Articles & Research from Venn Life Sciences

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).

Clinical PK and PD Support for Biopharma R&D

For over 25 years, the clinical pharmacokinetic (PK) and pharmacodynamic (PD) team of Venn Life Sciences have supported (model-independent) noncompartmental (NCA) PK and PD analyses for top ten pharmaceutical companies.

How our Drug Development Plan can help you get funding

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...

10 Essential Considerations for Successful Clinical Development of ATMPs

The clinical development of Advanced Therapy Medicinal Products (ATMPs) can be a daunting task, but partnering with a team of experts can pave the way for success. In this blog, we highlight ten key considerations that can make the development process less risky and more...

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