Drug discovery and development can be filled with analytical challenges, miscommunication and last minute surprises. But it doesn't have to be that way. Here's a look at how Enthalpy helped three new clients get projects back on track.
After working with two CROs, a pharmaceutical company was stalled in the development of a promising delivery technology due to analytical problems. With a second set of clinical samples approaching stability limits and tension rising at the sponsor's corporate offices, the sponsor contacted Enthalpy.
Enthalpy quickly developed a rugged method for quantitating the analyte over the sponsor's required range, solving several difficult analytical problems along the way. Thanks to Enthalpy's quick response in discovering and solving the analytical method issues, the sponsor was not forced to collect a third set of clinical samples.
A sponsor sent several pre-clinical studies for two promising drugs to a large CRO. As deadlines approached, the sponsor was told the results would not be ready on time. The CRO had not initiated method development, and due to its current backlog, was unsure when it could start.
The sponsor quickly moved all the bioanalytical work to Enthalpy. The sponsor prioritized the studies, defined must-meet timeframes, and requested timely, accurate updates. Enthalpy met all deadlines and moved the stalled development programs forward.
The FDA notified a pharmaceutical company of a hold on its lead compound. To lift the hold, the sponsor needed fast-track sample analyses for studies requested by the Agency.
Enthalpy prioritized the sponsor's project by reconfiguring schedules and resources. Team members worked over the weekend to analyze almost 1,000 samples. Enthalpy sent preliminary results to the sponsor four days after receiving the notification to start work. The sponsor received QA-reviewed results the following week, meeting the sponsor's deadline.
