Reminders

Changing Life Sciences Value Chain

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Looking Forward Post 2016 Political Elections

By Dr. Alan S. Louie

While the healthcare industry is most visibly targeted with the promise to repeal Obamacare, the life science industry can expect to experience significant changes in the shadow of the 2016 elections.

The life science analyst team plans on diving more deeply into the topic over the next several weeks, but our high level view is that repatriation of off-shore revenue, weakening of the FDA, re-importation of drugs, and easing of calls for drug price controls will drive early, life science-related Trump presidency discussions and actions.

The quote "May you live in interesting times," is more relevant than ever. Stay tuned. As always, comments and alternative opinions are always welcome and appreciated.


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While IT is probably the only ones talking about the 3rd platform, key stakeholders holding company purse strings have continued their focus on productivity, performance, and outcomes as ongoing justification of internal resources remains tightly managed. While seemingly simple, operational excellence in life science R&D remains challenging as the goalposts continue to move, driven by both changing business models and rapid innovation (both scientific and technological). This is not expected to change in 2016 (and beyond), but the pace of progress is expected to greatly exceed that of times past. Agility, regulatory rigor, and ease of transition will be among the key differentiators separating the winners from the losers in 2016, driving the industry closer towards the operational maturity already present in other industries.


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Having attended the BioIT World for much of its 14 year history, I noticed that this year's efforts were decidedly more solution and outcomes related than in the past. As part of an IT market research organization that heavily focuses on advances in infrastructure, it was great to see that presentations and individual discussions focused on industry advances that are more centered in the science and health outcomes and less on the hardware and software supporting the efforts. This was also evident in the Best Practices award winners (with the caveat that I was a contributing Best Practices Judge this year as well), signaling clear progress in the field.


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The recent Apple introduction of ResearchKit is a clear indicator that direct patient engagement by the life science industry is beginning to be realized. In conjunction with Apple's previous introduction of HealthKit, that enables consumers to begin to use iPhone apps to directly measure (in conjunction with devices like the FitBit) and track their own health status in real time, ResearchKit extends individual health monitoring to population health monitoring, allowing for much more data to be captured in conjunction with disease research, clinical trials, and other studies seeking to better understand disease metrics at the population level.


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As we move forward into 2015, it is becoming increasingly clear that the life science industry is actively moving forward in ways that should help to create a strong foundation for growth over the long term. The active embrace of technology to empower more effective data exploitation within an increasingly externalized ecosystem (building on cloud, big data, cognitive computing, access anytime-anywhere) is becoming the common infrastructure that help users from the bench to the boardroom to use data, information, and knowledge to work smarter and more effectively, both now and for the foreseeable future.


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In our about to be published 2015 Predictions report for the life sciences, Eric Newmark and I predict that there will be a major data breach in the life sciences within the next 18-24 months. This breach (and its associated public blowback) will be the beginning of significant changes in the industry where data security moves to the forefront. Leading innovators in the industry have already been moving forward on this issue and will not likely be the company name plastered across network and newspaper headlines when this occurs.


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We are at the cusp of adoption of the medical Internet of Things (IoT) in the life sciences industry. This disruptive innovation promises to help deliver improved performance, compliance, and safety in clinical trials (and general patient care) as information sharing becomes increasingly transparent.


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The persistence of elegantly crafted and refined paper templates and Excel spreadsheets to manage regulated documents and processes in the life sciences can in large part be attributed to a strong resistance to change, the lack of time, money, and a measurable ROI needed to assess and validate new solution approaches. At the same time, the increasing use of external partners is further complicating document and process management for regulatory and IT staff, with many key project and process managers increasingly residing outside of the organization and often thousands of miles away geographically. While it may have been possible in the past to walk across the hall in the past to collect a signature or determine the status of a submission, today's efforts routinely rely on less personal phone or email to track project status and hear about issues that may arise. As an additional concern, documents supporting regulatory compliance often reside across multiple systems, including email, separate document repositories, individual laptop/desktops, and manual filing systems. Beyond conversion to electronic versions of their historically paper documents and processes, electronic content management systems (CMS) are designed to capture supporting metadata that can add significant immediate value to regulated documents and processes.


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Ubiquitous access to smartphones presents both a market opportunity and a conduit for clinical trials to more closely engage with patients.


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As I've discussed in my 2014 prediction of an industry shift towards one degree of separation, several sessions and the meeting keynote at the Drug Information Association annual meeting in San Diego, CA are focusing on better engaging patients as a key contributor to long term industry success. This greater engagement (enabled and empowered, in part, by tech innovation) has the potential to deliver a number of near term benefits to both patients and the industry while fundamentally changing the way that the industry interacts with patients and other key stakeholders.



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