What's happening?

The service sector’s increased growth can be attributed mainly to the fast pace of advancements in research.

The United States of America is facing a hugely concerning opioid addiction epidemic, causing roughly 46 deaths per day according to the US Centres for Disease Control.

Formulating a new candidate drug for first-in-human (FIH) trials must be considered carefully, as the decisions made can directly affect its chances of not only progressing to the next phase, but to achieving regulatory approval.

Pharma companies hoping to achieve regulatory approval for their candidate drug must be able to show efficacy and demonstrate safety for use in a Phase III trial. However, the journey to late stage trials begins with the complex path from formulation development to first in human (FIH) trials.

Moving forward there are tough decisions to be made in terms of site rationalisation. Industry consolidation is inevitable.

There are only a few months left before the introduction of the European Falsified Medicines Directive (EU FMD). Once these regulations are in place, unique codes on pharmaceutical packaging should increase supply chain transparency and make the infiltration of counterfeit medicines more difficult.

Companies that have been slow in their preparations will need to abandon the idea of customisation and stick to standardised solutions.

Many factors can result in a drug candidate failing at a phase I trial from problems with the actual medicine, such as unforeseen toxicity, or simple logistics and supply chain issues.

Drug stability testing is one of the most important parts of the drug production process. These tests aim to determine the performance of a drug under different conditions, such as humidity, sunlight and temperature, and therefore help to decide safe expiry dates.

The biggest challenge is often ensuring that limited time, effort and resources are spent developing a suitable formulation for Phase 1, and at the same time ensure that these results pave the way for further development into Phase II/III.