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June 7, 2010

Facilitating Drug R&D by Collaborating in the Cloud

Bruce Maches

At its core the drug R&D process consists of a large number of people working on many complex activities generating huge amounts of data that take years to complete. Managing all of these intricately intertwined tasks requires extensive coordination and an intense amount of collaboration to be successful. As the research effort progresses there are many activities running both sequentially and in parallel and at the end all of the relevant data must be pulled together into the NDA (New Drug Application) submission document for approval by the FDA.

Given the costs and high level of risk it is common for life science companies to work jointly on research efforts. It is also quite common for smaller companies to use outside vendors as part of virtual teams to perform some of the more specialized tasks around such things as:

• Target identification
• Genomic sequencing
• Toxicology studies
• Clinical trials execution
• Data analytics
• FDA submissions
• Drug manufacturing
• Adverse events reporting

The challenge is how do manage and track all of the data inputs and outputs across these multiple processes with virtual project teams existing in an environment of multiple languages, cultures, countries and time zones? In addition, this needs to be done while at the same time ensuring compliance with FDA regulatory guidelines, protecting intellectual property, trying to cut costs, and the need to speed time to market of new drugs. 

Early attempts by life science companies to use technology to foster collaboration were rudimentary at best. FTP sites to share large files, lack of shared tools for things such as calendaring and coordinating project schedules made hand offs between the project team members more of a ‘throw it over the wall’ process then true collaboration. Things have come a long way in this space and the use of cloud based collaboration tools to accelerate the drug development process will provide even more efficiencies. These tools can help companies support the four main areas of collaboration:

- Communication – how do I share all project activities with the team members and ensure that everyone is on the same page?
– Congregation – how do I provide a ‘knowledge gathering place’ and shared identity for the team?
– Aggregation – how do I condense and track the combined knowledge and data outputs of the team?
– Facilitation – how do I facilitate coordination of project and team activities?

There are a number of vendors providing cloud based or cloud related tools that can help with these processes. Many of these tools are provisioned either as true SaaS or as hosted solutions which speeds up implementation and reduces startup costs. Microsoft SharePoint has become a commonly used tool in life science R&D and while there are still issues with it becoming fully cloud enabled it can be obtained from a number of vendors, such as Rackspace, as a monthly-billed hosted service. There are also a whole slew of vendors providing industry specific software created to work with SharePoint such as Open Text, Quest Software and KnowledgeLake

Some vendors are taking a more social media oriented approach to facilitating team collaboration. ProtonMedia  has created ProtoSphere a virtual world based collaboration tool quickly allows project team members to start working together and can be accessed as either a hosted or cloud based solution.

In addition, there are cloud-based tools specific to the drug R&D process such as the e-Workbook suite from IDBS which facilitates the tracking the results and sharing data from scientific research activities. This software can be accessed via a hosted SaaS solution. Another life sciences product similarly available is the ISI eCTDXPRESS product used to create FDA regulatory submissions in the eCTD (electronic, Common Technical Document) format and provided by Image Solutions as a validated SaaS solution.

As cloud technology, and its acceptance in life sciences, matures and more technologies are built to facilitate reserch, R&D collaboration will be accessible via the cloud. Rather than having to deal with boundaries between team members, collaboration tools, especially those hosted in the cloud, will facilitate the ‘blurring of the lines’ between team functions to bring the right people and the right information together at the right moment to reduce the development time required as part of the drug R&D process.

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