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...

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

Pharmacokinetics of Dapivirine Vaginal Ring (25 mg) Co-administered with Clotrimazole

Dapivirine Vaginal Ring (25 mg) provides topical delivery of the microbicide,dapivirine, to the vagina. There is the potential of drug-drug interactions betweendapivirine and other co-administered vaginal products. Clotrimazole, an imidazolederivative with a broad spectrum of antimycotic activity, is widely used insub-Saharan Africa

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