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informatics in pharma

Daniel Weiner, senior vice president and general manager at Certara


here has certainly been an increase in the number and complexity of informatics solutions in the

pharmaceutical space, but the data remain heavily siloed. For example, solutions are being deployed in discovery or preclinical research, but the emphasis remains on these separate areas rather than accessing the information that spans them. Tere is a growing and marked

understanding in pharma that they’re not good soſtware developers and as large legacy systems reach the end of their life cycles, companies are looking to bring in external systems. Tere is still a belief, however, within some of the larger organisations, that they can build better than buy. I do believe that if IT departments reported to R&D rather than finance this would be a much different situation as the end users of such systems recognise the value of best-of-breed commercial solutions. Te reality in pharma is that failure rates

haven’t really improved over the past few decades and too many drugs are failing late in development. Te implication is that costs skyrocket accordingly. Again, this all comes down to the need for more of a translational view to development that would break

these data silos down and provide better opportunities for organisational learning. We have seen

many instances where a drug fails in Phase II or III and the company doesn’t have the mechanisms to share the cause of the failure with other departments. As a result, that company could attempt to develop a molecule that



fails for the exact same reason that a prior molecule that was structurally similar failed. Tis is happening across the industry as effective informatics mechanisms are not in place for the communication of successes and reasons for non-successes. Without the implementation of efficient workflows within each of the silos as well as spanning them, pharma companies are crippling themselves.

Nick Townsend, director of Life Sciences at LabWare

technology goes, we are living in exciting


times. Solutions are becoming incredibly powerful and companies are understandably eager to take advantage of the new levels of functionality being offered. Te opportunities and capabilities provided by cloud computing and modern mobile devices are also significant, but for highly regulated industries like pharmaceuticals the management of change to introduce new capabilities can also present a challenge. When attempting to adopt new soſtware solutions or modify existing ones, pharma has to shoulder the burden of ensuring that the implementation is executed in a compliant manner. Tis means that any alteration to any IT system, no matter


s far as laboratory information

how small, must be carried out in a very controlled way with thorough testing and an accompanying comprehensive ‘paper trail’ (now electronic) that documents the specifics of each change, how it was implemented and how it is was tested. Te impact of what may seem like an easy change to make on a technological



level soon mounts up in terms of the resource involvement and financial investment when all the change control procedures are taken into account. Tis is further complicated when attempting to manage connectivity between multiple

applications from different vendors if single platform solutions are not available. Te impact of how the update of one application will affect all the other interconnected applications must be fully evaluated. Te change control aspects are compounded by any potential variations in the supporting infrastructure and this must be taken into account when evaluating the overall cost. Te level of rigour required in the pharma

industry is considerable, so informed decisions on the impact of change control must be taken into account when decisions are made regarding informatics and infrastructure. It’s vital therefore that no matter what type of solution is desired, companies are able to work with vendors that can help them look beyond the product features and focus on the overall implementation and to understand the full cost of introducing new solutions.

@scwmagazine l


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