BBCR’s mission is to deliver cost-effective clinical plans and regulatory strategies for cell and gene therapy programs in the areas of rare disease. Cell and Gene therapy are the new frontiers in the fight against devastating diseases, including rare diseases and...
Our selected services include expertise with Biomarkers & Surrogate Endpoints, Regulatory Affairs FDA & EMA, Medical Affairs & Clinical Research, Due Diligence, and Trial Management & Trial Rescue. BBCR’s Strategic Clinical Innovation...
We provide expert guidance for Orphan Drug Development by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements. BBCR is dedicated to supporting pharmaceutical innovators in the specialized...
Cell and Gene therapy are the new frontiers in the fight against devastating diseases, including rare diseases and cancers. Clinical trial results have been promising, and the next generation of Cell and Gene therapies holds tremendous promise for many patients and...
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...
Innovation in clinical research is a long-term need due to several factors, including the high failure rate and skyrocketing costs. Healthcare has been changing rapidly for many years. The COVID-19 pandemic has accelerated by helping drive the shift to value-based...
Innovation in clinical research is a long-term need due to several factors, including the high failure rate and skyrocketing costs. Several factors contribute to the skyrocketing cost of clinical trials. Integration of advanced technologies into drug development....
Our mission is to support domestic and international pharma, biotech, and device companies by nurturing their products’ strengths while improving efficiency and safety. We specialize in strategy and provide early clinical research services to enable informed, timely...
Rare Diseases are conditions that affect less than 200,000 people in the U.S. However, over 7,000 Rare Diseases affect more than 400,000,000 people worldwide, including ~25 million in the U.S. and ~30 million in Europe (1). In recent years, the number of orphan drugs...
While an early clinical strategy offers numerous advantages, it also comes with certain challenges that need to be considered: Limited Information: Limited information available about the investigational product can make it challenging. High Risk of Failure:...
