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Mid-size Biopharmaceutical
Health Outcomes, Regulatory Affairs, Investor Relations
Phase III
Oncology
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Mid-size Biopharmaceutical
Health Outcomes, Regulatory Affairs, Investor Relations
Phase III
Oncology
A mid-size biopharmaceutical company was 18 months from launching a therapy for a rare oncologic disease with no prior approved treatments.
As Phase III progressed, the team needed clarity on how to select, position, and communicate patient-reported outcomes (PROs) to support regulatory interactions and external communications.
The client engaged Alkemi to develop an evidence-based PRO strategy and translate complex trial outcomes into a compelling narrative for regulators and investors.
1. Conducted a rapid review of validated PRO instruments, prior use cases, and regulatory precedent.
2. Assessed analogue therapies to inform endpoint selection and positioning strategy.
3. Developed structured guidance and documentation to support DCOA review and regulatory submissions.
4. Synthesized patient, provider, and outcomes data into a burden and value framework.
5. Created investor-ready communication materials translating PRO outcomes into clear, meaningful impact.
Elevate patient-reported outcomes into a strategic asset.
“Alkemi helped us translate complex PRO data into a clear, compelling narrative that resonated with both regulators and investors.” - Senior Director, Regulatory Affairs
Internal teams aligned on PRO instrument selection and positioning strategy for clinical development.
Clear articulation of disease burden and meaningful patient impact strengthened investor communications.
PRO data were positioned as a core component of the therapy’s value story.