Medical Affairs and Clinical Research

Clinical Research & Clinical Trials

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 […]

Our experienced CRO Management and Drug development team identify study remediation strategies and provide a resource for any Study Rescue

December 10th, 2019 | Medical Affairs and Clinical Research

Every clinical study has its unique challenges that initially may not have been factored for. Experienced management can help sponsors to address prolonged trial timeline and high quality data. Rare Diseases and Precision Medicine Require Unique Approaches In Clinical Trial Design. There could be any number of factors that could necessitate a study being rescued. […]

PKAN drug fails Phase III trial: How to avoid a similar disaster.

November 26th, 2019 | Medical Affairs and Clinical Research

Retrophin’s experimental PKAN drug fosmetpantotenate fails phase III trial Pantothenate kinase-associated neurodegeneration (PKAN) is a rare disease characterized by a progressive neurodegenerative disorder and buildup of iron in the brain which is estimated to affect up to 5000 patients worldwide. PKAN is inherited in an autosomal recessive manner and is caused by mutations in the […]

Inflammation is a recognized cause of Neurodegeneration.

November 21st, 2019 | Medical Affairs and Clinical Research

Neuroinflammation is inflammation of the nervous tissue. It may be initiated in response to a variety of cues, including infection, traumatic brain injury, toxic metabolites, or autoimmunity. In the  CNS, including the brain and spinal cord, microglia are the resident innate immune cells that are activated in response to these cues. The CNS is typically an immunologically privileged site because peripheral […]