Monthly Archives: July 2020

Goldman explains Apple Card algorithmic rejections, including bankruptcies – VentureBeat

Posted: July 4, 2020 at 8:44 am

When Apple launched a new slate of services last year, including News+, TV+, and Arcade, the one that generated the most excitement was Apple Card, the companys first self-branded credit card offering. Developed in partnership with investment bank Goldman Sachs, Apple Card promised users a reinvented credit card experience, eliminating fees, simplifying payments, and delivering Daily Cash perks. But for some people, applying for the Apple Card has been an endless exercise in frustration.

While Apple made the application process as simple as possible open the iPhones Wallet app, tap two buttons, and provide a very modest amount of personal information Goldman implemented an algorithm that either accepts or rejects applicants within seconds. If your application is successful, youre offered personalized credit terms such as those shown above. If not, you receive an instant rejection letter without an equally fast route to appeal. Due largely to that algorithm, which forsakes human decision-making in the name of efficiency, Apple and Goldman were accused of gender discrimination in the Apple Card approval process last year and have racked upnumerous complaintsand questions regarding the systems transparency.

This week, the companies quietly launched Path to Apple Card, a program that will let some previously rejected customers demonstrate their commitment to earning the famously fragile titanium charge plate. The pair has also provided more clarity on their approval process through an updated How your Apple Card application is evaluated support document and Financial Health page. But since they continue to issue rejection letters that may confuse customers and are still using that mysterious algorithm to determine Apple Card worthiness I contacted the companies to clarify what was going on with their system. Heres what I learned.

As Goldman managing director Andrew Williams made clear, the companies acceptance/rejection algorithm is a pretty simple decision tree, not AI. This means its built to use basic financial metrics to reach a yes or no decision. The key input is a TransUnion credit report, notably evaluated using the FICO Score 9 (aka FICO9) rating system, though the specifics of that evaluation arent completely transparent. It also considers your reported annual income to determine how much cash you will likely have left after paying your monthly debt obligations.

Williams emphasized that the Apple Card has been available for less than a year and that the companies are still working to evolve their credit policy and add additional customers. In other words, an applicant rejected last August might be accepted in the future without personally making any changes. But my impression is that the simple decision tree wont change much unless the companies decide to open their gates wider. The Path to Apple Card is there to help more people meet Goldmans prior creditworthiness standard, rather than to ease that standard.

Goldmans algorithm appears to rely considerably on your FICO score, which was developed by the Fair Isaac Corporation in 1989 to objectively rate customer creditworthiness. Despite lingering questions about the accuracy of FICO scores and the extent to which they should be relied upon, theyre widely used by credit issuers for approval and rejection decisions. In 2006, the three major credit reporting agencies (Equifax, Experian, and TransUnion) created a FICO alternative called VantageScore, which now uses the same 300 to 850 point scale as FICO but tends to be more generous in calculating ratings. According to the companies, a FICO score of at least 670 or VantageScore of 700 typically signifies good credit.

Consumers seeking Apple Cards have to surmount multiple hurdles, but a big one is understanding the difference between these scores, and that there are actually more than two of them. FICO8 is currently the most widely used version of Fair Isaacs popular system, but Goldman uses the newer not newest FICO9. If you use a credit monitoring app such as Credit Karma to track your credit ratings, you may find the numbers come from VantageScore 3.0, and theres a newer version of that, too, called VantageScore 4.0. Four companies pulling the same TransUnion report could see four different scores based solely on differences between the scoring systems and versions.

This leads to perplexing scenarios in which the same TransUnion report viewed by Goldmans FICO9-dependent algorithm looks numerically worse than what the consumer sees with VantageScore 3.0. Apples current Financial Health page says FICO9 scores over 660 are considered favorable for credit approval, yet its possible that a customer with a TransUnion score of 716 will be rejected and receive an email from Apple saying Goldmans decision was made based on a score of 682. None of that seems right. And its possible to be rejected even if your FICO9 score is higher than that.

Either for regulatory or business reasons, Goldman couldnt provide clear-cut answers as to how the pretty simple decision tree was structured. Armed with numerous MyFICO forum reports, including Apple Card acceptance with a 620 FICO9 score and rejection with scores higher than Apples stated 660 threshold, I found that bankruptcy regardless of whether its explicitly named as Goldmans cause of rejection appears to place a heavy finger on the scale.

The President of the United States has had at leastsix business bankruptcies, and as the COVID-19 pandemic amply demonstrated, circumstances outside of individual control an unexpected medical condition or a macroeconomic crisis can force even an otherwise thriving business or individual into bankruptcy. To the extent that bankruptcy was once stigmatized, national meltdowns and all-too-frequent personal tragedies have largely eroded that stigma. Moreover, it wasnt that long ago that Goldman Sachs itself took a $10 billion bailout from U.S. taxpayers to resolve its own financial crisis, an ask considerably larger than even the most serious personal bankruptcy filing.

But Goldmans Apple Card algorithm appears to instantly reject an applicant with a past bankruptcy filing, regardless of their other indicators of creditworthiness. Apples Financial Health page says Goldman considers multiple conditions before an Apple Card decision is made, with negative public records only one of those factors, which sounds reasonable on the surface. But the companies werent as transparent about the role a past bankruptcy will play in nixing an Apple Card application until I pointed out that rejection letters were dancing around the issue.

Williams and Goldman digital consumer banking VP Gretchen Silver confirmed to me that a recent bankruptcy was enough to prevent a successful Apple Card application on its own. By Goldmans standard, recent is apparently three years, regardless of any extenuating circumstances. This is notably a full year longer than the federal Fannie Mae standard for offering post-bankruptcy home loansand stricter than some popular consumer credit card companies.

When I asked whether the Apple Cards three-year bankruptcy rule was firm, Goldmans representatives initially said that applicants rejected due to bankruptcy could keep trying to apply and that each time the totality of the application would be considered. Pressed on whether consumers would keep being rejected until the three years had passed, however, they conceded that this could happen unless the current credit policy evolves in the interim.

Online discussion forums now have plenty of data points on the terms of Apple Card acceptance offers, as well as countless examples of rejection letters that confound recipients. Given that Apple exalts simplicity, theres something wrong when even credit card mavens cant understand Apple Card rejections, so the algorithms method for explaining its reasoning might also need some fine-tuning.

I asked Goldmans representatives about apparent inconsistencies and inaccuracies in Apple Card rejection letters. In some cases, a rejection letter may not explicitly identify bankruptcy as the critical issue, preventing rejected applicants from moving on with the knowledge that they wont be accepted anytime soon. Alternately, a rejection letter might list three reasons for rejection based on the same underlying situation contradicting an otherwise stellar payment history report from Credit Karma, including a multi-year history of 100% on-time debt payments.

Silver suggested that there may be disconnects between what people see summarized by third-party credit monitoring services and the more granular data Goldmans system uses to make decisions. As such, a single bankruptcy filing might inaccurately show up twice on the list of rejection reasons and trigger the listing of a third reason that might not be correct. Contacting TransUnion could help applicants resolve some problems, but others are clearly attributable to disclosure issues with Goldmans automated rejection system.

As I mentioned to Goldman, the underlying problem is over-reliance on a completely automated system for credit decision-making and applicant rejection communications in the name of efficiency. Customers would benefit from having humans involved in the final rejection decision, as well as appeals and error corrections. A human might parse multiple related or identical items on a credit report differently from a computer, take important factors such as past Goldman or Apple customer relationships into account, or fix a rejection letter to avoid confusing or contradictory information. My sense is that this wont happen anytime soon.

The new Path to Apple Card program is designed to increase the cards customer base, but Apple and Goldman arent publicly advertising the program its open by invitation only. Assuming you get the initial invitation and then successfully complete the program, youre promised an invitation to reapply for the Apple Card.

Path to Apple Card apparently requires up to four months of personalized steps and monthly credit reviews. Depending on how the Path is customized for your circumstances, you may be required to make payments on time, lower your debt, and/or resolve past due balances, with the threat of immediate program termination in the event of a new bankruptcy, foreclosure, repossession of secured property such as a vehicle, or an account going to collections or getting charged off. While none of this is hugely onerous, its a lot of hoops to jump through for an Apple Card.

Another caveat: It appears you wont be offered the Path to Apple Card if your personal situation, such as a 2.5-year-old bankruptcy, wouldnt yield a successful application within the Paths four-month timeframe. Until and unless something changes with Goldmans and Apples credit policy, the Path will remain somewhat obscure and narrow.

On the one hand, thats unfortunate, as its clear Apple and Goldman have come up with a credit card offering that appeals to a lot of people and has some tangible benefits, particularly for frequent Apple Store customers. Thankfully for those who havent been accepted, there are hundreds of other credit cards out there, many of which would accept an applicant with a small or moderate credit limit rather than turning them away or putting them through a gauntlet of advance obligations. Apple Card membership may have its privileges, but if youve been turned down by Apple, youll still find similar if not better alternatives from other companies.

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Goldman explains Apple Card algorithmic rejections, including bankruptcies - VentureBeat

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Increase in bankruptcy filings anticipated due to pandemic job losses – theday.com

Posted: at 8:44 am

New London Attorney Gregg W. Wagman has been spending a good portion of his workdays on the phone, helping clients navigate remote bankruptcy proceedings in U.S. District Court in Hartford.

The conference calls necessitated by the coronavirus pandemic have made his work easier, sinceWagman usually travels to Hartford two or three days a week and spends hours in court while hearings are conducted.

As one of the few local attorneys who handle bankruptcy cases, Wagman said he expects to hear from more financially troubled clients due to the rising unemployment rate and continued shutdowns.

"There's all the people who were living without their six months to a year of expenses in the bank," he said by phone this past week. "It's not unprecedented, but it's been 100 years since we had something like this to affect the nation all at once."

In Connecticut, 2,041 people or entities filed for bankruptcy in May, a 23% decrease from May 2019, according to the American Bankruptcy Institute. But the unemployment rate was 9.3% during the same month, compared to 3.6% in May 2019.

Bankruptcy claims tend toinvolve people who have recently gone through divorce, lost their jobs or fallen behind on medical bills, Wagman said. Clients tend to come in a couple of years after getting into financial trouble andtrying to pay off bills through a debt management plan or loan.

"I would just say to people, make sure you know it's an option, and don't be afraid," Wagman said. "It's a powerful tool to help straighten a lot of this out. The biggest thing I can tell you is, don't take money out of your 401(k) or IRA until you talk to a bankruptcy lawyer. It may not be an option for you, but it's available."

Most people go through bankruptcy without losing their house or car and are considered better credit risks to lenders after emerging from bankruptcy.

"The basic idea is that you owe more than you're paying," Wagman said. "The creditors come in and take your money and split it up. Otherwise, they come in, put liens on your house and garnish your paycheck."

Homeowners are allowed to keep $25,000 to $75,000 of equity in their home, an amount than can double if they are married. The two important dates in a bankruptcy are the date of filing and the date of discharge, or the date the court says that debts have been discharged.

There are several different types of bankruptcy, including Chapter 7, a personal bankruptcy option that takes just four months; Chapter 13, which is a three- to five-year restructuring process for individuals or small businesses; and Chapter 11, which is a renegotiation or liquidation of debt.

People think of it as a moral failure, but Wagman said debt forgiveness is rooted in the Holy Bible, where the Book of Deuteronomy calls for release of debts every seven years, and in theU.S. Constitution, which authorizes Congress to enact uniform bankruptcy laws throughout the nation.

"Most of my clients are good, honest debtors who just got into a pickle," he said.

The Day spoke with two of Wagman's clients, both of whom asked that their names not be used because they didn't want their family members or employment to be affected by it.

A Norwich man in his 40s said that after going through a divorce, he made some financial mistakes and incurred approximately $80,000 in debt. He tried debt consolidation loans, but when he realized he couldn't swing the payments, he looked for an attorney.

"I was just doing what everyone does, that kind of rob-Peter-to-pay-Paul kind of thing," he said. "I was taking one credit card out to pay the other."

Wagman helped him file for Chapter 7 bankruptcy, and while he felt ashamed, he was amazed at how "by the book" and routine the process was for those involved. He was required to take a financial management course online, which he said was helpful. As soon as he received the discharge letter from the court, hewas able to find a bank that was willing to give him a car loan. He had been making high payments on a car that was worth less than the amount he owed.

He resolved the $80,000 worth of debt for about $3,000, which included lawyer's fees and filing charges. His credit score had fallen, but climbed back up to 670, which is considered average.

"I don't know if it's cliche or not, but they say it's a fresh start," the man said.

The other client also found himself in financial trouble following a divorce and retained Wagman to help him reorganize his finances and pay off debt through a five-year Chapter 13 bankruptcy filing.

The 56-year-old said he made a good salary working in information technology but found himself owing back payments on his mortgage and a lot of credit card debt associated with the marriage. He had children and dogs at home, or would have considered walking away from his property. He didn't like admitting that his life had gotten out of control, but he was able to make court-ordered payments of $1,500 a month to clear his debt.

"I felt good about that, and it also forced me to truly budget my money and look at what was coming in and going out," he said.

Now, he said he has ahealthy savings account andoperates on the "cash and carry plan."

"If I can't buy it right now (with cash), I can't have it right now," he said.

k.florin@theday.com

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Sammie’s Friends celebrates 10-year anniversary of operating animal shelter – The Union of Grass Valley

Posted: at 8:43 am

It all started when Cheryl Wicks began walking dogs at the animal shelter for two hours a week.

One thing led to another, and now its huge, said Wicks, co-founder of Sammies Friends.

Sammies Friends has a contract with the Nevada County Sheriffs Department to run the Nevada County Animal Shelter, and celebrated 10 years of doing so Tuesday.

Over the years, when I think about all the people who have donated money or time, fostered animals, and volunteered in other ways, its very encouraging, said Wicks.

According to Wicks, Nevada County had a 68% rate of euthanasia for stray animals when she and her partner, Curt Romander, founded the organization. The rate is now less than 1%.

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Sammie, the inspiration for the nonprofits name, was a Shar-Pei Wicks adopted as a 7-week-old puppy who lived to be 16 years old. Never having had a pet until adulthood, Wicks doesnt consider herself to have had much of an animal background until Sammie, whom she calls an amazing dog that will now have an amazing legacy.

Wicks expressed that she would have enjoyed connecting with the community for a celebration of this milestone for Sammies Friends.

We had a fundraiser celebration planned for April which we had to cancel, and assuming that things improve, we plan to have it next April, she said, adding that this would make perfect timing to celebrate both this 10-year mark for operating the shelter and 20 years of Sammies Friends.

The local nonprofit has saved about 30,000 animals since 2001.

MAKING LIVES HAPPIER

As for the organizations goals in the near future, in light of some restriction as to how much in-person outreach can be done through events, its leadership is turning attention to internal projects.

The shelter itself is pretty old, and were looking to make it prettier and a bit more inviting, said Wicks. We try to figure out every possible way of making their lives happier while theyre in the shelter.

Shelter director Lizette Taylor, who has worked with the organization since 2012, echoed this, saying, While were waiting through this time, were trying to focus on how we can do more training, improve our systems, and polish the facility a bit more.

Reflecting on this milestone, Taylor said, Its funny because 10 years is a long time, but when youre doing this work, it goes so fast it feels like we just got started.

Taylor shared that one of the most impactful pieces of Sammies Friends work is the behavioral differences in animals after guidance and attention from dedicated staff.

The staff drive so much into these animals on a daily basis to love them and help them back into a place where they can be adopted, she said. It feels amazing all the things weve been able to do in these 10 years, and all the animals that have been adopted, rescued, and worked with.

Taylor said the community has continuously shown support for Sammies Friends throughout the years, but in especially high numbers throughout the last several months.

Without the public and the county, we wouldnt be here for 10 years, said Taylor. Were very grateful for the outpouring of support we see on a daily basis. We really appreciate the support of fosters, volunteers, and people who just throw love at us whenever they can.

Victoria Penate is a freelance writer for The Union.

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Dr. Fox: When to stop treatments and say goodbye – Winston-Salem Journal

Posted: at 8:43 am

Dear Dr. Fox: We have a 23-year-old female cocker spaniel named Ed. She was just diagnosed with very bad diabetes. It has been a heartbreaking ordeal.

The vet is still trying to determine what dose of Vetsulin to administer. She is currently refusing to eat, and has to be fed critical-care food orally by syringe. We will have to increase the feedings to give her the Vetsulin. She takes Entyce, an appetite stimulant, once per day. The vet said she may be insulin-resistant.

We have to make a decision as to what we will do, and we do not want her to suffer in any way. What advice you would give us? This is a most difficult decision to make, and our hearts are in such pain to think about seeing her go. L.P., New Rochelle, New York

Dear L.P.: Your dog has reached a remarkable age. From your account, it seems that chronic organ failure has set in, which could be partially rectified with various medications, after more tests and determining the proper dosages, but to what end?

If this were my dog, I would provide whatever she likes to eat and give her lots of tender loving care, and let her go. No more medications or tests. Whether this answer upsets or relieves you, let me know.

L.P. replied:

Dear Dr. Fox: Thank you for reaching out to me. Yesterday, we said goodbye to her, and my heart is crushed. Its so hard to lose our companions when we love them as family. Im trying to focus on believing we made the right decision in not allowing her to suffer, but its still very hard to convince myself. I have been filled with guilt and second-guessing if we decided to let her go too soon.

You have relieved me somewhat, and for that, Im grateful. Thank you for the wonderful work you do on behalf of all beloved animals.

Dear L.P.: I always hesitate to recommend euthanasia, because it is such a huge responsibility, and often a painful decision to make for a loved one. Most veterinarians feel this burden when having to euthanize terminally ill animal patients, and those whose owners cannot afford costly treatments that may or may not improve the animals quality of life. But there are some who would delay this, not necessarily just to make more money, but because they see some diseases as conditions that should always be treated. The caregiving burden and continued worry of the animals owner-clients must also be considered. Sending warm regards and my condolences.

United Feature Syndicate

Write to Dr. Fox c/o Universal Uclick, 1130 Walnut St., Kansas City, MO 64106.

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"I was stuck in my bed, all I could do is cry" is COVID making you burnout at work? – ABC News

Posted: at 8:43 am

Is Covid-19 making you push yourself too far at work? Could you be at risk of burnout?We explore what causes burnout, how to recognise and deal with it and how burnout can even become deadly.

GUESTSProfessor Michael Leiter has extensively researched the experience of burnout at work, most recently through Deakin University in Victoria.Dr Nadine Hamilton is a psychologist who works with veterinarians and her PhD research looked at vets lived experience of animal euthanasia.And sharing their stories of burnout, Marie Cecile Godwin UX designer and Editor of Burnout: lets reignite the flame; Alice Cooney, Law Institute of Victoria young lawyer president and vet Dr Claire Stevens.

This episode kicks off our four-part series: Performing in a Pandemic. We know that things wont snap back exactly to the way they were - so how do you prepare yourself to adjust to this new way of working? In our next episode: what to eat to optimise mental performance.

FURTHER INFORMATION:

Nadine's book is Coping with Stress and Burnout as a Veterinarian and her charity is Love Your Pet Love Your Vet.

Claire's book is Love Your Dog.

Producer: Maria Tickle

Never miss a show! Subscribe to our weekly podcast on theABC Listen app,Apple Podcasts,Google Podcastsor your favourite podcast app. (And if you enjoy the show help us out by rating us with those little stars it helps others find us.)

Producer: Maria Tickle

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Piper is ready to be a Delaware dog – Smyrna-Clayton Sun Times

Posted: at 8:43 am

Delaware News Desk

FridayJul3,2020at6:00AM

She was saved from a high-risk shelter in Louisiana and flown to safety

Piper flew to Delaware on a plane, scared and unsure of her future.

What she didnt understand was that her chances of getting adopted in Louisiana were not good. In fact, Louisiana has the fifth highest euthanasia rate in the country and at 10 months old, she was just enough of an adult to put her at risk of being euthanized for space. While the Brandywine Valley SPCAs priority is the pets in their own community, if there is extra room at the shelter, they take pets like Piper to give them a second chance.

The next thing Piper knew, she in Georgetown, surrounded by new friends who were excited to meet her. Being a playful, affectionate girl, she couldnt stop her tail from wagging and she cuddled with everyone who pet her.

Piper is dreaming of a home with an active and loving family. She is definitely dog-friendly! Meet her at the Brandywine Valley SPCAs Georgetown campus.

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In the Future, Lab Mice Will Live in Computer Chips, Not Cages – Undark Magazine

Posted: at 8:43 am

Animal models, especially mice, have given scientists valuable insights into the mechanisms behind countless human diseases. They have been instrumental to the discovery of drug targets, metabolic pathways, and gene function. Theyve helped to lay bare the basic biochemistry of metabolism, hunger, cognition, and aging. Because mice are, to a certain extent, miniature facsimiles of human anatomy and genetics, science has an array of tools at its disposal to manipulate and visualize their bodily processes in real time, in highly controlled settings.

But, as the recent Covid-19 pandemic has revealed, science doesnt always have the tools to minimize loss of animal life. As the pandemic took hold and academic research labs across the U.S. shuttered indefinitely, scientists were faced with an unprecedented animal care dilemma. Without the teams of veterinary nurses and technicians who usually attend to the animals daily, many labs were forced to resort to wholesale euthanasia. Some labs sacrificed hundreds of animals, and were criticized harshly for their management of their experimental colonies. Many started to consider more durable, long-term plans for preserving and storing their mouse lines.

In the lab where I work at the University of California, San Francisco, and where for the past two years Ive been the designated rodent surgeon, we were asked to euthanize all but our most irreplaceable mice. As new animal researchers, we are trained to sacrifice our mice humanely to give them a dignified death. Returning to lab after the shutdown to find rows of empty racks that once held cages of mice we had worked with for months was a shock, and it was hard to conjure dignity in that moment.

That experience led me to reflect on how we as a research community use animal models in biomedical research, and how we might better use them in the future. And Ive become increasingly convinced that the animal model of the future will live not in a cage but in a computer chip: By simulating biological systems rather than experimenting with them, we can make drug development and biomedical research safer, more efficient, and more effective.

This is not to say that researchers treatment of animals has been haphazard. Research in animal models is highly regulated. These regulations vary in austerity from country to country and institution to institution, but they revolve around a common set of principles known as the three Rs: Replace the use of animals when possible, reduce the number of animals used per experiment, and refine methods to minimize suffering and improve welfare.

As the recent Covid-19 pandemic has revealed, science doesnt always have the tools to minimize loss of animal life.

A few years ago, when I was a new mouse surgeon, the three Rs were the guiding tenets of a week-long course I took at the Ren Remie Surgical Skills Center in Almere, Netherlands. The centers founder, Ren Remie, advocated for meticulous surgical technique, held to the same standards of sterility and post-operative care as any human surgical procedure. But he was also a proponent of the thinking that longer-term strategies can hasten recovery time from infection and surgical procedures. For instance, Remie and other researchers advocate whats called environmental enrichment, a method that helps animals cope with the inherent stress of being isolated after a surgical procedure or during an experiment. The researchers place toys, nesting material, or other inanimate objects in the cage that allow the mouse to engage with its surroundings, similar to the way it would in the wild. Studies suggest that environmental enrichment may even promote wound healing in rats.

But the success of strategies like environmental enrichment highlights an inherent weakness of the animal research model: An animals behavior is often extremely sensitive to its environment, in ways that are difficult if not impossible to control. This raises a perennial issue in biomedical research of just how reliably conclusions drawn based on studies in mice can be faithfully applied to human disease treatment. For instance, rodents are housed in groups as a rule, but certain kinds of experiments and treatments require them to be isolated, triggering a stress response that could significantly affect their immune activation. Studies have shown that mice and rats who live with companions fare better against injury, stroke, and even tumor growth than their lonely counterparts. As a result, when mice studies ask questions about human diseases, the housing status of the mouse is often a confounding factor. Even slight variation in the ambient temperature of a mouses housing room can cause stress responses that affect experimental outcomes. This variability is one reason that treatments that seem promising in mice often produce underwhelming outcomes in human clinical trials.

One attractive complement to animal studies that may address some of these shortcomings is in silico, or on a chip medicine. In silico models apply computational modeling strategies to genomic data to predict physiological responses to drugs or other stimuli. Although they are far from being able to replicate the full complexity of a living, sentient being, the U.S. Food and Drug Administration has begun consider computer modeling-based strategies to update the cumbersome and costly clinical trial pipeline. Research with in vitro models, which attempt to replicate animal physiology in test-tube style experiments, have also shown promise. These efforts have given birth to projects like the Comprehensive in Vitro Proarrhythmia Assay initiative, which integrates modeling and in vitro strategies to evaluate the potential for new drugs to cause heart rate abnormalities

Likewise, in 2013, the European Commission assembled a consortium of research groups known as the Avicenna Alliance to unify academia and industry around a set of standards for computer modeling in medicine. Based in Belgium but comprised of independent organizations around the world, the goal of the Alliance is to enable virtual clinical trials whose results can be validated by the same kinds of rigorous standards that are applied to traditional clinical trials.

As the Avicenna Alliance envisions them, virtual clinical trials would be based on unique genetic models derived from individual patients, rather than on large, genetically variable sample groups. Conceivably, this could allow a researcher to simulate a patients unique response to a treatment strategy, capturing the effects of subtle variations in baseline metabolism, bodyweight, or underlying health conditions that might influence the patients treatment outcomes. It might also significantly reduce the time and expense traditionally required to usher a new drug or medical device from the lab bench to the clinic potentially lowering the barrier to care for large swaths of the population who cant afford the often-astronomical costs of life-saving medications.

In silico clinical trials, if and when they are realized, could also address the long-standing problem of sample bias in drug development. Demographically, clinical trials tend to be disproportionately White and, until recently, overwhelmingly male. They therefore dont fully capture the therapeutic value and potential risks that drugs present to the patients who eventually rely on them. If in silico strategies become widely adopted, theyll hold potential to both increase the efficacy of new drugs and expand access to treatment.

The ethical debate around the use of animals in research has roiled for hundreds of years and will likely continue to do so. But what the Covid-19 outbreak has made clear is that there are severe weaknesses in the current animal model paradigm. As experiments have come to a halt during the coronavirus lockdowns, researchers have been given time to consider new, more sustainable approaches to discovery. Hopefully, we will look beyond the short-term technical challenges that will inevitably accompany the resumption of business as usual and gaze further afield, toward more humane, more modernized approaches to doing science.

Lindsay Gray is a lab manager at the University of California, San Francisco.

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Hansa Biopharma announces exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as pre-treatment ahead of gene therapy in se…

Posted: at 8:41 am

Hansa grants Sarepta exclusive license to develop and promote imlifidase as a potential pre-treatment prior to the administration of gene therapy in Duchenne muscular dystrophy and Limb-girdle muscular dystrophy, for patients with neutralizing antibodies (NAbs) to adeno-associated virus (AAV).

Under the terms of the license: Hansa will receive a USD 10 million upfront payment and is eligible for up to USD 397.5 million in development, regulatory and sales milestone payments. Hansa will book all sales of imlifidase and would be eligible for royalties in the high single-digits to mid-teens on any gene therapy sales enabled through pre-treatment with imlifidase in NAb-positive patients.

Lund, Sweden July 2, 2020. Hansa Biopharma (Hansa), the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, announced today that it has entered into an agreement with Sarepta Therapeutics Inc. (Sarepta), the leader in precision genetic medicine for rare diseases, through which Sarepta is granted an exclusive, worldwide license to develop and promote imlifidase as a pre-treatment to enable Sarepta gene therapy treatment in Duchenne muscular dystrophy (DMD) and Limb-girdle muscular dystrophy (LGMD). The pre-treatment is intended for patients with pre-existing neutralizing antibodies (NAb-positive patients) to adeno-associated virus (AAV), the technology that is the basis for Sareptas gene therapy products.

Sarepta will be responsible for conducting pre-clinical and clinical studies with imlifidase and any subsequent regulatory approvals. Sarepta will also be responsible for the promotion of imlifidase as a pre-treatment to Sareptas gene therapies following potential approval.

Under the terms of the agreement, Hansa will receive a USD 10 million upfront payment, and is eligible for a total of up to USD 397.5 million in development, regulatory and sales milestone payments. Hansa will book all sales of imlifidase, and earn high single-digit to mid-teens royalties on Sareptas incremental gene therapy sales when treating NAb-positive patients enabled through pre-treatment with imlifidase.

Sren Tulstrup, President & CEO of Hansa Biopharma comments,We see significant potential for our enzyme technology in the gene therapy space overall, and we are excited to partner with Sarepta, a leading player in the field, to use the unique features of imlifidase to potentially enable gene therapy treatment in patients who today arent eligible for these breakthrough therapies due to pre-existing neutralizing antibodies in two conditionswith a very high unmet medical need.

Doug Ingram, President & CEO, Sarepta Therapeutics said,As we expand our leadership position in genetic medicine and build out our gene therapy engine, one of Sareptas central ambitions is to find scientific solutions that bring our potentially life-saving therapies to the greatest number of the rare disease patients we serve. One of the current limitations of gene therapy is the inability to treat patients who have pre-existing neutralizing antibodies to the AAV vector. While our AAVrh74 vector has been associated with a low screen out rate for neutralizing antibodies, even that low rate is inconsistent with our mission.

In pre-clinical and clinical models, Hansas technology has shown the ability to clear the IgG antibodies that prevent dosing AAV-based gene therapies. If successful, this could offer the potential of extending our gene therapy treatments to DMD and LGMD patients who would otherwise have been denied access due to pre-existing antibodies.

Hansa Biopharma will be hosting a conference call with President & CEO Sren Tulstrup, CSO & COO Christian Kjellman and CFO Donato Spota.

Conference Call Partnership agreement with Sarepta TherapeuticsA conference call will take place July 2nd, 2020 at 10:00am CET. The audio cast will be recorded and subsequently be available on the Hansa website https://hansa.eventcdn.net/202007

Participants dial-in numbersSE: + 46 81 241 09 52UK: + 44 203 769 6819US: + 1 646 787 0157

This is information that HansaBiopharma AB is obliged to makepublic pursuant to the EU MarketAbuse Regulation.

About imlifidaseImlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response. It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration. CHMP/EMA has adopted a positive opinion, recommending conditional approval of imlifidase for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. Endorsement of the positive opinion by the European Commission is expected in the third quarter of 2020.Hansa has also reached an agreement with the FDA on a regulatory path forward for imlifidase in kidney transplantation of highly sensitized patients in the U.S. and has three ongoing phase 2 trials in autoimmune diseases and post-transplant indications.

About gene therapy and neutralizing antibodiesGene therapy is a growing and revolutionizing treatment technology in which healthy gene sequences are inserted into cells of a patient. The treatments are potentially curative in monogenic diseases like hemophilia and muscular dystrophy through a single dose. Harmless recombinant viruses are used to carry the healthy genes into the cell. Due to the partial viral origin of the gene therapy constructs, a certain subset of patients carry neutralizing anti-AAV antibodies towards gene therapy products, depending on what AAV serotype being used, forming a barrier for treatment eligibility.Antibodies prevent effective transfer of healthy gene sequence and can be a safety concern. Imlifidase as a pre-treatment may have the potential to eliminate neutralizing antibodies prior to gene therapy. Similarly, imlifidase may have the potential to enable any potentially necessary re-dosing of gene therapy for all patients.

About Duchenne Muscular Dystrophy (DMD)Duchenne muscular dystrophy is a rare genetic disease caused by mutation in the DMD gene, encoding for the protein dystrophin. Duchenne is an irreversible, progressive disease that causes the muscles in the body to become weak and damaged over time. It is eventually fatal and there is no cure. DMD affects one in 3,500 to 5,000 males born worldwide (approximately 400-500 annual cases in the US) and causes muscles in the body to become weak and most patients use wheelchair by the age of 12.

About Limb-Girdle Muscular Dystrophy (LGMD)Limb-girdle muscular dystrophy or (LGMD) is a genetically and clinically heterogeneous group of rare muscular dystrophies. It is characterised by progressive muscle wasting which affects predominantly hip and shoulder muscles. LGMD has an autosomal pattern of inheritance and currently has no known cure or treatment. It can be caused by a single gene defect that affects specific proteins within the muscle cell, including those responsible for keeping the muscle membrane intact. LGMD has a global prevalence of approximately 1.63 per 100,000 individuals worldwide.

For further information, please contact:Klaus Sindahl, Head of Investor RelationsHansa Biopharma Mobile: +46 (0) 709-298 269E-mail: klaus.sindahl@hansabiopharma.com

About Hansa BiopharmaHansa Biopharma is leveraging its proprietary immunomodulatory enzyme technology platform to develop treatments for rare immunoglobulin G (IgG)-mediated autoimmune conditions, transplant rejection and cancer.The Companys lead product candidate, imlifidase, is a unique antibody-cleaving enzyme that potentially may enable kidney transplantation in highly sensitized patients with potential for further development in other solid organ transplantation and acute autoimmune indications. CHMP/EMA has adopted a positive opinion, recommending conditional approval of imlifidase for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. Endorsement of the positive opinion by the European Commission is expected in the third quarter of 2020. Hansas research and development program is advancing the next generation of the Companys technology to develop novel IgG-cleaving enzymes with lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology.Hansa Biopharma is based in Lund, Sweden and also has operations in Europe and US.

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Movers & Shakers, July 3 | BioSpace – BioSpace

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AVROBIO: On Monday, clinical-stage gene therapy company AVROBIO, headquartered in Massachusetts, announced the appointment of Kim Raineri as chief manufacturing and technology officer.

I am thrilled to join AVROBIO, a leader in lentiviral gene therapy and a true pioneer in driving manufacturing advances that address the gene therapy fields need for faster, more scalable and more automated production, Raineri said. The AVROBIO team has created a state-of-the-art gene therapy platform and is clearly committed to continuous innovation on behalf of the patient communities they strive to serve. I am excited to contribute to that work.

Raineri will be replacing AVROBIO co-founder Kim Warren in the position, who will be retiring at the end of July. Before joining AVROBIO, Raineri served as the vice president of operations for Nikon CeLL Innovation Co.

Scenic Biotech: On Wednesday, Netherlands-based Scenic Biotech announced the appointment of their new chief executive officer. Newly appointed CEO Oscar Izeboud brings more than 20 years of life sciences and finance industry experience.

Prior to joining Scenic, Izeboud served as managing director at NIBC Bank in Amsterdam, where he led its corporate finance and capital markets team with a focus on innovation and growth companies.

Former acting CEO and scientific co-founder Sebastian Nijman takes on the role of chief scientific officer.

Akari Therapeutics: Biopharmaceutical company Akari Therapeutics on Wednesday announced the appointment of Torsten Hombeck as chief financial officer and a member of the company's executive team.

Torsten brings a deep understanding of financial strategy, the capital markets and business development to Akari. We are delighted to have him as a permanent member of Akaris executive leadership team," said Clive Richardson, Chief Executive Officer of Akari Therapeutics. "His appointment comes at a time of significant company opportunity and growth. His business and financial expertise will be instrumental in helping us to further develop the Company."

Hormbeck joins Akari with over 20 years of biopharmaceutical industry experience in financial and strategic planning.

Sarepta Therapeutics: Earlier this week, Cambridge-based Sarepta Therapeutics announced the retirement of Sandy Mahatme, the company's executive vice president, chief financial officer and chief business officer. Mahatme will be leaving the company effective July 10.

The Sarepta from which Sandy retires is a very different one from the organization he joined as our chief financial officer some eight years ago. And the Sarepta of today a financially solid biotechnology organization with perhaps the industrys deepest and most valuable pipeline of genetic medicine candidates with the potential to extend and improve lives would not have been possible without Sandys business acumen and dedication, said Doug Ingram, president and chief executive officer of Sarepta Therapeutics.

Sarepta has launched a search to identify the future chief financial officer.

BioMarin: On June 29, BioMarin, a global biotechnology company, announced a pair of promotions. Brian Mueller was promoted to executive vice president, chief financial officer and Andrea Acosta was promoted to group vice president, chief accounting officer.

Mueller has been with BioMarin since 2002, during which he has taken on roles of increasing responsibility. Acosta has been with BioMarin since 2017 as vice president, corporate controller.

Theravance Biopharma: Dublin-based Theravance Biopharma on Thursday announced the appointment of Deepika Pakianathan to its Board of Directors. Pakianathan serves as a managing member at Delphi Ventures, a venture capital firm focused on biotechnology and medical device investments.

"We are honored to welcome Dr. Pakianathan to our board of directors," said Rick Winningham, chief executive officer of Theravance. "We believe her vast experience in the biotechnology sector, translating breakthrough science and taking important therapies from pipeline to patients, will further enhance our already talented Board of Directors."

Novavax: On Thursday, Maryland-based Novavax announced the appointment of Frank Czworka as senior vice president, global sales. Czworka will be responsible for leading sales planning and distribution for the company. He brings more than 20 years of biopharmaceutical experience to the company, with his most recent experience being as vice president, global customer enngagement at U.S. Pharmacopeia.

Novavax also announced the promotion of Brian Webb to senior vice president, manufacturing. Webb will be responsible for overseeing antigen manufacturing and supply activities in support of the company's vaccine candidates. Webb has been with Novavax since May 2014.

eGenesis: On Wednesday, Massachusetts-based eGenesis announced that it appointed Peter Hanson as chief operating officer. Hanson will be in charge directing eGenesis' day-to-day organizational and operational activities including production and manufacturing.

Peter is a highly experienced biopharmaceutical executive across multiple disciplines, which will be critical to support our next phase of growth as we integrate production and R&D, said Paul Sekhri, President and Chief Executive Officer of eGenesis. Peters operational leadership and veterinary knowledge will help us accelerate our product development as we move closer to IND filing for human clinical studies. We are very grateful for Kenneth Fans many contributions as our founding COO. I am delighted that he will continue to serve as an advisor to the company.

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IHS Pets: Bringing Cell And Gene Therapy To Cats, Dogs & Horses – Anti Aging News

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Integrated Health System is bringing cell and gene therapy to cats, dogs, and horses. Recently IHS Pets has helped a paralyzed dog with a spinal cord injury to walk again after it was treated with experimental PRP and prolotherapy. Click here to see the video.

Telomeres

Aging is the root of virtually every complex noncommunicable disease in humans and animals. Telomeres are the protective end caps on the ends of our chromosomes, they are as important for the health of both humans and our pets, and they play roles in longevity.

One of the contributing factors in the lifespan in dog breeds is telomere length. As in humans researchers have found that telomere length is a strong predictor of average life span among 15 different breeds consistent with telomeres playing a role in life span determination. Dogs lose telomeric DNA ~10-fold faster than humans, which is similar to the ratio of average life spans between these species. As such telomerase therapy may be beneficial to pets as well as their human caretakers.

Telomerase gene therapy has been shown to extend lifespan in animals, this therapy may help to increase bone mineral density, improve motor performance, improve metabolism, and improve brain function.

Follistatin

The loss of muscle mass with age is just as problematic for animals as it is to humans; in cats for instance a study showed that for each 100g loss of lean body mass increased the risk of death by 20%. This is typically accompanied by frailty, and it is a contributing factor to metabolic syndrome, diabetes, heart disease, and overall mortality.

Diet and exercise have been shown to pay key roles in keeping pets healthy, but the loss of muscle mass is unavoidable without an effective intervention. Enter follistatin: myostatin blocks muscle growth, when it is inhibited then follistatin is able to let muscles grow freely to stop them from wasting away.

Follistatin gene therapy has been shown to be safe and effective in animals, this therapy may help to protect against frailty, increase muscle density, increase strength, and increase endurance.

Klotho: The Queen of Anti-Aging Proteins

1 in 3 cats will suffer from renal disease, but these numbers are under scrutiny with some suggesting that estimate may be too conservative. Chronic kidney failure can occur gradually over months or years, and it is one of the most common conditions affecting older cats with most cases progressing over time worsening the disease.

Klotho is known to play a significant role in the development of chronic kidney disease, and researchers are now turning to its broader role in the anging process as a whole; such as induces expression with gene therapy in mice has been shown to extend lifespan by targeting many of the same pathways as caloric restriction. Blocking Klotho has been shown to cause premature aging.

Klotho also helps to protect the brain, and contributes to more differences in intelligence than any one single gene. Research from the University of California has shown it to protect the brains of mice and improve brain function within 4 hours; and this result included young mice, old mice, and those that were models of Alzheimers disease.

In addition Klotho also plays a critical role in the inflammaging process. Inflammaging is the long term result of the chronic physiological stimulation of the innate immune system which can become damaging during the aging process.

Circulating levels of Kloto decreases with age, this decrease is associated with an increased risk of age related disease. Gene therapy with Klotho has been shown to increase lifespan in animal models, and it may improve kidney function, brain function, clear damage caused by oxidative stress, and protect against cardiovascular disease.

With the remarkable progress being made in genetics, gene therapy may play increasingly prominent and transformative roles in medicine for both humans and animals due to the potential to treat diseases and congenital disorders.

Pets can be an important part of life, they calm us, make us laugh, and create a bond of unconditional love. The company does note that all therapies are experimental, they are not approved by any regulatory body, and they make no claims that outcomes will be positive or beneficial.

IHS Pets is the veterinary wing of Integrated Health Systems, BioViva Sciences exclusive partner. IHS connects with doctors and patients who are interested in the power of gene therapy to pave the way to healthy aging and longevity.

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