Articles & Research from Venn Life Sciences

BiotechNEWS & Life Sciences Article - Drug Development Plan

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

Accelerated regulatory pathway for pandemic vaccines

Vaccines form an important part of the combat against the current COVID-19 health crisis. Getting a range of effective vaccines to the market quickly will be essential if we are ever to “return to normal”.

Non-Clinical Development

Non-clinical testing is conducted throughout all phases of drug development to assess the safety profile and pharmacokinetic/toxicokinetic (PK/TK) characteristics of drug candidates. If performed well, it can identify key ‘knock-out’ criteria early, maximizing the chances of success in subsequent clinical development.

Planning a Clinical Trial? Here’s why Data Management matters

Data from therapy development, especially those involving cells, can quickly mushroom into an unmanageable pile in the lab — what happens when you move to the clinic? We sat down with Venn Life Sciences to discuss effective strategies in data management that might benefit companies looking to...

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