Fence to go up around Kentucky Governor’s Mansion in response to Beshear effigy – Courier Journal

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An effigy of Gov. Andy Beshear was hanged from a tree outside the Kentucky state Capitol during a Memorial Day weekend protest. Louisville Courier Journal

In response to an effigy of Gov. Andy Beshear gettinghanged from a tree outside the state Capitol in May, afence is going uparound the Kentucky Governor's Mansion "for the safety of the current and future first families."

Crystal Staley, a spokeswoman for Beshear, said the Kentucky State Police executive security team requested the fence be put up after attendees of a Second Amendment rally on May 24 hanged the effigy on Capitol grounds.

A request for bids for the installation of the security fence was sent out July 8, and contractors have until July 20 to make their bids, said Jill Midkiff, a spokeswoman for the stateFinance and Administration Cabinet.

The fence will be 4 feet tall in most places, except for one area where it will be 5feet, according to state procurement documents.

Midkiff told The Courier Journal that "we cannot provide an estimated value of the contract" until the bids are received.

"Due to the historic nature of the mansion, the security fencing installed must maintain the integrity of the mansions exterior," Midkiff wrote in an email.

"The initial cost of the installation will be paid out of the Department for Facilities and Support Services budget. The private Kentucky Executive Mansion Foundation indicates they plan to vote on the possible reimbursement of this expenditure," Midkiff added."It is believed that Kentuckys Governors Mansion may be the only Executive Mansion in the United States that does not currently have security fencing."

The Second Amendment rally in May, which drew a crowd of more than100 people outside the Capitol in Frankfort, beganas a celebration ofconstitutional rights.

But it eventually turned into a protest of the Beshear administration and the Democratic governor'scoronavirus-related restrictions.

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Near the end of the rally, organizers led the remaining attendees to the Governor's Mansion to attempt to deliver a request for Beshear to resign, with the group chanting, "Come out Andy" and "Resign Andy."

From May: Beshear hanged in effigy as Second Amendment supporters rally at Capitol

More: Kentucky state senator announces he has tested positive for the coronavirus

No one came to the door, as several statetroopers monitoring the rally got out of their vehicles to observethe group but not intervene.

The crowd returned to the Capitol, and an effigy ofBeshear was hanged from a tree while God Bless the U.S.A. played over a loud speaker.

The effigy bore a sign that read, sic semper tyrannis, which means thus always to tyrants." John Wilkes Booth shouted the phrase after assassinating President Abraham Lincoln in 1865.

Staley told The Courier Journal that the "group ofarmed demonstrators crossed over barriers to stand on the front porch of the mansion, just a window pane away from where the Governor and First Lady raise their two young children, and chanted for him to come outside."

As a result of the group also hanging Beshear in effigy, Staley said the Kentucky State Police executive security team "requested a fence be built for the safety of the current and future first families."

The effigy brought swift condemnation from Democrats and Republicans.

In addition, the man who was captured on video hoisting the effigy of Beshear from the tree, identified as the president of the Kentucky ThreePercenters group, was later fired from his job at an auto dealership.

A few days after the rally, Beshear denounced the "mob" that carried out "acelebrationof assassination on our Capitol grounds" and chanted "on the other side of the glass from where I raisemy kids."

"I will not be afraid," the governor said."I will not be bullied.And I will not back down."

Reach Billy Kobin at bkobin@courierjournal.com. Support strong local journalism by subscribing today: courier-journal.com/subscribe.

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Trump joins Hagerty in tele-town hall as early voting begins – Alton Telegraph

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Kimberlee Kruesi, Associated Press

Republican U.S. Senate candidate Bill Hagerty speaks to supporters on Friday, July 17, 2020, after casting an early voting ballot at the Nashville Public Library Bellevue Branch in Nashville, Tenn.

Republican U.S. Senate candidate Bill Hagerty speaks to supporters on Friday, July 17, 2020, after casting an early voting ballot at the Nashville Public Library Bellevue Branch in Nashville, Tenn.

Photo: Jonathan Mattise, AP

Republican U.S. Senate candidate Bill Hagerty speaks to supporters on Friday, July 17, 2020, after casting an early voting ballot at the Nashville Public Library Bellevue Branch in Nashville, Tenn.

Republican U.S. Senate candidate Bill Hagerty speaks to supporters on Friday, July 17, 2020, after casting an early voting ballot at the Nashville Public Library Bellevue Branch in Nashville, Tenn.

Trump joins Hagerty in tele-town hall as early voting begins

NASHVILLE, Tenn. (AP) President Donald Trump on Friday once again threw support behind his former U.S. Ambassador to Japan Bill Hagerty, a Republican running in the primary for an open U.S. Senate seat in Tennessee.

Hagerty, 59, has frequently touted Trump's endorsement ever since the president broke the news the former ambassador was running for political office nearly a year ago.

Ill never forget I went to Japan and he knew every person over there, he knew the businessmen, he could pronounce those names I had a hard time with, Trump said in a tele-town hall with Hagerty. I had a very hard time pronouncing those names.

Trump encouraged Tennesseans to vote early, warning that it was critical to elect senators in office who would vote in favor of the judges he appoints.

Your Second Amendment is under siege. If I werent here I dont think you would have a Second Amendment," Trump added while praising Hagerty's support of law enforcement. You would certainly have a very weak one.

Hagerty's main opponent in the Senate primary is trauma surgeon Manny Sethi, who is also seeking the position being vacated by outgoing Republican Sen. Lamar Alexander. The two candidates have recently increased attacks on one another as early voting kicked off Friday.

In a recent ad, Sethi attacked Hagerty's past political donations to Republican Mitt Romney the only Republican to vote to convict the president during his impeachment trial.

Why is the establishment attacking a nice guy like me? Sethi asks. Well, folks are finding out that Bill Hagertys endorsed by Mitt Romney."

Romney has not publicly endorsed Hagerty since the former ambassador joined the race, but Romney had previously supported the idea, according to the Wall Street Journal in mid-2019.

Meanwhile, Hagerty criticized Sethi in an ad as a liberal elitist.

I volunteered full-time for six months when nobody else was supporting President Trump, certainly not Manny Sethi didnt lift a finger, didnt donate a dime back in 2016 to help President Trump get elected, Hagerty told The Associated Press on Friday.

Early voting ahead of the Aug. 6 primary will be open Monday through Saturday until Aug. 1.

For those who do not want to vote in person, a judge is giving all eligible voters the option to vote absentee during the pandemic. Absentee ballots can be requested until July 30. First-time voters can only vote absentee if they have shown ID at a county election office.

___

Associated Press writer Jonathan Mattise in Nashville, Tennessee, contributed to this report.

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Letter: Irons’ letter missed the mark – Opinion – HollandSentinel.com

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SundayJul19,2020at12:01AM

Kerry Irons letter to the editor of July 14th ("Character issue in Park Twp. race") is a disgusting shot at Jim Chiodo. It is an obvious attempt by someone who does not even live in Park Township to taint the race.

In addition, take a look at Irons list of grievances beyond the distortions. People lose elections all the time only to return and, in notable cases, return to be congressmen, senators and U.S. presidents. Banned from web forums? Guess who else has been victims of such moves; the current president of the U.S. and several leading conservative national VIPs. My own conservative Facebook shares have been recently taken down.

Lastly, take a look at the rest. Chiodo dares to exercise his Second Amendment rights, his widely held conservative views on global warming, and for Mr. Irons, Jims worst sin criticizing Black Lives Matter which the new leftist cancel culture just cannot tolerate.

Jim Chiodos "crimes" are really summed up in this; he is an unabashed vocal conservative, believes in the U.S. Constitution and the Bill of Rights.

Jane Ashby

Holland

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Letter: Irons' letter missed the mark - Opinion - HollandSentinel.com

Right-Wing Domestic Terrorism Has Increased By More Than 300% Since Trump Took Office: Report – Law & Crime

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President Donald Trump walks between columns outside the White House.

According to a recent report, deaths attributable to so-called right-wing domestic terrorists have increased by more than 300% since President Donald Trump took office in 2017.

A database compiled by the Type Media Centers David Neiwert and based on government interpretations of ideological motivations showed that at least 87 people were killed by far-right terrorists during Trumps first three years in office. That number swells to 145 dead in three years if the 58 people killed by Stephen Paddock during the Las Vegas massacre in October 2017 are added in.

The Type Media Center was formerly known as The Nation Institute and was previously attached to The Nation magazine.

From 2013 through 2016, right-wing terrorists in the United States killed some 46 people.

Conversely, Neiwert notes, only 17 people have died due to domestic Islamic terrorism over the past three years. Left-wing domestic terrorism barely registered during the time span; only four such deaths occurred in the past three years.

The stuff about the Las Vegas killing is interesting because it shows how police literally cant SEE right-wing ideology because it is naturalized as normal politics, claimed The Nations National-Affairs Correspondent Jeet Heer on Saturday.

According to Neiwert and others, there is every indication that Paddock was an anti-government, gun-rights zealot. Paraphrasing numerous acquaintances of the killer into a composite explanation of his ideology, Neiwert writes that Paddock had a thing about guns and the Second Amendment and harbored a deep fear that the government would attempt to take them away.

One such acquaintance said that he defended the Second Amendment with an incredible degree of vigor.

Stephen Paddock [Image via the FBI]

But, because Paddock lacked any explicit right-wing organizational affiliations and because he did not leave behind a manifesto after he shot nearly 900 people, the government declined to assign him any ideological motivation.

The Paddock case is odd in that if there were the same number of links to ISIS or Al Qaeda ideologies, there would be no question that the government would highlight them and call him an Islamist terrorist, Brennan Center for Justice Liberty and National Security Fellow Michael German told Neiwert. But here, law enforcement tried to hide and downplay his many links to far right groups/ideology.

The aftermath of the Oct. 2017 mass shooting in Las Vegas, Nev. [Photo by Ethan Miller/Getty Images]

The database shows that during the first three years of the Trump administration, cases involving Islamist extremists were preempted 18 times, compared with seven completed attacks, or 72% a powerful indicator of the resources federal agencies poured into such probes. In contrast, a minority of right-wing extremist cases were preempted 18, compared with 30 realized attacks, or 37.5%.

[L]aw enforcement priorities remain skewed, Neiwert claims.

The top-line numbers are based on the total number of killings that were committed by far-right domestic terroristsunder an expansive definition of the termin the first three years of Trumps presidency compared to those committed by the same ideological cohort during the last three years of Barack Obamas time in the White House.

A less expansive definition of what constitutes right-wing domestic terrorismduring the same time frameshows that such killings have risen by nearly 200% since Trump became president.

[photo by Drew Angerer/Getty Images]

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Tiny particles, big solutions – The Hindu

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Over the past 15-plus weeks, how many times in a day have you furiously wiped down surfaces with disinfectants? The COVID-19 fear factor has turned scientists to research on products based around nano technology, the application of a group of few atoms. They are looking for a solution aimed at a surface coating that bonds to the material with long-term protection against germs (bacteria, viruses, fungi, protozoa).

What are these surface protectors?

They are substances that use metals such as silver and copper or biomolecules such as neem extract known for their microbial activity, or cationic (i.e positively charged) polymers in combination with chemical compounds (like ammonia plus nitrogen) that can be used as a long lasting protective coating. The compound can be sprayed on metal, glass, wood, stone, fabric, leather, and other materials and the effect can last from a week to 90 days depending on what type of surface it is used on.

Are they out in the market?

Until the pandemic, there were products for anti-bacterial application, but now the focus has shifted to viruses. For instance, Prof Ashwini Kumar Agrawal, the Head of Textile and Fibre Engineering Department at IIT Delhi, developed N9 blue nano silver in 2013, with a much higher potency than other metals and polymers to catch and kill bacteria. He has now evaluated the anti-viral properties and re-formulated the compound to work against COVID-19. He says different kinds of silver (yellow and brown) have been patented by countries including the US, China, Australia to establish the uniqueness of the metal for surface hygiene. "But the N9 blue silver can be 100 times more effective with the longest lasting protection."

Institutions (particularly the IITs) across the country are in different stages of developing these nanoparticles as surface coatings. All are awaiting validation against viruses, through field trials before they can legally mass manufacture.

The required certification needs to ideally go through government-approved labs (like ICMR, CSIR, NABL or NIV) that are currently all engaged only in research on medicinal drugs and vaccines.

Nano-products that are available

There are some products that have been tested by private labs either in India or abroad. For instance, Delhi-based start-up, Germcop has launched a disinfection service with a US manufactured and EPA-certified water-based anti-microbial product which, it is claimed, when sprayed over metallic, non-metallic, tiled and glass surfaces gives protection up to 120 days with a 99.9% killing rate in the first 10 days. Dr Pankaj Goyal, the founder, says the product is good for homes that have had a COVID positive patient home-quarantined. She is speaking to the Delhi Transport Corporation to disinfect 1,000 buses. However, the testing has been conducted in a private lab.

IIT Delhis samples were sent in April to the microbiological testing laboratory, MSL in UK. The reports are expected only by the end of the year. "The battery of lab tests will confirm the efficacy of the compound in dry state, how fast and for how long it can continue to kill the virus and if it is non-toxic and safe to use," says Prof Agrawal.

While Prof Agrawals N9 blue silver comes under the Government of Indias Nano Mission project funded by the Department of Science & Technology, another by IIT Madras, funded by the Defence Research Development Organisation, has developed a nano-coated filter for PPE kits, masks, and gloves that can be used by frontline healthcare workers. The coating filters sub-micron sized dust particles in the air. However, its practical application is also subject to field testing and is therefore, pending.

Why cant we just use regular disinfectants?

We can, but theyre not a healthy option for us or the environment, over a long term. Dr Rohini Sridhar, the COO of Apollo Hospitals in Madurai, says common disinfectants used so far in high density public places such as hospitals and clinics contain alcohol, phosphates or hypochlorite solutions, more commonly known as household bleach. "These solutions lose their function as they evaporate quickly, and break down when exposed to UV lights such as the sun, requiring the need for surfaces to be disinfected several times a day.

Are the long lasting surface protectors in use anywhere else in the world?

Following the findings from the Diamond Princess cruise ship that the coronavirus can last on surfaces up to 17 days, the development of a new disinfectant technology arose. While anti-viral coatings are undergoing clinical tests in several countries, three months ago scientists from Haifa's Institute of Technology, in Israel, claimed to have developed anti-viral polymers that could kill the coronavirus without getting diminished.

Researchers in Hong Kong University of Science & Technology also developed a new anti-microbial coating known as MAP-1 that can kill most bacteria and viruses -- including the coronavirus -- for up to 90 days.

Prof Agrawal says many countries are engaged in developing heat-sensitive polymers that respond to contamination from touch or droplets, from the time of previous epidemics of SARS. Many of those formulations have been modified during the current pandemic and sold under different brand names in Japan, Singapore, and the US. However, the surface protectors currently available in international markets are pocket-pinching.

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MRSEC wins major new grant from the National Science Foundation – Brandeis University

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The cutting-edge research center received $18 million to develop the next generation of machines and materials.

MRSEC harnesses the power of organic matter to develop new materials and machines.

Brandeis' MRSEC program, which is developing revolutionary new types of nano-sized machines and materials, has received an $18 million, 6-year grant from the National Science Foundation (NSF).

It is the third time Brandeis has received the prestigious award. This year it was given to only 10 other universities besides Brandeis, including Columbia, Harvard and Princeton.

MRSEC, which stands for Materials Research Science and Engineering Center (MRSEC), is a long-term, nationwide effort to invent devices that are right out of a science fiction movie self-mending clothing, self-healing artificial organs, nanobots that travel through the bloodstream to wipe out cancer cells and cyborgs that move with the agility and grace of human beings.

Brandeis MRSEC researchers also recently began a long-term project to develop cures for viruses, including COVID-19.

It is extremely stimulating to be part of a sustained, well-supported team like the MRSEC that addresses grand challenges at the forefront of science, said Brandeis MRSEC director and professor of physics Seth Fraden. Brandeis is a fitting home for such a center because our small size and passionate community of researchers support a highly collaborative environment.

"The MRSEC program is a flagship program for the [NSF Division of Materials Research] and with these new awards will continue its long history of forging discoveries and fueling new technologies," the division's director, Linda Sapochak, said in a press release.

At Brandeis, Fraden and his colleagues focus on soft matter compounds like gels, liquid crystals, foams and polymers that exist somewhere between a liquid and a solid state.

They aim to endow these materials with features and abilities found in nature.

Fraden and his collaborators also work on "self-propelling" or "self-powered" liquids.

These are made from motor proteins taken from animal cells that consume chemical energy to keep on going. In the same way, these liquids move on their own without any kind of human intervention, and act like self-pumping fluids.

The MRSEC is an example of "horizontal connectivity" at Brandeis, where scientists transcend programmatic, departmental and school affiliations to work across disciplines. Some 17 Brandeis faculty, from 6 science departments, work alongside 30 graduate students, postdocs and MRSEC staff.

The MRSEC also offers a broad range of educational outreach programs for K-12 students and teachers, undergraduates, graduate students and postdocs.

As part of the NSF's Partnerships for Research and Education in Materials (PREM), MRSEC collaborates on research into cutting-edge materials with Hampton University, a historically black university in Virginia.

This 6-year, $3.6M PREM grant aims to boost diversity in the sciences by building Hampton's research capacity and increasing the recruitment, retention and graduation rates of individuals from underrepresented groups.

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MRSEC wins major new grant from the National Science Foundation - Brandeis University

The best and worst choices for a cloth face mask – Times Union

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Any face mask is better than no face mask during the pandemic. But all masks are not created equal.

Anti-maskers argue that forcing someone to wear a face covering is an infringement on rights, such as the right to decide what represents an acceptable risk to oneself. Thats the same argument that bareheaded motorcycle riders made before helmet rules went into effect.

When it comes to masks, however, the infringement justification does not hold water. The primary duty of a face covering is not to protect the wearer like a helmet does, but to protect others. If you are COVID-19 asymptomatic and you refuse to wear a mask in public, your body effectively becomes a bioweapon.

The Centers for Disease Control and Prevention says the general public should wear cloth face coverings, not medical-grade N95 masks and surgical masks. Those should be reserved for health-care workers and first responders.

So what are the best and worst cloth masks for everyday use?

Bandanas are the least-effective. In a Florida Atlantic University study, scientists found that droplets from a bandana-covered cough traveled 3 feet, 7 inches, compared to 8 to 12 feet with no mask at all. Holding a double-folded handkerchief over ones mouth was much more efficient it stopped droplets from going more than 1.25 feet.

Get one made of cotton. Tightly woven, 100-percent cotton works well. Christopher Zangmeister, a researcher at the National Institute of Standards and Technology and co-author of a new study published in ACS Nano, told NPR that microscopic cotton fibers have a more three-dimensional structure than synthetic materials, which makes them more efficient at snagging incoming particles.

The more layers, the better. Two layers of tight-weave cotton are good, three or more are better. The CDCrecommends at least three fabric layers, which can include a middle layer of filtering material.

Masks with a filter pocket between two layers provide more protection. A two-layer, tight-weave cotton mask alone can filter out about 35% of small particles, Stanford University Professor of Materials Science and Engineering Yi Cui told NPR. But if a filter made out of two layers of charged polypropylene is placed in the pocket, the masks filtration efficiency could double to up to 70%. Polypropylene, also known by the brand name Oly-fun (Walmart) and spunbond, holds an electrostatic charge that traps incoming and outgoing particles.

Fit matters. Its important that a cloth mask seals snuggly to your face. If gaps open up where the mask touches the skin, its effectiveness is compromised. Folded, pleated and duckbill masks allow more air flowing through the fabric and less leaking out the sides compared to a flat-front mask.

Neck gaiters, tubes or buffs, which cover the nose down to the neck, solve the air-leakage problem. Many people find them more comfortable than masks because they dont have ear loops or ties. However, they are generally made of polyester and/or spandex, which are less effective at filtering particles than cotton. Some come with filters. Sample complaints from product reviews include: too hot during the summer, easy to slip off nose, filter does not stay over the mouth.

Dont buy a mask with a vent or exhalation valve. While they make breathing easier, vents defeat the masks purpose because they release unfiltered air that can contain droplets. Industrial-grade N95 masks designed for smoky or smoggy environments often have these valves.

Reports of stores and other businesses barring entry to customers wearing vented masks are increasing. If you already own one, either put a second mask over top of it or completely cover the vent with tape or a sewn-on patch.

Make sure your mask is washable. Unlike medical masks, which are normally designed for single-use, cloth masks should be washed after every use and worn until the fabric or structure breaks down.

Mike Moffitt is an SFGATE Reporter. Email: moffitt@sfgate.com. Twitter: @Mike_at_SFGate

There are few studies on face mask fabrics, but the current consensus is that tight-weave cotton is the best material for a cloth mask.

This mask has two layers of cotton.

Pleated face masks allow more air circulation inside the mask, making it less likely air will escape through the sides.

A cone-shaped mask is more effective than a flat-front design in stopping incoming and outgoing droplets.

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Synthetic Biology Market (2019-2025) with COVID-19 After Effects Analysis by Emerging Trends, Industry Demand, Growth, Key Players – Jewish Life News

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The synthetic biology market is segmented on the lines of its product, technology and application. The synthetic biology is segmented on the lines of its product are enabled products, core product and enabling products. The enabled product is further segmented into pharmaceuticals, chemicals, biofuels and agriculture. Under core product segmentation it covered synthetic DNA, synthetic genes, synthetic cells, XNA and chassis organisms. The enabling product is segmented into DNA synthesis and oligonucleotide synthesis. The synthetic biology is segmented on the lines of its technology like enabling technology and enabled technology. Under enabling technology it covers genome engineering, microfluidics technologies, DNA synthesis & sequencing technologies, bioinformatics technologies, biological components and integrated systems technologies. The enabled technology the market is segmented into pharmaceuticals, chemicals, biofuels and agriculture. Under application segmentation the market covered into research & development, chemicals, agriculture, pharmaceuticals & diagnostics, biofuels, environment, biotechnology and biomaterials. The synthetic biology market is geographic segmentation covers various regions such as North America, Europe, Asia Pacific, Latin America, Middle East and Africa. Each geography market is further segmented to provide market revenue for select countries such as the U.S., Canada, U.K. Germany, China, Japan, India, Brazil, and GCC countries.

FYI, You will get latest updated report as per the COVID-19 Impact on this industry. Our updated reports will now feature detailed analysis that will help you make critical decisions.

The global synthetic biology market is expected to exceed more than US$ 12.50 billion by 2024, at a CAGR of 20% in given forecast period.

You Can Browse Full Report @: https://www.marketresearchengine.com/reportdetails/synthetic-biology-market

The report covers detailed competitive outlook including the market share and company profiles of the key participants operating in the global market. Key players profiled in the report include BASF, GEN9 Inc. , Algenol Biofuels , Codexis Inc. , GenScript Corporation , DuPont , Butamax Advanced Biofuels , BioAmber , Biosearch Technologies, Inc. , OriGene Technologies, Inc. , Synthetic Genomics, Inc. , GeneArt (Life Technologies) , GENEWIZ, Inc. , Eurofins Scientific, Inc. , Integrated DNA Technologies, Inc. , DNA2.0, Inc. , Pareto Biotechnologies , Synthorx, Inc. , TeselaGen Biotechnology , Editas Medicine, Inc. , Twist Bioscience , GeneWorks Pty Ltd. , Proterro, Inc. and Blue heron (OriGene technologies Inc.) . Company profile includes assign such as company summary, financial summary, business strategy and planning, SWOT analysis and current developments.

Synthetic biology market also called as constructive biology or system biology in which creating and designing new biological device, part which is not exist in environment. It also reconstructs the existing system to perform better job. It is branch of biology as well as engineering. The main aim of synthetic biology is to develop biological system same like engineers produce mechanical and electronic system. System based on molecular are helpful in detection and changes in health of body. It also helpful in developing synthetic vaccines. Synthetic biology plays vital role in HIV and cancer treatment. Synthetic biology accepts different technology such as nano-technology, bio-technology and more.

The scope of the report includes a detailed study of global and regional markets for various types of synthetic biology market with the reasons given for variations in the growth of the industry in certain regions.

The Synthetic biology Market has been segmented as below:

The Global Synthetic biology Market is segmented on the basis of Product Analysis, Technology Analysis, Application Analysis and Regional Analysis .

By Product Analysis this market is segmented on the basis of Enabling Products, DNA Synthesis, Oligonucleotide Synthesis, Enabled Products, Pharmaceuticals, Chemicals, Biofuels, Agriculture, Core Products, Synthetic DNA, Synthetic Genes, Synthetic Cells, XNA and Chassis Organisms. By Technology Analysis this market is segmented on the basis of Enabling Technology, Genome Engineering, Microfluidics technologies, DNA synthesis & sequencing technologies, Bioinformatics technologies, Biological components and integrated systems technologies, Enabled Technology, Pathway engineering, Synthetic microbial consortia and Biofuels technologies. By Application Analysis this market is segmented on the basis of Research & Development, Chemicals, Agriculture, Pharmaceuticals & Diagnostics, Biofuels and Others (Environment, Biotechnology & Biomaterials, etc.). By Regional Analysis this market is segmented on the basis of North America, Europe, Asia-Pacific and Rest of the World.

This report provides:

1) An overview of the global market for synthetic biology and related technologies.

2) Analyses of global market trends, with data from 2015, estimates for 2016 and 2017, and projections of compound annual growth rates (CAGRs) through 2024.

3) Identifications of new market opportunities and targeted promotional plans for synthetic biology

4) Discussion of research and development, and the demand for new products and new applications.

5) Comprehensive company profiles of major players in the industry.

The major driving factors of synthetic biology market are as follows:

The restraints factors of synthetic biology market are as follows:

Request Sample Report: https://www.marketresearchengine.com/reportdetails/synthetic-biology-market

Table of Contents

1 INTRODUCTION

2 Research Methodology

3 Executive Summary

4 Premium Insights

5 Industry Speaks

6 Market Overview

6.1 Introduction6.2 Market Dynamics6.2.1 Drivers6.2.1.1 Rising R&D Expenditure of Pharmaceutical and Biotechnology Companies6.2.1.2 Increasing Demand for Synthetic Genes6.2.1.3 Rise in the Global Production of Genetically Modified Crops6.2.1.4 Increase in Funding6.2.2 Restraint6.2.2.1 Ethical and Societal Issues6.2.3 Challenge6.2.3.1 Standardization of Biological Parts6.2.4 Opportunities6.2.4.1 Rising Concerns on Fuel Consumption6.2.4.2 Increasing Demand for Protein therapeutics

7 Industry Insights

8 Synthetic Biology Market, By Tool

9 Market, By Technology

10 Market, By Application

11 Synthetic Biology Market, By Geography

12 Competitive Landscape

13 Company Profiles

13.1 Introduction

13.2 Amyris, Inc.

13.3 Dupont

13.4 Genscript USA, Inc.

13.5 Intrexon Corporation

13.6 Integrated Dna Technologies (IDT), Inc.

13.7 New England Biolabs, Inc.

13.8 Novozymes

13.9 Royal DSM N.V.

13.10 Synthetic Genomics, Inc.

13.11 Thermo Fisher Scientific, Inc.

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Synthetic Biology Market (2019-2025) with COVID-19 After Effects Analysis by Emerging Trends, Industry Demand, Growth, Key Players - Jewish Life News

Research Assistant or Research Fellow in Electromagnetic Actuation job with CRANFIELD UNIVERSITY | 213886 – Times Higher Education (THE)

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OrganisationCranfield UniversitySchool/DepartmentSchool of Water, Energy and EnvironmentBased atCranfield Campus, Cranfield, BedfordshireHours of work37 hours per week, normally worked Monday to Friday. Flexible working will be considered.Contract typeFixed term contractFixed Term Period21 monthsSalary30,600 per annum (Research Assistant) or 33,309 per annum (Research Fellow)Posted Date14/07/2020Apply by14/08/2020

Role Description

An exciting opportunity has arisen for an innovative individual, with expertise in electromagnetic modelling and electric circuit design, within the Centre for Thermal Energy and Materials (CTEM). The CTEM has a strong record in applied research in the academic and industrial sectors. Our research areas include renewable and low carbon energy systems, advanced power generation systems for efficiency benefits, heating and cooling and next generation technologies for reduction in energy demand.

As the UKs only exclusively postgraduate university, Cranfields world-class expertise, large-scale facilities and unrivalled industry partnerships is creating leaders in technology and management globally. Our distinctive expertise is in our deep understanding of technology and management and how these work together to benefit the world.

Our people are our most valuable resource and everyone has a role to play in shaping the future of our university, developing our learners, and transforming the businesses we work with. Learn more about Cranfield and our unique impacthere. Our shared, stated values help to define who we are and underpin everything we do: Ambition; Impact; Respect; and Community. Find out morehere.

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Targeting brain metastases with ultrasmall theranostic nanoparticles, a first-in-human trial from an MRI perspective – Science Advances

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Abstract

The use of radiosensitizing nanoparticles with both imaging and therapeutic properties on the same nano-object is regarded as a major and promising approach to improve the effectiveness of radiotherapy. Here, we report the MRI findings of a phase 1 clinical trial with a single intravenous administration of Gd-based AGuIX nanoparticles, conducted in 15 patients with four types of brain metastases (melanoma, lung, colon, and breast). The nanoparticles were found to accumulate and to increase image contrast in all types of brain metastases with MRI enhancements equivalent to that of a clinically used contrast agent. The presence of nanoparticles in metastases was monitored and quantified with MRI and was noticed up to 1 week after their administration. To take advantage of the radiosensitizing property of the nanoparticles, patients underwent radiotherapy sessions following their administration. This protocol has been extended to a multicentric phase 2 clinical trial including 100 patients.

Combined with surgery and/or chemotherapy, external radiotherapy (RT) is one of the most frequently used therapeutic solutions for patients with solid tumors. In Western countries, approximately 40% of cancer cures include the use of RT either as a single modality or combined with other treatments (1). However, despite its indisputable curative efficacy, RT is associated with deleterious side effects for the patient, the main undesirable one being the destruction of normal cells and healthy tissues in the vicinity of tumor areas or on the passage of high-dose radiation. Several strategies have been developed over the years to limit this issue of nonspecific dose deposition. In addition to major technological improvements such as intensity-modulated RT, image-guide RT, hypofractionated therapy, and ablative therapy, the use of radiosensitizers has been extensively studied, developed, and applied as an effective approach to limit undesirable side effects of RT (2). By definition, a radiosensitizer is an agent (molecule, drug, or nanoparticle) that sensitizes tumor cells preferentially to RT and, thus, increases the therapeutic window, in which the radiation dose allows the tumor to be eradicated while maintaining normal tissue tolerance. Standard chemotherapeutic agents, often combined with RT, are the most common agents used for increasing the efficacy of RT. Among the nanoscale-size particles recognized as nanoenhancers, those whose composition includes high-Z metals (gadolinium, hafnium, gold, silver, etc.) may interact with x-rays through various mechanisms of action, including the creation of photoelectric Compton and Auger electrons, themselves at the origin of secondary electrons. The high and local deposition of energy induced by these secondary electrons in the vicinity of the high-Z atoms results in synergistic effects that potentiate the deleterious effects of x-rays on the cells (36).

Considering the local radiosensitizing effect induced by these nanoenhancers, it seems all the more important to have access to their static and dynamic biodistribution and, possibly, to their in vivo concentration to make the most of the widening of the therapeutic window allowed by their presence. The use of theranostic nanoparticles, combining both diagnostic and radiosensitizing properties on the same nano-object, is an elegant solution to achieve this objective (7). This approach has recently been evaluated in a phase 2-3 clinical trial in patients with soft-tissue sarcoma using intratumoral administration of hafnium oxide nanoparticles visualized using computed tomography before preoperative external beam RT (8).

Similarly, the engineering of a new type of theranostic platform, consisting of a polysiloxane core matrix covalently bound to gadolinium chelates (Gd-DOTA), was first reported less than 10 years ago (9). Since then, the diagnostic and radiosensitizing properties of this Gd-based nanoparticle (AGuIX, NH TherAguix, Meylan, France) have been validated in numerous in vitro (1013) and in vivo studies (1420) using intravenous administration of nanoparticle suspension to tumor-bearing (glioma, pancreas, lung, brain metastases, etc.) animals followed by magnetic resonance imaging (MRI) sessions and RT treatment.

On the basis of the positive results obtained in these preclinical studies, a first-in-human phase 1 clinical trial with intravenous administration of AGuIX nanoparticles, filed in 2016 and inclusion completed in 2018, was conducted in 15 patients with multiple brain metastases from four types of primary tumors (melanoma, lung, colon, and breast). In this paper, we compile the main MRI findings obtained on the patients during this clinical trial. In particular, we report, through comparison with a commercial clinical MRI contrast agent, the diagnostic value of AGuIX nanoparticles for the detection and the characterization of brain metastases. Last but not least, we present quantitative measurements of theranostic nanoparticle concentration in all four types of brain metastases obtained 2 hours after administration to patientand incidentally 2 hours before the first session of whole-brain RTand up to 1 week after nanoparticle administration.

No acute grade 3 (severe) or grade 4 (life threatening) adverse effects attributed to the AGuIX nanoparticles were observed at each escalation step of administered dose (N = 3 patients for 15, 30, 50, 75, and 100 mg/kg body weight), with the highest dose corresponding to the dose retained for the multicentric phase 2 clinical trial.

The patient recruitment resulted into the inclusion of four types of brain metastases, namely, NSCLC (nonsmall cell lung carcinoma), N = 6; breast, N = 2; melanoma, N = 6; and colon cancer, N = 1.

Two hours after AGuIX injection, MRI signal enhancements (SEs) were observed for all measurable metastases (longest diameter greater than 1 cm), regardless of the type of brain metastases, the patient, and the dose administered. Tumor enhancements are exemplified in Fig. 1 for each type of brain metastasis. Within the region of interest drawn around each metastasis, MRI SEs were found to increase with the administered dose of AGuIX nanoparticles (Fig. 2A). SEs, averaged over all measurable metastases, were equal to 26.3 15.2%, 24.8 16.3%, 56.7 23.8%, 64.4 26.7%, and 120.5 68% for AGuIX doses of 15, 30, 50, 75, and 100 mg/kg body weight, respectively. The mean MRI SE was found to linearly correlate with the injected dose (slope 1.08, R2 = 0.90) as shown in Fig. 2A.

First and second row images are obtained pre/postadministration of Gd-based nanoparticles using three-dimensional (3D) T1-weighted imaging sequence. The green arrows are pointing highlighted metastases. Third row images are corresponding SE maps with conspicuous local increase of intensity (light blue to orange color) in all different types of brain metastases. The fourth row shows a 3D visualization of all metastases with SE.

(A) MRI SE as a function of the injected dose of AGuIX nanoparticle. Each point corresponds to an MRI SE value measured in a metastasis for all patients. Mean value and SD (error bar) are displayed. The solid line and the equation correspond to the linear regression on the mean values. BW, body weight. (B) MRI SE by primary tumor type. Each point corresponds to an SE value, normalized to the administered AGuIX dose, measured in a metastasis for all patients. Mean value and SD (error bar) are displayed. NSCLC, nonsmall-cell lung carcinoma. (C) MRI SE as a function of the longest diameter of metastases for each type of primary tumor. Each point corresponds to an SE value, normalized to the administered AGuIX dose, measured in a metastasis for all patients.

The dependence of the MRI SE on the primary tumor type is illustrated in Fig. 2B. To take into account the difference in SE due to the injected dose, the SE values were multiplied by a normalization coefficient corresponding to the ratio of the highest injected dose, 100 mg/kg, to the actual injected dose in mg/kg. The mean MRI SEs were equal to 115 81%, 107 62%, 124 52%, and 87 58% for melanoma, NSCLC, breast, and colon primary cancer, respectively. No statistical differences in SE values were observed between the different types of primary tumor.

Similarly, the dependence of SE as a function of the metastasis size for each primary tumor type is presented in Fig. 2C. The same corrective coefficient was applied to take into account the effect of the injected dose on the SE. No SE variation with size was found. For example, the mean SE values were 114 70% and 117 70% for metastases with the longest diameter between 10 and 20 mm and between 20 and 50 mm, respectively.

For each patient, the MRI SE was also measured at day 0, 15 min after injection of a clinically approved Gd-based contrast agent (Dotarem, Guerbet, Villepinte, France). Averaged over all measurable metastases with longest diameter larger than 1 cm, the MRI SE was equal to 182.9 116.2%.

The detection sensitivity of AGuIX nanoparticles, defined as their ability to enhance MRI signal in measurable brain metastases, was assessed for all administered doses and compared with the sensitivity of the clinically used contrast agent Dotarem. Expressed as a percentage of Dotarem sensitivity, the AGuIX nanoparticle sensitivity was equal to 12.1, 19.5, 34.2, 31.8, and 61.6% for injected doses of 15, 30, 50, 75, and 100 mg/kg body weight, respectively.

A tumor-by-tumor comparison of the MRI SE 15 min after Dotarem injection and 2 hours after nanoparticle injection is shown in Fig. 3A for patients treated at 100 mg/kg body weight. This largest injected dose of AGuIX nanoparticle represents the same quantity of injected Gd3+ ions as for the Dotarem administration, i.e., 100 mol/kg body weight of Gd3+. The MRI SEs were found to linearly correlate by primary tumor type (NSCLC, R2 = 0.96; breast cancer, R2 = 0.93).

(A) Each point corresponds to an MRI SE value measured in a metastasis for patients receiving 100 mg/kg body weight AGuIX dose. The solid lines and the equations correspond to the linear regressions for each primary tumor type (e.g., NSCLC and breast cancer). (B) Correlation between MRI SE and AGuIX concentration following AGuIX administration. Each point corresponds to an MRI SE and AGuIX concentration value measured in a metastasis of patients #13, #14, and #15 injected with a 100 mg/kg body weight AGuIX dose. The solid lines correspond to the linear regression applied to the series of points.

The multi-flip-angle three-dimensional (3D) FLASH acquisitions were successfully used to compute pixelwise maps of T1 values (fig. S1) and to enable quantification of the longitudinal relaxation time over regions of interest. The decrease in T1 relaxation times in brain metastases, induced by the uptake of AGuIX nanoparticles, is clearly shown in these T1 maps. As expected, the decreases in T1 values are colocalized with the contrast-enhanced brain metastases.

The concentrations of AGuIX nanoparticles in contrast-enhanced metastases were computed on the basis of the changes in T1 values following their administration. The measurements of AGuIX concentration were performed in metastases with longest diameter larger than 1 cm for the patients administered with a dose of 100 mg/kg body weight. The mean AGuIX concentration in the brain metastases was measured to be 57.5 14.3, 20.3 6.8, and 29.5 12.5 mg/liter in patient #13 (NSCLC metastases), #14 (NSCLC metastases), and #15 (breast cancer metastases), respectively.

The correlation between MRI SE and nanoparticle concentration was assessed for the three patients with the highest (100 mg/kg) administered dose. The relationship between the two MRI measurements is illustrated in Fig. 3B for the three patients. The slopes and R2 values of the linear regression were 3.31 (R2 = 0.80), 1.69 (R2 = 0.39), and 3.95 (R2 = 0.64) for patient #13, #14, and #15, respectively.

For each patient, the MRI SE and T1 values were assessed in brain regions of interest free of visible metastases (three representative regions of interest per patient, with a similar size for all patients). No substantial MRI SE and no T1 variations were observed in any of these healthy brain regions.

For patients administered with the largest dose (100 mg/kg body weight), persistence of MRI SE was noticed in measurable metastases (longest diameter greater than 1 cm) at day 8, 1 week after administration of AGuIX nanoparticles as shown in Fig. 4. The mean MRI SEs in metastases were measured equal to 32.4 10.8%, 14 5.8%, and 26.3 9.7% for patient #13, #14, and #15, respectively. As a point of comparison, the mean MRI SEs at day 1 were equal to 175.8 45.2%, 58.3 18.4%, and 154.1 61.9% for patients #13, #14, and #15, respectively. Because of small T1 variations, the concentration of AGuIX nanoparticles could not be computed. On the basis of the observed correlation between MRI SE and nanoparticle concentration, an upper limit of 10 M can be estimated for the AGuIX concentration at day 8 in brain metastases. No noticeable MRI SE was observed in any patient at day 28, 4 weeks after the administration of AGuIX nanoparticles.

3D visualization of patients brain superimposed with color-encoded SE in NSCLC metastases 2 hours p.i. (postinjection) on the left and 7 days p.i. on the right. The patient was administered with the largest dose of nanoparticles (100 mg/kg body weight).

The clinical evaluation of the diagnostic value of the AGuIX nanoparticles for brain metastases was one of the secondary objectives of the clinical trial NanoRad, and the first and main purpose of this paper is to present the MRI results obtained with these Gd-based, MRI-visible, ultrasmall nanoparticles. In this clinical trial, the MRI protocol included a large panel of MRI sequences giving access to many imaging readouts and biomarkers (relaxation time, diffusion, edema, hemorrhage, etc.). Despite its 40-min duration, the protocol was found to be compatible with the patients health status. However, if necessary, this protocol could easily be shortened in clinical routine and restricted to the sole MRI sequences needed to assess the volume and number of metastases and the concentration of nanoparticles.

The target dose for the theranostic application of the AGuIX nanoparticles in patients corresponds to the largest administered dose to the patients, and for this reason, the conclusions and perspectives of this study focus essentially on this dose. This largest dose (100 mg/kg body weight or 100 mol/kg body weight Gd3+) corresponds as well to the amount of chelated Gd3+ ions injected in one dose of clinically used MRI contrast agent such as Dotarem (100 mol/kg body weight Gd3+). It is therefore appropriate to compare the MRI SEs observed in metastases with the largest AGuIX dose to a dose of Gd-based contrast agent used in clinical routine.

A dose escalation was included in the design of this first-in-human clinical trial, and five increasing doses of AGuIX nanoparticles were investigated. From the linear correlation observed between the SE in metastases and the administered nanoparticle concentration, it can be concluded that the dose of nanoparticlesin the range of investigated dosesis not a limiting factor for the passive targeting of metastases. Despite the limited number of patients participating in this first clinical study, the initial results show that uptake of nanoparticles and SE is present at similar levels in the four types of investigated metastases (NSCLC, melanoma, breast, and colon) regardless of the injected dose of nanoparticles. In addition, the uptake of nanoparticles appears to be independent of the diameter of the metastases in the 1- to 5-cm range.

In this study, there was a 2-hour delay between the nanoparticle administration and the MRI acquisitions. As part of the safety protocol of this first-in-human trial, the patient was kept in bed under medical monitoring by a dedicated nurse for 1 hour after the start of the injection. An additional hour was necessary to transport and install the patient from the phase 1 unit, where the injection took place, in the MRI scanner. Note that this safety delay is not applicable for the phase 2 clinical trial and that the injection can be performed with the patient inside the MRI scanner.

With a mean nanoparticle plasma half-life of about 1 hour, this 2-hour delay results in an 86% decrease in the nanoparticle concentration in the plasma. In contrast, there was only a 15-min delay between the Dotarem injection (plasma half-life of about 1.5 hours) and the MRI acquisition. Despite this significant clearance of nanoparticles and the decrease in concentration in the patients bloodstream, the MRI SE at the highest nanoparticle dose is close to that observed with the clinical contrast agent. It is also of great interest to note that, from the tumor-by-tumor comparison of SE after AGuIX and after Dotarem administration, there is a notable correlation between the uptake of nanoparticle and the uptake of clinical contrast agent for two different types of primary tumors.

This remarkable diagnostic performance of AGuIX nanoparticles to enhance the MRI signal in brain metastases can be attributed to two independent factors. The first factor is related to the intrinsic magnetic properties of nanoparticles. Their larger diameter and molecular weight, as compared with clinical Gd-based contrast agent, result in a higher longitudinal relaxation coefficient r1, equal to 8.9 and 3.5 mM1 s1 per Gd3+ ion at a magnetic field of 3 T (21) for AGuIX nanoparticles and Dotarem, respectively. This higher relaxivity of nanoparticles results in a larger SE in tumors compared with that obtained with Dotarem, as observed in preclinical studies when identical delays between injection and MRI acquisitions are used for both Gd-based agents (15).

The second factor may be related to the ability of the ultrasmall AGuIX nanoparticles to passively accumulate in brain metastases. This passive targeting phenomenon takes advantage of the so-called enhanced permeability and retention effect, which postulates that the accumulation of nano-objects in tumors is due to both defective and leaky tumor vessels and to the absence of effective lymphatic drainage (22). The passive targeting of tumors by AGuIX nanoparticles has been consistently observed in previous investigations of animal models of cancer. In a mouse model of multiple brain melanoma metastases, internalization of AGuIX nanoparticles in tumor cells was reported and the presence of nanoparticles in brain metastases was still observed 24 hours after intravenous injection to the animals (18). At the highest 100 mg/kg dose, all metastases with a diameter larger than 1 cm were contrast enhanced up to 7 days after the nanoparticles were administered. The persistence of MRI SE in metastases 1 week after administration confirms this accumulation and delayed clearance of nanoparticles from the metastases. To the best of our knowledge, there is no report in the literature of such late SE in metastases after administration of clinically used Gd-based contrast agents.

Considering the radiosensitizing properties of AGuIX nanoparticles, it is key to evaluate and possibly quantify the local concentration of nanoparticles accumulated in metastases. To that end, the MRI protocol included a T1 mapping imaging sequence from which the nanoparticle concentration was derived. The concentration values obtained in this clinical study can be put in perspective with those obtained in preclinical studies in animal models of tumor. The computed concentration of AGuIX nanoparticles in the NSCLC and breast cancer metastases of the three patients injected with the highest dose varied between 8 and 63 mg/liter, corresponding to a concentration range of Gd3+ ions between 8 and 63 M in brain metastases. Although the experimental conditions differ in some respects (concentration, dose, and administration modalities of the nanoparticles), the concentration of nanoparticles obtained in animal models is very similar to the concentration values observed in patients. In a rat model of glioma, Verry et al. (19) reported a Gd3+ concentration in the order of 70 M, 4 hours after the nanoparticle administration to the animals. Similarly, in an experimental mouse model of lung cancer, Bianchi et al. (23) reported a Gd3+ concentration close to 40 M in tumor, 2 hours following the nanoparticle administration.

The percentage of injected dose per gram of tissue (% ID/g) in metastasis can be derived from the measured concentration of nanoparticle in the metastasis and from the total dose of nanoparticle injected to the patients. For instance, approximating the tissue density to 1 kg/liter, the percentage of injected dose is equal to 0.001% ID/g for a measured nanoparticle concentration of 60 mg/liter in a 60-kg patient administered with 100 mg/kg nanoparticles. As a point of comparison (and bearing in mind the differences in protocols, measurements, and administered nanoparticles), Harrington et al. (24) reported values ranging between 0.005 and 0.05% ID/g in passively targeted solid tumors of patients injected with radiolabeled pegylated liposomes. More recently, Phillips et al. (25) approximated the percentage of injected dose to 0.01% ID/g in melanoma metastasis of a patient injected with radiolabeled and pegylated nanoparticles engineered for cRGD (cyclic arginine-glycine-aspartate) targeting.

In this study, we evaluated as well the relationship between the nanoparticle concentration and the MRI SE obtained using a robust T1-weighted 3D MRI sequence. In the range of measurable nanoparticle concentration in metastases, a linear relationship between the MRI SE and the nanoparticle concentration is observed with the acquisition protocol used in this study. Hence, with the specific protocol used in this study, the SE can be used as a robust and simple index for assessing the concentration of AGuIX nanoparticles.

While metastasis targeting is beneficial for both diagnosis and radiosensitization purposes, it is desirable to maintain nanoparticles at low concentration in healthy surrounding tissues. In this respect, no SE could be observed in the metastasis-free brain tissues 2 hours after the highest dose of AGuIX nanoparticles was administered. This lack of enhancement is consistent with the rapid clearance of nanoparticles measured in patients plasma and is a positive indication of the innocuousness of the nanoparticles for the healthy brain.

The occurrence of brain metastases is a common event in the history of cancer and negatively affects the life expectancy of patients. For patients with multiple brain metastases, despite advances in stereotactic radiosurgery and new systemic treatments (immunotherapy and targeted therapy), the overall 2- and 5-year survival estimates across all primary tumor types are 8.1 and 2.4%, respectively (26). Consequently, new approaches need to be developed to improve the treatment efficacy for these patients. The use of radiosensitizing agents is thus of great interest. The in vivo theranostic properties (radiosensitization and diagnosis by multimodal imaging) of AGuIX nanoparticles were previously demonstrated in preclinical studies performed on eight tumor models in rodents (20), and particularly in brain tumors (14, 19).

The MRI results of this study show in humans, that the accumulation of Gd-based nanoparticles is also present in tumors (brain metastases) and can therefore potentially be used to increase the effectiveness of RT in patients.

Although Gd-based contrast agents used in clinical practice are also known to enhance brain metastases, it is important to note that radiosensitization requires the presence of nanoparticles and is not observed in the case of Gd-based molecular agents such as Dotarem (27). It is generally thought that it is the clustering of gadolinium atoms on the nanoparticle that leads to the formation of an Auger shower inducing a strong increase in the dose deposited in the vicinity of the nanoparticle (6).

Another key property of nanoparticles is their prolonged retention in metastases. As a result, the radiosensitizer can be used under optimal conditions with the elimination of nanoparticles in healthy tissues and remanence in tumors. In addition, prolonged persistence in metastases provides a wide therapeutic window that could benefit to fractionated RT.

The expected benefits of radiosensitizers are to increase the effectiveness of the radiation dose administered in metastases to improve the local response to RT and the overall survival of the patient, without increasing the dose in the surrounding healthy tissues. Alternatively, radiosensitizers can be used to obtain an equivalent local response with a reduced radiation dose. In the particular case of AGuIX theranostic nanoparticles, MRI visualization can be advantageously used to achieve personalized and adaptive RT based on the local uptake of the Gd-based radiosensitizers. In the future, the use of Gd-based radiosensitizers will be particularly relevant to the emerging MR-Linac technology combining an MRI scanner and a linear accelerator on the same instrument (28).

There are some limitations to this study. First, because of the dose escalation objective of this phase 1 clinical trial, the number of patients receiving the highest dose is relatively low and corresponds to only two types of brain metastases. This limitation will be addressed in a recently launched phase 2 clinical trial that includes 100 patients injected with an identical dose of 100 mg/kg body weight and that covers similar types of brain metastases. The second limitation concerns the quantification of T1 relaxation values and nanoparticle concentration. These quantifications require a sufficiently high signal-to-noise ratio and are therefore carried out on regions of interest corresponding to metastases greater than 1 cm in diameter. However, we have shown in this study that the acquisition protocol yields a quasi-linear correlation between the MRI SE and the nanoparticle concentration. Therefore, the more reliable and sensitive measurement of SE will probably be preferred in future clinical trials to more accurately assess the nanoparticle uptake in smaller metastases. Last, only metastases with a diameter greater than 1 cm were considered in this study, in accordance with the response evaluation criteria in solid tumors (RECIST) criteria. Although SEs do not show variation with tumor diameter between 1 and 5 cm, it remains important to evaluate nanoparticle uptake in smaller metastases. In the phase 2 clinical trial, metastases with diameter down to 5 mm will be included in the protocol. The analysis of these smaller metastases will be facilitated by the largest administered dose (100 mg/kg body weight) and by the shortened delay between nanoparticle injection and MRI acquisitions.

In summary, the preliminary results of the clinical trial reported in this paper demonstrate in patients that an intravenous injection of Gd-based nanoparticles is effective for enhancing different types of brain metastases in patients. These first clinical findingspharmacokinetic, passive targeting, and concentration in metastasesare in line with the observations obtained in previous preclinical studies in animal models of brain tumor and bode well for a successful translation of this theranostic agent from the preclinical to the clinical level. In addition to this, the preliminary results of the NanoRad phase 1 clinical trial indicate good tolerance of intravenous injection of AGuIX nanoparticle up to the 100 mg/kg dose selected for this study. All these results and observations make it possible to confidently start a phase 2 clinical trial on the same indication (NANORAD2, NCT03818386).

This study is part of a prospective dose escalation phase I-b clinical trial to evaluate the tolerance of the intravenous administration of radiosensitizing AGuIX nanoparticles in combination with whole-brain RT for the treatment of brain metastases. This investigator-driven trial was sponsored by the Department of Clinical Research and Innovation of Grenoble Alpes University Hospital and performed in the Department of Radiotherapy of Grenoble Alpes University Hospital. Its Data and Safety Monitoring Board is composed of physicians who specialized in RT, oncology, and pharmacology. Approval was obtained from the Agence nationale de scurit du mdicament et des produits de sant (ANSM) (French National Agency for the Safety of Medicines and Health Products; EudraCT number 2015-004259-30) in May 2016. The NanoRad trial (Radiosensitization of Multiple Brain Metastases Using AGuIX Gadolinium Based Nanoparticles) was registered as NCT02820454. The study began in June 2016 and was completed in February 2019. Here, we report the findings of the MRI protocol applied to the 15 recruited patients. The objectives assigned to this MRI ancillary study were (i) to assess the distribution of AGuIX nanoparticles in brain metastases and surrounding healthy tissues and (ii) to measure the T1-weighted contrast enhancement and nanoparticle concentration in brain metastases and surrounding healthy tissues after intravenous administration of AGuIX nanoparticles. Detailed information on the NanoRad trial is available in the paper from Verry et al. (29).

Patients with multiple brain metastases ineligible for local treatment by surgery or stereotactic radiation were recruited. Inclusion criteria included (i) minimum age of 18 years, (ii) secondary brain metastases from a histologically confirmed solid tumor, (iii) no prior brain irradiation, (iv) no renal insufficiency (glomerular filtration rate, >60 ml/min per 1.73 m2), and (v) normal liver function (bilirubin, <30 M; alkaline phosphatase, <400 UI/liter; aspartate aminotransferase, < 75 UI/liter; alanine aminotransferase, < 175 UI/liter). All patients provided written informed consent in accordance with institutional guidelines.

AGuIX product was provided by NH TherAguix. It is a sterile powder for solution containing gadolinium-chelated polysiloxane-based nanoparticles. AGuIX product was manufactured, controlled, and released according to Current Good Manufacturing Practice (cGMP) standards. This theranostic agent is composed of a polysiloxane network surrounded by gadolinium cyclic ligands, derivatives of DOTA (1,4,7,10-tetraazacyclododecane acid-1,4,7,10-tetraacetic acid), covalently grafted to the polysiloxane matrix (Fig. 5). Its hydrodynamic diameter is 4 2 nm, its mass is about 10 kDa, and it is described by the average chemical formula (GdSi47C2430N58O1525H4060, 5 to 10 H2O)x. On average, each nanoparticle presents on its surface 10 DOTA ligands that chelate core gadolinium ions. The longitudinal relaxivity r1 at 3 T is equal to 8.9 mM1 s1 per Gd3+ ion, resulting in a total r1 of 89 mM1 s1 per AGuIX nanoparticle.

(A) Schematic representation of AGuIX nanoparticles. DOTA(Gd) species are grafted to the polysiloxane core (Si, pearl gray; O, red; C, gray; N, blue; Gd, metallic blue; and H, white). (B) Main properties of AGuIX nanoparticle. (C) Hydrodynamic diameter distribution of AGuIX nanoparticles as obtained by dynamic light scattering. (D) Zeta potential of AGuIX nanoparticle as a function of the pH.

The timeline of the trial is summarized in Fig. 6. The main steps of the trial protocol were as follows. At day 0, patients underwent a first imaging session (see MRI protocol in next paragraph) 15 min after the intravenous bolus injection of Dotarem (gadoterate meglumine) at a dose of 0.2 ml/kg (0.1 mmol/kg) body weight. One to 21 days after the first imaging session (depending on patient availability and radiation therapy planning), the patients received a single intravenous administration of AGuIX nanoparticle suspension at doses of 15, 30, 50, 75, or 100 mg/kg body weight. The date of AGuIX nanoparticle administration is referred as day 1. The same MRI session, without injection of gadoterate meglumine, was performed 2 hours after administration of the nanoparticles. All the patients underwent a whole-brain radiation therapy (30 Gy delivered in 10 sessions of 3 Gy) starting 4 hours after administration of the nanoparticles. Seven days (day 8, no Dotarem injection), 4 weeks (day 28, Dotarem injection), and then every 3 months during 1 year after the AGuIX nanoparticles were administered, a similar MRI session was performed for each patient.

At day 0 (D0), the patients underwent an MRI session with injection of Dotarem. At D1, the patients received a single intravenous (IV) injection of AGuIX nanoparticles. Two hours later, the patients underwent an MRI session. After 2 more hours, the patients received their first session of whole-body radiation therapy (WBRT; 30 Gy split in 10 fractions). Further MRI sessions were performed at D8 (no Dotarem injection), D28 (Dotarem injection), month 3 (M3), and then every 3 months for 12 months (Dotarem injection).

The MRI acquisitions were performed on a 3 T Philips scanner. The 32-channel Philips head coil was used. Patients underwent identical imaging protocol including the following MRI sequences: (i) 3D T1-weighted gradient echo sequence, (ii) 3D FLASH sequence with multiple flip angles, (iii) susceptibility-weighted imaging (SWI) sequence, (iv) fluid attenuated inversion recovery (FLAIR) sequence, and (v) diffusion-weighted imaging (DWI) sequence. Some of these imaging sequences are recommended when following the RECIST and RANO (response assessment in neuro-oncology) criteria for assessing brain metastases response after RT (30, 31). The 3D T1-weighted imaging sequence provides high-resolution contrast-enhanced images of healthy tissue and brain metastases following MRI contrast agent administration. The 3D FLASH sequence is repeated several times with a different flip angle for computing T1 relaxation times and contrast agent concentration. The SWI sequence is used for detecting the presence of hemorrhages. The FLAIR sequence is applied for monitoring the presence of inflammation or edema. Last, the DWI sequence can be applied for detecting abnormal water diffusion in tissue or brain metastases. The total acquisition time ranged between 30 and 40 min depending on patient-adjusted imaging parameters. The key features and the main acquisition parameters of these imaging sequences are detailed in the Supplementary Materials.

MRI analyses were performed using an in-house computer program called MP3 (https://github.com/nifm-gin/MP3) developed by the GIN Laboratory (Grenoble, France) and running under MATLAB software. Image analyses include counting and measurements of metastases, quantification of contrast enhancement, relaxation times, and concentration of nanoparticles. Following RECIST and RANO criteria, solely metastases with longest diameter above 1 cm were considered as measureable and were retained in subsequent analyses. The MRI SE, expressed in percentage, was defined as the ratio of the difference between the amplitude of the MRI signal after the administration of the contrast agent and before the administration of the contrast agent over the amplitude of the MRI signal before the administration of the contrast agent, the MRI signal amplitude being measured in the 3D T1-weighted image dataset. The T1 relaxation times were derived from the 3D FLASH images obtained at four different flip angles. The concentration of nanoparticles in brain metastases was derived from the variations of T1 relaxation times before and after contrast agent administration and from the known relaxivity of the nanoparticles. The details about the acquisition and the procedure for computing the T1 values and the concentration are given in the Supplementary Materials.

A 3D image rendering was performed using the BrainVISA/Anatomist software (http://brainvisa.info) developed at NeuroSpin (CEA, Saclay, France). To better visualize the location of the different metastases, the Morphologist pipeline of BrainVISA was used to generate the meshes of both the brain and the head of each patient.

All analyses were performed using GraphPad Prism (GraphPad Software Inc.). Significance was fixed at a 5% probability level. All of the data are presented as means SD.

Acknowledgments: This work was performed on the IRMaGe platform member of France Life Imaging network (grant ANR-11-INBS-0006). Funding: The clinical trial was funded by the Centre Hospitalier Universitaire (CHU) of Grenoble and the company NH TherAguix (Meylan, France). Author contributions: C.V. is the trial coordinator and the main investigator of the clinical trial. C.V., J.B., S.D., G.L.D., and O.T. defined the study design. C.V., S.G., S.D., G.L.D., and O.T. designed the MRI protocol. J.P. and I.T. performed the MRI acquisitions. S.D., B.L., S.G., Y.C., S.M., B.L., E.L.B., and O.T. contributed to data quantification and MRI analysis. S.D. and Y.C. performed statistical analysis. Y.C. wrote the paper, and all authors revised it critically, contributed to it, and approved the final version of the manuscript. Competing interests: F.L. and O.T. are authors on a patent filed by NANOH, Universit Lyon 1, Institut National des Sciences Appliques de Lyon (no. WO2011135101 A3, published 31 May, 2012). G.L.D. and O.T. are authors on a patent filed by Universit Claude Bernard Lyon 1, Hospices Civils de Lyon, Centre National de la Recherche Scientifique, NANOH, European Synchrotron Radiation Facility (no. WO2009053644 A8, published 17 December 2012). These patents protect the AGuIX nanoparticles described in this publication. S.D., Y.C., O.T., F.L., and G.L.D. are employees from NH TherAguix that is developing the AGuIX nanoparticles. The authors declare that they have no other competing interests. Data and materials availability: All data needed to evaluate the conclusions in the paper are present in the paper and/or the Supplementary Materials. Additional data related to this paper may be requested from the authors.

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Targeting brain metastases with ultrasmall theranostic nanoparticles, a first-in-human trial from an MRI perspective - Science Advances

You can see Comet NEOWISE this month. Here’s what we know about it – CNN

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Once it disappears from view, the comet will not be visible in Earth's skies for another 6,800 years, according to NASA.

While July began with the comet visible low on the horizon in the early morning sky, NEOWISE has now transitioned to become an evening comet, perfectly visible as the skies darken.

It's named after NASA's Near-Earth Object Wide-field Infrared Survey Explorer, otherwise known as the NEOWISE mission, which discovered it in late March.

You may be able to see it with the naked eye, but grab a pair of binoculars or peer through a small telescope, if you have either, for a better view.

If you live in an urban area with a lot of light pollution, you may want to find a spot to watch the sky that has less light and obstructions, like tall buildings.

After the sun sets, look for the Big Dipper constellation in the northwestern sky, according to NASA. Just below it, you'll see the comet. It looks a bit like a fuzzy star with a tail.

The comet will continue to rise higher above the northwestern horizon for the rest of this month. It will come closest to Earth on July 22 -- just 64 million miles away.

While comets are unpredictable and can disappear from view at any time, astronomers predict that we should be able to see it for the rest of the month.

Comets are really just made up of ice and dust, with some organic material. Many of the comets with long orbits, like NEOWISE, only venture through the inner solar system and close to the sun for a short time.

Scientists compare it to coming out of "cold storage" for the comet because the outer solar system where they originate is so much colder. The warmth of the sun and the inner solar system causes the ice to melt, although astronomers aren't sure why ATLAS broke apart.

After its closest approach to Earth, Comet NEOWISE will continue on its very long orbit to the edge of the solar system, stretching out 715 astronomical units from our sun. (As a comparison, Earth is one astronomical unit from the sun.)

This is why we won't see the comet again in our lifetimes -- it takes thousands of years to travel the outer solar system before returning to the inner solar system.

But, scientists point out, this means the comet isn't exactly new, only new to us, because it previously passed through Earth's skies when humans were present about 6,800 years ago.

Discovering Comet NEOWISE

While Comet NEOWISE was spotted on March 27 by NASA's Near-Earth Object Wide-field Infrared Survey Explorer, the mission didn't start out to find comets.

Ten years ago, the mission was launched as WISE and it was designed to do an all-sky map in infrared light.

But the team realized that it was also pretty useful for observing asteroids and comets and measuring their sizes and how reflective they were, said Amy Mainzer, the NEOWISE principal investigator at the University of Arizona, in a NASA press conference this week. The NEOWISE mission has found a couple dozen comets so far.

The WISE mission was only designed to last for about seven months, but NASA asked the team to reactivate it after its prime mission concluded in 2013, and they've been using NEOWISE to watch the skies ever since, Mainzer said. The team estimated that the NEOWISE mission only has about one year left.

"We're excited it's still able to find spectacular things like this comet," Mainzer said.

The team spotted Comet NEOWISE by its infrared emissions, meaning they could pick out its heat signature. In late March, the scientists determined it was a comet and when it would pass close to the sun -- and they've been tracking it ever since.

By observing the comet, the researchers have learned that it's about three miles in diameter, the average size for a comet with a long orbit. And it's incredibly bright, even if it's not as spectacular as Comet Hale-Bopp as witnessed in 1997.

Sometimes when comets that have a lot of mass, like NEOWISE, they can blow apart when they come close to the sun. Their ice becomes heated so quickly that it shreds and destroys the comet, Mainzer said. Because this comet survived, it tells astronomers there is something unique about its structural strength.

The comets in our solar system formed at its very beginning. Gas and dust formed in clumps orbiting in a disk around our young sun, and those clumps became planets, asteroids and comets. The comets were kicked out to the edge of the solar system, so their ice remains pristine.

NASA scientists and the NEOWISE team will continue observing the comet with various instruments and cameras to see how it progresses, said Emily Kramer, co-investigator on the NEOWISE science team at NASA's Jet Propulsion Laboratory in Pasadena, California.

Because the comet is so bright, the scientists expect to get better data, and much more of it, than they typically do for most comets, Kramer said.

Most comets are so faint that they can only be seen using the most powerful telescopes. Scientists are looking forward to learning the composition of this comet based on the data they gather. That composition could reveal more information about the "ingredients" used to make our solar system.

Although this comet takes a long time to complete one orbit around the sun, some that originate further out in the solar system can take hundreds of millions of years to orbit the sun or even longer, Mainzer said. Meanwhile, some of the closer comets only take about five or six years to complete an orbit. Comet NEOWISE is in the middle, taking about 7,000 years.

"This is coming in from a medium-long distance," Mainzer said. "How it got there is a bit of a mystery. It may have had a more distant orbit that was perturbed to create this current orbit."

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You can see Comet NEOWISE this month. Here's what we know about it - CNN

Snap a pic of this spectacular comet now — it won’t be back for 6,800 years – Bangor Daily News

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PORTLAND, Maine The newly discovered comet NEOWISE is putting on a show in the early evening skies over Maine right now. Its one of the rare comets to reveal its tail to anyone with a modest set of binoculars and NEOWISE gets even more impressive when you take its picture.

In my life, Ive seen 30 or 40 comets. This is only the fourth one Ive seen that has a tail you can obviously see, said astronomy educator and photographer John Meader of Fairfield.

Meader knows what hes talking about.

Since 1987, hes operated the Northern Stars Planetarium. Its an inflatable star dome that travels to about 100 elementary and middle schools in Maine every year, reaching upwards of 18,000 students. Before that, Meader worked in planetariums at the Francis Malcolm Science Center in Easton and the University of Maine in Orono.

You cant see most comets without a telescope and, most of the time, they look like a star someone tried to erase with an eraser and theres no discernable tail, he said. With this one, you look through binoculars and youll see that tail. Its really clear.

NEOWISE has been visible in Maine for at least a couple weeks but until a few days ago, you had to be up before dawn to see it. Now, its viewable in the evening just after sunset. NEOWISE is expected to be 10 percent brighter by this weekend and it will hang around in the sky until mid-August.

The comets propper name is C/2020 F3 NEOWISE. Its named for NASAs Near Earth Object Wide Field Infrared Survey Explorer orbiting telescope, which first spotted it on March 27. Like all comets, its basically a giant, space-traveling dirty snowball of ice and organic materials leftover after the formation of our solar system 4.6 billion years ago. NEOWISEs tail is made of dust and vaporizing gases given off as it travels close to the sun.

Its worth noting that, as the comet comes close to Earth on its giant orbit around the solar system, this is our only chance to get a good look at it and its conspicuous tail. NEOWISE wont be back this way in any of our lifetimes.

To find the comet yourself, Meader said, just grab some binoculars. Any pair will do. They dont have to be expensive. Their power lies not in making NEOWISE look bigger but by gathering more light than your eyes can on their own.

Scan just above the horizon in the northwest just after sunset and it will pop right into view, Meader said. Youll see it with a nice little tail. Its very sweet.

Its possible, with a very dark sky, to see the comet without binoculars, Meader said, but it will be difficult. Also, he warns that through binoculars, it wont look exactly like the impressive photographs hes taken. Just as the binoculars collect more light with their lenses, a camera takes in even more with long exposures.

You have to remember that when you do photography, youre gathering photons over time, which brightens everything up, Meader said. Your eyes cant do that.

Its the same reason glossy space pictures of the sky always show more stars and a clearer Milky Way than the human eye can detect. Meaders recent photo of NEOWISE in Skowhegan was a 5-second exposure.

To make a photograph of the comet, Meader said photographers will need a camera with manual controls, a tripod and some kind of remote shutter control or timer.

First, find the comet with binoculars and then point your tripod-mounted camera in the same direction, manually focusing it to infinity. Then, crank the ISO up high thats the cameras light sensitivity and open the aperture up all the way. The aperture is the hole inside the lens, controlling how much light gets through.

To make the exposure, set the shutter to something like 5 seconds and fire away. Use a remote control or the timer function which will ensure you dont shake the camera by pressing the shutter button with your finger.

If the picture comes out too light, make the shutter speed a tad faster. If its too dark, make it longer.

But you cant take a very long exposure because the stars will start to trail, Meader said.

Thats because, even though we cant perceive it, the Earth is rotating on its axis, making the stars appear to revolve around the North Star every night.

Meader said its all about experimenting with your cameras settings and admits, theres some nights when his pictures dont come out, either. The important part is to have fun outside, under the heavens, he adds.

It gets you out to someplace interesting, he said. Its getting yourself in front of something of beauty. I like that.

John Meader is hosting a socially-distanced public star party at the Quarry Road Trails in Waterville from 11 to 11:45 p.m. Wednesday.

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Snap a pic of this spectacular comet now -- it won't be back for 6,800 years - Bangor Daily News

Don’t Miss the Comet! – SETI Institute

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Have you ever seen a comet in the flesh? If you live in the northern hemisphere, you can cross that experience off your bucket list before bedtime tonight.

The NEOWISE comet takes its name from the instrument that found it, the repurposed Wide-field Infrared Survey Explorer (WISE) telescope. Launched in 2009, WISEs mission was to map the sky in infrared wavelengths. But after its coolant dissipated, the telescope gaze was turned on a different sort of prey: small objects in our solar system. So far, this orbiting instrument has bagged nearly three hundred nearby asteroids and 28 comets. One of the latter, NEOWISE, has been adorning the pre-dawn sky for weeks. But as of today its emerging in the early evening. It awaits your inspection.

Heres what you have to do: Grab a pair of binoculars and go out into the evening twilight, about an hour after sunset. While the sky becomes darker, look towards the north-northwest and scan just above the horizon. In the coming days, the comet will gradually climb higher, but also become fainter as it pulls away from the Sun.

Once youve spotted NEOWISE, youll be able to pick it out with the naked eye. Obviously, a dark sky is a plus, particularly if you want to see the tail. You might wish to consider a quick road trip to a rural area if you live in an urban or suburban conurbation.

The comet will get no closer than 64 million miles to Earth (on July 22), so no need to dig a bomb shelter. SETI Institute astronomer Peter Jenniskens also advises that there will be no meteor shower associated with this object.

Seeing a comet in the sky used to be taken as an omen (see: King Harold and the Battle of Hastings.) NEOWISE may not be an omen, but is an opportunity. Sure, you could bide your time until Halleys comet returns, but that will be in 2061. Waiting will be a drag.

More observing details published bySky & Telescopecan be found athttps://skyandtelescope.org/press-releases/new-bright-visitor-comet-neowise/

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Don't Miss the Comet! - SETI Institute

Dennis Mammana: The Iceball Cometh This Week with Comet NEOWISE – Noozhawk

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Its been quite a while since weve seen a bright comet in our skies. Many stargazers remember the show put on by Comet Hale-Bopp 23 years ago, but most folks cant recall seeing another one since.

One is now swinging past the Earth and, while it wont compare to Hale-Bopp, it has become barely visible to the unaided eye.

Im referring to a visitor from space called C/2020 F3, aka Comet NEOWISE, named for the NASA space telescope that discovered it: Near-Earth Object Wide-field Infrared Survey Explorer.

Comet NEOWISE, like all others, is one of billions of small icy remnants of the primordial solar system that tumble silently through space. Occasionally, one of these cosmic nomads drifts inward toward the suns heat, and its ices disintegrate into a cloud of gas and dust around its nucleus (the coma). Sunlight and the solar wind act as a fan and blow this material outward to create one or two tails that always point away from our star.

With a diameter of about 3 miles, the icy nucleus of NEOWISE is fairly large but much too small to be seen with the eye or even a powerful telescope. Its long tail, however, can be seen as it stretches away from the direction of the sun (below the horizon after dark, of course).

As compact as a comets tail may appear to us from Earth, its material is actually distributed over tens of millions of miles; in fact, to achieve the density of the air we breathe, a comets entire tail would need to be compressed to fit into the size of an average suitcase. In other words, a comets tail is the closest thing to nothing thats still something!

Comet NEOWISE is a type of comet known as a periodic comet; it passes through our cosmic neighborhood about every 6,800 years. During this visit, it swung close to the sun in early July and brightened enough to become barely visible to the unaided eye during predawn hours.

Now its crossing over into the evening sky, and on July 22, it will reach its nearest approach to the Earth of 64.3 million miles.

Just how bright NEOWISE will appear as it passes us this week is anyones guess. Will it be bright enough to see with the unaided eye, or will it fade as it recedes once again into the depths of space? No one can say for sure.

Comets are notoriously fickle. As noted comet-hunter David Levy likes to say: Comets are like cats. They both have tails and they both do what they want.

Their unpredictable and ghostly nature has led people over the ages even some today to interpret them as cosmic harbingers of doom.

Nevertheless, it may be possible to spot this interplanetary nomad in the evening sky this week if youve got very dark skies far from the lights of large cities. Over the next week, NEOWISE will appear in the northwestern sky shortly after dark, just below the Big Dipper.

Be sure to check out the accompanying illustration and grab binoculars to locate and enjoy the amazing interplanetary iceball this week after dusk!

Dennis Mammana is an astronomy writer, author, lecturer and photographer working from under the clear dark skies of the Anza-Borrego Desert in the San Diego County backcountry. Contact him at [emailprotected] and follow him on Twitter: @dennismammana. The opinions expressed are his own.

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Dennis Mammana: The Iceball Cometh This Week with Comet NEOWISE - Noozhawk

Applying to residency is tough even in normal times. The pandemic isn’t helping. – AAMC

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Last year, Samuel Bunting, a student at the Chicago Medical School at Rosalind Franklin University of Medicine and Science, spent his psychiatry clerkship helping LGBTQ+ patients handle such painful issues as family rejection, social stigma, and substance use. He quickly saw that working with this population was his calling. I knew that if I had been a little less fortunate in how I grew up, that very easily could have been me, says the fourth-year student. "It was one of the most meaningful experiences Ive ever had.

Now, though, Bunting worries about landing a spot in a residency program that shares his values and supports his goals. Like tens of thousands of other residency applicants, Bunting fears the numerous ways that COVID-19 is hobbling this years application process.

Honestly, Im not a good standardized test-taker, but I am an outstanding student by other measures like leadership, says Bunting. I worry that those wont matter as much given the lack of in-person interviews and the many other changes in the application process that were seeing.

The transition to residency is tough even in normal times. It typically starts during the third year of medical school, when students gather key components letters of recommendation, a personal statement, and more that they can then load into the Electronic Residency Application Service (ERAS) starting in June. The goal is to land coveted interview invitations, which usually get taken almost as soon as theyre offered. Interviews begin in the fall, span months, and culminate, applicants hope, with offers from their top picks in the National Resident Matching Program in March.

But this years application cycle will be far from typical.

Program directors are stressed out about how were going to recruit and pick the right students for our programs and the medical students are a thousand times more stressed than we are.

Melvyn Harrington, MDProgram director for orthopedic surgery, Baylor College of Medicine

Clinical clerkships were disrupted, so applicants will have difficulty getting desired letters of recommendation, and many students had their board exams postponed, some more than once, says Jessica Kovach, MD, director of the psychiatry residency program at Lewis Katz School of Medicine at Temple University. On top of that, the Coalition for PhysicianAccountability a group of medical education organizations that includes the AAMC recommended ending all in-person interviews and strictly limiting audition rotations at residency programs because of the pandemic.

This is a seismic shift, says Melvyn Harrington, MD, program director for orthopedic surgery at Baylor College of Medicine. Program directors are stressed out about how were going to recruit and pick the right students for our programs and the medical students are a thousand times more stressed than we are.

Harrington and others worry that student stress may send application numbers skyrocketing. In fact, candidates were already submitting increasing numbers of applications even before COVID-19. Thats because the number of U.S. medical school students has grown 31% since 2002 but residency slots have not kept pace, largely due to insufficient federal funding.

Perhaps even more worrisome, experts say, is the potentially unequal impact of changes on certain students, including those from groups that are underrepresented in medicine, many of whom have been hit hard by COVID-19, racial injustice, and current social, political, and racial unrest.

All this has sent leaders in academic medicine searching for effective solutions. ERAS extended its deadline from Sept. 15 to Oct. 21 to give applicants extra time to build their application portfolios. In addition, medical schools, program directors, and national organizations have been pumping out resources and recommendations to guide all involved through this unprecedented application cycle.

This year, there has to be robust engagement between schools, residency programs, and learners, and Ive certainly been seeing this, says Jennifer LaFemina, MD, general surgery program director at the University of Massachusetts Memorial Medical Center. Sometimes, as we educators work to support our learners at different phases, we dont always work in tandem, but now we must be collaborative every step of the way. If we dont, we could lose sight of what this comes down to: safety and equity for all our learners.

For residency applicants, there are two basic stages in the quest for a slot: the steps leading up to landing an interview and then, hopefully, acing the interview.

Several factors go into a program's decision to offer an interview, and many of those have been upended by the need to protect students and the public during the pandemic.

Among the most influential metrics are scores on the United States Medical Licensing Examination (USMLE), which assesses such crucial areas as clinical knowledge. This year, the test-taking process has been unusually unnerving.

In March, as the pandemic spread, the company that runs USMLE test sites temporarily ended all exams in the United States and Canada. Sites began reopening in May, but many students have been affected by last-minute cancellations as the company has limited the number of test-takers to enable social distancing.

I was ready, but I didnt know when I could take the test, says Adiba Matin, a fourth-year student at the University of Missouri - Kansas City School of Medicine. It was very stressful trying to keep all the information fresh in my mind, she adds. Ultimately, my test was postponed four times.

Also topping applicants worries are landing valuable letters of recommendation.

Students have a lot of anxiety about getting letters that reflect their true abilities, says Angela Jackson, MD, associate dean of student affairs at Boston University School of Medicine. Much of the concern lies in lost opportunities to impress faculty as the pandemic shuttered clerkships for months this spring. Even now that students are back, sometimes the volume of patients is down, so they have fewer chances to show their skills, she notes.

It was very stressful trying to keep all the information fresh in my mind. Ultimately, my test was postponed four times.

Adiba MatinUniversity of Missouri - Kansas City School of Medicine

Students are also concerned about the canceling of away rotations often called audition rotations that work like weekslong trial runs at outside institutions. In 2019, 56% of medical students completed these rotations, and some did several.

Now, 98% of responding schools have decided to curtail away rotations, according to an AAMC survey, with a number allowing exceptions for medical specialties that are unavailable at their own schools.

Meanwhile, some students say they will take advantage of a new option: virtual away rotations. In fact, nearly 70 of these remote options have sprung up in more than a dozen specialties. How will they work? A program might send students information about patients and then ask them to present their treatment recommendations via Zoom, for example. Its not the same as in-person interactions, students say, but theyre glad to have some creative alternatives.

Even though the experience will be remote, I believe it still can deepen my knowledge in my future specialty, says Ushasi Naha, a fourth-year student at the University of Illinois College of Medicine. I also like that virtual aways can provide me the opportunity to show interest in some of my top residency programs.

Before COVID-19, applicants attended 13 interviews on average and often spent thousands of dollars traveling to them. This year, as the pandemic has forced interviews online, students are thrilled with the cost-savings. But many also fear the downsides of going virtual.

People are concerned about conveying personality in a virtual interview, Naha says. Then there are worries about good lighting, good internet, and a quiet place to take an interview that could last all day.

Virtual interviews also mean applicants will lose traditional opportunities to size up programs, especially such intangibles as interpersonal dynamics that they might assess at pre-interview dinners and other informal events.

Now, applicants are hoping for other ways to gain such glimpses. For example, students want private chats with existing residents where they can ask some tougher questions, says Robbie Daulton, a fourth-year University of Cincinnati (UC) College of Medicine student who surveyed fellow students for a paper on this years process.

People are concerned about conveying personality in a virtual interview. Then there are worries about good lighting, good internet, and a quiet place to take an interview that could last all day.

Ushasi NahaUniversity of Illinois College of Medicine

Meanwhile, as programs and applicants all gear up for interviews, they share one key concern: Will candidates accept many more interviews than before since they wont have to travel?

Now it could be a lot easier for students to hold on to more invitations than they truly need, says Aurora Bennett, MD, associate dean for student affairs at the UC College of Medicine. Advisors will have to help more competitive students let go of some interviews, she adds. They need to identify a reasonable number to have a successful match and release others so their peers who need them can have them.

Faced with unprecedented challenges, leaders in academic medicine say theyre working hard to determine how to ease application obstacles and assess students fairly.

Each program will determine how it can best address any current limitations in the process, notes Alison Whelan, MD, AAMC chief medical education officer. I continue to be impressed with the creativity, energy, and commitment that both schools and programs are using to overcome barriers and create a successful process. Some programs are considering such new approaches as requesting secondary essays about why an applicant is drawn to that institution.

Certainly, we hope programs will use holistic review, looking at a candidates full range of experiences and attributes and we have heard of a variety of ways programs are tackling this, given their time limitations and stresses related to their current residents and the ongoing pandemic, Whelan adds.

Richard Church, MD, emergency medicine residency director at the University of Massachusetts Medical School, is determined to give every application its due. This year, I have to be even more diligent, examining every single part of applications, he says. The increased load may require him to enlist additional application readers an option that may not be feasible for all programs, he notes.

Church advises this years residency hopefuls to think carefully about how to highlight key achievements in their ERAS applications.

A lot of applicants went to great lengths to do something productive with themselves [when clerkships closed], so even if its not the usual type of experience, they should present that. And if they didnt do much, they should explain why.

He also notes that letters will be particularly important to him this year in the absence of some other metrics. Id tell applicants to put serious thought into who you want to write your letters. Look for people who can speak to you as a student as well as to you as an individual.

On his end, Harrington predicts research output will play a larger role since students could perform duties like literature reviews online during the pandemic. We will, of course, continue to look at grades and traits like leadership, he adds. Also, I think applicants will need to be creative with their personal statements to really tell their individual stories and help them stand out.

As programs and applicants feel their way forward, national organizations are providing guidance and support. For one, USMLE leaders say they are committed to testing applicants in time for scores to reach programs in October.

Meanwhile, the AAMC and other groups are working to create resources to support students and programs in navigating the many changes. For one, the AAMC and several other organizations recently began providing a tool called Residency Explorer to help candidates apply more effectively. The AAMC also released resources on virtual interviews and issued guidance for explaining students pandemic-related limitations on the Medical Student Performance Evaluation, a structured assessment provided by an applicants medical school.

Theyre not going to believe me until its over, but its going to be okay. I tell them its our job to help make sure its okay.

Angela Jackson, MDAssociate dean of student affairs, Boston University School of Medicine

In addition, many medical specialty organizations have issued COVID-19-related suggestions, such as that programsloosenrules around numbers and types of recommendation letters.

Medical schools are stepping up to help as well. For example, Boston Universitys Jackson is offering various application-related events, including a virtual-interview workshop featuring tips from broadcast journalists. The office also is increasing the number of scheduled guidance sessions and connecting students with recent alumni who can provide insights as applicants assess whether a program might make a good fit.

Jackson says shes determined to help students succeed despite any obstacles. Theyre not going to believe me until its over, but its going to be okay, she notes. I tell them its our job to help make sure its okay.

As leaders strive to help all applicants, they worry in particular about those who may be most affected by the pandemic, including students of color.

Theres an ongoing sense of exhaustion from having to deal with racism in this society, says Alex Lindqwister,national chair of the AAMCs Organization of Student Representatives. On top of that, theres COVID-19, which disproportionately affected African American students, many of whom also live in cities that have been affected by police brutality and recent protests, he adds. I hope holistic review will help, that programs will look at the context in which applicants managed to make their achievements.

Harrington worries that some students who lack connections will be at a disadvantage. With so many changes, Im concerned that things are going to fall back a bit to the old boys club of who's making phone calls or sending emails for you. In his field of orthopedic surgery, national organizations dedicated to diversity are trying to mentor students and reach out to programs on their behalf, he notes.

Economic disparities play a role as well, say observers. For example, some students may have weak Wi-Fi or other less-than-ideal at-home interviewing conditions. Maybe someone is in their small childhood bedroom for their virtual interview, but someone else is at their parents lake house, so thats their beautiful backdrop, says Daulton.

In response, schools are working to offer students campus spaces for their interviews. Daulton makes another suggestion: Schools or programs should provide a standardized interview backdrop to level the playing field. "Were also recommending anti-racism and implicit bias training for people involved with application evaluation.

Individuals from lower-income backgrounds also sometimes attend lesser-known medical schools, which could hurt their chances, says Lindqwister. A lot of these issues all tie in together as certain students face multiple inequities.

Matin says she attends a lesser-known school, and she worries that given all the COVID-19-related changes, programs are going to look at names and numbers a little bit more intensely this cycle.

Still, Matin remains optimistic. At the end of the day, Im confident Ill match somewhere, she says. I know Ill be able to help patients, which is really all I want to do.

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Applying to residency is tough even in normal times. The pandemic isn't helping. - AAMC

New COVID-19 Medical Response Office to Oversee University-wide Virus Monitoring and Testing – UPJ Athletics

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Expert faculty members in the University of Pittsburghs School of Medicine are at the helm of a new COVID-19 Medical Response Office, which will oversee the implementation of a virus monitoring program on all five Pitt campuses. The program will direct the Universitys COVID-19 testing, contact tracing, reporting procedures and isolation and quarantine protocols.

Tracking this virus will be vital to our response and return to campus in the fall, said Anantha Shekhar, senior vice chancellor for the health sciences and John and Gertrude Petersen Dean of theSchool of Medicine. Fortunately, Pitt is home to some of the best and brightest scholars in this fieldresearchers and clinicians from our world-renowned health sciences programand few universities are better equipped to support the well-being of its faculty, staff and students.

The COVID-19 Medical Response Office will report to Shekhar, who also chairs the Universitys Healthcare Advisory Groupa team of medical experts responsible for setting and monitoring campus health and safety guidelines during the pandemic.

John V. Williams, chief of the medical schools Division of Infectious Diseases, Henry L. Hillman Endowed Chair in Pediatric Immunology and professor of pediatrics, will direct the new office.

Williams is a member of the Universitys Healthcare Advisory Group and serves as the director of the Institute for Infection, Inflammation, and Immunity in Children. He is alsoa faculty member in the graduate program in Microbiology and Immunology and an affiliate in the Center for Vaccine Research.

Supporting Williams as the offices chief operating officer isChristopher P. O'Donnell,and faculty membersElise Martin and Joe Suyama.

ODonnell is a professor of medicine in the medical schools Division of Pulmonary, Allergy and Critical Care Medicine and executive vice chair of academic affairs in theDepartment of Medicine. He is also assistant vice chancellor for Special Projects in the Health Sciences and played a central role in developing School of Medicine guidelines for the restart of research operations in June.

Martin is an assistant professor in the Department of Medicine and Division of Infectious Diseasesand the associate medical director of infection prevention and hospital epidemiology for UPMC Presbyterian.

Suyama is an associate professor in the Department of Emergency Medicine and chief of emergency medicine services at Magee-Womens Hospital of UPMCs emergency department. He recently co-chaired the UPMC Pandemic Flu Task Force and assisted in its preparedness and response efforts to the 2009 H1N1 pandemic.

What we are doing, along with our teams, is taking the great work done by the Healthcare Advisory Group and others and translating it into practice across the University, Williams said.

For example, we know testing plays a crucial role in virus monitoring. The COVID-19 Medical Response Office is charged with looking at what testing is available, what the latest guidance says, what the best science says and determining who should be tested, when they should be tested and where those tests should be performed.

With the help of data analytics and administrative staff members, the office will develop and oversee implementation of the virus monitoring program, including strategies, protocols and methods for testing, symptom monitoring, contact tracing and quarantine and isolation on all five of the Universitys campuses.

While this office will implement virus monitoring protocols, the COVID Medical Response Office will not provide medical care or medical advice.

Symptomatic individuals and those with positive COVID-19 test results should call Pitts Student Health Service or employee health clinic, MyHealth@Work.

The University will continue posting information about COVID-19 on campus at coronavirus.pitt.edu.

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New COVID-19 Medical Response Office to Oversee University-wide Virus Monitoring and Testing - UPJ Athletics

‘Foundational knowledge’: School of Medicine reflects on anti-racist curriculum changes – University of Pittsburgh The Pitt News

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Gabby Gilmer, a rising second-year medical student, said she believes racism is deeply ingrained in medicine, which is why an anti-racism curriculum is necessary for every future physician.

We as physicians in training need to be trained to understand our patients, because right now our curriculum trains us to be racist not directly, but with implicit biases, Gilmer said. Removing our blinders and forcing us to see this reality is one tiny baby step to improving.

This belief is what prompted Gilmer along with another 97 rising second-year medical students to sign up for a voluntary book club this summer and read Medical Apartheid by Harriet Washington. This book focuses on medical experimentation and other cruelties against Black people by health care providers and how this history impacts medical care today.

The book club is a continuation of an anti-racism curriculum change introduced last year in Clinical Experiences a required course for all medical students that runs from the beginning of spring semester of the first year through the fall semester of the second year. The anti-racism component was implemented for the first time in January 2020 with two mandatory lectures on health equity for all 147 medical students.

The course is taught by Andrew McCormick, an associate professor of pediatrics in the School of Medicine. McCormick developed this curriculum last fall alongside Dara Mendez, an assistant professor of epidemiology in the Graduate School of Public Health, and Jada Shirriel, the CEO of Healthy Start, a nonprofit focusing on improving maternal and child health.

This curriculum change was adopted months before a list of nearly 20 demands was drafted by medical students Casey Tompkins-Rhoades, Rachel Eleazu and Wheytnie Alexandre, as well as public health student Alexander Schuyler, in early June. The demands vary from scholarships for Black students to additional support staff to reforming school curriculum and policies.

Anantha Shekhar, the senior vice chancellor for health sciences and the schools dean, agreed to some of the demands, including creating four scholarships, reevaluating the role of the Schools Honor Council and enforcing serious consequences for racist behavior.

Mendez said this curriculum adjustment is only one component of the broader changes students are pushing for.

We have students who have demanded some really important things that should shift our culture, should shift our institution and what were doing in this class is a really small piece, Mendez said. Especially me as a Black faculty member, these are things weve been asking for a long time.

McCormick said while this curriculum revision is an important first step, it is not nearly enough. He said he hopes to make the book club mandatory next year, as well.

This is a starting conversation for a long, multiyear curriculum intervention, McCormick said. The ultimate goal is to have this be a springboard to larger curriculum changes to other courses in the School of Medicine and have it be not just a first-year intervention, but first-year, second-year, third- and fourth-year continuous dialogue.

In the American health care system today, Black patients health outcomes are markedly worse than white patients. Black people tend to receive lower-quality health services, including for cancer, H.I.V. and cardiovascular disease, as well as prenatal and preventative care. They are also more likely to have unnecessary limb amputations and have more than double the infant mortality rate.

Medical Apartheid touches on many of these statistics and how they originated. The first half of the book, which students have discussed thus far, focuses on some historical wrongdoings, including those of James Marion Sims, whos considered to be the father of modern gynecology, in which he conducted invasive experiments on enslaved Black women, often without anesthesia.

It also describes the Tuskegee syphilis experiment, a federally funded study where hundreds of Black men infected with syphilis were not given penicillin to cure the disease, so researchers could observe its natural course. Pitts Public Health building used to be named after Thomas Parran Jr., a former Pitt dean who presided over the Tuskegee and Guatemala syphilis experiments during his time as U.S. surgeon general. The building was renamed two years ago.

Gilmer said she was shocked upon learning this historical context, and is concerned about how many doctors before her never knew about this legacy of mistreatment.

I was appalled by this history, and I was further appalled by the fact that I am halfway through my pre-clinical experience and I had never heard of any of these things, Gilmer said. Thinking of all the doctors who have gone through medical school and likely have never heard any of this its imperative that everyone read it.

Arnab Ray, a rising second-year medical student who is also in the book club, said participating has been an eye-opening experience because it helped him recognize how injustices against Black patients were perpetuated in medicine and how to recognize these biases within himself.

The author mentions that surgeons didnt show empathy to Black bodies used for demonstrations in the surgical theater which got passed on to students, Ray said. Ive adopted a lot of views and attitudes about medicine from docs I respect, and with unconscious biases, sometimes you could inherit those values.

Ray added that the current medical school curriculum doesnt allow for self-introspection required to get rid of those biases, which is something he hopes will change.

Just because medicine isnt participating in what we would now completely condemn as horribly racist, it is more insidious in the forms it is creeping into medicine, Ray said. It should be mandatory because it directly plays into the oath we took at the beginning of medical school to learn how to be a supporter and advocate of every patient, no matter what kind of patient.

McCormick said these biases need to be examined because they impact medical care for many members of the Pittsburgh community and beyond.

This is foundational knowledge, just as much as learning anatomy and physiology, McCormick said. If we are physicians that care about the health of everyone in the community, we need to know how racism is impacting our ability to provide that care.

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'Foundational knowledge': School of Medicine reflects on anti-racist curriculum changes - University of Pittsburgh The Pitt News

Back to school: What physicians can say to parents weighing the decision – American Medical Association

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Should children return to school this fall? Amid the COVID-19 pandemic, its a question physiciansmost notably pediatricians and those practicing family medicineare likely to hear with increasing frequency in the coming months from patients. And its not an easy one to answer.

"Like any issue related to COVID-19, you are going to find a lot of opinions about it, said John Andrews, MD, the AMAs vice president for graduate medical education innovations, who has been a practicing pediatrician for three decades. Parsing those opinions is not at all easy.

So how should physicians address parental concerns about a return to school? Dr. Andrews offers these thoughts.

In late June, the American Academy of Pediatrics (AAP) released a statement that, with a number of caveats, strongly advocated all policy considerations for the coming school year should start with a goal of having students physically present in school.

Andrews says data that indicates children appear less likely to contract the disease, and when they do, they tend to recover well. Further, spread of the disease from asymptomatic children to other children or adults is uncommon. Communicating that to worried parents and presenting the adverse outcomes from keeping children home may, in fact, outweigh those of sending them back to school.

Its clear that the remote learning that many schools went to at the conclusion of the school year last year was essentially no learning at all, Dr. Andrews said. Educational outcomes will suffer if kids arent in school come the fall.

When kids are at home there are risks to that, as well. There may be increases in behavioral health issues. And, the risk of maltreatment as their families face distress is higher.

While its important to consider sending children back to school, theres going to be a risk, which many parents will, naturally, point out. Pushing back on those concerns isnt the role Andrews believes a doctor should play in current circumstances.

Im a pediatrician, Dr. Andrews said. Im a source of advice. The decision-makers in the lives of children are their parents. My approach is to share the information objectively and when asked for my opinion offer it. But its important to recognize parents make independent decisions.

When things really are a judgment call, and this is a case where that is true, Ill present the evidence and offer my opinion, but Ill acknowledge there will be some parents who wont be comfortable sending their kids back to school and thats something well have to figure out how to manage.

Theres more debate surrounding how the disease presents and afflicts older children, so the AAP advocates for schools to mandate more preventative measuressuch as mask-wearing and physical distancingin facilities that host older children. Even still, at any level of education, certain children will be more at risk.

The risk profile of the child is important, Dr. Andrews said. There are kids who are unique cases. The benefits of a structured education have to be weighed against the risk of exposure to infection.

As far as reducing the risk of that exposure, it is likely going to fall on the school systems to be realistic about what they can and cannot do. The AAP calls for policies to be nimble and responsive to new information regarding the pandemic. It also calls for them to be practical, feasible, and appropriate for child and adolescent's developmental stage.

Physicians can offer their take on what that could look like.

Parents need some reassurance about their ability or the ability of the school system to manage the behavior of children in a way that will reduce the risk of infection, Dr. Andrews said. Parents and the school systems may have unreasonable expectations about the way children behave at school. Activities like meals and recesses that promote uncontrolled contact between children may need to be carefully evaluated. As a physician, to have some frank conversations about that will be helpful.

Stay current on theAMAs COVID-19 advocacy effortsand track the pandemic with theAMA's COVID-19 resource center, which offers resources fromJAMA Network, the Centers for Disease Control and Prevention, and the World Health Organization.

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Back to school: What physicians can say to parents weighing the decision - American Medical Association

Bergenbio Announces First Patient Dosed in Recurrent Glioblastoma Investigator Sponsored Phase I/II Study Assessing Selective AXL Inhibitor…

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BERGEN, Norway, July 20, 2020 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, announces that the first patient has been dosed and continues on therapy in a trial assessing bemcentinib in recurrent glioblastoma (GBM). The trial is sponsored by Prof. Ichiro Nakano, MD, Professor in the Department of Neurosurgery and co-leader of the Neuro-Oncology Program at University of Alabama at Birmingham and funded by the National Cancer Institute (NCI).

This is an open label, multi-centre, intra-tumoral tissue pharmacokinetic (PK) study of bemcentinib in patients with recurrent glioblastoma for whom a surgical resection is medically indicated. The study will enrol up to 20 recurrent GBM patients, at up to 15 sites in the USA. 10 patients will be treated prior to surgery and 10 patients will have no pre-surgical treatment. However, all patients will receive treatment with bemcentinib following surgery. The endpoints of the study include an evaluation of bemcentinib's ability to cross the blood brain barrier, AXL expression, pharmacokinetics, safety and tolerability, as well as efficacy assessments including Progression Free Survival and Overall Survival. More information about the trial can be found at https://clinicaltrials.gov/ct2/show/NCT03965494

Increased expression of the receptor tyrosine kinase AXL is significantly correlated with poor prognosis in GBM patients and preclinical data has suggested that bemcentinib may be a promising therapeutic agent for GBM, particularly in post-irradiation mesenchymal-transformed GBM tumors[1]. A comprehensive translational research programme will run in parallel with the clinical trial, this will be conducted by Prof. Jeff Supko, Harvard Medical School and Director of the Clinical Pharmacology Laboratory, Massachusetts General Hospital (Boston, USA).

Prof. Burt Nabors MD, the Chairman of the trial and Director of Neuro-Oncology at University of Alabama at Birmingham (UAB) and Director of UAB's Centre for Clinical Translational Science's Clinical Research Unit, commented: "GBM is among the most lethal of adult cancers. The median survival of patients remains less than two years despite the current available therapies, including surgery, radiation, and chemotherapy; development of more effective therapies is urgently needed. We welcome the opportunity to offer patients access to the investigational AXL inhibitor bemcentinib in this pilot study and look forward to initiating additional trial sites across the Adult Brain Tumour Consortium in the USA later this year."

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We congratulate Prof. Nakano and Prof. Nabors on the start of this exciting clinical study, which we believe will provide us with important data regarding the ability of bemcentinib to cross the blood-brain barrier and potentially treat GBM patients. This clinical trial is based on pioneering preclinical research carried out by our collaborators, conducted at high profile research hospitals in the USA and is funded by National Cancer Institute (NCI). We look forward to reporting the potential of bemcentinib to improve patient outcomes in this very aggressive cancer."

About BerGenBio ASA

BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including immune-evasive and therapy resistant cancers. The company's proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad Phase II oncology clinical development programme focused on combination and single agent therapy in lung cancer, leukaemia and COVID-19. A first-in-class functional blocking anti-AXL antibody, tilvestamab, is undergoing Phase I clinical testing. In parallel, BerGenBio is developing companion diagnostic tests to identify those patient populations most likely to benefit from bemcentinib or tilvestamab: this is expected to facilitate more efficient registration trials and support a precision medicine-based commercialisation strategy. For further information, please visit: http://www.bergenbio.com

About Investigator-Sponsored Trials

Investigator-sponsored clinical trials are clinical trials proposed by front-line patient-facing physicians who act as the regulatory sponsor and are supported by industry in bespoke clinical development partnerships. The industry partner does not assume the role of sponsor according to European or US regulatory guidelines but may offer support in a variety of different ways, such as providing investigational medicinal product at no cost.

About Glioblastoma

Glioblastoma (GBM) ranks among the deadliest of all human cancers with no curative options available[2]. It is the most aggressive of the gliomas, a collection of tumors arising from glia or their precursors within the central nervous system. Gliomas are divided into four grades, grade 4 or glioblastoma multiforme (GBM) is the most aggressive of these and is the most common in humans. Most patients with GBMs die of their disease in less than a year[3].

For more information, please contact

Richard GodfreyCEO, BerGenBio ASAmedia@bergenbio.com+47 917 86 304

International Media RelationsMary-Jane Elliott, Chris Welsh, Carina Jurs,Lucy Featherstone, Maya BennisonConsilium Strategic Communicationsbergenbio@consilium-comms.com+44 7780 600290

Forward looking statements

This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties, and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

[1] 3. Sadahiro H, Kang KD, Gibson JT, et al. Activation of the Receptor Tyrosine Kinase AXL Regulates the Immune Microenvironment in Glioblastoma. Cancer Res. 2018;78(11):3002-3013.

[2,3] 1. Cloughesy, T., Finocchiaro, G., Belda-Iniesta, C., et al. (2016). Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study of Onartuzumab plus Bevacizumab versus Placebo plus Bevacizumab in Patients with Recurrent Glioblastoma: Efficacy, Safety, and Hepatocyte Growth Factor and O6-Methylguanine-DNA Methyltransferase Biomarker Analyses. J Clin Oncol, JCO2015647685. Gilbert, M.R., Sulman, E.P., and Mehta, M.P. (2014). Bevacizumab for newly diagnosed glioblastoma. N Engl J Med 370, 2048-2049.

This information was brought to you by Cision http://news.cision.com

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SOURCE BerGenBio ASA

Company Codes: Bloomberg:BGBIO@NO, ISIN:NO0010650013, Oslo:BGBIO, RICS:BGBIO.OL

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Bergenbio Announces First Patient Dosed in Recurrent Glioblastoma Investigator Sponsored Phase I/II Study Assessing Selective AXL Inhibitor...

Medical textbooks are designed to diagnose white people. This student wants to change that – Fast Company

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Malone Mukwende was in his first day of medical school when he noticed something odd. As he learned about diseases of the body, all of the diagnostics were grounded in white skin. Red bumps from rashes. Blue lips from oxygen deprivation. Such colors are masked by melanin, meaning these diagnostics dont work for much, even most, of the worlds population.

As a person who is of African origin, I knew that the symptoms we were seeing and being told about, on my own skin, they would not appear the same, and that was very problematic, Mukwende says. My first year of university, it was almost a curiosity. Second year, I thought the issue would get better. But there was no progress. So I said, Okay, I need to address this myself somehow.'

Teaming up with two of his professors, Mukwende has spent the past year and a half writing Mind the Gap. Its a richly photographed and annotated clinical handbook for diagnosing diseases on Black and Brown skin thats slated to be released at an unannounced time in the future. Mukwende hopes that it will become required reading in medical schools and hospitals around the world.

While he doesnt claim its the first publication to address racial diagnostic biasindeed, the last decade has brought multiple textbooks on this topicthe need for Mind the Gap is still pressing. Theres plenty of evidence that Black people have worse outcomes when facing the same diseases as white people.

There are all sorts of reasons for this. Genetics may play a role in some cases. But many issues are tied to systemic racism: One study found that diagnostic algorithms used in hospitals are racially biased and recommend treatment to Black people less often than white people for the same symptoms. Another study shows that African Americans and Hispanic people in the U.S. are less likely to have health insurance than white people, because in the United States, proper medical care is tied closely to economic advantage.

Structural racism in medical education goes beyond skin to nearly every field of medicine, says Andrew Ibrahim, an MD who is also assistant professor of surgery, architecture & urban planning at University of Michigan and a senior principal and chief medical officer at the architecture firm HOK. Ibrahim points out that the number of Black male doctors is going down rather than up. This sort of exclusion leads to poor practices across the board in healthcare. A new study flagged 10 common diagnostic tests, which software analyzes with different criteria depending on race. The same lab value may be interpreted as normal in a white patient, but abnormal for a Black patient because medical education has set the normal ranges differently by race, says Ibrahim. In making race an objective measurement rather than a social construct, we run the risk of accepting racial disparity as an immutable fact rather than an injustice that requires intervention.

Of course, treating everyone the exact same way is a problem, too. Mukwende points out that doctors are trained to spot diseases through just one racial lens. Textbooks are racially biased, sometimes to the point of flagrant racism, and as a result, the medical community is beginning to realize that Black people tend to get diagnosed and treated later for the same disease white people might have, at which point, the disease is harder to treat and often more deadly.

Mukwende gives examples of how bad training leads to poor health outcomes. With the rise of COVID-19, which has disproportionately killed Black people, doctors have seen an increase of Kawasaki disease, which is an inflammatory condition that involves swelling across parts of the body. One of its telltale signs on white skin is a bright red rash. But on Black skin this same rash appears without a clear color signifier; to the untrained eye, it might look like goosebumps.

Meningitis is another problem, Mukwende says. Meningitis is harder to spot in darker skin, he says. In this case, poor medical training hurts the Black community twice as much, because the disease may be more difficult to see due to melanin, and the doctor is looking for the wrong clues to spot it.

In some cases, these late diagnoses are literally a matter of life and death. [Take] lips turning blue . . . even with that point, what we describe as blue on white skin. On darker skin it would not be the same blue, says Mukwende. It would just not appear the same because of the melanin in the skin . . . [and] if you dont see that early enough, that person might literally have a lack of oxygen in their blood.

Mukwende has managed to finish the Mind the Gap while completing his second year of medical school, and thats largely thanks to his collaboration with two school lecturers who are helping with the book.

Speaking to others I didnt work withsome people who teach me time to timeat first the response was like, Surely thats common sense, or, Surely people learn how to just apply their knowledge,' says Mukwende. Unfortunately, this gray zone of assumption is whats leading to people ultimately losing their lives. People are just assuming everybody knows. But clearly people dont know.

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Medical textbooks are designed to diagnose white people. This student wants to change that - Fast Company