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Syner-G BioPharma Group is the premier solution provider of Chemistry, Manufacturing, and Controls (CMC) services for the life sciences industry. The company`s approach is based on CMC 360™, a fully integrated suite of CMC solutions that encompasses pharmaceutical development, regulatory affairs, and quality/cGxP compliance. The entire Syner-G organization is built around the premise of guiding small molecule, biologics, cell and gene therapy, and medical device innovators through the CMC process.
Cognito Therapeutics is a pioneer in non-invasive neuromodulation to treat neurodegenerative diseases and improve human cognitive performance. The company has completed multiple clinical studies demonstrating its investigational therapeutic has the potential to safely slow or stop cognitive decline and loss of brain volume in Alzheimer`s disease. Cognito has received FDA Breakthrough Device Designation for the treatment of Alzheimer`s disease and expects to start pivotal studies in 2022. The company`s technology was based on pioneering optogenetics research by scientific co-founders Professors Li-Huei Tsai and Ed Boyden at MIT.
Global CMO for medical device & component manufacturing
Tricida, Inc., is a pharmaceutical company focused on the development and commercialization of its drug candidate, TRC101, a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). Metabolic acidosis is a chronic condition commonly caused by CKD that is believed to accelerate the progression of CKD, increase the risk of muscle wasting and cause the loss of bone density. Tricida has successfully completed all of the clinical trials that it planned to complete prior to submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), including a successful 135-subject, Phase 1/2 clinical trial (TRCA-101), a successful 217-subject, pivotal Phase 3 clinical trial (TRCA-301), and a successful 196-subject, Phase 3 extension trial (TRCA-301E). We plan to submit an NDA, in the second half of 2019, seeking approval of TRC101 through the FDA`s Accelerated Approval Program. Tricida was founded in August 2013 by a seasoned management team that has extensive experience in the development and commercialization of therapeutics, with substantial expertise in developing polymers for the treatment of kidney-related diseases. Tricida`s shared culture of teamwork, camaraderie and empowerment is evident in the dedication and focus our team demonstrates, with a commitment to the ultimate goal of improving and prolonging the lives of people living with CKD, and bringing critically needed new therapies to patients.
DMD Pharmaceuticals is a Noblesville, IN-based company in the Healthcare, Pharmaceuticals, and Biotech sector.