City of Paris

Five years ago, I was a starry-eyed admirer of personalized medicine and one of the first in the healthcare communication industry to write an article about this exciting topic. In June, the American Society of Clinical Oncology (ASCO) meeting gave me insights into the complexity and enormity of the challenges just in designing and implementing clinical trials for targeted therapies. No wonder the conversation at ASCO’s 2008 meeting buzzed around just one single marker, the KRAS. No wonder so few targeted therapies have been introduced since the approval of Herceptin® (trastuzumab) ten years ago.

My curiosity about the pace of new product launches took me to the recent Burrill Personalized Medicine Meeting. I got an even better sense of the multitude of scientific, technological, economic, cultural and sociopolitical issues surrounding personalized medicine. I particularly appreciated the insight of Dr. Susan Desmond-Hellmann, president, Product Development, Genentech. She stated that our knowledge of molecular genetics far exceeds what we know about biology, with the latter being the rate-limiting step. Thus, a key reason for the dearth of targeted therapies today is the deficit in our fund of scientific knowledge. Once a target and the corresponding therapy are identified, one of the challenges in therapeutic development is in developing and validating a suitable, robust assay for the target. The financial incentives for the diagnostic and pharmaceutical companies have to be there, as does reimbursement and acceptance by the clinical community.

But targeted therapy is only one component of personalized medicine. Much of the unharnessed power of personalized medicine—defined more broadly as individualized healthcare based on genetic variations—lies in identifying and understanding risk factors and developing a plan for mitigating those risks. This shift toward a focus on wellness from our current mindset of intervention and treatment requires more than a change in attitude among consumers and physicians. It demands new health policies that provide financial rewards for wellness. Toward that end, it will not be surprising to see an increasing role for the consumer as the seeker of the additional information that genetic testing can provide. In fact, recent history with BRCA1 and BRCA2 testing, and now the emergence of companies such as Navigenics and 23andMe, point to consumers’ appetite for personal genetic information and, more important, their willingness to pay. Perhaps the consumer will be the one leading the charge as champion and advocate for personalized medicine?

In the increasingly challenging environment of healthcare marketing, diagnostic marketers need to take a page from the pharmaceutical industry—no, not to learn from their excesses and extravagances, but for insights into how they work to understand the way doctors make decisions and adopt new technology. It may seem obvious, but I have watched too many clinical diagnostic marketers fail to realize the market potential of their offerings by not putting into practice what they need to do if they expect their innovations to move more quickly into clinics. I have long been intrigued by the low value assigned to diagnostics by the healthcare system, and I have been looking for tangible, actionable ideas I can give to my clients in the diagnostics space. Here is the beginning of a short list, which I hope to build with the help of colleagues and visitors to our website.

I was in the audience at the Burrill Personalized Medicine Meeting recently when Alberto Gutierrez, PhD, an official from the FDA’s Office of In Vitro Diagnostics, was interviewed. Dr. Gutierrez must have said at least three times that the FDA “doesn’t look at clinical utility” when it comes to IVD clearance. This fact is well known by regulatory specialists and embraced in their filing strategies. Yet many marketers do not seem to realize that marketing’s work begins, not ends, with FDA clearance, unless the product is truly a me-too version with a well-established place in clinical practice. Most diagnostic marketers I know can produce a respectably thick binder of published studies demonstrating the analytical performance of their products, including studies comparing their products with traditional methods and showcasing superior results. Then, months to years after launch, the same marketers are surprised to learn that doctors continue to use these other methods even though they take longer and provide incomplete and/or inaccurate results, and even though reimbursement is available for the new and improved test.

So, rule number one: Don’t equate performance with utility. Proving that the performance of a new diagnostic test has been demonstrated through properly designed, robust trials, and getting FDA clearance must be paralleled by an equally arduous effort to work with clinicians in understanding and demonstrating clinical utility—what is the relevance of the test results in the clinical setting, how will it influence patient care (e.g., where in the clinical pathway does the test fit, what action should be taken based on the result) and how all of this will improve outcome. Working with clinicians, conducting the studies, publishing the findings and communicating them to the target market are just a few of the necessary steps toward adoption.

Lately, I’ve been getting more phone calls and e-mails from people looking for the next career opportunity, which is not surprising given the current economic climate. A lot of books have been written about the many facets of looking for a job, and certainly there are plenty of resources on the Internet. So I thought I’d put down a few of my pet peeves and pitfalls that are not always obvious but that might make a difference.

An intelligent file name for your resume: After spending hours consulting experts, writing, reviewing and editing a resume, many people don’t give much thought to how they name it. Names like resume.doc, dave.doc or LSJ.doc have absolutely no meaning to a total stranger or a relatively new acquaintance who may be a decision maker for a dream job. A self-documenting file name, such as MarySmith.doc, would help people on the recruiting team to file a resume and, more important, find one that had been filed temporarily to read later or for future reference.

Don’t let formatting mess you up: Too many times, I have received resumes that look like something unexpected happened along the way in translating from Windows to Mac or vice versa. I appreciate it when people send resumes in a universal format such as PDF. Not only does this save me from any potential problem with reading the resume, it also gives me a favorable impression of someone who is thoughtful about his/her audience.

Handle your network with care: Networking is the best way to find positions, especially those plum ones that are filled quickly, sometimes before they are even posted. Always but always report back to the person who gave you the job lead—how you fared, whether or not it turned out to be a good fit, etc. Following up on a lead when a personal introduction has been extended is simple but mandatory professional courtesy, even if you are no longer interested in the position for whatever reason. I had a colleague who “cried wolf” periodically about needing to find a new job, and eventually I learned to ignore his requests for help. By the same token, don’t be presumptuous. A referral is not necessarily a commitment to help you navigate through the whole process, all the way to negotiating compensation.

Be your own best marketer: Marketers go to great lengths to learn about their target audience (in this case the potential employer, both at a company/organization level and at the individual levels of the search committee and hiring manager), in order to understand the audience’s wants and needs, pain points and company culture. Developing the value proposition (what you can bring to your future employer), positioning against competition, your key messages—does all this sound familiar?

Do you have a tip or two to share?

Much has been written about the erosion of public trust in the pharmaceutical industry. Today, major pharmaceutical companies and their biggest industry group, Pharmaceutical Research and Manufacturers of America (PhRMA), are making rebuilding trust a centerpiece of the underlying mission in their conversation with society. With Election Day drawing near, industry observers are beginning to speculate on how the pharmaceutical industry will fare under a new president. It seems that on the issue of getting tough with the industry, the two candidates agree.

So, with a likely scenario of continued price pressures, patent expiration, the proliferation of generics and declining marketing budgets, what is the healthcare marketer’s path to success? How should healthcare communications be shaped to compete effectively in what some may call a hostile environment, without losing sight of that loftier goal of rebuilding trust with the public?

This week’s poll looks at some of the recurring themes in the media and in conversations among marketers. Give us your perspective by casting your vote, posting a comment, or sending me an e-mail. I’ll give you a summary report in a couple of weeks.