N-of-8 for managed care story development

Last month, I had the opportunity to facilitate a workshop with 40 market access account executives, sales managers, and marketing team leaders to create a new presentation for health plan formulary decision-makers. Using the N-of-8 story development technique, we divided into five teams to explore different scenarios for improving the contract position of their specialty pharmacy brand. The consolidated output will be used to develop new slides, data references, and materials. In addition, I led two other managed care projects recently: Interviews with case managers at health plans on the role of patient support programs in drug evaluations (with a […]

No8 Kindle Cover 2

My new book N-of-8 just published this week.   Recently updated !

In this book you’ll learn how to shift from just brainstorming, focus groups, and advisory boards to create groups that truly innovate. That’s why the model is called N-of-8. Since the publication of my first book, ForwardFast, I’ve benefited from many of your comments and suggestions. So in this N-of-8 book, I’ve applied a conversational style to present a workshop-in-print. And I’ve added more case study examples, key-point summaries, and actual templates and guides to make the model actionable. Thanks to many clients and friends, the book has already enjoyed a tremendous response. In the Amazon Kindle Store, it was […]


Creative inspiration: Museum of Musical Instruments

During a layover in Phoenix on a recent trip, Jenny and I visited this fascinating collection of musical instruments from all over the world. Around every corner, there was another surprising way of making song. And in every room, there was another story of how music impacts our lives. We especially loved the showcases of Johnny Cash’s personal guitars, Roy Orbison’s handwritten lyrics of Pretty Woman,” and the drum set played by The Who’s Keith Moon. Read more about the museum at http://themim.org/      

Summary: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

In summary, I presented seven relevant cases and some key learnings for promotional guidance. In a new class, the mechanism of action needs to be pulled through to show that it actually made a difference in the clinical trial results. In the pharmacokinetics, we saw that a difference on label of PK performance could have promotionally relevant and competitively viable differences in dosing. In drug delivery and release, we saw that the profile of the therapeutic window could be promotional, allowed, if it were also shown to be patient-relevant in either efficacy or side effects. When we looked at dermatological […]

Case 7 “Ingredient Performance”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

Now the seventh area is ingredient performance. The brand example here is a PICC line or a peripherally inserted central catheter that was in development by a major medical device company. This central catheter was made from a novel plastic compound as well as an anticoagulant coating that actually prevented clots in the patient. They had some very dramatic photographs showing side-by-side results of other catheters and the clots that actually formed around them versus this catheter that was made of the novel plastic and coating that did not have any of the blood clots. However, when it came time […]

Case 6 “Surrogate Markers”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

Now let’s take a look at the sixth case, surrogate cardiovascular markers. The brand examples I share here are Advicor, which was a combination statin and niacin for the reduction of cholesterol and other related lipid components. In addition, Enkaid was a class 1-C antiarrhythmic. Now, in the case of both Advicor and Enkaid, we were able to promote that they reduced surrogate markers of cardiovascular disease, but not necessarily reducing the end results of those diseases. Let me explain. Advicor could be shown to reduce total cholesterol, reduce triglycerides, and reduce LDL cholesterol, as well as increasing the HDL. […]


Case 5 “Potency”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

The fifth case is an antibiotic potency. Now, over my career, I’ve been able to work on three particular oral antibiotics, Augmentin, Biaxin, and Cipro, all in slightly different classes of antibiotics, but all with a similar kind of message or claim, and that is the broad spectrum coverage of a lot of bacteria and less resistance to those potentially affected bugs. Now the regulatory lesson here is that the idea of spectrum coverage always had to have a footnote that in-vitro activity did not necessarily imply in-vivo efficacy. In English, that meant that just because in a petri dish […]

Case 4 “Efficacy”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

The fourth case is in the area of efficacy, specifically dermatological efficacy. I think this has always been fascinating to me. That’s why I wanted to share a range of over-the-counter brands like Keri Lotion and PreSun, a high SPF sunscreen product, as well as prescription brands, particularly Lac-Hydrin and Botox, a well-known injectable product. Now the key claim for these products range from simply treating dry skin to aging skin. There was actually a big difference between showing the signs and symptoms of dry skin to PreSun, which was, because of the sunscreen component, could actually claim to prevent […]

vivaglobin release

Case 3 “Drug Delivery & Release”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

Let’s take a look at the next case. Number three is drug delivery or a different kind of drug release. The brand examples here are Vivaglobin, an IVIg product, and the octreotide implant that was a growth hormone inhibitor product in development at a major pharma company. The key claim for both of these is that there would be no more roller coaster of drug effects, either over delivery of the drug, which would cause untoward side effects, or, along the way, a roller coaster down of loss of effect and even under-protection because the product went below the therapeutic […]

Case 2 “PK”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

Let’s take a look at the second case. This is in pharmacokinetics. A particular brand example was Daypro, a non-steroidal anti-inflammatory drug. The key claim for Daypro was that it could provide day-long confidence and proactive control – a tagline that was created to reflect its brand name. This was based on a PK profile that there was no drug accumulation with chronic dosing. The kidneys could be spared drug accumulation even if the patient took it once a day, every day — instead of just as needed for pain. This became a real promotional and competitive difference for Daypro, […]