The event will be held on March 3 2009, 8:00 am - 1:30 pm, Westin Copley Place, 10 Huntington Avenue, Boston, MA. As part of the company’s seminar series “Data to Power Decisions in Early Phase Trials”, ERT and its partner AAI Pharma invite interested parties to attend informative talks and engage in active discussion on the latest trends and approaches for utilizing cardiac safety and biomarker data in early phase clinical trials. This seminar is aimed at clinical project managers, therapeutic heads, clinical data mangers, medical directors and pharmacovigilance specialists seeking insights on maximizing their clinical activities and data.

Online registration to the seminar is open and accesible via the company article webpage link on the right hand side of the screen.

The keynote speaker is industry expert Dr. Jeffrey Litwin, M.D., F.A.C.C., Executive Vice President and Chief Medical Officer at ERT, who will discuss optimized study designs of intense cardiac monitoring in exploratory development clinical pharmacology. Early development stage compounds have limited data available for traditional statistical analysis of cardiac safety. If carefully designed, exploratory studies such as First in Human (FIH) and Single and Multiple Ascending Dose (SAD/MAD) studies can include cardiac monitoring to develop exposure-response models. Quantification of the Pharmacokinetics and Pharmacodynamics (PK/PD) relationship may provide early insight into potential cardiac safety issues in the evaluation of commercialization prospects as well as a decision gate for further development.

John Todd, Vice President, Research & Development at Singulex, will speak about troponin as an early development biomaker for cardiac events. Blood cardiac troponin-I (cTnI) concentration has been validated as a biomarker for cardiotoxicity in numerous animal models and holds promise as a predictor of cardiotoxicity in humans. In his data driven presentation, Todd will discuss the use of cTnI, measured using new generation high sensitivity assays, as a biomarker of cardiac injury in preclinical and early clinical drug development outside the accepted paradigm of QT prolongation.

Finally, Harsh Singh, Vice President at AAI Pharma North American Clinical Operations will speak about the management of complex FIH cardiac intense studies. Focused, excellent project management is the lynchpin to the success of an intense cardiac monitoring clinical pharmacology study from early design discussions through completed integrated clinical study reports. Singh will discuss how to implement a clinical project operations plan to define the scope of work, forecast recruiting and enrollment, accurately predict overall timelines using industry standards and Gantt charting, provide critical path analysis, risk analysis and contingency planning. Additionally industry trends will effectively illustrate the value of clinical project management in leveraging multiple operations and data streams to produce high quality, on time results.

ERT is a leading provider of technology and services to the biopharmaceutical and medical device industries around the world. The recently re-branded company encompasses four key areas: Cardiac Safety Solutions; EDC Solutions; ePRO Solutions and the Clinical Research Consulting Group, all of which are enabled by the company’s innovative technology platform – EXPERT™.

“Data to Power Decisions in Early Phase Trials” is part of a series of seminars being held over the next four months. For further information please follow the company website link on the right hand side of the screen.