Fecal microbiota transplantation (FMT) promotes the response of check point inhibitors (CPI) to melanoma patients By: Dr. Maria Niu Fecal microbiota transplantation (FMT) is a procedure that delivers fecal bacteria and other microbes from a healthy individual into another individual with various diseases or disorders. It has been recently tested in infection, immune conditions, and […]
Progress and limitation of therapeutic approaches targeting DMD By: Dr. Maria Niu Duchenne muscular dystrophy (DMD) is an X—a chromosome-linked recessive disorder caused by mutations in the gene coding muscle cytoskeletal protein dystrophin. Because of the X-linked inheritance, nearly 1 in 3,500 males are affected worldwide, while females occasionally develop symptoms. There is no curative […]
True or false: Virus variants weaken the effectiveness of COVID 19 Vaccine Coronavirus vaccines have significantly reduced the infectiousness of COVID 19 cases and showed significant protective efficacy against COVID 19. However, the recent reported COVID19 variants B.1.1.7 in the UK and B.1.351 in South Africa are of concern because of their more accessible and […]
Emerging cell and gene therapy may offer sustained long-term correction for LSD patients Dr. Maria Niu Lysosomal storage diseases (LSDs) are rare inherited metabolic diseases and characterized by the accumulation of substrates in excess in various organs’ cells due to lysosomes’ defective functioning. The combined incidence of LSDs is between 1 in 5000 to 1 […]
Depending on your project goals, our consultants work with you to design cost-effective early clinical studies that hold potential for reducing Phase III failures. Our services include: POM & POC Translational Research Clinical Plan & Study Design Phase 1 & 2 Protocol Development Medical Monitors Study Management
Biologic treatments show promise in providing clinical solutions to a variety of diseases including rare cancers and precision medicine. Services include: Indications analysis and prioritization Strategic drug assessment Clinical study design and protocol Biomarker strategy Early Clinical Development FDA meeting and submission Pre-ND integrated development plan CRO and project management Study remediation and rescue […]
Our Strategic Clinical Innovation Organization (“SCIO”) method enables our clients to save time, create cost efficiencies, and reduce risk on the path to achieving optimal product market positioning. The Strategic Clinical Innovation Organization (SCIO) concept developed by BBCR was designed specifically to help pharmaceutical innovators address the concerns and maneuver around evolving challenges. SCIO allows […]
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. BBCR Consulting offers world-class regulatory, clinical research, and biomarker consulting services that provide high-value, and support our clients’ operational and functional needs. Our process is designed […]
Expertise in integration of in vitro and in vivo analysis during early clinical research is a critical development milestone for efficient candidate development. In addition, the BBCR team guides in identifying the right target, the right biomarker, the right safety, the right patients and the right commercial potential. BBCR can assist clients across a variety […]
Biomarkers are considered a routine part of drug development. Learn more about how BBCR can help get your product to market more efficiently with proper plan development and strategy. Plan Development Insightful strategy is the most effective way to ensure quality when including biomarkers into your product development plan. Validation or Qualification Understanding where […]