MedComms at the Speed of Science
Core Findings
Agility drives SUCCESS
Scenario planning and flexible workflows kept the launch on track despite unpredictable FDA timelines.
Integration accelerates EXECUTION
Centralized content and close stakeholder alignment sped up reviews and approvals.
Consistency builds CREDIBILITY
Omnichannel coordination ensured every peer-to-peer, digital, and live touchpoint told the same seamless story.
Big moments MATTER
Delivering a live broadcast within days of approval created lasting momentum and reinforced our client as being a leader in rare disease.
Situation
A rare disease biotech was preparing to launch the first FDA-approved therapy for a community with high unmet need. But launch conditions were anything but simple: FDA label updates arrived late and often, early approval was possible, and planning timelines shifted constantly.
The team needed to align rapidly across stakeholders, vendors, and MLR reviewers to deliver Day 1 communications that were ready, compliant, and impactful — with no margin for error.
Solution
With limited internal infrastructure, RevHealth was selected to act as both strategic advisor and executional engine, ensuring all medical communications were accurate, compliant, and delivered on time.
- We designed and executed a peer-to-peer “First-to-Know” broadcast, going live within days of FDA approval, ensuring the community heard the news from trusted medical voices right away.
- We developed a flexible medical communications framework that prioritized accuracy and speed.
- We created multiple content pathways through scenario planning, ensuring core medical materials were ready no matter how the label evolved.
- A centralized content repository streamlined MLR reviews, keeping references, data, and messaging consistent across channels.
At the same time, we handled KOL recruitment, investigator engagement, and live broadcast logistics—so the client could deliver scientific updates immediately post-approval. Every step emphasized responsiveness and compliance, enabling the team to stay ahead of shifting conditions.
Results
The First-to-Know broadcast launched just three days after FDA approval, a major milestone for both the client and the community
Despite multiple late label changes, all content was delivered fully compliant, aligned, and on time
Client feedback praised our responsiveness and agility, calling out the flawless execution under highly compressed timelines