The client had recently completed the second Phase 3 study
The client’s novel therapy had positively differentiated results that could change the practice of medicine but in a yet undefined therapeutic area
Although a Phase 2 study and a prior Phase 3 study had been completed and demonstrated strong safety and efficacy, there were no publish manuscripts available to the public or the medical and scientific community
Challenge
Without education on the specific impact that the novel therapy could have and understanding of the data that demonstrated clear clinical efficacy differentiation, the community at large undervalued the investigational agent’s potential and value
Reviewers felt that the subject matter was an old topic with nothing new happening and therefore the manuscript and the novel therapy were considered not of high scientific or medical interest
Manuscript submissions to mid tier specialty specific journals were rejected
The Xelay Approach
Xelay Acumen focused on describing not only the differentiate results but how the results were achieved through the novel mechanism of action as well as the significant potential impact to patients and the practice of medicine
Xelay Acumen consistently described the agent throughout all congress publications, discussions, and communications to ensure not only understanding of results but the reasons to believe the results as well as the real unmet medical needs being addressed. Within a year, Xelay performed the medical writing and publication planning for over 80 conference publications presented at major global scientific conferences with the majority being podium and late-breaking presentations
Xelay Acumen rewrote the Phase 3 manuscripts which were subsequently accepted in the top two prestigious medical journals: The New England Journal of Medicine (NEJM) and the Journal of American Medical Association (JAMA)
