Michael Naimoli

In the past few years, Microsoft has been working hard to create clinical trial platforms for the pharmaceutical industry. This year, the Redmond, WA-based behemoth has moved full-speed ahead with its virtual-server system, dubbed Azure.

Microsoft is not only working on hosted applications, instead the company has established a massive online server or “cloud” that forms the backbone for online software providers (in-house pharma or third party) to host their programs on. Pharm Exec sat down with Microsoft’s National Director, US Life Sciences Michael Naimoli to find out if pharma is ready to move its software from the back room to the cloud.

Is cloud computing catching on with pharma customers?

Pharma companies are very interested in the technology. Right now, I can’t mention their names or what they are doing, but much of it centers around high-performance computing. The fact that Azure is an expandable fabric that allows a company to spin up servers as needed and spin them down when not, allows companies to pay for compute time as they need it rather than maintain their own servers.

Azure is your cloud, but do you have plans to create applications that can sit on the cloud?

We want pharma companies to put their own applications on Azure, because it is a platform for developers. What’s nice about it is that there can be a migration from on-premise to off-premise in terms of the applications. Thinking pharma specific, all the products that these companies develop are essentially data–it’s not like manufacturing chairs. You must be able to converse and make sense around the data. A service that allows people to put data on it and then have applications there to have the sense making opens up all sorts of possibilities with respect to pipeline and portfolio management.

So who is your customer, the pharma companies or the software developers?

There are software vendors that we would like to see move their software onto our platform–that would be ideal. But we are also looking to enable the developers in pharma as well. It’s a little bit of both.

Can you give me an example how a pharma company can move one of their in-house software platform to the cloud?

Look at all the data that goes into protein folding. Companies that are developing large molecule products–usually they are called monoclonal antibodies. The activity of that molecule is bound up in how it folds itself. During the discovery process they like to look at the primary sequence of that product and they want to do calculations about how it’s going to fold. They have traditionally maintained a large number of CPUs that have to be spun up around that activity and it can take 70 hours to finish up the whole protein folding analysis. With a cloud-based utility model, the servers don’t have to be on all the time, Something like that, that you don’t do all the time, scientists can work with the data when they need to, and the servers don’t have to be spinning when they are not needed.

How does compliance work? If the software is already compliant, does that mean Azure is too?

Ultimately it is up to the sponsor to decide if it is a validated application. It depends on what the server is being used for.

Microsoft sells a clinical software (Amalga). Are there plans to make that a hosted application?

I can’t speak to that. As far as I know there are no plans to make a cloud version of Amalga.

Are companies forced to stay online when they move their software to a cloud-based system?

The customers get to pick and choose what commodity applications they want to host in the cloud and if they want to move some applications to the cloud today and others tomorrow they are able to. They can do a combination of on-premise and off-premise. That’s the big competitive difference with a Google where software is all or nothing in the cloud.

Pharma is notoriously nervous about new technology. Has there been a huge buy-in so far or are companies simply dipping their toes in the water? Is it hard to get pharma to jump into SaaS?

Pharma is in the same area that a lot of other industries are. They are willing to take the risk when you are talking about business functions and applications that aren’t mission critical to pharma. I think we are definitely going to be in a place, in the not too distant future where you are going to see companies take their portfolio of products and pushing them up to a data exchange and sharing that information out. They can’t get to all the work, and a risk profile for one company is different from a risk profile from another company so they might want to push that information up and have other companies look at it.

If they want to in-license it, they can do the work around the data rather than hirer teams of people to move the data over. I think that we are coming to a situation where R&D will be collaborative in the cloud and the cloud is going to host data around all products and development and in the end the world will have access to pharmaceutical products to develop and ultimately get market because they won’t have to wait for someone to discover it in their data center because they don’t have time.

At the Drug Information Association’s annual meeting, Pharm Exec got a few minutes to talk with a little software company named Microsoft’s about its work in creating integration between electronic data capture [EDC] and electronic health records [EHR], and its new Amalga technology.

Electronic Data Capture Integration
“I don’t think electronic data capture has evolved to where it should be yet – It’s not an adult yet,” said Microsoft life science strategist Les Jordon. “Companies say that they have a mature application, which is true, but we’ve got a lot of mature applications and everyone’s spin on EDC is slightly different. Where we see EDC going is really a merger of clinical trials management, which includes project management, electronic data capture, and integration with electronic medical records.”

Microsoft expects this merger of data sources will provide a seamless environment, so that pharma companies can find trial sites a lot easier and lower the expense of recruiting trial sites and maintaining them.

A pharma company can look at the different sites they want to use and choose one that uses technologies that can be joined with an existing EDC system. All it has to do is connect its electronic medical records with a Web service to an in-house EDC system. That significantly lowers the cost of entry for a trial site to be used.

Still Standardless
One of the biggest problems with electronic records is the lack of standards. Take one look around DIA and you see dozens of companies touting their wares, but none of them work together. So a trial site must deal with a different system for every client and vice versa.

Microsoft is working with the Clinical Data Interchange Standards Consortium (CDISC) and other facilitators to adopt a standard for integration of the EMR and EDC. “Are we there yet? No,” said Jones.

The way the integrated platform will work is that the EMR will call into the EDC system and state that it has a patient on a particular clinical trial that needs a specific form to fill out. The EDC system then will send the form over to the EMR, which then will display the form in a Web browser. The physician can then fill out the form while the patient sits in the visit. Once completed, the form is then sent back to the EDC system.

“It’s the evolution of what we call single source – a project Microsoft started with CDISC seven years ago,” Jordan said.

Microsoft is pushing an open standard that will work with any system over Web services using CDISC and SAFE standards.

“We’ve been pushing along the players and trying to get some harmonization in the IHA to get this done,” Jordan said. “For us the biggest hurdle has been the development of standards. One of the beauties of open standards is that they are open, but one of the downfalls of open standards is that they are open. That’s the problem. We have to drive consensus between parties with different interests.”

Amalga Life Sciences
Microsoft revealed new information about its Amalga data integration/aggregation engine that allows companies to point data from disparate sources into Amalga and return relationships among the data.

The key word is relationships. It’s an inference engine that looks at all the clinical trials that are going on, existing early stage discovery data bases, lists of publications – any source that the company would want to point it to – and see what the relationship is between the data.

The program visually shows all the different ways data is related. For instance, there might be a biomarker that a particular compound in a certain set of individuals would lead to a particular adverse event, Jordan said. “We can prescreen for that and tell physicians not to prescribe to patients with this particular biomarker or that it’s more effective for patients with a particular biomarker,” Jordon said.

The system was boosted by Microsoft’s recent purchase of Rosetta, a genomics analysis software, previously owned by Merck. No word yet on how that data system will be incorprated into Amalga.