BBCR Voice
From the Perspective of Researchers, Clinicians, and Regulatory Experts
The most efficient path in the clinical research process is a moving target. Technology innovation and regulatory requirements require constant updates. Through BBCR Voice, we aim to share not only our knowledge and expertise but also solutions to current challenges. BBCR embraces the challenges of developers and investors seeking a more straightforward path to market.
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Our CRO Management services reduce trial costs while achieving high data quality. BBCR takes a SCIO approach to CRO management that efficiently communicates back to senior management meeting the needs of the new economy and the needs of patients and shareholders.
BBCR takes a SCIO approach to CRO management that efficiently communicates back to senior management meeting the needs of the new economy and the needs of patients and shareholders. BBCR focuses on providing biotech and pharmaceutical companies with an assortment of...
With Biomarkers now a routine part of drug development, BBCR assists companies with the identification and adoption of biomarkers, especially valuable in rare disease and precision medicine product development.
The FDA recognizes biomarker development as a high priority area for future research. BBCR can help your company with your product development plan and validation. [button...
BBCR embraces innovative strategy consulting for effective clinical development plan and regulatory strategy. Reach out today to learn more about how we can help advance your project.
Our industry needs innovative strategies, and reduced-risk clinical trials. BBCR clinical development services and drug development consulting integrates real world evidence into clinical development plans and regulatory strategies. Focus must go to cost containment...
Small molecule mediated targeting provides alternative strategies for polypharmacology, systems biology and personalized medicine.
Most ongoing research and clinical programs have precision medicine at the core. BBCR can assist in a number of areas in relation to precision medicine, including small molecule research, including: Strategic drug assessment Early Clinical Development Regulatory...
The most efficient path in the clinical research process is a moving target. Biotech innovation and regulatory requirements require constant monitoring. Through BBCR Voice, we aim to share not only our knowledge and expertise, but also solutions to current challenges in the regulatory and research environments.
BBCR is dedicated to meeting the challenges of developers and investors seeking a clearer path to market. We invite you to bookmark our blog page and follow us across social media to keep abreast of timely and relevant topics in our industry. [button...
BBCR meets clients’ needs in the ever-changing regulatory environment. As specialists in Orphan and Personalized Medicine, BBCR helps clients identify areas of need or economic interest and helps them find homes for treatments for rare diseases and precision medicine.
BBCR helps orphan drug developers find direction in clinical trials involving biologics, biosimilars, small molecules, medical devices, and repurposing. BBCR consultants have the experience to guide you through the development process with a clinical plan and a...
Boston Biotech Clinical Research specializes in rare disease and works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process.
Our proprietary Strategic Clinical Innovation Organization (SCIO) concept was developed to address and maneuver around evolving challenges, allowing for time and cost efficiencies, and mitigating risk. BBCR works with clients in the areas of Biomarkers, Clinical...
BBCR can help you better understand the role Real World Evidence (RWE) plays for natural history in rare diseases
Knowledge of disease and its Natural History is an essential element of any clinical development program. Real-World Data (RWD) is data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources. Under the right...
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.
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. [button...
The BBCR team of experts works with clients to build a customized strategy in the areas of pre-clinical and clinical product development and regulatory affairs.
We believe that understanding the perspective, challenges, and needs of our clients allows us to serve as a trusted adviser throughout the clinical development process. BBCR clients are domestic and international, small and medium sized drug and device biotechnology...
Has Covid-19 hampered your clinical research projects? Let BBCR help jump start your product development initiative in order to achieve optimal product market positioning
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...
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 ensures time and cost efficiencies, and risk mitigation.
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...
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.
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...
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.
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...
Application of CAR Cell Therapy in Solid Cancer
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...
Electrographic Seizures and COVID-19
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...
Obesity Associated Gut Microbiota Alterations Worsen GVHD
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...
Recent Advance of Gene Therapy in Rare Diseases
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...
New Drug Approved in the Field of SiRNA-based Therapeutics Targeting Rare Disease
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...
COVID-19 Pandemic and Mental Health
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...
The Effect of Fecal Transplant on Melanoma
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...
Drug Development for Rare Duchenne Muscular Dystrophy (DMD)
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...
Mutants: the challenges of COVID 19 Vaccine
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...
Cell and gene advanced therapy in the Battle for Lysosomal Storage Disease
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...
BBCR offers innovative approaches to de-risk your product development during Early Clinical Development
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...