This piece was originally published at PharmaVoice.

In full transparency, I am a high-science geek. I am jazzed by data, by new technologies and pathways, but most importantly, I am particularly motivated when I have the ability to work on clinically meaningful advancements that truly make a difference in patients’ lives. I am the one in the crowd who readily raises my hand when the opportunity to work on a high-science brand pops up, knowing the opportunity will be rewarding and challenging, where the stakes are often life-saving.

Targeted therapy, immunotherapy, biomarkers, genetic testing, gene therapy, gene editing, and CRISPR — they are all reflections of the new world in which we live. This is the new language that we speak and as marketers, we are charged with clearly communicating the opportunities available within this ecosphere to our customers. These high-science innovations can fill huge, unmet patient needs where therapy has often been inadequately addressed, if at all. The value of a new therapy is not only defined by its ability to slow or halt disease progression to course-correct or cure disease, but also by its ability to offer hope to patients, caregivers and healthcare practitioners. With so many stakeholders needing multiple levels of information, our goal as marketers is two-fold: to communicate the clinical evidence of the brand, and to deliver a meaningful, relatable story for all stakeholders — patients, caregivers, and healthcare professionals alike.

To work on high-science brands, you need deep-rooted scientific knowledge (or at the very minimum, a real passion to learn and understand complex science), combined with the ability to translate those learnings into impactful messages. High-science messaging is complicated and requires certain skills, thinking and planning that go well beyond more traditional drug messaging. When developing messaging for a high-science therapy, my teams and I consider the following:

1. It’s important to recognize the role clinical and regulatory strategy has on messaging
2. Your approach should be to first define the overall brand story, then decide how it gets executed
3. Marketers must understand and communicate what surrogate markers/endpoints mean to healthcare providers and patients
4. It’s essential to recognize the patient and/or caregiver as an informed decision-maker in your messaging
5. And it’s extremely important to respect your clients’ tolerance for risk

Recognize the Role Clinical and Regulatory Strategy Has on Messaging

The increasing speed of development to market with high-science therapies has resulted in companies having abbreviated approval timelines. Because these therapies often serve an urgent unmet medical need, they may have benefited from expedited FDA approval pathways.

This includes Breakthrough Therapy Designation and Accelerated Approval, where approval may be based on phase 2 data and where there may or may not be a comparator arm. While limited data might affect how we develop a claim, they don’t have to limit the overall story we’re trying to tell.

An up-front conversation between brand team, the clinical and regulatory teams, and the agency is vital to align on the overall messaging strategy to ensure that we’re making informed decisions earlier in the process to avoid misinterpretations later.

Define the Overall Brand Story First, Then Decide How it Gets Executed

I would be retired and living on a private island if I had a dollar for every time a client has told me “we can’t say that.”

It’s important to encourage clients to first begin by thinking about the optimal brand story they would like to tell (one that can be referenced and supported by data), assuming there were no limitations or parameters. Think of it this way: to start from the point of view of “what we can’t say”and “what we can’t do”is like asking a person to tell you all the things they don’t like about someone and then working backwards to identify what qualities are left in that person that are still redeeming. It’s much harder to achieve the bigger picture if we begin from a narrow or negative point of view. We want clients to think about the functional elements of a story that need to be told, as well as the key emotional elements that should be brought to life. This helps us understand what the client wants the overall theme to be. Once we’ve determined what the desired message is, then it’s on us as marketers to identify the best way to execute the story.

Building a brand story for a high-science therapy is like weaving a fine tapestry, where all of the threads need to come together seamlessly to deliver the most compelling picture. While the promotional, branded story rests in the center of the tapestry, the surrounding fibers are critically important for building a more complete picture. Some questions marketers should ask themselves:

Do we need an unbranded or disease awareness story to highlight an unmet need?

How does the publications plan help to tell the story?

Is there a role for the Medical Affairs team to proactively complement the story?

No one piece of the brand story can do all of the lifting; instead, it is often the sum of all parts and how each of these “threads” weaves together into a convincing story.

Don’t forget the emotional threads when building a high-science story. These brands have relevance beyond a data point and affect people’s lives and decision-making. Data may rule the day in our storytelling, but the emotional end benefit is often life-saving and should be acknowledged.

Understand and Communicate What Surrogate Markers/Endpoints Mean to Both Healthcare Providers and Patients

Let’s use oncology as an example. For years, the gold standard and most meaningful clinical endpoint in cancer research has been overall survival (OS), followed by progression free survival (PFS). Today, we have a number of surrogate endpoints used in cancer trials. The FDA’s Accelerated Approval regulations allowed drugs for serious conditions that filled an unmet medical need to be approved more quickly based on a surrogate endpoint. Surrogate endpoints do not represent direct clinical benefit, but instead predict clinical benefit. For example, tumor shrinkage can be used as a surrogate endpoint for longer survival in clinical trials for drugs intended to treat some cancers.

Currently, we use a host of terms like RR (response rate), ORR (objective response rate), MRD (minimal residual disease), HR (hazard ratio), and others to serve as surrogate endpoints for survival. These data points need to be relevant to the clinician and the patient for the messaging to be truly meaningful making it incumbent on us to ensure these stakeholders are not only familiar with them, but that these terms become part of their vernacular, so communication is comfortable, open, and everyone is speaking the same language.

Recognize the Patient and/or Caregiver as an Informed Decision-Maker

The voices of patients are important in all pharmaceutical developments, but in high-science therapies, their voices are critical. In rare disease and cancer research, it has been advocacy and patient groups that have often led the way, playing a pivotal role in driving research and disease education.

As high-science research continues to evolve and commercialize, the days of the passive patient are disappearing. With a vast armamentarium of digital resources available to them, patients are becoming increasingly educated on and invested in their treatment options. With this abundance of resources comes a responsibility to ensure that pharmaceutical company and healthcare providers consider a strong engagement strategy, ensuring patients are educated and ready to make informed treatment decisions. This may require a brand manager to think about individualized messaging that educates and supports patients within their unique treatment journey.

Respect Your Clients’ Tolerance for Risk

The role of the agency is to guide, build, and push to deliver the ultimate brand story. The very nature of many high-science therapies has an innate competitive edge that we want to tap into as a part of our storytelling. Who doesn’t like hearing language that includes “the first and only”? But the very nature of a high-science approval (i.e., accelerated approvals, lack of comparator arms, limited data) can sometimes leave even the most aggressive marketer and company a bit skittish. It’s our job to push, but once a decision is made on risk tolerance, it is also our job to ensure the delivery of the strongest story within the context of what is acceptable to the client.

I am grateful to be living in a time where I get to personally be a part of some of the most exciting breakthroughs in therapeutic research.

I have worked on more than 30 high-science brands in my career, including 13 drugs launched under an accelerated approval. I’ve been afforded the opportunity to use words like “cure” in hepatitis C therapy, and been on the front lines as gene therapy has moved from a theoretical concept to a remarkable reality. I’ve had the privilege of working on brands that have turned cancers into chronic diseases, and helped launch others that are able to treat tumors based on a biomarker. It’s truly an extraordinary time to be a healthcare marketer.

With these high-science triumphs come a responsibility — and as an agency partner, it is our responsibility to ensure that the messaging delivers an engaging and meaningful connection between our stakeholders and the brands entrusted to our care.