ERT will offer a free seminar on effective strategies for early phase clinical trials on 3 March 2009, 08:00-13:30, Westin Copley Place, Boston, US.
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 discussion on the latest trends and approaches for utilising 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 maximising their clinical activities and data.
The keynote speaker is Dr Jeffrey Litwin, executive vice-president and chief medical officer at ERT, who will discuss optimised 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 commercialisation prospects as well as a decision gate for further development.
John Todd, vice-president, research and 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 high-sensitivity assays, as a biomarker of cardiac injury in pre-clinical 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 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.
