Category Archives : Forward Fast

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 […]

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, […]

Case 1 “New Class”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

The first is new class. The brand examples are from my experience with Cozaar & Hyzaar, these are A-II receptor blockers for hypertension. The other is Celebrex. It was the first COX-2 inhibitor for arthritis. The key claim in both of these was that they were first in a new class of treatments for their respective diseases. They were effective without causing a specific and well-understood side effect in the class. In the case of Cozaar and Hyzaar, there was a reduced incidence of ACE inhibitor cough. In the case of Celebrex, there was greatly reduced NSAID gastrointestinal problem. Cozaar […]

Introduction to “Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion”

This week, I presented views on “Navigating Regulatory Expectations” from my role as a brand innovator. The first part I shared was the basis for commercialization strategies that I’ve seen pharma and medical device companies use. Then I shared lessons learned from seven relevant cases. I’ve chosen this illustration of an Idaho river and some rafters to illustrate the idea of navigating regulatory guidelines, because I believe that there are ups and downs and there are some calm waters and there are some choppy, white waters all through the process. If you learn to navigate them then you can have […]

The American Health Care Paradox: Is spending more getting us less?

Discouragingly, many health care innovations in which Americans have placed so much stock have largely failed to deliver the desired outcomes or value. I had the opportunity to serve on a panel discussion about the future of home care with Lauren A. Taylor. Lauren has a master’s degree from the Yale School of Public Health and is now a doctoral student of health policy and management at Harvard Business School. “When we look to the front lines of health care and of social service delivery, however, we found that those who interact most closely with patients are recognizing the intersection […]

Community Support: The CORE MedBuild+ workshop

On November 12, I will present at talk at this inaugural workshop, entitled “How to move your medtech brand forward – fast. More than just another talk on branding, I will share 6 steps, tools, and examples of ForwardFast branding – specific to medtech companies and products. Because it’s an interactive workshop, ForwardFast will help make these principles of brand innovation more practical and actionable. Workshop attendees will discover how to: >   Define both your quality offering and your quality experience >   Understand what positive brand associations you can create >   Learn what your logo can really stand for – and the […]

Community Support: Idaho Global Entrepreneurial Mission

The IGEM – Idaho Global Entrepreneurial Mission – is a grant program that funds commercialization research in which university researchers and business experts partner to bring viable technologies to market. The IGEM program is a powerful force in the growth of Idaho’s economy. So, I was pleased to serve on a committee to provide input for its new website to support commercialization partnerships, IGEM invests in the development of new businesses and supports Idaho’s research facilities, thereby helping to create new products, companies, and high-value jobs. To learn more about the IGEM grant program, visit the new website: