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Volume 35, Issue 9
The age of genomics is giving rise to highly specialized diagnostic tools, targeted therapies, and personalized drug monitoring. This new generation of individualized treatments will require life sciences companies to evolve how they reach and educate the healthcare community. Are your commercial operations up to the task?
Since cracking the human genome code more than a decade ago, life sciences companies have been working on innovative ways to apply genomics to drug development and delivery for personalized and precision medicines. A classic example of success is the blood thinner, Warfarin. Patients vary widely in their required dose and, in the past, this meant that initial doses for some patients were too high or too low, which led to negative side effects. However, by reading individual biomarkers, physicians can now accurately determine the best starting dose for each patient, potentially saving lives.
Another significant breakthrough in the use of biomarkers for personalized medicine is Kalydeco (ivacaftor) from Vertex Pharmaceuticals. The drug treats cystic fibrosis in patients who have any one of nine specific mutations in a gene called the cystic fibrosis transmembrane regulator (CFTR). Mutations in that gene, which expresses a protein that regulates ion (such as chloride) and water transport in the body, cause the accumulation of thick mucus in the lungs and digestive tract. Kalydeco is the first drug that offers a way to "work around" the defects caused by these genetic mutations.
Prognostic biomarkers are also having a transformative effect on cancer care. For example, genetic anomalies in malignant tumors can sometimes be used to predict the effectiveness of therapies. A preliminary study from the M.D. Anderson Cancer Center illustrated the potential benefits from matching targeted therapies with specific gene mutations across many cancer types. Patients who received a targeted therapy demonstrated a 27% response rate compared to 5% for those whose therapy was not matched.
A powerful example of personalized drug development in oncology is Zykadia, an inhibitor that blocks proteins that promote the development of cancerous cells. The drug, developed by Novartis, is targeted at very specific patient populations. The approval was lauded by the FDA, whose director of the Office of Hematology and Oncology Products noted, “today’s approval illustrates how a greater understanding of the underlying molecular pathways of disease can lead to the development of specific therapies aimed at these pathways.”
Remarkably, personalized medicines represent nearly half (42%) of drugs in the pipeline today, according to a
by the Tufts Center for the Study for Drug Development (CSDD). More and more life sciences firms are moving away from the old model of developing a single blockbuster product to address the largest patient population possible to a more personalized approach. These companies are working to develop specialized drugs for smaller groups to match patients to the best therapy based on their genetic makeup and other predictive factors. For instance, the one or two drugs used to treat high cholesterol are splintering off into many slightly different therapies based on the genetic variables of particular patient populations.
Given the potential of personalized medicine, the White House is requesting an initial budget of $215 million for its precision medicine initiative. President Obama believes “the possibilities are boundless” and the administration’s program begins with a plan to collect genetic data on one million Americans so scientists can develop more diagnostics and therapies tailored to the characteristics of individual patients.
While highly specialized drugs produce better outcomes for patients, they present a tougher challenge for marketers. A therapeutic that can benefit 30,000 patients instead of, say, three million requires a special kind of advocacy as it enters the marketplace. It also requires a fundamentally different pricing model. Brand teams now must convince both payers and healthcare providers that their personalized drugs not only produce better outcomes but also reduce the total cost of treatment. The education and messaging required to communicate the value of precision medicines to all of their targets is exponentially more complex.
Commercial adjustment required
In this new landscape, the one-drug-fits-all mass marketing approaches of the past simply won’t work, upending the commercial model in life sciences once again. Marketers must now deliver tailored information to healthcare providers based on very
specific patient use cases. The education of all healthcare stakeholders on personalized medications must be more fluid, more accessible, and more bi-directional than ever before.
Essentially, the more specific the treatments become, the faster and more targeted the information flow must be. A doctor trying to remember vital information conveyed during a rep visit the week prior or from a web site is not good enough when it comes to a specialized patient case. Personalized medicine requires equally personalized sales and marketing.
A field sales rep that owns a physician relationship cannot possibly be available to him or her all the time nor can he quickly and efficiently get the physician all of the information that’s needed for personalized care. Reps will certainly evolve to provide more concierge-type services, but the broader knowledge and resources of the company must be made accessible in an organized and efficient way. In essence, the brand is on call. Medical science liaisons need to be instantly accessible for deep scientific discussions. And pharmacoeconomists will need to be on hand to demonstrate the financial benefits and savings associated with specialized healthcare.
Addressing the information accessibility problem is a big step. But it is not the only step. Unique combinations of diagnostics and therapies will also be required that will extend well beyond the product and information boundaries available from a single pharmaceutical company. The question is, how will all this information come together to create a complete, personalized treatment plan?
What is required is a new approach to connecting healthcare providers with the life sciences industry in an organized, fair, and efficient way-an approach that makes industry-wide information accessibility and service possible.
So what will this new approach look like? Consider a model like Travelocity employs for travel but applied to healthcare. In booking a flight from Newark to Detroit to San Francisco, then back to Newark, a traveler could go directly to the United Airlines website because they have a hub in Newark. But they would quickly discover United does not have any direct flights to Detroit. The traveler would be forced to do a layover, have fewer departure options, and pay a higher fare. When going to Travelocity, travelers are presented with optimized itineraries that combine flights from multiple carriers to best meet their specific preference for timing, layovers, and price.
A Travelocity-like service that connects healthcare providers with the entire life sciences industry can, likewise, bring together unique information from across the industry required for very specialized treatments. And, better yet, it is much more convenient for healthcare professionals who will increasingly need a single source for all their information needs.
But, in this type of industry-wide service, whose information will be presented to the healthcare provider?
There are many models in the consumer world that work. For instance, every Google search leverages a detailed, proprietary algorithm that incorporates hundreds of factors, such as sponsorship, relevance, site reputation, and usability, to deliver the right search results. But we can do even better in healthcare where patient lives and well being are at stake. Surfacing the right information based on historical patient outcomes and unique patient needs is possible with big data analytics. By correlating large volumes of causal physician engagement data with actual behaviors and outcomes, commercial teams can begin to predict what they want and serve it up preemptively.
All about access
Will it ever take the decision entirely out of the healthcare provider’s hands? Certainly not. But it will get the right information to healthcare providers faster and more efficiently, which is required in a world where the combination of genomics and specialized medicine will become the new standard.
With cloud-based systems, too, details about healthcare providers’ preferences and habits can be easily accessible for internal groups. External partners like advertising agencies and contract sales organizations can efficiently contribute insights from their customer interactions for all to see in a single place. The same applies to regional affiliates for a truly holistic view of the customer worldwide.
The technology is now available to make personalized marketing a reality. But a “Travelocity” for healthcare takes more than technology. It takes a new way of thinking-one that will fundamentally transform how the pharma industry approaches this new age of personalized medicine.
Matt Wallach is President and Co-Founder, Veeva Systems. He can be reached at firstname.lastname@example.org.