NGT BioPharma Consultants understand the challenges our clients face when developing preclinical candidate drugs. To succeed in this space, we work collaboratively with our clients and customize our services to efficiently navigate preclinical development’s interdependent processes, enabling initiation of First-in-Human (FIH) studies. Our collective expertise and extensive experience is leveraged toward developing business plans; evaluating risk, intellectual property, and market landscapes; solving complex CMC issues; outsourcing/managing manufacturing and nonclinical study activities, and interacting with US and international regulatory agencies. NGT provides the following Strategic and Operational services:
CASE STUDY – Candidate To Clinic Acceleration
A pharmaceutical company’s promising lead compound unexpectedly failed in a Phase 1 trial due to insufficient exposure. Despite the trial failure, the company had confidence that the knowledge and experience gained from previous pre-clinical pharmacokinetic (PK) testing and the Phase 1 trial would allow them to quickly and efficiently advance structurally similar compounds.
NGT’s consultants identified structurally similar compounds from the company’s candidate drug library that met the desired in vitro criteria and had profiled well in a non-human primate PK study. Two of these compounds were selected for testing in healthy human volunteers.
Focusing on molecules structurally similar to the first asset enabled the company to leverage the lead's preclinical safety package and profile multiple compounds in a new Phase 0/1 study at sub-therapeutic doses. Ultimately, the company selected a new progression compound more quickly and at a lowered cost compared to the original lead compound's development.