N-of-8 helped articulate vision of Baxter as emerging leader in Regenerative Medicine

My work with the Cellular Therapies business unit of Baxter Healthcare Corporation is an important case study in which the N-of-8 tool helped articulate a vision of Baxter as an emerging leader in Regenerative Medicine.

As it was initiating a major Phase II clinical trial for the advancement of stem cell therapy, Baxter Cellular Therapies was preparing to exhibit at the 2006 American Heart Association’s annual conference. Although current interest in stem cell therapy was high, it was often misunderstood.

With a market early in its development, a novel approach was needed to differentiate Baxter Cellular Therapies from its competitors, all relatively small, unknown start-up companies. On the one hand, Baxter was uniquely poised to distinguish itself by lever- aging its size, scope, and name recognition.

On the other hand, the AHA meeting was dominated by giant players with mega-brands, leaving little room for early phase research to get noticed.

Metrics for success included:

• Increased awareness and interest among interventional cardiologists
• Established connections with new potential major investigators
• Recognition of Baxter Cellular Therapies as a credible and trusted emerging leader in Regenerative Medicine

Instead of applying a traditional pre-marketing approach, we worked with the team at Baxter Cellular Therapies to find a different strategy using N-of-8.

1. First, Baxter would position itself as category leader, one that would be seen as a central source of information in the field of regenerative medicine.
2. Next, we would help co-brand a scientific booth with The Angiogenesis Foundation to establish third-party credibility with one of the foremost authorities in angiogenic therapeutics and research.
3. Finally, we helped create a series of highly clinical, scientific presentations, enlisting an expert panel of investigators. As the main booth draw, these “live” and interactive presentations were presented every hour, on-the-hour, during the convention. These speakers are central to creating “evangelists” in the field to further establish interest in the Baxter research.

Prior to the convention, attendees received multiple e-invitations from the expert panel to learn about advances in cellular therapy trials and potential applications in cardiovascular disease.

During the conference, attendees were asked to complete a brief survey to assess the derived value of the information presented and to gauge their level of interest. In gratitude, attendees received a branded flash drive that contained unique graphics, teaching slides, and PDFs of 32 published clinical papers in cellular therapy.

Booth attendance exceeded the conference goals — achieving 5 times the desired traffic.

As a result, a database with more than 800 physicians at leading institutions was created with a majority of attendees requesting future updates from Baxter.  Equally important were the connections made with several potential major investigators.

Engaging “Opinion Leaders” that may be “Practice Influencers”

I've shared many examples of how N-of-8 can shift opinion to practice.

Another case was when I moderated a group of leading cardiologists to discuss eplerenone, the first agent designed to selectively block aldosterone for the treatment of high blood pressure.

The eight participants in this group included the chair of a major medical society, the client’s chief medical director, and six of world’s top hypertension specialists.  We were to discuss how aldosterone blockade reduces mortality and morbidity among patients with severe heart failure.  Simply put, eplerenone is used to treat high blood pressure by blocking aldosterone, which in turn lowers the amount of sodium and water the body retains. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. Eplerenone is also used to treat congestive heart failure following a heart attack.

To say I felt intimidated would be an understatement.  As their facilitator, however, my job was not to go toe-to-toe on the science.  Instead, I was to help determine how emerging science could apply to practice.

The conversation turned to the difference between diastolic and systolic blood pressure.  And after several minutes, I asked the most innocent and naive question:  

“When you say systolic BP, 

what would that mean to 

the average family physician?”

Well, the question was apparently so elementary that my client almost had a cardiovascular event right there.  But then, one doctor responded, “You know, that’s a very provocative question and one that has created some controversy.”  This led to a lively, engaging, and fruitful debate – with more implications for practice than we expected.

Approximately 50 million, or one in four, adult Americans, have high blood pressure. Of those, 73 percent are not adequately controlled, and are at increased risk of heart attack, stroke, kidney failure, damage to the eyes, heart failure and atherosclerosis. Control of hypertension has remained inadequate despite the availability of several key classes of compounds.

"Hypertension is a complex disease with many factors contributing to the problem," said the advisors during our N-of-8.  "For patients and their health care providers who face unique challenges in achieving and maintaining control of their high blood pressure, eplerenone could represent an important new treatment option that goes beyond standard therapies in targeting the aldosterone pathway."

Preclinical and clinical studies had suggested that eplerenone works with relative selectivity to block aldosterone receptors, a key component within the RAAS (renin angiotensin aldosterone system).  This fact, the advisors said, plays a significant role in the body's regulation of the cardiovascular system.

In the discussion, they concluded that data showed the addition of eplerenone to optimize medical therapy could reduce morbidity and mortality among patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure.

This all ultimately contributed to the company’s marketing strategy.  FDA initially approved eplerenone for the treatment of hypertension, but the brand team decided to wait another year for a second indication – the treatment of congestive heart failure (CHF) secondary to an acute myocardial infarction – a first for any drug in the class. 

Eplerenone was launched, and marketed by Pfizer, under the brand name Inspra.