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.

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 desired effect
• Identify the PK/PD relationship

Proof of Concept (PoC)

• In Disease of Interest Patients, Phase 2 study
• Inform on indicative effectiveness of desired clinical activity
• Typically are short and involve a small number of patients
• PoC lack of statistical power
• High quality PoC study yield insight into drug interaction with patient’s physiology
• High quality reads-out enable highly educated Go/noGo decisions

Reach out today to learn more

Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.

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