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Pharma R&D finally sees the technology light
Ruchi Mallya
Pharma R&D finally sees the technology light
The cost and time associated with bringing a new blockbuster drug to market is reaching astronomical heights - an average of $1 billion over 12 years. As companies begin to adopt a new business model that involves becoming leaner, global entities, IT could make a huge contribution to boosting R&D efficiency and productivity through strategies that include globally integrated data management, in silico research, and paperless clinical trials. However, getting there will be a challenge, as executives and end users remain hesitant to replace manual protocols that have taken years to develop with unfamiliar automation. IT vendors must take an active role in educating the life sciences industry to overcome its traditional skepticism of pharma-specific commercial IT solutions.
Data management is even more crucial to drug discovery as the industry becomes global
With an increasing number of generic drugs entering the market, companies are taking action to streamline operations in order to reduce costs and increase R&D efficiency, thereby increasing the window of market exclusivity. In the new pharma business model, this involves increasing knowledge-sharing between siloed departments and global organizations to allow for greater collaboration in the early stages of research. In order to enable and enhance communication and data-sharing across the enterprise, as well as with partners around the world, life sciences organizations are embracing IT-based knowledge and data management solutions, particularly laboratory information systems (LIMS), e-notebooks, and data repositories. As the industry moves beyond the US and Europe into emerging markets, robust data management systems become even more of a necessity as researchers attempt to mine through mounds of non-standardized structured and unstructured information existing in a variety of languages and formats. Technology is necessary for enabling the shift towards personalized medicine
As the blockbuster drug era comes to an end, life sciences companies are shifting their drug development strategies towards personalized medicine. This requires an investment in hardware and software, since biotech research is very data-intensive. Hardware vendors must provide storage solutions and servers to handle the tremendous amount of data generated through genomic research. In addition, companies will require high processing power to support their simulations and high-throughput screening experiments. Software vendors will need to develop a variety of solutions, ranging from in silico technologies and genome analysis software to bioinformatics tools and business intelligence solutions, to help identify potential drug candidates in a cost-effective and efficient manner, and ultimately develop safer drugs for the public.Paperless clinical trials will save life sciences companies millions
With companies spending $500-700 million on clinical trials, IT investment could be critical in bringing costs under control. Pharma companies are increasing investment in Phase I and II trials and adaptive trials in order to provide safety and efficacy data earlier in the clinical development process. This will allow companies to optimize the go/no-go decision-making process before investing in expensive Phase III trials. To maximize savings from this strategy, Ovum recommends the use of eClinical technologies, particularly electronic data capture (EDC) and clinical trials management systems (CTMS), to ease the paper-based data collection and trial management processes. While there have been many success stories of cost and time savings from using eClinical technologies, the drastic change in workflow associated with EDC adoption makes many clinical researchers and managers hesitant. Vendors will need to work with customers to ease the transition to a paperless clinical trial environment. Educate life sciences companies on the benefits of pharma-specific commercial IT solutions
While technologically advanced when it comes to research, life sciences companies are far behind other industries in the adoption of IT solutions. The skepticism of commercial applications and the lack of pharma-specific technology solutions have resulted in an industry plagued by home-grown legacy systems that are difficult and expensive to maintain, upgrade and integrate with new solutions. Vendors must take an active role in educating and convincing the industry about the advantages of moving away from custom-developed or highly customized solutions, towards adopting readily available, prepackaged, configurable, pharma-specific commercial IT solutions that are built on industry best practices, and offer guidance on how to realize full value from technology.
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