Every clinical readout, IND clearance, or breakthrough designation your company announces is a scientific comms opportunity and an SEC disclosure event at the same time. Most biotech PR teams plan the story without the IR team's clock, and most IR teams clear the disclosure without a communications plan built around it. We build both together, before the data lands.
The Problem
Data readout announcements get drafted before the data is understood
Teams write the topline press release template weeks before results land, built on the outcome they are hoping for, then scramble to fit real numbers into an over-promised narrative once the data arrives. The opposite failure is just as common: legal, worried about liability, guts the release into a statement so hedged it tells physicians and investors nothing they can act on. Both versions cost you the one moment a readout actually earns coverage.
Regulatory milestones are treated as one press release template, not four different ones
An IND clearance, a breakthrough therapy designation, a complete response letter, and a full approval are different events with different audiences, different disclosure stakes, and different tones. A company that runs every milestone through the same template either wastes a genuinely big moment on generic phrasing, or overclaims a routine regulatory step as if it were an approval. Each milestone needs its own framework, decided before the letter arrives, not after.
Crisis comms for a trial hold or safety signal gets built during the crisis
Most biotech companies have no pre-drafted holding statement, no notification tree, and no trained spokesperson for a clinical hold, partial hold, or DSMB safety flag. The first six hours after an FDA letter or a safety signal are spent drafting language and deciding who is allowed to talk to media, instead of executing a plan that already exists. Those six hours are exactly when the story gets set by whoever gets there first – often not you.
PR and investor relations plan the same event on two different clocks
A material trial result is a scientific comms opportunity and a material non-public information event at the same time, and if the comms team builds the story without the IR team's 8-K timeline, one of two things happens: the release goes out with forward-looking language legal never approved, or coverage gets delayed past the disclosure window because nobody synced the calendars. Either failure creates real legal exposure, not just a missed news cycle.
How We Help
Our assessment starts with your disclosure protocol as it actually exists today, not as it is written in a policy document. We review your last several milestone and readout announcements, map who signs off at each stage across comms, legal, medical affairs, and IR, and identify where the process stalled or produced a release that under- or over-claimed the result. We also check whether a crisis comms plan exists at all – most companies do not have one until we ask.
Strategy development builds milestone-specific communication frameworks ahead of anticipated events – a different structure and sign-off path for an IND clearance versus a Phase III topline versus an approval – so nobody is deciding tone and content for the first time under deadline pressure. In parallel, we build the crisis comms playbook: pre-drafted holding statements for a clinical hold, partial hold, and safety signal scenario, a notification tree that names who gets called and in what order, and spokesperson training so whoever is in front of media or investors is prepared before it matters.
Execution means drafting milestone templates in advance of anticipated readouts and running a tabletop exercise on the crisis scenario most relevant to your pipeline stage, so the plan gets tested before it is needed. For every material announcement, we coordinate release timing directly with your IR team's 8-K and material non-public information clock, so the comms plan and the disclosure obligation move on the same schedule instead of competing for control of the date.
Measurement tracks media pickup and accuracy against your actual data, analyst note tone and whether coverage reflects what you actually disclosed, and for crisis scenarios, response time from event to public statement. We also track a quieter but important metric: how often a release needs a follow-up correction or clarification, which is usually a sign the first version tried to say too much or too little.
What we deliver
- Disclosure protocol audit – mapping sign-off across comms, legal, medical affairs, and IR for the last several announcements
- Milestone-specific press release frameworks – IND clearance, breakthrough designation, complete response letter, and approval built as distinct templates
- Crisis comms playbook – pre-drafted holding statements, notification tree, and trained spokesperson for trial hold and safety signal scenarios
- IR-synced disclosure calendar – comms timing coordinated with the 8-K and material non-public information clock before a readout, not after
A clinical trial readout is not a press release with a stock price attached to it – it's a disclosure event with a press release attached to it. Companies that plan comms and IR on the same clock get both right. Companies that don't get neither right.
Our Methodology
Our PR and comms build for biotech and pharma runs as a 90-day installation, and it starts with the disclosure protocol before it touches any messaging. Phase one audits your last several announcements and crisis readiness, and gets comms, legal, medical affairs, and IR in the same room to agree on who owns what at each stage – this conversation alone surfaces most of the gaps that cause a bad readout announcement.
Phase two builds the milestone-specific frameworks and the crisis comms playbook, drafted against your actual pipeline and the regulatory milestones you are realistically approaching in the next 12-18 months. We do not build a generic crisis plan – we build for the specific hold or safety signal scenario your trial design and patient population make plausible.
Phase three tests the system: a tabletop exercise for the crisis scenario, a dry run of a milestone announcement against a hypothetical readout, and a working session with your IR team to confirm the disclosure calendar sync. Unlike a PR agency that shows up after the data lands, we build the framework and train the team before there is anything to announce, so the first real readout is not the first time anyone has run the process.
How We Work
Initial engagements run 3-4 months to build the full framework – disclosure protocol, milestone templates, and crisis playbook – then shift to a standing retainer for ongoing announcement support and plan maintenance as your pipeline advances. The first 30 days are the audit and cross-functional sign-off mapping described above. Days 31-60 build the milestone frameworks and crisis playbook. Days 61-90 run the tabletop exercise and confirm the IR sync.
Our team includes a comms lead who owns the milestone frameworks and drafts announcements, a crisis comms specialist who builds and runs the tabletop exercise, and an account lead who coordinates directly with your IR counsel on disclosure timing. From your side we need access to legal and IR stakeholders during the build phase, and a named spokesperson or two to go through crisis training.
Once the framework is built, cadence shifts to as-needed support around actual milestones and readouts, with a standing monthly check-in to keep the crisis plan current as your trial design or pipeline stage changes. Most companies renew the crisis playbook and spokesperson training annually, since trial phases and regulatory exposure shift year to year.
We are not a retained agency that writes every press release for you indefinitely – the goal is a framework your team can execute against, with us available for the announcements and moments where the stakes are highest.
If your biotech & pharma company needs pr / comms leadership, we should talk.
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Frequently asked questions
How much does PR and comms cost for a biotech or pharma company?
The initial framework build – disclosure audit, milestone templates, and crisis playbook – typically runs $45K-$110K depending on how many regulatory milestones we are planning for and how much of the crisis plan needs to be built from scratch. Ongoing retainer support for milestone announcements and plan maintenance is scoped separately based on how many events you expect in a given year.
How long does it take to build a crisis comms plan for a clinical hold or safety signal?
The core playbook – holding statements, notification tree, spokesperson identification – is usually built within the first 60 days. Spokesperson training and the tabletop exercise happen in the final 30 days of the initial engagement, so the plan is tested before it is needed.
How does the comms team coordinate with our investor relations and legal counsel?
We work directly with your IR team on the 8-K and material non-public information timeline for every announcement, and with legal on what language a release can carry before it becomes a forward-looking statement issue. This coordination happens during the framework build, not improvised during an actual readout.
What makes Winston Francois different from a healthcare PR agency?
Most healthcare PR agencies write releases after the data lands and treat crisis comms as a separate, rarely-used service. We build the disclosure protocol, the milestone frameworks, and the crisis playbook before there is anything to announce, coordinated directly with your IR and legal teams from day one. We think about comms as a disclosure function with a narrative attached, not a narrative function that occasionally checks with legal.
How do you measure ROI on a PR and comms engagement?
We track media pickup accuracy against your actual disclosed data, analyst note tone following major announcements, and how often a release requires a follow-up correction or clarification – a strong signal the first version was drafted wrong. For crisis scenarios, we track time from event to public statement against the plan's target. ROI here is measured in avoided restatements and avoided crisis mishandling as much as in earned coverage.
What stage of biotech or pharma company is the right fit for this service?
Public and pre-IPO companies with active clinical programs get the most immediate value, since disclosure stakes and milestone frequency are highest at that stage. Private companies approaching a Series B or C with a first major readout on the calendar benefit from building the framework before the stakes get higher. The first step is a disclosure protocol audit to see where your current process actually breaks.
