What's happening?

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.

 

Both serialisation and driving down the costs of producing medicines have been hot topics in 2017. Despite the delay of the active enforcement of the US Drug Supply Chain Security Act (DSCSA), companies are still facing an uphill battle to compliance and drug developers and manufacturers are continuing to focus on new ways to reduce time, and by extension costs, to market.

Serialisation represents a huge challenge for the industry. From the costly and complex implementation process, to the enormous task of data management, many within the pharmaceutical industry have found serialisation to be a daunting prospect.

Mark Quick,executive vice president of corporate development at Recipharm, joins a panel of industry experts in this roundtable with European Pharmaceutical Manufacturer to talk about the biggest trends of 2017 and the future of the industry.

Poor solubility can be a real issue during drug development, as it can lead to low bioavailability, which causes suboptimal drug delivery, and often risks the drug being withdrawn from development.

Serialisation has been widely talked about across the industry for some time. Despite this, many companies have failed to prioritise developing a solution meaning ensuring compliance come the various market deadlines is becoming increasingly difficult. 

Getting a drug from formulation development to first in human (FIH) trials can be a complex process that costs pharmaceutical companies huge amounts of time and money, and if a drug fails, it can be catastrophic for the businesses involved.