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May 27, 2010

The Way Forward for R&D Applications in the Life Sciences

Bruce Maches

I was working on my blog entry this week when I decided to make a change of direction on the topic I would be exploring. Rather than to continue taking you through the stages of the drug development process, I though I would provide you with a more holistic overview of the life sciences IT eco-system, especially in the R&D area. I also wanted to provide some thoughts and background on the issues and challenges that many of today’s life sciences CIO’s are facing and how cloud computing can help. In future posts I will delve back into the drug development process as well as expanding on some of the issues/challenges mentioned below.

Imagine you are the CIO of the R&D division at a large pharmaceutical company. You sit in your office and take stock of your application portfolio and technology environment. The applications you manage run from very complex scientific research oriented systems through development, clinical trails and FDA submissions management systems. It seems that every time your turn around there is a need for additional compute resources to support these applications as the drug development discovery process gets more and more complex.

Most big pharma IT departments have extensive application portfolios that in most companies range into the hundreds of systems. Many of these systems have overlapping functionality and use a variety of different platforms and technologies. This tower of Babel is caused by a number of different factors:

- multiple acquisitions where there were insufficient resources allocated to complete the IT integration process and retire unneeded systems

- Upgrading, migration or retirement of existing validated applications cannot be cost justified due to the Part 11 compliance burden so many systems are essentially ‘frozen’ from a technology standpoint on the date of release leaving the CIO to somehow manage aging and even obsolete platforms

- the need to keep all drug related data up to 2 years after the last sale (think of Aspirin in this context)

- Scientist ‘system huggers’ don’t want to give up their existing systems as new ones are deployed

- Advancements in the drug R&D process that require new and more complex applications to support

Layer on top of this the usual CIO challenges dealing with supporting business goals, managing cost pressures, refreshing aging infrastructures, increasingly shorter vendor upgrade cycles, supporting business continuity planning, meeting regulatory requirements and appropriately managing the IT resources and skill sets. It is enough to have any CIO reaching for the Excedrin. On top of that, given the limited exclusivity on a drug under current patent law, each additional day spent in the R&D process can cost millions in lost sales and profits. This puts enormous pressure on the organization to reduce the R&D cycle and speed time to market.

So how can cloud help in an environment like this? Given the myriad of issues there are many opportunities where cloud computing can provide the CIO with options to solve some of their problems. Below is an initial, and far from conclusive, list of areas in drug R&D where cloud can have a major impact on the overall process.

- as mentioned in a prior post, providing scalable on-demand resources for large complex in-silico experiments and research efforts

- support cost reduction efforts by providing cheaper alternatives to self-provisioning of resources thereby reducing both CAPEX and support overhead

- speed time to market by allowing the IT group to quickly provide needed resources via the cloud

- supporting regulatory compliance through the pre-validation of resources either machine images or infrastructure that can be leveraged for future system deployments

- facilitate business continuity planning by giving CIO’s the option to restore systems in the cloud instead of with physical hardware

- allowing CIO’s to retire legacy systems by capturing machine images and data and migrating them into the cloud

- enable better scientific collaboration and sharing of documents through cloud enabled tools

- allow IT departments to quickly create instances for systems testing as needed

Hopefully I have made clear that there are many options and potential solutions to the problems facing R&D IT organizations. Those vendors who understand the life science CIO’s world and can align their solutions to deal with these problems at reasonable costs can provide a very compelling value proposition to the life science community. I will provide additional thoughts on these topics, along with continuing to delve into the drug R&D process in future posts.