What's happening?

Friday 9th February marks one year until the EU Falsified Medicines Directive (FMD) enforcement date. Although a year may sound like a long time it’s a very short period to implement a lot of changes.

In recent years, pharmaceutical outsourcing has grown in popularity amongst drug developers across the industry. Companies are increasingly outsourcing to contract development and manufacturing organisations (CDMOs) due to the benefits outside expertise can bring to their business.

Fredrik Lehmann PhD, General Manager and Sales Director Preclinical and Chemistry Services at Recipharm, partners with Uppsala Bio to discuss the global services in pharmaceutical development provided by Recipharm’s development facility in Uppsala.

As we move into 2018, compliance with serialisation regulations is becoming more and more urgent. Implementing suitable solutions puts pressure on contract manufacturing organisations’ (CMOs) internal infrastructure as they find a way to introduce and integrate serialisation with their current systems and improve supply chain communication.

According to PwC, the counterfeit drug market is worth over $200 billion per annum. In recent months the pharmaceutical industry has taken huge steps to tackle the rising problem of falsified medicines with the introduction of serialisation regulations in more than 50 countries worldwide.

2017 has been an eventful year in the world of pharma, with new track and trace regulations driving investment and opening up new possibilities in the pharmaceutical supply chain, while consolidation continues to shape the outsourcing sector.

The pharmaceutical industry has changed significantly over the last two decades.

Today (Monday 27th November 2017) marks the original deadline date for the Drug Supply Chain Security Act (DSCSA). While the FDA has granted a one-year grace period before it will actively enforce the new requirements, preparing for US serialization should still be a priority.

Currently, serialisation should be the highest priority across the market.

We are beginning to see companies turning to contract partners with tried and tested solutions in place and it is likely this outsourcing trend will continue.

 

Selecting excipients to solubilise compounds is a vital part of the drug development process.

Automating this element of the drug development cycle will help pharmaceutical companies to improve their formulation strategies and in the long-run take new therapeutics to market more efficiently.