Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.
With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings.
Our operations are strategically located in:
Lincoln, Nebraska (Corporate Headquarters)
Philadelphia, Pennsylvania
Phoenix, Arizona
Belfast, Northern Ireland,UK
Zurich, Switzerland
Vienna, Austria
Richmond, Virginia
Montreal, Quebec, Canada
For more information, visit: www.celerion.com
Organogenesis™ is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care.
Mesoblast (ASX:MSB; Nasdaq:MESO) is developing and commercializing allogeneic cellular medicines to treat serious and life-threatening inflammatory diseases with significant, unmet medical needs.
The Company's Phase 3 off-the-shelf mesenchymal lineage cell product candidates are:
• RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GVHD)
• Remestemcel-L for moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection
• REVASCOR® for advanced chronic heart failure, and
• MPC-06-ID for chronic low back pain due to degenerative disc disease.
The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast’s approach to product development is to ensure rigorous scientific investigations are performed with well-characterized cell populations in order to understand mechanisms of action for each potential indication. Extensive preclinical translational studies guide clinical trials that are structured to meet stringent safety and efficacy criteria set by international regulatory agencies. All trials are conducted under the continuing review of independent Data Safety Monitoring Boards comprised of independent medical experts and statisticians.
Mesoblast has an extensive patent portfolio comprising approximately 1,000 patents and patent applications with protection extending through 2040 in all major markets. This intellectual property portfolio covers composition of matter, manufacturing, and therapeutic applications of mesenchymal lineage cells. The Company believes this patent estate provides strong global protection.