Physicians-Owned Circles For Rare Diseases
April 21, 2025
Physicians-Owned Circles For Rare Diseases
RegenMed’s Physicians-Owned Circles (POCs) offer an innovative solution to some of the most significant challenges in rare disease research. Rare diseases — of which there are approximately 7,000 — affect 350 million people globally, including 25 million Americans. Shockingly, 95% of these conditions have no approved treatments, and one-third of the 15 million U.S. children affected will not live past age five. The financial burden is equally staggering, with costs estimated at 15 times those of more common diseases.
POCs are physician-led collaborations focused on indication- and treatment-specific observational studies. Each POC operates under an Observational Protocol (OP) tailored to a specific anatomy, pathology, and treatment, with longitudinal outcomes tracked over time. All data generated are compliant with HIPAA, GDPR, and FDA Part 11 standards, ensuring the highest levels of quality, security, and clinical relevance.
For physicians, POCs offer the opportunity to collaborate globally with peers, achieve earlier and more accurate diagnoses, follow evidence-based protocols, and engage patients more deeply. Members also share 85% of licensing revenues generated from the data, while gaining professional opportunities for publishing research and presenting at conferences.
Industry stakeholders — such as pharmaceutical companies, clinical researchers, and value-based care organizations — also benefit. POCs provide access to validatable, clinically relevant datasets at a fraction of traditional costs. The data supports regulatory submissions, enables adaptive trial designs without placebo arms, and enhances post-market surveillance, all while minimizing risks like data gaps and ownership disputes that are common in “big data” solutions.
By enabling multi-center, global collaboration with clear clinical hypotheses and real-world outcomes, RegenMed’s POCs are poised to accelerate innovation, improve patient outcomes, and transform the economics of rare disease research.
For more information, contact us at Contact@rgnmed.com.
Physicians-Owned Circles For Rare Diseases
April 21, 2025
RegenMed’s Physicians-Owned Circles (POCs) offer an innovative solution to some of the most significant challenges in rare disease research. Rare diseases — of which there are approximately 7,000 — affect 350 million people globally, including 25 million Americans. Shockingly, 95% of these conditions have no approved treatments, and one-third of the 15 million U.S. children affected will not live past age five. The financial burden is equally staggering, with costs estimated at 15 times those of more common diseases.
POCs are physician-led collaborations focused on indication- and treatment-specific observational studies. Each POC operates under an Observational Protocol (OP) tailored to a specific anatomy, pathology, and treatment, with longitudinal outcomes tracked over time. All data generated are compliant with HIPAA, GDPR, and FDA Part 11 standards, ensuring the highest levels of quality, security, and clinical relevance.
For physicians, POCs offer the opportunity to collaborate globally with peers, achieve earlier and more accurate diagnoses, follow evidence-based protocols, and engage patients more deeply. Members also share 85% of licensing revenues generated from the data, while gaining professional opportunities for publishing research and presenting at conferences.
Industry stakeholders — such as pharmaceutical companies, clinical researchers, and value-based care organizations — also benefit. POCs provide access to validatable, clinically relevant datasets at a fraction of traditional costs. The data supports regulatory submissions, enables adaptive trial designs without placebo arms, and enhances post-market surveillance, all while minimizing risks like data gaps and ownership disputes that are common in “big data” solutions.
By enabling multi-center, global collaboration with clear clinical hypotheses and real-world outcomes, RegenMed’s POCs are poised to accelerate innovation, improve patient outcomes, and transform the economics of rare disease research.
For more information, contact us at Contact@rgnmed.com.
