CASE STUDIES
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.
Case Study #1: Cracking A Tough Method
Problem
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.
Solution
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.
Case Study #2: Getting Back On Track
Problem
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.
Solution
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.
Case Study #3: Moving Past A Clinical Hold
Problem
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.
Solution
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.