What Are Cell-Free Systems?

What Are Cell-Free Systems?

Living systems are not only complex, they are relentless in their demands to be kept alive, with all the attendant limitations and challenges for experimentation and measurement. So-called “cell-free systems” inhabit the space between chemistry and biology proper, obviating some of the requirements of living, cell-based systems and enabling biochemical processes and experimental interventions toxic, … Read more

FDA: Artificial Intelligence/Machine Learning (AI/ML)-Based Software As A Medical Device (SaMD)

FDA: Artificial Intelligence/Machine Learning (AI/ML)-Based Software As A Medical Device (SaMD)

Human biology and new, more advanced computing is creating new territory for therapies that were not capable even five years ago. Artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform health care by deriving new and important insights from the vast amount of health data. Medical device manufacturers are using these … Read more

Pacific Biosciences And Invitae Agree To Develop Ultra-High-Throughput Clinical Whole Genome Sequencing Platform

Pacific Biosciences And Invitae Agree To Develop Ultra-High-Throughput Clinical Whole Genome Sequencing Platform

Pacific Biosciences today announced a multi-year collaboration with Invitae Corporation to begin development of a production-scale high-throughput sequencing platform. Identifying the many underlying genetic influences on human health is emerging as a tool for evaluating overall clinical care and prognosis. Whole genome sequencing offers the most comprehensive view of medically relevant genetic variations. PacBio cites … Read more

Synthetic Biologics Targets The Microbiome For GI Therapies

Synthetic Biologics Targets The Microbiome For GI Therapies

Synthetic Biologics, Inc is clinical-stage company leveraging the microbiome to develop therapeutics designed to treat gastrointestinal (GI) diseases. The Company’s lead clinical development candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent (a) microbiome damage, (b) Clostridioides difficile infection (CDI), … Read more

This Clinical Trial Will Test A Combination Monoclonal Antibody Therapy For Mild/moderate COVID-19

This Clinical Trial Will Test A Combination Monoclonal Antibody Therapy For Mild/moderate COVID-19

People who have mild or moderate COVID-19 could benefit from the results of a Phase 2/3 safety and efficacy clinical trial to evaluate a combination investigational monoclonal antibody therapy. The two experimental antibodies, BRII-196 and BRII-198, target SARS-CoV-2, the virus that causes COVID-19. The trial, known as ACTIV-2, is sponsored by the National Institute of … Read more

DARPA Dive: Biological Responders For Brain Injury

DARPA Dive: Biological Responders For Brain Injury

The Defense Advanced Research Projects Agency (DARPA), established in 1958, is an agency within the Department of Defense (DOD) responsible for catalyzing the development of technologies that maintain and advance the capabilities and technical superiority of the U.S. military. In short, it’s the way the U.S. military tries to prevent technical surprise. Product Service Code: … Read more

Completed Gene Therapy Trials Tracked By U.S. National Library Of Medicine As Of December 2020

Completed Gene Therapy Trials Tracked By U.S. National Library Of Medicine As Of December 2020

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. … Read more

NIH’s 4DN Nucleome Program Targets DNA

NIH’s 4DN Nucleome Program Targets DNA

The goal of the National Insitute of Health’s (NIH) Common Fund’s 4D Nucleome (4DN) program is to study the three-dimensional organization of the nucleus in space and time (the 4th dimension). The nucleus of a cell contains DNA, the genetic “blueprint” that encodes all of the genes a living organism uses to produce proteins needed … Read more