Accelerating Drug Development By Harnessing Technology
By Thomas (Tom) Grundstron, VP, integrated processes and technologies, Quintiles
The biopharma industry has always taken well-deserved pride in being rooted in the life sciences, using the fields of medicine and biology to develop a vast range of lifechanging therapies. Today, however, in order to meet the challenges of rising product development costs, generics, and patent cliffs, the industry must reach out to another discipline — information technology — to accelerate clinical development and to bring drugs to market faster, better, and cheaper.
How can biopharma take advantage of the latest IT? A decade ago, the finance industry faced a similar situation in which banks had to decide whether to continue doing things “business as usual” or embrace technology to deliver the best product to their customers. Now, we cannot imagine a world without online banking — and we have those early adopters to thank.
The biopharma sector is at a similar point in its evolution and has the opportunity to tackle its challenges through technology-based solutions and/or collaborations with CROs to plan, design, and execute clinical development. This approach can help companies get the most out of their core strengths in the life sciences.
The biopharma sector is at a similar point in its evolution and has the opportunity to tackle its challenges through technology-based solutions and/or collaborations with CROs to plan, design, and execute clinical development. This approach can help companies get the most out of their core strengths in the life sciences.
Access to data is essential
A large and growing number of trials are being run by CROs, so how does a biopharma company reap the benefits of the latest information technology? Biopharma executives considering a CRO to partner with in the technology space should recognize that it involves a change in approach from the typical relationship between biopharma companies and CROs. Traditionally, the CRO has been viewed primarily from a client-vendor perspective and as a source of cost-effective headcount. However, partnerships with a technology focus demand that both parties move beyond that limited position to a relationship where trust is built through transparency and shared access to data that allow biopharma and its CRO partners to work side-byside to make proactive decisions to identify signals and trends. Biopharma companies that fully grasp the trustthrough- transparency partnership model realize it is access to data that is essential, rather than physical custody of data. As a result, these companies are reaping the greatest rewards from new technology — to aggregate data from multiple sources into a manageable format, enabling views across studies, programs, and portfolios leading to a greater probability of success.
Address All Phases Of Clinical Trials
Today, information technology that simply automates clinical trial processes that drive incremental change is not enough. Visionary companies need technology solutions that drive more effective processes — triggers, alerts, and calls to action — to improve efficiency during each of the four major cycles within clinical trials. In the first cycle of identifying suitable sites, biopharma would benefit from historic information about which geographies or sites are appropriate for a specific study or therapeutic. In the second cycle, patient recruitment, instant access to data across sites, studies, regions or therapeutics on the recruitment rate, screen failures, or the impact of specific inclusion/ exclusion criteria, could better inform users how to modify the trial protocol at the earliest stage for optimum patient recruitment. In the third cycle, maintenance, data on protocol deviations, queries, subject safety issues, and drop-out rates could be used to minimize delays. Finally, at database lock, early information on data readiness would save time and point to where efforts should be focused to clean the data.
Systems as a Service, or system hosting, is another approach where technology can help to drive efficiency in clinical trials and produce potential cost savings. In this case, technology is leveraged across multiple companies, while retaining access to best-in-class systems, thereby converting fixed costs to variable costs.
The pressure is on for biopharma to radically improve the drug development model, and forwardlooking companies realize that harnessing data creates an advantage in driving their promising molecules to market.