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.
Clinical trials are essential in development of innovative medicines, providing insights into novel treatments’ safety and effectiveness. Their execution, however, is complex, governed by Good Clinical Practice (GCP) guidelines from the International Council for Harmonisation (ICH).
An academic spin-off biotech with only a handful of people on board was preparing for their new biological entity for clinical development. For the drug product itself, they needed to a CMC process and conduct necessary nonclinical studies. To make all these happen, they needed to raise the necessary funds. This is where the client came across challenges.
Venn Life Sciences is an Integrated Drug Development partner offering a unique combination ofdrug development consultancy, clinical trial design and execution. We offer a combination ofcarefully combined services offers our customers a complete service on all the stages of theirdrug development programs, from the early planning phase to final execution.
Venn Life Sciences was approached by a small biotech company to perform the noncompartmental pharmacokinetic analysis for one of their animal studies. Further to this they wanted to correlate exposure and other PK parameters with results of performed immunogenicity assays in the animals.
A small sized pharmaceutical company, who had already performed proof-of-concept studies with a small molecule drug candidate came to Venn Life Sciences with the aim to bring their product into clinic as soon as possible.