Seasoned communications expert helps defend critical labeling
We supported a major pharma client to defend additional labeling text for an established antidiabetic drug. The information was derived from a 16,500-patient cardiovascular outcome study, the largest of its type, and we produced the Briefing Book for an FDA AdCom meeting.
the challenge
The goal was to allay FDA concerns about some safety results from the outcome study and to achieve a positive AdCom vote and label.
our approach
We assigned a highly skilled and experienced medical writer who used storyboards to develop a strategy for the Briefing Book and prioritize its content. She built close working relationships with medical and statistical experts and senior executives, including lawyers, and developed a rapid understanding of complex statistical issues, communicating them in a convincing manner. She coordinated information between parallel activities (eg, AdCom script and slides) to ensure consistency, and remained flexible and responsive to last-minute additional analyses or changes from senior reviewers.
“You bring scientific expertise, ability to focus under pressure, and ability to translate (disjointed) thoughts into rational and clear statements. Your attention to detail is commendable.
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the results
The AdCom delivered a positive vote, leading to a positive label in the US.
our value
We are at ease with the criticality of the task and the need to work with senior experts in a confidential environment, and are able to deliver quality under pressure—companies would normally be given 8 or 9 months to prepare for an AdCom. In-depth knowledge of the drug and client, combined with continuity of support, drove efficiency and increased trust.
“We have been spoiled by you. Other vendors do not even come close to your technical excellence and strategic views.”