October 29, 2025

Do Public Biotechs Need a Crisis Communications Team and Plan?

Crisis communications may sound like pseudo-science, but it’s a very real thing that every public biotech should take seriously. Why? Well, a bit like health, fire or even earthquake insurance, you never quite know when you’re going to need it… but when you do, you’re very thankful you have it in place.

Of course, it would be nice to think that crises only happen to other people, but that would be naive. And the preparations you make today for that dark moment when crisis strikes will put you in good standing to retain credibility when the market may be looking for a reason to sell (or worse, short) your stock.

Let’s start by listing a few of the unforeseen events that may befall a public biotech (note: over the years I’ve dealt with most of these and more):

• Patient deaths, negative data, an unexpected clinical hold or unexpected data revisions – for an otherwise ongoing clinical trial.
• Your CEO/CFO/CMO being fired by the Board over a weekend for business or non-business reasons.
• A fire, natural disaster, or live shooter-incident befalling your headquarters or R&D center.
• A plane crash involving one or more key members of your leadership team.
• Manufacturing issues with your approved or unapproved drugs.
• Allegations of financial or data fraud.
• An SEC investigation into potential insider trading.  
• A cyber-attack (and possible ransom situation) on the company’s servers.

These are just some of the events you need to be prepared for, however unlikely you think they are (see our blog on “What Did U.S. Biotechs Learn from Silicon Valley Bank’s Collapse in 2023?”).  

What is the purpose of crisis communications planning?

In short, the answer is to create conditions for the optimal development and dissemination of public and internal communications during a time of company crisis. This is done by planning in advance for potential scenarios and by creating a small, highly skilled team (with decision-making capability and expertise covering any and all affected stakeholders) to handle potential real-world crises.

By establishing a preassigned team and preparing advanced templates or draft materials, during a time of crisis a biotech should be able to: i) communicate with appropriate tone and in a factual and unambiguous manner with all relevant stakeholders in a way that contains misinformation and retains credibility; and ii) maintain regulatory compliance with agencies and organizations including the FDA/EMA, SEC, NASDAQ or NYSE etc.

Who should be part of a crisis communications team?

A crisis communications team brings together key decisions makers, advisors, and communications professionals from within a firm. The team is generally smaller than the average Senior Leadership Team (SLT).

Typically, members would include:

• A biotech’s Chief Executive Officer (CEO) – the company’s ultimate spokesperson and the only individual with final decision-making authority.
• A biotech’s Chief Medical Officer (CMO) – to provide expertise on a crisis’ readthrough to the company’s clinical programs and drug development.
• A biotech’s Chief Financial Officer – to provide a financial perspective and to potentially act as liaison to the company’s Board of Directors.
• A biotech’s General Counsel – to assess any legal liability, or FDA/SEC-related risk.
• Your Investor Relations Officer (IRO) – to lead external messaging and investor (and other financial stakeholder) communications.
• Your Head of Public Relations – for internal communications, employee morale considerations, as well as media relations.
• Alternates for each of these, in case any are unavailable at the time of crisis.

Though all of the above are typically career professionals, by prior agreement each should agree to be available 24/7 in the event of need.

When should a crisis communications team be activated?

Your team should be convened within 30 minutes of an event that could materially affect your biotech’s reputation, stock price, or the public’s safety. While this may seem sensational at first glance, you should consider that by this time your company may already have been contacted by either NASDAQ or the NYSE’s Market Watch teams to ask if trading in your stock should be halted. During a crisis, time is of the essence.

Once convened, your crisis communications team should:

• Immediately verify the facts of the situation using internal sources.
• Assign a single spokesperson (typically your CEO).
• Draft an initial holding statement within one hour – using the templates you have already drafted as part of your advanced preparation.
• Agree on an internal timeline for a more in-depth response (if appropriate) and/or next steps.

Messaging during a time of crisis.

When crisis strikes, it’s important that your response be transparent, factually accurate, empathetic, and not come across as defensive. These are all key to retaining the credibility you will have worked hard to build up previously.

Tone (linked to empathy) is all-important, and the real time monitoring of social media, the press, and/or any equity analyst notes should guide you to an appropriate understanding of what people’s concerns are.

A holding statement may be warranted while you work to form a lengthier response. This is because, in a time of crisis, no news is bad news. The worst will be assumed, and your silence will be seen as damning.

In any holding statement you should:

• Acknowledge the issue at hand.
• State relevant verified facts (if possible).
• Explain the initial steps being taken and/or when a more in-depth update will be provided.
• Provide reassurance on your company’s commitments to the likes of patient safety and/or health outcomes, corporate integrity, and transparency.

E.g. “Biotech ABC is aware of [reports regarding] [issue]. The safety and wellbeing of patients and the integrity of our [clinical] data are our top priorities. We are working closely with [regulators/our CRO/our partners] to fully understand the situation and will provide updates [as more information becomes available].”

Changing company guidance.

Crises have the potential to materially derail existing company guidance. At such a time remember the golden rules of changing guidance:

• Only change guidance when you are bordering-on-certain you will no longer be able to meet what you have previously said.  
• When updating or replacing existing guidance, your new guidance needs to be both accurate and credible.
• If you are unable to provide a credible update to your prior guidance, think about rescinding the old guidance and providing a timeline for when you will be able to provide new guidance.

Investors will be looking for a “floor” for your stock and the more information and structure in your response that you can provide (without overpromising) the better.

Remember Regulation FD (Fair Disclosure).

In a crisis, your phone and inbox are likely to be inundated with inquiries from investors and analysts. Be mindful to treat all investors equally, however, and not to respond to some inbounds and not others, for fear of being guilty of selective disclosure. A holding statement is meant to keep inquiries at bay, but they will occur nonetheless. With a holding statement in place, however (which you can refer people to), you have a “good reason” to ignore inbound communications until you are prepared to provide a more in-depth response.

What forms might a longer crisis response take?

Your fuller response will be much like any other company announcement (earnings or data announcements, etc.), and could include any of the following components depending on the audience you are trying to reach:

• A company-issued press release.
• An 8-K filing.
• A scripted investor call.
• A dedicated page on your website (including FAQs).
• Internal email (or Teams/Slack) updates.
• Direct outreach to trial investigators, patient advocacy groups and/or partners and suppliers.
• Approved posts on the company’s official social media platforms.

What work can you do ahead of time?

There are a number of materials that can be drafted ahead of time to save you valuable time when crisis hits:

• Create a contact list (including emails and cell numbers) for every member of your crisis communications team, external counsel, and your IR and PR agencies.
• Create pre-approved statement templates (simple drafts) for potential press releases.
• Brainstorm and document Q&As for a variety of potential events, with a focus on inquiries coming from media and/or investors/analysts.

Note that your job isn’t finished once a crisis has been contained.

Once a crisis has abated, and hopefully normal course of business is resumed, it’s good practice for your crisis communications team to:

• Conduct a debrief following resolution of the crisis in question, documenting what worked, what didn’t, and what can be done better next time.
• In a perfect world, a biotech’s crisis plan should be updated (with members of the crisis communications team retrained) annually.