Articles & Research from Venn Life Sciences

The Drug development plan – Your roadmap to success

Each journey begins at a starting point, and we believe that few journeys are as exciting as developing a drug. In order to succeed and reach your destination, you need a solid roadmap, the drug development plan (DDP), this is the outline of your drug...

Safe starting dose in a First-in-Human trial: When & How to Prepare?

The first‐in‐human (FIH) clinical trial is an important milestone for each development program. For small (bio)pharma companies the FIH trial requires a significant investment, and every sponsor wants to make sure that all is well set for starting the trial. It is indisputable that successful...

Methodology & Statistics in Clinical Research: Do you want to know more?

Did you ever ask yourself one of the following questions?: Statistics play a fundamental role at each step of a clinical trial (trial design, protocol development, the statistical analysis planification and execution, interpretation of the results). With the evolution of statistical science (e.g., progresses in...

BioTech News & Life Sciences Article – Drug Development Plan – English Version

BiotechNEWS & Life Sciences Article - Drug Development Plan - Dutch Version

Don't be afraid of the FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It is the US Agency responsible for the regulation of drugs and biologics, including, vaccines for humans, blood and blood products and cellular and gene therapy products....

Design of Experiments (DoE), a valuable tool in (bio)pharmaceutical product, process and test method development

Design of Experiments (DoE), introduced in the 1920s, is a valuable modelling tool to support in amongst the systematic development of (bio)pharmaceutical products, processes and analytical methods. Especially in combination with risks assessments (e.g. FMEA), DoE is paramount of importance to establish quantitative relationships between...

Rolling reviews: a useful tool to speed up the regulatory review process

Rolling reviews have been in the media spotlight because of a global need to approve COVID-19 treatments and vaccines quickly. This article provides an overview of how rolling reviews work and the process in several key regions

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