.png)
Small R&D focused Biotech
R&D, Clinical Development, Commercial Lead, HEOR
Novel Phase IIb Therapy
Rare Disease
Subscribe to our newsletter to receive the latest case studies.
Small R&D focused Biotech
R&D, Clinical Development, Commercial Lead, HEOR
Novel Phase IIb Therapy
Rare Disease
The client was advancing a novel therapy for a rare disease and needed to define value early, before pivotal decisions were locked in.
With limited data, multiple stakeholders, and a compressed timeline, teams needed clarity on which outcomes would matter most to future payers, clinicians, and regulators.
The client engaged Alkemi to rapidly align on an early value story and define an evidence strategy that could support development decisions and future access.
1. Conducted a rapid review of available clinical data to identify emerging value themes and evidence gaps.
2. Led cross-functional working sessions with Clinical, R&D, HEOR, and Commercial leaders to align on priority value messages and decision needs.
3. Assessed potential clinical and RWE endpoints against future access and evaluation requirements.
4. Developed a clear, actionable evidence roadmap outlining recommended studies, sequencing, and rationale.
Create early clarity to guide development and reduce downstream access risk.
"Alkemi helped us clarify exactly what evidence we needed and gave us a roadmap we could implement immediately." - VP of Medical Affairs
Teams aligned early on how value should be articulated and supported as the program advanced.
The roadmap provided clarity on which endpoints and studies would best support future access and reimbursement.
Early alignment helped the client make informed development decisions and prepare for future market access expectations.