CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with Greg Ambra, vice president of clinical operations at DZS Clinical Services.
Q: How could the 21st Century Cures Act—signed into law in December authorizing $6.3 billion in funding—impact small to mid-size CROs, small to mid-size biotech, pharma and companies?
A: There are many exciting items in the Cures Act that will impact what we see in the small CRO and the small biopharma space. The act includes incentives to develop additional tools in the drug development process, including encouraging surrogate biomarkers. Additionally, the act will promote and create efficiencies in the process, particularly in trial design aspects—specifically adaptive design. Many small CROs have developed specialized services in this area, which will allow them to compete with some of the mid-size and large CROs better.
Any advantage that allows a company to develop strong evidence and make an informed decision sooner will be an advantage. Companies realize that if you can make your go/no-go decision sooner, that will reduce costs, potentially get your product to market quicker or move on to more promising alternatives.
Q: How might the act affect mergers and acquisitions (M&A) activity in the industry?
A: In my opinion, the act is very encouraging for small organizations as it will accelerate M&A activity in the field. M&A activity was already expected to be high this year as many drugs come off patent, causing larger companies to begin looking for new products for their pipeline. Combine that with some of the aspects of the Cures Act that will smooth the development pathway and I think it will accelerate activity on the CRO and services side as well.
Small to mid-sized pharma companies will be looking at small to mid-sized CROs to partner with. I believe that will drive larger companies to come looking for smaller companies to work with in some specialty areas. We’ve seen a lot of M&A in companies that do adaptive design in oncology. That could easily start to push into other therapeutic areas.
Q: What problems does the drug development industry still face when it comes to electronic data?
A: The excitement about electronic data capture (EDC) is there, but at the same time, adoption has plateaued at 65 to 75%. I don’t see it pushing into 80 to 90% soon. Why has it plateaued? That’s the big question, along with: How do we improve that? It’s tough. One reason might be that the space is still very fractured despite the big companies dominating EDC market share—Medidata, Oracle, etc. However, there continues to be an ongoing trend of digitizing other processes, including trial master file activities, eConsent and site start-up activities.
The fact that there are so many choices of products out there confuses companies and overwhelms them, so they choose to rely on a more conservative, manual approach. Now, we are seeing second generation systems where multiple functions are being designed on the same platform. I feel this unified approach with expansion capabilities could stimulate the next wave of increased adoption. But that’s not common yet. Right now, you see companies extracting data from multiple systems and then manually combining them. As integration and unification between systems becomes more standard and more visible to companies, I think adoption will increase. It’s on its way, but we are not there yet.
This article was reprinted from Volume 21, Issue 25, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »