Senior Director of Global Quality Systems, Thermo Fisher Pharmaceutical Services
Automated data capture and integrated informatics platforms can boost compliance, reduce “data drudgery” and speed drugs’ road to market.
Drug product success relies on robust, reliable, validated data – something that has become increasingly difficult to provide, as clinical trials have become more global and complex.
Consolidating and standardising processes into single lab information management systems (LIMS) can save money, reduce “data drudgery” and, ultimately, speed up market authorisation.
Bill Weiser, Senior Director of Global Quality Systems, at Thermo Fisher’s Pharmaceutical Services business: said: “There’s a great saying in the FDA: In God we trust, all others must have data. The scientific process of manufacturing a pharmaceutical product relies heavily on data.
“But the traditional approaches have been manual, largely consisting of things like paper-bound laboratory notebooks, written validation reports and hand-signed documents.”
These methods carry inherent windows for error, and these have been compounded by the increasingly global nature of clinical trials.
Organisations with the desire to stamp out inaccuracies and speed up development and manufacturing, while ensuring compliance with increasingly stringent regulations, need to embrace end-to-end technical solutions.
Closing the loop
Creating a “single system of truth” with the use of integrated informatics and data platforms is the answer, said Weiser.
The approach allows study sponsors and contract research organisations (CROs) to automate day-to-day data capture, eradicating the risk of human error, and link disparate, siloed systems from across all areas of the business.
“The key is a robust informatics platform that releases scientists from the day-to-day drudgery of just recording things, and saves their mental energy to focus on the science,” said Weiser.
“Every decision you make in drug development and manufacturing is based on analytical data. Being able to quickly retrieve data and use it to make informed decisions is vital.”
Common deployment challenges
Thermo Scientfic™ SampleManager LIMS™ software recently went live at the company’s Cork site, as part of a global roll-out project. The experience taught Weiser and his team that implementation challenges tended to focus around “a few key areas”.
“One is validation. All our manufacturing requirements must meet GMP regulations and so everything needs to be validated according to protocols and a structured approach,” he said.
“Our Pharma Services business was built by acquisition, meaning that many of our sites have legacy systems.”
Part of the deployment process, then, must be understanding how different systems are used in different areas, and how each can be transitioned to a common platform.
“We also need to remember that manufacturing operations are all run by people; people need to understand why the processes they have been using for a number of years need to change.
“Any informatics deployment that doesn’t appreciate the change management aspect is doomed to fail.”
Luckily, “bringing people along” isn’t difficult when the value of change can be so clearly demonstrated, said Weiser.
“Think about a current paper-based process. You might write a reagent’s lot number in a logbook, then run multiple experiments, and report and transcribe that number multiple times.
“If we can reduce that to it being recorded once and verified, and know it’s true from that point on, not only have we reduced the burden of data recording, but we’ve also improved compliance by eliminating multiple opportunities for transcription error.”
Ultimately, this approach improves regulatory compliance, reduces the overhead of data recording and helps manufacturers move products to market faster.
And in a world where the average drug development pathway takes a decade and costs $2.6bn, anything that eases the process, and gets life-changing new drugs to patients quicker, must be embraced.