If you’re interested in learning more about drug repurposing to treat rare disease, BBCR can help with your regulatory consulting needs. We offer expertise in the following areas: FDA meeting and submission Pre-IND integrated development plan Clinical consultant Clinical study design and protocol CRO and project management Study remediation and rescue
Our Boston-based, integrated, boutique consulting team specializes in rare disease and orphan indications, and is dedicated to supporting pharmaceutical innovators and nurturing each product’s strengths. The BBCR mission is to simplify clinical research, encourage cost-effective trials, and help innovators navigate through the regulatory process.
A strategic approach creates opportunity for time efficiencies The Orphan Drug Act is an important piece of legislation that uses financial incentives to encourage the development of drugs that treat rare diseases and precision medicine impacting disease sub-populations. BBCR’s team of experts can help your company create a roadmap specially customized to ensure successful product […]
Read more about BBCR’s Streamlined Clinical Development Strategies in DigiTech Insight
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 […]
Duchenne Muscular Dystrophy is the most common fatal genetic disorder to affect children around the world. The first patient, a six year old boy, received, in November 2021, an infusion of DT-DEC01, a novel cell therapy containing Dystrophin Expressing Chimeric Cells (DEC), in Phase I pilot clinical study for the treatment of Duchenne muscular dystrophy (DMD). […]
BBCR specializes in the strategy and delivery of early-phase clinical development services to enable informed, timely decision making for our clients. 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 site of action Investigate […]
From the beginning, pharmaceutical companies engaged in the development of COVID-19 vaccine were aware that to defeat the pandemic they had to address proactively virus variants. Moderna in a Nov. 2021 press release (https://investors.modernatx.com/news/news-details/2021/Moderna-Announces-Strategy-to-Address-Omicron-B.1.1.529-SARS-CoV-2-Variant/default.aspx) stated that a 100-µg booster dose of the Moderna approved COVID-19 vaccine is studied for protection against the Omicron variant. In addition, the […]
The FDA reviewed data from Israel from children 12–15 years old who received a booster five months after the primary Pfizer-BioNTech COVID-19 vaccine and is amending the Emergency Use Authorization (EUA) to allow the booster five months after the primary two-dose vaccination for children aged 12–15. In addition, real-world data that has become available provide […]
Several SARS-CoV-2 variants have been identified since the beginning of the COVID-19 pandemic: Alpha (B.1.1.7 and Q lineages) Beta (B.1.351 and descendent lineages) Gamma (P.1 and descendent lineages) Epsilon (B.1.427 and B.1.429) Eta (B.1.525) Iota (B.1.526) Kappa (B.1.617.1) 1.617.3 Mu (B.1.621, B.1.621.1) Zeta (P.2) On November 30, 2021, the U.S. government SARS-CoV-2 Interagency Group (SIG) […]