The Appliance of IT in Science

NGP catches up with Geoff Odell, Chairman of the LSIT Global Institute and CIO of the Novartis Genomic Research Institute, to discover how instrumental IT is to the life science drug pipeline.

NGP. Typically, how long does it take for a company to develop a blockbuster drug in the life sciences industry?
GO. It takes eight to 15 years and you won’t know if it’s really a blockbuster until it hits the market. Is this likely to improve with more advanced IT? It depends on how and where you apply IT. For instance, you can’t speed up a clinical trial with better IT as it is the patient recruitment and protocols driving it.

NGP. What are the challenges unique to the life science, compared to other sectors within the industry, when trying to bring drugs to market?
GO. First you must define ‘industry’. Many don’t realize that Big Pharma is categorized by the financial markets as ‘discrete manufacturing’, right along side automotive and aerospace. For clarification, here we’ll define the life science industry as pharmaceuticals (Big Pharma and specialty pharma), biotechs, medical devices, biologics and diagnostics.

Compared to other sectors, there are a few things that are unique about the life science industry. One is the time and cost of development, as the range is broad depending on the therapy and its protocol. Additionally, in the marketplace one must look at timing and competition for sustainable growth. A factor that is becoming more and more prevalent as required by FDA is post-market surveillance or Phase IV clinical trials. An example of this requirement is the silicon breast implant technology. Implants are back on the market, and have a 10-year post-market study to follow patients. There are other unique aspects and costs associated in a life science company that are particularly challenging of a drug company as it goes from researching 10,000 compounds to get to one drug on the market.

We have to make decisions early on to invest or divest in a compound, the stress is to this as soon as possible. The further downstream in development a compound goes, the more the company has to invest in not only the development of that one compound but the third party reimbursement issues, as well as the marketing and manufacturing plans. All of these must begin well before a regulatory agency accepts the compound to go on the market. There are many uncertainties along the way and tough decisions for investing in each step must be made. It takes a thick skin and a lot of trust in the company’s processes – both with IT and its overall decision-making strategy.

Another area to compare is the level of regulatory requirements for life sciences. As a company must address Part 11 for example, each company will have their own expert interpretation and compliance model. It is not as black and white as other regulatory bodies such as the US Securities and Exchange Commission (SEC). We have a lot to learn from the financial industry in how they have exploited regulations to be a part of strategy and a competitive advantage. This include investing heavily in IT for such processes as high volume transactions, security and data management that fulfils any regulatory requirement and IT standards.

NGP. There has been major investment in IT over the last decade or so. What major benefits has technology brought and what do you see as the biggest obstacles to integrating and operating new technologies to realise their true potential?
GO. Validation. Validation is a big bottleneck to innovation. When one compares the freedom and innovative climate in discovery and research, a very limited regulated environment, there is freedom to explore, create new processes and systems with little mandated bounds from a federal agency. Furthermore, there are many products and choices in other disciplines that alleviate the mundane and simplify or accelerate getting the job done. These would include such products as off-the-shelf applications for sales force management, automation, CRMs, finance, and supply chain technologies. Yet in development and on through to clinical trials and beyond, we have limited off-the-shelf products and we have a huge hurdle in the validation of new technologies that limit the level of being able to be truly innovative.

This is why we believe our work in building the Good Informatics Practices Guidance Document will be relevant and helpful as we focus on compliance and standards, while bringing forth best practices, and even more so bringing forth the most ‘effective practices’ for IT in a regulated environment. GIP will create a common ground for any IT department to work from. Eventually, simplifying and trusting the processes by both the company and the regulators allows more room for innovation and strategy.

In order to realize the full potential of IT in any environment for a life science organization, including research and academic institutes, GIP will break down barriers with commonly understood best practices for compliance and IT processes. It will do this by creating more consistency (as standards are supposed to do anyway) throughout such areas as validation, security, data management, and policies and procedures etc.

NGP. According to your research, how costly has the gaps in IT efficiency been for industry?
GO. Costs can be equated to time spent. IT definitely saves time, which saves money. The gap in this industry is large. The problem is that many organizations run projects on old, even antique, IT systems. Even though the cost of upgrading is manageable and an ROI can be measured, it is the unknowns from the IT vendor’s naiveté of serving our needs and the validation costs that are too great. Validation has no ROI, other than some quality, therefore, one must look at the gap of running on old systems that are slow, inefficient, and limiting, to the cost of configuring and validating a new system. Either way, we carry the risk of meeting the FDA inspector’s expectations and interpretation of the regulatory codes. Going back to the valuation slide, if we can compress the timeline at any point with better IT, we bump up the value immensely.

NGP. How is LSIT looking to bridge that gap?
GO. We believe if we can level the playing field by providing an all-in-one reference guide like GIP, it addresses compliance, approaches IT through risk analysis and leverages the standards already out there. We will help users find ways to track discrete costs, savings and re-allocation of resources that produce an ROI.

Bridging the gap by sharing as much knowledge and expertise with as many life science organizations and regulatory agencies as possible, we hope to become the de Facto reference guide that brings clarity and understanding to IT in a way that has never been done before. In the United States, almost every company has recently experienced, through federal mandate, the Sarbanes Oxley Act that requires new levels of regulations and reporting so that shareholders can trust the corporate information and governance.

LSIT is doing the same thing by offering guidance through GIP in another area of already regulated processes. Like the cliché says, we will “raise all boats with the tide” to a new level of compliance and best practices to save us all time and money. It’s the lesson of doing it right the first time. Aligning your IT strategies with the business goals and maintaining the highest level of quality, which means the highest level of trust and integrity.

NGP. And how is LSIT bringing together industry leaders, regulators and IT professionals to ensure its initiatives are both comprehensive and effective?
GO. Just like any project, you want to have input and buy in from a multi-functional or disciplinary perspective; we are doing the same thing. We are bringing together the Life Science industry, IT industry, Research and Academia, Government Regulators, and eventually healthcare to contribute to GIP. The input and feedback from all five communities in actual content, reviews, and even beta testing are all part of our overall strategy to bring out the best. We are using tools that our members use to manage projects and documents, have a review process that includes the regulatory agencies and standards organizations, and the public.

We have an internal discussion group and soon to come, a public forum for further review and content through the Wiki technology. And most importantly, we have over 60 volunteers who are subject matter experts at senior levels from CEO, CIO, directors and project managers who come from a blend of life sciences, technologies, NASA and defence.