William Leonard, ScD, Chief Information Officer, MPI Research
Cloud Computing- A Trend Setter in Biotechnology
Cloud computing is certainly a game-changer for all industries, especially for Biotech. Like many other biotech companies, our usage of cloud computing is, at present, limited to non-study, administrative systems – CRM, scheduling, and financial platforms. We are investigating further use of the cloud to support Human Capital and Learning Management.
“Cloud computing alters the entire life-cycle of infrastructure and application projects by shortening the time to plan, acquire and stand up new infrastructure and applications”
Normally, it takes several months to build in-house infrastructure with new applications. Cloud computing alters the entire life-cycle of infrastructure and application delivery by shortening the time to plan, acquire and stand up new infrastructure and applications. In biotech, IT organizations are always facing change. As we grow our business and establish new research capabilities with an ever widening set of study sponsors from large pharma to small biotech, as much as 40 percent of the IT projects we complete each year are not known or included in our annual IT Operating Plan at the beginning of the year. In order to have an IT organization capable of responding to this uncertain demand, the IT leadership must embrace the idea that the IT operating and control model must support this variability. Some of the differences between in-house IT capabilities and cloud computing are obvious and some are not so obvious. In-house infrastructure is all about the cost to acquire, and technical knowledge to support these capabilities. How much you use these capabilities doesn’t really matter much in terms of overall cost. On the other hand, cloud computing costs very little to acquire and are adjusted based on overall usage of the capability. Cost considerations further extend to maintenance and support of the infrastructure – in the traditional in-house computing model, support and maintenance agreements are sometimes seen as an optional decision and many companies fall behind in patching, cyber security and updating to new releases of software. Most often, the cloud provider builds new releases and maintenance into the agreed-upon contract. Maintenance may seem an unnecessary increase in annual operating costs, but good maintenance can often offset what appears as a high Total Cost of Ownership by greatly extending the life of a system.
Data Integration- A Part of Successful Research
I have worked both in large pharma and contract research, and the two data environments are very different. In pharma, the research is all about owning and the use of Intellectual Property. The objective of research pharma companies is how best to keep the research pipeline full at each stage of development. Risk and potential value at product launch are used to decide which research projects receive funding and which projects wait for opportunities to get funding, when compounds either move ahead to the next development phase or fill in where other research projects are halted due to negative results. Obviously, lots of money can be saved by early and aggressive attrition all along each phase of the research pipeline. Both biotech and pharma benefit from the development of an enterprise architecture and master data management strategy. These data integration strategies eliminate point to point interfaces that can become dominant, resulting in environments that are brittle and difficult to support.
Fostering Quality and Efficiency through IoT
The internet of things (IoT) in biotech help tie together firms needing biotech services with those providing robust, quality laboratory and information technology services. IoT is an online market place enabling those seeking biotech services to link up quickly with providers having the technology, science and know how to conduct high quality research and provide the data on an agreed date, in accordance with applicable regulations. In contrast, Biotech CROs are focused on how to best fill capacity with other companies’ research, and market the ability to produce timely research results within an agreed date and cost.
Differentiating the Leaders from the Followers
I am not an expert on the latest individual breakthrough scientific technology and processes that biotech companies need, but from where I sit, I can make the following general statements about a set of often overlooked innovative technologies that can have tremendous impact across a whole set of biological processes, and in turn, can differentiate the leaders from the followers. In biotech, one of the most impactful approaches can be the ingenious adoption of planning and implementation tools commonly used in other companies to support and facilitate growth and optimization of study sales, scheduling, and logistics to produce high-quality research data meeting the study sponsors’ exact specifications and timeframes. However, I am suggesting the real business success of biotech companies lies in their ability to plan and grow their businesses as a whole. This involves recognizing and exploiting existing tools that many manufacturing business are very familiar with–Enterprise Resource Planning, Project and Material Logistics, Portfolio and Project Management, Scheduling Optimization. While the latest biotech methods may get you in the game, these tools will keep you in it and allow you to grow your business and maximize the return.
IT Responsibilities of CIOs
As mentioned earlier, I spent many years as an IT leader within large pharma. I’ve hadresponsiblility for the operational aspects of IT in research and manufacturing, my move to a CIO in a CRO has a new focus and different measures of success. Pharma companies are determined to make the most of the IP they have while filling gaps in existing products lifecycles with either new in-house development or the acquisition of additional IP from outside the company. In this setting, the success of the CIO is mostly measured in their ability to run acquisitions of whole companies, targeted skills and technology, and successful licensing and patent protection of specific compounds. My role as CIO within a CRO is focused on the ability to respond to opportunities that outside enterprises present to our company to help them build the case of safety, efficacy and profile of new compounds and devices. In my particular case as CIO, my ultimate responsibility is to support and enable the production of data needed to make the most critical of all pharma research decisions - we provide with both ‘in vitro’ and ‘in vivo’ testing results that support a compound or devise gaining the approval of regulators to move from pre-clinical to clinical trials.
Successful CIOs Require Result-focused Efforts
The most valuable lesson I can share is, “do everything in your power to make sure your IT organization is aligned with the cadence of your business.” There is a good discussion of this in Broadbent and Kitzis’ book, ‘The New CIO Leader Setting the Agenda and Delivering Results’. There are two parts to this idea; one is to be sure even in the pressure of day to day activities, you have to look far enough down the road to have a clear vision of your environment, your IT organization and the role you have in making your company successful. The other is not to get caught up in the day-to-day affairs that go along with supporting a CRO in regulated environment – I like to remind myself and others, “you can’t dance looking at your feet”.