IQVIA (NYSE:IQV), a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, and Medera Inc. (“Medera”), a clinical-stage biopharmaceutical company pioneering next-generation therapeutics for cardiovascular disease, today announced a strategic collaboration to accelerate the development of cardiac gene therapies and human-based drug discovery platforms.

The collaboration brings together IQVIA’s global clinical trial and commercialization infrastructure with Medera’s pioneering platforms: Sardocor, focused on developing disease-modifying gene therapies for difficult-to-treat cardiovascular diseases, and Novoheart, a leader in engineered human-based cardiac tissue for disease modelling and drug screening.

Sardocor will leverage IQVIA’s regulatory and trial execution expertise to advance its FDA-cleared, first-in-human AAV-based gene therapy programs. IQVIA will support patient recruitment, data quality and regulatory filings, including applications for expedited FDA designations.

Novoheart’s mini-Heart platform is already instrumental in securing IND and Fast Track designations and offers a predictive, human-based alternative to animal testing. The platform is expanding into multiple organ systems to support drug discovery and safety testing under the FDA Modernization Act 2.0.

“By combining IQVIA’s global expertise with Medera’s mini-Heart platform and gene therapy programs, we can bring safer, more effective therapies to patients faster,” said Ronald Li, Co-Founder, Chairman & CEO of Medera. “This collaboration expands our reach, while reinforcing the scientific and regulatory momentum around human-based drug discovery and cardiac gene therapy innovation.”