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 […]
Boston Biotech Clinical Research (BBCR) works with biotech, pharmaceutical, and device companies to develop a clinical/regulatory roadmap consisting of simplified clinical programs, streamlined protocols, and cost-effective trials. 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.
We help to Identify areas of need or economic interest that can help companies find homes for treatments for rare diseases and precision medicine. 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 […]
A strategy that clearly marks the path to success creates opportunity to reduce risk. BBCR works with clients to achieve a successful pre-IND meeting by: Reviewing scientific data Setting regulatory strategy Setting integrated plan Creating messages and outlines Developing realistic Q&As Providing constructive critique
FDA guidance (March 2020 and updated July 2020) acknowledged that the impact of COVID-19 may require companies conducting clinical trials to consider virtual patient visits or put new processes in place regarding their current protocols. Since COVID 19 has changed many of our normal way to conduct Clinical research, most organizations reported some level of […]
Neuroblastoma is a childhood cancer that develops when immature nerve cells fail to develop into normal mature nerve cells. These tumors can begin anywhere in the body, but are often found in the abdomen or chest, neck, hips, and bone marrow. Despite intensive chemotherapy, neuroblastoma can be difficult to cure and the prognosis is often […]
Currently, there are two approved drugs to treat ALS: Riluzole, which can extend lifespan by an average of a few months and has been on the market for 25 years Edaravone, approved in 2017, which in clinical trials showed to help patients function for longer into their disease. Unfortunately, ALS is still a deadly disease […]
Last June 16, researchers announced that they’d seen an improvement in survival at 28 days after entry into the a large, randomized controlled trial for COVID-19 trial for the sickest patients who received the drug dexamethasone. These results, outcomes of 2,104 patients who received dexamethasone, are a logical solution to the immune system overreaction that […]
The IND requires very detailed product and development data such as information related to manufacturing, data from nonclinical studies, and previous clinical studies related to the IMP. IND also requires a comprehensive source of documentation including study reports. It follows the CTD structure developed by ICH and is mandatory to be submitted in the eCTD […]
Pediatric Rare diseases and Rare Pediatric Disease Designation FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified. Section 529 of the FD&C Act is intended to encourage development of new drug and biological products for the prevention and treatment of rare pediatric diseases. Section […]