
NGP. How does IT investment help pharmaceutical companies to meet the aggressive timeframes and constrained budgets of their drug discovery and development processes?
SW. IT solutions obviously help organizations to manage the huge amounts of data and information generated during both drug discovery and development – enabling them to meet the ever-increasing regulatory burdens. Advanced software solutions can go far beyond this, by optimizing the way data is transformed into information and knowledge. When this cycle works effectively, what begins as lab data ultimately becomes knowledge that enables the corporation to make more judicious decisions.
In the drug discovery and development process, well-informed decision-making is vitally important. Data and information about potential new drugs must be readily available so that project teams and project boards can make well informed Go/No Go decisions. Making the right Fail Early decision may mean saving large amounts of time, effort and money on a project that will not succeed, while identifying high potential discovery or development projects means that resources can be targeted more effectively. IT investments must be aimed at increasing the efficiency of the data supply chain, ensuring that the right information is made available to the right people or systems at the right time.
SG. The last several years have seen a significant trend – the migration of biology from the lab to the computer. This migration is often in the form of enormous databases, but is also evidenced by in silico experiments, complex simulations, and theoretical predictions. There is more basic research and clinical data available now than ever before, and the ongoing data deluge indicates that this computer-as-bench trend will rapidly accelerate. Scientists want to spend time with their data, not looking for it or making sure that samples and data are correctly matched. Well thought out IT investments are critical if drug discovery and development processes are to be successful. Large-scale proteomics and genotyping experiments are only in their infancy. Pharmaceutical companies demand that their data must be available quickly, easily accessible, and easily shared. These data requirements make a web-based IT strategy critical to the pharmaceutical industry. This increasing demand has led the pharmaceutical industry to push the limits of IT technology. The IT industry is starting to incorporate new technologies to improve process efficiencies, data management capabilities, and regulatory submissions. Every step of the drug discovery process is information intensive.
NGP. What constitutes a superior alternative to traditional software?
SG. The entire software lifecycle must fully incorporate the revolutionary changes in IT infrastructure that we have witnessed over the past decade. Every aspect of scientific software development – including the development of large-scale scientific enterprise software systems – can now be completely web-based, enabling one to realize extraordinary collaborative benefits that are only possible through a web-based approach. A Web 2.0 development platform like PointDragon can also form the basis for an entirely new way to look at the development process. The extraordinary advances in both processing power and visualization software makes possible an entirely new, completely visual, software development paradigm with no reliance on the rigid programming languages of the past. A web based visual development paradigm will facilitate the creation of a whole new class of software systems empowered with robust functionality and able to handle the enormous complexity required of today’s life sciences discovery and clinical platforms. A truly visual development platform will also push more of the system creation process into the hands of scientists and other end users, thus allowing those users to create systems that better meet their rigorous needs.
SW. At the most technical level, there are certainly advantages to web-based systems over more traditional Client Server or web-enabled systems. On a broader level, this question can be viewed from a systems and systems architecture point of view. Within the laboratory informatics market there are a large number of different types of systems available that meet different needs. These may include Instrument Data Systems (i.e. Chromatography Data Systems), Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), Scientific Data Management Systems (SDMS) and to some extent Enterprise Resource Management (ERP) systems. Typically, each type of system meets a subset of all the IT needs of a laboratory; and a combination of several is normally required. Close scrutiny typically reveals that laboratories also share information with other systems, such as data warehouses, financial systems and HR systems. While some of the laboratory-specific systems may be newer than others, virtually all of them are traditional software solutions meeting particular and generally quite specific needs.
The crucial fact to consider here is that by using multiple discrete systems, a laboratory runs the risk of parcelling out its information into multiple repositories, which are physically or logically separated. Clearly, this sort of parcelling out is counterproductive, as it impedes the lab and organisation from maximizing the value of its information assets. More and more pharmaceutical organizations are making it a point to use enterprise-level laboratory informatics solutions.
NGP. To match their dynamic processes, laboratories need to be able to configure their platforms easily. What else does a flexible platform have to offer?
SG. Flexibility implies a number of important capabilities and features in a software platform. The underlying core software technology must accommodate frequent and rapid changes, which is very difficult to achieve with traditional software technology. Rapid modifications alone, however, are not sufficient to define flexibility. A truly flexible platform should allow both simple and high-end process modifications to be implemented by non-technical end users who are closest to the laboratory processes and truly understand the issues. A truly flexible platform should greatly simplify much of what now requires labor-intensive efforts by highly skilled software engineers. High-end modifications can involve changes to the database, redesigning the GUI, and adding or deleting workflow steps. If platform configurations like these can be implemented rapidly but require full time senior software engineers, they tend to turn into requests that stagnate on the IT priority list and become costly in terms of time and money. The PointDragon platform allows applications to be modified easily by designated non-technical end users, providing immediate feedback to the end-user and an opportunity to assess the change. The iteration cycle is very rapid.
SW. The one thing that is constant in business is change, and this is as true in laboratories as anywhere else. Laboratories are subject to changing business pressures, changing working practices and changing regulatory requirements. This means that even once a system is in place, has been validated and has gone live it will not, and cannot remain fixed. In the midst of all these dynamic pressures, flexibility is essential in all lab systems. A system that cannot easily be modified to keep pace with changing practices will quickly become obsolete.
Flexibility is also important because it enables labs and organisations to continually optimise the effectiveness of the system and their operations. For example, LIMS implementations often have as a first priority to ensure that the laboratory working practices are modelled within the system. However, once this has been achieved, the laboratory can start to think how it can use the data and information available within LIMS to improve its processes and performance.
NGP. Where do you see the future of web-based reporting, surveillance and networking solutions?
SW. Truly web based-systems offer all the power and functionality of Client/Server or web-enabled systems, together with the convenience, rapid implementation and flexibility of web applications. One of their major benefits is facilitating the timely distribution of laboratory information, on a global basis, according to the user’s needs and access levels. The use of protocols such as SSL ensures that this is done securely. With increasing globalization of business practices, such as drug discovery and development, simple but secure access to information is an important priority for almost every company. Increased collaboration between separate organizations (for example, pharmaceutical companies and CROs), also means that the sharing of systems and the information within those systems is of increasing importance. Finally, changing working practices (flex-time, telecommuting, extended travel on the part of executives and researchers), are making web-based access more crucial than ever.
The important point to make here is that it is not only access to data that makes web-based systems an obvious choice. Far more important is web-based systems’ capacity to provide access to all the features and functionality within a system. For example, pharmaceutical companies could create their own samples or testing requests within the LIMS of a contract testing organization (eliminating the need for written testing requests) and follow the request throughout the entire testing process. Conversely, the contract organization could be a user of the pharmaceutical company’s LIMS. Work requests could be received automatically within the LIMS and results entered directly by the contract organization into the LIMS. A system that can promote seamless collaboration of this type is positioned to vastly enhance the efficiency of an organization’s business processes.
SG. The web will become the dominant computing platform in the coming years. Every traditional software application will be ported to the web and will run on industry standard browsers. The technology to do this is available today. The processing power and network speeds are obviously sufficient today. If one can watch full-length movies over the web, then one can easily satisfy the demands of any traditional computer application. The enormous consumer demands of the web have likewise spurred an avalanche of software advances that facilitate the most demanding visual applications. Already, web based visualization tools far exceed what is available on any other platform. This is the promise of the Web 2.0 PointDragon platform. It is the future of the software industry and it is here today.
“Increasing demand has led the pharmaceutical industry to push the limits of IT technology” – Dr. Steven Gold
A system that cannot easily be modified to keep pace with changing practices will quickly become obsolete – Dr. Simon Wood
Dr. Steven Gold, Founder and CEO of GraphLogic, is the lead inventor behind PointDragon. Dr. Gold has over twenty years of commercial development experience. As Director of Bioinformatics at CuraGen Gold was responsible for the LIMS and Core Architecture groups. While at Echlin, a Fortune 500 company, Gold pioneered the use of LANS in large-scale commercial applications, replacing a mainframe computer with a network of PCs. His work was frequently profiled in the trade literature; as he was among the first ever to employ such techniques. Dr. Gold received his Ph.D. in computer science from Yale University where he studied AI and neural networks.
Dr. Simon Wood is Executive Director of Marketing and Education for STARLIMS Corporation of Hollywood, Florida. Simon is a leading authority in laboratory informatics and has over 18 years experience in the area of Laboratory Informatics. In a previous position he was responsible for creating the LIMS industry’s largest consultancy, implementation and support team. Prior to joining STARLIMS, Simon was with Labformatics Ltd, a consultancy specializing in laboratory and laboratory informatics performance management and improvement. He has written and presented numerous papers on various aspects of laboratory informatics including system implementation, laboratory IT project performance management and measurement, laboratory performance improvement and laboratory informatics strategy. Simon can be contacted be e-mail at STARLIMS Corporation: simonw@starlims.com