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
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 challenges. SCIO allows for time and cost efficiencies, and risk mitigation. The BBCR team is armed with extensive clinical, regulatory […]
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 mechanisms is still in its relative infancy, scientists pursue understanding of neurodegenerative disease pathogenesis and development that paves identification of new potential therapeutic and treatment approaches. Neurodegenerative […]
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 […]
The publication suggesting a link between COVID-19 and Magnetism has been retracted.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 controlling the COVID-19 pandemic: Serpentinization-induced lithospheric long-wavelength magnetic anomalies in Proterozoic bedrocks in a weakened geomagnetic field mediate the aberrant […]
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 candidate as of November 8. On Monday, November 9th, the company announced […]
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, or even via the smaller aerosolized droplets capable of circulating in the air for long periods of […]
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 virus characteristics at the top of that specific check box list. One […]
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 been looking for alternatives to nasopharyngeal swabs since the early days of the pandemic. Recently, it has been […]
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 which is more than 80% of participants. Of all enrolled subjects, 10,025 have received the full vaccine. This mRNA-1273 Moderna’s vaccine consists of two shots – one delivered on day 1, and a booster shot that participants […]