Proof of Mechanism (PoM) Usually in Healthy Volunteers, Phase 1 study Essential for the selection of appropriate dose for PoC, disease model and biomarkers Investigate drug concentration at the target site of action Investigate drug engagement with target molecular receptor or enzyme (e.g. Receptor binding Investigate if drug biological response after target binding match the […]
Tagged: Drug Clinical Plans
The BBCR team designs Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies with the drug clinical plan and regulatory strategy in mind.
December 19th, 2019 | Drug Clinical PlansCategories
- Biomarkers & Surrogate Endpoints
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Recent Posts
- BBCR is highly experienced in developing innovative approaches to de-risk your product development during the early clinical development stage, including designing Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies. Learn more at bbcrconsulting.com #PoC #PoM #proofofconcept #proofofmechanism #earlyclinicaldevelopment #strategy
- BBCR partners with small and medium sized drug and device biotechnology firms. Our clients are clinical researchers and innovators looking for an efficient path to approval, and come to us from across the globe. Learn more about our consulting services at bbcrconsulting.com.
- From Preclinical through Phase I and POC studies, BBCR provides early clinical research services to enable informed, timely decision-making for our clients. We offer clinical, regulatory, translational, and biomarker consulting services that support our clients’ needs. Our process is designed to maximize time and cost efficiencies while mitigating risk.
- With Biomarkers a routine part of drug development, BBCR assists companies with the identification and adoption of biomarkers, especially valuable in rare disease and precision medicine product development.
- “The beginning is the most important part of the work.” — Plato. BBCR is dedicated to developing and nurturing a product’s unique strengths from conception to market. Our expertise with cell, biologics and gene therapy as they relate to rare disease is the cornerstone of our consultancy practice.