From CAR T to CAR macrophage: The improvement of CAR cell therapy in solid cancer treatment The Chimeric Antigen Receptor T (CAR T) cell technology is a revolutionary therapy and has shown promising clinical response in cancer treatment. In 2017, anti-CD19 CAR T cell therapy against B cell malignancies was approved by US FDA. However, […]
We help to Identify areas of need or economic interest that can help companies find homes for treatments for rare diseases and precision medicine. Developing drugs for rare diseases and precision medicine indications can be rewarding, but navigating the challenges is not for the faint of heart. Expert guidance is essential in an area where […]
FDA guidance (March 2020 and updated July 2020) acknowledged that the impact of COVID-19 may require companies conducting clinical trials to consider virtual patient visits or put new processes in place regarding their current protocols. Since COVID 19 has changed many of our normal way to conduct Clinical research, most organizations reported some level of […]
Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements. Click the button below to learn more about how we have helped companies with their clinical trial needs.
The IND requires very detailed product and development data such as information related to manufacturing, data from nonclinical studies, and previous clinical studies related to the IMP. IND also requires a comprehensive source of documentation including study reports. It follows the CTD structure developed by ICH and is mandatory to be submitted in the eCTD […]
Confirmed cases reported from each country so far. Data from cruise ship outbreaks not included. SOURCE: ECDC
Worldwide, over 4,000 patients with Gaucher disease have received enzyme replacement treatment (ERT), which is safe and well tolerated. Gaucher disease is a rare disease caused by mutations in GBA1. GBA1 mutations drive extensive accumulation of glucosylceramide (GC) in immune cells in the spleen, liver, lung and bone marrow. Extensive GC storage induces complement-activating IgG […]
Retrophin’s experimental PKAN drug fosmetpantotenate fails phase III trial Pantothenate kinase-associated neurodegeneration (PKAN) is a rare disease characterized by a progressive neurodegenerative disorder and buildup of iron in the brain which is estimated to affect up to 5000 patients worldwide. PKAN is inherited in an autosomal recessive manner and is caused by mutations in the […]
In practice, for a given clinical trial, it is not uncommon to have 3–5 protocol amendments after the initiation of the clinical trial. One of the major impacts of many protocol amendments is that the target patient population may have been shifted during the process, which may have resulted in a totally different target patient […]
