Real World Evidence

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How soon can a vaccine can be tested in Clinical trials? #clinicaltrials

March 13th, 2020 | Real World Evidence

How do viral genomes’ sequences from swabs taken from infected patients help you build a family tree of the virus? Random mutations in the SARS-CoV-2 pathogen’s genome help researchers track the spread and transmission of COVID-19, the disease it causes. Source: News & Opinion Articles | The Scientist Magazine®

How to shape clinical plan and study design to test how microbiome shapes immunity.

February 27th, 2020 | Real World Evidence

The gut microbiome serves many useful functions in the body, but it can also rev up the immune system in harmful ways. Zit has been pustulated that Diet can influence the microbiome and the mucosal immune response. In the paper: “Diet modulates colonic T cell responses by regulating the expression of a Bacteroides thetaiotaomicron antigen,” Sci Immunol, 4:eaau9079, […]

Innovative therapies clinical plan requires understanding Why Immune Cells Extrude Webs of DNA and Protein

February 25th, 2020 | Real World Evidence

Today, it is widely accepted that NETs have both a protective and a pathological impact on the host. When neutrophils encounter pathogens, not only engage in phagocytosis and degranulation, they also release neutrophil extracellular traps (NETs) In CANCER, NET-associated proteins lead to reawakening of dormant cancer cells and convert them to proliferating metastatic cells. In […]

Clinical plan and trial design challenges to develop new cancer treatment that modulate neutrophil extracellular traps (NETs)

February 14th, 2020 | Real World Evidence

Neutrophils use an enzyme called neutrophil elastase (NE) to cleave bacteria. Human neutrophils release NE which looks like a fibrous structure like webs. These webs, able to trap bacteria, are called neutrophil extracellular traps (NETs). These webs are constituted of NE, other proteins, and copious amounts of DNA. It is important to keep in mind […]

Head off the 2019-nCoV pandemic: Clinical plan for a possible therapy.

January 29th, 2020 | Real World Evidence

We’ve had a few events where they’ve jumped from animals into people. There’s a lot being done on how coronaviruses infect people from animals. We know the real key is to know what the host cell receptor is—that’s the protein on the surface of cells that viruses bind to and invade. For SARS coronavirus, the […]

2019 Successful Clinical Plan and Drug Development Stories

January 27th, 2020 | Real World Evidence

Gene therapies for disorders such as X-linked Severe Combined Immunodeficiency (SCID, sometimes known as “bubble boy disease”), and Spinal Muscular Atrophy (SMA) have, for the first time, shown remarkable safety and efficacy results in clinical trials. FDA approved Trikafta, a gene-based therapy creating hope for children with cystic fibrosis and Zolgensma, a gene therapy drug, […]

Experience in rare disease and enzyme replacement treatment may help clinical plans for Parkinson’s disease: Lysosomal Dysfunction – A Parkinson’s-Gaucher Link?

January 17th, 2020 | Real World Evidence

Worldwide, over 4,000 patients with Gaucher disease have received enzyme replacement treatment (ERT), which is safe and well tolerated. Gaucher disease is a rare disease caused by mutations in GBA1. GBA1 mutations drive extensive accumulation of glucosylceramide (GC) in immune cells in the spleen, liver, lung and bone marrow. Extensive GC storage induces complement-activating IgG […]

Potential Clinical Plans for Gene Therapies in Rare Disorders

January 9th, 2020 | Real World Evidence

BBCR Consulting, for the first time this year, decided to attend the European edition of the Gene Therapies in Rare Disorders conference in London UK. In our opinion, the event, as promised, proved to be: ”…uniquely focused conference that will bring the leaders in the field together to discuss the critical factors involved in driving […]

Challenges in autoimmune disease clinical plans

January 3rd, 2020 | Real World Evidence

Autoimmunity occurs when the body is unable to differentiate “self” from “non-self” which results in overactive immune response against own cells and tissues. Autoimmune diseases affect 5 %-8% of the population; 78% affected are females. Low level autoimmunity is normal. Over 80 conditions linked to autoimmunity have been identified and 15 diseases directly linked to […]

BBCR’s Innovation strategy consulting includes a clinical development plan service integrated into regulatory strategy which is supported by the proprietary SCIO method

December 20th, 2019 | Real World Evidence

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 and industry experience that we use […]

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