By Natalie Wright Curley, J.D.
This summer’s center stage appearance of Eric Snowden removed any doubt as to the importance U.S. government places on big data. In fact, last year, President Obama initiated the Big Data Research and Development Initiative. The sole purpose of this $200 million project, encompassing 84 programs, is to use big data to solve government’s biggest problems. Towards this end, the U.S. government owns six of the ten most powerful super computers in the world. This includes those used by Snowden’s previous employer, the NSA. These computers can potentially store yotta bytes of data. While it is clear that big data is the big trend, it is sometimes difficult to see how this new wave of technological advancement will affect individuals and companies in the everyday world.“Big data” is simply the collection of data sets so large and complex that it is difficult to process using current database management tools or traditional data processing applications. The belief is that if we can harness these massive data sets, we will be able to make accurate correlations that will lead to improved decision-making. This includes areas such as business trends, marketing, health care, life sciences, economic productivity, security, natural disasters and resource management.
Just a decade ago and at the cost of $1 billion, the first human genome was sequenced – the result of a 13 year effort. Today, the time and cost of sequencing has dropped dramatically. It is well understood that we will be able to sequence an individual’s genome for under $1,000 in a couple days time in the very near future. While exciting, this sequencing capability will generate an incredible amount of data that must be interpreted and deciphered to have real impact on patient care and treatment. This concept is the essence of big data and the dawn of true personalized medicine.
By linking genomic sequences and corresponding mutations with outcomes information (e.g., responses to medications, progression, survival, etc.), the goal is to make treatment decisions from a specific patient’s data set. This will enable health care providers to effectively predict and treat each patient according to their own genetic profile. Currently, while some patients can afford the relatively high, unreimbursed cost of full genetic testing (around $7000), doctors have no easy way to interpret the results or determine how a patient’s care should be affected. This issue is a focus of research and development by many hospitals and universities worldwide.Cancer is one area of concentration. Currently, there are 200-300 known genes that, if mutated, can be treated with a corresponding targeted therapy. The chance of a patient responding to a targeted therapy in the presence of such mutation is very high. Unfortunately, even with this ability, results are not always ideal. Many of these mutations occur in a very small subset of patients (e.g., ALK mutation in lung cancer may occur in less than one percent of patients), and often patients develop resistance to such therapy. Another problem is the amount of biopsied tissue available for genetic analysis. While several targeted therapies have corresponding genetic tests, often times, there is not enough tissue to run each test sequentially. Accordingly, if a patient did not have the mutation being tested for, there may not be enough sample to test for other potential treatment options. Ideally, it would be best to obtain the entire genomic sequence, or at least the mutational status for all treatable mutations through multi-plexing technologies. While this technology exists, reimbursement for such testing is uncertain and currently under debate. In the future, with the accumulation of better patient data sets tied to corresponding outcomes, there is no doubt that future treatments will improve and new targets, pathways and therapies will become available.
The ability to accumulate data on individuals has progressed much faster that the legal environment surrounding it. Many tracking and behavioral targeting advertising programs also raise privacy concerns. In June of this year, Google was the target of a class action lawsuit directed to Gmail’s scanning of email communications to create targeted advertising. In the legal pleadings, Google asserts that people sending emails to any of its 425 million Gmail users have no “reasonable expectation” of a right to privacy.
Similarly, Snowden’s revelation that the US National Security Agency is tracking cell phone calls, and monitoring emails and Internet traffic of virtually all Americans has raised concerns over civil liberties and rights to privacy. Clearly, the legal rights of all parties will continue to be clarified as big data continues to grow and information on individuals is compiled, from their genetic make up to their purchasing habits.While the impact of big data is just emerging, it is here to stay. Big data will impact the way we think about all major areas of our lives: health care, employment, purchasing decisions, and privacy. Tracking systems are seamlessly integrated in the technologies that make our lives easier and more convenient. For the youngest generation, this is their world. Like records, typewriters and phones with cords, bygones of days long gone, the absence of personalized data is a thing of the past. As big data continues to evolve, let us hope it is accompanied by big judgment. As George Orwell said, “Big Brother is watching.” Successful companies will be watching too.
Natalie Wright Curley, J.D., consults start-up companies on intellectual property, licensing and university transactions. Prior to starting her own business, Natalie practiced with a large patent law firm and went on to become in-house counsel for the University of Texas M. D. Anderson Cancer Center. During the last five years of her 13 year tenure, she served as Managing Director for M. D. Anderson’s Office of Technology Commercialization handling patents, licensing, and start ups for the university. Natalie can be contacted in Houston at 713-857-3705.
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