Just a few days shy of the one year anniversary of the launch of Oracle’s Health Sciences Global Business Unit, Neil de Crescenzo, senior vice president and general manager for the business unit sat down with Pharm Exec to talk about the future of clinical trial software and technology and the need for standards and integration.
What’s the biggest challenge pharma companies are facing when it comes to their IT systems?
I think things are changing. Historically, pharma might have focused on one area where they were looking for new business functionality. Now, I think they’ve stepped back and asked, “How do I step back and get an end-to-end process that’s flexible to [provide different capabilities as my business changes], but also to serve as a platform to add new capabilities as we go forward?”
Companies are approaching us and other companies to find out how they can create a new way of approaching their business problems, where they can get many of them solved through the platform approach.
Where does cloud computing fit into the mix? It’s generating a lot of buzz, but is it the future?
I think the challenge of cloud computing is that they are really focusing on one element of how to deliver software and it’s often by companies who are trying to differentiate themselves by delivering that. You will find that the largest companies generally want options, because they would like different methods for delivering hosted software.
Hosted applications work well in environments like smaller countries or developing markets, but there might be other areas where they might have outsourced IT services and they might want them to host the applications. And there are other instances where they initially or eventually would want to take the applications “in house.”
It’s important to differentiate between the product and the delivery of the product. A lot of companies say that the future is cloud computing, but the reality is that some companies want cloud computing for some instances but not for the whole enterprise.
Have you had a boost in requests for your platform in the “Pharmerging” markets like India and China?
We are seeing that market growing dramatically in the past couple of years. I think it started with many of the global companies having operations there and expecting their local affiliations to use the same software as the rest of the corporation uses.
In the last couple of years, we have seen a newer trend where the domestic or regional companies deciding to start investing in global software solutions. In the past year we expanded our footprint in India and sold our systems to the largest CRO there. There is an enormous amount of innovation happening in India with smaller companies and all of them are expected to continue to grow quite rapidly.
We also sold our software into domestic Chinese CROs that are trying to take into account the trial growth in China, as well as Taiwan and South Korea. These are all institutions that have been active for quite some time in clinical development and research, but more recently decided that they need to have similar platforms to what companies outside the region have had historically.
Are pharma companies coming to you looking for more cost effective ways of streamlining their IT?
While the economic environment has been constrained for everybody, in particular because of the continued interest in the pharma companies to innovate to fill their pipeline, and the fact that software can be so instrumental in helping them do that, they’ve continued to maintain a reasonable investment in this space. At the end of the day, the value they get from the software offsets whether they can save 20 percent by going with a vendor with more affordable software.
We give our customers capabilities to free up what would have been labor expense in a process and allow them to get insights earlier into the issues around trial process. It’s all about getting accurate information earlier in the process that you can rely on and you need software to do that. You can’t have someone taking notes faster in the notebook.
What has impressed you at DIA?
Did you go to the OMO project panel? It’s the Observable Measures of Outcomes partnership that FDA and NIH put together that looks at taking data from insurance claims, electronic health records, and other sources and data mining that data in order to get insights into safety issues going forward.
FDA said in a panel that they envision a platform for safety and pharmacovigilance which has certainly been encouraged by the legislation. But, the agency wants to create a platform around safety and extending it from the clinical trial process to post marketing and into the healthcare environment. They talked articulately about extending it from therapeutics to devices, to veterinary health, to food.
How far out do you think we are out from having universal standards for data?
We are getting closer, but it’s not so much that we’ll ever reach a environment where all the standards necessary to have the kind of data one might want will be accessible instantaneously. It’s really a matter of picking upÂ the pace and picking up the breadth. The pace happens when a number of vendors that operate in multiple industries decide to focus on standards in life sciences and pushing them forward.
In the past, the standards have been looked at as if they were in silos. But what we would like to see is standards around data information that extend beyond boundaries. We need to pick up the pace in specific areas, but in addition we need to look at standards that are broader as well as deeper in specific areas.