Articles & Research from Venn Life Sciences

CMC team capabilities New Chemical Entities

For 20+ years, members of the CMC (Chemistry Manufacturing and Control) team have supported and are supporting numerous pharmaceutical companies to ensure the timely development and manufacture of high-quality drug substances and drug products for non-clinical- and clinical studies.

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.

CMC team capabilities for biologics

For 20+ years, members of the CMC (Chemistry, Manufacturing and Controls) team supported numerous (bio)pharmaceutical andbiotechnological companies to ensure the development and manufacture of high-quality drug substances and drug products

CMC regulatory team capabilities

For 20+ years, members of the CMC regulatory team supported several (bio)pharmaceutical companies to ensure manufacture of safe, effective, and high-quality drug products for patients globally

Strategies for Non-clinical safety assessment of vaccines

Setting the scene Over the past century, vaccines have made a large impact on public health, as recently demonstrated by the treatment of the worldwide Covid-pandemic. Since, in general, vaccines are administered to healthy individuals, including infants and children, it is important to demonstrate the...

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...

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