By Al Topin

Originally published by Pharmaceutical Executive

Volume 36, Issue 1

It’s a new year with new forecasts  informed by last year’s rear view mirror. They’re often insightful. Sometimes misguided. Always interesting.

What many in our industry overlook as they try to identify some new trend are the changes that move below our feet—biopharma’s tectonic plates. These are forces so powerful they will continue to shift our business not just this year, but into the foreseeable future. And they have the potential to disrupt even the most thoughtful marketing plans. So ignore these “seven significants” at your peril as you plan for 2016.

#1 The 10-year century. Change is faster today. Technology moves quickly. Thinking, experimenting, and iterating happen rapidly. And while this acceleration is bringing life-changing therapies to market faster than ever before, it’s also bringing more failed molecules and more “me-too” competitors. Leveraging exclusivity and setting competitive barriers become more difficult.

How to succeed at this pace? You can either jump in and swim as fast as you can, or take the time to examine the market and focus your resources on the greatest potential for success. Each approach has its risks, so it’s a matter of which makes you less uncomfortable.

#2 The ubiquitous 800-pound gorilla. 85% of pharmaceutical units sold in the US are generic. Pick virtually any specialty drug category, and sitting right in the middle is a well-known, generic 800-pound gorilla that dominates the market. All are effective, cheap, taught in medical school, and on most formularies.

A new drug with any hope to take down a generic gorilla must offer an advantage so clear, so meaningful that it makes up for a price tag that makes payers instantly nauseous. The game today is outcomes and long-term cost reduction. And it is happening—with high-priced drugs that in some cases turn out to be cures. These are tomorrow’s blockbusters. So as they say in TV commercials, “What’s in your Pipeline?”

#3 High drama in the exam room. The key diagnostic questions have been asked, test results are in, and the critical moment is here. The physician informs the patient that he or she has a serious disease and begins to explain treatment options and next steps. A very personal, devastating version of “shock and awwww” begins. The patient is now forced to face the reality of a disease and make treatment decisions they barely understand.

Moments of truth like this have been a part of medicine for centuries. So what’s different today? The opposing forces of a more complex dialogue versus a time-challenged physician. Doctor-patient communication, so critical to therapy compliance, is compromised from the start.

What can be done to improve this moment of truth? More, better patient education and support. But perhaps more important, practitioner training designed to improve sensitivity and clarity when he or she is having that difficult conversation.

#4 The morphing of the pharma sales rep. According to Cegedim Strategic Data, the number of pharmacy industry sales reps declined 40% between 2006 and 2014. Not quite last man or woman standing, but dramatic nonetheless.

So in an era of no-see docs and dramatically-priced complex new drugs, what does today’s remaining  rep force look like? The “attack of clones” approach is over. No longer will a rep be successful just by delivering the script they role-played at the sales meeting.

The successful rep’s new role has shifted from sales to support:  Isolating barriers and patient problems, then providing support/solutions to the physician, the practice, and the office staff. The question for the manufacturer then becomes: What can we do to support our reps in this changing role?

#5 The Hollywood pharm team. Have you ever thought about the surprising similarity between today’s Hollywood business model and that of pharmaceutical companies? What was once a studio system in which the directors, writers, and stars were all kept in-house on contract and used for movie after movie is now a business of outsourcing. And what once were the in-house resources of pharmaceutical giants are now a pharm team of outsourced specialties. CROs, medical review, discovery, and more are now orchestrated from best-of-class, proven partners that play well with others.

So the lesson learned here is that in a high-risk venture like launching a new movie or a new drug, it’s best to spread the risk. How can you spread yours?

#6 The Hollywood opening weekend. To keep going with the Hollywood analogy, let’s look at the concept of the opening weekend. Many Hollywood movies win or lose on first weekend’s receipts. Expensive blockbusters turn into failures in a few short days, while cheaper independent films with low expectations become heroes by Monday.

Sound familiar? A new drug misses early, sky-high forecasts that management pushed higher. Uptake is slower than expected. All of a sudden, the brand is lucky to keep its initial budget for a full year and risks losing the attention of the sales force.

How can brand teams manage expectations when management, shareholders, and competitors expect a big box office weekend each launch?  Thinking long term anyone?

#7 The missing quarterback. With all the attention focused on patient centricity, one reality continues to be overlooked. In a world that’s shifted from treatment from primary care to specialties, where drugs are more complicated and expensive, and where illogical insurance coverage continues to frustrate patients, there’s a clear unmet need—for a quarterback.

Specialists focus on a specific body part or set of symptoms, handing the patient to the next specialist once their job is done. Some medical specialties have taken a broader view and adjusted their approach to overall patient care. Neurological teams, diabetes specialists, cancer clinics, and cardiology practices now focus on the whole patient and their treatment. The patient’s specialist becomes the quarterback directing the process. Pharmaceutical manufacturers in these specialties have supported this model with in-depth patient and practice support programs. They should be the ones to emulate.

Seven tectonic plates moving at their own pace, sometimes one at a time, sometimes in combination. Pay attention to how they continue to shift the healthcare landscape, and adjust your plans accordingly.

Al Topin is President, Topin & Associates, an HCB Health Company. He is a member of Pharm Exec’s Editorial Advisory Board.