Early-stage biotech companies experience many important inflection points from funding milestones to regulatory updates to an IPO. However, data readouts arguably carry the biggest risks and potential rewards. Whether providing proof of concept, proving safety and tolerability, or clearing the way for final regulatory approval, clinical trial readouts are critical de-risking events. Communicating a clear, consistent message to your audiences is crucial to success, no matter what the data show.
Preparation for a data event should begin long before the data are in hand. In fact, the most sophisticated and equipped companies are the ones that begin preparing for the trial’s completion when only just beginning to conceptualize their clinical development program.
Stakeholder analysis
Communicating early and often with investors, analysts, the scientific community, and other key audiences is fundamental to long-term success. As you are determining your biomarkers, endpoints, and other details, ensure your communities understand the goals of your clinical development program and the milestones that are anticipated along the way. Providing a clear and unwavering roadmap of anticipated milestones will ensure that, no matter the inevitable bumps or detours, your stakeholders can always see the path forward and track your progress.
One of the first exercises management teams should undertake when considering their clinical development path is a stakeholder analysis. Investors, analysts, patients, potential partners, prospective employees – each audience has their own concerns and expectations. Understanding the interests and apprehensions of your community is key to developing messaging that not only resonates, but reassures your key audiences.
While best practice is always to tailor your messaging to the needs of your specific audience, it is important to remember that in our digital age, messages are both immutable and porous. Milestones communicated early in your development are forever searchable and even private companies will have to answer for missed timelines when they have been recorded for posterity.
Additionally, with social media, video sharing services, and global search, information created for one audience is often shared amongst many. Evaluate all materials and messages developed through the unique lens of each of your audiences. What would you change about your scientific presentation if it was recorded and accessible to your patient and caregiver community on YouTube after the event? What is in your quarterly earnings updates that might concern your KOLs or clinical investigators? Evaluating the impact of messages on each of your audiences in addition to your intended targets is essential.
The importance of feedback loops
Listening is a vital element of any successful communication program and one that is frequently overlooked. In a global survey by the Economist Intelligent Unit (EIU), which surveyed 500 companies, 63% of companies said feedback loops help them to implement new strategies based on updated information to reach strategic goals. Too often, companies treat conversations with their core audiences as one-way interactions, but the most strategic and forward-thinking leadership teams use these early interactions as important sources of insight. After each conversation, take a moment to reflect. What questions surprised you from investors? What concerns are patients or caregivers raising that you haven’t addressed? Was there a concept the scientific community didn’t seem to grasp? Fill the gaps in your messaging early and update accordingly as your work progresses.
Timing is critical
Once the first participant has been dosed and the trial is progressing as planned, companies should quickly shift into preparing to receive and disseminate the data. No less than 90 days before the interim or final read, management teams should start to forecast potential outcomes and prepare accordingly.
Working in close collaboration with patient advocacy, legal, clinical, regulatory, IR, PR, and other key stakeholders, leaders should plan for positive, negative, and neutral outcomes. Every possible outcome should be evaluated through the lens of each audience and their concerns and expectations. What are the variables that will need to change with the different scenarios? What are the regulatory implications of the findings – will you be seeking accelerated approval, for example? Will you communicate the nuances around each scenario? How will analysts, investors, and patients view the results?
Addressing the laundry list of questions and considerations is only the first step in scenario planning. For each foreseeable outcome, companies must develop supporting materials including Q&As, press releases, decks, scripts, etc. that are vetted and approved by legal, regulatory, and management. Tackling these all-important elements early will help the team to unearth and address misalignment and ensures that when the data are available, everyone agrees on the approach and next steps.
Once the data are in hand, the materials are finalized, and the messages have been shared with external audiences, management teams should evaluate the success of the event and begin planning for the next stage. What resonated and what fell flat? What points were particularly confusing for patients? What signals did analysts give about their expectations for upcoming milestones? How can you begin preparing and adapting your message today for future milestones?
With so many potential hurdles on the road to commercialization, it’s important to be proactive and have a solid plan to address the elements within your control – you can’t control the data, but a robust plan will ensure you are prepared for all possible results.
Source: exdez, getty images
