Posted on - February 6, 2012

Prashanth Visweswaran, Practice Director – Drug Safety, Social Media and Mobility, TAKE Solutions, Inc.

Pharmaceutical and biotech companies are going through rapid change with significant pressures on cost management, increased customer value and globalization of healthcare practices. Traditional models of drug discovery, development, safety and commercialization has been challenged in recent years, thereby compelling the industry to look for newer ways of developing and delivering medicine to patients, with safety being a key driver. With these stringent safety requirements and rising cost pressures, global drug-safety groups within pharmaceutical companies are keenly looking at delivering "more with less." This has indeed been one of the main reasons why drug-safety groups have refocused their efforts to what is considered as “core.”

Traditionally, drug-safety groups have operated as "drug-safety factories" where significant capital expenses were incurred 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 information technology infrastructure groups managed these applications and safety databases. With the rapid evolution of the Internet in the late nineties, the business landscape changed. Although pharma was a little late to adapt to this changing technology, the concept of outsourcing became prevalent. So from 2000 until about 2010, global pharmaceutical companies spent significant time and efforts 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. This was indeed 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, rather than focusing on drug safety operational issues, technology investments and running the factories.

Over the next 5 to 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 in general a more aware and educated public who would recognize drug-safety issues in a comprehensive manner. The age-old challenge of underreporting of adverse drug reactions will see improvement. 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 perhaps an auto-pay system will facilitate transactions. Of course, sponsor companies will have very 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 seamlessly move in the cloud in a secure manner and advanced signal detection capabilities will be possible. Healthcare data exchanges with common information models will become prevalent, thereby making medicine safer for patient treatment. The concept of “data is universal” will become popular. Industry will share data across various 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 risking running out of business. This will be a challenge for traditional technology companies that are so used to making revenues through licenses and support. Clearly, this is an opportunity for industry partnerships and consolidations where 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 over the next 2–10 years.

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 montly bills. Of course this change will make the world a better and safer place. Finally, in conclusion, 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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