Preliminary results from an Israel-based study suggest that one dose of the Pfizer’s vaccine reduces viral load- a key factor in slowing virus spread. Several of the approved to market COVID-19 vaccines are over 90% effective in preventing disease. But no much data have been available about whether vaccinated individuals can still transmit the SARS-CoV-2 […]
Biomarkers are now a routine part of drug development The FDA recognizes biomarker development as a high priority area for future research. The FDA and European Medicines Agency (EMA) have developed similar processes for the qualification of biomarkers intended for use as companion diagnostics or for development and regulatory approval of a drug or therapeutic. […]
Multiple SARS-CoV-2 variants are circulating globally. Several new variants have emerged in the fall of 2020. Many variants are relatively unremarkable. But scientists have been keeping a close watch on three rapidly spreading variants—first identified in the UK, South Africa, and Brazil—which harbor an unusual constellation of mutations. They all share a mutation that affects […]
Moderna announced on January 25 plans for testing two different booster vaccines aimed at the SARS-CoV-2 variant B.1.351 that emerged in South Africa and has now spread to numerous countries. Moderna COVID-19 Vaccine produced neutralizing titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and Republic of South […]
Scientists report that gut microorganisms in COVID-19 patients were very different from those in uninfected individuals and lack of good bacteria that regulate our immune system. The presence of an abnormal gut bacteria persists after the virus is gone and may be responsible of the long-lasting symptoms in some patients. In addition, reduction of inflammation […]
Type1 diabetes usually develops in children or young adults and requires daily insulin to survive. Scientist report that patients with Type 1 diabetes who become infected with the COVID19 may develop a diabetes complication known as ketoacidosis. A study in 180 patients from across the United States with type 1 diabetes and COVID-19 included 43% […]
The immunosuppressive drugs Tocilizumab and Sarilumab improved survival and recovery time of intensive care of Covid-19 patients The UK government encourages (https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103134) the use of c and Sarilumab, medications initially developed to improve arthritis symptoms, to treat severe COVID-19 cases. The study, which has not yet been peer-reviewed, evaluating around 800 patients in intensive care […]
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 […]