A common accord – harmonised data exchange15 April 2014
The various divisions of a pharma company can sometimes seem like separate organisations, each adopting its own distinct IT systems. This can create problems for information flow – not to mention the barriers that can emerge when partnering with another organisation. Gabor Fari, director of strategy and business at Microsoft, tells Nic Paton how his company and its partners are developing harmonised, compliant solutions for data exchange across technological boundaries.
Developing and bringing pharmaceuticals to market is, everyone recognises, an increasingly global and collaborative game.
Pharmaceutical organisations have to collaborate across multiple cultural, language and time zone barriers; and they have to work with an increasing array of partners, academic and commercial. They operate in a world where communication and conferencing technologies mean there is now the potential for real-time, 24/7 collaboration on research, supply chain and even production and operational issues.
As Gabor Fari, director of strategy and business development at Microsoft explains, this means that the modern-day pharmaceutical company is markedly different from how it was even a decade ago.
"The pharmaceutical environment is becoming more complex because the business model is no longer focused on fully integrated pharmaceutical companies that do everything in-house, all the way from basic discovery through clinical research to regulatory submissions," he says.
"Now, there is more outsourcing of information and activity - often on a global scale - around clinical trials. There is also more reaching out to academia and, often, many smaller companies involved in the discovery process. So the chain of custody of information and data has become a lot more complex with all these outside partners."
Yet, for an industry that is generally happy to invest heavily in cutting-edge technology and R&D, when it comes to IT system investment and management, pharmaceutical companies are often playing catch-up with other sectors and industries.
"In our experience, pharmaceutical companies are often one to two generations behind when it comes to adopting the latest technologies," says Fari. "We still come across companies that are using Windows XP or Office 2003, so it is imperative that pharmaceutical companies adopt modern tools and modern standards."
The challenge of disparate data formats
This is has become a significant problem. It can mean that the various divisions of a pharmaceutical company can sometimes seem like separate organisations, with each adopting its own IT systems. These can include laboratory information management systems, document management, electronic data capture, even clinical trial management. Variable data formats can create issues and headaches around internal information flow and data exchange, and can exacerbate the challenges of operating in an increasingly global, lean and flexible marketplace.
"The challenge of disparate data formats is one that the pharmaceutical industry has been facing for a very long time. As part of a new drug application, it can take up to 12 years to turn structured data into unstructured information that can be submitted to the FDA," points out Fari.
"One problem that remains challenging is that of reconciling data from multiple, disparate sources, including interpretive and clinical studies and reporters. Moreover, there is not only a lack of common data standards, but also a lack of comprehensive metadata standards. A lot of the work that goes into getting a drug approved is interpretive writing, which also lacks common standards."
There is work, of course, going on around this. The Clinical Data Interchange Standards Consortium (CDISC), for one, has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. It works to develop and support global, platform-independent data standards to enable better system interoperability. Ultimately, this is intended to improve medical research and related areas of healthcare.
The Drug Information Association also has a strong focus on facilitating knowledge exchange and collaboration, and helps develop reference models around metadata. In addition, there are other standards-setting bodies such as HL7 and OASIS.
But, argues Fari, there is still a long way to go. "The biggest issue is the lack of common standards and interoperability between existing standards, which means extra work to reconcile the different data sets," he says. "Pharmaceutical companies need to have agility and be able to respond quickly to regulatory enquiries, so it just makes everything more cumbersome. The regulatory agencies are asking for more and more types of information, for example, around structured product labelling. But, when it comes to data exchange, it is a bit like the Tower of Babel."
A more complex chain of custody
So, what's the answer? While it is partly an issue of technical solution adoption, it ultimately comes down to basic leadership, wherewithal and vision.
"Having control over who has access to data is, of course, imperative," says Fari. "There are privacy issues as well as issues around the Health Insurance Portability and Accountability Act (HIPAA), so it is a consumer privacy issue, but also about privacy in the wider healthcare context. Everyone recognises the importance of tightly controlled data. However, the pharmaceutical industry generally could do much better with data security and inter-operability.
"The technology exists today to ensure the security of data. The biggest problem is the lack of common data formats and the lack of interoperability between formats. Prioritising the interoperability of formats is absolutely vital."
Fari feels that the only way to really secure information is to encrypt it at the point of creation and then decrypt at the point of consumption. The use of biometric authentication is also becoming more common to, as he puts it, "protect against Edward Snowden-type occurrences."
The key is therefore transparency around the 'chain of custody' of information. The global and increasingly collaborative environment within which pharmaceutical companies work means, as highlighted earlier, that the chain of custody is becoming more complex. But increasingly, being able to secure your data is becoming something that has to be prioritised.
"With clinical trials and interpretive data, the regulatory authorities need to be able to track back the chain of custody of the information to make sure that information has not been compromised," says Fari.
"Regulatory authorities increasingly expect pharmaceutical companies to be able to show the chain of custody so they can, in turn, ensure that data has not been compromised and approve a drug after it has been proven that it is safe and efficacious.
"For companies that have in-house systems and do not have the necessary standards, making the data interoperable can be a huge challenge. The technological platforms are already here, but it needs the people to agree the standards and the metadata standards; it needs the people using and managing the systems to come up with well-defined interoperability standards," he adds.
He concedes it might seem curious for a company such as Microsoft to be promoting the benefits of interoperability so strongly, but emphasises that the company has done a lot of work around open standards. In many cases, it uses open source, such as the Open XML file format for document specification. This has been standardised by ISO and Ecma, and is used by Microsoft Office as its underlying document format. Microsoft Office is one of the most heavily used systems within the regulatory and clinical environment.
Ultimately, what is important is that pharmaceutical companies work to strike a balance between openness and interoperability, while at the same time protecting their intellectual property.
"Pharmaceutical companies have to figure this out. The regulatory consequences of getting this wrong can, of course, be pretty severe," says Fari.
Increased cloud cover
What, then, of the future? Given the pace of change within this environment, how is technological innovation going to create opportunities and address challenges around data exchange, collaboration and management? Fari feels that the biggest elephant in the room is the cloud.
"Innovations such as the cloud, too, are transforming how data is managed and stored. Pharmaceutical companies are now beginning to dip their toes into this area but there is still not enough recognition that the cloud is here and here to stay, and that its usage and importance are just going to grow," he says.
"Pharmaceutical companies will need to become more agile, open and collaborative, and will need to operate in a more cooperative environment. I think the cloud will help to enable that, but what is important in any move to the cloud is trust. You need to have trust in the system," he adds.
Again, this will have to come back to leadership and the willingness to invest in change. Technology does not stand still, and pharmaceutical companies can ill afford to be complacent about the need to create harmonised, compliant solutions for data exchange.
As Fari puts it: "The technological platform and foundation is there; what is lacking is the adoption. The pharmaceutical industry has historically been very conservative in adopting modern systems, but there is not enough of a realisation about just what a major cost and burden it is to have all these older, disparate systems in place, and of course the security weaknesses too."