Articles & Research from Venn Life Sciences

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...

Medical Devices Development

Since the 2017 New Regulation announcement, manufacturers have up until 2020 to prepare and get their products ready and compliant. Venn provide the knowledge and support to organisations developing medical in vitro, traditional and software devices. Under the New EU Medical Device Regulations, staying competitive...

Planning a Clinical Trial? – Think Smart Design

By using smart designs, sponsors can save time and money while optimizing the knowledge accrued during the development of their products. “Traditional” study designs and statistical methodology do not allow changing the main features of a study protocol once the study has been initiated. The...

Lyophilization Process Optimization Within Strict Boundaries of Commercial Manufacturing Sabien van der Schoot, Pharm.D, PhD. Venn Life Sciences

An established commercial product sensitive to oxygen and moisture had to be transferred to a new lyophilizer with the option to load on pre-cooled shelves

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