Who We Are
Biomarkers Solutions LLC is a 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.
Unlike general regulatory consultants, we provide rare, specialized expertise in leading end-to-end biomarker qualification submissions with the FDA and EMA.
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.
Regulatory Achievements
First-ever qualified endpoint in kidney transplantation
Led and authored iBox Scoring System as a secondary efficacy endpoint, resulting in an EMA Qualification Opinion.
CPATH
Only FDA reasonably likely surrogate endpoint with an accepted Qualification Plan in the FDA Biomarker Qualification Program
Led and authored DDT-BMQ-000097. Full Qualification Package is currently under Agency review.
CPATH
First FDA liaison engagement with CBER for CPA-1 Consortium
Established a precedent for regulatory collaboration in this rare disease area.
CPATH
What People Are Saying
“I worked closely with Amanda on the Qualification of the iBOX, a composite biomarker endpoint in kidney transplantation, by EMA and the Qualification Plan submission and acceptance by the FDA. She is results-oriented, rolls up her sleeves, and gets the work done with a sense of urgency. Uniquely, she also balances colleagues' needs and connects with team members in a personally meaningful way.
Few regulatory professionals have her experience with EMA endpoint qualification with EMA and Qualification Plan with FDA.”
— Bill Fitzsimmons, PharmD MSc, Founder, Tutela Pharmaceuticals Inc.; Adjunct Professor, Colleges of Pharmacy and Medicine at University of Illinois at Chicago, Former Executive Vice President, Regulatory Affairs, Clinical and Research Quality Assurance, Astellas Pharma Global Development, Inc
“As the developer of iBOX, I witnessed firsthand Amanda’s unique ability to navigate the complex intersection of science, regulation, and collaboration. She was a driving force in building the global partnerships and regulatory strategy necessary to advance iBOX from an academic achievement toward qualification as a reasonably likely surrogate endpoint, creating a pathway that could ultimately accelerate innovation for kidney transplant patients worldwide.”
— Alexandre Loupy, MD PhD, Director of PITOR (Paris Institut of Transplantation and Organ Regeneration)
Publications
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Modernizing the FDA Biomarker Qualification Program: Strengthening Regulatory Clarity and Broadening Biomarker Use in Drug Development. White Paper. Friends of Cancer Research. Published online June 4, 2026. https://friendsofcancerresearch.org/wp-content/uploads/Modernizing-the-FDA-Biomarker-Qualification-Program-Strengthening-Regulatory-Clarity-and-Broadening-Biomarker-Use-in-Drug-Development-White-Paper.pdf
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Klein A, Siegel J, Hoffmann S, et al. The Biomarkers Consortium: 20 years of advancing precision medicine. Nat Rev Drug Discov. Published online January 29, 2026. doi:10.1038/d41573-025-00187-8
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Klein A, Kosinski L, Loupy A, et al. Comparing prognostic performance of iBOX vs biopsy-proven acute rejection for long-term kidney graft survival. Am J Transplant. 2024; doi:10.1016/j.ajt.2024.04.004.
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Roufosse C, Naesens M, Haas M, Klein A, et al. Banff 2022 Kidney Meeting Work Plan: data-driven refinement of the Banff classification. Am J Transplant.2024;24(3):350–361.
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Klein A, Toll A, Stewart D, et al. Applying propensity methods to the U.S. transplant registry for external real-world evidence control arms. Am J Transplant. 2024;24(2):250–259.
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Klein A, Loupy A, Stegall M, et al. Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes. Am J Transplant. 2023;23(10):1496–1506.
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Klein A, Loupy A, Stegall M, et al. Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes. Transpl Int. 2023;36:11951. doi:10.3389/ti.2023.11951.
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Kosinski L, Frey E, Klein A, et al. Longitudinal estimated glomerular filtration rate (eGFR) modeling in long-term renal function to inform clinical trial design in kidney transplantation. Clin Transl Sci. 2023;16(9):1680–1690. doi:10.1111/cts.13579.
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Agyeman AS, Bandukwala A, Bouri K, Klein A, et al. US FDA public meeting: concepts and terminology for multicomponent biomarkers. Biomark Med. 2023;17(11):523–531.
Professional Experience
Founder & Principal Consultant at Biomarker Solutions LLC
Provides strategic regulatory science and consulting services to accelerate the development, qualification, and implementation of biomarkers and DDTs for decision-making.
Present
Clinical Instructor, Pharmacy Practice & Science at the University of Arizona, R. Ken Coit College of Pharmacy
Regulatory science elective rotation. 2024 Professional Achievement Award. Keynote Speaker, Class of 2027 White Coat Ceremony.
2014 - Present
Director, Biomarkers Consortium at the Foundation for the National Institutes of Health (FNIH)
Led multi-stakeholder initiatives advancing biomarkers and DDTs toward regulatory acceptance. Primary FDA/EMA liaison.
2024 - 2026
Executive Director & Scientific Director at the Critical Path Institute (C-Path)
Directed global consortia advancing regulatory-grade biomarkers and endpoints. Led FDA/EMA interactions, qualification submissions, and cross-sector program governance.
2019 - 2024