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) […]
Depending on your project goals, our consultants’ work with you to design cost-effective early clinical studies that holds potential for reducing Phase III failures. Our team of consultants can assist in the areas of: POM & POC Translational Research Clinical Plan & Study Design Phase 1 & Phase 2 Protocol Development Medical Monitors Study Management […]
BBCR provides expert market guidance and embraces innovative strategy consulting for effective clinical development plan and regulatory strategy. Developing drugs for rare diseases and precision medicine indications can be rewarding, but navigating the challenges is not for the faint of heart. Expert guidance is essential in an area where the patients are few, lack of […]
We aim to transform the transition stage between pre-clinical and clinical endpoints with smart strategy that, at a minimum, redirects the costs to benefit patients. The FDA has been calling for a smarter, more innovative approach, and we believe SCIO is the integrative, multidisciplinary approach to deliver it. Why SCIO? Investing in Strategy Accelerate Patient […]
According to recently released data, 12 out of the 28 drugs approved in the first quarter of 2020 by the FDA were repurposed drugs. The drug repurposing approval process is an effective tool that accelerates the development of drugs for new indications or drug reformulation. In addition, the development of drug repurposing compared to a […]