Partnered Article

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

Read the article to learn more about how fostering a culture of competence and fairness is allowing CF Pharma to deliver on its API and CMO capabilities.

Since its launch in 2018, Adalvo has grown in the B2B pharma space through a four-pillar strategy and has completed over 600 transactions. It aims to be the leading European player in this space by 2025.

Experts from WuXi AppTec explain the importance and benefits of using biophysical methods at every step of drug discovery.

The advantages of decentralized clinical trials (DCTs) are well recognized. COVID-19 showed that the DCT model was not only viable but practicable as a means of overcoming physical constraints on patient access to trial sites.

The drug development process can be incredibly costly, especially for small and mid-sized biopharma companies that rely heavily on external funding in order to progress through the stages to commercialization.

Biologics have great potential for the treatment of many diseases, especially regarding unmet medical needs, due to their target specificity.

Real-world evidence (RWE) is an increasingly important component of drug development. These data are even more powerful, though, if patients can be followed right through the continuum of care, and multiple data sources, both primary and secondary, linked to generate deeper insights.

Unforeseen circumstances can easily cause delays at any part of the drug research, development and commercialization process.

The FDA Data Monitoring Committee guidance refers to the interaction between two different expert committees: endpoint adjudication committees (EACs), and data monitoring committees (DMCs).