BBCR Voice
From the Perspective of Researchers, Clinicians, and Regulatory Experts
The most efficient path in the clinical research process is a moving target. Technology innovation and regulatory requirements require constant updates. Through BBCR Voice, we aim to share not only our knowledge and expertise but also solutions to current challenges. BBCR embraces the challenges of developers and investors seeking a more straightforward path to market.
Recent Posts
Comparing Saliva Test to Swabs for COVID-19 diagnosis
Nasopharyngeal swabs are considered the gold standard to accurate test COVID19 infection. Unfortunately, these tests require specific supplies, some significant time for results, and place health care workers at risk of infection. Thus, clinicians and researchers have...
Covid-19 Vaccine trials are 80% enrolled
Moderna published (https://medcitynews.com/2020/09/moderna-publishes-phase-iii-covid-19-vaccine-study-protocol-as-trial-enrolls-more-than-80-of-participants/?rf=1) that the Phase III Covid-19 vaccine study protocol enrolled 25,296 of its planned 30,000 participants...
Promising news from drug combo for slowing ALS progression
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...
WHO recommends Steroid Treatment for Severe COVID-19
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...
COVID Vaccine Works in Macaques
Pfizer, a pharmaceutical company, in partnership with BioNTech has reported that its lead vaccine candidates has shown promising results in protecting monkeys against coronavirus infections. Pfizer ‘s experimental vaccine is different from other vaccine candidates....
Endangered animal species susceptible to COVID 19 infection
On August 24, PNAS – A very high risk of COVID 19 infection in primate species has been reported. Their analysis predicts that several critically endangered primate species are at very high risk of the virus, although the results need to be confirmed with further...
Three cytokines are tied to severe COVID-19
Blood-based immunological changes that are linked to the disease and, in some cases, to symptom severity were published in Nature Medicine Source: (https://www.nature.com/articles/s41591-020-1038-6). For a disease with such diversity of symptoms and outcomes, and in...
Boston Biotech Clinical Research specializes in rare disease, working with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process.
Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements. Click the button below to learn more about how we have helped...
Breakthrough Therapy Designation and Orphan drugs
A Priority Review designation does not alter the scientific/medical standard for approval or the quality of evidence necessary and it does not affect the length of the clinical trial period. Prior to approval, each drug marketed in the United States must go through a...
IND submission’s main objective is to obtain approval from FDA to perform clinical trials of an investigational medicinal product (IMP) in humans in the US.
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...
Why Bacterial Consortia May Stop C. diff. Recurrences – Dr. Candida Fratazzi, MD interviewed on Voice America for the C Diff Foundation
We were pleased to be invited by Nancy C. Caralla of the C Diff Foundation to this important discussion on the Voice America Radio Network about how Microbiome functions and how its changes impact our health. [button...
Pediatric Rare diseases and Rare Pediatric Disease Designation – Boston Biotech Clinical Research
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...
BBCR Consulting will attend the World Orphan Drug Congress USA 2020 August 24 – August 26
The World Orphan Drug Congress USA will be a live virtual conference. BBCR’s Team invites you to send an email at [email protected]/bbcr2. We hope to meet many of you that will attend the World Orphan Drug Congress. We are very much interested in learning about...
Long-Term effects of COVID 19 infection
Patients with mild COVID 19 infection, from a variety of age groups, were still experiencing major symptoms for months after COVID 19 disease is over. Read full article: https://jamanetwork.com/journals/jama/fullarticle/2768351 The Jama study was conducted in 143...
Decline of antibody (Ab) anti Covid19 within 60 days post infection
A transient neutralizing Ab (nAb) response is a feature shared by both COVID19 infection and the coronaviruses that cause common colds (https://www.medrxiv.org/content/10.1101/2020.07.09.20148429v1) Antibody (Ab) responses to SARS-CoV-2 can be detected in most...
Airborne SARS-CoV-2 Transmission – World Health Organization addresses the potential for airborne transmission of the coronavirus
SARS-CoV-2 outbreaks that cannot be explained by large droplets and contact with surfaces alone. Droplets from speech can float in air for eight minutes. A growing body of evidence suggests beyond any reasonable doubt that the virus spreads indoors through tiny...
Severe COVID-19 linked to a Genetic Region
Scientists launched studies in search of genes that could explain why some people infected with SARS-CoV-2 get really sick, while others have only mild symptoms. We know that chronic health conditions—such as hypertension and diabetes can play a role, but there are...
Developing Drugs Able to Treat Neurological Disease – Boston Biotech Clinical Research
Techniques that bypass or trick the guardian of the central nervous system. Developing drugs that can penetrate into the brain requires some creativity. The approaches vary, each technique comes with its benefits and drawbacks, making it appropriate for some patients...
Early loss of COVID-19 antibodies! …Plus hope for good news from the several vaccines currently in development.
Preliminary data suggest that survivors of SARS-CoV-2 infection may be susceptible to reinfection within weeks or months. One study in ~1,500 COVID patients show that 10 percent % of these patients had undetectable antibody levels within weeks of first symptoms or...
Artificial intelligence Diagnostic tool for COVID-19 and Neurodegenerative Diseases
Lesions in the lungs of patients with pneumonia caused by a SARS-CoV-2 infection are distinct from those caused by bacteria. SARS-CoV-2 is known to damage lung tissue as many COVID-19 patients develop pneumonia, which can progress to respiratory failure and sometimes...
Drug repurposing acts to lower the need for early stage clinical trials and can help identify new uses for existing drugs.
People tend to believe that a repurposed therapy can never be truly novel or transformative. Nothing could be further from the truth. One attractive option of Drug Repurposing is to use a scientific approach to identify new uses for existing drugs. About a third of...
Biologic treatments show promise in providing clinical solutions to a variety of diseases. BBCR can assist with the development of a targeted strategy to meet your study needs.
BBCR's team has experience in biologics for rare diseases including rare cancers and precision medicine and can help develop a targeted strategy including studies with fewer patients to control safety issues. Services include: Indications analysis and prioritization...
BBCR Streamlines Clinical Development with the Clinical and Regulatory Expertise to Support Your Development Needs
BBCR Consulting offers world-class regulatory, clinical research, and biomarker consulting services that provide high-value, and support our clients’ operational and functional needs. Our process is designed to maximize time efficiencies, risk mitigation, and cost...
The future of Orphan Drug Clinical Trials
Biotech companies' continued participation in the Global Orphan Drug Market Opportunity requires the development of new strategies rooted in the established knowledge of orphan developer experts. Participation of big pharmaceutical companies in the ongoing clinical...
First Coronavirus deaths reported in indigenous communities that live in Amazonia (National Geographic).
At least 28 communities living in extreme isolation in the Brazilian Amazon, and there may be as many as 80 more, have confirmed to be in existence. On April 9, a Yanomami adolescent had died of COVID-19 in the northern state of Roraima. The youth had moved back and...