Medical Affairs and Clinical Research

Clinical Research & Clinical Trials

Severe COVID-19 linked to a Genetic Region

July 6th, 2020 | Medical Affairs and Clinical Research

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 also evidences that people’s genes can influence how their bodies react to other […]

Jump start Clinical Research after COVID 19

April 27th, 2020 | Medical Affairs and Clinical Research

Given the global Covid19 emergency and the global nature of the pharmaceutical and biotech industry, key operational areas will be impacted. As with any emergency response, the key to management is implementing mitigation plans. Early stage pharmaceutical and biotech companies need to be proactive in developing contingency plans to jump start clinical research after Covid19. […]

The worldwide spread of COVID-19 – How soon we will have Clinical trials?

March 9th, 2020 | Medical Affairs and Clinical Research

Confirmed cases reported from each country so far. Data from cruise ship outbreaks not included. SOURCE: ECDC  

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

February 27th, 2020 | Medical Affairs and Clinical Research

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 | Medical Affairs and Clinical Research

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 to test reconstitution of a normal gut microbiome in atopic dermatitis

February 20th, 2020 | Medical Affairs and Clinical Research

Over the past 50 years, the frequency of allergies and autoimmune diseases has risen rapidly. Unfortunately, there hasn’t been much progress in understanding this epidemic of allergic disease. Hay fever and atopic dermatitis have both increased more than two-fold in the past 50 years. The easy hypothesis would be to attribute this increasing incidence to […]

Innovative Approach to Clinical Plan: Virtual Trial Design.

February 18th, 2020 | Medical Affairs and Clinical Research

Health app designed to engage users through increased healthful living styles are at the base of this innovation in clinical plan and trial design. The design of the Health app was a collaborative effort between Janssen Pharmaceuticals and Apple Watch. The randomized trial is designed to determine if wearable technology can detect atrial fibrillation (AFib). […]

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

February 14th, 2020 | Medical Affairs and Clinical Research

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 […]

2019 Successful Clinical Plan and Drug Development Stories

January 27th, 2020 | Medical Affairs and Clinical Research

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, […]

Challenges in autoimmune disease clinical plans

January 3rd, 2020 | Medical Affairs and Clinical Research

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 […]