Daily Archives: December 17, 2021

This may be the year that safe, inexpensive over-the-counter (OTC) hearing aids become available. In 2017, Congress passed a law directing the FDA to come up with a new category of hearing aids requiring special regulations and FDA approval. These hearing aids would be available from any seller, without doctor appointments or fittings, and sold at a fraction of the typical cost about $600 per pair instead of the average $5,000 (which includes fittings and follow-up services). Just one problem: the FDA missed the August 2020 deadline to come up with safety and labeling rules. In October 2021, the FDA moved forward and issued proposed rules for the OTC category. Approval is expected sometime this year. When will the devices appear? "Manufacturers are already creating self-fit OTC devices and business models, and theyre using the proposed regulations to fine-tune devices. We expect theyll launch shortly after regulations are finalized," says Meaghan Reed, director of clinical audiology at Massachusetts Eye and Ear. OTC devices will have the same fundamental technology as traditional hearing aids, and theyll be targeted to people with perceived mild-to-moderate hearing loss. "If you know you only need amplification, the devices might be right for you," Reed says. "But if youre not sure whats causing your hearing loss, we still advise that you get an evaluation so an underlying condition wont go undiagnosed."

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Progress toward over-the-counter hearing aids - Harvard Health

WASHINGTON The U.S. Department of Labor today announced the award of a $3 million cooperative agreement to the International Labour Organization to improve compliance with international labor standards in the Democratic Republic of the Congo. The project will seek to strengthen the ability of governments, employers and workers to improve work conditions related to wages and hours and workplace safety.

Administered by the departments Bureau of International Labor Affairs, the funding will support efforts in the capital city of Kinshasa primarily, and in some pilot provinces across one or more economic sectors.

The project applies a comprehensive approach to strengthen the labor inspectorates ability to provide advice, guidance and enforcement of legal provisions, bolster mediation and conciliation with labor officials and increase the capacity of labor judges to resolve labor disputes properly.

This cooperative agreement allows ILAB to continue its work to strengthen global labor standards, enforce labor commitments among trading partners and combat international child labor, forced labor and human trafficking. This project aims to:

Learn more about the departments international work.

The International Labour Organization, the United Nations only tripartite agency, brings together governments, employers and workers of 187 member states to set labor standards, develop policies and devise programs promoting decent work for all women and men.

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awards $3M grant to support progress on labor standards in the Democratic Republic of the Congo | US Department of Labor - US Department of Labor

The Blackhawks have attempted 1,139 shots at even strength so far this season.

Only 591 of those shot attempts have made it on goal, either going in the net or forcing a save. And that on-goal percentage 51.9% is the lowest in the NHL.

Meanwhile, on several occasions this season, the Hawks have used the phrase one and done to describe their offensive struggles. Alex DeBrincat did so after practice Monday; interim coach Derek King did so after practice Tuesday.

The problem the Hawks on-goal percentage suggests and the problem to which one and done refers are arguably the same thing. At the least, theyre strongly connected.

Shots on goal ideally go in, but even if they dont, they typically create rebounds or second opportunities, force defenders to make split-second decisions or create offensive-zone faceoffs. Blocked and missed shots more frequently ricochet out of the zone or stay in but allow the defending team to gain possession and exit the zone.

A lot of this year, weve pretty much been one and done in their zone, DeBrincat said. We get a chance, and then we have to play [in the] D zone again.

Weve got to put pucks on the net, which causes chaos, and then you can make all those cute plays, King said.

King attributed the Hawks difficulty getting shots on goal to players missing the net too much, but the data indicates thats not the true culprit. The Hawks actually have the ninth-lowest missed-shot rate at even strength (19.3%) and second-lowest missed-shot rate on the power play (15.9%).

Instead, the Hawks keep getting blocked. Whether its because theyre taking shots when tightly covered, being too predictable with puck movement or not keeping shooting lanes free of defensemen, their blocked-shot percentage is the highest in the league at even strength (28.8%) and sixth-highest on the power play (25.1%).

But there are a couple of reasons to believe the Hawks can improve in that regard.

First, their practice days Monday and Tuesday afforded them much-needed time to work on some offensive stuff [having] some net-front presence, getting shots through, supporting each other, changing sides, [passing] low to high, all those little things, King said.

The lines from practice with Dylan Strome on the first line and Brett Connolly on the second also potentially indicate a more offense-oriented game plan Wednesday against the Capitals.

Second, the Hawks already showed signs of progress in their most recent game, a 5-4 loss to the Maple Leafs on Saturday.

They not only scored four even-strength goals, tied for their most this season, but also had 30 even-strength shots on goal, their second-most this season. And they did so with only 39 even-strength shot attempts, equating to a 76.9% on-goal percentage.

Last game, we were holding it down there pretty [well], and that helps everyone out, DeBrincat said. Its a lot easier to create chances, and their D get tired, and you get to have that extra chance. If we do that more, were going to be able to win a lot more of these games and stay with some of those top teams.

NOTES: A week removed from his brutal concussion, Jujhar Khaira has been able to hang out around the locker room the last two days. The guys were excited to see him, [to see] hes up and moving around pretty good, coach Derek King said, adding its still going to take some time for Khaira to fully recover.

Henrik Borgstrom remains out with a non-COVID illness, and Kurtis Gabriel hasnt practiced the last two days because of pending immigration paperwork. In Rockford, top prospect Lukas Reichel was removed from concussion protocol Tuesday.

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Blackhawks hoping to finally progress past one-and-done offense - Chicago Sun-Times

(Washington, DC) On Thursday, December 16, at 10:30 am, Mayor Muriel Bowser will be in Rock Creek West to provide an update on the communitys progress in meeting the affordable housing goals that were included in the 2019 Housing Equity Report. The Mayor and the DC Office of Planning and the Department of Housing and Community Development will also share new tools that the District will be using to increase the production of affordable housing.

At the start of her second term, Mayor Bowser set a bold goal to deliver an additional 36,000 units of housing including at least 12,000 units of affordable housing by 2025. In October 2019, the Mayor released the Housing Equity Report, which set targets for new affordable housing for each of the Districts ten planning areas. The release of the Housing Equity Report made Washington, DC the first jurisdiction in the nation to set affordable housing goals by neighborhood.

Throughout #FairShot Week, the Bowser Administration is highlighting various new and existing programs designed to give Washingtonians a fair shot and accelerate the Districts economic recovery. The Mayor is promoting some of the many programs listed on ObviouslyDC.com that provide financial assistance to local businesses and businesses that want to open in, expand to, and create jobs in Washington, DC.

Where:

Thursday, December 16, at 10:30 am

Who:

Mayor Muriel BowserJohn Falcicchio, Deputy Mayor for Planning and Economic DevelopmentAndrew Trueblood, Director, Office of PlanningDrew Hubbard, Interim Director, DC Department of Housing and Community DevelopmentDr. Joseph W. Daniels, Leader Pastor, Emory FellowshipRandy Speck, Chair, ANC 3/4G

Where:

Chevy Chase Community Center Courtyard5601 Connecticut Avenue, NW*Closest Metro Station: Friendship Heights Metro Station**Closest Bikeshare Station: Connecticut Avenue & McKinley Street, NW *

Press interested in attending the event are asked to RSVP to[emailprotected].

The DC Office of Cable Television, Film, Music, and Entertainment will provide a live feed of this event to watch from a safe, virtual space.To view event online visitmayor.dc.gov/live, tune in on Channel 16 (DCN) or any of the social media platforms below.

Social Media:Mayor Bowser Twitter:@MayorBowserMayor Bowser Instagram:@Mayor_BowserMayor Bowser Facebook:facebook.com/MayorMurielBowserMayor Bowser YouTube:https://www.bit.ly/eomvideos

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Mayor Bowser to Provide Update on the Housing Equity Report's Progress in Rock Creek West | mayormb - Executive Office of the Mayor

Last month at the 2021 United Nations Climate Change Conference (commonly referred to as the COP26), the International Financial Reporting Standards Foundation (IFRS Foundation) announced the formation of an International Sustainability Standards Board (ISSB).

The IFRS Foundation also announced that it had reached an agreement to consolidate with the Climate Disclosure Standards Board (CDSB), an initiative of CDP (formerly the Carbon Disclosure Project), and the Value Reporting Foundation (which resulted from the already merged International Integrated Reporting Council (IIRC) and Sustainability Accounting Standards Board (SASB) Foundation).

In light of these developments, the Corporate Reporting Dialogue (CRD), an initiative convened in 2014 to strengthen cooperation, coordination and alignment amongst key international standard setters and framework developers dissolved last month. The IIRC formed the CRD as a response to market calls for better alignment and reduced burden in corporate reporting. In connection with its dissolution, the CRD cited the success of its mission given the upcoming consolidation of four of its seven members with the formation of ISSB.

By way of background, the CRD made significant progress since it was convened in 2014. Some of its work included a landscape map showing the connections amongst various reporting initiatives through the lens of integrated reporting, and a paper setting out principles of transparency and accountability necessary for all corporate reporting. Its efforts more recently culminated in the Better Alignment project that was pivotal in laying the foundation for the recent announcements to consolidate and deliver a comprehensive, aligned system for international reporting. See our blog posts from June 2021 and December 2020 regarding consolidation efforts.

All parties within the dissolving CRD will support the ongoing work by the ISSB. The IFRS Foundation and the ISSB plan to establish an advisory group structure that will allow the continued coordination and collaboration among organizations committed to enhanced, standardized disclosure an effort previously facilitated by the CRD.

The Staff at the Securities and Exchange Commission (SEC) has been tracking these efforts. Earlier this month, SECs Acting Chief Accountant, Paul Munter, issued a statement concerning High Quality Financial Reporting in a Complex Environment, in which he highlighted international developments on th[is] topic, specifically including the formation of a global sustainability standards board, namely the International Sustainability Standards Board (ISSB) to set IFRS sustainability disclosure standards. In our July 2021 blog post, we also described how the Staff has previously expressed support and considered the IFRS as the entity that creates global sustainability reporting standards.

Link:

Consolidation and Globalization of ESG Standards Progress: CRD Dissolves to Support IFRS Foundation and ISSB - JD Supra

The kiddos have their virtual Santa visit scheduled for tonight its like a Zoom from the North Pole which Im very happy they get to do, because its sweet and silly and fun, but Id be lying if I didnt admit its a painful reminder of how things are still effed up even after two years of this crap. I just hate how things have been for my kids for so long now.

As expected, the public fronting from certain aldermen about not permitting sportsbooks at stadiums and arenas around the city led to lobbying behind the scenes, and then an approval from a key committee. The full vote at City Council is today, which would allow all the major teams to construct/operate sportsbooks at their various facilities. The Chicago Cubs already have a deal in place with DraftKings to open one of the largest sportsbooks in the country at Wrigley Field, so this approval is the final step before construction will begin.

Cubs Owner and Chairman Tom Ricketts testified at the committee, per ABC-7:

Before the final vote, Cubs Chairman Tom Ricketts said his team is ready to go today on its $100 million partnership with DraftKings that will pave the way for Wrigley Field to house the first stadium sportsbook in Major League Baseball.

With your approval of this ordinance, construction would begin immediately with the aim of opening a restaurant with a sportsbook in time for the 2023 season. This will create construction jobs and revenues now and permanent jobs in just over a year, Ricketts said.

Ricketts said the ordinance would provide additional resources to the citys professional sports teams that will help them compete.

This is not a casino or even a mini-casino. Its a sports bar-restaurant. It only allows for fans who wish to place a wager to have a window to do so. I expect many fans will come to the sportsbook and never place a bet, he said.

Personally, I have no issue with sportsbooks and look forward to this one opening. I think it will be fun. But your mileage may vary, and I respect that. One thing I think we can all get on board with, though, is that if the book is going to generate significant extra revenue for the organization as Ricketts says then it will be fair game to hold the organizational accountable for using those revenues to contribute directly to baseball operations.

Endeavor has added the Triple-A Dodgers to their stable of minor league clubs (they are the group that bought the Iowa Cubs), as they are clearly going for as many premium opportunities as they can:

Not every athlete lives permanently in the city where they played, and life changes can make for a moving decision that is based on a lot of things. Still, you get at least a whiff of finality:

Im still welcoming Anthony Rizzo back on the Cubs if the circumstances lead to a reunion, but I just dont think those circumstances probably takes a bargain deal that he cannot find anywhere else are going to come to pass.

A look at Cedric Mullins breakout with the Orioles this year after dropping the switch-hitter thing and exclusively hitting from the left side. Mullins had been so bad against lefties when batting as a righty that it kinda made sense to just say eff it, and see how much it could hurt just sticking with his natural side it turns out, he wound up being excellent against lefties when batting lefty. A switch made during his age 26 season. Pretty incredible. I mention this, because a lot of us have thought for years about Ian Happ making the same change, given his huge splits and how awkward his right-handed swing looks at times. The big difference, though, is that Happ has periodically been close to a league-average hitter from the right side, albeit in very limited doses. Mullins, by contrast, hit like a terrible-hitting pitcher from the right side. Still, you will always wonder when a switch-hitter would be better off accepting the platoon disadvantage in exchange for getting to use his more natural swing.

Scott Rolen really fell off in his plate coverage this past year, and the defense took a step back, too:

Twitter asked, I answered:

The Bulls are obviously in the middle of their outbreak (thankfully games have been postponed), now the Bears have a little outbreak starting (four positives over the past couple days), and the NHL is having all kinds of issues, too. None of this is good, and you try not to read too much into limited data points, but simultaneous pops like this just make you wonder if this thing is hockey-sticking everywhere again. Apropos of my intro: I just hate all of this so much.

The trade market opens up in the NBA today:

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Wrigley Sportsbook Progress, Rizzo Moves Out, Dropping Switch-Hitting, and Other Cubs Bullets - bleachernation.com

HALIFAX, Nova Scotia In early November, I flew to southern Africa to report a series of stories about the state of the Covid-19 pandemic in the region, including one about the remarkable work being done to stanch the emergence of new coronavirus variants. My last afternoon there, South African scientists announced the discovery of the Omicron variant. Hours later, I got on a plane in Johannesburg to head home to Canada.

By the time I landed for my connection in Amsterdam on the morning of Nov. 26, the world had gone into full panic mode and I was swept up in a chaotic, at times frightening, tangle of orders and conflicting rules that seemed driven more by fear than medical science.

My firsthand journey through Covid response measures has shown me that, two years into this, we have yet to learn how to anticipate how both viruses and people will behave, or how to plan accordingly. We are going to need to get much better at both if we are to get through the next pandemic with less loss of life, and less suffering.

When my plane touched down in Amsterdam, a flight attendant informed us that passengers would need to be tested for Covid before we could continue our journeys. Five hours later, we were still on the tarmac, the plane sealed up tight, with more and more travelers shedding their masks.

My despair at a missed connection progressed to alarm when the pilot informed increasingly restive passengers that he could not procure food and drink for us because airport authorities would not permit catering trucks to approach the plane.

We were eventually bused into an unused departure area, and over the course of three hours, given Covid tests. As the hours ticked by in the stuffy room where we were being held, many gave up even a pretense of masking. None of the authorities made any attempt to enforce masking rules.

I was tweeting about the experience, and near midnight, a Dutch journalist whod seen my posts got in touch to say that test results were being reported by the health ministry. Between my flight and another that had come in from Cape Town at the same time, 110 tests had been processed, and 15 were positive, he said an infection rate of 14 percent.

I looked around the room full of people, many shouting men and wailing toddlers, and began quietly to panic.

It would be hours more before I received my results. Finally at 3 a.m. a couple of weary-looking public health staff members packed us into a line, had us hold up our passports, one by one, and read the results from a database.

If our tests were negative, as mine was, we were required to sign a document in Dutch. The traveler who hastily translated for me said that I was promising that I had somewhere to quarantine at home, and that I would leave the country to go there.

It seemed like a bad idea for public health, that pledge, but Id been awake for 42 hours, and I was desperate to get out of that room, so I signed and handed it over.

I was taken by bus into a dark and silent section of the terminal. There I spent another nine hours in an increasingly frantic search for someone who could help me access a copy of my putative negative test, without which I could not continue the journey I had just signed a promise to make.

In the days after this chaotic detention, Dutch airport and health authorities would blame the protracted delays on the fact that they had never anticipated such a situation and had no provisions for how to safely screen passengers even though we were held just weeks short of the second anniversary of the first known case.

I managed at the 11th hour to get access to my negative test, and flew on to Toronto. My phone was filled with alerts about new regulations for people arriving from southern Africa, and when I identified myself to a border agent as having flown from Johannesburg, he waved me into a special line. A public health screener took my name, address and temperature then sent me on my way.

I edged away from her but stayed in the line, confused.

I was just held in detention for almost a day with people we know have Omicron, I said, almost pleading. You want to quarantine me!

She shrugged. I think you should go get your connection, and maybe quarantine yourself at home. Get tested on Day 4. I have no other guidelines for you.

This was the first of what would be days of conflicting, confusing messages from health authorities that left me struggling to figure out how best to keep people safe.

I flew on to Halifax, my N95 clamped as tightly as I could get it, gratefully collected a series of P.C.R. test kits from a table in the airport and made my way as fast as I could to an Airbnb near my home. My children came for a weird reunion, standing masked at the opposite side of the backyard.

Over the next week, I received a dozen phone calls from federal and provincial health authorities. They said I should quarantine for a full 14 days. Or that I only needed to quarantine until I had a negative test on Day 4. No, Day 8. Oh, fully vaccinated? Well in that case, no quarantine! I could isolate at home until a negative test on Day 4. Or 8. Or 10. No test notwithstanding, I had to isolate at home until Day 14.

Lacking any kind of useful guidance, I stayed in the Airbnb.

On Day 7, I missed my daughters 12th birthday party. A kind friend brought over Thai food and beer and a portable fire pit, and we sat in parkas on opposite sides of it and had a heartfelt conversation in raised voices.

On Day 8, the doorbell rang at 11 p.m. I didnt answer because I assumed it was visitors for the second-floor tenants (no one was visiting me, obviously). The ringing turned to banging that grew more insistent and louder. When I cracked the door open, I found a police officer who demanded my name, and said she was there to do a Covid check.

I asked her what her instructions were for me maybe she would have insight. Were supposed to keep checking you until Dec. 11, she said.

The next day, another federal public health tracker called. She asked if Id had visitors. I said that I had seen my children from across the yard. She became distressed, and told me she would have to report that. Distanced outdoor visits were expressly forbidden.

I said that no one had ever told me this. (I kept my opinion, that it made no scientific sense and worked directly against the conditions that would help people keep quarantine, to myself.)

My instructions from Canadian officials were confusing. But I learned from emails and LinkedIn messages from other passengers on my flight how far we are from any uniform global response for travel. The ones who went on to the United States and Britain were going about their lives without quarantining. Those in Germany and the Netherlands had been made to quarantine until a Day 4 negative test.

I couldnt understand how 18 passengers on the two South African flights had tested positive when wed had to show a negative test to board the flight. But then I learned, while I was in airport lockup, that preflight testing requirements are set by the country of destination. South African airport authorities closely scrutinized the negative test Canada required of me, but passengers to the United Kingdom (and there were many) didnt have to test to fly. A belligerent British man in front of me in the final line in Amsterdam was told he was positive, and led away by a police officer.

Since Omicron began to be detected across Europe and the United States, the British policy has finally been changed, and the U.S. requirement strengthened to a test conducted one day before a flight. It should not have taken this debacle to create a basic testing standard for safer flying.

I dont object to having my travel disrupted; I would have gone willingly into quarantine in Amsterdam. I am, perhaps unsurprisingly for someone in this job, a fan of public health measures.

But I am furious about the entirely unnecessary risk the Dutch subjected me and all the other passengers to. After they concluded our flight was a health risk, they should have bundled us off the plane, distributed N-95 masks (and insisted people wear them), and taken us to a location where we could be held separately from each other while they made a plan.

I am equally frustrated that Canada has done such a lousy job of communicating its rules or of using evidence to make them. There is rapidly accelerating circulation of Omicron across Europe now, but still, only flights from southern Africa are banned.

The discovery of Omicron, and the swift transmission of critical information about the variant around the world, showed how well the sophisticated scientific response to the pandemic is working.

But everything that I saw in the days since then makes clear we still havent mastered the messy, human steps at all and they may matter even more.

Link:

How Conflicting Guidance on Travel During the Pandemic Shows Little Progress - The New York Times

When Hong Kong venture capital firm ORI Capital poured $30 million into CAR-T developer AffyImmune Therapeutics in October, the VC firms founder Simone Song cited more than a half-dozen obstacles facing AffyImmune and other biopharmas seeking to translate CAR-T technology to solid tumors.

But Song, who also serves on AffyImmunes board, said she was confident the Natick, Massachusetts-based companys could overcome those hurdles.

AffyImmune is one of several startups raising interestand dollarsto back innovative strategies for cell therapies to treat solid tumors. Verismo Therapeutics, a spinout from CAR-T pioneer University of Pennsylvania, and PACT Pharma are also making headway with their solid-tumor technologies, as are several research teams in academia.

But their task is far from easy. FDA-approved CAR-Ts like Novartis Kymriah and Gileads Yescartaboth of which treat blood cancerswere considered the low-hanging fruit of cell therapies, because they could be programmed to recognize a single target, or antigen, on cancer cells and kill them. Finding one or more targets that exist in solid tumorsbut not normal tissuesis considerably more challenging.

Then, as AffyImmunes Song pointed out, there are other hurdles like manufacturing complexities and the risk of T-cell exhaustion, a process by which engineered immune cells poop out, allowing the cancer to roar back.

And all of the innovation in CAR-T for solid tumors is happening against a backdrop of safety worries, many stemming from a clinical hold the FDA placed on Allogene in October. Allogene is developing off-the-shelf T-cell therapies for both blood and solid tumors but had to pause all of its clinical trials after a lymphoma patient in one of the studies was reported to have developed a chromosomal abnormality.

RELATED: AffyImmune attracts $30M with its CAR-T strategy for beleaguered solid tumor cancers

Allogene is still collecting data and engaged in discussions with the FDA about the side effect, said David Chang, M.D., Ph.D., co-founder and CEO, in an interview. But the safety scare hasnt dampened the companys enthusiasm for developing off-the-shelf cell therapiesor for translating the technology to solid tumors.

A few years ago, everyone was questioning whether CAR-T therapy will work in solid tumors, Chang said. But there has been positive data from CAR-T as well as T-cell receptor approaches, so I think the next few years will be quite exciting.

AffyImmunes approach follows the model of the CAR-T products for blood cancers in that its cell therapies are tailored to individual patients. The companys lead asset, AIC100, targets Intracellular adhesion molecule 1 (ICAM-1), which is highly expressed in thyroid, gastric and triple-negative breast cancers. The product is made from each patients T cells, which are removed, reengineered to target ICAM-1 and then infused back into the patient, in a process that takes about 20 days.

In addition to designing the CAR-T to bind to ICAM-1, AffyImmunes scientists built the CAR (chimeric antigen receptor) with a natural ligand that not only fine-tunes the affinity to ICAM-1 but also up-regulates its expression so the T cells can better recognize the cancer, explained Matt Britz, senior vice president of business development, in an interview. The hope is that these features will help prevent T-cell exhaustion.

AffyImmune also included a tracking feature in AIC100 that allows its scientists to use PET scans to see exactly where the CAR-T cells are going in patients. The company is using the technology in an ongoing phase 1 study in thyroid cancer patients.

Weve seen CAR-T localization to tumors and not to normal healthy tissues, Britz said, raising optimism that the cell therapy will not cause unexpected toxicities, he added. A readout from the thyroid cancer trial is expected in early 2023. AffyImmune hopes to expand the trial to include gastric cancer patients in a year or so, he added.

AffyImmune is also in preclinical studies with CAR-Ts that target ICAM-1 and another molecule found in abundance in solid tumors, mesothelin, as well as CAR-Ts that secrete cytokines to maintain a strong immune response to cancer. Were armoring CARs with things that will aid in their longevity and their ability to kill, Britz said.

Penn spinout Verismo is taking a different approach that it has dubbed SynKIR-T. In place of traditional CARs, Verismo uses KIRs, or killer immunoglobulin-like receptors, which T cells and natural killer (NK) cells use in modulating the response to foreign invaders. Verismos lead asset, SynKIR-meso, targets mesothelin, which is highly expressed in mesothelioma, as well as ovarian and pancreatic cancers.

The SynKIR-T cells are specially designed to overcome elements of the tumor microenvironment that normally prevent immune cells from invading and killing solid cancers, explained Laura Johnson, Ph.D., chief scientific officer of Verismo, in an interview.

Tumors sometimes form barriers around themselves so immune cells cant get in, Johnson said. They shut off T cells or make themselves invisible by hiding their antigens. That requires a different approach to treating these types of cancers.

Instead of using an artificial CAR, Verismos cells use a signaling component that occurs in natural killer cells, she said. When a binder in the engineered cell finds its target, it brings a stimulatory protein into contact with the cell that activates it and prompts it to kill tumor cells.

The company hopes to be dosing the first patients in a phase 1 trial about a year from now and is targeting mesothelioma and ovarian cancer to start, Johnson said. Like AffyImmune, Verismo will personalize the treatment to individual patients by engineering their own T cells.

RELATED: A personalized CAR-T to attack every solid tumor? Pact Pharma has a plan

PACT Pharma is taking the notion of personalized cell therapies even further with its imPACT isolation technology. The platform is designed to target cancer-related proteins that are so specific to each patients tumor that theyre highly unlikely to be found in another persons cancer. The companys technology identifies these neoantigens, which typically result from many different mutations. Then theyre built into T cells and infused back into patients.

The notion here is that because cancers are so unique, and their mutation structure is so different, its best to understand the underlying mutations of each patient and target those, said Scott Garland, CEO of PACT, in an interview.

The company uses an algorithm to pare down the hundreds of mutations found in a tumor to the three most likely to generate a strong response, Garland explained, creating a polyclonal T cell. The company is now in the dose-escalation portion of a phase 1 study in eight tumor types, including melanoma, colorectal cancer and prostate cancer.

The risk of safety issues is top of mind, Garland said. And not just because of Allogene. One rival with a prostate-targeted CAR-T, Tmunity, stopped development of its product in June after two patients in a clinical trial experienced neurotoxicities and died. (Tmunity did not respond to a request from Fierce for an update.)

One of the reasons PACT went for a personalized approach was to try to minimize the probability of side effects, Garland said. The specificity should result in a better toxicity profile, but well have to wait until the clinical trials are complete to make definitive statements about safety, he added.

The genetic abnormality seen in Allogenes clinical trial patient is unlikely to be related to the behavior of the artificial T cells, said Wendell Lim, Ph.D., a professor of cellular and molecular pharmacology at the University of California, San Francisco and a member of Allogenes scientific advisory board, in an interview.

Lim is also working on a CAR-T approach to solid tumors called synNotch. The cells are engineered to be able to distinguish between tumor tissue and healthy tissue. In preclinical studies published earlier this year, synNotch cells cleared glioblastoma tumors that didnt respond to either T cells or traditional CAR-Ts. Lim hopes the cells will be ready for clinical trials in about a year.

One thing that all the developers of CAR-T for solid tumors share is an integrated approach to clearing the hurdles raised by these challenging cancers, Lim said. People have worked on the individual problems of increasing specificity, overcoming heterogeneity and attacking the suppressive microenvironment, he said. We need to integrate those into one intelligent cell.

The rest is here:

Biopharma charts progress in translating CAR-T cell therapies to solid cancers - FierceBiotech

Nick Yorke was a surprise pick with the No. 17 overall selection in the 2020 draft but nobody is questioning the decision following a strong season at the Single-A levels that has him rapidly rising in prospect rankings. Hes now the top second baseman in the Boston Red Sox farm system and the only question is whether or not hell remain at that position long-term.

Yorke was outstanding in his first season of professional baseball, hitting .323 with a .913 OPS, 10 home runs, 14 doubles, four triples and 11 stolen bases in 76 games with Low-A Salem. The 19-year-old impressively performed even better when tested at High-A Greenville, hitting .333 with a .978 OPS in 21 games following his promotion.

Baseball America named Yorke their Red Sox Minor League Player of the Year. Hes only the 10th teenager since 2006 to slash .300/.400/.500 in a full minor league season, joining an impressive list that includes Mike Trout, Bryce Harper, Carlos Correa and Vladimir Guerrero Jr.

Theres little doubt that Yorke will continue to hit as he climbs the minor league ladder but his defense has been a bit questionable. He committed nine errors in 85 games this year to produce a .976 fielding percentage. Only six major league second baseman owned a lower fielding percentage this season (minimum 50 games at the position).

According to Chad Jennings of The Athletic, Red Soxdirector of player development Brian Abraham was encouraged by Yorkes progress in the field and believes hell stick at the position.

He showed how much improvement he can make in one offseason, just with his body, his athleticism, his improvements on defense, Abraham said. To me, theres no reason to think he couldnt continue to improve and be an impact player there.

Its notable that all nine of Yorkes errors were committed during his time in Salem. The sample size in Greenville is small with only 19 games as a second baseman (he was the designated hitter for two games) but Yorke was mistake-free in the field when he moved up to the higher level. This points to the improvement that Abraham noted and bodes well for Yorkes future.

The Red Sox value versatility and weve seen them test their prospects at different positions to open more paths for them to advance through the system. Many teams let their prospects focus on one position early in their careers before expanding their versatility as they move up in the system but the Red Sox are embracing a utility role for certain players early. Ceddanne Rafaela is a defensive wizard who can provide elite defense at almost any position. TylerMcDonough was drafted primarily for his bat but he was used as an infielder and in the outfield when he arrived in Salem.

The same approach to development wasnt taken with Yorke, who remained exclusively at second base or DH. It seems the Red Sox are intent on grooming him as their second baseman of the future by giving him every opportunity to improve and learn the fundamentals.

That strategy could change depending on what the Red Sox do with their major league roster in the time it takes Yorke to reach the big leagues. Top prospect Marcelo Mayer, the No. 4 overall pick in this years draft, wont be far behind in his ascension to the majors. Assuming Xander Bogaerts doesnt opt-out with the intention of leaving after next season, he should still be around when Mayer emerges to claim the shortstop position. Moving Bogaerts to second base to clear a path for Mayer would be a logical solution but that would block Yorke.

While the lockout has temporarily frozen activity on the free-agent market, the Red Sox are expected to be active once a new collective bargaining agreement is in place. If the Red Sox sign a middle infielder to a long-term deal to handle second base or push Bogaerts to the position earlier than anticipated, Yorke would find another roadblock in his path.

Yorke is still several years away from reaching the majors and we could see plenty of turnover with Bostons roster in the meantime. Second base appears to be a position of need right now but its uncertain if that will be the case when Yorke is ready. The Red Sox could cycle through temporary solutions until then but if they find a long-term option instead, Yorke needs to be prepared to adapt.

Yorkes bat will undoubtedly lead him to the majors at some point, its just a matter of where hell play. His promising improvements are an encouraging sign that hes capable of sticking at second base. If the Red Sox ultimately move him to another position, it should be based on a need to fit him on the roster rather than a sign that he cant handle second base.

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Red Sox prospect Nick Yorke making progress defensively at second base - BoSox Injection

All organizations have three elements in common: structure, systems and culture. Generally, we tend to tinker with structure and systems much more often than we do with culture. This is not to say that changes in structure and systems cannot accomplish progress.

There is no doubt, however, that culture guides change in an organization. Large health care organizations interested in becoming more equitable can take a page from community health centers, and their approach to community engagement. Not surprisingly, many of these organizations have African American and Latinx individuals who have risen through the ranks to become leaders. They have the proverbial finger on the pulse of community issues, both those directly related to the provision of medical care, but even more criticallythose that impinge on access and outcomes: the social determinants of health.

The scale of challenges in health and health care in Chicago demands a lot more than what community health centers may achieve on their own. The opportunity for leadership of larger health care institutions in this space is so vast that even if we were able to involve all of them immediately, it would take some time to achieve equity. It is worth reiterating that diversity, equity and inclusion is everyone's job. Diversity facilitates forward movement and is a catalyst for change, but genuine change in culture is imperative for lasting progress.

Jorge A. Girotti, Ph.D., is research assistant professor of medical education and founder and former director of the Hispanic Center of Excellence, and associate dean for admissions and special curricular programs at the University of Illinois College of Medicine.

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Culture shift is needed to achieve equity in health care leadership - Crain's Chicago Business