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Avellino Lab USA is the first and only lab in the United States performing commercial genetic testing for Avellino Corneal Dystrophy.
Brammer Bio is focused on providing clinical and commercial supply of autologous and allogeneic cell therapies, and viral vector products for in vivo and ex vivo therapeutic applications. Along with process and analytical development and regulatory support we enable large pharma and biotech clients to accelerate the delivery of novel medicines and improve patient health. Brammer Bio occupies 45,000 ft2 of process development and phase I/II clinical manufacturing space in Alachua, FL, and is developing a 50,000 ft2 facility in Lexington, MA, with plans to build-out large-scale, phase III/commercial ready viral vector manufacturing suites, segregated cell and gene therapy suites, and QC and analytical laboratories for clinical and commercial launch services.
Just. is an integrated design company focused on the technology of biotherapeutics, from molecule to manufacturing plant. We believe that technological innovation will accelerate biotherapeutic development and dramatically reduce the cost of these vital medicines.
AuraSense Therapeutics (AST) is a biopharmaceutical company developing first-in-class therapies based upon its proprietary Spherical Nucleic Acid (SNA) gene regulation and immune modulation strategies. AST is leading the translation of SNA constructs as innovative medicines with a core focus on debilitating diseases with limited or no treatment options. AuraSense Therapeutics' uniquely engineered SNA™ constructs possess attractive biocompatibility and versatility as therapeutics and hold great promise for combating the most life-threatening diseases, including many forms of cancer, infectious disease, and skin conditions.
Vital Therapies, Inc. is a biotherapeutic company focused on developing a cell-based system for the treatment of acute liver failure. Our product candidate, the ELAD® System, is a human cell-based, bio-artificial liver support system that operates outside the body, or extracorporeally, and is designed with the proposed intent to allow the patient’s own liver to regenerate to a healthy state, or to stabilize the patient until liver transplant. The ELAD System incorporates our human liver-derived cells, or VTL C3A cells, contained in four hollow fiber cartridges, that are combined with single use customized disposable sets and an ancillary delivery system. Data from ELAD clinical studies has shown trends that may indicate a potential to increase survival rates in patients with acute liver failure. ELAD has received orphan designation in the United States and Europe for the treatment of acute liver failure. Prior to the initiation of our ongoing Phase III clinical trial program, over 145 subjects have received therapy with the ELAD System in seven clinical trials and through a compassionate use program, which we believe collectively suggests a promising therapeutic profile. In March 2013, we initiated VTI-208, a Phase III randomized, controlled clinical trial in 200 subjects with alcohol-induced liver decompensation. We reached the midpoint in enrollment of this trial in April 2014, and anticipate the release of preliminary data in the first half of 2015. In addition, we are conducting a second Phase III randomized, controlled clinical trial, VTI-210, in 150 subjects with severe acute alcoholic hepatitis, or AAH, which is a subset of AILD, and expect to initiate enrollment of subjects later in 2014. In the second quarter of 2014, we began enrollment of a Phase II clinical trial of the ELAD System in subjects with either fulminant hepatic failure, or FHF, or surgery-induced acute liver failure, or SILF. We anticipate the release of data from VTI-210 in 2016 and the Phase II component of VTI-212 in 2015 or 2016.