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(August 8, 2022 / JNS) Operation Breaking Dawn was a textbook illustration of Israels tactical brilliance and prowess on the one hand, and strategic blindness on the other.

Tactically, Israels Iron Dome system allows its civilians to remain almost entirely unharmed while terror armies pummel Israels cities and villages with missiles and rockets. So too, Israel has developed precision-guided weapons and operational intelligence capabilities which in combination enable it to conduct pinpoint assaults against targets and destroy them with little to no collateral damage.

From Friday through Sunday, Islamic Jihad shot nearly a thousand projectiles at Israel. But largely thanks to Iron Dome, no Israelis were harmed by direct hits. In precision strikes, Israel was able to eliminate Islamic Jihads commanders.

However, while Israels leaders are right to trumpet the operations tactical, technology-based success, Operation Breaking Dawn was a strategic fiasco on multiple levels.

The first level of strategic failure is the operational one. Breaking Dawn was precipitated by Islamic Jihads decision to respond to Israels arrest of its senior operative Bassem Saadi early last week in Jenin with a threat to carry out a mass casualty attack on Israeli civilians and military personnel from Gaza.

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According to Egyptian mediators, Israel agreed to consider releasing Saadi and perhaps another Islamic Jihad terrorist in exchange for a ceasefire. If the Egyptian announcement is accurate, then Islamic Jihad will be able to present its missile assault as a victory. By lobbing a thousand projectiles at Israeli cities from Gaza, the terror group was able to coerce Israel into freeing terrorists in Samaria.

Even better, from Islamic Jihads perspective, for the four days that preceded Israels initiation of Operation Breaking Dawn, the government ordered more than a million Israelis to remain in their homes and closed rail service and the major highways connecting population centers in southern Israel to the rest of the country. That four-day lockdown, based solely on Islamic Jihad threats, was the greatest victory the terror group ever achieved.

Israels operation demonstrated the depth of the strategic challenge Gaza poses. Islamic Jihad is a wholly owned subsidiary of Irans Revolutionary Guards Corps, which founded it in 1988 and still arms and commands its operations today. Islamic Jihad used to be seen as a mere nuisance in the Gaza Strip. But this week it showed it has amassed an arsenal capable of presenting Israel with a massive security challenge. Even worse, it has just a fraction of the capabilities that Hamas enjoys.

Hamas is not a wholly owned subsidiary of Iran, but it is an Iranian client. Hamas receives funding and arms from Tehran. Its leaders are in direct, intimate contact with the Iranian regime, which they brag about. Hamas chief Ismail Haniyeh was in Tehran last April to participate in Iranian President Ebrahim Raisis inauguration. Hamas tens of thousands of missiles cover nearly all of Israel. Its anti-aircraft and anti-tank missiles pose a threat to Israeli ground and air operations in Gaza.

Iranian sponsorship isnt the only thing Hamas and Islamic Jihad share. They are partners. According to media reports, there were Hamas officers in Islamic Jihad command centers all week long. Hamas approved every missile volley Islamic Jihad launched and provided it with logistical support. Given the intimacy of their cooperation, the fact that Hamas didnt use its own missiles to attack Israel is a meaningless distinction. Indeed, its worse than that. Pretending that Hamas is not involved in an operation it actually enabled and participated in gives Hamas a free pass for waging war.

But for the Lapid-Gantz caretaker government, none of this mattered. The government and its attendant media insisted Hamas and Islamic Jihad are totally separate from one another, and even rivals. The governments narrative claimed Hamas was acting like a responsible adult.

Between Friday and Saturday, the IDFs job quickly moved from attacking Islamic Jihad to ending the operation as quickly as possible to avoid Palestinian civilian casualties that would compel Hamas to start shooting its own missiles at Israel. In other words, the government put the onus on itself. Hamas would come in if Israel made a mistake. Hamas is responsible. It cares about its people. And it will only join the fray if Israel forces its hand.

This false narrative is doubly destructive given Hamas actual nature. Hamas isnt a responsible governing authority. Its a terrorist organization ideologically committed to annihilating Israel and the entire Jewish people. By treating Hamas as the responsible adult in the room, the government gave legitimacy to an actor that is morally, militarily, ideologically and politically illegitimate.

This is not to say that Israel should have opened a major campaign against Hamas. A caretaker government lacks the political legitimacy to initiate a large-scale conflict. But the governments kowtowing to Hamas, like its anxious acceptance of Islamic Jihads ceasefire terms, was unnecessary and destructive.

Caretaker Prime Minister Yair Lapid and Defense Minister Benny Gantzs behavior vis--vis Gaza is in keeping with the overall strategic blindness that has afflicted this government in relation not only to Irans Palestinian proxies Islamic Jihad and Hamas, but also to Irans Lebanese legion Hezbollah and, indeed, Iran itself.

Lapid and Gantz are poised to accept a deal to transfer some of Israels sovereign economic waters to Lebanon. There are two concepts behind the deal, negotiated by the Biden administration. First, most importantly and like the White House, Lapid and Gantz insist Lebanon is a political entity separate from Hezbollah. This is entirely false. Hezbollah is the most powerful military organization in Lebanon. It has swallowed the Lebanese Armed Forces, which operate at Hezbollahs pleasure. And it has also swallowed the government, which will not do anything Hezbollah opposes.

The second concept, which flows from the first, is that by enabling Lebanon to develop natural gas fields in the eastern Mediterranean, Israel will empower the government against Hezbollah. This too is entirely false. Hezbollah controls the negotiations. Lebanon will not profit from the deal at Hezbollahs expense. The deal will transform Hezbollahand Iraninto players in the Mediterranean gas industry, opening up a whole new sphere of profit, as well as potential extortion and blackmail of Israel.

As for Iran itself, from the moment they formed their government with their erstwhile partner Alternate Prime Minister Naftali Bennett, Lapid and Gantz opted to subordinate Israels policies towards Iran to the Biden administration. They announced a policy of no surprises, which effectively gave the administration veto power over all Israeli operations against Irans nuclear installations and other offensive operations.

Since the Biden administrations central Middle East policy is to reinstate Barack Obamas 2015 nuclear deal with Iran, the implication of no surprises is that Israel agreed to subordinate its confrontational policy towards Iran to the U.S. policy of appeasing Iran.

Lapid/Gantzs predecessor and nemesis is opposition leader Benjamin Netanyahu. During his long premiership, Netanyahu also sought to avoid major military confrontations with Hamas and Hezbollah. But unlike Lapid and Gantz, Netanyahu did so while adhering to a strategic concept that had the virtue of not only being right, but effective.

Netanyahu recognized that the Palestinians, like Hezbollah, are part of Irans war machine. As Iranian Revolutionary Guard Corps General Asghar Emami said in a May 2021 interview, Iran doesnt need to directly attack Israel because its proxies Hezbollah, Islamic Jihad and Hamas are on Israels borders.

Emami said, Due to our presence in the axis of resistance, we have placed [Israel] under siege. We dont need to send airplanes or missiles to Israel. Now, with our presence in the axis of resistance, we can hit Israel with mortar shells.

Netanyahu adopted an integrated, three-pronged Iran strategy. He sought to deprive Iran of funds to diminish its economic capacity to fund its proxies. He built and used the capacity to carry out near-continuous acts of sabotage against Irans nuclear installations and personnel. And he led Israel in waging a full-scale diplomatic war against Iran.

One of the crowning achievements of Netanyahus strategy was his success in persuading then-president Donald Trump to withdraw from Obamas 2015 deal with Iran. Obamas deal transferred more than $100 billion to Tehran through sanctions relief. Immediately after the deal went into effect in August 2015, Iran began funneling massive funds to Hamas, Islamic Jihad and Hezbollah, as well as the Houthis in Yemen, enabling them to escalate their wars against Israel and the Sunni states. By walking away from the deal and reinstating U.S. economic sanctions on Iran, Trump set Iran on the road to poverty, and its funding for its terror proxies dried up. Had the policy been continued under Biden, Islamic Jihad would likely not have had a thousand missiles of varying ranges to lob at Israel over three days.

Iran crossed the nuclear threshold in recent weeks for two reasons: First, the Biden administration stopped enforcing sanctions and thus emboldened the Iranians to massively increase their levels of uranium enrichment and stockpiles of enriched uranium. Second, Israel dramatically scaled back its operations in Iran as part of the Lapid-Gantz-Bennett no surprises policy.

Netanyahus diplomatic war against Iran, even in the face of U.S. animosity, is what drew the Arab states to Israel. The 2015 nuclear deal threatened the Sunnis no less than it threatened Israel. Netanyahus unapologetic opposition to the agreement drew Saudi Arabia, the UAE, Egypt and Bahrain to Israels side.

As for the Palestinians, Netanyahu largely ignored them. And when he was forced to fight them, he made clear that they were first and foremost Iranian proxies. His argument was convincing because it was accurate. In 2014, recognizing the truth of Netanyahus claim, the UAE, Saudi Arabia and Egypt stood with Israel against Hamas, Turkey, Qatar and the Obama administration, which tried to force Israel to accept Hamas ceasefire demands.

Over the past week, Lapid and Gantz barely mentioned Iran, despite the fact that Islamic Jihads leader Ziad Nahalka was in Tehran the entire time. Their reticence was likely due to the fact that as Irans Palestinian proxy pummeled Israel with missiles and rockets, Bidens negotiators are in Vienna, yet again begging Iran to accept sanctions relief in exchange for a nod to the 2015 nuclear deal. By hiding the fact that Iran stood behind Islamic Jihad/Hamas entire assault, Gantz and Lapid returned the Palestinians to center stage, to devastating effect for Israel.

By giving Iran a free pass, Israel alienated its Arab allies. Instead of supporting Israel, the UAE is co-sponsoring a U.N. Security Council meeting to discuss Israels operation. Saudi Arabia published a full-throated condemnation of Israels operation against an Iranian proxy.

It is easy to understand the logic of a limited campaign. But by carrying it out in a state of strategic blindness, the caretaker government legitimized Hamas and undermined Israels position in the strategic battle of our timesagainst Iran.

Caroline Glick is an award-winning columnist and author of The Israeli Solution: A One-State Plan for Peace in the Middle East.

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The strategic blindness of Israel's caretaker government - JNS.org

What comes to mind when you think of blindness?Is it a person donning dark sunglasses, possibly with a cane, or a guide dog?

There are certainly people with vision loss who fit this bill, but for many others, their experience of blindness is not quite so black and white.

Karan Nagrani is legally blind, but if you passed him in the streetit's likely you wouldn't know.

Diagnosed at the age of 11 with a degenerative genetic condition called retinitis pigmentosa, the now 36-year-oldonly has a fraction of his vision remaining.

"It starts off asnight blindness and loss of side vision, and then the central [vision] starts to get affected," Mr Nagrani said.

"When people look ahead, they see 180 degrees I see less than three degrees, and at night, it's completely black."

From his home in the southern coastal city of Albany, Western Australia, Mr Nagrani has made it his mission to educate people on what he calls the "spectrum of blindness".

"I think people have this misconception that if you're blind, your eyes don't look normal," he said.

"I can still make eye contact because I can still see a little bit, so people get a little confused."

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When meeting new people, Mr Nagrani said he often felthe hadto "convince"them of his disability.

"I feel a sense of fear until I've convinced them that I have a disabilitybecause I don't want to be called a fraud.

"That is the fearthat people are going to say, 'His eyes look normal, he's making eye contact, I think he's faking it'."

Knowing there would come a day when he would lose his sight, hedidn't let his diagnosis deter him from pursuing his dream career.

"Growing up, I knew I was going to go blind, but I didn't want to pick a career based on that I wanted to live my life and do something that I enjoy," he said.

"Being creative, I got into graphic design and filmmaking, and I did that for 14 years.

"I'm proud to say I had a really successful career in marketing that I had to give up because I can't use laptops or computers anymore."

With the knowledge and skills gained from his career, Mr Nagrani is putting them to use bycreating infographics and videos for social media using his smartphone.

"Growing up, I never saw any content that prepared me for what it is that I will or won't see," he said.

"Now, I'm using my graphic design skills while I still can to create resources that other people are using."

His Instagram account showcases a sense of humour that hasn't happened totally by chance.

"Social media is all about entertainment you can present serious information, within reason, in a fun manner.

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"Going by the responses that I get, it's actually the entertaining, informative posts that are most engagingbecause people actually stop and read and comment."

But not everyone on the internet has his positive energy.

"There's always that one person who has something nasty to say," he said.

"I remember putting up a post once where I showed people what it's like to wake up with retinitis pigmentosa one of the shots was on the balcony, showcasing the beautiful Albany landscape.

"Someone commented,'What a waste of such a beautiful view on someone like you'.

"I get those comments, but I actually think that's a reflection on them, and I brush it off."

Blind people experience an extra layer of difficulty navigating day-to-day life because of social stigma, according to eye expert Professor William Morgan.

Often patients put in a lot of effort to appear "normal".

"Many people will think they're just normal peopleand get irritated and annoyed if they bump into them, for example, or take longer to sit down on a busbecause they're having to feel their way around the seat," Professor Morgan, from the University of Western Australia and managing director of Lions Eye Institute in Perth, said.

"I do get those comments from patients actually; that they put an enormous amount of effort into nullifying the disability as much as possible."

Professor Morgan said services hadimproved dramatically for vision-impaired people in recent years, but there wasstill a way to go in regard to awareness.

"These people are putting a huge effort into mixing in society, and so increasing the tolerance [would help, as well as] an awareness of the different sorts of vision that you lose with these broad categories of diseases."

For Mr Nagrani, sharing his personal experience online is aboutfostering acceptance for all forms of blindness.

"It makes me so happy to see people from across the globe message me, asking me if they can share my posts to raise awareness," he said.

"I feel likeeven though I've had to give up my marketing career, I'm actually finding this more fruitful, in the sense that I feel like I'm really making a difference now."

ABC Great Southern will deliver a wrap of the week's news, stories and photos every Thursday. Sign up here.

See the rest here:
Karan Nagrani is using social media to raise awareness about the 'spectrum of blindness' - ABC News

Permanent Secretary for Health, Doctor James Fong says this is why the Ministry is considering using eye screening tests to diagnose other underlying health problems.

Most cases of blindness and vision impairment in the country stem from non-communicable diseases.

Permanent Secretary for Health, Doctor James Fong says this is why the Ministry is considering using eye screening tests to diagnose other underlying health problems.

There is a lot of undiagnosed NCDs around and what is most unfortunate is that many of those NCDs only become visible only when a person starts to lose their sight. I am hoping that we do not have to pick up diseases at that point, that there is some degree of screening of the eye, we will be able to early detect impairment and do something about it.

Dr Fong says blinding NCDs such as cataract, glaucoma and diabetic retinopathy are the most common eye diseases in the country.

He adds 80 percent of blindness and vision impairment is preventable or treatable, depending on early detection.

Read the original post:
Vision impairment and blindness related to NCDs: Fong - FBC News

By Caroline Glick

Operation Breaking Dawn was a textbook illustration of Israels tactical brilliance and prowess on the one hand, and strategic blindness on the other.

Tactically, Israels Iron Dome system allows its civilians to remain almost entirely unharmed while terror armies pummel Israels cities and villages with missiles and rockets. So too, Israel has developed precision-guided weapons and operational intelligence capabilities which in combination enable it to conduct pinpoint assaults against targets and destroy them with little to no collateral damage.

From Friday through Sunday, Islamic Jihad shot nearly a thousand projectiles at Israel. But largely thanks to Iron Dome, no Israelis were harmed by direct hits. In precision strikes, Israel was able to eliminate Islamic Jihads commanders.

However, while Israels leaders are right to trumpet the operations tactical, technology-based success, Operation Breaking Dawn was a strategic fiasco on multiple levels.

The first level of strategic failure is the operational one. Breaking Dawn was precipitated by Islamic Jihads decision to respond to Israels arrest of its senior operative Bassem Saadi early last week in Jenin with a threat to carry out a mass casualty attack on Israeli civilians and military personnel from Gaza.

According to Egyptian mediators, Israel agreed to consider releasing Saadi and perhaps another Islamic Jihad terrorist in exchange for a ceasefire. If the Egyptian announcement is accurate, then Islamic Jihad will be able to present its missile assault as a victory. By lobbing a thousand projectiles at Israeli cities from Gaza, the terror group was able to coerce Israel into freeing terrorists in Samaria.

Even better, from Islamic Jihads perspective, for the four days that preceded Israels initiation of Operation Breaking Dawn, the government ordered more than a million Israelis to remain in their homes and closed rail service and the major highways connecting population centers in southern Israel to the rest of the country. That four-day lockdown, based solely on Islamic Jihad threats, was the greatest victory the terror group ever achieved.

Israels operation demonstrated the depth of the strategic challenge Gaza poses. Islamic Jihad is a wholly owned subsidiary of Irans Revolutionary Guards Corps, which founded it in 1988 and still arms and commands its operations today.

Islamic Jihad used to be seen as a mere nuisance in the Gaza Strip. But this week it showed it has amassed an arsenal capable of presenting Israel with a massive security challenge. Even worse, it has just a fraction of the capabilities that Hamas enjoys.

Hamas is not a wholly owned subsidiary of Iran, but it is an Iranian client. Hamas receives funding and arms from Tehran. Its leaders are in direct, intimate contact with the Iranian regime, which they brag about. Hamas chief Ismail Haniyeh was in Tehran last April to participate in Iranian President Ebrahim Raisis inauguration. Hamas tens of thousands of missiles cover nearly all of Israel. Its anti-aircraft and anti-tank missiles pose a threat to Israeli ground and air operations in Gaza.

Iranian sponsorship isnt the only thing Hamas and Islamic Jihad share. They are partners. According to media reports, there were Hamas officers in Islamic Jihad command centers all week long. Hamas approved every missile volley Islamic Jihad launched, and provided it with logistical support. Given the intimacy of their cooperation, the fact that Hamas didnt use its own missiles to attack Israel is a meaningless distinction.

Indeed, its worse than that. Pretending that Hamas is not involved in an operation it actually enabled and participated in gives Hamas a free pass for waging war.

But for the Lapid-Gantz caretaker government, none of this mattered. The government and its attendant media insisted Hamas and Islamic Jihad are totally separate from one another, and even rivals. The governments narrative claimed Hamas was acting like a responsible adult.

Between Friday and Saturday, the IDFs job quickly moved from attacking Islamic Jihad to ending the operation as quickly as possible to avoid Palestinian civilian casualties that would compel Hamas to start shooting its own missiles at Israel.

In other words, the government put the onus on itself. Hamas would come in if Israel made a mistake. Hamas is responsible. It cares about its people. And it will only join the fray if Israel forces its hand.

This false narrative is doubly destructive given Hamas actual nature. Hamas isnt a responsible governing authority. Its a terrorist organization ideologically committed to annihilating Israel and the entire Jewish people. By treating Hamas as the responsible adult in the room, the government gave legitimacy to an actor that is morally, militarily, ideologically and politically illegitimate.

This is not to say that Israel should have opened a major campaign against Hamas. A caretaker government lacks the political legitimacy to initiate a large-scale conflict. But the governments kowtowing to Hamas, like its anxious acceptance of Islamic Jihads ceasefire terms, was unnecessary and destructive.

Caretaker Prime Minister Yair Lapid and Defense Minister Benny Gantzs behavior vis--vis Gaza is in keeping with the overall strategic blindness that has afflicted this government in relation not only to Irans Palestinian proxies Islamic Jihad and Hamas, but also Irans Lebanese legion Hezbollah and, indeed, Iran itself.

Lapid and Gantz are poised to accept a deal to transfer some of Israels sovereign economic waters to Lebanon. There are two concepts behind the deal, negotiated by the Biden administration.

First, most importantly and like the White House, Lapid and Gantz insist Lebanon is a political entity separate from Hezbollah. This is entirely false. Hezbollah is the most powerful military organization in Lebanon. It has swallowed the Lebanese Armed Forces, which operate at Hezbollahs pleasure. And it has also swallowed the government, which will not do anything Hezbollah opposes.

The second concept, which flows from the first, is that by enabling Lebanon to develop natural gas fields in the eastern Mediterranean, Israel will empower the government against Hezbollah. This too is entirely false. Hezbollah controls the negotiations. Lebanon will not profit from the deal at Hezbollahs expense. The deal will transform Hezbollah and Iran into players in the Mediterranean gas industry, opening up a whole new sphere of profit, as well as potential extortion and blackmail of Israel.

As for Iran itself, from the moment they formed their government with their erstwhile partner Alternate Prime Minister Naftali Bennett, Lapid and Gantz opted to subordinate Israels policies towards Iran to the Biden administration. They announced a policy of no surprises, which effectively gave the administration veto power over all Israeli operations against Irans nuclear installations and other offensive operations.

Since the Biden administrations central Middle East policy is to reinstate Barack Obamas 2015 nuclear deal with Iran, the implication of no surprises is that Israel agreed to subordinate its confrontational policy towards Iran to the US policy of appeasing Iran.

Lapid/Gantzs predecessor and nemesis is opposition leader Benjamin Netanyahu. During his long premiership, Netanyahu also sought to avoid major military confrontations with Hamas and Hezbollah. But unlike Lapid and Gantz, Netanyahu did so while adhering to a strategic concept that had the virtue of not only being right, but effective.

Netanyahu recognized that the Palestinians, like Hezbollah, are part of Irans war machine. As Iranian Revolutionary Guard Corps General Asghar Emami said in a May 2021 interview, Iran doesnt need to directly attack Israel because its proxies Hezbollah, Islamic Jihad and Hamas are on Israels borders.

Emami said, Due to our presence in the axis of resistance, we have placed [Israel] under siege. We dont need to send airplanes or missiles to Israel. Now, with our presence in the axis of resistance, we can hit Israel with mortar shells.

Netanyahu adopted an integrated, three-pronged Iran strategy. He sought to deprive Iran of funds to diminish its economic capacity to fund its proxies. He built and used the capacity to carry out near-continuous acts of sabotage against Irans nuclear installations and personnel. And he led Israel in waging a full-scale diplomatic war against Iran.

One of the crowning achievements of Netanyahus strategy was his success in persuading then-president Donald Trump to withdraw from Obamas 2015 deal with Iran. Obamas deal transferred more than $100 billion to Tehran through sanctions relief.

Immediately after the deal went into effect in August 2015, Iran began funneling massive funds to Hamas, Islamic Jihad and Hezbollah, as well as the Houthis in Yemen, enabling them to escalate their wars against Israel and the Sunni states. By walking away from the deal and reinstating US economic sanctions on Iran, Trump set Iran on the road to poverty, and its funding for its terror proxies dried up. Had the policy been continued under Biden, Islamic Jihad would likely not have had a thousand missiles of varying ranges to lob at Israel over three days.

Iran crossed the nuclear threshold in recent weeks for two reasons: First, the Biden administration stopped enforcing sanctions and thus emboldened the Iranians to massively increase their levels of uranium enrichment and stockpiles of enriched uranium. Second, Israel dramatically scaled back its operations in Iran as part of the Lapid-Gantz-Bennett no surprises policy.

Netanyahus diplomatic war against Iran, even in the face of US animosity, is what drew the Arab states to Israel.

The 2015 nuclear deal threatened the Sunnis no less than it threatened Israel. Netanyahus unapologetic opposition to the agreement drew Saudi Arabia, the UAE, Egypt and Bahrain to Israels side.

As for the Palestinians, Netanyahu largely ignored them. And when he was forced to fight them, he made clear that they were first and foremost Iranian proxies. His argument was convincing, because it was accurate.

In 2014, recognizing the truth of Netanyahus claim, the UAE, Saudi Arabia and Egypt stood with Israel against Hamas, Turkey, Qatar and the Obama administration, which tried to force Israel to accept Hamas ceasefire demands.

Over the past week, Lapid and Gantz barely mentioned Iran, despite the fact that Islamic Jihads leader Ziad Nahalka was in Tehran the entire time. Their reticence was likely due to the fact that as Irans Palestinian proxy pummeled Israel with missiles and rockets, Bidens negotiators were in Vienna, yet again begging Iran to accept sanctions relief in exchange for a nod to the 2015 nuclear deal.

By hiding the fact that Iran stood behind Islamic Jihad/Hamas entire assault, Gantz and Lapid returned the Palestinians to center stage, to devastating effect for Israel.

By giving Iran a free pass, Israel alienated its Arab allies. Instead of supporting Israel, the UAE is co-sponsoring a UN Security Council meeting to discuss Israels operation. Saudi Arabia published a full-throated condemnation of Israels operation against an Iranian proxy.

It is easy to understand the logic of a limited campaign. But by carrying it out in a state of strategic blindness, the caretaker government legitimized Hamas and undermined Israels position in the strategic battle of our times against Iran.

See the original post here:
Strategic blindness of caretaker government - The Jewish Star

The victim of a gruesome attack in Massachusetts is trying to turn her suffering into something good.Janet Blanchard, of Haverhill, was left blind and almost died from a random attack in her hometown last year.NewsCenter 5's Maria Stephanos lived next door to Blanchard when they were growing up in Groveland, and Stephanos shared Blanchard's story following the attack.Blanchard is now focused on spending time with her family and friends, especially her 14-month-old grandson, Lincoln.She is still searching for a cure for her blindness and working to help others who suffer from complete vision loss.On Sept. 2, the Bradford Country Club in Haverhill will host the Janet's Journey Golf Tournament, a fundraiser for the Second Chance for Sight Foundation a nonprofit that was founded in Blanchard's honor by her son-in-law, Zach.The money raised by the golf tournament will help assist complete-vision-loss organizations, medical research and individuals. Blanchard and her family hope to help others who have been affected by blindness by improving their quality of life through research and development.Anyone who is interested in donating to the Second Chance for Sight Foundation should email Leadership@secondchanceforsight.com.Those who are interested in sponsoring the Janet's Journey Golf Tournament should click here for more information.

The victim of a gruesome attack in Massachusetts is trying to turn her suffering into something good.

Janet Blanchard, of Haverhill, was left blind and almost died from a random attack in her hometown last year.

NewsCenter 5's Maria Stephanos lived next door to Blanchard when they were growing up in Groveland, and Stephanos shared Blanchard's story following the attack.

Blanchard is now focused on spending time with her family and friends, especially her 14-month-old grandson, Lincoln.

She is still searching for a cure for her blindness and working to help others who suffer from complete vision loss.

On Sept. 2, the Bradford Country Club in Haverhill will host the Janet's Journey Golf Tournament, a fundraiser for the Second Chance for Sight Foundation a nonprofit that was founded in Blanchard's honor by her son-in-law, Zach.

The money raised by the golf tournament will help assist complete-vision-loss organizations, medical research and individuals. Blanchard and her family hope to help others who have been affected by blindness by improving their quality of life through research and development.

Anyone who is interested in donating to the Second Chance for Sight Foundation should email Leadership@secondchanceforsight.com.

Those who are interested in sponsoring the Janet's Journey Golf Tournament should click here for more information.

See the original post here:
Massachusetts woman blinded by attack working to help others regain sight - WCVB Boston

Trying to achieve fairness through blindness has not worked.

A woman, lets call her Lisa, applies for a loan. Shes 35 with a graduate degree, a high earning trajectory and a 670 credit score. She also just returned to work after taking time off to start a family.

Her application goes to an algorithm, which assesses her risk profile to determine whether she should be approved. The algorithm sees her recent gap in employment and labels her a risky borrower. The result? Her application is rejected.

Examples like this happen every day in lending. Are these decisions fair?

When it comes to fairness in lending, a cardinal rule is, Thou shalt not use variables like race, gender or age when deciding whether to approve someone for a loan.

This rule dates back to the Equal Credit Opportunity Act (ECOA), passed in 1974 to stop lenders from deliberately denying loans to Black applicants and segregating neighborhoodsa practice called redlining. The problem got so bad, the government had to ban the consideration of race or gender when making loan approval or other high-stakes decisions.

The assumption behind ECOA was that if decision makersbe they humans or machinesare unaware of attributes like race or gender at decision-time, then the actions they take will be based on neutral and objective factors that are fair.

Theres just one problem with this assumption: Its wishful thinking to assume that keeping algorithms blind to protected characteristics means the algorithms wont discriminate.

In fact, building models that are blind to protected status information may reinforce pre-existing biases in the data. As legal scholar Pauline Kim observed:

Simply blinding a model to sensitive characteristics like race or sex will not prevent these tools from having discriminatory effects. Not only can biased outcomes still occur, but discarding demographic information makes bias harder to detect, and, in some cases, could make it worse.

In a credit market where Black applicants are often denied at twice the rate of White applicants and pay higher interest rates despite strong credit performance, the time has come to admit that Fairness Through Blindness in lending has failed.

If we want to improve access to credit for historically underrepresented groups, maybe we need to try something different: Fairness Through Awareness, where race, gender and other protected information is available during model training to shape the resulting models to be fairer.

Why will Fairness Through Awareness work better?

Consider the example of the woman, Lisa, above.

Many underwriting models look for consistent employment as a sign of creditworthiness: the longer youve been working without a gap, the thinking goes, the more creditworthy you are. But if Lisa takes time out of the workforce to start a family, lending models that weigh consistent employment as a strong criterion will rank her as less creditworthy (all other things being equal) than a man who worked through that period.

The result is that Lisa will have a higher chance of being rejected, or approved on worse terms, even if shes demonstrated in other ways that shes just as creditworthy as a similar male applicant.

Models that make use of protected data during training can prevent this outcome in ways that race and gender blind models cannot. If we train AI models to understand that they will encounter a population of applicants called women, and that women are likely to take time off from the workforce, the model will know in production that someone who takes time off shouldnt necessarily be deemed riskier.

Simply put, different people and groups behave differently. And those differences may not make members of one group less creditworthy than members of another.

If we give algorithms the right data during training, we can teach them more about these differences. This new data helps the model evaluate variables like consistent employment in context, and with greater awareness of how to make fairer decisions.

Fairness Through Awareness techniques are showing impressive results in healthcare, where identity-aligned algorithms tailored to specific patient populations are driving better clinical outcomes for underserved groups.

Lenders using Fairness Through Awareness modeling techniques have also reported encouraging results.

In a 2020 study, researchers trained a credit model using information about gender. The gender-specific model resulted in about 80% of women getting higher credit scores than the gender-blind model.

Another study, done by my co-founder John Merrill, found that an installment lender could safely increase its approval rate by 10% while also increasing its fairness (measured in terms of adverse impact ratio) to Black applicants by 16%.

The law does not prohibit using data like gender and race during model trainingthough regulators have never given explicit guidance on the matter. For years lenders have used some consciousness of protected status to avoid discrimination by, say, lowering a credit score approval threshold from 700 to 695 if doing so results in a more demographically balanced portfolio. In addition, using protected status information is expressly permitted to test models for disparate impact and search for less discriminatory alternatives.

Granted, allowing protected data in credit modeling carries some risk. It is illegal to use protected data at decision time, and when lenders are in possession of any protected status information theres the chance that this data will inappropriately influence a lenders decisions.

As such, Fairness Through Awareness techniques in model development require safeguards that limit use and preserve privacy. Protected data can be anonymized or encrypted, access to it can be managed by third party specialists, and algorithms can be designed to maximize both fairness and privacy.

Fairness Through Blindness has created a delusion that the disparities in American lending are attributable to neutral factors found in a credit report. But studies show again and again that protected status information, if used responsibly, can dramatically increase positive outcomes for historically disadvantaged groups at acceptable levels of risk.

Weve tried to achieve fairness in lending through blindness. It hasnt worked. Now its time to try Fairness Through Awareness, before the current disparities in American lending become a self-fulfilling prophecy.

See the original post:
Is It Time To Start Using Race And Gender To Combat Bias In Lending? - Forbes

Its 2022, and the modernisation project of the regency era is well underway. Each year, a new season ofBridgertondescends upon us and gives the internet a new diamond of the season to rave over. If 2021 was Reg-Jean Pages year, 2022 would be Simone Ashleys. Not only are the two protagonists in theGossip Girl-Esque period drama, but both stand out as actors of colour in a conventionally white story.

A more recent case of colour-blind casting in regency-era dramas has been in the case of the Netflix adaptation of Jane AustensPersuasion. With Malaysian-British actor Henry Golding, Nigerian-British actress Nikki Amuka-Bird, and many more, Persuasion joins the race-blind casting club.

Within the casting itself, critics point out that race-blindness has compromised historical accuracy. As in the case of most race-blind period dramas, this argument has also been extended to instances such as the questions of accuracyregardingHalle Baileys casting inThe Little Mermaid(2023).

However, such casting in historical dramas is not a new phenomenon. Be it Dev PatelplayingDavid Copperfield(2019) and Adeel AkhtarplayingLestrade inEnola Holmes(2020), colour-bind casting has been a feature in showbiz for quite some time. In fact, lest we forget, even Amitabh BachchanplayedMeyer Wolfsheim inThe Great Gatsby(2013), a character is originally written to be an Ashkenazi Jew.

Disney-fantasy films such as the upcomingLittle Mermaid(2023) and superhero movies likeThor: Ragnarok(2017) have also embraced a colour-blind cast. So if the colour-blind casting is so rapidly expanding to all forms of film and television, what is with the whole debate over it?

It all began with the operaTannhuser(1961), whichfeaturedmezzo-soprano Grace Bumbry as Venus. Bumbry led on to become the first black singer to ever perform at the Bayreuth Festival in Germany. However, her casting was not just a move to make the opera seem more inclusive, but in fact, there lay a much deeper vision on the part of the director Wieland Wagner. Hiring a black singer for a white role waspartof a larger picture to sever post-War Bayreuths ties from its turbulent and racist past.

Opponents of heterogeneous casting in implausible roles and plotlines have also alleged that racial inclusion has been reduced to atick-box exercise. Race-blindness solely for the purpose of scoring DEI (Diversity, Equity, and Inclusion) points is increasingly common and a lot less desirable.

The opera soon became a huge scandal, and Bumbrys casting swelled up to a high level of national significance. Contrast this with the deluge of critical views thatPersuasionfinds itself in. Leaving the casting aside the screenplay itself is facing a lot of flak- especially from Austens deepest admirers, who regard the movie to be a greatly watered-down andFleabag-ifiedversion of the novel.

Within the casting itself, critics point out that race blindness has compromised historical accuracy. As in the case of most race-blind period dramas, this argument has also been extended to instances such as the questions of accuracyregardingHalle Baileys casting inThe Little Mermaid(2023).

Opponents of heterogeneous casting in implausible roles and plotlines have also alleged that racial inclusion has been reduced to atick-box exercise. Race-blindness solely for the purpose of scoring DEI (Diversity, Equity, and Inclusion) points is increasingly common and a lot less desirable.

As in the case of the 2020 Huluadaptationof Sally Rooneys novel Normal People, thoughtless race-blind casting led to the three major anti-heroes being people of colour for no specific reason. Colour-conscious casting in modern fiction would rather focus on racial diversity by answering why a specific character needs to belong to a specific race.

As in the case of the 2020 Huluadaptationof Sally Rooneys novel Normal People, thoughtless race-blind casting led to the three major anti-heroes being people of colour for no specific reason. Colour-conscious casting in modern fiction would rather focus on racial diversity by answering why a specific character needs to belong to a specific race.

This, in turn, would require self-interrogation and accountability, which could be the factors that filmmakers try to avoid by random race-blind casting.

The damages that can be done by race-blind casting are deeper. At best, it is implausible and almost hilarious to see a host of actors from various racial backgrounds play characters from theMahabharatain the 1989 film adaptation, written by English and French screenwriters. At worst, it ignores the history of discrimination in the entertainment industry and dismisses any accountability about the intention of why an actor of a specific race was cast for a specific role.

A 2018articlein the Harvard Journal of Sports and Entertainment Law addresses another facet of race-blind casting in Hollywood. Race-blind casting does not appropriately deal with the discriminatory environment that exists even in the present-day labour market. Ignoring race, as done inPersuasionandBridgerton, feeds into the harmful notion that not talking about race and the contexts it adds would fix Americas deeply entrenched racist rhetoric.

Movies and TV have great potential to contribute to meaningful societal changes, learning about the world, understanding diverse contexts, and connecting with various cultures.

However, a very elementary and widely-observed purpose of cinema is entertainment and even escapism. For instance, most mainstream Hindi cinema is aimed at being anescapistexperience for the masses, providing a brief distraction from the trials and tribulations that the lower and middle classes face.

Along these lines, proponents of race-blind casting argue that people of colour, too, deserve escapist, fantastical, and implausible storylines in mainstream cinema. Addressing historical oppression and marginalisation in each story with a character of colour would not only take the focus away from the primary plotline but also restrict people of colour to only see themselves represented through reminders of a painful past and present.

Also read:Women, Race & Class: Angela Davis And The Womens Movement In India

What acts as a middle ground on both sides of this debate is the need to replace colour-blind casting with colour-conscious casting. While the former succeeded in bringing in a larger number of actors of colour to our screens, the latteracknowledgesand embraces the various layers and dimensions that racial contexts bring to a story.

In order to meaningfully and accurately include characters of colour in historical dramas, it is essential, to begin with choosing a racially diverse historical setting in the first place. Such a plotline can act as the perfect vehicle to not only address issues of racial representation in traditionally white-dominant storylines, but it would also provide depth to the story by appropriately weaving in conversations on race within backgrounds they have been missing in all this time.

Not seeing colour and being colour-blind has always been ineffective and even harmful response to tackling deeply-rooted racism. Duplicating the same within film and TV would not have any different effects either. Heres hoping that whichever upcoming period drama is going to be the next talk-of-the-town, it does away with the pattern of feeding viewers false and one-dimensionalhistoriesunder the garb of representation.

Also read:A Racist India & How Its Racism Is Different For North-Eastern Women

Featured image source:British GQ

Excerpt from:
Persuasion Film Review: Is Heterogeneous Casting Race-Inclusionary Or Escapist? - Feminism In India

The Hindus concept of Satyug vs Kaliyug is actually on the difference of free-self-respecting life versus dependent-bonded slavery period. fearless vs fearful mood, intelligence vs blindness, There is a difference in the time of Karmavaad vs. Fatalism. that is when India became independent in 1947 So India had to make that constitution which would change the mood of the Hindus, He was worried about his behavior. The question is, what should have been the objectives of independent India and its constitution? My The straight forward answer is that the first priority of the nation-state of India is to end the Kali Yuga of the Hindus. Citizens out of the experience of fourteen hundred years of slavery. Fear, Liberation of the people from the systems of hunger and loot.

India of seventy five Kaliyuga decreased or increased,,2 : The issue is complex. I have analyzed the Hindu character in the past as well. The Hindu nature created in the slavery of fourteen hundred years has already been discussed. The essence is that the concept of Satyug versus Kaliyug of the Hindu is actually on the difference of free-self-respecting life versus dependent-bonded slavery period. There is a difference between fearless versus fearful mood, intelligence versus blindness, karmavad versus fatalism. We all know why Kali Yuga was formed for Hindus and what are its symptoms. Because of that, when India became independent in 1947, India had to make a constitution in which the change of mood of the Hindus, their behavior and behavior would have been concerned.

The question is, what should have been the objectives of independent India and its constitution? Its straight forward answer is that the first priority of the nation-state of India is to end the Kali Yuga of the Hindus. The citizens came out from the experience of fourteen hundred years of slavery. Liberation of the people from the systems of fear, hunger and loot.

Only then the constitution had to adopt the resolutions of these three tasks, objectives (1) To eliminate the fear of governance, governance among the citizens. So that people get out of the mood of slavery and have the nature to live with vivacity. So that they (2) be free from the habit of fear, devotion, hunger and dependent life created in the experience of subordination. Citizens left the escapist-fatalistic nature and became puritan-karmicists. (3) To embrace these two objectives in the mind of the country, importance should have been given to the knowledge sources, energy and sense of Sanatani Dharma-Shastras. So that the ideals of the character-moral-cultural values would form and blossom the resolve of the Hindu majority community. In the education-understanding of the citizens, that intellectual force would have been made possible by which the renaissance of the eternal heritage of ancient civilization-culture would have been possible. The unique identity of India could have been created by the eternal intellectual force. The global contribution of Hindus would have been possible.

Think, in seventy-five years from the Constitution of India, its results and the behavior of the nation, what identity of India has developed in the world? Is there such an identity that has been created in the last 75 years of other constitutions like Japan, Germany, Israel, China made around the time of 1947. Japan, Germany, Israel, and China all have their own distinctive identities of culture and culture. He has a status in his world fraternity. Think what is the identity of India in the world ahead of them?

stupid superstition

The objectives of ending Kali Yuga were not laid down in the Constitution of India. Rather, the Kali-yuga nature of the people, the official methods of slavery were made more powerful. The above mentioned three did not work. The Constituent Assembly of India did not consider it necessary to refine the merits and demerits of Hindu mood-disposition, intellect and education, nor did it make it the purpose of molding the civil rites into the moral parameters of religion-culture!

As a result, in a crowded civil society without culture, without character, labor is done like donkeys, but the result is poverty, vanity, wildness, living in cages, tying and sharing in caste-religion. Pay attention to the current times. What kind of India photos have been found in the world? What news was heard from India in the global concerns of the pandemic? The world has seen photos of India like cremation grounds and unclaimed deaths on the banks of the Ganges, in the same way, symbols of any other civilization-culture were seen in the country? What superstitious things the world has heard and known from India. Like the diagnosis of virus with cow dung. To drive away the epidemic by clapping. Means the scriptures of the past (there is no such thing in any Satyug Sanatani theology) and not by knowledge, but by cooking up the superstitions of myths, the Hindu was proved to be a foolish nature. In the myths itself, the Prime Minister of India talks about organ transplant surgery in ancient India and the devotees shout that the solution to every disease and problem is the mantra. Cow urine cures diseases and cow releases oxygen. Not only this, the peacock pregnant with the tears of the peacock and leaving the duck in the pond created oxygen in the water of the pond. Whatsup foolishness is the identity of India. An IIT head from India releases the video that the father of a friend of his in Chennai was captured by a ghost and he chased away the ghost by reciting the Bhagavad Gita. Imagine, a robotics professor and his skull telling the world that his friends father was physically very weak but after reciting the mantra, he got such power that he got up and started dancing. Later, the friends mother and wife were also caught by the ghost. Then he recited the mantra loudly for 45 minutes to an hour and freed both of them from the ghost.

Is all this the nectar of knowledge of India for 75 years? Know that the Sanatani Hindu did not live in such superstitions. Such straw is not in the Vedas of Hindus. On the contrary, the Adi Sanatani Dharmashastras of the Hindu were composing the Vedas and Vedangas by understanding nature, revealing and invoking its powers. There was debate with Ilham then.

In fact, this mental disability of India is the Kali-yuga nature of the time of slavery. The subjection of the heretics has made us fatalists-superstitions. That is why the Hindu elite leaders before and after independence had to seriously consider the reality of mental handicap. Had to find a solution. In its truth it was to become the primary objective of the Constitution. But the opposite happened. There was a superstition among the gentry of the Constituent Assembly that there is no such idea of political philosophy, polity in Hindu religion-civilization-culture, so that the citizens of the concept of nation-state can make themselves cultured and responsible. It was also thought that if the values of culture-religion or its insistence on the constitution-country were prestige, then the state religion should not be considered biased. We the people of India will be called antiquarians. Such fear and superstition apparently stemmed from the dreadful mood of the slavery period. Gandhi continued to see the ideal of Ram Rajya but his followers, the Constituent Assembly, rejected the truthful light of Ram Rajya and the original Sanatani religion behind it in horror and cynicism that religion and theology were opium and gapaudi!

As a result, the constitution was formed only which was the already made fabric of the Britishs language, philosophy, thought, intention, the tendency to rule the people. The making of the constitution did not take place in the priority of giving sovereign wings to the individuals freedom, his self-ownership, charitableness, but was building democracy in the stamp of making sovereignty-monarchy of power and government.

The result is in front. Seventy-five years later, Hindus (be it secular or communal) are fighting fiercely for their freedom. He lives in hunger, fear and devotion. He is filling his stomach with donations, donations, freebies. One gets rich from corruption. And when it comes to human nature, it is superstitious, brazen and scattered.

am i wrong? (Ongoing)

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The journey of Kali Yugi started with the mistake of objectives! - Youthistaan

Executive Summary

State Medicaid websites are a key source of information and an avenue for enrollment in or renewal of coverage for many applicants and existing enrollees. Medicaid households include a disproportionate share of nonelderly adults with limited English proficiency (LEP), and three in ten nonelderly Medicaid adults report having a disability. When the continuous enrollment requirement related to the COVID-19 public health emergency (PHE) ends and states resume regularly scheduled redeterminations and renewals, individuals with LEP and/or disabilities may be at increased risk of losing coverage, despite remaining eligible, due to barriers in accessing eligibility and renewal information. Several federal laws require state Medicaid agencies to provide information in a way that is accessible to people with LEP and people with disabilities (Appendix).

This issue brief reviews accessibility of information for people with LEP and people with disabilities provided through state Medicaid websites and call center automated phone trees as of June 16, 2022. The analysis shows that while states have taken some steps to support access to information and applications for people with LEP and people with disabilities, gaps in accessibility remain. Given the potential challenges people with LEP and people with disabilities may face maintaining coverage once Medicaid renewal and redeterminations resume following the end of the public health emergency, specific steps to minimize barriers and ensure easy access to information, applications, and assistance could help prevent coverage losses among those who remain eligible.

Most states have taken steps to support access to information and applications for people with LEP and people with disabilities. Such steps include the following:

While states have taken steps to support access to information and applications for people with LEP and people with disabilities, continuing gaps in accessibility remain. Some of these gaps include:

State Medicaid websites are a key source of information and an avenue for enrollment in or renewal of coverage for many applicants and existing enrollees. Medicaid households include a disproportionate share of nonelderly adults with limited English proficiency (LEP), and three in ten nonelderly Medicaid adults report having a disability. While Spanish is the most common language spoken among nonelderly adults in Medicaid households who have LEP, Chinese and Vietnamese are each spoken by 3% of these adults, and there are a diverse set of languages spoken overall by this group. Medicaid enrollees have a variety of disabilities, including blindness or low vision; deafness or hard of hearing; intellectual and developmental disabilities such as autism or Downs syndrome; traumatic brain or spinal cord injuries; and mental illness. Some people may have both LEP and a disability.

When the continuous enrollment requirement related to the COVID-19 public health emergency (PHE) ends, and states resume regularly scheduled redeterminations and renewals, individuals with LEP and/or disabilities may be at increased risk of losing coverage, despite remaining eligible, due to barriers in accessing eligibility and enrollment information. The Centers for Medicare & Medicaid Services (CMS) guidance about the PHE unwinding reminds states about these obligations and prompts states to review their communications with people with LEP and people with disabilities as a strategy to mitigate inappropriate coverage loss. Several federal laws require state Medicaid agencies to provide information in a way that is accessible to people with LEP and people with disabilities. The Appendix provides background information on these laws.

This issue brief reviews accessibility of information for people with LEP and people with disabilities provided through state Medicaid websites as well as call center automated phone trees and information on application assistance, as of June 16, 2022. We assessed homepages and call center automated menu options in all 50 states and DC and PDF applications in the 41 states that provide them online (Appendix Table 1). We had limited ability to assess online applications because, while all states except Alaska provide an online application, individuals must create an account to view the online application in all but three states (IN, MS, UT) (Appendix Table 1). We identified sixteen states that provide information about how to obtain one on one assistance with completing an application on their homepage or application. See the Methods box for more detail.

Overall, about two-thirds of states (33) provide information on their Medicaid program homepage in a language other than English (Appendix Table 2 and Figure 1). The number of languages other than English range from 1 to over 100 in 17 states using automated translation systems such as Google Translate. Five states (GA, KY, LA, MA and NE) also use Google Translate to offer translations in a more limited number of languages. In the remaining 11 states with translated information, the number of languages available other than English ranges from 1 to 22. All 33 states that offer translation on their homepages offer information in Spanish, and, in five states, Spanish is the only language other than English that is available. The other languages most commonly available include Chinese, Vietnamese, and Tagalog. There may be potential quality issues with translations in states using automated translations, such as Google Translate. Google has indicated that it is not intended to replace human translators or to be used in public health contexts without having translations verified and other research has found Google Translate to be unreliable in medical contexts., Two states (MD and GA) include disclaimers that the English version of the homepage is the most reliable. In three states (FL, MS, and KY), some content in the headers, footers, and/or menus of the translated versions of the homepage remains in English. In nine states, clicking links in translated versions of the homepage leads to English content. Ten state homepages included automated chatbots to address simple questions. In seven of these states, the chatbots can address questions in Spanish, including Florida, which also translates into Haitian Creole, and Rhode Island, which uses Google Translate to offer over 100 languages.

Most states with online PDF applications (34 of 41 states) offer the application in languages other than English (Appendix Table 2 and Figure 1). In 23 of these states, Spanish is the only other language in which the PDF application is available. In the remaining 11 states, PDF applications are offered in additional languages, including in over 10 languages in California, New York, Oregon and Washington. The most common other languages available are Vietnamese (6 states), Chinese (5 states) and Korean (5 states). Most PDF applications (37 of 41) ask about the applicants preferred spoken language, which may facilitate access to linguistically accessible communications in the future. Seven states had mobile device applications through which individuals could access applications and eligibility information and submit documents, and in three of these states (CO, MD, and MI), these applications could be accessed in languages other than English, primarily Spanish.

Seventeen states include multilingual taglines on their homepages or within one click of their homepages with information on how to access language assistance services (Appendix Table 2). Eleven of these states provide taglines in at least 15 languages other than English. All 17 states include taglines in Spanish, and the other most common languages are Chinese (13 states) and Vietnamese (12 states).

Most states with PDF applications (29 of 41 states) include multilingual tagline notices regarding the availability of language assistance services on the PDF application (Appendix Table 2). These taglines are generally present on the first or second page of the application or as a footer running across every page. In 11 of these states, taglines are only provided in Spanish and English, and, in the remaining 18 states, they are provided in between 5 and 19 languages other than English. In addition to Spanish, the most common other languages in which taglines are offered are Chinese (13 states) and Vietnamese (13 states)

In 49 states, call centers answered with automated phone trees, and 40 of these states offered menu options in languages other than English. However, in 31 of these states the only other language offered through the menu is Spanish (Appendix Table 2 and Figure 1). In the remaining states, phone tree menus offer between two and six languages other than English. In some states, other language options are only offered after the applicant listens to a long set of options in English.

Approximately half of states (25) provide general information about the availability of reasonable modifications (also known as reasonable accommodations) for people with disabilities on their homepage or within one click from their homepage, while 32 states provide this information on their online PDF application (Appendix Table 4 and Figure 4). States often provide information about reasonable modifications for people with disabilities on a separate webpage titled Nondiscrimination policy or Accessibility rather than directly on their homepage. Users can usually find these separate webpages by clicking on a Nondiscrimination policy link at the bottom of the homepage. States often use these separate webpages to outline their general commitment to serving the needs of people with disabilities (CT). Most of these separate webpages include information about free auxiliary aids and services necessary to afford an individual with a disability an equal opportunity to participate in all services, programs and activities (KY). Additionally, states often include information about reasonable accommodations such as alternative formats including Braille or large print materials, teletypewriter (TTY) numbers, and how to request qualified American Sign Language (ASL) interpreters on these separate webpages. The availability of information in plain language also is an important means of providing access for people with cognitive disabilities, though our website review did not assess content for plain language.

Two states (CA, CO) post a large print PDF application form online, while another 15 states include information on their homepage about how to obtain materials in large print or Braille (Appendix Table 4 and Figure 4). For example, Wyomings homepage indicates that a large print PDF application is available upon request. Like Wyoming, most other states often list a phone number (and/or a TTY number) for individuals to call to request materials in alternative formats or advise users to contact their local office. The remaining 35 states do not mention alternative formats on their homepage or within one click from their homepage. Ten state homepages (CT, DE, HI, KS, LA, MS, NH, NY, TN, and VA) allow users to increase or decrease the font size of text on the webpage. Connecticut and Louisiana are the only two states that allows users to change the homepage to a high contrast mode to improve readability for users. Making information and applications available in multiple formats is an important means of increasing access for people with disabilities. People with disabilities may access information in different ways, depending on their type of disability and type of assistive technology they use.

State homepages and online application landing pages were evaluated using WAVE, a suite of automated web accessibility measurement tools that includes 110 elements that assess potential accessibility errors for people who are blind or have low vision. WAVE is developed and made available as a free community service by WebAIM (Web Accessibility in Mind) at Utah State University. WAVE assesses web accessibility, including compatibility with screen reader software, which can be used by people who are blind to convert web content to synthesized speech, and screen magnifiers or zoom, which can be used by people with low vision. Because WAVE is automated, it does not assess all aspects of accessibility that may be encountered by website users. However, WAVE does identify the accessibility errors that are most frequently encountered and that tend to have the greatest impact on users who are blind or have low vision. Additionally, errors identified by WAVE have been found to correlate with the existence of other accessibility issues that WAVE does not detect but which can be encountered by a website user. The WAVE analysis was applied to a total of 101 webpages, including the homepages for all 50 states and DC and the online application landing pages for 49 states and DC.

The most common accessibility issue detected by WAVE is very low contrast text, with 67% of the assessed webpages (in 47 states) showing at least one incidence of this error (Appendix Table 3 and Figure 5). Overall, WAVE detected an average of seven instances of very low contrast text errors per page across the 101 webpages assessed. Low contrast text refers to the difference in brightness between text or a graphic and its background colors and is difficult for people with color blindness or low vision to read. Other commonly detected accessibility issues include missing labels to describe the various fields of content in a form (27% of pages, 24 states) and images missing alternative text (25% of pages, 23 states) (Appendix Table 3). Alternative text is used to describe the content of an image. Images that lack alternative text and forms without text labels cannot be properly identified by screen readers, making this content very difficult to access for people who rely on that technology.

The average number of accessibility errors detected by WAVE across the 101 assessed state homepages and online application landing pages is substantially lower than the average number of errors found on webpages in general. Specifically, WAVE detected an average of 11.4 errors per page across the 101 webpages assessed, compared to the average of 50.8 errors per page found on the top one million web homepages generally. The number of web accessibility errors detected on the assessed webpages varies widely across states (Appendix Table 3). Over half of the states have 15 or fewer errors across their homepages and online application pages and in seven states, there are less than five errors (Figure 5). These findings suggest that states have given notable attention to ensuring accessibility on these pages overall, although some pages may have errors that could pose difficulty for users with disabilities.

Thirty-two states list a TTY call center number directly on their homepage or within one click from the homepage (Appendix Table 4 and Figure 6). Eight of these states require users to click on a contact us tab to find a TTY number, while 13 states require users to click on a different link to a nondiscrimination or access for users with special needs webpage to find a TTY number. TTY numbers allow individuals who are deaf or hard of hearing to communicate by sending typed messages over the phone line. If states communicate with applicants or the public by phone, they also must handle calls via TTY or similar technology. North Carolina is the only state to list a Spanish language TTY (Relay Service) on its homepage. Similarly, Utah is the only state to list a Spanish Relay number for individuals with speech and/or hearing impairment on their PDF application.

Twenty-two states provide information about how to request an ASL interpreter on their website (Appendix Table 4 and Figure 6). One of these states (WA) directly lists this information on their homepage, while the other 21 states require users to click on another link such as a nondiscrimination webpage to find information about how to request an ASL interpreter. Both TTY numbers and ASL interpreters can help promote effective communication for people who are deaf or hard of hearing that could be essential for someone to understand how to enroll in or retain Medicaid coverage.

The large majority (49 of 51) of call centers answer with an automated phone tree and only 12 of the automated phone trees include an option to speak to a live person in the first set of menu options (Appendix Table 4 and Figure 6). Two call centers (DC, SD) answer with a live person instead of an automated phone tree. Access to a live person can improve accessibility for people with LEP and/or intellectual or developmental disabilities and people with mental health disabilities. As of the time of our data collection, the call center wait time to speak with a live person was less than 15 minutes in 34 states, while in six states, the wait time was more than 15 minutes. In the remaining seven states, we were unable to reach a live person. The end of the COVID-19 PHE may increase these wait times, as states resume processing redeterminations and renewals.

As the COVID-19 PHE ends and states resume regularly scheduled Medicaid redeterminations and renewals, people with LEP and/or disabilities may face increased challenges to maintaining coverage despite remaining eligible due to barriers in accessing eligibility and enrollment information. Under Title VI of the Civil Rights Act, Section 1557 of the Affordable Care Act, and the Rehabilitation Act, state Medicaid agency program information must be accessible to people with LEP and people with disabilities. The Biden Administration has issued a proposed rule revising implementing regulation for Section 1557, taking steps to reverse Trump Administration policy and regulations that significantly narrowed the implementation and administrative enforcement of the regulations. The proposed rule reinstates the requirement that Medicaid agencies provide notice of the availability of language assistance services and auxiliary aids and services in both physical locations and on their websites. Additionally, the rule, for the first time, requires state Medicaid agencies to give staff clear guidance and training on the provision of language assistance services, and effective communication and reasonable modifications to policies and procedures for people with disabilities, in order to improve compliance. Regardless of the status of the regulations, the underlying statutory protections of Section 1557, which require meaningful access to federal programs for people with LEP and/or disabilities, remain as well as protections under other federal laws and federal Medicaid regulations that require public programs be accessible to people with LEP and/or disabilities.

As states prepare to resume Medicaid redeterminations and renewals, they can take steps to prevent and minimize potential administrative barriers to maintaining coverage, particularly for people who have LEP and/or disabilities. CMS guidance outlines specific steps states can take, including ensuring accessibility of forms and notices for people with LEP and people with disabilities and reviewing communications strategies to ensure accessibility of information. Increasing access to a live person through call centers and/or providing a dedicated call center line for people with LEP may also help improve accessibility for people with LEP and people with disabilities. Ensuring accessibility of information, forms, and assistance will be key for preventing coverage losses and gaps among these individuals.

KFF appreciates the assistance of Jared Smith, program manager at Utah State University Institute for Disability Research, Policy and Practice, with analyzing and interpreting the WAVE results.

More:
A 50-State Review of Access to State Medicaid Program Information for People with Limited English Proficiency and/or Disabilities Ahead of the PHE...

iHealthScreen Inc. completed a prospective study for early diagnosis of AMD in primary care settings. The initial clinical trial results show adequate accuracy for FDA clearance. The study was funded by NIH SBIR grants and completed with the collaboration of the New York Eye and Ear Infirmary at Mount Sinai.

AMD, with no early signs or symptoms, is a leading cause of adult blindness in the developed world. Early detection can enable preventative measures in time to reduce the incidence of AMD. Currently, AMD diagnosis has been limited to retinal examination by an ophthalmologist. AMD cases in the U.S. are expected to grow from 2.1 million to 5.4 million in the next ten years, and there is an increasing need for large-scale screening and identification of individuals who are at risk of developing late AMD. iHealthScreens AI-based tool can facilitate this screening and help prevention of late AMD, i.e., blindness.

In an interview, Dr. Bhuiyan spoke about the study and the findings: We are encouraged by the results and believe that the new AI-based technology can diagnose early AMD in primary care settings, which enables the timely preventative measures by ophthalmologists and prevent this deterioration of vision. We want to express our sincerest thanks to the participants and professional staff who were involved in this clinical trial and gathered the data.

These results speak to the feasibility of this approach, said Theodore Smith, M.D., Ph.D., Trials Principal-investigator and Professor at Icahn School of Medicine at Mount Sinai. I believe that the ease of use of iHealthScreens AI tool will contribute to its adoption in the wider primary care community.

iHealthScreen is in the final stage of submitting the results to FDA for 510K clearance.

About iHealthScreen

iHealthScreen is a private, clinical-stage, medical diagnostic/device company. iHealthScreen has developed iPredict, an AI and telemedicine-based HIPAA compliant platform for automated screening and prediction of individuals at risk of developing late age-related AMD, diabetic retinopathy (DR), glaucoma, cardiovascular heart disease, and stroke.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220808005447/en/

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iHealthScreen Completed Prospective Trial of AI-Based Tool for Age-Related Macular Degeneration (AMD) Screening and Submitting the Results to FDA for...

Tuna and various other seafood are rich in Vitamin B12

Vitamin B12 is one of the less talked about vitamins. Unlike vitamin C and other vitamins, we often neglect the significance and need for vitamin B12. In this article, we discuss why you need to add vitamin B12 to your diet. We also list foods that are rich in vitamin B12 and can improve your consumption.

Why do we need Vitamin B12?

Our bodies rely on our food to stay alive. Being a complex mechanism, there are numerous nutrients our bodies needs and various ways in which these nutrients influence our health. Vitamin B12 improves and facilitates many functions in our bodies.

Here's why you must add sufficient vitamin B12 to your diet:

1. Protect eye health

Eating sufficient vitamin B12 lowers your risk of developing macular degeneration. This eye condition can cause blindness. Macular degeneration is common in older adults. However, not consuming enough vitamin B12 might increase your risks.

2. Prevent and treat depression

Serotonin is one of the happy hormones. Meaning, that it promotes better moods and improves mental health. Vitamin B12 plays an integral role in the production of serotonin. Studies show that people with vitamin B12 are at almost double the risk of developing depression.

3. Improve brain health

Vitamin B12 not only improves but is responsible for facilitating various functions in the brain and the nervous system. Lack of enough vitamin B12 might cause brain atrophy. Brain atrophy means a loss of neurons. This loss of neurons in the brain may also result in dementia and memory loss.

Besides these functions, vitamin B12 also facilitates energy production, aids our ability to think, and maintains the proper functioning of the brain and nervous system. Hence, vitamin B12 is an essential nutrient and necessary for survival.

What foods provide Vitamin B12?

Here are 7 foods that are rich in vitamin B12 and can significantly improve your intake:

1. Organ meats

Organ meats especially livers and kidneys are often the most abundant in various nutrients including vitamin B12. These foods may be ideal if you have a vitamin B12 deficiency or any other nutrient deficiency.

2. Dairy products

Dairy products are a great source of vitamin B12 for vegetarians. You can also incorporate them into your daily routine as they are extremely versatile and of many varieties. Try consuming milk, yogurt, cheese, etc. daily.

3. Eggs

Eggs are another more commonly consumed food that is rich in Vitamin B12. Similar to other foods, eggs are also abundant in various other foods that are beneficial to our bodies.

4. Fish

Fish is easily available seafood that is rich in vitamin B12 and many other nutrients. In fact, fish like tuna and salmon may also provide other nutrients such as protein, selenium, phosphorous, vitamin B3, vitamin A, etc.

5. Fortified cereal

Fortified cereals are a great source of vitamin B12 and many other nutrients for vegans and vegetarians. Fortification refers to adding nutrients to food that does not naturally have them. It may be beneficial but you are always encouraged to eat foods that are naturally rich in nutrients.

In conclusion, it is important for you to ensure you consume all the nutrients you require. Having a well-balanced diet can help you achieve your daily nutrient requirements. Although the most amount of vitamin B12 is often sourced from meats, vegans and vegetarians can still manage to consume the right amounts of B12.

If you think you might have a B12 deficiency, it is ideal to see a doctor. If yes, your doctor might prescribe supplements that are the best way to maintain the right intake. Make sure to only consume vitamin B12 supplements if prescribed as they can clash with other medications.

Disclaimer: This content including advice provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.

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Vitamin B12: Why You Need It & Foods To Increase Your Vitamin B12 Intake - NDTV

HEIDELBERG, Germany, and CAMBRIDGE, MA, Aug. 9, 2022 /PRNewswire/ -- Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol water-free technology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for CyclASol (cyclosporine ophthalmic solution), a proposed novel treatment for the signs and symptoms of dry eye disease (DED).

CyclASol has demonstrated in two pivotal studies fast onset of therapeutic effect in the indication, clinical meaningful improvement of ocular surface damage, and excellent tolerability. Results from a 12-month long-term study confirmed that the effects are maintained, and even improved for most sign and symptom endpoints.

"This is the first submission of a novel product category of water-free topical drug therapies utilizing EyeSol as a drug carrier", said Christian Roesky, Ph.D., CEO, Novaliq. "CyclASol is a first-of-a-kind drug therapy and aims to expand treatment success for patients with dry eye disease and their eye care professionals. If approved by the FDA, CyclASol addresses important unmet medical needs in DED through its ocular surface healing effect combined with high comfort of administration."

Dry eye is one of the most common ocular surface disorders, with approximately 18 million Americans diagnosed with DED.1,2 Inflammation and immunologic processes play a key role in the pathology of the disease.

A compromised ocular surface secondary to DED may also compromise refractive measurements before keratorefractive and phacorefractive surgeries and adversely impact expected visual outcomes after these surgeries.3,4 The impact of the corneal surface damage secondary to DED on visual function is an underestimated aspect of the disease. Multiple guidelines recommend treatment of the corneal surface damage prior to ocular procedures. A high unmet need remains for better tolerated drugs with an early onset of therapeutic effect, which are compelling to be used and prescribed.5,6

"We are very proud to see another product rapidly moving to the market, which marks yet another important inflection point and milestone in Novaliq's growth trajectory", said Dr. Mathias Hothum, board member and managing director of dievini. "We are currently evaluating the commercialization strategies which includes talking to interested parties."

About CyclASol CyclASol is a first-of-a-kind topical treatment of cyclosporine, a potent anti-inflammatory and selective immunomodulatory drug. Whilst not water-soluble, cyclosporine is soluble in the EyeSol excipient perfluorobutylpentane allowing for its improved bioavailability and better efficacy on the target tissue. The product contains no oils, no surfactants and is preservative-free due to the novel carrier. This provides additional clinical benefits for patients, such as improved tolerability and decreased visual disturbances.

The NDA is supported by safety and efficacy results in over 1,000 patients with DED from a Phase 2 dose finding study, the Phase 2b/3 ESSENCE-1 study, the Phase 3 ESSENCE-2 study and its open label extension study.7,8

CyclASol has demonstrated in two independent adequate and well-controlled, multicenter studies (ESSENCE-1 and ESSENCE-2) clinically meaningful and statistically significant improvements in the indication.

Effects on the ocular surfaceinclude a statistically significant reduction in total corneal fluorescein staining (tCFS) score favoring CyclASol in both studies at Days 15 and 29. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement of 3 grades in total corneal staining. This proportion of responders was significantly higher compared to vehicle-treated patients in both studies. Responders showed also statistically significant improvements in a variety of symptoms compared to non-responders at day 29. The ASCRS guidelines recognize corneal staining as the single most important clinical sign of DED as it indicates the level of epithelial damage and visual impairment, and if left undertreated, DED can become chronic and more difficult to treat.3

Effect on tear production: In both studies, compared to vehicle at the end of treatment, there was a statistically significant (p<0.05) higher percentage of patientswith increases of 10 mm from baseline in Schirmer's tear test score at Day 85 and Day 29, respectively, confirming a known effect of the active ingredient cyclosporine. Meeting this endpoint in two independent studies is clinically meaningful on its own and considered to demonstrate efficacy for the treatment of signs and symptoms of DED.

Head-to-head dataversus Restasisfrom the phase 2 study suggest that CyclASol has a stronger and faster therapeutic effect on the ocular surface.8

Maintenance of effectresults from the long-term study CYS-005 confirmed that the effect of CyclASol was maintained, and even improved for most endpoints, over the 52-week treatment period.

Safety and Tolerability: Tolerability of CyclASol was shown by high drop comfort patient ratings in both studies. The most common adverse reaction observed was instillation site reactions, which was reported in 8.1% of patients in the pooled studies. These were in all but one case mild. The only other adverse reaction reported in > 2% of the patients was visual acuity reduced (2.7%).

About NovaliqNovaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol, the worldwide first water-free technology.

EyeSol is Novaliq's proprietary water-free technology using ultrapure semifluorinated alkanes (SFAs) that are physically, chemically, and physiologically inert with excellent biocompatibility and a very good safety profile. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases.

In July 2022 submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) was announced seeking approval for NOV03 (perfluorohexyloctane), for the proposed indication of treating the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). In addition to CyclASol, the company continues to progress multiple additional pipeline opportunities based on its validated EyeSol platform, both in ophthalmology and adjacent indications like dermatology.

Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on http://www.novaliq.com.

Recommended Readings

Any product/brand names and/or logos are trademarks of the respective owners. 2022 Novaliq GmbH, Heidelberg, Germany.

Novaliq Media Contact: Simone Angstmann-Mehr[emailprotected]+49 6221 50259-0

Logo: https://mma.prnewswire.com/media/1804666/Novaliq_GmbH_Logo.jpg

SOURCE Novaliq GmbH

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Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol - PR Newswire

When coronary arteries are blocked, starving the heart of blood, there are good medications and treatments to deploy, from statins to stents. Not so for heart failure, the leading factor involved in heart disease, the top cause of death worldwide.

Its whats on death certificates, said cardiologist Christine Seidman.

Seidman has long been interested in heart muscle disorders and their genetic drivers. She studies heart failure and other conditions that affect the myocardium the muscular tissue of the heart not the blood vessels where atherosclerosis and heart attacks come from, although their consequences are also felt in the myocardium, including heart failure.

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With her colleagues at Brigham and Womens Hospital and Harvard Medical School, she and a long list of international collaborators have been exploring the genetic underpinnings of heart failure. Based on experiments deploying a new technique called single-nucleus RNA sequencing on samples from heart patients, on Thursday they reported in Science their discovery of how genotypes change the way the heart functions.

Their work raises the possibility that some of the molecular pathways that lead to heart failure could be precisely targeted, in contrast to treating heart failure as a disease with only one final outcome.

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Were not there yet, but we certainly have the capacity to make small molecules to interfere with pathways that we think are deleterious to the heart in this setting, she said. To my mind, thats the way to drive precision therapeutics. We know the cause of heart failure. We intervene in a pathway that we know is activated. And for the first time, we have that information now from human samples, not from an experimental model.

Seidman talked with STAT about the research, including how snRNAseq solves the smoothie problem, and what it might mean for patients. The conversation has been edited for clarity and brevity.

What happens in heart failure?

The heart becomes misshapen in one of two ways. It either becomes hypertrophied, where the walls of heart muscle become thickened and the volume within the heart is diminished, in what we call hypertrophic cardiomyopathy. Or it becomes dilated, when the volume in the heart is expanded and the walls become stretched. I think of it as an overinflated balloon, and that is called dilated cardiomyopathy.

Hypertrophy and dilatation are known to cause the heart over time to have profoundly diminished functional capacity. And clinically, we call that heart failure, much more commonly arising from dilated cardiomyopathy.

What does it feel like to patients?

When we see patients clinically, theyre short of breath, they have fluid retention. When we look at their hearts, we see that the pump function is diminished. That has led to a hypothesis of heart failure as sort of the end stage of many different disorders, but eventually the heart walks down a final common pathway. Then you need a transplant or a left ventricular assist device, or youre going to die prematurely.

What can be done?

Heart failure is a truly devastating condition, and it can arise early in life, in middle age, and in older people. There is no treatment for it, no cure for it, except cardiac transplantation, of course, which provides a whole host of other problems.

How did you approach this problem?

One of the questions we wanted to answer is, are there signals that we can discern that say there are different pathways and there are molecules that are functioning in those pathways that ultimately converge for failure, but through different strategies of your heart?

We treat every patient with heart failure with diuretics. We give them a series of different medications to reduce the pressure against which the heart has to contract. Im clinically a cardiologist, but molecularly Im a geneticist, so it doesnt make sense. If your house is falling down because the bricks are sticking together or if its falling down because the roof leaks and the water is pooling, you do things differently.

Tell me how you used single-cell RNA sequencing to learn more.

Looking at RNA molecules gives us a snapshot of how much a gene is active or inactive at a particular time point. Until recently, we couldnt do that in the heart because the approach had been to take heart tissue, grind it all up, and look at the RNAs that are up or down. But that gives you what we call a smoothie: Its all the different component cells those strawberries, blueberries, bananas mixed together.

But theres a technology now called single-cell RNA sequencing. And that says, what are the RNAs that are up or down in the cardiomyocytes as compared to the smooth muscle cells, as compared to the fibroblasts, all of which are in the cells? You get a much more precise look at whats changing in a different cell type. And thats the approach that we use, because cardiomyocytes [the cells in the heart that make it contract] are very large. Theyre at least three times bigger than other cells. We cant capture the single cell it literally does not fit through the microfluidic device. And so we sequenced the nuclei, which is where the RNA emanates from.

What did you find?

There were some similarities, but what was remarkable was the degree of differences that we saw in cardiomyocytes, in endothelial cells, in fibroblasts. Theres a signature thats telling us I walked down this pathway as compared to a different one that caused the heart to fail, but through activation or lack of activation of different signals along the way.

And that to me is the excitement, because if we can say that, we can then go back and say, OK, what happens if we were to have tweaked the pathway in this genotype and a different pathway in a different genotype? Thats really what precision therapy could be about, and thats where we aim to get to.

Whats the next step?

It may be that several genotypes will have more similarities as compared to other genotypes. But understanding that, I think, will allow us to test in experimental models, largely in mice, but increasingly in cellular models of disease, in iPS [induced pluripotent stem] cells that we can now begin to use molecular technologies to silence a pathway and see what that does to the cardiomyocytes, or silence the fibroblast molecule and see what that does in that particular genotype.

To my mind, thats the way to drive precision therapeutics. We know the cause of heart failure. We intervene in a pathway that we know is activated. And for the first time, we have that information now from human samples, not from an experimental model.

What might this mean for patients?

If we knew that an intervention would make a difference thats where the experiments are we would intervene when we saw manifestations of disease. So the reason I can tell you with confidence that certain genes cause dilated cardiomyopathy is theres a long time between the onset of that expansion of the ventricle until you develop heart failure. So theres years for us to be able to stop it in its tracks or potentially revert the pathology, if we can do that.

What else can you say?

I would be foolish not to mention the genetic cause of dilated cardiomyopathy. Ultimately, if you know the genetic cause of dilated cardiomyopathy, this is where gene therapy may be the ultimate cure. Were not there yet, but we certainly have the capacity to make small molecules to interfere with pathways that we think are deleterious to the heart in this setting.

My colleagues have estimated that approximately 1 in 250 to 1 in 500 people may have an important genetic driver of heart muscle disease, cardiomyopathy. Thats a huge number, but not all of them will progress to heart failure, thank goodness. Around the world, there are 23 million people with heart failure. Its what ends up on most peoples death certificate. It is the most common cause of death.

Its a huge, huge burden. And there really is no cure for it except transplantation. We dont have a reparative capacity, so were going to have to know a cause and be able to intervene precisely for that cause.

Read more:

New research digs into the genetic drivers of heart failure, with an eye to precision treatments - STAT

Wilmington, Delaware, United States, Transparency Market Research Inc. The healthcare category research depicts a clear overview of various inter-connected factors that can influence the development of global gamma probe device market in coming years. Players and manufacturers in the global gamma probe device market are focused on developing new products that feature advanced gamma probe technologies in their product offerings.

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The healthcare survey report sheds light on various important trends as well as latest developments that can positively affect the global gamma probe device market over the forecast years i.e. 2021 to 2031. It also presents important information regarding the regional, geographical, and the competitive landscape of the global gamma probe device market over the forecast period.

Global Gamma Probe Device Market: Major Trends and Drivers

Rising cases of cancer, especially breast cancer is one of the major and foremost driving factors for the global gamma probe device market. For example, as per a 2018 report by the World Cancer Research Fund, there were approximately 2 million new instances of breast cancer cases that were promoted for the surgical procedure. Products in the global gamma probe device market are used for both diagnostic as well as therapeutic purposes. Rising utilization of mobile gamma probes for both sentinel lymph node snapping for diagnostics as well as treatment for parathyroid surgical treatment is expected to create new opportunities for the global gamma probe device market.

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Moreover, rising preference of radio guided surgeries using products from the global gamma probe device market owing to their minimally invasive operating nature may also boost the demand in industry in near future. On the other hand, high cost associated with acquirement of products in the global gamma probe device market may hamper the growth trajectory of the industry in coming years.

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Some of the most prominent and leading players functioning within the global gamma probe device market include Lake Shore Cryotronics Inc., Wake Medical, Thermo Fisher Scientific, Tron Medical Ltd., Hologic Inc., Raditec Medical AG, Dilon Technologies, Inc., as well as the Intramedica Imaging, among others. Various leading and established players in the global gamma probe device market are engaged in new product launches as well as product innovations in a bid to attract more consumers. Players are also focused on discovering ways to expand their grographical reach in order to expand their consumer base across the world.

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Global Gamma Probe Device Market: Regional Assessment

Regionally, North America is anticipated to lead the global gamma probe device market in terms of demand. Key factors that may motivate sales in the global gamma probe device market in North America include rising number of patients suffering from cancer, new product launches, technological advancements, and rising usage of nuclear medicine.

Furthermore, increasing investment in research and development, coupled with government funding for usage of medical isotopes in the region have also led to dramatic increase in the demand in global gamma probe device market. Moreover, presence of well-trenched healthcare players and infrastructure as well as rising regional expenditure on healthcare is fuelling the development of global gamma probe device market.

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Gamma Probe Device Market Trends, On-going Demand, Opportunities, Segmentation, and Forecast till 2031 - BioSpace

August 8, 2022

Delivering the protein EPS8 via gene therapy rescues malfunctioning inner ear hair cells that transduce sound

LA JOLLAScientists from the Salk Institute and the University of Sheffield co-led a study that shows promise for the development of gene therapies to repair hearing loss. In developed countries, roughly 80 percent of deafness cases that occur before a child learns to speak are due to genetic factors. One of these genetic components leads to the absence of the protein EPS8, which coincides with improper development of sensory hair cells in the inner ear. These cells normally have long hair-like structures, called stereocilia, that transduce sound into electrical signals that can be perceived by the brain. In the absence of EPS8, the stereocilia are too short to function, leading to deafness.

The teams findings, published in Molecular Therapy Methods & Clinical Development online on July 31, 2022, show that delivery of normal EPS8 can rescue stereocilia elongation and the function of auditory hair cells in the ears of mice affected by the loss of EPS8.

Our discovery shows that hair cell function can be restored in certain cells, says co-senior author Uri Manor, assistant research professor and director of the Waitt Advanced Biophotonics Core at Salk. I was born with severe to profound hearing loss and feel it would be a wonderful gift to be able to provide people with the option to have hearing.

The cochlea, a spiral tube structure in the inner ear, enables us to hear and distinguish different sound frequencies. Low-frequency regions of the cochlea have longer stereocilia while high-frequency regions have shorter stereocilia. When sound travels through the ear, fluid in the cochlea vibrates, causing the hair cell stereocilia to vibrate. These hair cells send signals to neurons, which pass on information about the sounds to the brain.

Manor previously discovered that the EPS8 protein is essential for normal hearing function because it regulates the length of hair cell stereocilia. Without EPS8, the hairs are very short. Concurrently, co-senior author Walter Marcotti, professor at the University of Sheffield, discovered that in the absence of EPS8 the hair cells also do not develop properly.

For this study, Manor and Marcotti joined forces to see if adding EPS8 to stereocilia hair cells could restore their function to ultimately improve hearing in mice. Using a virus to help deliver the protein to hair cells, the team introduced EPS8 into the inner ears of deaf mice who lacked EPS8. They then used detailed imaging to characterize and measure the hair cell stereocilia.

The team found that EPS8 increased the length of the stereocilia and restored hair cell function in low-frequency cells. They also found that after a certain age, the cells seemed to lose their ability to be rescued by this gene therapy.

EPS8 is a protein with many different functions, and we still have a lot more to uncover about it, says Manor. I am committed to continuing to study hearing loss and am optimistic that our work can help lead to gene therapies that restore hearing.

Future research will include looking at how well EPS8 gene therapy might work to restore hearing during different developmental stages, and whether it might be possible to lengthen the therapeutic window of opportunity.

Other authors on the study are Colbie Chinowsky, Tsung-Chang Sung and Yelena Dayn of Salk; Jing-Yi Jeng, Adam Carlton, Federico Ceriani and Stuart Johnson of the University of Sheffield; Richard Goodyear and Guy Richardson of the University of Sussex; and Steve Brown and Michael Bowl of the MRC Harwell Institute.

The research was supported by the Biotechnology and Biological Sciences Research Council (BB/S006257/1, BB/T016337/1), Waitt Foundation, Grohne Foundation, National Institutes of Health (CA014195, R21DC018237), National Science Foundation (NeuroNex Award 2014862), Chan-Zuckerberg Initiative (Imaging Scientist Award) and Dudley and Geoffrey Cox Charitable Trust.

DOI: 10.1016/j.omtm.2022.07.012

More here:
Discovery advances the potential of gene therapy to restore hearing loss - Salk Institute

Published: Published Date - 09:21 PM, Wed - 10 August 22

Hyderabad: This concept may seem quite fictional and even futuristic. However, this is what geneticists worldwide through gene therapy are pursuing, while trying to find cure for a wide range of diseases that challenge modern medicine including cancers, heart diseases, diabetes, haemophilia, AIDS, genetic disorders, among others.

Gene therapy involves altering the genes inside the cells of the human body, in order to treat or prevent the disease progression. Essentially, geneticists worldwide are exploring ways to utilise gene therapy to alter genetic composition of cells that are responsible for causing diseases and in the process find a long term cure for diseases. The potential to unlock the cure for a wide range of diseases has become a major driving force for researchers and pharma giants worldwide to focus their energies and resources on gene therapy.

So what exactly is gene and gene therapy?

The Gene Therapy Advisory and Evaluation Committee (GTAEC), which monitors clinical trials across India on gene therapies, defines Gene is the most basic and functional unit of heredity and inheritance and consists of a specific sequence of nucleotides in DNA or RNA located on chromosomes that encodes for specific proteins. The human genome comprises more than 20,000 genes. Gene therapy refers to the process of introduction, removal or change in content of an individuals genetic material with the goal of treating the disease and a possibility of achieving long term cure.

The genetic material that has to be introduced to the diseased cell is done through a vector, whch is usually a virus. Viruses are the preferred vectors or vehicles as they are adaptable and efficient in delivering genetic material, the GTAEC, said.

While worldwide major pharmaceutical companies are developing gene therapies for treatment of single gene defects like haemophilia and muscular dystrophy, the Department of Biotechnology (DBT), Government of India, Tata Memorial Hospital, Mumbai and IIT-Mumbai have collaborated to start clinical trials of gene therapy on cancer in India.

Gene therapy in cancer:

In the last few years, CAR- (Chimeric Antigen Receptor) T therapy, a form of gene therapy has emerged as a breakthrough treatment for cancer, especially for leukemia, lymphoma (cancer of the lymphatic system) and multiple myeloma or the cancer of the plasma cells.

The CAR-T cells are genetically engineered in a laboratory and they bind with the cancer cells and kill them. The therapy is available in a few cancer research centres (on clinical trials basis) in US and cost of treatment ranges anywhere from Rs 3 crore to Rs. 4 crore.

To reduce treatment costs, promote and support development CAR-T cell technology against cancers, for the first time in India, Biotechnology Industry Research Assistance Council (BIRAC), established by DBT, Tata Memorial Hospital and IIT Bombay, have launched clincal trials of CAR-T gene therapy to treat cancers. The CAR-T cells were designed and manufactured at Bioscience and Bioengineering (BSBE) department of IIT Bombay. The gene therapy study on cancers is in early phase clinical trials at Tata Memorial in Mumbai.

Regulation of gene therapy:

Realising the potential of gene therapies in treating complex diseases, the GOI is providing financial and even technical guidance to researchers through ICMR, DBT and DST. To ensure gene therapies are introduced in India and clinical trials for gene therapies are performed in an ethical, scientific and safe manner, the ICMR has also framed National Guidelines for Gene Therapy Product Development and Clinical Trials document.

Original post:
Health and Tech: The promise of gene therapy to cure cancers - Telangana Today

DUBLIN--(BUSINESS WIRE)--The "Global Gene Therapy Market by Vectors (Non-viral(Oligonucleotides), Viral(Retroviral, Adeno-associated)), Indication (Cancer, Neurological, Hepatological Diseases, Duchenne Muscular Dystrophy), Delivery Method (In Vivo, Ex Vivo), and Region - Forecast to 2027" report has been added to ResearchAndMarkets.com's offering.

The global gene therapy market is valued at an estimated USD 7.3 billion in 2022 and is projected to reach USD 17.2 billion by 2027, at a CAGR of 18.6% during the forecast period. Factors such as rising cases of neurological diseases and cancer, growing gene therapy product approvals, and increasing investment in gene therapy related research and development drive the market growth. However, factors like high cost of gene therapy is restraining the growth of this market.

The cancer segment accounted for the highest growth rate in the gene therapy market, by indication, during the forecast period

In 2021, cancer segment accounted for the highest growth rate. Growing disease burden of cancer across the globe coupled with rising demand for gene therapies to treat cancer will augment the segmental growth of cancer over the forecast period.

Asia-Pacific: The fastest-growing region in the gene therapy market

The Asia-Pacific market is estimated to record the highest CAGR during the forecast period. The high growth rate of this market can be attributed to the improving healthcare expenditure in emerging economies, increasing product launches, and increasing incidence of cancer and neurological diseases.

Research Coverage

This report provides a detailed picture of the global gene therapy market. It aims at estimating the size and future growth potential of the market across different segments such as vectors, indication, delivery method, and region. The report also includes an in-depth competitive analysis of the key market players along with their company profiles recent developments and key market strategies.

List of Companies Profiled in the Report

Premium Insights

Market Dynamics

Drivers

Opportunities

Challenges

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights

5 Market Overview

6 Gene Therapy Market, by Vector

7 Gene Therapy Market, by Indication

8 Gene Therapy Market, by Delivery Method

9 Gene Therapy Market, by Region

10 Competitive Landscape

11 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/vhssny

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Global Gene Therapy Market 2022-2027: High Incidence of Cancer & Other Targeted Diseases to Drive Growth - ResearchAndMarkets.com - Business Wire

DUBLIN, Aug. 8, 2022 /PRNewswire/ --The "Gene Therapy Market by Type of Therapy, Type of Gene Delivery Method Used, Type of Vector Used, Target Therapeutic Areas, Route of Administration, and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering.

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Gene Therapy Market (5th Edition) report features an extensive study of the current market landscape and the likely future potential associated with the gene therapy market, primarily focusing on gene augmentation-based therapies, oncolytic viral therapies, immunotherapies and gene editing therapies.

One of the key objectives of the report was to estimate the existing market size and the future opportunity associated with gene therapies, over the next decade. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided informed estimates on the evolution of the market for the period 2022-2035.

Over the last two decades, there have been several breakthroughs related to the development of gene therapies. In 2020, LibmeldyT, an ex vivo gene therapy received approval for the treatment of metachromatic leukodystrophy. To provide more context, the treatment regimen of such therapies, encompassing gene replacement and gene-editing modalities, is aimed at correction of the mutated gene in patients using molecular carriers (viral and non-viral vectors).

Further, post the onset of the COVID-19 pandemic, there has been a steady increase in the investigational new drug (IND) applications filed for cell and gene therapies. In fact, in 2021, more than 200 gene therapies were being evaluated in phase II and III studies. Moreover, in 2022, six gene therapies are expected to receive the USFDA market approval. Promising results from ongoing clinical research initiatives have encouraged government and private firms to make investments to support therapy product development initiatives in this domain.

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In 2021 alone, gene therapy developers raised around USD 9.5 billion in capital investments. Taking into consideration the continuous progress in this domain, gene therapies are anticipated to be used for the treatment of 1.1 million patients suffering from a myriad of disease indications, by 2035.

Presently, more than 250 companies are engaged in the development of various early and late-stage gene therapies, worldwide. In recent years, there has been a significant increase in the integration of novel technologies, such as gene modification, gene-editing, genome sequencing and manipulation technologies (molecular switches), in conjugation with gene delivery methods.

For instance, the CRISPR-Cas9 based gene-editing ool is one of the remarkable technological advancements, which enables the precise alteration of the transgene. It is worth mentioning that the new generation delivery platforms, including nanoparticles and hybrid vector systems, have been demonstrated to be capable of enabling effective and safe delivery of gene based therapeutics.

Further, a variety of consolidation efforts are currently ongoing in this industry. Such initiatives are primarily focused on expanding and strengthening the existing development efforts; this can be validated from the fact that 56% of the total acquisitions reported in the domain were focused on drug class consolidation.

Driven by the collective and consistent efforts of developers and the growing demand for a single dose of effective therapeutic, the gene therapy market is anticipated to witness significant growth in the foreseen future.

Key Questions Answered

Who are the key industry players engaged in the development of gene therapies?

How many gene therapy candidates are present in the current development pipeline? Which key disease indications are targeted by such products?

Which types of vectors are most commonly used for effective delivery of gene therapies?

What are the key regulatory requirements for gene therapy approval, across various geographies?

Which commercialization strategies are most commonly adopted by gene therapy developers, across different stages of development?

What are the different pricing models and reimbursement strategies currently being adopted for gene therapies?

What are the various technology platforms that are either available in the market or are being designed for the development of gene therapies?

Who are the key CMOs/CDMOs engaged in supplying viral/plasmid vectors for gene therapy development?

What are the key value drivers of the merger and acquisition activity in the gene therapy industry?

Who are the key stakeholders that have actively made investments in the gene therapy domain?

Which are the most active trial sites (in terms of number of clinical studies being conducted) in this domain?

How is the current and future market opportunity likely to be distributed across key market segments?

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION3.1. Context and Background3.2. Evolution of Gene Therapies3.3. Classification of Gene Therapies3.3.1. Somatic and Germline Gene Therapies3.3.2. Ex Vivo and In Vivo Gene Therapies3.4. Routes of Administration3.5. Mechanism of Action3.6. Overview of Gene Editing3.6.1. Evolution of Genome Editing3.6.2. Applications of Genome Editing3.6.3. Available Genome Editing Techniques3.7. Advantages and Disadvantages of Gene Therapies3.7.1 Ethical and Social Concerns Related to Gene Therapies3.7.2. Constraints and Challenges Related to Gene Therapies3.7.3. Therapy Development Concerns3.7.4. Manufacturing Concerns3.7.5. Commercial Viability Concerns

4. GENE DELIVERY VECTORS4.1. Chapter Overview4.2. Viral and Non-Viral Methods of Gene Transfer4.3. Viral Vectors for Genetically Modified Therapies4.4. Types of Viral Vectors4.5. Types of Non-Viral Vectors

5. REGULATORY LANDSCAPE AND REIMBURSEMENT SCENARIO5.1. Chapter Overview5.2. Regulatory Guidelines in North America5.3. Regulatory Guidelines in Europe5.4. Regulatory Guidelines in Asia-Pacific5.5. Reimbursement Scenario5.6. Commonly Offered Payment Models for Gene Therapies

6. MARKET OVERVIEW6.1. Chapter Overview6.2. Gene Therapy Market: Clinical and Commercial Pipeline6.3. Gene Therapy Market: Early-Stage Pipeline6.4. Gene Therapy Market: Special Drug Designations6.5. Analysis by Phase of Development, Therapeutic Area and Type of Therapy (Grid Representation)

7. COMPETITIVE LANDSCAPE7.1. Chapter Overview7.2. Gene Therapy Market: List of Developers7.3. Key Players: Analysis by Number of Pipeline Candidates

8. MARKETED GENE THERAPIES8.1. Chapter Overview8.2. Gendicine (Shenzhen Sibiono GeneTech)8.3. Oncorine (Shanghai Sunway Biotech)8.4. Rexin-G (Epeius Biotechnologies)8.5. Neovasculgen (Human Stem Cells Institute)8.6. Imlygic (Amgen)8.7. Strimvelis (Orchard Therapeutics)8.8. LuxturnaT (Spark Therapeutics)8.9. ZolgensmaT (Novartis)8.10. Collategene (AnGes)8.11. ZyntelgoT (bluebird bio)8.12. LibmeldyT (Orchard Therapeutics)

9. KEY COMMERCIALIZATION STRATEGIES9.1. Chapter Overview9.2. Successful Drug Launch Strategy: ROOTS Framework9.3. Successful Drug Launch Strategy: Product Differentiation9.4. Commonly Adopted Commercialization Strategies based on Phase of Development of Product9.5. List of Currently Approved Gene Therapies9.6. Key Commercialization Strategies Adopted by Gene Therapy Developers9.6.1. Strategies Adopted Before Therapy Approval9.6.1.1. Participation in Global Events9.6.1.2. Collaboration with Stakeholders and Pharmaceutical Firms9.6.1.3. Indication Expansion9.6.2. Strategies Adopted During/Post Therapy Approval9.6.2.1. Geographical Expansion9.6.2.2. Participation in Global Events9.6.2.3. Patience Assistance Programs9.6.2.4. Awareness through Product Websites9.6.2.5. Collaboration with Stakeholders and Pharmaceutical Firms9.7. Concluding Remarks

10. LATE STAGE (PHASE II/III AND ABOVE) GENE THERAPIES10.1. Chapter Overview10.2. Lumevoq (GS010): Information on Dosage, Mechanism of Action, Clinical Trials and Clinical Trial Results10.3. OTL-10310.4. PTC-AADC10.5. BMN 27010.6. rAd-IFN/Syn310.7. beti-cel10.8. eli-cel10.9. lovo-cel10.10. SRP-900110.11. EB-10110.12. ProstAtak10.13. D-Fi10.14. CG007010.15. VigilT-EWS10.16. Engensis10.17. VGX-310010.18. InvossaT (TG-C)10.19. VYJUVEKTT10.20. PF-0693992610.21. PF-0683843510.22. PF-0705548010.23. SPK-801110.24. AMT-06110.25. VB-11110.26. Generx10.27. ADXS-HPV10.28. AGTC 50110.29. LYS-SAF30210.30. NFS-0110.31. AG0302-COVID1910.32. RGX-31410.33. Hologene 5

11. EMERGING TECHNOLOGIES11.1. Chapter Overview11.2. Gene Editing Technologies11.2.1. Overview11.2.2. Applications11.3. Emerging Gene Editing Platforms11.3.1. CRISPR/Cas9 System11.3.2. TALENs11.3.3. megaTAL11.3.4. Zinc Finger Nuclease11.4. Gene Expression Regulation Technologies11.5. Technology Platforms for Developing/Delivering Gene Therapies

12. KEY THERAPEUTICS AREAS12.1. Chapter Overview12.2. Analysis by Therapeutic Area and Special Designation(s) Awarded12.3. Oncological Diseases12.4. Neurological Diseases12.5. Ophthalmic Diseases12.6. Metabolic Diseases12.7. Genetic Diseases

13. PATENT ANALYSIS13.1. Chapter Overview13.2. Gene Therapy Market: Patent Analysis13.3. Gene Editing Market: Patent Analysis13.4. Overall Intellectual Property Portfolio: Analysis by Type of Organization

14. MERGERS AND ACQUISITIONS14.1. Chapter Overview14.2. Merger and Acquisition Models14.3. Gene Therapy Market: Mergers and Acquisitions

15. FUNDING AND INVESTMENT ANALYSIS15.1. Chapter Overview15.2. Types of Funding15.3. Gene Therapy Market: Funding and Investment Analysis15.4. Concluding Remarks

16. CLINICAL TRIAL ANALYSIS16.1. Chapter Overview16.2. Scope and Methodology16.3. Gene Therapy Market: Clinical Trial Analysis16.4. Analysis by Type of Sponsor16.5. Analysis by Prominent Treatment Sites16.6. Gene Therapy Market: Analysis of Enrolled Patient Population16.7. Concluding Remarks

17. COST PRICE ANALYSIS17.1. Chapter Overview17.2. Gene Therapy Market: Factors Contributing to the Price of Gene Therapies17.3. Gene Therapy Market: Pricing Models

18. START-UP VALUATION18.1. Chapter Overview18.2. Valuation by Year of Experience

19. BIG PHARMA PLAYERS: ANALYSIS OF GENE THERAPY RELATED INITIATIVES19.1. Chapter Overview19.2. Gene Therapy Market: List of Most Prominent Big Pharmaceutical Players19.3. Benchmark Analysis of Key Parameters19.4. Benchmark Analysis of Big Pharmaceutical Players

20. DEMAND ANALYSIS20.1. Chapter Overview20.2. Methodology20.3. Global Demand for Gene Therapies, 2022-2035

21. MARKET FORECAST AND OPPORTUNITY ANALYSIS21.1. Chapter Overview21.2. Scope and Limitations21.3. Key Assumptions and Forecast Methodology21.4. Global Gene Therapy Market, 2022-203521.5. Gene Therapy Market: Value Creation Analysis21.6. Gene Therapy Market: Product-wise Sales Forecasts21.6.1. Gendicine21.6.2. Oncorine21.6.3. Rexin-G21.6.4. Neovasculgen21.6.5. Strimvelis21.6.6. Imlygic21.6.7. LuxturnaT21.6.8. ZolgensmaT21.6.9. Collategene21.6.10. LibmeldyT21.6.11. Lumevoq (GS010)21.6.12. OTL-10321.6.13. PTC-AADC21.6.14. BMN 27021.6.15. rAd-IFN/Syn321.6.16. beti-cel21.6.17. eli-cel21.6.18. lovo-cel21.6.19. SRP-900121.6.20. EB-10121.6.21. ProstAtak21.6.22. D-Fi21.6.23. CG007021.6.24. VigilT-EWS21.6.25. Engensis21.6.26. VGX-310021.6.27. InvossaT (TG-C)21.6.28. VYJUVEKTT21.6.29. PF-0693992621.6.30. PF-0683843521.6.31. PF-0705548021.6.32. SPK-801121.6.33. AMT-06121.6.34. VB-11121.6.35. Generx21.6.36. AMG00121.6.37. OAV-10121.6.38. ADXS-HPV21.6.39. AGTC 50121.6.40. LYS-SAF30221.6.41. NFS-0121.6.42. AG0302-COVID1921.6.43. RGX-31421.6.44. Hologene 5

22. VECTOR MANUFACTURING22.1. Chapter Overview22.2. Overview of Viral Vector Manufacturing22.3. Viral Vector Manufacturing Process22.4. Bioprocessing of Viral Vectors22.5. Challenges Associated with Vector Manufacturing22.6. Contract Service Providers for Viral and Plasmid Vectors

23. CASE STUDY: GENE THERAPY SUPPLY CHAIN23.1. Chapter Overview23.2. Overview of Gene Therapy Supply Chain23.3. Implementation of Supply Chain Models23.4. Logistics in Gene Therapies23.5. Regulatory Supply Chain Across the Globe23.6. Challenges Associated with Gene Therapy Supply Chain23.7. Optimizing Cell and Advanced Therapies Supply Chain Management23.8. Recent Developments and Upcoming Trends

24. CONCLUSION24.1. Chapter Overview

25. INTERVIEW TRANSCRIPTS25.1. Chapter Overview25.2. Buel Dan Rodgers (Founder and CEO, AAVogen)25.3. Sue Washer (President and CEO, AGTC)25.4. Patricia Zilliox (President and CEO, Eyevensys)25.5. Christopher Reinhard (CEO and Chairman, Gene Biotherapeutics (previously known as Cardium Therapeutics))25.6. Adam Rogers (CEO, Hemera Biosciences)25.7. Ryo Kubota (CEO, Chairman and President, Kubota Pharmaceutical Holdings (Acucela))25.8. Al Hawkins (CEO, Milo Biotechnology)25.9. Jean-Phillipe Combal (CEO, Vivet Therapeutics)25.10. Robert Jan Lamers (former CEO, Arthrogen)25.11. Tom Wilton (former CBO, LogicBio Therapeutics)25.12. Michael Tripletti (former CEO, Myonexus Therapeutics)25.13. Molly Cameron (former Corporate Communications Manager, Orchard Therapeutics)25.14. Cedric Szpirer (former Executive and Scientific Director, Delphi Genetics)25.15. Marco Schmeer (Project Manager) and Tatjana Buchholz, (former Marketing Manager, PlasmidFactory)25.16. Jeffrey Hung (CCO, Vigene Biosciences)

26. APPENDIX 1: TABULATED DATA

27. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/kp21lo

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Cell culture and cell lines

The mouse cell lines MCA205 H-2b (MCA, methylcholanthrene derived sarcoma, provided by Dr. Guido Kromer, France) and B16F10 (B16, melanoma, kindly provided by Dr. Roger Chammas, ICESP) were maintained in a humidified incubator at 37C with 5% CO2 and cultivated in Roswell Park Memorial Institute (RPMI) medium (Thermo Fisher Scientific, Waltham, MA, USA), supplemented with 10% fetal bovine serum (Invitrogen) as well as 1X Anti-Anti (AntibioticAntimycotic -100X, Thermo Fisher Scientific). HEK293 cells were cultivated in Dulbeccos modified Eagle medium (both from Thermo Fisher Scientific), supplemented and maintained in the same conditions as above.

Here we use the MCA sarcoma cell line and employed an intratumoral (i.t) application model since it was demonstrated under these conditions the ability of Dox to unleash ICD and stimulate immune responses in vivo11. We also used the B16 cell line, as it was with this model that we revealed the cell death and immune stimulatory events of our p19Arf/IFN treatment. With regard to the treatment order, we based our approach on the work of Fridlender and collaborators (2010) that showed that association of an adenoviral vector encoding IFN with chemotherapy is more effective when gene transfer is applied first23.

The MCA-DEVD cell line was generated by transduction with a lentivirus reporter for caspase-3 activity and selection for puromycin resistance (0.5g/ml). This vector, previously described24, encodes a constitutively expressed luciferase-GFP protein separated from a polyubiquitin domain via a caspase-3 cleavage site and was generously provided by Dr. Chuan-Yuan Li (Department of Radiation Oncology, University of Colorado School of Medicine, Aurora, CO, USA).

Construction and production of AdRGD-PG adenoviral vectors (serotype 5) containing modification with the RGD motif in the fiber as well as the p53-responsive promoter (PGTx, PG) has been described previously14. Titration of adenoviral stocks was performed using the Adeno-X Rapid Titer Kit (Clontech, Mountain View, CA, USA) and titer yields were: AdRGD-CMV-LacZ (3.6109IU/mL, infectious units/milliliter), AdRGD-PG-LUC (11011IU/mL), AdRGD-PG-eGFP (51010IU/mL), AdRGD-PG-p19 (1.31010IU/mL) and Ad-RGD-IFN (51010IU/mL). This biological titer was used to calculate multipilicity of infection (MOI).

MCA or B16 cells (1105) were plated in 6 well plates containing 1mL of RPMI media and transduced with adenovirus at the desired MOI. After an overnight transduction period (1216h), 2mL of media was added and cells kept in culture until needed. When combining adenoviral transduction with chemotherapy, Dox (doxrubicin hydrochloride, Sigma, St. Louis, MO, USA) was added immediately after the overnight transduction using the concentration indicated for each experiment. Importantly, in the Dox single treatment condition, Dox was added at the same moment as in the association group, 12 to 16h after cell plating. After 12h treatment with Dox (1mg/mL) or Nutlin-3 (10M, Sigma), expression of eGFP from AdRGD-PG-eGFP was analyzed by flow cytometry (Attune, Life Technologies). Cell viability was assessed by MTT assay where, 8h after transduction in 6 well plates, 2104 cells/well were plated in 96 well plates, treated with Dox, and analyzed after 16h of incubation. Non-transduced cells were used as viable control and protocol was carried out as described previously25. Cell cycle analysis by propidium iodide (PI) staining was carried out 72h after p19Arf/IFN and Dox single treatment, as previously described16. Analysis of caspase 3 activity in vitro was performed 16h after combined treatment using the CellEvent Caspase-3/7 Green Reagent (Thermo Fisher Scientific) by flow cytometry, following manufacturers instructions. Last, analysis of ICD markers upon p19Arf/IFN+Dox was conducted as detailed previously14. Briefly, detection of calreticulin+ and PI- cells was made 14h after combined treatment, by staining with a CRT-specific antibody (1:100, Novus, Biologicals, CO, USA) and after cells were washed with PBS, they were incubated with Alexa488-conjugated anti-rabbit secondary antibody (1:500, Thermo Fisher Scientific) followed by PI staining to exclude dead cells, immediately before flow cytometry. Accumulation of ATP in the cell supernatant was detected using the ENLITEN ATP Assay (Promega, Madison, WI, USA), as per the manufacturer's instructions. Luminescence was observed using a GloMax Plate Reader (Promega). HMGB1 in cell supernatant was detected by Western blot after conditioned medium was supplemented with protease inhibitor cocktail (Thermo Fisher Scientific). Then, 180l of the medium was concentrated (Concentrator PlusEppendorf, Hamburg, Germany) and subjected to western blotting. Unrelated, high molecular weight regions of the membrane were removed before detection was performed using anti-HMGB1 (Abcam ab79823, Cambridge, UK) and a secondary antibody conjugated with horseradish peroxidase before visualization using ECL (GE Healthcare, Chicago, IL, USA) and the ImageQuant LAS4000 imaging platform (GE Healthcare). See Supplementary Information Westerns S2 for original images from three independent assays. Additional Western blots were performed using cell lysates, high-molecular weight regions of the membranes were removed and then detection was performed using anti- PARP (Cell Signaling, Danvers, MA, USA, #9542), anti-Actin (Santa Cruz Biotechnology, Dallas, TX, USA, #47778), anti-Caspase 3 (Cell Signaling, #9662), anti-Tubulin (Millipore, Burlington, MA, USA, #05-829) and the appropriate secondary antibodies conjugated with horseradish peroxidase (anti-mouseSigma #A9044 e anti-rabbitSigma #A0545). See Supplementary Information Westerns S2 for original images from two independent assays.

The influence of two independent variables, namely, MOI of adenoviral vectors encoding p19Arf/IFN and the concentration of Dox, was investigated on MCA and B16 cells using factorial experiments in five levels (Table S1), with the percentage of hypodiploid cells as the variable response. The experiments were carried out employing central composite rotational design (CCRD) where, for each cell line, a set of twelve combinatory assays containing a central composite factorial matrix plus rotation points, central points and controls was performed (Table S2, where the assays and conditions are provided in detail). To better visualize the effects and interactions of MOI and Dox concentration on the percentage of hypodiploid cells, assessed by PI staining after 20h of treatment, the results were plotted in response surface graphs.

Importantly, the statistical significance of the independent variables and their interactions was determined by Fishers post-test for an analysis of variance (ANOVA) and Pareto chart analysis, both at a confidence level of 95% (p0.05). Moreover, five repetitions at the central point (CP) assays were used to minimize the error term of the ANOVA. Experimental designs, data regression and graphical analysis were performed using the Statistica software v.7.0 (Statsoft, Inc., Tulsa, OK, USA).

Both C57BL/6 and Nude mice were female, 7weeks old, obtained from the Centro de Bioterismo da FMUSP and kept in the animal facility in the Centro de Medicina Nuclear (CMN) in SPF conditions, with food and water ad libitum. The methods are reported in accordance with ARRIVE guidelines. The well-being of the mice was constantly monitored and all methods, including vaccination protocols, in vivo gene therapy, imaging, echocardiographic assessments, anesthesia and euthanasia were carried out in accordance with relevant guidelines and regulations of Brazil and our institution whose ethics committee (Committee for the Ethical Use of Animals, CEUA, University of So Paulo School of Medicine, FMUSP) approved this project (protocol n 165/14).

In the first step of the immunotherapy model, nave C57BL/6 mice were inoculated (s.c) in the right flank (tumor challenge site) with fresh untreated MCA (2105) or B16 (6104) cells and in the second step, vaccinated (s.c) on days+3,+9 and+15 with 3105 ex vivo treated cells applied in the left flank (vaccine site). Ex vivo treatment was carried out as follows: MCA or B16 cells were seeded in 10cm plates with 2mL of media and co-transduced with the AdRGD-PG-p19 and AdRGD-PG-IFN (MOI 500 for each) for 4h before the addition of 8mL of fresh media. Then, cells were kept in culture for 16h and in the p19Arf/IFN+Dox or Dox groups, Dox (14M) was added for 6h, until cells were harvested, washed twice with cold PBS, counted and resuspended in 100 L of cold PBS. For the DEAD cell+GFP control group, cells were transduced with the AdRGD-PG-eGFP vector (MOI 1000) and after 16h, harvested, washed twice with cold PBS, resuspended and lysed by three cycles of freezing and thawing.

MCA (2105) or B16 (5105) cells were harvested, washed twice with cold PBS, resuspended in 100 L of PBS per mouse and then inoculated subcutaneously (s.c) in the left flank of immune competent C57BL/6 or immune deficient Balb/c Nude (Foxn1n) mice. While mice were not randomized after injection of cells, but there was no specific selection of animals for each treatment group. No blinding of group allocation was performed at any phase of experimentation. No animals were excluded from the data. Approximately 8days later, palpable (60 mm3) tumors were treated three times, once every 2days, with intratumoral (i.t) injections (administered with precision Hamilton glass syringes (volume 100L) and 26G needles) of the following adenoviral vectors, AdRGD-CMV-LacZ or AdRGD-PG-LUC (4108IU, resuspended in 25 L final volume of PBS/mouse) or treated with the combination of AdRGD-PG-p19 and AdRGD-PG-IFN (2108IU, for each vector and maintaining the 25 L final volume per mouse). For the Dox single treatment model, chemotherapy was applied (i.t) once on day 12 with the following doses: 60, 20, 10 or 5mg/kg (in the final volume of 30 L of PBS/mouse). Whereas in the association model, adenoviral vectors were injected as explained above and Dox given 2days after the last viral injection (day 14), following the injection method as the Dox single treatment group. Tumor progression was measured by calipers every two days and volume calculated as described17. For the survival analysis comparing C57BL/6 and Nude mice, treated mice were euthanized by anesthesia with ketamine/xylazine followed by CO2 inhalation when tumor volume reached 1000 mm3 unless otherwise noted. See figure legends for the number of animals in each experimental group.

For the analysis of caspase 3 in vivo, MCA-DEVD tumors were treated in situ as described above and 24 and 48h after the last treatment injection, mice were submitted to bioluminescence imagining (IVIS Spectrum, Caliper Life Science) to detect the luciferase activity from the DEVD reporter. To this end, 10mg/kg luciferin (Promega) was administered by intraperitoneal (i.p) injection of each mouse and these were anesthetized with isoflurane (Cristalia, So Paulo, Brazil) using the Xenogen anesthesia system before imaging. Images were captured and only the strongest signal from each tumor was included in the analysis with Living Imaging 4.3 software (PerkinElmer, Waltham, MA, USA). Luciferase activity was obtained from the average radiance value [p/s/cm2/sr]. To calculate the fold activity overtime, average radiance values obtained for each mouse 48h post-treatment were divided by its respective value at 24h. Parental MCA tumors were used as negative control and no emission was detected (data not shown).

The systolic cardiac function was assessed by echocardiography. Exams were performed 10days after treatments with AdRGD-PG-eGFP (adenovirus control), Dox 10mg/kg, Dox 20mg/kg and p19Arf/IFN+Dox 10mg/kg. Mice were anesthetized with 1.5 to 2.5% isoflurane (in 100% oxygen ventilation). They were trichotomized and placed in supine decubitus to obtain cardiac images. Parasternal-long and short axis images were captured using VEVO 2100 ultrasound equipment (Vevo 2100 Imaging System, VisualSonics, Toronto, Canada) with a 40MHz linear-transducer. Analyses were performed off-line using VevoCQ LV Analysis software (VisualSonics). Parameters such as systolic and diastolic volumes were calculated using Simpsons modified algorithms present in the analysis software (parasternal-long axis images). Based on these volumes, stroke volume (L) and left ventricle ejection fraction (LVEF, %) were calculated. Also, linear measurements were obtained from parasternal short axis images. Left ventricle shortening fraction (LVSF, %) was calculated, using systolic and diastolic diameters. Left ventricle mass (LV mass, mg) was estimated by linear measurements. Beating rate (beats per minute, BPM) was recorded directly by an animal table-ECG system connected to the VEVO 2100 system. Echocardiographic results were interpreted considering the American Society of Echocardiography recommendations concerning the mouse model26. All parameters were shown as the mean values of three consecutive cardiac cycles. Transthoracic echocardiography image acquisition and analysis was performed by an expert investigator who was blind to the experimental groups.

Data are presented as meanSEM. Statistical differences between groups are indicated with p values, being *p<0.05, **p<0.01 and ***p<0.001. Statistical tests are indicated in each figure legend along with the number of independent experiments performed or number (n) of mice in each group. These analyses were made using the GraphPad Prism 5 (La Jolla, CA, USA) software, with the exception of the CCRD analysis (explained above).

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Potentiation of combined p19Arf and interferon-beta cancer gene therapy through its association with doxorubicin chemotherapy | Scientific Reports -...

DALLAS, Aug. 09, 2022 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric, pivotal-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS) in both rare and large patient populations, today announced that it will report its financial results for the second quarter ended June 30, 2022, and host a corporate update conference call and webcast on Thursday, August 11, 2022, at 8:00 AM Eastern Time.

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our teams proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platforman engine for potential new cureswith a goal of dramatically improving patients lives. More information is available atwww.tayshagtx.com.

Company Contact:Kimberly Lee, D.O. Chief Corporate Affairs OfficerTaysha Gene Therapiesklee@tayshagtx.com

Media Contact:Carolyn HawleyEvoke Canalecarolyn.hawley@evokegroup.com

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Taysha Gene Therapies to Release Second Quarter 2022 Financial Results and Host Conference Call and Webcast on August 11 - GlobeNewswire