Articles & Research from Venn Life Sciences

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...

Accelerating Drug Development from lab to patient, fast & efficiently

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...

How previous experience with a notified body will help in the drug/medical device development consultancy.

As a medicinal expert at one of the leading notified bodies of the EU, I’ve been involved in the assessment of medicinal files of many different device-drug combination products. These are devices that include ancillary medicinal substances, in which the device has the primary mode...

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