A Perspective on "Expanded Access" to Experimental (Cell) Therapies

| February 13, 2017

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“Expanded Access,” is a regulatory pathway for physicians to gain access to experimental therapies for patients who usually do not qualify for the clinical trial. This pathway often represents one final chance against a condition that is severely debilitating and/or fatal. Often called “Compassionate Use,” the number of patients and physicians requesting access to experimental therapies has been growing steadily over the past three decades.

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LeanTaaS

LeanTaaS is a software company that uses lean principles, machine learning, and predictive analytics to digitally transform core operational processes in healthcare. This transformation increases patient access, decreases wait times, improves staff satisfaction, reduces healthcare delivery costs, and improves operational performance. LeanTaaS's cloud-based iQueue platform mathematically matches the demand for expensive, constrained healthcare resources – operating rooms, infusion chairs, imaging assets, inpatient beds, etc.

OTHER ARTICLES

Defense biotech research looks to eliminate bacteria causing traveler’s diarrhea, reduce jet lag duration

Article | April 9, 2020

World traveler‘s will rejoice at the idea of a seemingly magical device that would guarantee they never suffer from the all-too-familiar stomach issues that come from traveling internationally while reducing jet lag at the same time. But it’s not just privileged globetrotters that would benefit from a device that eliminates the bacteria associated with the so-called Montezuma’s Revenge. In 2016, more than 230,000 children around the world died from some of the same types of bacteria as those that cause traveler’s diarrhea, and the bacteria mainly come from unsafe “drinking water, poor sanitation and malnutrition,” according to Oxford University’s Our World In Data portal. On Monday, DARPA announced it was researching an “implantable or ingestible bioelectronic carrier” that would eliminate the five major bacteria associated with traveler’s diarrhea.

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Ruminating on Bioprocessing 4.0

Article | February 18, 2020

The Bioprocessing 4.0 concept seeks to apply automation and technology to the digital transformation of biologics manufacturing. As the paradigm moves forward, it faces barriers to its adoption, according to Eric Langer, president of BioPlan Associates. “Perhaps the greatest challenges involve unsecured links and adapting the applications to areas where automation is critically needed today,” says Langer. “Unresolved security issues could seriously affect a company’s data in a regulated environment, so they will need to have iron-clad anti-hacking protection in place. Unfortunately, cyber security is not yet a top focus for the industry.”

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Closing bacterial genomes from the human gut microbiome using long-read sequencing

Article | February 12, 2020

In our lab, we focus on the impact of the gut microbiome on human health and disease. To evaluate this relationship, it’s important to understand the particular functions that different bacteria have. As bacteria are able to exchange, duplicate, and rearrange their genes in ways that directly affect their phenotypes, complete bacterial genomes assembled directly from human samples are essential to understand the strain variation and potential functions of the bacteria we host. Advances in the microbiome space have allowed for the de novo assembly of microbial genomes directly from metagenomes via short-read sequencing, assembly of reads into contigs, and binning of contigs into putative genome drafts. This is advantageous because it allows us to discover microbes without culturing them, directly from human samples and without reference databases. In the past year, there have been a number of tour de force efforts to broadly characterize the human gut microbiota through the creation of such metagenome-assembled genomes (MAGs)[1–4]. These works have produced hundreds of thousands of microbial genomes that vastly increase our understanding of the human gut. However, challenges in the assembly of short reads has limited our ability to correctly assemble repeated genomic elements and place them into genomic context. Thus, existing MAGs are often fragmented and do not include mobile genetic elements, 16S rRNA sequences, and other elements that are repeated or have high identity within and across bacterial genomes.

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2 Small-Cap Biotech Stocks You Haven't Heard of, But Should Know About

Article | April 17, 2020

With everything that's going on with the COVID-19 pandemic, many healthcare companies have grabbed plenty of spotlight during these challenging times. At the same time, a number of otherwise promising businesses have slipped under the radar. That's especially true for small-cap biotech stocks that aren't actively involved in developing tests, vaccines or treatments for COVID-19. Vaccine developers, protective equipment producers, and healthcare service providers are all attracting plenty of attention during this pandemic, but there are just as many promising biotech stocks that aren't involved in these areas. Here are two such companies that you might have missed, but they deserve a spot on your watch list.

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Spotlight

LeanTaaS

LeanTaaS is a software company that uses lean principles, machine learning, and predictive analytics to digitally transform core operational processes in healthcare. This transformation increases patient access, decreases wait times, improves staff satisfaction, reduces healthcare delivery costs, and improves operational performance. LeanTaaS's cloud-based iQueue platform mathematically matches the demand for expensive, constrained healthcare resources – operating rooms, infusion chairs, imaging assets, inpatient beds, etc.

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