More than 20 years ago, Gleevec ushered in a therapeutic revolution in oncology based on a relatively simple premise: If cancer cells are “addicted” to oncogenic mutations, targeting the troublesome protein might provide long-lasting disease control.1 Fast-forward to the present and it becomes clear that the relative simplicity of the “Gleevec revolution" belied the complexity that was to come.
Today, the same discovery engine that brought us Gleevec continues to churn out new therapeutic revolutions at a seemingly accelerated clip. Who would have thought that, in just a few years, gene therapy would move from bench to bedside and then, even more quickly, to a standard approach across rare disease?2 That, in less than a decade, the center of gravity in immunotherapy would move from checkpoint inhibition to therapeutic combinations that marshal the full force of the innate and adaptive immune systems?3 Or that 3-D printed organs would be confidently predicted within the scope of a publicly disclosed pipeline?4 The net effect is that even the clinical expert may need an immunology lesson or molecular biology primer to understand a pipeline compound.
Within this context, crystallizing the science is essential for companies looking to stake a claim within the increasingly competitive mindshare “marketplace.” To build a scientific story that will deliver generally requires navigating 3 key principles:
Principle #1: Start Early and Make the Science (Really) Simple
In a world where there are not enough clinical trial patients to go around,5 the old model of investing in a comprehensive communication strategy only after proof-of-concept simply does not work. At the same time, even the experts have limited time to understanding the scientific rationale for a potential but unproven advance, so the scientific story must be ruthlessly prioritized and have sticky takeaways to excite them. If the fundamentals of the scientific story cannot be communicated in a simple takeaway supported by a few key details, continue to refine.
Principle #2: Co-creation is Essential
While the scientific story trades in data and facts, using them effectively requires consideration of direction and magnitude, with the resultant vector defining how the message will land. Doing this well requires stakeholder insight, but also, recognizing the key role clinical experts will play in relaying the message (to their peers, to the community, and even to savvy analysts at major investment houses), partnership in defining story. For this reason, even though co-creation in partnership with experts means relinquishing a modicum of control, the benefits do outweigh the risks when the result is a consistent message from the company and the community.
Principle #3: Evolve the Story with the End-Goal in Mind
Ultimately, the strongest scientific stories connect early promise with tangible clinical benefits to set a new product apart. Planning to evolve the scientific story should ideally begin when the clinical development program, and thus the potential product labeling, can still be shaped. Even when it can’t, defining the data points that collectively and meaningfully provide the objective reasons to believe for a nascent therapeutic revolution is a critical input for positioning and messaging. Starting as soon as possible, with multidisciplinary input, provides the opportunity plan for different scenarios and pivot effectively as these clinical data read out.
While these principles may seem obvious, navigating them in practice usually requires concerted effort, and frequently, agency partners that can break down traditional barriers between disciplines to see the bigger picture. At Syneos Health, the breadth of our network and clinical expertise give us a unique ability to assemble the right team to deliver on this need. In short, we’ve done this before, and we’re ready to do it again for you.
References
- Pray LA. Nature Education. 2008; 1(1):37.
- Genetic Engineering & Biotechnology News. https://www.genengnews.com/magazine/319/gene-therapy-ever-more-common-for-rare-disorders/. Accessed July 30, 2021.
- Torjesen I. BMJ. 2019;365: l1824.
- United Therapeutics. https://pipeline.unither.com/. Accessed July 30, 2021.
- The New York Times. https://www.nytimes.com/2017/08/12/health/cancer-drug-trials-encounter-a-problem-too-few-patients.html. Accessed July 30, 2021.
