An Asian client, a biotech startup, nominated a drug development candidate and contacted Venn for support and consultation on its early drug development with a vision for business expansion overseas.

The clinical team of pharmacokinetic (PK)/ pharmacodynamic (PD) data analysts and consultants at Venn Life Sciences performed the non-compartmental analysis (NCA) required for regulatory submission in an oncology trial involving a uniquely designed antibody as part of a combination therapy.

A small biotech company, is developing a groundbreaking therapy for a debilitating, ultra-rare genetic disease. This condition presents a significant unmet medical need, severely affecting early development in infants. Due to the unique nature of the disease, the therapy must be administered in the earliest stages of life, often to newborns, which adds considerable complexity to the clinical development process.

A biotech company developing a treatment for cancer and immune disorders planned to conduct their Phase 1b clinical trial in the United States (US). They approached Venn Life Sciences seeking a partner to provide comprehensive support for their pre-Investigational New Drug (IND) meeting...

Venn Life Sciences was approached by a small biotech company to perform the non-compartmental pharmacokinetic analysis for one of their animal studies. Further to this they wanted to correlate exposure and other pharmacokinetic (PK) parameters with results of performed immunogenicity assays in the animals.

In this case study, Venn’s client requested an expedited timeline for a planned phase I/II oncology trial to secure regulatory submission deadline.

How did Venn’s expertise and collaboration empower a small pharmaceutical company to overcome these challenges and breathe new life into a six-decade-old small molecule drug? In an ambitious endeavour, a small sized pharmaceutical company aimed to repurpose a small molecule drug that has been available for approximately six decades. Venn staff was involved in the project from 2007, which was temporarily halted in 2012. In 2021, the venture was revived in collaboration with Venn.

Venn Life Sciences was requested to perform the non-compartmental pharmacokinetic analysis (NCA) for an oncology trial for a bispecific antibody. For this trial, strict timelines were set to meet the regulatory deadlines, however due to setbacks in the trial conduct/analysis the critical timelines were at risk. Venn Life Sciences was approached on the advice of the client’s biotech partner as the client was informed that Venn would assist in accelerating the analysis and de-risking the submission timelines. In addition to the NCA analysis, Venn Life Sciences was also requested to deliver the pharmacodynamic and immunogenicity analysis for this trial within the same strict timelines.