Bridging Scientific Innovation and Regulatory Acceptance
Specialized regulatory science and strategy consultancy focused on advancing innovative biomarker and diagnostic solutions that are fit-for-purpose for clinical and regulatory decision-making.
Mission
To advance patient-centered drug development by enabling the successful regulatory qualification and adoption of biomarkers and innovative endpoints.
Vision
To become a leading global partner in biomarker regulatory strategy, shaping the future of evidence frameworks used by regulators like the FDA and EMA.
De-Risk Your Program
Successfully navigate FDA/EMA biomarker qualification versus traditional regulatory pathways.
Avoid costly missteps with proven FDA/EMA engagement strategies.
Accelerate Approval Time
Strengthen Market Access
Build the evidentiary foundation that supports payer and commercialization strategies.
Amanda Klein, PharmD
Founder & Principal Consultant
Amanda Klein, PharmD, CDCES, is the founder and principal consultant of Biomarker Solutions LLC. An internationally recognized leader in regulatory science, she brings over 15 years of experience spanning biomarker development, drug development tools, and global regulatory strategy. She authored and led the first-ever qualified biomarker in kidney transplantation, resulting in an EMA Qualification Opinion, and led the only FDA-accepted Qualification Plan for a reasonably likely surrogate endpoint. Her collaborations with agencies such as the FDA, EMA, CMS, & NIH, help ensure that new therapies reach patients safely & efficiently.
Let’s Work Together
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