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A Systematic Approach To Extractables And Leachables: A Review Of Guidance From The Industry
HI Bio is a clinical stage biotechnology company focused on the development of targeted therapies for patients with immune mediated diseases (IMDs).
OrphoMed is a San Francisco based clinical stage pharmaceutical company focused on the development of novel first-in-class dimer conjugates with superior therapeutic profiles. The company is leveraging its proprietary dimer platform technology to address the issues of visceral hypersensitivity and hypermotility in functional gastrointestinal disorders. OrphoMed dimers are protected by composition of matter and method of use patents.
Tobira Therapeutics is a clinical-stage biopharmaceutical company developing cenicriviroc (CVC), an oral potent dual inhibitor of chemokine receptors CCR2 and CCR5. Tobira is initiating a Phase 2 clinical trial of cenicriviroc for the treatment of Nonalcoholic Steatohepatitis (NASH), a leading cause of cirrhosis and liver transplant. The company has also completed a Phase 2b clinical trial of cenicriviroc in 143 HIV-infected subjects, and the compound is positioned for Phase 3 studies as a novel, once daily, fixed-dose cenicriviroc/lamivudine backbone as part of combination HIV therapy. Tobira is backed by a syndicate of leading life science investors including Domain Associates, Frazier Healthcare Ventures, Montreux Equity Partners, Novo Ventures and Canaan Partners.
KemPharm is a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs that are designed to be improved versions of widely prescribed, approved drugs. Developing and encouraging a unique creativity, leveraged throughout the process of scientific discovery is the foundation of our corporate culture. At KemPharm we employ our Ligand Activated Therapy (LAT™) platform technology to create prodrugs that are new molecules which can improve one or more of the attributes of approved drugs, such as susceptibility to abuse, bioavailability and safety. We create new prodrugs by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug. When combined with the parent drug, our ligands create prodrugs designed to have improved drug attributes while maintaining efficacy equivalent to the parent drug. Once administered, targeted human metabolic processes, such as those in the GI tract, separate the ligand from the prodrug and release the parent drug, which can then exert its therapeutic effect. KemPharm has employed its LAT™ prodrug platform to create a diverse pipeline of prodrug therapeutics that target large market opportunities in pain, attention deficit hyperactivity disorder (ADHD) and other central nervous system indications.