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 has experience in biologics for rare diseases and can assist with the development of a targeted strategy to meet your study needs.
Biologic treatments show promise in providing clinical solutions to a variety of diseases including rare cancers and precision medicine. Services include: Indications analysis and prioritization Strategic drug assessment Clinical study design and protocol Biomarker...
Our Strategic Clinical Innovation Organization or SCIO method enables our clients to save time, create cost efficiencies, and reduce risk on the path to achieving optimal product market positioning. Reach out to BBCR today to learn more.
Our Strategic Clinical Innovation Organization (“SCIO”) method enables our clients to save time, create cost efficiencies, and reduce risk on the path to achieving optimal product market positioning. The Strategic Clinical Innovation Organization (SCIO) concept...
Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to help 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. BBCR Consulting offers world-class regulatory, clinical research,...
Depending on your project goals, BBCR can work with you to design cost-effective early clinical studies that hold potential for reducing Phase III failures.
Expertise in integration of in vitro and in vivo analysis during early clinical research is a critical development milestone for efficient candidate development. In addition, the BBCR team guides in identifying the right target, the right biomarker, the right safety,...
In rare diseases and precision medicine, implementation of biomarkers during product translation into clinic and early clinical development moves treatment to market faster. BBCR is experienced in helping you understand the role of biomarkers and how to move your product to market more efficiently.
Biomarkers are considered a routine part of drug development. Learn more about how BBCR can help get your product to market more efficiently with proper plan development and strategy. Plan Development Insightful strategy is the most effective way to ensure quality...
Covid-19 vaccine reduces infectiousness—a key factor in slowing virus spread.
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...
Identification and adoption of biomarkers are especially valuable in rare disease and precision medicine product development. Learn more about how BBCR can help.
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...
New Spike Mutants from SARS-CoV-2
Multiple SARS-CoV-2 variants are circulating globally. Several new variants have emerged in the fall of 2020. [button...
Moderna COVID-19 Vaccine Protects Against New COVID Variants
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...
COVID-19 Severity and Immune Response Tied to Gut Bacteria
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...
Diabetes Type 1 adds to COVID-19 Risks
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...
Arthritis Drugs for Critically Ill COVID-19 Patients
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,...
BBCR designs Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies with the drug clinical plan and regulatory strategy in mind.
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...
From Project to Proposal to Results – Learn how BBCR has worked with clients in the Biotech field to find success with their pre-clinical strategy needs.
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,...
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...