We all want free and safe new medical treatments and cures today. Despite this desires and the habit of politicians to pander to their constituencies, the realities of the cost and time required to bring new treatments to market remain unmoved.  It continues to cost a billion dollars and a decade to bring new drugs to market, a reality that is unlikely to change over the foreseeable future.  Technology takes time to deliver on its promise and wishes for faster progress ignore the reality of high safety thresholds, development times, and the threat of lawsuits from failures arising from any perceived shortcuts to the detailed process.  Recent irrational rants include, "Why haven't embryonic stem cells delivered on their promise?", "how is it acceptable to limit formulary access to new drugs?", and "why haven't advances in the human genome project translated into cures?"  The answer is the reality of time and money.  Despite the spin, it is not possible to reduce the cost of development by proclaiming otherwise (in the absence of changing the rules of development) and shortening the time needed to properly advance efforts (in the absence of reduced drug safety or legal liability).  One presumes that consumers are either naïve or ignorant in believing political spin, but we can only hope otherwise for society's sake.  This political and otherwise tabloid noise does have real impact on potential progress by diverting resources from making progress to defending the obvious.  In the shadow of limited healthcare budgets and few easy new drug development wins, a clash is going to be inevitable.

As life science companies frantically pursue new drug approvals to replace expiring blockbusters, they are actively tightening their organizations to improve operational efficiency, acquiring promising external drug candidates and companies in hopes of speeding time to market, and pursuing alternative partnerships and collaboration models in hope of gaining competitive advantage and early access to knowledge and/or drug candidates.  With multiple, geographically diverse R&D resources working under the same umbrella, it is increasingly no longer possible for any one single individual to independently drive a drug development effort forward.  It is clear that collaboration and team approaches will be core for organizations hoping to become sustainable and successful over the long term.  Supporting these teams, technology and innovation is helping to drive progress through relatively mature and constantly improving tools that are often available at the touch of a keystroke.

Notwithstanding the current issues with the iPhone 4, the use of mobile technologies (including, cell phones, Blackberries, iPhones/iTouches, PDAs, and iPads) are delivering significant benefits to the life sciences industry today.  In an upcoming short report, I plan to highlight some of the specific areas where mobile solutions are justifying their use and delivering value in the industry across a wide variety of applications.  With the role of consumers in the greater health industry continues to grow, this trend will likely increase, bringing new data and insights to drive better medical interventions and constantly moving the industry forward.  Patient recruitment, treatment compliance, eDiaries, medical alerts, adverse event reporting, remote patient monitoring, collaboration, and consumer marketing are all areas where mobile solutions are likely to have early impacts.  I welcome a discussion on where else mobile solutions will change existing practices for the better as well as assessment of applications likely to result in dead ends. 

One should expect that any quote from a politician that is included in a discussion on the globalization of clinical trials is going to bring an agenda … and present a heavily one sided slant on the issue.  In this case it was a democrat in a New York Times article, positing that the growth in the contribution of foreign clinical trial sites and patients to U.S. drug applications is a clear sign of exploitation of lower standards and limited FDA oversight in pursuit of lower costs and higher profits.  A reverse politicalization of the issue would focus on raising the quality of healthcare worldwide, better managing the increasingly high cost of new drug development, and speeding up the availability of new treatments for the benefit of mankind.  The insidious nature of both extreme arguments is the fact that they include tidbits of truth wrapped in a blanket of extremism, introducing doubt as to the extremity of the proclamation.  In a short report to be published shortly, I lay out the complex drivers and issues that contribute to the growth in globalization of clinical trials.  It is clear that this trend is here to stay and that the issue cannot and should not be reduced to an extreme sound bite that is likely to reinforce personal biases and hamper discussions needed to move the industry forward in a rational and positive fashion.

No, I'm not talking about the second coming of the Terminator as the next blockbuster movie. And machine may be a bit of a stretch, although computers, servers, and even in vitro medical devices are all machines. What is becoming apparent, however, is that software applications and the devices that they are associated with or power are becoming increasingly intelligent and able to provide much more than a simple regurgitation of data on demand. Advances in technology and the decreasing cost of IT are driving continuing innovation in the life science industry. With the ability to effectively run larger and more complex applications both on user laptops or on the web, it is becoming increasingly common to codify known knowledge into sophisticated applications that allows users to make smarter decisions based on knowledge that they may not be directly aware of. Workflow engines are enabling real-time data events to automatically initiate actions and alerts, ensuring that critical activities (e.g. drug safety events) are acted upon in the shortest time possible. Beyond exceptional events, intelligent apps are supporting improved productivity at basic levels (including, for example, the ability of Microsoft Word to automatically correct my poor typing in the generation of this blog!).

As anyone (including me) that has ever worked in retail knows, product placement is key to driving impulse purchases.  The candy bars at the checkout stand, preferred branded products at eye level, and lead sales items at the ends of the aisle are all purposefully designed to encourage potential customers to spend their hard earned dollars.  Pathway Genomics efforts to partner with Walgreens drugstores to provide a retail access conduit for their genetic testing services ($20-30 retail for a spit kit with additional costs depending on the genetic testing desired) seem to have breached the tipping point at the FDA on decisions as to whether to regulate direct to consumer (DTC) genetic testing.  In an FDA enforcement letter dated May 10, Pathway Genomics was requested to demonstrate FDA approval for the testing (which doesn't exist) or respond as to why FDA approval isn't required.  This action has triggered a wait-and-see response from Walgreens (and also CVS) regarding sale of Pathway's product and is likely to delay retail DTC genetic test options over the near term (or possibly for the foreseeable future).  It remains to be seen whether these FDA's efforts stop at DTC products or whether they further expand to all currently unapproved genetic testing. 

I can clearly remember wandering "the stacks" in our university's libraries, accompanied by a pocket full of nickels to collect and Xerox relevant articles to further our research.  Acquiring relevant reports often took days, if not weeks to collect (e.g. requesting a document to be mailed from Dialog) and that was the accepted norm.  The same information is now available at the push of a mouse, instantaneously available on our laptops.  Beyond the savings in time and effort, this change in the availability of information has resulted in the ability to better support creative thinking, since access to data is no longer the slow point in the process.  As technology has continued to advance, we are now moving beyond the historic direct paper/electronic information access to smarter, more intelligent access using tools that recognize a researcher's intent and presents relevant information to best further creative and analytical processes.  This automated intelligence is becoming increasingly ubiquitous across the industry and can be expected to directly contribute to accelerating progress in science and beyond.