Articles & Research from Venn Life Sciences

Non-Clinical Pharmacokinetic Analysis

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.

Accelerated timelines using dry run for clinical PKPD analyses

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

Integrated Drug Development Solution

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...

Data-Centric End-to-End Trial Support

Venn provides data-centric End-to-End Trial Support, providing data driven trial design and methodology. The Service Sheet describes where Venn designed a single seamless phase II/III adaptive pivotal study, supporting the marketing authorisation application for a product in a high unmet medical need in a pediatric...

Decoding the variability and the heterogenicity of the allogeneic cell-based medicinal products

According to the definition, the cell-based medicinal products (CBMPs), either somatic cell therapies or tissue engineered product, contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in...

PK Consultant Knowledge of Trials

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...

Non-Clinical aspects in ATMP development

ATMPs definition The advanced therapy medicinal products (ATMPs) represent a fast-growing field with a lot of potential in severe, rare, or chronic diseases for which no adequate conventional treatments exist. The ATMPs can be classified into three main types: gene therapy products, cell-based products, and...

The critical value of GCP guidelines in clinical trials - An auditor’s perspective

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).

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