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.
Rare Disease
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.
September 22nd, 2021 | Rare DiseaseSmall molecule mediated targeting provides alternative strategies for polypharmacology, systems biology and personalized medicine.
September 7th, 2021 | Rare Disease
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 consultant FDA meeting and submission Pre-IND integrated development plan Clinical consultant Clinical study design and protocol CRO and […]
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.
August 2nd, 2021 | Rare Disease
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 regulatory strategy. Our team will empower you with medical insight, effective regulatory expertise, strategy, and streamlined early clinical […]
Boston Biotech Clinical Research specializes in rare disease and works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process.
July 20th, 2021 | Rare Disease
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 Research consulting, Regulatory Affairs, and Early Clinical Development. To learn more about how BBCR can help with your research […]
BBCR can help you better understand the role Real World Evidence (RWE) plays for natural history in rare diseases
July 13th, 2021 | Rare Disease
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 conditions, data derived from real world sources can be used to build Rare diseases […]
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 | Rare Disease
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.
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
June 16th, 2021 | Rare Disease
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 | Rare Disease
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 | Rare Disease
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 | Rare Disease
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, […]