MIAMI, FL – June 19, 2025 – bioaccess®, a leading contract research organization specializing in accelerated clinical trial pathways, today announced a strategic partnership with a premier Miami-based molecular diagnostics and theranostics center to deliver specialized first-in-human clinical trial services for radiopharmaceutical companies. This exclusive alliance positions bioaccess® as the only CRO offering integrated access to on-site cyclotron capabilities, multi-isotope production facilities, and FDA Exploratory IND designation pathways specifically designed for radiopharmaceutical development.
The radiopharmaceutical industry, valued at $13.21 billion in 2025 and projected to exceed $35.04 billion by 2034, faces significant challenges in accessing specialized clinical trial infrastructure. Most clinical research sites lack the essential on-site cyclotrons, hot cells, and radiation safety facilities required for radiopharmaceutical trials, forcing companies to rely on third-party suppliers that cause delays and quality control issues.
Through this partnership, bioaccess® now offers exclusive access to a Miami-based facility featuring an IONETIX ION-12SC cyclotron with dual clinical and research capabilities, multi-isotope production for Ga-68, Cu-64, and F-18 under one roof, and N-13 ammonia production capability – a service offered by only 16 centers in the United States. The integrated facility eliminates third-party dependencies while providing real-time dosimetry adjustment via PET/CT systems and proprietary MyoFlow™ software with 0.92 correlation to invasive coronary measurements.
The Miami-based partner facility has demonstrated exceptional performance across multiple clinical trial phases, including completion of 13 radiopharmaceutical trials spanning oncology, cardiology, and nuclear medicine applications. Notable achievements include six major PSMA-targeted radiopharmaceutical trials for prostate cancer, multiple first-in-human studies, and participation in multinational Phase 3 trials involving 52 global sites.
Key performance metrics that distinguish this partnership include a remarkable 94% patient enrollment rate among eligible patients compared to 63% at NIH sites, 48-hour diagnostic reports versus the 7-10 day industry average, and 14-month average translation from preclinical to human trials compared to the 22-month industry standard.
"After three decades in molecular imaging and cyclotron technology, I've witnessed the evolution of radiopharmaceutical development from experimental curiosity to mainstream therapeutic modality," said R. Rippin, Group CEO of the Miami-based partner organization. "What sets our collaboration with bioaccess® apart is the convergence of specialized nuclear medicine infrastructure with proven clinical trial expertise – we're not simply another imaging center attempting clinical research, but a purpose-built radiopharmaceutical development ecosystem."
Rippin continued, "The results demonstrate the value of this integrated approach: our FDA Exploratory IND designation enables accelerated pathways, our ADEPT framework reduces Phase 1 trial costs by 40% versus traditional designs, and our AI-driven adverse event prediction achieves 87% accuracy for enhanced safety optimization. For radiopharmaceutical companies seeking to compress development timelines while maintaining rigorous quality standards, this partnership delivers capabilities that simply don't exist elsewhere in the market."
The comprehensive service offering includes:
Infrastructure Advantages:
Regulatory Expertise:
Patient-Centric Operations:
This strategic alliance addresses a critical gap in the radiopharmaceutical development ecosystem, where companies previously faced limited options for specialized first-in-human trial sites. With over 121 radioligand therapy assets currently in development by more than 40 companies, and 40% of these assets in clinical development phases, the demand for specialized clinical research capabilities continues to accelerate.
The partnership particularly benefits small to mid-sized radiopharmaceutical companies that require access to sophisticated infrastructure and expertise typically available only to large pharmaceutical organizations. By offering shared-risk partnership models and integrated development pathways, bioaccess® enables innovative companies to advance their programs more efficiently and cost-effectively.
bioaccess® is a specialized contract research organization focused on accelerated clinical trial pathways for innovative medical technologies. With proven expertise across Latin America, Eastern Europe, Australia, and now the United States, bioaccess® delivers comprehensive clinical development services that reduce timelines and costs while maintaining the highest quality standards. The company's unique approach combines strategic geographic diversification with specialized therapeutic area expertise to optimize clinical development outcomes for biotechnology and pharmaceutical clients.
For more information about bioaccess® radiopharmaceutical clinical trial services, contact us by visiting https://www.bioaccessla.com/contact-us
This press release contains forward-looking statements regarding bioaccess®'s business prospects and clinical trial capabilities. Actual results may vary based on regulatory requirements, market conditions, and other factors.