Devices & Diagnostics

Drugs and devices: Preclinical communications strategies to set the stage for FDA approval

For early stage drug and device companies, communication in the preclinical stage is much more about listening than putting out your own message. Nonetheless, these early communications establish the foundation for the company and will be key to achieving U.S. Food and Drug Administration approval down the road. For example, a strong early communications strategy […]


For early stage drug and device companies, communication in the preclinical stage is much more about listening than putting out your own message.

Nonetheless, these early communications establish the foundation for the company and will be key to achieving U.S. Food and Drug Administration approval down the road.

For example, a strong early communications strategy can set the stage for better eventual clinical trial recruitment and can help a company catch the attention of key opinion leaders, investors and potential partners — basically anything needed to lay the groundwork for a successful clinical program.

Even at an early stage, there are many different audiences that drug and device companies may need to communicate with — patients, investors, regulators and the scientific and medical communities.

But what are the best practices around managing these communications?

Executives from Fleishman-Hillard and ProEd Communications shared their thoughts on the topic at a forum Thursday morning that was sponsored by Cleveland-based nonprofit business development group BioEnterprise. Here are a few highlights and key tips:

Stay consistent. You’ll communicate slightly different messages to different audiences, but maintain consistency as much as possible when discussing your product. Accuracy is key, so make sure any claims you make about your product have some grounding in data. Don’t oversell or make excessive claims. Everything should be science-based and focused on the unmet medical need that your product will meet.

Do you really need a pre-IND/IDE meeting with the FDA? Even if you think you need a meeting, you might not get one. The FDA simply doesn’t have time to meet with the thousands of small, pre-product companies that pop up every year so the agency often denies meetings, said John Cutt, ProEd’s vice president of regulatory affairs. If you’re developing something truly novel, you may need some early guidance with the FDA. But be warned that you can’t be assured of the outcome of such meetings, and they can lead to delays in establishing your clinical program.

Engage with the medical and scientific communities. Publish your preclinical research to set the stage for your rationale for why the research should be continued in humans. That should help build awareness among key opinion leaders. Begin researching possible members of your scientific advisory board. Monitor relevant literature to keep up with the latest in your therapeutic area and keep an eye on Congress for legislation that might affect your industry.

Monitor patient groups and begin reaching out to investors. Identify patient-advocacy groups in your therapeutic area and track what they’re saying about competing products via traditional media and social media. Don’t underestimate the power of social media in helping to connect with patients and to deliver a precise message to a targeted audience. Before you reach out to investors, develop a strong understanding of the competitive landscape and perform a thorough market analysis. Then, create a brief presentation that makes the business case for your company, and begin asking contacts for investor introductions.

[Photo from flickr user l_bo]