With the continued rise in the cost of drug research and development, pharmaceutical, biotechnology, and research companies are rethinking the way they do business. Such organizations are typically active in one or more of the following initiatives:
- Growing their large molecule strategy either through acquisition, partnering, or organic growth
- Increasing their use of outsourcing to contract research organizations (CROs) and academic and health-care institutions, or extending their facilities in Asia-Pacific to address bottlenecks and move drugs through the pipeline as quickly as possible
- Instituting a translational science or translational medicine initiative to discover and use biomarkers to test the effectiveness of a drug in the clinic
- Trying to make their production environments as efficient as possible through Six Sigma or similar lean initiatives.
A theme that is common to all of these initiatives is their reliance on informatics solutions such as LIMS and chromatography data systems (CDS) to enhance productivity and facilitate collaboration. This climate is a classic example of the need for an integrated information management system across an entire business cycle. Companies must be able to pass information back and forth to their partners, to external sites, to CROs, and to the clinic. In research and development, they need to take advantage of what they are learning from each compound they test or synthesize and put it to use. In manufacturing, they must have the ability to efficiently pass data between systems so that they can respond to out-of-specification products or potential production issues.
The net result is that businesses describe these integration challenges in a variety of ways, i.e., difficulty in system integration, or data being located in information silos based on disciplines or functional areas, etc., but the root cause remains the same. The lack of open standards in the life sciences industry makes system integration occur at the project level or by vendors on a case-by-case basis. Integration would become much easier if open standards existed that were universally adopted and followed in life sciences research, development, and manufacturing.
A variety of initiatives have arisen between industry and vendors to make this happen. SAFE-BioPharma was formed as a consortium of vendors and pharmaceutical and biotechnology companies agreeing to standards around digital signatures. The anticipated release of Analytical Instrument Markup Language (AnIML) represents years of vendor and industry discussions to arrive at an XML standard for analytical data. The continued need for open standards has led Microsoft® (Redmond, WA) to create the BioIT Alliance, including key members of industry and vendors such as Thermo Fisher Scientific (Waltham, MA) to drive open standards across the life sciences industry. Microsoft’s goal is to enable business, which is why it has partnered with companies that have the industry expertise to drive such standards. With open standards for the life sciences industry, vendors and drug manufacturers will benefit from better integration and more efficient information sharing and collaboration.
Why open standards?
XML enables two different software applications to speak a common language and thus is essential to the creation of data standards. It is important to note, however, that such standards can be either open (published publicly and available for anyone to use) or closed (proprietary to one organization). If the goal is to increase interoperability, it is vital that data standards be as open as possible. Traditionally, in life sciences, data standards have been kept closed primarily for intellectual property reasons or for perceived competitive advantage. This has to change if the goal of true interoperability is to be achieved, which is why many organizations today are changing their business models and are actively promoting and advocating the use of open standards.
Web services are used to transfer XML from one application to another. A Web service is essentially an application programming interface (API) that is exposed via the Web. APIs have been around more or less since the dawn of software programming, and provide a way for software programs to expose their functionality to other software programs. There are a number of benefits to using Web services as an API, but the most important include:
- Language independence: Web services are independent of the software programming language (e.g., C, C++, Visual Basic, C#, etc.) in which the software program is written. For example, a program written in C++ can communicate with a program written in Visual Basic if both use Web services.
- Web services use HTTP as their base transport mechanism. Since the Web is so ubiquitous, software mechanisms (e.g., libraries, development kits, etc.) that work with HTTP are available on practically all platforms and software languages.
SAFE-BioPharma: Pharma and biotechnology standardization
Key industry and vendor associations have been formed in recent years to drive open standards for the pharmaceutical and biotechnology sectors. One of these is the SAFE-BioPharma Association. The organization includes Adobe (San Jose, CA), IBM (Armonk, NY), and Microsoft, and its goal is “to be the digital identity and signature standard for the global biopharmaceutical and healthcare communities.” The organization recognizes that, by establishing a standard, a great deal is brought to the table. The SAFE-BioPharma Association believes that its standard:
- “Mitigates legal, regulatory and other business risk associated with electronic transactions
- Facilitates interoperability between disparate information systems
- Provides a secure, enforceable, and regulatory-compliant way to verify identities and apply digital signatures in electronic transactions
- Helps green the pharmaceutical and healthcare industries by dispensing with paper originals and other cumbersome forms of backup.”
Furthermore, a common digital signature standard allows SAFE-BioPharma to move toward secure electronic record-keeping and data management.1
AnIML: Instrumentation format standardization
In the quest for a standard analytical instrument XML format, in 2003 the American Society for Testing and Materials (ASTM) began the project to create an AnIML. The premise is that there will be a core schema that vendors can extend to meet specific instrument and file format outputs through less flexible technique schemas. The fact that AnIML has not been agreed to as a standard highlights the complexity of the problem. When one considers the number of analytical vendors and the number of instruments that have been released in the past 20 years, it is easy to see that for AnIML to be successful it needs to accommodate literally thousands of instruments.
While waiting for AnIML to be ratified, vendors have created their own XML formats to allow information sharing and aggregation.
Many of the standards noted above have been built on XML to provide specific data format solutions for the life sciences. Similarly, there are technologies available that build on Web services (and other transport mechanisms) to enable the flow of such standardized data between systems.
Figure 1 - Thermo Scientific Integration Manager connects laboratory instrumentation as well as ERP, ELN and PIMS. ERP: enterprise resource planning; ELN: electronic laboratory notebook; PIMS: process information management systems.
One such technology is the Thermo Scientific Integration Manager (Thermo Fisher Scientific), which permits the easy building of integrated work flows between any two disparate business systems (see Figure 1). “Agents” are responsible for data specific to a particular hardware or software system, and the integration is achieved via the combination of such agents. These agents support both Thermo Fisher Scientific hardware and software, and other vendors’ instruments as well.
In April 2006, Microsoft announced the formation of the BioIT Alliance, a group of organizations working together to realize the potential of IT solutions for improving health care and fostering personalized medicine. The Alliance will accomplish this goal through the development of standards and technologies, which will be implemented through proof-of-concept collaborations between members. Members of the Alliance are drawn from across the health-care, science, technology, and software fields.
Standards cannot be developed in a vacuum, and Microsoft realizes that participation will be required from both industry leaders and vendors to achieve success. As an umbrella organization with the potential to drive open standards adoption and creation in the life sciences, the BioIT Alliance is a perfect fit and has already seen participation from many organizations, both on the industry and vendor sides.
According to Dave Champagne, Vice President and General Manager at Thermo Fisher Scientific, and a BioIT Alliance board member, “With the ongoing advances in clinical research and personalized medicine, it is more important than ever that any superficial technical barriers are dissolved so that the science of the laboratory becomes transparent and readily accessible to the clinicians and physicians on the front lines of medical advancement for disease management and eradication. Our role as a member of the BioIT Alliance is to work with the industry to help enable the bidirectional flow of information from the lab to the patient’s bedside and back to the lab again, with the ultimate goal to provide more understanding of disease and individualized responses to patient cure.”
The need for open standards in the life sciences has never been clearer, with practitioners in all areas plagued by the segregation of data systems and lack of integration. While various vendors are driving their own standards, not all companies want to outfit their laboratories with products and technologies from a single vendor.
With the creation and adoption of life sciences open standards finally coming to fruition, an umbrella organization to drive the success of such standards is not only useful, but essential, since representation from both industry leaders and vendors is necessary to achieve consensus. The BioIT Alliance can give the life sciences industry a forum to enable these necessary open standards to finally come to pass.
Rooting such open standards in XML and Web services is a given, simply due to their ubiquity in other industries. Though it will take time to solve the problem completely, standards such as SAFE and AnIML make great strides for particular applications within this industry. Integration technologies such as Thermo Scientific Integration Manager play a key role in solving this problem.
- SAFE-BioPharma; http://safe-biopharma.org.
Mr. Mac Conaonaigh is Director of Technology, and Mrs. Meek is Director of Product Strategy, Life Sciences, Thermo Fisher Scientific, 1601 Cherry St., Ste. 1200, Philadelphia, PA 19102, U.S.A.; tel.: 215-964-6020; fax: 215-964-6021; e-mail: Seamus.firstname.lastname@example.org.