Communicating R&D Innovations Early And Carefully

By Louis Garguilo, Chief Editor, Outsourced Pharma

Question: How do you know your industry is highly regulated?

Answer:   When your communications specialists hold a conference but discuss what not to say as much as what to publicize.

You would expect a room full of communications, marketing and public relations professionals to be exuberant in their discussion of how to deliver the company message across platforms and generally boast about their brands. While some of that did take place at the 3^rd Annual Life Science Brand Reputation and Communications Conference in Atlanta (February 20-21), a lot of the discussion focused on FDA regulations and SEC concerns, and the checks and balances applied to patient, media and investor communications by internal legal and investor relations departments.

Today, no part of our industry is immune from downstream considerations. From the first signs of life in drug discovery programs – including those being conducted at CROs – internal sponsor considerations are now matched by external forces. Today more than ever, several factors need to be in the back of sponsors’ minds from the early discovery phases. This includes strategic planning for trials, FDA guidelines and current stances, patient acceptance and future advocacy, acceptance by payers, and even investors in the stock markets. A part of the renewed vernacular for strategic sponsor-CRO/CMO relationships includes what we might call this “full stream” consideration.  

The conference was put on by Q1 Productions and included a diverse group of professionals from companies such as Covidien, GE Healthcare, Genzyme, Kimberly-Clark, Olympus Medical Systems Group, Purdue Pharma, Regeneron, Siemens Healthcare, ThermoFisher Scientific and more. Interbrand Health was the main sponsor.

Even social media, the new doyen of dispersed discussion, was put under a yellow light of caution as speakers stressed the importance of not losing control of your message. Although the goal is still search engine optimization, even here there is a heightened concern regarding maintaining product and corporate brand narratives and messaging. The FDA has issued warning letters over meta-tag placement on websites, and Novartis has received one from the FDA for its Facebook Share Widget[1]. In this environment we should not be surprised that oversight is headed into overdrive, and that pharmaceutical and medical device communications experts are growing more nervous.

Jeff Macdonald, senior director of corporate communications, Acorda Therapeutics

One presentation that exemplified the tension between what and what not to communicate publically was delivered by Jeff Macdonald, senior director of corporate communications for Acorda Therapeutics. Titled “Effectively Communicating R&D Innovations,” the presentation included a video clip of Acorda CEO Ron Cohen (see Life Science Leader cover story on innovation) being interviewed by CNBC’s Jim Cramer on Mad Money. The interview had its humorous moments and drew some laughs, but the presentation covered a serious topic for many in attendance.

Promising R&D innovations and early phase data are now pursued by investors even more vehemently than they are dissected by the scientific community. The balance is in not leading Wall Street one way or another. “At this point in the new drug discovery process, you have got to remember that you are talking to potential investors…who may try to get inside information,” says Macdonald. Early data is of interest to the pharmaceutical and scientific community, but investors are the ones to throw money at the data – or pull it out – on the slightest nuance. Because of this, it is imperative the communications groups within pharma, bio and medical device companies are in unison with their Investor Relations department like never before. “IR and PR have to be telling the same story and they need to realize both play a crucial part in the brand narrative and corporate message,” adds Macdonald.

The heightened importance of early data does not dissuade Macdonald from having his company erring on the side of putting more information in the hands of stakeholders. He notes what is critical is how the information is sent out and what is said about it. R&D milestones are the lifeblood of pharmaceutical and biotech firms, in this economic environment perhaps even more than ever. For both pharma and biotech companies, generating news flow on a promising new chemical entity or biologic starts early. Still, executives need to decide what is material information and what should be made public.

“A rule of thumb for us is if it does not rise to the level of a press release, is it data or other information you would want to put out on the other outlets, like Twitter or Facebook?” he asks. If that’s the case, then what rises to the level of a press release? Even phase 1 data (such as safety milestones and proof of concept data) on a potentially important drug can rise to that level. For savvy and even not so savvy investors, early data becomes ‘material.’ The so-called Reg FD (or “fair disclosure”) is all about limiting selective disclosure while at the same time the “press release level” by necessity may not be as high a bar as it once was.

With the heightened scrutiny over what you can say on the one hand and the need to provide investors, patients, and the scientific community with as much information as possible on the other hand, the potential for misinterpretation of the data increases. Interestingly, a traditional journalism practice might help here. The “media embargo” is the pact between, for example, a biotechnology company and a member of a certain media outlet, where in-depth and background information is provided in advance of an announcement to give the media outlet the opportunity to analyze data and digest the significance of the news. Trust is paramount here of course, and selecting one media source over another can be difficult.

The upside here is that market investors, from institutions to individuals, can benefit if the communications/IR departments have statements and supporting documentation already in the hands of the media to answer questions or dispel misunderstandings of the data, before they jump into a stock purchase. Background can be provided quickly and efficiently. However, a caveat for media embargo was expressed at the Atlanta conference by Ron O’Brien, Director of Public Relations for Thermo Fisher: “The important point is if you decide to use this technique, keep doing it. Changing your behavior sets off concerns within your own internal legal and other departments, and of course can produce questions from the FDA and even the SEC.”

Regarding press releases, big pharma are for the most part adept at phraseology and sticking to primary endpoints when possible. A statement such as “It is estimated there is a population of xxx people living with this condition” is much more prevalent than “We think the market for this new drug is huge.” And “We experienced improvement in drug vs. placebo of xx%” is more effective than “We saw very positive results in our endpoint of this study.” Getting data out early and carefully, and remembering the target audience at each point in the long drug discovery process, will keep healthcare companies and investors reading from the same page.