1. Watch out for that last step, it’s a doozy – That cliff you see in front of you, it’s not the coast of Scotland, it’s an expiring patent. Some of the biggest grossing medications in the last decade are going generic, and this means big changes for those of us who market them. We are all going to be expected to do more with less. This translates to marketing teams facing bigger challenges with smaller budgets. These folks need our help, but often do not see it, until its too late. Make them see it.

2. For the hand that rocks the cradle is the hand that rules the world – When I see this quote, a modern image that comes to mind is of pharmacists, because they are emerging as key decision makers in thousands of patient lives. Pharmacists see medications and then see their prices—what they sometimes do not see are the differences between 3 or 4 drugs that they may believe are equal. If we believe our product will serve patients better, we need to target pharmacists aggressively, because they often have the patient’s ear, and their opinions matter.

3. Dancing with the right partner – I never understood why some of my more seasoned colleagues were not as excited as me every time we got an RFP. The answer was, I learned, that they were much better at reading the tea leaves, and they knew what was worth (or not worth) pursuing. What I learned was that “just because you got invited to the dance does not mean you are going to dance.” So how do you decide if it’s time to throw your hat into the ring? Here are a few ideas to keep in mind:

• How did they hear about you? – If no one at your agency knows anyone of importance with that brand or the parent company, stay away, you are an interloper.

• Are they too big for you? – I think we all like to believe in the fairytale, that the little agency that could was able to bring a billion dollar therapy to market. Big pharma likes to hire big agencies, because they are more comfortable wrapping themselves in the security provided by a big bureaucracy. Deal with it and move on.

• Take a good look in the mirror. Do you have the experience to help? – We all think that there is no challenge we cannot overcome, but that thought may be a little self-serving. The question we should be asking is do they think we can help them? If you have not succeeded in a space that they can personally relate to, it might be better to pass.

So we have come to another years end. Hopefully, it has been one filled with personal and professional success, and that you can find some time to reflect on your good fortune while remembering those who might be less fortunate. Here’s to a happy and prosperous 2012.

Pharma can learn valuable lessons from the work of Steve Jobs. Home electronics and pharmaceuticals have a few justifiable similarities: the target audience is large, there is a lot of competition, and they are both dominated by brands that can deliver a “wow factor.” What that “wow factor” is can take on many forms, but its importance in undeniable. As more and more brands vie for space in the American medicine cabinet, pharmaceutical marketers need to convince patients they should want (or even need) what they are selling.

So how does pharma capture and use some of that Apple magic? In the pharmaceutical space, it comes down to two basic elements: an educated consumer/patient and brands that deliver more than just the essentials.

Consumer/patient education: We are all consumers in one way or another, but not all of us are patients. A patient is a consumer who has been diagnosed with a disease, disorder, or condition. Are these groups separate or are they two sides of the same coin? In the United States, almost 19 million people have been diagnosed with Type 2 diabetes mellitus, and this makes them patients. However, an additional 86 million are either undiagnosed diabetics or have a condition known as prediabetes. Technically speaking, these are not patients, but I believe we can agree that they could benefit from educational programs and communications on a disease that could make them consumers of antihyperglycemic medications.

Bang for the buck: Years ago, you could have 5 or more drugs in a therapeutic class competing for market share with little differentiating them. Most of the time, the data available for decision-making were limited to common endpoints used in the registration trials for FDA approval. Furthermore, since little or no head-to-head data were available, medication choices were only “lightly” based on evidence. Therefore, if you want your target audiences “to want” your product, you need to give them a reason. These reasons do not need to be clinically based*, but can take on other forms with surprising effectiveness. One place we are seeing growth is in the number of brands providing financial support to patients in the form of prescription rebates and coupons. A brand that can reduce a burden, in this case a financial one, may find itself with many fans.

The take home message today is simple – if you want to succeed and you exist in a crowd, you need to be noticed. In pharma, you need to offer your providers, customers, patients, and payers a reason(s) to buy what you are selling. It worked for Apple, and it can work for us.

Rest in peace, Steve.

*However, these are always the best places to begin.

Merriam-Webster has three main definitions for strategy. I will include the only one that does not involve a reference to warfare:

• Strat-e-gy (noun)
  • A careful plan or method
  • The art of devising or employing plans toward a goal

By definition, strategies are definable, actionable and measurable — but too often, they are none of these. They are the thinking and planning behind the tactics that help us get from where we are to where we want to be. Strategies are not objectives, they are not key success factors, and they are certainly not tactics.

Part of the problem is that too many agencies try to develop strategies in a vacuum. This should never happen. Instead, the process should be seen as a progression toward a final goal or outcome. Strategy can be seen as one of the “stations” along a predefined route to a final destination. Here are the stations the “thought train” should always move through: Objectives, Key Success Factors, Strategies, Tactics, and Outcomes. Like a train, our thoughts should always move through one station at a time to prevent a derailment. If your strategy is not defined, how can you possibly plan tactics that will achieve good outcomes?

Here is a simple example.

Objective: I want to drive a new car.

Key success factor: More money each month to cover a high car payment.

Strategy: Cut expenses and/or raise income (see, these are definable, actionable, and certainly, measurable).

Tactics: Reduce dining out by 50% and spend $200 less each month on clothes.

Outcomes: $450 more cash each month to put toward a new car.

It is easy to see that if the key success factor were different, maybe, “Need to learn how to drive,” then everything following would also change.

Now, let us put this into pharma-speak for an imaginary 432nd-to-market antidepressant, Brand X.

Objective: Patients currently on SSRI monotherapy switch to Brand X.

Key success factor: Prescribers and patients recognize that Brand X has comparable efficacy but superior tolerability to SSRIs with respect to insomnia.

Strategy: Refocus sales force activities on HCPs who are high-decile prescribers of SSRIs associated with high rates of insomnia.

Tactics: Update digital and printed sales pieces emphasizing low rates of insomnia.

Outcomes: Increased sales and satisfied patients.

Again, a change in any one of the previous steps could have a profound effect on what the strategy looks like.

Objectives are too often intertwined with strategy and implementation in a way that makes it difficult for an agency to decide where to start. We at The Core Nation have found success with setting objectives and then developing strategies to achieve them. Others often look for a winning strategy and then carve out objectives from their understanding of what is achievable. Such confusion about where to begin causes planning paralysis.

What has been your experience with strategy development? Do you agree with our approach or does something else work for you? Share your thoughts with us.

In the closing years of the 20th Century (ok, it was 1992), the scientific world was exploding with work performed with new molecular biology techniques. These were the days when new methods such as polymerase chain reaction (PCR) analysis and site-directed mutagenesis were getting into the hands of everyday researchers. They were so much fun to use! We spent a lot of time impressing one another by doing experiments that showed off the capabilities of the technology.

We in pharma marketing are now experiencing something eerily similar. A technology explosion has delivered us Twitter, Facebook, iPads, tablet PCs, smartphones, and an entire blogosphere. Each of these technologies is ripe for use as a tactical vehicle to achieve our brand objectives. Moreover, we are tripping over one another in a race to plant our flag in the social media space. (As an aside, there is still no guidance from the FDA on how social media can be used. Unfortunately, I am not convinced that we are using it correctly, and I am feeling that the rush to use social media is at the expense of useable content.)

New technologies are great, and they will help us achieve many goals, but they need to be used correctly. Let us resolve to tailor the content to the technology and not the other way around. Remember, the tag line for the New York Times is “All the News that’s Fit to Print” and not “All the News that Prints to Fit.” Here are three ideas for you to consider:

1. Brand messaging should be tailored to the media stream. As we say often, the one-size-fits-all approach does not work. Your grandmother is not likely to be on Twitter, but your 18-year-old niece can certainly communicate in 140 characters or less. If both are diabetics, you need to reach them in ways that mesh with their sensibilities and behaviors. This approach will increase the likelihood that your messages will be seen and understood.

2. When using social media, remember: EVERYONE is watching. In the old days, brand messages were found in medical journals, sales aids, and other vehicles that had restricted access. In the world of new technology, once the “Tweet” button is clicked, it’s out there for the world to see. At this point, anybody, including a competitor or just someone in a bad mood, can cause trouble if they want. The FDA’s Bad Ad program wants the public to report activities and messages that they consider false or misleading. You have been warned.

3. Make your audience want to learn MORE. Let’s be frank for a moment. You can say only so much in 140 characters. Thus, your brand’s presence in social media is only successful if it stimulates your target audience to learn more. It is that simple, and without it, you have missed a great opportunity to create a lasting relationship.

What has been your experience using social media? Are you looking before you leap? Please share your thoughts with us.

To illustrate this point, let us consider two very different therapeutic areas: diabetes and Pompe disease. In the United States, 23.6 million children and adults—7.8% of the population—have diabetes. The US diabetes marketplace is conservatively valued at more than $9 billion per year and includes medications ranging from generic metformin to branded incretins and insulin. Now, let us look at Pompe, which is a genetic, lysosomal storage disease. Worldwide, there are about 10,000 patients with Pompe disease. The total market for Pompe is estimated at more than $1 billion, assuming 30% to 60% of patients have access to high-value therapeutics and an average cost of therapy that is comparable to other enzyme replacement therapies. Putting this into perspective, if Pompe had the same prevalence as diabetes (in the US only), its market value would be more than $2 trillion. The take-home message: just because sales are high, do not automatically think it is business as usual.

It is easy to see how the business models differ considerably for a disease state with 24 million patients and one that can hold a meeting for all in a Texas high school basketball arena. We should accept that many of our clients may be new to the world of rare diseases and will need our guidance more than ever. This is especially true for those companies who have acquired a compound rather than developed it in-house. Customer Relationship Marketing (CRM) has become the go-to strategy; however it is clear that CRM strategies should never follow a one-size-fits-all approach. So much needs to be different, from what you need to do during the earliest market-shaping activities through the post-approval marketing period. Our own experiences with Pompe disease have taught us that no two patients have identical needs. While many things about successful marketing of rare disease treatments remain fluid, one thing is clear—we cannot allow ourselves to be tempted to squeeze a square peg into a round hole. We need to tailor a proper approach to facilitate success for all involved.

How has your company helped clients adapt to smaller patient populations? Drop me a line at ken.k@core-create.com.

To demonstrate how a perceived lack of credibility is affecting the way the medical community views some physician-speakers, here are some recent data: In a survey of 508 physicians, only 17% of respondents said industry-sponsored educational programs (non-CME) featuring physician-speakers had “a great deal” of influence on their prescribing habits. That is a shocking number when you realize how far science has advanced in the past 10 years. To put this into perspective, 47% of respondents said articles appearing in peer-reviewed medical journals had the same level of influence. Finally, while it has become evident that physicians are closing their doors to pharmaceutical sales representatives, information originating from this disappearing source carries a greater level of influence (18%) compared with that derived from key opinion leaders (KOLs). It is apparent that physicians are open to learning new things; however, it is crystal clear that the messenger is as important as the message. Here are some tips:

Step 1: Let’s stop making it all about the big names.
The conventional wisdom has always been to get the biggest name possible to speak on behalf of your brand. This is the “celebrity-endorsement” model, and it is really no longer relevant to our needs. Why? Because the big names are speaking for you and for your competition. Nowhere is this more evident than at a key congress. If you attend any of the industry-sponsored symposia, chances are that the overlap in faculty will make you cringe. If you are looking for answers, it is hard to get a straight one from someone who is speaking for everyone.

Step 2: Look for the rising stars.
Nothing gets the attention of a bored audience more than new blood — and there is a ton of it in medicine. Each year, post-graduate medical programs are pumping out thousands of fellows and residents looking for a chance to impress. Anyone who has graduated medical school in the past decade has sharpened their research and speaking chops and can relate to changing audience demographics. But more than that, they desire a chance to be heard and live outside the shadow of their former mentors. The best part is that these young go-getters were likely trained by the very KOLs you once (over)used. Take a chance on them — it could be the start of a beautiful friendship.

Step 3: Look for people who still treat patients.
It seems difficult to speak on behalf of four companies, participate in three clinical trials (simultaneously), attend six advisory boards a year, and still have the time to see your own patients. I am sure it happens, but how likely is that in reality? As we are moving toward changing the way we evaluate the value of treatment by adding concepts like comparative effectiveness, it is vital that we assess how all aspects of a patient’s life are changed by therapy. This can be very tough to do unless you are practicing in the real world.

At the end of the day, it should always be more about the content than the person who delivers the message. However, if your faith in or opinion of the speaker is compromised, then the message — no matter how good it is — will have little impact on altering patient outcomes. By changing the model we use to select, develop, and deploy our speakers, we can go from identifying key opinion leaders to creating key influencers.

Share with us how your company has changed the way you identify, select, train, and deploy your physician advocates.

The first place to begin is for us to lose the “O.” I was once told that opinions are like…noses; everybody has one. A doctor can have the opinion that a particular drug is better for his/her patients than another, and that is fine. But the real cache to an opinion is this: will what one person believes influence what others do? Now, that is the real trick. It is becoming increasingly clear to many that people with opinions can come and go, but influencers have staying power. Even the most powerful message loses steam after it is heard for the 10th time from the same speaker.

So how do we accomplish this transformation? Believe me, it could be more painful than one might first think because it will take something that is often too scary to mention in the halls of pharma: CHANGE!

It is time we begin to re-evaluate whom we choose to speak on behalf of a company or a specific drug. For years, the same small group of faculty has spoken at meetings, authored papers, and delivered symposia. To be brutally honest, this model no longer works for two reasons: (1) Many people are tired of hearing the same old messages coming from the same mouths, and (2) They are not just speaking on our behalf; they are speaking for our competitors as well. Thus, it is not surprising to see how this severely hurts a speaker’s credibility as a key opinion leader.

So how do we develop influencers, and more importantly, how do we keep from making the same mistakes over time? That we save for part 2.

What happened to elicit this withdrawal?
Avastin was approved in 2008 to treat mBC based on data obtained from a single clinical trial (E2100) using the FDA’s accelerated approval process. Since then, four clinical trials have been conducted and the FDA has determined that Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks.

Was this the correct decision?
In my opinion, it was. Avastin is a good medication for its other oncology indications, but not for breast cancer. The lack of significant separation between benefit and risk makes it almost impossible to justify its use in patients with mBC. Furthermore, it’s difficult to rationalize the cost of Avastin, which is about $50,000 per year given the present data. With other options available for this patient group, and more negatives than positives, it was a logical decision.

What will be the ripple effect(s) of this decision?
This is where we need to pay particularly close attention. Several key events helped to shape the current Avastin situation. It is important to understand these, as they will affect the way we do business in the future.

• Accelerated approval: The essence of this program is to get drugs to market faster with less evidence than is typical and confirm a drug’s risk-benefit profile once more evidence becomes available. Over time, some drugs will fail to confirm the results of earlier studies, necessitating occasional revocations. For Avastin, this means the loss of a high-revenue indication. How do we adjust our brand positioning accordingly, depending on what the follow-up data show?
• Surrogate endpoints: Accelerated approval programs, especially in cancer trials, permit the use of surrogate endpoints, because assessing survival takes time. How should this impact the creation of a brand plan or promotional materials? How much effort should be dedicated to laying the groundwork for the data that follow? This is one of those rare cases where an approved drug needs work streams in medical affairs and marketing moving simultaneously and at the same speed.
• Risk-benefit or risk-benefit-cost: If Avastin cost $5,000 per year instead of $50,000 per year, would that have made any impact on the FDA’s decision? We do not know and may never know. However, several drugs in 2010 had been denied approval or additional indications based on their cost and the availability of cheaper, equally effective alternatives. Conducting superiority trials makes many people nervous, but if you have a high price point compared with your competition, it may be worth the risk.
• FDA going against advisory committee: Understanding the motivation for this decision will always be an exercise in speculation. The FDA is not, nor will it ever be, immune to the opinions of the masses. For the agency to break with its advisory committee, more than just science must have been part of the discussion, which brings us to…
• Influence of patients and their advocates: These groups are particularly well versed and not afraid to voice their opinions to the FDA on cancer issues. One might predict that the loss of any treatment option would be met with an uproar. Surprisingly, major patient advocacy groups were split on their thoughts about this decision. In one camp, patients who have done well on Avastin want it to be available and affordable. Another breast cancer advocacy group testified against Avastin’s initial mBC approval due to the use of surrogate endpoints. It appears that the advocate door swings both ways.

What will be the enduring lesson from this experience? Brand plans have an expiration date on them and need to be viewed as living entities. They need to be flexible and able to adapt to changing times. The luxury of strategic and tactical forecasting for 3-5 years down the road has become outdated. Staying nimble and informed might be the best future strategy.

Why is pain so poorly managed in the United States? It’s not because the healthcare community has no access to potent analgesic medications. Actually, it is just the opposite. US physicians have a number of effective opioid analgesics at their disposal that work very well to control chronic pain. These medications are just waiting on pharmacy shelves to have their names called so they can do their job.

So, what’s the problem?

The problem is that they carry significant risks, which can be very serious if not proactively managed. These risks include misuse, abuse, addiction, diversion, and legal ramifications to the prescriber if their patient goes off program. Because of these risks, real or otherwise, thousands of patients are suffering unnecessarily from pain that could be controlled. In fact, many physicians have made the conscious decision not to treat, but to refer patients in pain to other practitioners. For some, it is just too much of a pain to treat patients in pain.

The answer to this problem has been to design a risk evaluation and mitigation strategy (REMS) to support the safe use of opioids. REMS programs have traditionally been the responsibility of the company marketing the opioid, with few ever really hitting the mark. Therefore, the FDA tasked itself to design comprehensive REMS to cover most long-acting opioids. On July 22, 2010, this plan was soundly rejected by the FDA’s own advisory committee as not being tough enough. However, the result was not all bad: what came out of this was better insight into the true problem, and in this case, it’s not just the drugs.

Medicine is a risky endeavor; has been from the beginning. All medications carry some risk, but with proper training and oversight, it can be managed. For pain, in prescribing opioids there is more fear of what might happen, rather than focus on what will happen. It is time to realize that effective treatment of chronic pain is everybody’s responsibility. Not mine, not yours, but ours. If you make it, take it, or prescribe it, you are part of the solution. Patients need to be properly evaluated and educated before beginning treatment. Physicians need to be properly trained in anticipating and seeing the signs of trouble. Most importantly, pharma needs to champion both sides of this equation. It’s not just about building a better mousetrap; it’s also about showing everybody how to avoid getting their fingers caught.

During qualifying, there is only one car on the track, you have brand new tires, and there is only enough gas in the tank to go 10 miles. During the race, tires are worn, there are 32 additional cars on the track, and the gas tank is full of fuel. While the components are the same, the conditions in which they exist are very different.

The same is true for pharmaceutical marketers. We position medications in the real world using data collected from the idyllic world of clinical trials. Yet, we are often caught flat-footed when safety signals begin to emerge after a drug has been on the market. The question is, why are we constantly surprised? The answer is, we shouldn’t be, and we need to be better prepared when it happens.

Just like the Indianapolis 500, in a clinical trial, not everyone who participates in the qualifier gets to race. For example, the TIDE trial is investigating “the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone when used as part of standard of care compared to similar standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes mellitus (T2DM) who have a history of or are at risk for cardiovascular disease.” A brief look at the first five exclusion criteria for this trial demonstrates that the average trial subject is very different from the average patient with T2DM.

Out of the 20 million or so patients with T2DM, how many of them would be excluded from participating in this trial? Best guess is that very few “average” patients would be included. For those of us engaged in medical communications, this raises important issues. Should physicians take into consideration that the data they are reviewing might not be applicable to some of their patients?

This could explain why some patients respond well to a treatment and others do not; however, should it also influence the decision making process?

Pharma marketers need to be adequately prepared if/when questions like these arise. One way to accomplish this is for us to engage in therapeutic “war games” where different scenarios and outcomes are modeled under the guidance of a practicing physician. For the sales force, exercises like this would be very beneficial if they must answer questions or criticisms from healthcare professionals. Many of our colleagues often scramble for the appropriate response when something like this happens. Our mandate is to change our way of thinking from reactive to proactive to respond better to these eventualities.