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The drug safety utility.


Against a backdrop of stringent safety requirements and rising cost pressures, global drug safety groups within pharma companies are keenly looking on delivering 'more with less' and refocusing their efforts on what is considered as 'core.'

Traditionally, drug safety groups have operated as drug safety factories, which incurred significant capital expenses in building infrastructure related to technology, processes, people and other operational investments. Technology solution providers also built systems that were licensed to sponsor companies, where internal IT infrastructure groups managed these applications and safety databases. The rapid evolution of the Internet in the late 1990s has changed the business landscape. Although pharma was a little late to adapt to this changing technology, the concept of outsourcing became prevalent. During 2000-2010, global pharma companies spent significant time and effort to outsource several key aspects of drug safety operations. This transition in methodology also forced drug safety database vendors to develop newer models of solution platforms. Software as a Service (SaaS), with superior and secure cloud-based technology spread rapidly to drug safety organizations. Pay-as-you-go models started to evolve. The mindset of 'price per case' was beginning to get discussed in conference rooms more often and marked a paradigm shift for drug safety groups, where refocus happened. Drug safety groups started to emphasize their time and resources on risk management, signal detection and emerging markets; less was spent on drug safety operational issues, technology investments and running the factories.

Nostrapharmus predicts that during the next 5-10 years drug safety operations will become almost completely commoditized. Sponsor companies will demand transactional pricings from their vendors. Vendors will, in turn, benefit from higher case volumes through new media such as social networks, mobile smart phones, emerging nations, and a more aware and educated public who will recognize drug safety issues in a comprehensive manner. The age-old challenge of under-reporting of adverse drug reactions will improve. There will be higher case volumes to be managed. Clearly, technology vendors will further enhance their solutions and offerings and become more 'utility' companies than software or technology providers. Monthly invoices will be mailed to customers on 'number of cases consumed' and, maybe, an auto?pay system will facilitate transactions. Of course, sponsor companies will have strict service level agreements with their vendors for quality of service, timeliness, compliance, security and data privacy. Drug safety groups will reorganize and align to be able to provide oversight, diligence and ensure process confidence. Data will move seamlessly and securely in the cloud and advanced signal detection capabilities will be possible. Healthcare data exchanges with common information models will become prevalent, thus making medicine safer for patient treatment. The concept of 'Data is Universal' will become popular. Industry will share data across therapeutic areas with the sole objective of improving patient safety. When the world of medicine changes, associated solution and technology providers will be forced to adapt and innovate accordingly, otherwise they risk running out of business. This will challenge traditional technology companies who are so used to making revenues through licences and support. Clearly, this is an opportunity for industry partnerships and consolidations--revenue share between technology companies and service providers will become critical. This has happened in other industries and life sciences companies will follow this model during the next 2-10 years.


Nostrapharmus concludes: "All this change is good. It will refocus and repurpose pharma, to where it truly belongs--science and medicine. Pharma will stop building massive power stations and will start paying monthly bills. Of course, this change will make the world a better and safer place. It is truly amazing how technology can save lives, improve quality of life and spread the philosophy of 'global healthy citizens.'
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Title Annotation:NOSTRAPHARMUS
Date:Mar 1, 2012
Previous Article:Focus and deepen.

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