Partnering with Biotechnology Companies
Team Approach
Scientific Expertise
Internal Collaboration
Need
- A client required GLP validated study drug, metabolite and several biomarker methods established to support their first-in-human trials
- One biomarker method required analysis in freshly drawn samples; co-location of the Phase I clinic and bioanalytical laboratory was critical to measuring the biomarker
- Other biomarkers were closely related isomeric forms that presented stability challenges; these also required close work with an on-site clinic to ensure top quality data was available to the Sponsor
Approach
- Advised the client and our Clinical Pharmacology colleagues on several key steps to ensure that sample collection was well documented in the study protocols and all samples were collected and transferred from the clinic to the laboratory in following appropriate guidelines
- Ensured that validated scientists were available for all clinical sample draws so that the quality of the biomarker data would be optimized
- Were able to provide rapid turnaround for pharmacokinetic and biomarker data because of careful coordination of efforts between the client, clinic staff and bioanalytical laboratory scientists
Benefits
- The pharmacokinetic and pharmacodynamic data was of top quality and supported the client’s study goals
- Top quality pharmacokinetic and pharmacodynamic data allows for rapid assessment of drug safety and efficacy and may assist in meeting the client’s proof of concept goals