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
BBCR Specializes in Orphan and Personalized Medicine helping orphan drug developers find direction in clinical trials involving biologics, biosimilars, small molecules, medical devices, and repurposing.
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...
BBCR can help with your Pre-ind Integrated Development Plan
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...
BBCR’s Innovation strategy consulting includes a clinical development plan service integrated into regulatory strategy which is supported by the proprietary SCIO method
Strategic Clinical Innovation Organization (SCIO) – A Clear Path to Approval The Strategic Clinical Innovation Organization (SCIO) concept developed by BBCR was designed specifically to help pharmaceutical innovators address the concerns and maneuver around evolving...
Neurodegenerative Diseases: In Pursuit of a Cure
Neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, and others, cause neuronal degradation, resulting in progressive brain function deterioration. Although our understanding of neurodegenerative disease...
Impact of COVID 19 on the future of Rare Diseases and Oncology Clinical Trials
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...
Is COVID-19 linked to Magnetism?
The publication suggesting a link between COVID-19 and Magnetism has been retracted. The study, published in a peer-reviewed journal, has attracted widespread derision from researchers. The study titled “Can Traditional Chinese Medicine provide insights into...
Closer to a COVID-19 vaccine with over 90% effectiveness
Early Phase III data from Pfizer and BioNTech BNT162b2 is the experimental mRNA-based vaccine candidate from Pfizer and BioNTech's in Phase III study. Since June, 43,538 participants have been enrolled to date, 38,955 of whom have received a second dose of the vaccine...
Droplet sizes transmit COVID 19 infection
Observational data suggest that SARS-CoV-2 spreads between people at short distances. SARS-CoV-2 may spread by the primary method of transmission of the SARS-CoV-2 virus—via relatively large respiratory droplets, which fall quickly to the floor under their own weight,...
Durability of antibodies support validity of vaccination anti COVID19
The big question on COVID 19 is about the nature and durability of the antibodies against the virus that people develop after infection. Previous reports have suggested that anti-COVID19 antibodies sharply decline following recovery from the clinical symptoms of the...
What Gives Viruses Pandemic Potential
In 2002–03, the SARS virus infected 8,000 people in more than two dozen countries and killed almost 800. Infectious disease specialists created a specific check box list to identify viruses to watch out for pandemic potential in the future. Two are very important...
Orphan drug for rare cancers: New therapies for Neuroblastoma
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...
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 info@nisse.serpcom.com/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...