OUR STRATEGIC PARTNERS

TWIN CITY BIO

Manufacturing Partner

Twin City Bio is a cGMP compliant contract manufacturing and development organization dedicated to the manufacture of cell therapy products. Twin City Bio provides expertise from conception through production for clinical/commercial scale cell-therapy products including Bioprocess R&D, Manufacturing, Quality testing and release functions.

CTI CLINICAL TRIAL AND CONSULTING SERVICES

CRO Partner

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization.

CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. For more information visit ctifacts.com.

PPD, Inc.

.

Frenova

Frenova, a Fresenius Medical Care (FMC) company, supports sponsors and principal investigators conducting research specific to chronic kidney disease (CKD and ESRD) and it’s adjacent conditions, including rare diseases. We manage the world’s largest network of renal research assets, providing access to a global network of clinical trial resources including 350 research sites and 550 investigators. These resources, combined with our access to FMC’s data assets, provide unparalleled advantage to sponsors seeking to advance the science of renal therapies.

Scendea

Scendea is a leading product development and regulatory consulting practice serving the pharmaceutical and biotechnology industry. Scendea was founded as a result of a management buyout of the product development and regulatory consulting function of a clinical research organisation. Our origin dates back over 20 years, with involvement in over 1,000 development programmes. Scendea has team members based in the UK, Ireland, the Netherlands and the US.

Scendea’s expert team deliver strategic and operational support in the fields of quality/CMC, non-clinical/toxicology, clinical/medical and regulatory to successfully guide products from early development to marketing approval. A combination of scientific excellence, industry experience and commercial awareness allow our expert team to solve complex issues associated with medicinal product development, aligned to jurisdiction-specific regulatory requirements.

IQVIA

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Formed through the merger of IMS Health and Quintiles, IQVIA applies human data science — leveraging the analytic rigor and clarity of data science to the ever-expanding scope of human science — to enable companies to reimagine and develop new approaches to clinical development and commercialization, speed innovation and accelerate improvements in healthcare outcomes. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. With approximately 67,000 employees, IQVIA conducts operations in more than 100 countries.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.

Our partners work diligently with inRegen on our Phase II clinical trial.

Clinical Trials