The megatrend of personalized medicine gained a significant boost of adrenaline recently as Vertex Pharmaceutical’s cystic fibrosis drug, Kalydeco (ivacaftor), earned FDA approval. As with much of personalized medicine’s recent news, behind the story beats the heart of a companion diagnostic.

Kalydeco is approved for a small subset of cystic fibrosis (CF) patients with the G551D mutation of the CTFR gene. Of the roughly 30,000 patients in the United States with CF, it has been estimated that only 4 percent, or 1,200 patients, have this particular mutation. And how does one find out if they have this particular gene mutation? Kalydeco’s label states, “If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the G551D mutation.” The availability of a CF diagnostic was critical to Kalydeco’s clinical success. It allowed clinicians to select the correct patients for the trials and prove greater efficacy. If a diagnostic had not been available, Vertex Pharmaceuticals would have needed to partner with a company capable of developing a companion diagnostic.

This was the case for both of the personalized medicines approved by the FDA in 2011. Xalkori (crizotinib), a lung cancer drug that targets tumors with the abnormal ALK gene was approved in August and Zelboraf (vemurafenib), a drug to treat malignant melanomas that have a certain gene mutation was also approved in August. Each drug was approved simultaneously with first-in-class companion diagnostic tests to identify if patients have a susceptible tumor. Neither of these drugs would have been approved without the ability to properly screen and select patients.

In other words, the success of each drug rested on the successful development of a companion diagnostic — a trend that the FDA would like to continue. Here is a quote from the FDA news release for the Zelboraf approval in august by Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health:

“Today’s approval of Zelboraf and the cobas test is a great example of how companion diagnostics can be developed and used to ensure patients are exposed to highly effective, more personalized therapies in a safe manner.”

Companion diagnostics can help improve the efficacy of a drug by properly segmenting patient populations. And, in doing so, increase the drug’s likelihood for regulatory approval. If companion diagnostics are not a key consideration for your clinical development program, they may well be soon.
 

REPORT: Companion Diagnostics and Biomarker Development (PH169)

Harness companion diagnostic metrics to set strategy, improve partner selection and build a program of targeted therapy development.

More about this Report | Download Report Summary

 

Once upon a time, a brand team’s quest ended at marketing approval; revenues would take care of themselves. Fast forward 20 years, and the industry faces a much more challenging road to brand success. Receiving marketing authorization has become just another stage to complete. The more crucial step now is gaining and keeping the desired level of reimbursement.

A growing reliance on insurance companies and government payers to cover the cost of therapy has led to increased scrutiny of drug and device prices and benefits. With increases in patient populations and disease prevalence, payers no longer turn a blind eye to rising prices necessary to recoup product development costs. To successfully maintain their business model, they must find ways to cut their required expenditures or place more of the burden on patients. With the latter either forbidden (countries such as the United Kingdom and Canada) or severely frowned upon (the United States), they look to trim their expenses. To accomplish this, payers have begun limiting access to and decreasing the payments for new drugs and technologies.

Price has emerged as the easiest measure to determine which drugs and devices to cover. For insurance plans in the United States, price can relegate products to certain tiers of coverage, which specify how much of the cost the payer will reimburse and what percentage of cost must be covered by the patient. The more that a burden gets placed on the patient, the less of a market the company will see for its product. After an intense outcry from manufacturers and patients, payers now attempt to look beyond price to cost-effectiveness on a long-term basis. To help make these decisions, payers require companies to provide an increased level of clinical and economic data. This puts the onus on the drug developer to ensure sufficient levels of health economic and outcomes data make it into submitted Health Technology Assessments (HTAs). Most companies now task their health economics team with aiding the clinical development team in creating endpoints that not only point to efficacy but also relate to long-term outcomes and cost-savings to meet payers’ requirements.

While this has resulted in more work for manufacturers, interviewees from our latest pricing study agree that owning the health economics process has also provided incredible side benefits. Because payers require health outcomes data as early as Phase II – if not earlier – drug and device companies collect it, but they have found that they can also utilize this data strategically. Many companies see these advanced economic models as a way to trim their product portfolios. Instead of wasting money sending products to Phase III that will not prove efficacious enough to receive approval or at a low enough cost to guarantee reimbursement, they reallocate the money to earlier-stage compounds and technologies. Companies have also found uses for health economics within marketing campaigns and business development due diligence.

In this era of intense scrutiny over the cost of healthcare, life sciences companies cannot afford to enter the game ill-prepared. Meeting the ever-changing demands of payers has required dedicated health economics teams, increased spending and the ability to embrace new trends in an effort to communicate drug and device value. Many companies house strategy people internally and outsource health economics modeling work to vendors of varying magnitude and geography. Some companies have experimented with risk-sharing agreements and health outcomes liaisons to better address payers’ concerns over price. Through all of this, health economics teams must remember why their function is vital to the industry as a whole. Though challenging and often downright frustrating, health economics is here to stay. The cost of healthcare must be controlled in order to effectively provide care for all who need it. Payers do not want to outright forbid the best treatments simply because of a price tag. They need help understanding why the price has been set at that level and how reimbursing for the product will eliminate other costs incurred if the patient does not receive that treatment. Companies must find ways to effectively communicate this knowledge or it will be difficult to receive the reimbursement they desire.

One interviewed health economics executive summed up the entire health economics push: “We cannot avoid this debate, and we do not want to avoid this debate. We have good products and technologies, and we want to contribute to showing that they not only work but are also worth the money.” Health economics analysis, though it takes time and money to complete, showcases the value of innovation, which benefits the entire life sciences industry.
 

REPORT: Health Economics and Outcomes Research (PH137)

Develop your HEOR team to support product success, manage costs and workflow, and communicate ROI.

More about this Report | Download Report Summary

 

Our newly updated Fair-Market Value Benchmarking and Analysis service now provides medical, scientific and regulatory staff at life sciences companies with fair-market value benchmarks for thought leaders and influential physicians in more than 100 countries. The service is built upon a decade of detailed key opinion leader management research and the Research and Consulting teams’ expertise in FMV benchmarking and developing physician fee schedules.

With a decade of thought leader development and medical affairs management work to build on, we’ve developed a time-tested methodology for collecting fair-market value data for specific activities around the world. The FMV Benchmarking service now includes a database of hourly rates and flat fees for 25 specialty areas. With more than 10,000 data sets available to set up region- or country-specific fee schedules worldwide, Cutting Edge Information has the largest FMV database currently available. The FMV benchmarking service is designed to quickly deliver customized data required to set fair-market value fee schedules for healthcare providers. Solutions are customized based on each company’s need and can be presented by various ‘cuts’ including:

• Region or country
• Therapeutic or specialty area
• Company size
• Thought leader category
• Physician activity

Our research has been driven by several key goals for our partners and clients:

• Develop a reliable FMV fee schedule based on legitimate and detailed KOL compensation benchmarks
• Establish sound consultant and advisor payment practices
• Reduce compliance risks

Developing a dependable global thought leader compensation plan is proving tricky for many companies. Not many teams had thought systematically about global fair-market values for their physician consultants and advisors until the last year or two. Finding benchmarks and best practices takes time that many companies don’t have.

In-depth analysis of current benchmarks and trend forecasts

For example, some of our clients wanted to understand more about the differences between what companies pay U.S. physicians and their European counterparts for the same consulting and advising activities. Part of the industry’s evolution has been an attempt to standardize compensation rates around the world. To provide a better guide for thought leader compensation, CEI analysts calculated average hourly rates for U.S. and European physicians. These averages were derived from 800 fair-market value (FMV) compensation data points. Based on average hourly rates for various expertise levels, company sizes, therapeutic areas and activities, we determined that the average U.S. hourly rate for 2010-2011 was $306; the average European hourly rate was €183, meaning the average U.S. rate is roughly 13 percent higher. At many companies, compensation varies based on both the type of healthcare professional and the activity he or she is performing. As expected, a drug company’s size and areas of specialty expand these possibilities. We also found regional variation, based on both regulatory and cultural differences, plays a substantial role in global physician compensation levels.

Large pharmaceutical companies provide the single highest data points for hourly rates to the most in-demand European thought leaders, at €600 per hour. However, the average large-company compensation across all therapeutic areas is €186 per hour. Smaller drug companies pay slightly more, on average, at €191. The study found that small drug companies often have less negotiating power with highly influential physicians, or they expect to pay more to work with thought leaders who might otherwise opt to work with larger, better-known companies that offer more research opportunities.

The FMV Benchmarking service and our customized consulting projects were designed to assist medical affairs executives at large, medium and small companies to:

• Avoid overpaying or underpaying thought leaders for specific activities.
• Use FMV benchmarking data to determine appropriate spending levels.
• Understand payment ranges made to European thought leaders to attract top-tier KOLs.

REPORT: Determining European KOL Compensation (PH150)

Set fair-market value compensation and fee schedules for European key opinion leaders (KOLs).

More about this Report | Download Report Summary

 

REPORT: KOL Fair-Market Value and Aggregate Spend (PH155)

Set a physician fee schedule with fair-market value compensation data for key opinion leaders across multiple specialty areas.

More about this Report | Download Report Summary

 

The emerging markets are not the United States, nor are they the European Union. It seems like a simple statement, but in Cutting Edge Information’s latest research on clinical development in the emerging markets, one finding rose to the top: the life sciences industry consistently tries to run emerging markets clinical trials the same way they run them in more developed markets. They just expect more favorable timelines and resource figures.

But they are not the same. The emerging markets offer different opportunities and different challenges for clinical development, and therefore require a separate strategy and mindset than the developed world. Companies must change strategy and cease entering the region attempting to Americanize (or Europeanize) the process. When sponsors try to run a trial this way, all they accomplish is building their own logjam to development and angering the local personnel whose influence and respect they rely on in these countries. Over the course of our study, we heard several examples of cultural issues that companies need to be aware of and plan for. One interviewee gave an example spotlighting Latin American clinical trials, saying, “much of the region is highly Roman Catholic. Do not plan to run a data sweep on Easter weekend or any other holy day; it won’t happen. Everyone will be home with their families celebrating the holiday.” Forcing the site team to work over Easter will not engender trust or respect for a company. This holds for practically all countries’ religious and political holidays.

From clinical experts working in India, we heard that as a culture, Indians do not like to say “no.” In fact, it is often considered rude. According to one interviewee, “it is much more acceptable in their culture to give you a noncommittal answer and to keep giving you that noncommittal answer in hopes that you will stop asking the question soon.” This can be disconcerting for clinical trial executives not familiar with the practice. Weeks and months pass before anyone enlightens the sponsor. Is this solely the sponsor’s fault? No, but sponsors must be aware of the culture and train their local staff to offer alternatives when something cannot be done instead of saying that it will be and then missing critical milestones.

Deciding that regulations for clinical trials in emerging markets are not as “right” as those in the West can also damage the success of a trial. One of the major stumbling blocks for sponsors is the requirement in several countries that the company must continue providing treatment for trial subjects as long as the treatment benefits the patient, regardless of whether or not the company continues development on the product. Interviews with CROs suggest that several companies refuse to work in a country whose regulations do not perfectly align with those to which they are accustomed.

However, companies must respect the nation, its government and its people if they want to succeed in emerging locations for clinical trials. Investigators and CRAs do not have to continue working for a company that does not support them. The growing interest in these markets will allow them to switch to working for a company that will respect and value its local staff. With many of the industry’s hopes riding on the emerging markets, it would behoove clinical development teams to recognize and respect the cultural challenges of clinical trials in new markets.

REPORT: Emerging Markets Clinical Trials: BRIC Countries (PH143)

Confidently tap BRIC's potential to deliver patients and lower costs - and avoid the pitfalls common to these intriguing markets.

More about this Report | Download Report Summary

 

REPORT: Emerging Markets Clinical Trials: Asia (PH144)

Navigate the maze of emerging Asian markets to improve patient access and retention while sidestepping clinical teams' common mistakes.

More about this Report | Download Report Summary

 

REPORT: Emerging Markets Clinical Trials: Eastern Europe (PH145)

Make sense of Europe’s emerging markets to accelerate clinical development and save money while addressing region-specific cultural
challenges in clinical trials.

More about this Report | Download Report Summary

 

REPORT: Emerging Markets Clinical Trials: Latin America (PH146)

Boost trials with Latin America’s untapped clinical promise, including patient availability, established infrastructure, and convenient communication.

More about this Report | Download Report Summary

 

REPORT: Emerging Markets Clinical Trials: Africa (PH147)

Explore the next frontier of emerging markets to build a clinical foundation that generates decades of benefits for developers and patients.

More about this Report | Download Report Summary

 

REPORT: Clinical Operations (PH152)

Maintain clinical trial budgets and efficiency through up-to-date resource benchmarks and adaptive trial design.

More about this Report | Download Report Summary

 

The first few decisions of Germany’s new drug pricing body have arrived, and the results are mixed. Brilique (known as Brilinta in the United States) in December became the first product to complete the new product review process under Germany’s new drug evaluation law (AMNOG). It received a favorable opinion in one indication, allowing Brilinta manufacturer AstraZeneca to negotiate a price with the country’s public healthcare organization rather than be subjected to reference pricing.

Trajenta (known as Tradjenta in the U.S. market), a diabetes product marketed by Boehringer-Ingleheim and Eli Lilly was not as lucky. Drug evaluator IQWIG requested the product be evaluated against a different class of drug than was provided by Eli Lilly and Boehringer Ingleheim. Because they did not submit information on a specified comparator drug, the product was not found to have clinical superiority in any of the three indications evaluated.

AMNOG’s clinical advancement and cost-effectiveness evaluation applies to all new drugs approved in Germany except orphan products with low sales volumes and drugs which are exclusively administered in hospitals. Drug companies can launch their drugs with pricing freedom upon approval, but this free pricing period lasts only six to twelve months. In order to gain favorable pricing after this period, the product must be judged to provide a clinical benefit that exceeds any currently marketed products.

For the many companies watching the process and trying to determine how the new legislation will affect their own submissions, these two cases provide some insight but do not completely clear the air. Germany has until now been seen as the best place to introduce new drugs in Europe, due to the freedom allowed when pricing products. As a result, Germany was often the first European company to receive innovative products; countries using reference pricing only received new products after Germany’s launches were completed. If the revised German regulatory process lowers prices, the fear is that these cuts will cascade across Europe due to the number of countries referencing Germany’s prices. Because a low German bellwether will be referenced by so many other countries, it might be preferable to receive no German business at all.

This concern is altering the launch equation in Europe. Novartis was already marketing high blood pressure product Rasilamlo when it pulled the product from the Germany market due to a data request from IQWIG’s governing body, the G-BA. Eli Lilly in September decided against launching Trajenta in advance of the G-BA’s evaluation, waiting instead to see what reimbursement would be offered after IQWIG’s evaluation. Now that Eli Lilly has seen IQWIG’s opinion – a negative one – it’s not clear that Trajenta will ever launch in Germany. The number of follow-on products which will follow Trajenta’s lead is yet to be seen, but if skipping Germany becomes a popular tactic, the country will likely find itself with one option per drug class.
 

REPORT: Pharmaceutical Pricing Strategy (PH153)

Set an optimal price for your product while addressing the concerns of both internal and external clients.

More about this Report | Download Report Summary

 

Joining the ever-growing list of organizations, associations and trade groups to weigh in on social media, the American Medical Association this week adopted a non-binding policy suggesting how physicians should go about their business on social networks.

Though there is nothing especially groundbreaking within the document, it signifies a recognition by the nation’s preeminent physicians’ organization that physician participation in social media is happening and will likely continue. Each week brings a new and staggering statistic in my Twitter stream about doctors’ technology adoption rates. Pretty soon smartphone ownership will be near universal for physicans, with tablets not far behind. These technologies provide real and meaningful tools to overworked doctors in all walks of life. From aspiring med students to seasoned surgeons, the medical profession is uniquely inclined to want, need and ultimately buy into digital technology, explaining the disproportionate rate at which doctors own and use those technologies. One of the outcomes of that early adopter status is increased exposure to all of the social media thriving in those technologies; thus it’s no surprise, really, that physicians tend to report social media usage rates higher than the average individual. What is completely unclear, though, is how they are using those media and for what purpose. Is it for personal use? Is it for professional use? Which platforms and services? Who are they interacting with?

All of this makes physicians’ use of social media an emerging area of interest to healthcare marketers, pharma companies, and device companies. Heck, even phone companies want to understand this lucrative demographic. Which is why the AMA was smart to take this first step in recognizing that doctors are most definitely using social media, and to attempt to shape the way in which they do so.

The policy describes the following six principles:

1) Physicians should be cognizant of standards of patient privacy and confidentiality that must be maintained in all environments, including online, and must refrain from posting identifiable patient information online.

Stating the fundamentals (that we hope are obvious) is not a bad start when creating a new policy.

2) When using the Internet for social networking, physicians should use privacy settings to safeguard personal information and content to the extent possible, but should realize that privacy settings are not absolute and that once on the Internet, content is likely there permanently. Thus, physicians should routinely monitor their own Internet presence to ensure that the personal and professional information on their own sites and, to the extent possible, content posted about them by others, is accurate and appropriate.

I think this is intriguing primarily because it suggests to those doctors who don’t use social media that they probably should if they want to protect their reputation, or at least make a habit of trolling the digital waters for mentions of their name, practice, etc. This seems to me a concession by the AMA that the option of staying on the social media sidelines may eventually become infeasible or professionally inadvisable.

3) If they interact with patients on the Internet, physicians must maintain appropriate boundaries of the patient-physician relationship in accordance with professional ethical guidelines just as they would in any other context.

This, to me, is where physician social media usage will get very interesting as physician-patient interaction begins to test the bounds of HIPPA, FDA regulations and FTC regulations. The policy is careful here to go back to the generic “Internet” rather than social media. Internet interactions can run the gamut from completely exposed and publically accessible by anyone with a modem to highly encrypted, password protected exchanges that provide more privacy and security than a telephone ever could. In social media, the distinction between privacy is more blurred, especially on the monolith of social media, Facebook. If you are friends with your doctor on Facebook, exchanges could occur via private message or in a variety of other ways and with varying degrees of privacy. I suspect legal clarification will eventually be required on this front.

4) To maintain appropriate professional boundaries physicians should consider separating personal and professional content online.

To split or not to split. That is the question every professional must answer, doctors included. I see plenty of advantages to separating online identities, while I fail to see a commensurate set of advantages to exposing one’s private life to those of one’s patients. Perhaps I’m wrong, and I’d love to hear people’s thoughts on why it might be a good idea.

5) When physicians see content posted by colleagues that appears unprofessional they have a responsibility to bring that content to the attention of the individual, so that he or she can remove it and/or take other appropriate actions. If the behavior significantly violates professional norms and the individual does not take appropriate action to resolve the situation, the physician should report the matter to appropriate authorities.

A bit of self-regulation can never hurt; this appears to be merely an extension of physicians’ existing code of conduct.

6) Physicians must recognize that actions online and content posted may negatively affect their reputations among patients and colleagues, may have consequences for their medical careers (particularly for physicians-in-training and medical students), and can undermine public trust in the medical profession.

In other words, social media is serious business, folks, and people can get hurt. We can all use that reminder from time to time, lest we become the next social media punchline or scandal.

REPORT: Pharmaceutical Digital Marketing and Social Media (PH161)

Build digital marketing capabilities while navigating the challenging regulatory environment.

More about this Report | Download Report Summary

 

The Research team is right in the middle of our new study of patient adherence and compliance, and we’ve now interviewed executives from a variety of companies in the life sciences industry about their patient adherence groups’ reporting structures and organizational charts.  Over half of all companies surveyed report having a dedicated team; the rest use staff on an ad-hoc basis.  While no two companies have exactly the same structure due to different needs and resources available, several trends have emerged.

Over 80% of companies involve their patient communications/education/marketing group.  This group has its ear closest to the patients’ voice, so it is natural that they are involved in many companies’ groups geared toward improving adherence.  Next most commonly involved are brand teams, with 72% of companies involving brand and product teams in their patient adherence and compliance efforts.  When companies are looking at adherence on a product level, brand teams must explore every avenue to best reach patients.

Market access teams are only involved in patient adherence groups at a third of the companies surveyed.  This may seem surprising because payers work closely with physicians and pharmacists – who work with patients – to find drugs and devices that will best increase the health outcomes of their representative patient population.  However, efficacy of adherence programs is harder to quantify than pharmacoeconomic data might yield, so market access groups are only involved in adherence programs on a case by case basis.

Percentage of Companies Including Each Function - click for more detail

Okay, it’s been almost 24 hours since ePharma Summit 2012 wrapped. Like a good holiday feast, if you did it right you’re probably still digesting the experience like I am. Day One’s symposia offered a more intimate setting for attendees to interact with panelists, while Day Two was a big bacchanal of sessions, networking, keynotes, and panels. Day Three was a tamer affair, with more targeted sessions focusing on case studies and practical applications of the principles discussed the day before. Based on conversations with fellow attendees, Wednesday’s content was a welcome transition from the “what and why” to the “how.”

I’ll briefly recap roughly half of the day’s sessions, but before I do I wanted to share some general observations I took away from the event as a whole. First, there are some very impressive individuals working within the epharma space. I won’t open Pandora’s box and start naming names lest I inevitably overlook someone, but suffice it to say that the future of digital promotion in pharma is bright if the industry figures out how to retain the enterprising intellectual capital on hand at this conference (and that’s a big if – there is a brain drain underway in digital pharma). I spend a lot of my professional time taking a long view of the role that digital can, should and is now playing in the industry, and clearly so do a great many of the people asked to speak at ePharma Summit.

A general takeaway was that the industry is gradually shifting from a tactically driven approach to a one driven by strategy. Hallelujah, might I add. Companies are less and less interested in being the first kid on the block with a sweet new iPad app than they are being the kid on the block with an iPad app that has real uptake, aligns with broader marketing goals and serves the customer in some kind of meaningful way. Again, hallelujah. In my experience conducting digital pharma benchmarking research, this shift has been underway for some time, and because it is being codified by new internal structures like centralized dedicated digital departments and multidisciplinary digital task forces, you’re now starting to see how pharma is beginning to get a handle on smarter ways to execute digital promotion.

This is critically important for the following reason: in the years since the internet came onto the scene MLR (Medical, Legal, Regulatory) has been unjustly portrayed as a monolithic, unmovable object standing in the way of digital “progress,” and as a result, an already tense relationship between it and marketers became downright antagonistic. It used to be that marketers would push to open a branded Facebook page for their product simply because everyone else had one, or because their marketing friend at Nike said it was The Future. It used to be that these things were undertaken hastily, rashly even, due to a perceived urgency that if they were not, everyone would laugh at them. And in so doing, marketers had a hell of a time justifying them to leadership and to MLR. Now, though, it seems that people in digital pharma are learning the wisdom of tying digital campaigns to an existing bedrock of marketing strategy, thereby contributing to a more collaborative and less combative approach to building digital creative and getting it out the door. In other words, the more epharmateers recognize the value (and lack thereof, in many some cases) of digital and how it fits within the broader marketing strategy of a brand, be it corporate or product, the more likely it is that it will not only get approved but have some kind of real and measurable impact. The days of building smartphone apps to reach an elderly target audience who don’t own smartphones are mercifully coming to an end. This shift is painfully slow, but it is underway.

My one suggestion for next year’s ePharma Summit is simple: open the back channel up to the rest of the audience. It’s no secret that a significant proportion of attendees are active on Twitter, and actively use it during the conference sessions to communicate to one another and those following the conference-sponsored hashtag, #epharma. What would greatly add value to the conversations taking place on the stage, on the floor and online is if everyone could see the thoughts of their peers and react or respond to dissenting views, nearly all of which are as insightful and thoughtful as the ones being agreed upon on stage. Open the kimono, put the “e” in ePharma, and put up the Tweetstream next year. I guarantee a more lively and engaged audience. Because that’s what everyone here is after anyway, right? Engagement?

Okay, onto the sessions. What can I say about Andy Smith, author of The Dragonfly Effect? Smith is an able presenter with a gift for beautiful storytelling through slides. I won’t get into the nitty gritty specifics of his talk (I suggest you read the book), but his message to pharma was that when lives are on the line, you have carte blanch to invent compelling ways to engage with people on behalf of other people. He told a touching story about two friends diagnosed with Leukemia around whom a rather incredible effort was built to find suitable bone marrow donors (they were both South Asian, exacerbating the difficulty of finding a match stateside). Social media and digital channels played a massive role in organizing hundreds of marrow registration drives that led to matches for both friends. Sadly, they relapsed and lost the struggle, but the lesson Smith took away was the power of social networking to drive remarkable health outcomes. “Revolutions start by the actions of a few ordinary people. Find the ignition point and light it,” Smith said.

Two interesting case study panels followed. The first, I Wish I’d Done That!: Social Media, was led by Todd Kolm, director of emerging channel strategy at Pfizer, who was joined by panelists Alison Woo, director of social media, BMS and Zoe Dunn, principal, Hale Advisors. Kolm delighted in showing the audience what not to do with Twitter through non-pharma examples of social media failings, from the f-bomb drop at Chrysler to the utter ignorance showed by Kenneth Cole during Egyptian uprising. For those who aren’t familiar with these examples, I encourage you subscribe to a feed such as Mashable or TechCrunch where you will be sure not to miss the latest flub in corporate social media. There are lessons to be learned, even if it is outside pharma. Among the most important of these lessons is to know that social media is earned media — so make sure you earn it. Dunn pointed out a number of examples of pharma social media done well, including Sanofi’s Allegra OTC campaign and Pfizer’s Viagra counterfeit YouTube video. Woo offered her own take on good examples of “socpharm” as well as her social media best practices, which are simple but indispensable:

• Have a target audience; you can’t reach everyone
• Create a compelling message
• Think about value for audience
• Use the right tool for the right audience
• Measure metrics
• Think of engagement as an ongoing practice

The I Wish I’d Done That!: Mobile session was led by David Kopp, senior VP of consumer media, Healthline Networks. Joining him were Jay Appel, director of physician relationship marketing, Amgen; Scott Wolf, executive VP of sales, Everyday Health; John Viera, senior director of strategic marketing, Daiichi Sankyo; and Kate Miller, director, Evolution Road. Two things really jumped out during this session: one idea and one tactic that both have a lot to say about where mobile is going. The idea was suggested by Viera, citing Progressive’s Snapshot, which documents real-time driving behavior and incentivizes people through lowered premiums to drive more safely. The application to pharma is already happening, he said, though the quantified self movement and apps that track human biodata. Viera thinks that the future of mobile will be in passive technologies that collect health outcomes data which companies can then leverage in negotiations with payers. That will be quite interesting indeed. Another example, also pointed out by Viera, of an effective campaign was the TextInTheCity SMS initiative to reach at-risk teens. The decidedly “low-tech” tactic actually helped the campaign have a much better penetration and uptake because the target population was much more likely to have feature phones than smartphones. Just another example where knowing your audience and using the appropriate channel to reach them. Had the campaign tried to get fancy for fancy’s sake, it would have failed.

After lunch (that flan in the tall shot glasses was pretty sweet … thank you, I’m here every Wednesday night), I attended the Multichannel Consumer Marketing track again. An interesting session by Deborah Radcliffe, director, Consumer Center of Expertise at Pfizer, focused on how to open up your content to sharing and how to do so compliantly. What follows is a handy list of questions you need to have the answers to if you want to take the plunge into the world of sharing (and there is ample reason to do so: 73% of people say they process info more deeply, thoroughly and thoughtfully when it’s shared with the):

• What’s the objective?
• How does sharing help achieve that?
• What’s the target’s sharing behavior?
• How does content you want sharable align to marketing objectives?
• Is your content relevant?
• Is it valuable?
• Is it share worthy?
• If you applied the seven factors that prompt sharing (laughter, inspiration, cuteness, originality, shock, surprise and nostalgia), what would you learn? Is it touching people?
• What might you do to increase share worthiness?
• What does your target think of your stuff?
• And most critically: do you have the tool to do it?

Following this was a brilliant session by Todd Siesky, communications and external relations, Roche Diabetes Care US and Robert Muller, associate marketing manager, global marketing, Roche Diabetes Care US. They talked about the success they’ve had in developing cause marketing. The reach of their campaigns grew exponentially when they were able to gain the trust and partnerships of some 30 of the most influential diabetes bloggers, which took guts, persistence and humility on Roche’s part. To me, the essence of the session was this: vision drives strategy drives tactics, and when you start with vision and add to it a long-term, sustained commitment, the results can be remarkable.

EPharma wrapped with a session on the global marketing environment. Mark Bard of the Digital Health Coalition led a panel comprising Peter Pitts, president of the Center for Medicine in the Public Interest, Ray Chepesiuk, commissioner, PAAB, and Muller from Roche. Pitts talked about the importance of intent when dealing with cross-jurisdictional snafus. If you’re trying to be cute and skirt compliance, regulatory agencies are going to catch you, Pitts said, adding that “the .eu or .ca is not a get out of jail free card.”

So, that’s it from ePharma Summit 2012. Hope you enjoyed the tweeting and blogging! If you have any feedback, I’d love to hear it. I’m on Twitter (@Casey_CEI), and I’d love to continue there the conversations we started this week. If you loved or hated what I brought to the table, do let @epharma know so they can decide whether the should can me or bring me back next time. Hopefully it’s the latter and I’ll be seeing you all again soon. Thanks for reading!

Distinct salary bands are emerging for new hire and senior liaisons as the function matures

With health outcomes liaisons in high demand, life sciences companies must offer a competitive salary package and a career map to attract and retain effective HOLs, according to our recent research. The study detailed compensation figures for US- and EU-based HOLs at different levels of experience: no experience, two years of experience and five years of experience. “Health Outcomes Liaisons: Managing a Field-Based Team that Speaks the Payer’s Language” also shows the financial benefit of increased experience. While salary increases at some companies are gradual, at one company, an entry-level HOL can start at $85,000 and progress to almost $200,000 after five years.

HOL staffing poses a special challenge because although the position is in high demand, it also calls for individuals with unique assets – knowledge in health economics, experience in clinical research operations, strong interpersonal and presentation skills, and a willingness to travel regularly – that is difficult to find. Without a competitive salary package, companies will find it difficult to fill HOL positions.

Critical need to develop an HOL career path

Beyond salary packages, companies must also develop pathways for professional advancement to keep Liaisons engaged in their work. Given that HOLs are a relatively new function – the average age of HOL groups in this study was only five years – career mapping is a step that only a few companies have fully developed. Without tracks for HOLs to follow as they gain experience and expertise, they may become restless and begin looking elsewhere for responsibility. Companies must continually create new leadership opportunities or expanded responsibilities.

The study explores five distinct strategies in place at surveyed companies:

• Maintaining an official management track
• Establishing seniority by differentiating between regional and national relationships
• Appointing high-performing HOLs to advisory roles
• Moving experienced HOLs into designated therapeutic areas
• Establishing additional career tracks for HOLs

REPORT: Health Outcomes Liaisons (PH159)

Develop HOL capabilities and reach payers via optimal team alignment and structure, competitive compensation and a strong slate of core HOL activities.

More about this Report | Download Report Summary

 

Well, we’re two thirds of the way through the 2012 ePharma Summit. Day One was a full day of symposia, while Day Two was a mishmash of sessions, keynotes, thought leader panels, futurists, multichannel tracks, examples of award winning campaigns and coffee. Lots of coffee. My colleague James Ellis and I were live tweeting the day’s events, but we are going to provide a roundup blog here to help flesh out beyond 140 characters what the sessions had to offer. We split up the job, so between both of our blog roundups, you’ll get a pretty comprehensive view of the day, minus coffee breaks and totally unrelated bathroom breaks.

Charlotte McKines, the Global Vice President of Marketing Communications and Channel Strategies at Merck had an excellent presentation on how a multinational company might look at the evolution of digital channels and how they can fit not just within a company’s overarching marketing strategy but within that company’s overall business goals. McKines’ well-organized presentation outlined three primary ways in which digital is transforming the industry. Looking beyond the pill, she said, digital is “the connecting point, the core enabler that allows us connect to our stakeholders.” With digital experiencing a meteoric rise — 86% of physicians go to the web daily to gather health, medical or prescription drug information — whoever “gets there” first will have a major competitive advantage, McKines said. The three keys to getting there are:

• Adjusting the organizational mindset
• Embracing new technology
• Building new business models

Adjusting the organizational mindset (no small task) means aligning to rapidly changing customer needs. This means improving sales force effectiveness (i.e. making the sales rep the quarterback in the middle who is calling the number of a certain channel depending on preference), engaging Generation Y (i.e. striving to make the pharma experience match the non-pharma experience they’re familiar with or recognizing their “self-service” mentality) and utilizing digital functionality (i.e. doing micro-segmenting, personalizing content and maximizing spend).

Embracing new technology means picking a strategy before it picks you, McKines said. Interestingly, her first point here was to use social media to promote collaboration, steer conversation, listen to customers and respond quickly. Her second point was to leverage mobility (i.e. enable mobile content delivery to reach consumers in real time, support sales and training, and increase customer engagement). She also pointed out the importance of integrating channels (i.e. deliver one message across all channels).

Building new business models means shifting the internal (i.e. centralizing innovation, decentralizing localization, and prioritizing content) and shifting the external (i.e. using collective intelligence, investing in infrastructure and choosing the right partners).

Her session ended with a Q&A highlighted by a pointed comment from the audience in which an agency attendee said, “We can only innovate as fast as quickly as you can change.” McKines’ responded by saying, “I realize we are not always a fast and nimble partner, but that’s why we need partners, to push us to change.”

…

The next session I covered was a moderated panel discussion led by Liz Cernak, CCO of Pozen, based out of my college hometown of Chapel Hill, NC. Founded in 1996 and public since 2000, Pozen focuses primarily on drug development but is in the process of transitioning to a commercialized model and as a result put together a coterie of thought leaders to form its digital advisory board, including Raj Amin, CEO, Healthnation; Bonin Bough, Sr. Director of Digital and Social Media, PepsiCo; Marc Monsseau, Founder, MDM Communication; Daniel Palestrant, MD, Founder, Sermo, CEO and Founder, Par8o; and Meredith Ressi, President, Manhattan Research. Among the highlights (paraphrased unless in quotations):

Monsseau: The biggest challenge digital can help with from a marketing perspective is in heralding the shift from one-way to two-way communication and targeted approaches, while in sales, it presents a way of reaching physicians with more efficacy and reach. “At the end of day, you still have to have great content.” It needs to be resonating, actionable, and useful. Content that lives in digital now is dry, not what you want to watch or share. Opportunity exists to create content that people can take in, but can also start a conversation with, with a doc or someone else struggling with the disease. Ultimately, what’s needed is content that can improve health outcomes.

Bough: Set it and forget it is passé. Deep customer listening on top of real-time customer engagement is the way of the future. The quantified self (referencing Kevin Kelly’s talk) allows people to their own progression through their own healthcare, meaning pharma and healthcare need to adapt. Bough also provocatively stated that pharma is negligent if it is not listening to its consumers through social listening techniques, highlighting the difficulty in applying non-pharma perspectives to the risk-averse, highly regulated industry.

Palestrant: How can pharma use digital to better relationships with physicians? One way is through sophisticated sales and techniques that can amplify efficacy data. He also talked about how social media can cost-effectively communicate important messages to stakeholders in ways that speak to their own preferences for information consumption. Among the communication revolutions to date (including the printing press, broadcast, etc.), the digital age means that now the tail is wagging the dog.

Amin: Digital allows pharma to touch consumers in deeper ways across multiple platforms. Consumers see media differently as they get comfortable with new devices, so the industry needs to learn when to present content based on the disposition of the consumer. Are they lean back? Lean forward? On the go?

Ressi: Mobile is completely changing the game. Platform adoption metrics change under our feet. Understanding the way it changes how healthcare providers learn and gather info and how it changes service expectations is critical if the industry is to properly leverage the opportunity.

…

I attended the post-lunch (no monster reuben today, just a forkful or two of salad and a cookie… okay, two cookies) multichannel consumer marketing track hosted by Alison Woo, director of social media at BMS. She had Mark Bard of the Digital Health Coalition and Jack Barrette, CEO of Wego Health, up to discuss the recent FDA draft guidance on off-label communication. Among the quotes that really stood out to me was Barrette saying that “not looking for [adverse events] or not trying to look for them is an indefensible position.” This was borne out of a lively conversation between Bard and Barrette on the scope and impact of the narrow guidance and how it may impact the way in which pharma chooses to address its digital presences in light of misinformation correction, off-label comments and AEs.

Gregg Zagras and Jen Willey of RealAge presented a session on their product, which depending on your orientation might equally frighten or excite you. Their digital health assessment produces a score that represents your actual age as compared to your real age (i.e. a heavy drinker and smoker who is into red meat and couch surfing might in reality be several years older than their age). The tool allows individuals to chart a path toward better health while offering pharma clients the ability to position their products in front of highly aligned segments of the population. People with high cholesterol, for example, might be presented with statin drug ads while they progress through subsequent health evaluations beyond the original assessment. Willey and Zagras argue that brands need to consider their patient population before launch in order to optimize their marketing efforts. Obviously, one way to do so would be to partner with RealAge. For the curious, the site also offers the ability for individuals to learn what their sex age is. Insert your own joke here.

The last session of the track was a refreshing perspective from patient advocates Amy Gurowitz, Founder, MS SoftServe; Jeffrey Roberts, Founder, IBS Self Help and Support Group; and Max Szadek, Founder and Executive Director, Divabetic.

…

The last panel discussion of the day back in the main hall brought some of the industry’s most influential thought leaders in the digital space together to talk about future trends. Of all the great insights, my favorites revolved around how the industry should handle the challenge of working with Medical, Legal, Regulatory (MLR). Julie Holcombe, senior director, US Vaccines Marketing at Pfizer referenced the hilarious Kevin Nalty-produced video that aired this morning called “Fear Factor: Pharmaceuticals” in which MLR was presented in a less than flattering light. She said that video is what is wrong with marketers’ thinking. She said MLR and marketing need to be “frenemies to the end. … Their job is to keep us safe, and we’re walking a fine line between wanting to not get a letter” and still get the job done. Since “we as marketers are not going to regulate ourselves, … we may have to extend the olive branch.”

Joe Shields, head of global strategic marketing at LifeScan, said that MLR departments need a tune-up to ensure that they are not an operational bottleneck, but he also suggested a curious idea that to save money, time and resources, some pharma companies purposefully dial back MLR capacity to throttle back marketing output. I’m not sure what the industry thinks about this, but it certainly provoked a reaction on the #epharma tweetstream by agency and media thought leaders who found that idea troubling.

Peter Dannenfelser, director of North American digital marketing for Jannsen, said that the MLR issue raises two key points: the industry clearly needs to play in the space, but it also needs to do a much better job of communicating to consumers the rules that it has to play by, something that he thinks pharma could do a much better job of.

…

One of two Best in Show sessions was hosted by James Chase, editor in chief for MM&M, in which he discussed the GetToKnowC campaign launched by Vertex Pharmaceuticals and Ignite Health that earned the top spot at the 2012 MM&M awards in the best disease/education website category. Brian Lefkowitz, chief creative officer at Ignite and Hugo Brown, associate director of marketing at Vertex joined Chase on stage to talk about the campaign and how it took shape. Brown said his company wanted to empower Hepatitis C patients while removing the stigma of the condition. Lefkowitz explained the way his agency created a multichannel campaign featuring deep, rich, informative content with the right tone. One feature of it that jumped out at me was the homepage, which opens with a creative segmentation feature, allowing visitors to choose the “person” that best represents where they are in the process of dealing with the disease.

…

So that’s a wrap from Day Two — looking forward to seeing you all tomorrow as we wrap up the 2012 ePharma Summit. I really hope that all this blogging is helping you attendees derive even more from what has so far been a rich conference experience for me. Please do forgive any egregious typos; a stenographer I am not. If we haven’t met yet, please do come introduce yourself and learn more about the benchmarking research and analysis that I do in the digital marketing space for my firm, Cutting Edge Information. You know where to find me: near a plug.