Case Study
Rapid Proof-of-Concept for Novel Drug Treatment
BENEFITS n Completely outsourcing drug development program enabled the client to focus internal resources on Discovery needs n Preclinical work completed and IND submitted within challenging investor-driven timelines n Biomarker results from Phase I MAD study demonstrated proof- of-concept, enabling the client to raise additional financing n Biomarkers translated from lab bench to clinic with “fit- for-purpose” assay validation; qualified assays available for the client to carry forward to Phase II and III n Knowledge acquired from program was leveraged by the client to facilitate even faster drug development of follow-on molecules NEED n Emerging US biotech company requiring integrated program management of outsourced IND-enabling preclinical studi