Biomarkers are now a routine part of drug development In rare diseases and precision medicine, implementation of biomarkers during product translation into clinic and early clinical development, moves treatment to market faster.
Medical Affairs and Clinical Research
Identification and adoption of biomarkers are especially valuable in rare disease and precision medicine product development. BBCR can assist in developing your biomarker plan and validation process.
July 8th, 2021 | Medical Affairs and Clinical ResearchHas Covid-19 hampered your clinical research projects? Let BBCR help jump start your product development initiative in order to achieve optimal product market positioning
June 16th, 2021 | Medical Affairs and Clinical Research
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’s team of industry experts help our clients match treatments to rare genetic conditions and unsolved diseases, then work with a product developer on the best plan to market.
June 8th, 2021 | Medical Affairs and Clinical Research
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 […]
Boston Biotech Clinical Research uses innovative approaches to de-risk your product development. For our clients interested in Proof of Mechanism and Proof of Concept – PoM and PoC – BBCR has the expertise to ensure successful product development at any stage of development.
June 3rd, 2021 | Medical Affairs and Clinical Research
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 […]
Application of CAR Cell Therapy in Solid Cancer
June 1st, 2021 | Medical Affairs and Clinical Research
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, […]
Obesity Associated Gut Microbiota Alterations Worsen GVHD
May 19th, 2021 | Medical Affairs and Clinical Research
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 […]
Recent Advance of Gene Therapy in Rare Diseases
May 13th, 2021 | Medical Affairs and Clinical Research
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 […]
Cell and gene advanced therapy in the Battle for Lysosomal Storage Disease
April 8th, 2021 | Medical Affairs and Clinical Research
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 […]
BBCR has experience in biologics for rare diseases and can assist with the development of a targeted strategy to meet your study needs.
March 24th, 2021 | Medical Affairs and Clinical ResearchBiologic 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 or SCIO method enables our clients to save time, create cost efficiencies, and reduce risk on the path to achieving optimal product market positioning. Reach out to BBCR today to learn more.
March 17th, 2021 | Medical Affairs and Clinical Research
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 […]