As an example of the efficacious use of genomics testing, Eng spoke about Lynch syndrome, the most common form of inherited colon cancer. Patients who are identified as at risk can then go through more frequent screening to potentially catch and remove precancerous polyps. Those who have already developed colon cancer and are identified as a carrier of Lynch syndrome genes can receive more aggressive treatment to reduce the risk of recurrence.

At the other extreme, Eng described how inappropriate use of DTC genomics testing cost a patient her life. When the physician suggested genetic counseling and testing of BRCA1 and BRCA2 based on family history, the patient declined the test. The patient rationalized that she had already taken a consumer genomics test, and that test had already told her that she was “at population risk” of breast, ovarian and colon cancers. So she did not see why she needed another round of genomics testing. Eng noted that this was a case of “misattributed equivalence.” To the consumer, DTC testing is no different from validated genetic practices—a dangerous assumption that can cost lives, as it did in this particular case. Had the patient undergone the testing as recommended and been confirmed to be “mutation positive,” she would have received aggressive monitoring and possible preventative surgery that may have saved her life.

Most of us in the healthcare business are aware of the lack of regulation and standardization of many DTC genomic tests. The lack of analytical validity (tests from different labs may offer contrary results), lack of clinical validity (the vast majority of SNP associations have not been validated), and lack of clinical utility (population statistics are not equal to clinical observations) are bewildering, to say the very least. And for all these reasons, most results are not actionable—hence the term “recreational genomics.” To their credit, however, proponents suggest that having access to one’s genetic information can be empowering, encouraging individuals to take ownership of their risk factors and perhaps even manage them through lifestyle adjustments.

Eng spoke about two key factors in successful use of genomics testing. The first is the importance of family history, which can guide testing strategy as well as complement genomics testing in risk assessment. The other is the genetic counselor, who is an invaluable and, to use Eng’s word, indispensable resource in guiding patients (and physicians) through the maze of options and probabilities. Eng noted an increase in patient uptake of the Lynch syndrome test from 14 percent in 2008, when testing began at Cleveland Clinic, to 80 percent in 2009, when genetic counseling became part of the patient care routine.

My take: As technology makes genomics more accessible, empowered consumers like all of us should incorporate the notion of responsible use and work with healthcare professionals to use genomics to the benefit of our health intelligently and without overtaxing our strained healthcare system.

Set up a biomarker program, with an appointed head, to lead companion diagnostics strategy development and implementation.

Start working on companion diagnostics early—in the discovery phase. Buxton suggested that starting at phase 2A/2B is too late. And one can see why when he explained how the process works as he talked through the best practices.

Consider multiple companion diagnostics test candidates and begin to think about what will be used in phase 2/3 trials. Think about logistics—such as methodology and platform—as they will drive which labs are most appropriate for running the tests and key parameters such as turnaround time for results. Envision how the test(s) will be adopted and commercialization.

Begin thinking about the clinical trials. Pick the best cut-off values, giving consideration to such factors as positive predictive value, and weighing the tradeoffs between regulatory approval and commercialization. Stratify patients first; randomize second.

In an emerging field such as personalized medicine, prior experience and conventional wisdom are often not enough to hone in on the regulatory strategy. Consider a pre-IDE meeting with the FDA at this point.

This would also be a good time for different business functions to gather, think together and reach consensus within the organization.

Select the companion diagnostics partner early. Buxton added that leading diagnostic companies such as Roche, Abbott and Qiagen are also leading players in companion diagnostics, but availability may be an issue as they are sought after by the pharmaceuticals industry.

Understand the clinical testing industry (the labs) and the lab/IVD industry value chains. Consider issues such as IP and royalties.

Choose a lab partner and work out the logistics.

Imagine the value an IVD company can bring to the pharmaceutical company in this process, through expertise, experience, platforms, markers and networks. More important, imagine how much more effective your business development efforts can be by demonstrating that your organization is the ideal companion diagnostics partner to address the many facets—scientific, clinical, regulatory and infrastructure—of your potential pharmaceutical partner’s needs.

Leisure began by making two points that make complete sense—that payers are in a tight spot today and that a reimbursement strategy should begin with prioritizing and sequencing payers, which sometimes requires weighing the reward of securing the biggest, most visible payer vs. the risk of a tough sell that may not lead to the desired outcome. And of course, reward is measured not only in size but also the level of influence of the payer and how a particular win could trigger others.

Leisure’s next two points reminded me of so many people I run across today—many of whom are marketers, which goes to say that we all should know better. “Solve their problems, not yours,” and “Use their language, their currency, and frame your conversation around their workflow.” How many candidates have we all run across in job interviews who tell you about their passion, their strengths and their experience, without bothering to convey how those align with your organization’s agenda? And I have lost count of presentations on novel diagnostics that neglect to mention how the wonder product being proposed fits into the current care pathway or even into the clinical lab’s workflow. I was asking an entrepreneur about the cost of a new test and he asked, “Do you mean cost or price?” I clarified that I was interested in the cost to payers and patients. While it was fair to ask for clarification, I thought the question was telling of the need to “solve their problems” and “use their currency.”

If anyone ever doubts that healthcare is patient-centric, or that healthcare is moving toward a patient focus, think again. The focus on patients is here. This was illustrated by providers like Ralph Snyderman, MD, of Duke University, who spoke of a study that demonstrated dramatic improvements in adherence and reduction in costs in congested heart failure patients who received personalized care plans, intensive education and feedback loops. The theme was echoed by Vance Vanier, MD, whose genomics testing company, Navigenics, is partnering successfully with employers to make preventive medicine a reality in the workplace. Kathy L. Hudson, PhD, Chief of Staff, Office of the Director, National Institutes of Health (NIH), boldly envisions a future where everyone participates in personalized medicine and thinks “it’s cool.” And Leroy Hood, MD, PhD, of the Institute for Systems Biology spoke of the need to educate physicians and patients. Andrew Schorr of Patient Power, a master of ceremonies at PMWC 2011, hosted a session on patient empowerment.

The bottom line is that every marketing plan for a drug or diagnostic-related product needs to take into account the role of the patient or, more broadly, the consumer audience. Increased adherence to therapeutic, monitoring or self-monitoring regimens is a well-established rationale for educating and involving the patient. The power of patient advocacy in driving reimbursement or regulatory approval has been proven many times over. The propensity of patients and families to take ownership of becoming informed and pursuing treatment options in life-threatening, complex and/or chronic diseases such as cancer is another reason for including the patient in one’s marketing and communication plan. But there are other reasons. For example, an educated and engaged patient can contribute to care efficiency by making providers’ jobs a little easier. The healthcare system will see savings due to a decrease in unnecessary complications and emergency room visits. And above all, the transition from disease management to health management begins with preventive medicine and the educated and empowered consumer.

And if healthcare is too conservative, too regulatory-constrained to consider some of these ideas, let’s at least take a baby step. To all you marketers who are stuck with unwieldy, antiquated websites that are mysteriously difficult to navigate, talk to your website team today! At the very least, get your corporate and product messages accessible to your audience.

I do know of a fairly robust survey and well-written report from Eccolo Media. The survey targeted the technology sector, but I think there are sufficient parallels to the medical devices and diagnostics industries to be relevant to us. More importantly, I would like to suggest three areas that healthcare marketers should consider in planning and implementing sales collateral.

Consider the sales cycle. Preparing the market for a new product and getting potential customers to think about their unmet needs, for example, call for very different types of information than convincing a prospective customer that your product is the right one. Understanding when to deploy a white paper to create awareness of important issues and when to get to the brass tacks with specific product information is key. A quick-hit sales piece that can be used in a brief hallway encounter is much different from a leave-behind for the curious technical buyer. Developing a multipurpose piece may sound efficient and cost-effective, but in reality it can diminish sales productivity.

Think online and offline. As more and more potential customers download literature from company websites, companies really need to think beyond printer-friendly. My pet peeve is the complex, multifold sales brochure that prints as miniaturized spreads or gatefolds that are difficult to read. It takes a minute to prepare files that can be printed page by page. Easy-to-read files containing useful information (yes, content is king) will be forwarded and shared with colleagues during the sales process. Who would want to miss that leverage?

Rigid formats can get in the way. I am all for adherence to corporate identity guidelines, but the people who set these guidelines need to know that sales brochures shouldn’t have the same look and feel as white papers and case studies, and vice versa. The answer, perhaps, lies in thinking through the purpose and usage of each type of collateral, and coming up with appropriate templates and treatments, rather than the one-size-fits-all approach that I see all the time.

But exactly what does thinking green mean in business and, more specifically, in marketing and branding? There is a fair amount of good reading out there. Here are a few thought starters.

Sustainability and corporate social responsibility are broader, and more meaningful, frameworks for thinking about a company’s interaction with its stakeholders, society and the environment. Beyond conservation of resources, companies must begin to think responsibly about their impact on behavior and culture. This concept is summarized nicely in a Bloomberg Businessweek article, Finding Promise in Sustainability 2.0 and in a McKinsey Quarterly article, When sustainability means more than ‘green’.

So how do we turn these ideas into practice? Or, where do corporate social responsibility and brand communications come together? Moving Up to Sustainability 2.0: Five Trends Shaping the New Agenda offers some good insights and importantly connects corporate social responsibility to social media, making a strong case about the convergence of the two. “Where social media has the biggest impact is in enabling greater openness and transparency between brands and people,” writes author Becky Willan. Well said.

How much do you rely on Flash for your work?
About half of the projects I’ve been building lately are Flash-based.

Does the fact that Flash will not be universally supported, at least for now, get in the way of your work?
No. The projects I’m working on are more custom builds for presentations and trade show booths, not so much over the Internet.

Is Flash overrated?
Not really. Flash is a fine product. In the right programmer’s hands it can do a lot of wonderful stuff.

Where/when does Flash excel?
Flash can be used by newbies and hardcore programmers alike. Naturally, with more programming knowledge, you can build a more robust product. And there is a niche industry for selling pre-built Flash content—much like stock images for designers.

Are there programming tools on the horizon that can do the same job—and perhaps better?
HTML5. The big issue with Flash has to do with browsers and the Web in general relying on one proprietary plug-in to run all these things. If something happened and Adobe killed Flash tomorrow, much of the Internet would break. You can see this when you surf on an iPhone. The HTML5 standard will replace Flash eventually, along with other things like Java and Silverlight. And HTML5 will have the features currently provided by the plug-ins.

What do you think are the ramifications for Apple? For Adobe?
HTML5 is a couple years behind in development, so I’m sure Steve Jobs is on the phone daily, yelling at people to speed it up. If Adobe is smart, they are already planning to integrate their tools into the HTML5 world in the near future and are seeing the demise of Flash in three to five years and either planning on morphing that into something else or phasing it out. A lot can happen in three years. Maybe something else will pop up that nobody saw coming and wipe out all of these things with something totally new.

Will this fuel the PC vs. Mac divide?
No. It’s not a Mac/PC issue. (Besides, Macs and PCs are getting closer all the time.) The plug-ins and HTML5 will work on both. What it is doing is pissing off developers who are losing money by things not being able to be seen on iPhone or iPad devices or by having to build a duplicate version in Apple-approved code.

If You’re Curious
How the iPad is already reshaping the Internet (without Flash)
Adobe drops effort to get Flash into Apple’s key products
Adobe vs. Apple war generates rage, Facebook group

There are many ramifications of this concept of resonance in Twitter advertising. Customers will applaud the removal of messages they don’t find useful. Marketers will be forced to think before they simply dispense information. To me, it is an advertising model that is tailored to the social media context and not just borrowed or adapted from print à la the early days of display advertising.

The Altimeter Group, whose founder Charlene Li wrote the social media primer Groundswell: Winning in a World Transformed by Social Technologies, posted what I believe is the best explanation and analysis of “promoted tweets.” I consider it a must-read for all marketers.

Personally I think it is a great idea for clients to take a more proactive role in shaping their relationship with agencies and, even more important, in integrating the service offerings from different agencies. The client who really understands his/her business and has a clear idea of what each agency can and needs to contribute to the communication mix will not have to “force collaboration” because that clarity of vision will replace needless jockeying to figure out specific roles. A lot of confusion and inefficiencies happen when the client is not clear on who does what, which leads to inappropriate assignments and sets up the entree to the blame game.

More important, agencies should take these rumblings, largely from the client side, as a cue to rethink their business. Why is it that so many technology-savvy digital agencies continue to rely more or less exclusively on traditional agencies for content? And what is stopping traditional agencies from bringing in new media talent—both technical and strategic—to lead instead of be led? With the way we work today, accessing top talent is much easier than it was not too long ago. And why not take the advice Forrester Research is giving clients for ourselves? Let’s redefine our role before it gets redefined for us. Let’s embrace these alternate service providers and integrate their offerings into what we do. Forrester also advocates “incentive-based compensation.” Why not? And I know many agency principals will respond with a wry chuckle to this one: “Create a productive relationship with procurement.”