Surveying the Challenges of Preclinical Development

25th October 2018 (Last Updated December 3rd, 2018 09:59)

CTA’s Adeola Coker delves into the key issues facing preclinical trials ahead of Arena International’s upcoming Preclinical Development Operations Summit in November

Surveying the Challenges of Preclinical Development

The Preclinical Development Operations Summit launched in 2016 in the East Coast, where a hub of preclinical development companies have flourished. Now, for the third year in a row, this platform brings recognized professionals in the preclinical development space annually to discuss, collaborate and network with a variety of key service providers and industry stakeholders. The aim is to create innovative and collaborative ideas in order to overcome the operational challenges facing preclinical development.

To gain a greater understanding of the trends and challenges within the industry, research was conducted with experts across the U.S. East Coast. I reached out to around 40 industry professionals and discussed the most pressing matters they currently face.

Vendor Management Remains a Large Sticking Point

Perhaps unsurprisingly, vendor management was still a predominant topic. About 90 percent of all experts mentioned their main priority was the development of their relationships with vendors, more specifically contract research organizations (CROs). They wanted to know the best way to work with them, while determining ways to identify preclinical vendors.

One expert mentioned they wanted a quality vendor that could perform run of the mill testing and could offer them advice on how to efficiently run their trials. Another mentioned they wanted to collaborate with their vendors in order to create an established partnership and bring out the best results from their preclinical trials. They would rather work with a vendor with genuine interest in their work, rather than do the bear minimum and send it back to them without a thorough update as to what is happening.

Guarding Against the Common Pitfalls of Preclinical Development

This branched off into other themes, such as timeline management, and the development of relationships both internally and externally within biopharmaceuticals. Timeline management as well as the management of potential pitfalls were interesting points of discussion for many industry experts. Specifically, sponsors are keen to learn how best to create flexibility within timelines in case something doesn’t go according to plan, and how to guard against falling too far behind schedule.

Another topic that also came up was the standardization of preclinical development, in comparison to clinical development. It is easier to reproduce trials in clinical development because of the rigid structures and procedures. However, it is completely different in preclinical development due the exclusion of small but significant details within the trials, which could essentially make the drug perform differently. This makes trials extremely difficult to reproduce within a different laboratory.

Lost Data and the Brexit Question

Furthermore, although in clinical development, there is a rigid and standardized processes when it comes to data collection, preclinical development is the complete opposite. Here, sponsors rely more on basic data logging processes, such as Microsoft Excel. The crux of the issue here is preclinical data can be easily lost or misplaced, which can severely disrupt timelines.

One enduring issue that remains at the forefront of industry is Brexit. Industry professionals are concerned about how this can potentially change EU and U.K. laws as well as the future relationship with the U.S. Will it be the same as before or will there be distinctive changes? There is so much speculation regarding the possibilities simply because there are too many unknown elements.

Communication Remains the Key to Success

Interestingly, an underlying theme across the industry seemed to be communication and how this is key between sponsors and vendors. Without communication these projects cannot flourish.

In conclusion, although there were a few quirky topics in the making, there seemed to be broad consensus within the industry on the main challenges affecting the preclinical development space, and questions that remain unanswered.

 

*To find information about the Preclinical Development Operations Summit, follow the hyperlink to learn more. We hope to see you there!