Given the global Covid19 pandemic and the global nature of the pharmaceutical and biotech industry, key operational areas have and will continue to be impacted. As with any emergency response, the key to management is implementing mitigation plans. Early stage pharmaceutical and biotech companies need to be proactive in developing contingency plans to jump start […]
BBCR has developed an approach to meet the challenges of researchers and innovators seeking a clearer path to market. Flexible Road-Map Successful clinical development, for drug and medical device companies (small and large), requires an early strategy with a flexible road-map that makes it actionable and sustainable. Robust Clinical Data Customized Strategy and Road-Map allow […]
Drug repurposing acts to lower the need for early stage clinical trials and can help identify new uses for existing drugs. People tend to believe that a repurposed therapy can never be truly novel or transformative. Nothing could be further from the truth. One attractive option of Drug Repurposing is to use a scientific approach […]
The BBCR team designs Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies with the drug clinical plan and regulatory strategy in mind. Proof of Mechanism (PoM) Usually in Healthy Volunteers, Phase 1 study Essential for the selection of appropriate dose for PoC, disease model and biomarkers Investigate drug concentration at the target […]
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, […]
Electrographic seizures and other epileptiform patterns are common in patients with COVID-19 and associated with adverse outcomes By: Dr. Maria Niu There have been 137,866,311 confirmed cases of COVID-19, including 2,965,707 deaths in the world, according to the WHO reports of April 15, 2021(https://covid19.who.int). In addition to the typical pulmonary complication, neurological manifestations were also […]
Obesity-induced gut microbiome composition is linked with graft-versus-host disease (GVHD) in mice and human after allogeneic hematopoietic stem cell transplantation (HSCT) By: Dr. Maria Niu GVHD is a potentially severe immune disorder related to HSCT. In brief, the donor T cells recognize the recipient as non-self or foreign, therefore trigger a wide range of immune […]
Gene Therapy improved vision in patients with leber hereditary optic neuropathy (LHON) By: Dr. Maria Niu Mitochondria, powerhouses of eukaryotic cells, is a certain kind of cytoplasmic organelle and plays a critical role in energy production. Mitochondria dysfunction results in a broad spectrum of multisystem disorders. LHON is a mitochondrial neurodegenerative disease typically caused by […]
Lumasiran, a siRNA Therapeutic drug for primary hyperoxaluria type1(PH1) By: Dr. Maria Niu PH1 is a rare genetic disease caused by deficiency of the liver peroxisomal enzyme alanine:glyoxylate-aminotransferase (AGT), resulting in overproduction of oxalate. The clinical manifestation includes kidney stones, widespread organ damage, and kidney failure. Liver transplantation is applied in PH1 patients to provide the […]
The Lancet: 34% COVID-19 survivors have neurological and psychiatric disorders By: Dr. Maria Niu Previous case reports had described the altered mental problems and psychiatric disorders in people diagnosed with COVID-19 infection. In the latest study (https://doi.org/10.1016/S2215-0366(21)00084-5) reported by The Lancet Psychiatry on April 6, 2021, the authors confirmed a high incidence of neurological and […]