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Researchers curb local immune response in horses receiving stem cell injury therapy – Horsetalk

Posted: February 7, 2021 at 12:48 am

Cultures with treated stem cells had a 50% higher stem cell survival rate than untreated cultures. Image by carolem41

Treating equine donor stem cells with a growth factor called TGF-2 may allow them to avoid tripping the immune response in recipients, according to new research.

The work carried out at North Carolina State University could simplify the stem cell treatment process for ligament and tendon injuries in horses, and may also have implications for human stem cell therapies.

Mesenchymal stem cell therapy is a promising avenue for treating musculoskeletal injuries, particularly tendon and ligament injuries, in horses.

Mesenchymal stem cells are adult stem cells found in bone marrow that act as repair directors, producing secretions that recruit healing-related paracrine factors to the site of injury.

Just as blood cells have types, depending upon which antigens are on the blood cells surface, mesenchymal stem cells have differing sets of major histocompatibility complex molecules, or MHCs, on their surfaces.

If the MHCs of donor and recipient arent a match, the donors stem cells cause an immune response. In organ transplants, MHCs are carefully matched to prevent rejection.

These treatments arent like a bone marrow transplant or an organ transplant, says Lauren Schnabel, associate professor of equine orthopedic surgery at the university and corresponding author of the study, reported in the journal Frontiers in Cell and Developmental Biology.

Since the mesenchymal stem cells are being used temporarily to treat localized injury, researchers once thought that they didnt need to be matched that they wouldnt cause an immune response. Unfortunately, that isnt the case.

Schnabel and Alix Berglund, a research scholar at the university and lead author of the paper, wanted to find a way to use mesenchymal stem cell therapy without the time, effort and additional cost of donor/recipient matching.

Since these cells dont have to be in the body as long as an organ does, hiding them from the immune system long enough for them to secrete their paracrine factors could be a way around donor/recipient matching, Berglund says. Downregulating expression of the MHC molecules could be one way to do this.

The researchers cultured stem cells and lymphocytes, or T cells, from eight horses, cross-pairing them in vitro so that the stem cells and lymphocytes had differing MHC haplotypes.

In one group, stem cells had been treated with transforming growth factor beta (TGF-2) prior to being added to the lymphocytes in the culture media; the other group was untreated. TGF-2 is a cell-signaling molecule produced by white blood cells that blocks immune responses.

Cultures with treated stem cells had a 50% higher stem cell survival rate than untreated cultures.

We use mesenchymal stem cells to treat musculoskeletal injuries particularly tendon injuries in horses very effectively, Schnabel says.

And while you can extract the secretions from the stem cells, you get better results with the cells themselves. Stem cells arent just a reservoir of secretions, theyre a communications hub that tells other cells what they should be doing. So finding a way to utilize these cells without stimulating immune response gives us better treatment options.

This is a promising pilot study, Berglund says. Our next steps will be to further explore the immune response in vivo, and to look at human cells in vitro, as this work has excellent potential to help humans with these injuries as well.

The research was supported by the National Institutes of Health and the Morris Animal Foundation. Research specialist Julie Long and statistician James Robertson, both with the university, also contributed to the work.

TGF-b2 Reduces the Cell-Mediated Immunogenicity of Equine MHC-Mismatched Bone Marrow-Derived Mesenchymal Stem Cells Without Altering Immunomodulatory PropertiesAlix K. Berglund, Julie M. Long, James B. Robertson, Lauren V. SchnabelCell Dev. Biol., 04 February 2021 https://doi.org/10.3389/fcell.2021.628382

The study, published under a Creative Commons License, can be read here.

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After Bone Marrow Donation Saves 9-Year-Old Boy With Cancer, Boston Mom Fights To Raise Awareness – Here And Now

Posted: February 7, 2021 at 12:48 am

Every year, about 10,000 people in the U.S. need a stem cell transplant but cant find a donor.

The intense medical procedure, which can help those with leukemia, lymphoma, sickle cell anemia and other blood diseases, can save lives but securing a donor can be like finding a needle in a haystack.

Be The Match is a nonprofit, national registry where people can sign up to donate their stem cells. More than 35 million people around the world have volunteered yet only a small percentage of those donors are Americans, and even the registry admits most Americans dont know it exists.

The mother of a 12-year-old boy with leukemia has set out to change that.

Mandy Goldman is a hairdresser who lives with her husband and four children outside Boston. She remembers the devastating day five years ago when doctors told her the chemotherapy they gave her son Mateo Goldman, 9 years old at the time, didnt work.

They told us that our only option of curing Mateo was a bone marrow transplant, she says, a risky procedure that often involves a host of complications. But they had no other choice, she says.

The family got to work on the monumental task finding Mateo Goldman a close enough match.

Linda Matchan first reported the Goldman familys experience for The Boston Globe. In her research, she found very, very few people had any awareness of the need for bone marrow and stem cells donors. The awareness campaign around the subject is severely lacking compared to other campaigns like the importance of donating blood, she says.

For example, there's a little boy right now in North Carolina named Thor Forte, who's 10 and has sickle cell disease. And he has been waiting for literally half his life, five years, for a donor to be available, Matchan says. He's a tough match, but they finally did find somebody. And then when the time came for the procedure, the person backed out. So two years later, the boy is still waiting.

Fortunately, quickly after finding out Mateo Goldman didnt match with anyone in his family, he was paired with a donor on the registry from Germany. Mandy Goldman says Laura Stterlin of Frankfurt was ready to go and donate, ultimately saving her son.

Mateo Goldman wrote Stterlin, whose name he did not know at the time, a thank you note reading: Dear Donor, thank you for giving me the bone marrow. You feel like youre already part of my family, he says.

And unlike usual Make-A-Wish requests, Mateo Goldman asked to meet Stterlin in person halfway across the world. The trip to Germany was planned for summer of 2020 but has since been canceled due to the pandemic.

In 2019 when she was reporting this story, Matchan had a trip planned to Germany. She ended up meeting Stterlin and hearing the story of how she became a donor. Stterlin said she was at a sporting event with her husband when she got hungry and went on the hunt for some grub.

Dear Donor, thank you for giving me the bone marrow. You feel like youre already part of my family.

Germany has a robust public service campaign to get citizens to donate bone marrow, Matchan says. So it came to no surprise to Stterlin when she came across a kiosk to sign up.

Just three months later, she got a call and an email from the registry saying that there is somebody in the United States for whom she could be a match and was asked if she would donate, Matchan says. A couple of days later, she went into the hospital and did the donation.

Stterlins stem cells then crossed the Atlantic Ocean, making their way to America during a snowstorm.

The cells started working in Mateo Goldman right away but not without some difficulties, Mandy Goldman says. He battled total body stiffness from graft-versus-host disease, a complication of the transplant.

But, you know, Matteo's an amazing kid, she says, so through it all, he was smiling and making the best of it, even though he was suffering for a lot of the time.

Two years later, in July of 2020, the cancer came back. But since Mateo Goldmans first transplant, the science had evolved greatly.

So much so that his older brother, Leo Goldman, became a candidate to donate his cells for the second stem cell transplant.

I didn't realize how I could get my brother's cells, Mateo Goldman, now 12 years old, says. Once that sank in, I felt that it would connect me and my brother more.

Right before Christmas last year, the family got extraordinary news: Mateo Goldman had zero cancer in his bone marrow, Mandy Goldman says.

Now the mom of four is on a mission to raise awareness on stem cell donations and share the story of how it saved her sons life.

The amazing feeling Leo got from being able to be the person who saved his brother's life is something he's going to carry with him forever, she says. And even Laura [Stterlin], she gave him three and a half years of his life that we get to spend with him. I just really want to educate people about how empowering it is to do something so incredible for somebody else.

When she started talking to others to raise awareness, she was shocked to discover how fearful people were in committing to be a donor.

If people could see the trauma these patients go through her son had a drain placed in his stomach, total body radiation, chemotherapy that left him head-to-toe in a skin-burning rash she says then maybe they wouldnt be scared to dedicate a small action for someone whose only cure is through a stem cell transplant.

Once people are educated about how much of a difference it makes, she says, then I feel like they would do it.

Click here to learn more about the Be The Match Registry.

Tinku Rayproduced and edited this interview for broadcast.Serena McMahonadapted it for the web.

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After Bone Marrow Donation Saves 9-Year-Old Boy With Cancer, Boston Mom Fights To Raise Awareness - Here And Now

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A Closer Look at the AI Hype Machine: Who Really Benefits? – Common Dreams

Posted: February 5, 2021 at 9:54 pm

The poet Richard Brautigan said that one day we would all be watched over by "machines of loving grace". It was a nice sentiment at the time. But I surmise Brautigan might have done a quick 180 if he was alive today. He would see how intelligent machines in general and AI in particular were being semi-weaponized or otherwise appropriated for purposes of a new kind of social engineering. He would also likely note how this process is usually positioned as something "good for humanity" in vague ways that never seem to be fully explained.

As both a technologist and a journalist, I find it very difficult to think of transhumanism and what I'll call the New Eugenics as anything less than deeply and literally dehumanizing.

The hits, as they say, just keep on coming. Recently I ran across an article advising recent college graduates looking for jobs that they had better be prepared to have their facial expressions scanned and evaluated by artificial intelligence programs during and after interviews.

An article in the publication "Higher Ed" warned that: "Getting a job increasingly requires going through an interview on an AI platformIf the proprietary technology [used to ] to evaluate the recordings concludes that a candidate does well in matching the demeanor, enthusiasm, facial expressions or word choice of current employees of the company, it recommends the candidate for the next round. If the candidate is judged by the software to be out of step, that candidate is not likely to move on."

If this were happening in China, of course, it would be much less surprising. You don't have to be a Harvard-trained psychiatrist to see that this kind of technology is violating some very basic human boundaries: how we think and feel and our innermost and private thoughts. And you don't have to be a political scientist to see that totalitarian societies are in the business of breaking down these boundaries for purposes of social and political control.

Facial recognition has already been implemented by some law enforcement agencies. Other technology being used for social control starts out in the corporate world and then migrates. Given the melding of corporate and government power that's taken place in the U.S. over the last few decades, what's impermissible in government now can get fully implemented in the corporate world and then in the course of time bleeds over to government use via outsourcing and other mechanisms. It's a nifty little shell game. This was the case with the overt collection of certain types of data on citizens which was expressly forbidden by federal law. The way around it was to have corporations to do the dirty work and then turn around and sell the data to various government entities. Will we see the same thing happen with artificial intelligence and its ability to pry into our lives in unprecedented ways?

There is a kind of quasi-worship of technology as a force majeure in humanity's evolution that puts AI at the center of human existence. This line of thinking is now linked to the principles of transhumanism, a set of values and goals being pushed by Silicon Valley elites. This warped vision of techno-utopianism assures us that sophisticated computers are inherently superior to humans. Implicit in this view is the notion that intelligence (and one kind of intelligence at that) is the most important quality in the vast array of attributes that are the essential qualities of our collective humanity and longstanding cultural legacies.

The corporate PR frontage for these "breakthroughs" is always the same: they will only be used for the highest purposes like getting rid of plastics in the oceans. But still the question remains: who will control or regulate the use of these man-made creatures?

The most hardcore transhumanists believe that our role is simply to step aside and assist in the creation of new life forms made possible by hooking up human brains to computers and the Internet, what they consider to be an evolutionary quantum leap. Unfortunately, people in powerful corporate positions like Ray Kurzweil, Google's Director of Engineering, and Elon Musk, founder of Neuralink, actually believe in these convoluted superhero mythologies. This line of thinking is also beginning to creep into the mainstream thanks to the corporate-driven hype put forth by powerful Silicon Valley companies who are pushing these ideas for profit and to maintain technology's ineluctable "more, better, faster" momentum.

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The transhumanist agenda is a runaway freight train, barely mentioned in the mainstream media, but threatening to run over us all. In related "mad science" offshoot, scientists have succeeded in creating the first biological computer-based hybrids called Xenobotswhich the New York Times describes as "programmable organisms" that "live for only about a week". The corporate PR frontage for these "breakthroughs" is always the same: they will only be used for the highest purposes like getting rid of plastics in the oceans. But still the question remains: who will control or regulate the use of these man-made creatures?In the brave new world of building machines that can think and evolve on their own because they combine AI programming with biological programming, we have to ask where all this is headed. If machines are being used to evaluate us for job interviews, then why won't they be eventually used as police officers or judges? (In fact, Singapore is now using robotic dogs to police parks for Covid-related social distancing.)

As both a technologist and a journalist, I find it very difficult to think of transhumanism and what I'll call the New Eugenics as anything less than deeply and literally dehumanizing. In the aftermath of WWII, eugenics used to be widely reviled when Nazi scientists experimented with and so highly valued it. Now it's lauded as cutting edge.There are two ugly flies in this ointment. The first is the question of who directs and controls the AI machines being built. You can make a safe bet that it won't be you, your friends, or your neighbors but rather technocratic elites. The second is the fact that programmers, and their masters, the corporate Lords of Tech, are the least likely candidates to come up with the necessary wisdom to imbue AI with the deeper human qualities necessary to make it anything more than a force used for social and political control in conjunction with mass surveillance and other tools.

Another consideration is: how does politics fit into this picture? In the middle ages, one of the great power shifts that took place was from medieval rulers to the church. In the age of the enlightenment, another shift took place: from the church to the modern state. Now we are experiencing yet another great transition: a shift of power from state and federal political systems to corporations and, by extension, to the global elites that are increasingly exerting great influence on both, the 1 percenters that Bernie Sanders frequently refers to.

When considering the use of any new technology, the question should be asked: who does it ultimately serve? And to what extent are ordinary citizens allowed to express their approval or disapproval of the complex technological regimes being created that we all end up involuntarily depending upon?

These trends have political implications because they have happened in tandem with the neoliberal sleight of hand that began with President Reagan. Gradually anti-democratic policy changes over a period of decades allowed elites to begin the process of transferring public funds to private coffers. This was done under the neoliberal smokescreen of widely touted but socially hollow benefits such as privatization, outsourcing, and deregulation bolstered by nostrums such as "Government must get out of the way to let innovation thrive."

Behind the scenes, the use of advanced technology has played a strong role in enabling this transition but it did so out of the public's watchful eye. Now, it seems abundantly clear that technologies such as 5G, machine learning, and AI will continue to be leveraged by technocratic elites for the purposes of social engineering and economic gain. As Yuval Harari, one of transhumanism's most vocal proponents has stated: "Whoever controls these algorithms will be the real government."

If AI is allowed to begin making decisions that affect our everyday lives in the realms of work, play and business, it's important to be aware of who this technology serves: technologically sophisticated elites. We have been hearing promises for some time about how better advanced computer technology was going to revolutionize our lives by changing just about every aspect of them for the better. But the reality on the ground seems to be quite different than what was advertised. Yes, there are many areas where it can be argued that the use of computer and Internet technology has improved the quality of life. But there are just as many others where it has failed miserably. Healthcare is just one example. Here misguided legislation combined with an obsession with insurance company-mandated data gathering has created massive info-bureaucracies where doctors and nurses spend far too much time feeding patient data into a huge information databases where it often seems to languish. Nurses and other medical professionals have long complained that too much of their time is spent on data gathering and not enough time focusing on healthcare itself and real patient needs.

When considering the use of any new technology, the question should be asked: who does it ultimately serve? And to what extent are ordinary citizens allowed to express their approval or disapproval of the complex technological regimes being created that we all end up involuntarily depending upon? In a second "Gilded Age" where the power of billionaires and elites over our lives is now being widely questioned, what do we do about their ability to radically and undemocratically alter the landscape of our daily lives using the almighty algorithm?

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Deadpool’s Monster Army and the X-Men’s Nation Share a Surprising Tactic – Screen Rant

Posted: February 5, 2021 at 9:54 pm

The X-Men are really big into combining their powers now, something Deadpool uses when it's time to smash invading symbiotes.

Having a country seems to be all the rage in comics these days. After all, in addition to traditional mainstays like Black Panther's Wakanda and Doctor Doom's Latveria, the X-Men now have the mutant nation of Krakoa, and Deadpool, of all people, has found himself the monarch of the Monster Nation. With countries come culture, and there seems to be some cultural cross-pollination going on in the pages of Marvel Comics. In Deadpool #10, written by Kelly Thompson and illustrated by Gerardo Sandoval, the Merc with a Mouth seems to have borrowed a page from X-Men to combine the powers of his constituents into a fearsome symbiote-smashing giant robot! But what precedent does this increasing common occurrence set, and what implications does it have going forward?

Combining powers is nothing new in comics. Perhaps is the most famous example is "the Fastball special" which would see Colossus launch Wolverine at their adversaries. However, Krakoa has taken this concept to a whole new level, developing much more intricate - and potentially dangerous - combinations. After all, some mutants wield various elements, controlled by sheer force of will. Any emotional instability could spell disaster. Fortunately, most mutants in Krakoa have an insurance policy in the form of their resurrection through psychic downloads.

Related: Deadpool Just Saved Captain America and Cyclops in the Most Ridiculous Way

On the pages of Deadpool, the titular monarch is using the powers of former enemy Jelby to create a massive gelatinous body to house his team, and then use their individual powers against the symbiotes threatening his nation and the world at large. Jelby also captures Deadpool's pet, Jeff the Landshark, who had been infected by a symbiote, and by the end of the adventure, even helps capture a massive symbiote dragon. Ultimately, the move to combine powers - which Deadpool fittingly refers to as "Plan X" - pays off.

Still, from a storytelling perspective, there are potential pitfalls for power combination. Its possible power combination could become nothing more than a plot device, or worse, a deus ex machina. After all, Krakoa is a blossoming transhumanist state, and it's possible no individual situation poses much of a threat thanks to the sheer number of power combinations at the mutants' disposal now. Ultimately, the story could suffer, especially if the emphasis falls on the "wow factor" of power combination instead of the character dynamics working behind the scenes.

Of course, this new mutant culture could be a way of raising the stakes. After all, would the mutants be so willing to engage in these dynamics if they didn't have resurrection pods? Cheating death typically doesn't end well. If or when Krakoa loses its resurrection capability, mutants could put themselves in considerable danger performing these maneuvers. The comics have already explored how vulnerable clones feel in the face of uncertain resurrection. What if the mutants had to perform these literally death-defying moves without a safety net?

Ultimately, the question is moot in Deadpool's case, as his Monster Nation is shown to be almost everything Krakoa is not - a rag-tag mix of monsters, aliens, villains, and even regular humans working together. If Deadpool can duplicate a key mutant technology without much effort, it's possible Krakoa might not be as innovative - or even stable - as they believe. All of this suggests Krakoa's recent breakthrough might really be leading the mutant nation down a path with very fragile feet of clay.

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Leukemia in children: Symptoms, causes, treatment, outlook, and more – Medical News Today

Posted: February 5, 2021 at 9:51 pm

Leukemia is a type of cancer that affects the blood. The two most common types in children are acute lymphoblastic leukemia and acute myelogenous leukemia.

In a person with leukemia, blood cells are released into the bloodstream before they are fully formed, so there are fewer healthy blood cells in the body.

Below, we describe the types of childhood leukemia, the symptoms, and the treatments. We then look at when to contact a doctor, what questions to ask, and where to find support.

Childhood leukemia is the most common form of cancer in children. It affects up to 3,800 children under the age of 15 in the United States each year.

Leukemia occurs when bone marrow releases new blood cells into the bloodstream before they are fully mature.

These immature blood cells do not function as they should, and eventually, the number of immature cells overtakes the number of healthy ones.

Leukemia can affect red and white blood cells and platelets.

The bone marrow produces stem cells. A blood stem cell can become a myeloid stem cell or a lymphoid stem cell.

Lymphoid stem cells become white blood cells. Myeloid stem cells can become:

Leukemia is typically acute or chronic, and chronic types are rare in children. They can include chronic myeloid leukemia or chronic lymphocytic leukemia.

Most childhood leukemias are acute, meaning that they progress quickly and need treatment as soon as possible.

Acute lymphoblastic leukemia (ALL) is the most common type in children, accounting for 75% of childhood leukemia cases.

It affects cells called lymphocytes, a type of white blood cell.

In a person with ALL, the bone marrow releases a large number of underdeveloped white blood cells called blast cells. As the number of these increases, the number of red blood cells and platelets decreases.

There are two subtypes of ALL: B-cell and T-cell.

In most childhood cases of ALL, the cancer develops in the early forms of B-cells. The other type, T-cell ALL, typically affects older children.

Research from 2020 reports that the majority of people diagnosed with ALL are under 18 and typically between 2 and 10 years old.

The American Cancer Society report that children under 5 years old have the highest risk of developing ALL and that this risk slowly declines until a person reaches their mid-20s.

The outlook for ALL depends on the subtype, the persons age, and factors specific to each person.

Myeloid leukemias account for approximately 20% of childhood leukemia cases, and most myeloid leukemias are acute.

Acute myelogenous leukemia (AML) affects white blood cells other than the lymphocytes. It may also affect red blood cells and platelets.

AML can begin in:

Juvenile myelomonocytic leukemia (JMML) accounts for approximately 12% of leukemia cases in children.

This rare type is neither acute nor chronic. JMML begins in the myeloid cells, and it typically affects children younger than 2 years.

Symptoms can include:

The symptoms of leukemia may be nonspecific similar to those of other common childhood illnesses.

A doctor will ask how long the child has been experiencing the symptoms, which can include:

Children may experience specific symptoms depending on the type of blood cell that the leukemia is affecting.

A low number of red blood cells can cause:

A low number of healthy white blood cells can cause infections or a fever with no other sign of an infection.

A low platelet count can cause:

Various factors can increase a childs risk of leukemia, and most are not preventable.

The following genetic conditions can increase the risk of leukemia:

Also, having a sibling with leukemia may increase the risk of developing it.

These can include exposure to:

If a child has symptoms that might indicate leukemia, a doctor may perform or request:

A bone marrow aspiration involves using a syringe to take a liquid sample of bone marrow cells. The doctor may give the child a drug that allows them to sleep through this test.

During the diagnostic process, a person might ask:

The doctor may recommend a variety of treatments for childhood leukemia, and the best option depends on a range of factors specific to each person.

The treatment usually consists of two phases. The first aims to kill the leukemia cells in the childs bone marrow, and the second aims to prevent the cancer from coming back.

The child may need:

Before or during treatment, a person might ask the doctor:

Questions to ask after the treatment might include:

Children who have undergone leukemia treatments require follow-up care, as the treatments often cause late effects.

These can develop in anyone who has received treatment for cancer, and they may not arise for months or years after the treatment has ended.

Treatments that can cause late effects include:

These complications may affect:

The late effects that may come can also depend on the type of treatment and the form of leukemia.

Because many leukemia symptoms can also indicate other issues, it can be hard to know when to contact a doctor.

Overall, it is best to seek medical advice if a child shows symptoms or behaviors that are not normal for them.

If a child has received a leukemia diagnosis, the effects can extend to parents, other family members, caregivers, and friends.

A person can find support and additional resources from:

The following organizations based in the United Kingdom also provide support and guidance:

Childhood leukemia can affect mental health, as well as physical health.

Learn more about mental health resources here.

According to the American Cancer Society, most children with leukemia have no known risk factors. There is no way to prevent leukemia from developing.

Because there are very few lifestyle-related or environmental causes of childhood leukemia, it is very unlikely that a caregiver can do anything to help prevent the disease.

A childs outlook depends on the type of leukemia. It is important to keep in mind that current estimates do not take into account recent advances in technology and medicine.

For example, the most recent 5-year survival rate estimates reflect the experiences of children who received their diagnoses and treatments more than 5 years ago.

The American Cancer Society report that the 5-year survival rate for children with ALL is 90%. The same rate for children with AML is 6570%.

Childhood leukemia is typically acute, which means that it develops quickly. As a result, a person should contact a doctor if they notice any of the symptoms.

The most common type of childhood leukemia is ALL, representing 3 out of 4 leukemia cases in children.

Treatment may include a combination of chemotherapy, targeted drugs, immunotherapy, stem cell transplants, surgery, and radiation.

The prognosis depends on the type of leukemia and the childs age.

This diagnosis can affect mental as well as physical health, and the effects can extend to caregivers, family members, and friends. Many different resources are available for support.

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Using proteogenomics to improve the treatment of squamous cell carcinoma – Baylor College of Medicine News

Posted: February 5, 2021 at 9:51 pm

Patients with head and neck squamous cell carcinoma (HNSCC), the sixth most common epithelial cancer worldwide, are treated with surgery, chemotherapy and radiotherapy. In addition, targeted agents, including an EGFR monoclonal antibody (mAb) inhibitor and two programmed cell death protein 1 (PD-1) inhibitors, have been approved by the U.S. Food and Drug Administration for HNSCC treatment, but response rates are moderate.

In this study, researchers led by Baylor College of Medicine, Johns Hopkins University and the National Cancer Institutes Clinical Proteomic Tumor Analysis Consortium (CPTAC) investigated what new insight proteogenomic analysis might offer into understanding why certain patients respond to certain treatments while other patients do not. They propose that their findings may help better match patients to an appropriate course of treatment in the future.

The team profiled proteins, phosphosites (a site on a protein associated with phosphorylation) and signaling pathways in 108 human papillomavirus-negative HNSCC tumors in order to understand how genetic aberrations drive tumor behavior and response to therapies.

We found three subtypes of head and neck squamous cell carcinoma, and each subtype may be a good candidate for a different type of therapy EGFR inhibitors, CDK inhibitors or immunotherapy, saidDr. Bing Zhang, lead contact of the study and professor in theLester and Sue Smith Breast Centerand theDepartment of Molecular and Human Geneticsat Baylor. We also identified candidate biomarkers that could be used to match patients to effective therapies or clinical trials.

One important finding involved matching HNSCC patients to EGFR mAb inhibitors. Cetuximab, an EGFR mAb medication, was approved by the FDA in 2006 as the first targeted therapy for HNSCC, however the success rate for this treatment is low. Moreover, EGFR amplification or overexpression cannot predict response to EGFR mAbs. In this study, researchers found that EGFR ligands, instead of EGFR itself, act as the limiting factor for EGFR pathway activation. When ligand is low, the downstream pathway will not be triggered, even if EGFR protein is highly overexpressed.

We proposed that the EGFR ligand should be used as a biomarker, rather than EGFR amplification or overexpression, to help select patients for the EGFR monoclonal antibody treatment, said Zhang, a member of the Dan L Duncan Comprehensive Cancer Center, a Cancer Prevention & Research Institute of Texas (CPRIT) Scholar and aMcNair Scholarat Baylor.

Tumors with high EGFR amplification do not necessarily have high levels of EGFR ligands, which may underlie their lack of response to EGFR mAb therapy. The team confirmed this hypothesis by analyzing previously published data from patient-derived xenograft models and a clinical trial.

Additionally, tracking a key tumor suppressor known as Rb (retinoblastoma), the research team identified a striking finding that suggests that Rb phosphorylation status could potentially be a better indicator of a patients response to CDK4/6 inhibitor therapy. The study showed that the many mutations in the genes regulating CDK4/6 activity were neither necessary nor sufficient for activation of CDK4/6.

The team found that the CDK4 activity was best measured through Rb phosphorylation measurements, thus identifying a potential measure for patient selection in CDK inhibitor clinical trials.

The research team also found important insights into the effectiveness of immunotherapy. PD-1 inhibitors target the interaction between immune checkpoints PD-1 and PD-L1, but success rates of immunotherapy are low, even when PD-L1 expression is used for patient selection. The researchers examined tumors with high expression of PD-L1 and found that when a tumor overexpresses PD-L1, it also upregulates other immune checkpoints, thus allowing the tumor growth despite the use of PD-1 inhibitors.

This observation suggests that PD-1- and PD-L1-activated tumors with hot immune environments may require multiple types of immunotherapy, which target different immune checkpoint proteins, to be effective.Conversely, tumors with cold immune environments are not good targets for immunotherapy.

Immune-cold tumors are tumors that contain few if any infiltrating immune T cells. Examination of how a tumor becomes immune-cold showed that the problem stems from a flaw in its antigen presentation pathway, a first step toward triggering an immune response against tumor antigens. In immune-cold tumors multiple key gene components of the antigen presentation pathway were deleted. As a result, although tumor antigens are being expressed, the immune system is not able to recognize them on the surface of cancer cells and therefore fails to activate the bodys defense system against the tumor. These deletions have the potential to be effective targets for future therapies.

This study extends our biological understanding of HPV-negative HNSCCs and generates therapeutic hypotheses that may serve as the basis for future studies and clinical trials toward molecularly-guided precision medicine treatment of this aggressive cancer type, saidDr. Daniel W. Chan, co-corresponding author of the study, professor of pathology and oncology, and director of theCenter for Biomarker Discovery and Translationat theJohns Hopkins University School of Medicine.

Find all the details of this study and a full list of contributing authors in the journalCancer Cell.

This work was supported by grants U24 CA210954, U24 CA210985, U24 CA210972, U24 CA210979, U24 CA210986, U24 CA214125, U24 CA210967, and U24 CA210993 from the National Cancer Institute (NCI) Clinical Proteomic Tumor Analysis Consortium (CPTAC), by a Cancer Prevention Institute of Texas (CPRIT) award RR160027, by grant T32 CA203690 from the Translational Breast Cancer Research Training Program, and by funding from the McNair Medical Institute at the Robert and Janice McNair Foundation.

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Using proteogenomics to improve the treatment of squamous cell carcinoma - Baylor College of Medicine News

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iSpecimen expands offerings to support regenerative medicine, adding cryopreserved stem and immune cells to existing biospecimens available through…

Posted: February 5, 2021 at 9:51 pm

LEXINGTON, Mass., Feb. 3, 2021 /PRNewswire/ -- iSpecimen today announced it has expanded its cellular biospecimen offeringsby introducing new cryopreserved stem and immune cell products for life science research and preclinical drug development. The new products are intended to support the growth of regenerative medicine by giving researchers broader access to the materials they need to develop new therapies.

Peripheral blood mononuclear cells (PBMCs), also provided as "leukopacks," are critical for the research and development of stem cell and immunotherapies, vaccines, diagnostics, and new treatments for cancer, infectious, and autoimmune diseases. PBMCs are an important source of CD34+Hematopoietic Stem Cells (HSCs), CD3+ Pan T cells, CD4+Helper T cells, CD8+Cytotoxic T cells, CD56+ Natural Killer (NK) cells, CD14+Monocytes, antibody-secreting CD19+ B cells, and other primary cell types that are commonly used in cell-based assays to help advance drug discovery and development.

iSpecimen provides centralized access to a repository of banked cell types available for prompt delivery, plus mononuclear cells that can be collected prospectively and subsequently cryopreserved, depending on project and specific donor phenotype requirements. When compared to fresh cell collections, cryopreserved products provide researchers with increased flexibility in the timing and rollout of their research studies, especially when dealing with unexpected changes to lab schedules or pandemic-related disruptions. Moreover, cryopreserved cells collected from multiple donor phenotypes may helpresearchers execute side-by-side studies within preclinical development workflows.

The new offerings, which supplement iSpecimen's line of fresh immune cells, include:

"We're committed to supplying life science researchers with more of what they need in some of medical research's most promising areas," said Wayne Vaz, iSpecimen's vice president of growth and corporate development. "To provide a broad choice for demanding research, we continue to focus on expanding our extensive network of trusted suppliers, increasing industry access to difficult-to-source specimens, and providing a proprietary Marketplace platform that improves the overall experience of acquiring annotated biomaterials."

Trusted, accredited partners

iSpecimen sources these stem and immune cells from a wide network of supplier donor facilities. Each leukopack has been collected and/or cryopreserved in a US-FDA registered, AABB-accredited cell collection and storage center using a controlled-rate freezer and validated processing protocols.

Streamlined discovery, access, and procurement

Researchers can access the new selection of cells, as well as a range of other human biospecimens, by contacting iSpecimen directly and through the iSpecimen Marketplace, an online platform that increases access to human biospecimens from specific patients and healthy donors who provide them.

For those needing cells, the iSpecimen Marketplace gives researchers centralized, single-source access to a growing population of healthy donors and patients with hematopoietic and immune cell phenotypes that can match particular research study criteria.

Hematopoietic stem and immune cells may be selected based upon a variety of donor phenotype parameters such as HLA type, blood type, body mass index, ethnicity, race, age, and gender. The iSpecimen Marketplace also offers a comprehensive donor screening capability, permitting researchers to select the required scope of infectious disease testing such as CMV, hepatitis (B&C), HIV, West Nile Virus, syphilis, Chagas, and more.

About iSpecimen

Headquartered in Lexington, MA, iSpecimen offers an online marketplace for human biospecimens, providing researchers with the specimens they need from the patients they want. The privately held company has developed theiSpecimen Marketplace, an online platform connecting healthcare organizations that have access to patients and specimens with the scientists who need them. Proprietary, cloud-based technology enables researchers to intuitively search for specimens and patients across a federated partner network of hospitals, labs, biobanks, blood centers, and other healthcare organizations. Researchers easily and compliantly gain access to specimens to drive scientific discovery. Partner sites gain an opportunity to contribute to biomedical discovery as well as their bottom line. Ultimately, healthcare advances for all. For more information about iSpecimen, please visitwww.ispecimen.com.

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iSpecimen expands offerings to support regenerative medicine, adding cryopreserved stem and immune cells to existing biospecimens available through...

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Cell Line Development and Characterization Services by Sources of Cell Lines / Expression Systems, Applications of Cell Lines, and Geography :…

Posted: February 5, 2021 at 9:51 pm

New York, Feb. 05, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Cell Line Development and Characterization Services by Sources of Cell Lines / Expression Systems, Applications of Cell Lines, and Geography : Industry Trends and Global Forecasts, 2020-2030" - https://www.reportlinker.com/p06020735/?utm_source=GNW As a result, the pipeline of biologics and biosimilars is growing at a commendable pace. Given that the development and manufacturing of such therapies require living biological systems, there has been a surge in demand for different types of cell lines. In fact, around 84% of the therapeutic proteins marketed in the last five years, were produced using various mammalian and microbial cells. A recent study revealed that over 30,000 research articles published in 33,000 journals featured data generated from experiments that used misidentified or contaminated cell lines. This is a genuine concern in the field of medical research, which is becoming increasingly dependent on cell-based assays and experimentation. Therefore, in modern medical research, proper cell line characterization is a necessity in order to preserve the authenticity and accuracy of experimental research.

Given the cost intensive nature of pharmacological R&D, medical researchers / drug developers are consistently on the lookout for ways to optimize operational efficiencies, as well as reduce affiliated costs; in this context, outsourcing has emerged as a preferred business model. Presently, there are several contact service providers that claim to have the necessary expertise to develop and characterize cell lines. The technical aspect of this field is also witnessing a lot of innovation, especially with regard to automating various steps of the cell line development process. New genome editing technologies, such as the CRISPR/Cas-9, are also being extensively used to improve the quality of recombinant cell lines. Unlike drug developers, the capabilities of service providers are usually more focused to their respective service portfolios. Moreover, such companies ensure that they have the latest upgrades in equipment and infrastructure, in order to improve the quality of services offered. In fact, in the recent past, a number of service providers offering cell lines-related services, have forged strategic alliances with and / or acquired other players, in order to further enhance their respective portfolios. Considering the growing trend of outsourcing and the ongoing efforts of service providers to improve / expand their offerings, we believe the contract services market for cell line development and characterization is likely to evolve at a steady pace, till 2030.

SCOPE OF THE REPORT The Cell Line Development and Characterization Services Market (2nd Edition), 2020-2030 report features an extensive study on the current market landscape, offering an informed opinion on the likely evolution in this industry, over the next ten years. The study underlines an in-depth analysis of the services offered for the development and characterization of cell lines, which are intended for use in various R&D and / or therapeutic purposes. In addition to other elements, it includes: - A detailed review of the overall landscape of the cell line development services market, highlighting the contributions of contract service providers, along with the information on year of establishment, company size, location of headquarters, sources of cell lines and expression systems offered (mammalian, microbial, insect and avian), integrated cell line characterization, biosimilar cell line development and gene editing cell line development services offered, gene delivery method used (physical, chemical, biological and non-biological), type of gene expression (stable and transient), usage of serum-free / animal component free cell culture media, types of cell cultures (suspension and mixed growth properties), types of cells offered (recombinant, hybridoma and primary), applications of cell lines (R&D, biomanufacturing, diagnostics and cell therapy / regenerative medicine / tissue culture). In addition, the chapter includes information on additional cell line related services (bio-analytical / protein purification, cell banking, cell bank characterization, process development, GMP manufacturing and fill-finish), types of cell banks developed (master cell banks, working cell banks, research cell banks and end-of-production cell banks) and protein yield from cell lines. - A company competitiveness analysis, highlighting prominent cell line development service providers based in different regions, taking into consideration their supplier strength (experience of the service provider), and portfolio specifications (sources of cell lines and expression systems handled, availability of proprietary / licensed technology platform, type of gene expression and availability of additional cell line related services). - Elaborate profiles of cell line development service providers. Each company profile features a brief overview of the company, its financial information (if available), cell line development and complementary services portfolio and an informed future outlook. - A detailed review of the overall landscape of the cell line characterization services market, highlighting the contributions of industry and non-industry players along with the information on year of establishment, company size, location of headquarters, types of cells handled (mammalian, microbial, insect and others), types of cell line characterization services offered (identity / stability testing, sterility / biosafety testing, expression testing and oncogenicity / tumorigenicity testing), types of cell line identity / stability testing services offered (analysis of cell morphology, cytochrome c oxidase 1 barcoding assay, DNA fingerprinting / profiling, gene copy number analysis, isozyme analysis, karyotype analysis, nucleic acid sequencing, southern blotting and viability testing) types of sterility / biosafety testing services offered (mycoplasma contamination testing, microbial contamination testing, viral / adventitious agents contamination testing, retroviral contamination testing and rodent virus testing / in-vivo biosafety testing), availability of other cell line related services (cell line development, cell banking and mycoplasma clearance service), information on regulatory accreditations / certifications and overall turnaround time. In addition, it lists the non-industry players and provides information on number of STR loci amplified, type of genotyping kit used and service fee charged. - A company competitiveness analysis, highlighting prominent cell line characterization service providers based in different regions, taking into consideration their supplier strength (experience of the service provider), and portfolio specifications (sources of cell lines and expression systems handled and size of the service portfolio.) - Elaborate profiles of cell line characterization service providers. Each company profile features a brief overview of the company, its financial information (if available), cell line characterization services portfolio and an informed future outlook. - A detailed analysis of the partnerships that have been established in the cell line development and characterization domain since 2015, covering technology platform utilization agreements, R&D collaborations, licensing agreements, mergers and acquisitions, product development and / or commercialization agreements, process development agreements, clinical trial agreements, and other relevant deals. - Detailed profiles of the biorepositories across the globe that play an important role in developing cell lines and have also undertaken initiatives to limit the use of contaminated and / or misidentified cell lines. Each profile features a brief overview of the repository and its cell line characterization service portfolio. - An elaborate discussion on the requirements established by various regulatory authorities, across different regions, related to characterization of cell lines. In addition, it provides insights from the various guideline documents that have been issued by these bodies on protocols that need to be followed and general tips for the testing of cell lines. It also features a brief historical overview and discussion on the contributions of key institutes / organizations involved in this domain. - A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing cell line development and / or cell line characterization services.

One of the key objectives of the report was to estimate the existing market size and future growth opportunities for cell line development and characterization service providers. Based on multiple parameters, such as the number of projects completed annually, price of the projects, the overall R&D expenditure available to CROs and the overall growth of the biologics market, we have developed informed estimates on the financial evolution of the market over the period 2020-2030.

For cell line development services market, our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] sources of cell lines and expression systems (mammalian, microbial, insect and avian), [B] applications of cell lines (R&D operations and drug development), [C] company size (small, mid-sized and large) and key geographies (North America, Europe, Asia, Oceania and Rest of the World).

For cell line characterization services market, our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] sources of cell lines and expression systems (mammalian, microbial and others), [B] applications of cell lines (R&D operations and drug development), [C] type of service provider (industry players and non-industry players) and [D] key geographies (North America, Europe, Asia, Middle East & North Africa (MENA), Latin America (LATAM) and Rest of the World (RoW)). To account for the uncertainties associated with this industry and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the markets evolution.

The opinions and insights presented in this study were influenced by inputs solicited via a comprehensive survey and discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following industry stakeholders (in reverse chronological order): - Fai Poon (Founder and President, Quacell Biotechnology) - Louis Boon (Chief Scientific Officer, Polpharma Biologics) - Fan Chen (Former Vice President BioProcessing, LakePharma) - Michael Pointek (Founder and Managing Director, ARTES Biotechnology) - Nienke Smits (Client Relations Manager, Immunoprecise Antibodies) - Oscar Hoogteijling (Former Global Business Development Manager, Polpharma Biologics)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include - Annual reports - Investor presentations - SEC filings - Industry databases - News releases from company websites - Government policy documents - Industry analysts views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED - Who are the leading players offering cell line development services? - What kind of CDMO support is available for cell line development, across different regions? - What are the common sources, gene delivery methods, protein yield and affiliated services offered by the cell line development service providers? - Who are the leading industry and non-industry players offering cell line characterization services? - What are the most popular services offered for characterization of cell lines? - Which partnership models are commonly adopted by stakeholders in this industry? - How is the current and future opportunity likely to be distributed across key market segments? - What are the anticipated future trends related to cell line development and characterization market?

CHAPTER OUTLINES Chapter 2 is an executive summary of the insights captured in our research. The summary offers a high-level view on the likely evolution of the cell line development and characterization services market in the mid to long term.

Chapter 3 provides a general introduction to cell cultures and cell lines, including details related to various types of cell lines, based on their sources of origin, and key characteristics, applications and concerns associated with their use in drug development and research. The chapter also elaborates the recombinant and hybridoma cell line development process workflow. Further, it outlines the general concepts of cell line characterization along with a detailed description of different types of testing methods used for such purposes. In addition, it also presents the advantages and associated risks related to outsourcing of cell line development and characterization operations. In this chapter, we have briefly discussed the most common services offered by the service providers, along with cell line development and characterization services.

Chapter 4 provides an overview of the overall cell line development services landscape. It includes information related to over 220 contract service providers that are currently active in this domain. It features an in-depth analyses of the market, information on year of establishment, company size, location of headquarters, sources of cell lines and expression systems offered (mammalian, microbial, insect and avian), integrated cell line characterization, biosimilar cell line development and gene editing cell line development services offered, gene delivery method used (physical, chemical, biological and non-biological), type of gene expression (stable and transient), usage of serum-free / animal component free cell culture media, types of cell cultures (suspension and mixed growth properties), types of cells offered (recombinant, hybridoma and primary), applications of cell lines (R&D, biomanufacturing, diagnostics and cell therapy / regenerative medicine / tissue culture). In addition, the chapter includes information on additional cell line related services (bio-analytical / protein purification, cell banking, cell bank characterization, process development, GMP manufacturing and fill-finish), types of cell banks developed (master cell banks, working cell banks, research cell banks and end-of-production cell banks) and protein yield from cell lines.

Chapter 5 provides an insightful competitiveness analysis of the cell line development service providers that we came across during our research. The analysis compares the companies on the basis of supplier strength (experience of the service provider) and service portfolio strength (considering sources of cell lines and expression systems offered, availability of proprietary / licensed technology platform, type of gene expression and availability of additional cell line related services).

Chapter 6 features detailed profiles of some of the key players that are active in the cell line development domain. Each profile presents a brief overview of the company, its cell line development and complementary services portfolio, financial information (if available), recent developments and an informed future outlook.

Chapter 7 provides an overview of the overall cell line characterization services landscape. It includes information related to over 140 industry and non-industry contract service providers that are currently active in this domain. It features in-depth analyses of the market, based on a number of relevant parameters, such as year of establishment, company size, location of headquarters, types of cells handled (mammalian, microbial, insect and others), types of cell line characterization services offered (identity / stability testing, sterility / biosafety testing, expression testing and oncogenicity / tumorigenicity testing), types of cell line identity / stability testing services offered (analysis of cell morphology, cytochrome c oxidase 1 barcoding assay, DNA fingerprinting / profiling, gene copy number analysis, isozyme analysis, karyotype analysis, nucleic acid sequencing, southern blotting and viability testing) types of sterility / biosafety testing services offered (mycoplasma contamination testing, microbial contamination testing, viral / adventitious agents contamination testing, retroviral contamination testing and rodent virus testing / in-vivo biosafety testing), availability of other cell line related services (cell line development, cell banking and mycoplasma clearance service), information on regulatory accreditations / certifications and overall turnaround time. For non-industry players, the report features additional information on number of STR loci amplified, type of genotyping kit used and service fee charged.

Chapter 8 provides an insightful competitiveness analysis of the cell line characterization service providers that we came across during our research. The analysis compares the companies on the basis of supplier strength (in terms of experience of the service provider) and service portfolio strength (considering sources of cell lines and expression systems handled and size of the service portfolio).

Chapter 9 features detailed profiles of some of the key players that are active in the cell line characterization domain. Each profile presents a brief overview of the company, its cell line characterization services portfolio, financial information (if available), recent developments and an informed future outlook.

Chapter 10 features an in-depth analysis and discussion on the various partnerships that have been inked between the players in the cell line development and characterization market in the time period between 2015 and 2020 (till September). It includes a brief description of partnership models (such as technology platform utilization agreements, R&D collaborations, licensing agreements, mergers and acquisitions, product development and / or commercialization agreements, process development agreements, clinical trial agreements and other relevant deals) adopted by the stakeholders.

Chapter 11 features detailed profiles of the biorepositories across the globe that play an important role in developing cell lines and have also undertaken initiatives to limit the use of contaminated and / or misidentified cell lines. Each profile features a brief overview of the repository and its cell line characterization service portfolio.

Chapter 12 presents an elaborate discussion on the requirements defined by various regulatory authorities, across different regions, related to the characterization of cell lines. In addition, it provides insights from the various guideline documents that have been issued by these bodies on protocols that need to be followed and general tips for the testing of cell lines. It also features a brief historical overview and discussion on the contributions of key institutes / organizations involved in this domain.

Chapter 13 presents a comprehensive market forecast analysis, highlighting the likely growth of cell line development services market till the year 2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of sources of cell lines / expression systems (mammalian, microbial, insect and avian), applications of cell lines (R&D operations and drug development), company size (small, mid-sized and large) and key geographical regions (North America, Europe, Asia, Oceania and Rest of the World).

Chapter 14 presents a comprehensive market forecast analysis, highlighting the likely growth of cell line characterization services market till the year 2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of sources of cell lines (mammalian, microbial and others), applications of cell lines (R&D operations and drug development), type of player (industry and non-industry) and key geographies (North America, Europe, Asia, Middle East & North Africa (MENA), Latin America (LATAM), Rest of the World (RoW)).

Chapter 15 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. We have presented details of interviews held with Fai Poon (Founder and President, Quacell Biotechnology), Louis Boon (Chief Scientific Officer, Polpharma Biologics), Fan Chen (Former Vice President BioProcessing, LakePharma), Michael Pointek (Founder and Managing Director, ARTES Biotechnology), Nienke Smits (Client Relations Manager, Immunoprecise Antibodies) and Oscar Hoogteijling (Former Global Business Development Manager, Polpharma Biologics).

Chapter 16 presents insights from the survey conducted for this study. The participants, who were primarily Directors / CXO level representatives, helped us develop a deeper understanding on the nature of their services and their associated commercial potential.

Chapter 17 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario.

Chapter 18 is an appendix, which provides tabulated data and numbers for all the figures in the report.

Chapter 19 is an appendix, which provides the list of companies and organizations mentioned in the report.Read the full report: https://www.reportlinker.com/p06020735/?utm_source=GNW

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Cell Line Development and Characterization Services by Sources of Cell Lines / Expression Systems, Applications of Cell Lines, and Geography :...

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FDA Issues More Guidance on Gene and Cell Therapy Products – JD Supra

Posted: February 5, 2021 at 9:51 pm

January was a busy month for the US Food and Drug Administrations precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on manufacturing considerations for certain cellular and gene therapy products during the COVID-19 pandemic.

The agency first issued a draft guidance to facilitate the development of individualized antisense oligonucleotide (ASO) drugs for patients with severely debilitating or life-threatening genetic disorders (ASO Guidance). The Food and Drug Administration (FDA) also issued a guidance, with immediate effect, on manufacturing considerations for licensed and investigational cellular and gene therapy products during the COVID-19 public health emergency (Manufacturing Guidance). Sponsors investigating or marketing these products should pay special attention to the discussion in these documents, as FDA outlines its approach to COVID-19 and development considerations with respect to these personalized therapies.

The Manufacturing Guidance supplements FDAs June 2020 guidance on Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing. However, because cell and gene therapy (CGT) manufacturers may face special challenges, FDA recommends that CGT manufacturers perform risk assessments to identify, evaluate, and mitigate factors that may allow for the transmission of SARS-CoV-2 through CGT products. Any plans should take into account FDAs view that allogeneic products may be associated with a higher risk of infection compared to autologous products.

FDA specifically recommends the following:

As always, any adopted risk assessment and mitigation strategies must be documented and approved by the manufacturers quality unit, should include scientific justification and literature references, and should be submitted to FDA.

Turning away from the current COVID-19 crisis, FDA indicated that it is also looking ahead to the continued advancement of personalized therapies, issuing the ASO Guidance to assist sponsor investigators in the development of individualized ASO products for severely debilitating or life-threatening genetic diseases that are tailored to a patients specific genetic variant. As noted by FDA, the ASO Guidance is targeted to academic investigators, who may be less familiar with FDAs requirements and less experienced in interacting with FDA.

While the specific impetus for this guidance is unclear, assumedly FDA is receiving more inquiries regarding individualized ASO drugs from investigators, patients, or those acting on their behalf. Regardless of the reason, healthcare institutions where ASO products are used should familiarize themselves with FDAs requirements and processes to ensure that any use of an investigational ASO product accords with FDAs regulations. It will also be important that manufacturers supporting the use of ASO products or that later intend to work with ASO product investigators ensure that programs comply with FDAs regulations via contractual agreements and, as appropriate, due diligence.

For these programs, FDA recommends the following:

The ASO Guidance is likely a first step in the development of individualized therapies. As stated by FDA, the agency is optimistic that development of [ASO] individualized drug products may spur gene sequencing that leads to the development of additional individualized drug products. Accordingly, through the ASO Guidance, FDA aims to determine the most effective and efficient way to bring personalized drugs to patients, while ensuring the right risk-benefit balance.

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FDA Issues More Guidance on Gene and Cell Therapy Products - JD Supra

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Global T-Cell Therapy Market by Type of Therapy, Target Indications, Target Antigens, Key Players and Key Geographies Global Forecast 2020-2030 -…

Posted: February 5, 2021 at 9:51 pm

New York, Feb. 05, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global T-Cell Therapy Market by Type of Therapy, Target Indications, Target Antigens, Key Players and Key Geographies Global Forecast 2020-2030" - https://www.reportlinker.com/p06020739/?utm_source=GNW In fact, the global cancer burden is anticipated to increase by 70% in the next 20 years, exerting tremendous physical, emotional and financial strain on individuals, families, communities and health systems. Although efforts are being made to develop safe and effective drugs for the treatment of different types of cancer, there is still a pressing need for more specific and potent drugs / therapies to combat this complex, life threatening clinical condition. Amidst the current initiatives to develop more targeted anti-cancer therapies, T-cell therapies (specifically CAR-T, TCR and TIL therapies) have emerged as a promising option owing to their capability to eradicate tumor cells from the body with minimal treatment-related side effects. These adoptive T-cell therapies (ACT) are based on the principle of harnessing the innate potential of the immune system to target and destroy diseased cells. A number of chimeric antigen receptor T-cell (CAR-T) therapies, including KYMRIAH (Novartis), YESCARTA (Gilead Sciences) and TECARTUS (Gilead Sciences), have already been approved in the recent years validating the potential of such ACTs in cancer treatment. In addition to the industry stakeholders, more than 300 academic and research institutes, till date, have made significant contributions to this field, mostly by convening the initial research on potential therapy candidates. Prominent scientists, acting as key opinion leaders, are leading the clinical development efforts of more than 975 T-cell therapy candidates for the treatment of various oncological and non-oncological disorders. Several promising leads are anticipated to be commercially launched over the coming decade, following which the market is projected to grow at a substantial pace.

It is also worth highlighting that capital investments worth over USD 17 billion have been made by various private and public sector investors during the last five years to fund the product development activity. In addition, there have been close to 350 recently reported instances of collaborations between industry / academic stakeholders to advance the development of various pipeline candidates. The ongoing research activity in this field has led to the discovery of several disease-specific targets, such as CD19, BCMA, CD22, CD20 and meso. Driven by the availability of innovative technology platforms, lucrative funding and encouraging clinical trial results, the T-cell immunotherapies market is poised for success in the long-run as multiple product candidates are expected to be approved over the coming decade.

SCOPE OF THE REPORT The Global T-Cell (CAR-T, TCR, and TIL) Therapy Market (5th Edition) by Type of Therapy (CAR-T, TCR and TIL), Target Indications (Acute Lymphoblastic Leukemia, Non-Hodgkins Lymphoma, Melanoma, Bladder Cancer, Lung Cancer, Head and Neck Cancer, Multiple Myeloma, Sarcoma, Chronic Lymphocytic Leukemia, Ovarian Cancer, Esophageal Cancer, Colorectal Cancer, Nasopharyngeal Carcinoma, Hepatocellular Carcinoma, Acute Myeloid Leukemia and Renal Cell Carcinoma), Target Antigens (CD19, BCMA, CD19/22, EGFR, NY-ESO-1, gp100, p53, EBV, MUC1, WT-1 and others), Key Players and Key Geographies (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World) Global Forecast 2020-2030 report features an extensive study of the current market landscape and the future potential of T-cell immunotherapies. The report highlights the efforts of both industry players and academic organizations in this rapidly evolving segment of the biopharmaceutical industry. Amongst other elements, the report features the following: - A detailed assessment of the current market landscape of T-cell immunotherapies with respect to type of product (CAR-T, TCR and TIL), type of developer (industry / non-industry), phase of development (preclinical, phase I, phase I/II, phase II, phase III and approved), therapeutic area (hematological cancer, solid tumor and others), target therapeutic indication (non-Hodgkin lymphoma, acute lymphoblastic leukemia, multiple myeloma, brain cancer, acute myeloid leukemia, melanoma, lung cancer, ovarian cancer, liver cancer, pancreatic cancer, chronic lymphocytic leukemia, stomach cancer, breast cancer, sarcoma, mantle cell lymphoma, mesothelioma, colorectal cancer, bladder cancer and others), key target antigen (CD19, BCMA, CD22, CD20, Meso, GD2, CD38, CD123, CD30, HER2, GPC3, CD33 and CD13), source of T-cells (autologous / allogeneic), route of administration (intravenous, intratumor, intraperitoneal, intrapleural, intraventricular and others), dose frequency (single dose, multiple dose and split dose), patient segment (children, adults and seniors), and type of therapy (monotherapy and combination therapy). Further, the chapter provides a list of the most active players (in terms of number of pipeline candidates) and an insightful logo landscape, highlighting product developers in North America, Europe and the Asia Pacific. - Detailed profiles of marketed and mid- to late stage clinical products (phase I/II or above); each profile features an overview of the therapy, its mechanism of action, dosage information, details on the cost and sales information (wherever available), clinical development plan, and key clinical trial results. - An analysis of the CAR constructs of clinical-stage CAR-T therapies based on the generation of CAR-T therapy (first generation, second generation, third generation and fourth generation), type of binding domain (murine, humanized, fully human and rabbit derived), type of vector (lentivirus, retrovirus, mRNA and other vectors) and type of co-stimulatory domain used. - An analysis highlighting the key opinion leaders (KOLs) in this domain. It features a 22 matrix assessing the relative experience of KOLs shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field, and a schematic world map representation, indicating the geographical locations of eminent scientists / researchers involved in the development of T-cell therapies. - An analysis of the various CAR-T cell therapy focused clinical trials registered across the world, between 2009 and 2019, highlighting the year wise trend of initiation of such studies and distribution across different geographies. In addition, we have provided a detailed list of factors that have influenced the growth of CAR-T therapies, especially in China. - An overview of the various focus therapeutic areas of therapy developers, including an assessment of the opportunity (in terms of revenue generation potential from therapy sales) across oncological and non-oncological disease indications. - A detailed discussion on innovative technology platforms that are being used for the development of T-cell therapies, along with profiles of key technology providers, and a relative competitiveness analysis of different gene editing platforms (used for the development of T-cell therapies), based on various parameters, such as ease of system design, cost of technology, level of toxicity and efficiency of technology. - An analysis of the partnerships that have been established in the recent past, covering R&D agreements, license agreements (specific to technology platforms and product candidates), product development and commercialization agreements, manufacturing agreements, clinical trial collaborations, product supply management agreements, joint ventures and others. - An analysis of the investments that have been made into companies that have proprietary T-cell based products / technologies, including seed financing, venture capital financing, capital raised from IPOs and subsequent offerings, grants and debt financing. - A case study on other T-cell based therapies, apart from CAR-Ts, TCRs and TILs, including a detailed analysis of approved / pipeline products, featuring information on current phase of development, target therapeutic area(s), type of T-cells used and source of T-cells. - A case study on manufacturing cell therapy products, highlighting the key challenges, and a detailed list of contract service providers and in-house manufacturers involved in this space. - An elaborate discussion on various factors that form the basis for the pricing of cell-based therapies. It features different models / approaches that a pharmaceutical company may choose to adopt to decide the price of a T-cell based immunotherapy that is likely to be marketed in the coming years. - An analysis of the prevalent and emerging trends in this domain, as represented on the social media platform, Twitter, highlighting the yearly trend of tweets, most frequently talked about product candidates, popular disease indications, target antigens, and prolific authors and social media influencers. - A review of the key promotional strategies that have been adopted by the developers of the marketed T-cell therapies, namely KYMRIAH and YESCARTA.

One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for T-cell immunotherapies over the coming decade. Based on several parameters, such as target consumer segments, region specific adoption rates and expected prices of such products, we have developed informed estimates of the likely evolution of the market over the period 2020-2030. The report also includes likely sales forecasts of T-cell immunotherapies that have been already commercialized or are in the late stages of development. Additionally, it features market size projections for the overall T-cell immunotherapies market, wherein both the current and upcoming opportunity is segmented across [A] type of therapy (CAR-T, TCR and TIL), [B] target indications (acute lymphoblastic leukemia, non-Hodgkins lymphoma, melanoma, bladder cancer, lung cancer, head and neck cancer, multiple myeloma, sarcoma, chronic lymphocytic leukemia, ovarian cancer, esophageal cancer, colorectal cancer, nasopharyngeal carcinoma, hepatocellular carcinoma, acute myeloid leukemia, and renal cell carcinoma), [C] target antigens (CD19, BCMA, CD19/22, EGFR, NY-ESO-1, gp100, p53, EBV, MUC1, WT-1 and others) and [D] key geographies (North America (US and Canada), Europe (UK, Germany, France, Italy, Spain and rest of EU), Asia Pacific (China, Japan, Australia), Latin America, Latin America, Middle East and North Africa and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios namely the conservative, base and optimistic scenarios, which represent different tracks of the industrys evolution.

The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals: - Tim Oldham (Chief Executive Officer, Cell Therapies) - Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies) - Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR) - Miguel Forte (Chief Operating Officer, TxCell) - Adrian Bot (Vice President, Scientific Affairs, Kite Pharma) - Vincent Brichard (Vice President, Immuno-Oncology, Celyad) - Peter Ho (Director, Process Development, Iovance Biotherapeutics) - Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing) - Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys) - Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital) - Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado) - Patrick Dougherty (SVP, Strategy, Planning and Operations, Windmil Therapeutics)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include: - Annual reports - Investor presentations - SEC filings - Industry databases - News releases from company websites - Government policy documents - Industry analysts views

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

KEY QUESTIONS ANSWERED - What are the prevalent R&D trends related to T-cell immunotherapies? - What are the key therapeutic areas for which T-cell immunotherapies are being / have been developed? - What are the challenges faced by stakeholders engaged in this domain? - Who are the leading industry and non-industry players in this market? - In which geographies an extensive research on T-cell immunotherapy is being conducted? - Who are the key investors in this domain? - Who are the key opinion leaders / experts in this upcoming field of therapeutics? - What kind of partnership models are commonly adopted by industry stakeholders? - What kind of contract manufacturing support is available for T-cell therapies, across different regions? - What kind of promotional strategies are likely to be adopted for T-cell therapies that are approved and commercialized in future? - What are the factors that are likely to influence the evolution of this upcoming market? - How is the current and future market opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES Chapter 2 provides an executive summary of the insights captured during our research. It offers a high-level view on the likely evolution of the T-cell immunotherapy market in the short to mid-term and long term.

Chapter 3 provides a general overview of T-cell immunotherapies. In this section, we have briefly discussed the conventional forms of therapy that are being used for the treatment of various oncological indications. Further, it includes a discussion on the advent and historical evolution of cancer immunotherapy, general manufacturing procedure of T-cell immunotherapies, factors supporting the growing popularity of T-cell based therapies and the challenges associated with such therapies. Moreover, it features detailed sections on the three major types of T-cell immunotherapies, namely CAR-T, TCR and TIL-based therapies, which are the main focus of the study.

Chapter 4 provides insights on the popularity of T-cell immunotherapies on the social media platform, Twitter. The section highlights the yearly distribution of tweets posted on the platform in the time period 2012-2019, and the most significant events responsible for increase in the volume of tweets each year. Additionally, the chapter highlights the most frequently talked about product candidates, popular disease indications, target antigens, and prolific authors and social media influencers.

Chapter 5 includes detailed assessment on more than 975 T-cell immunotherapies that are currently approved or are in different stages of development. It features a comprehensive analysis of pipeline molecules with respect to the type of product (CAR-T, TCR and TIL), type of developer (industry / non-industry), phase of development (preclinical, phase I, phase I/II, phase II, phase III and approved), therapeutic area (hematological cancer, solid tumor and others), target therapeutic indication (non-Hodgkin lymphoma, acute lymphoblastic leukemia, multiple myeloma, brain cancer, acute myeloid leukemia, melanoma, lung cancer, ovarian cancer, liver cancer, pancreatic cancer, chronic lymphocytic leukemia, stomach cancer, breast cancer, sarcoma, mantle cell lymphoma, mesothelioma, colorectal cancer, bladder cancer and others), key target antigen (CD19, BCMA, CD22, CD20, Meso, GD2, CD38, CD123, CD30, HER2, GPC3, CD33 and CD13), source of T-cells (autologous / allogeneic), route of administration (intravenous, intratumor, intraperitoneal, intrapleural, intraventricular and others), dose frequency (single dose, multiple dose and split dose), patient segment (children, adults and seniors), and type of therapy (monotherapy and combination therapy). Further, the chapter provides a list of the most active players (in terms of number of pipeline candidates) and an insightful logo landscape, highlighting product developers in North America, Europe and the Asia Pacific. Chapter 6 presents a collection of key insights derived from the study. It includes a bubble analysis, highlighting the most popular targets of CAR-T and TCR therapies in hematological cancer and solid tumor space. To offer due credit to the work of eminent researchers in this domain, we have mapped the presence of key opinion leaders (who are involved in this field of research) across the globe. In addition, we have presented an analysis of the CAR constructs being used in the clinical CAR-T therapies on the basis of generation of CAR-T therapies (first generation, second generation, third generation and fourth generation), type of binding domain (murine, humanized, fully human and rabbit derived), type of vector (lentivirus, retrovirus, mRNA and other vectors) and type of co-stimulatory domain used.

Chapter 7 presents an analysis of the CAR-T clinical trials registered across the world, between 2009 and 2019, highlighting the year wise trend and the distribution across different geographies. In addition, we have provided a detailed list of factors that have influenced the growth of CAR-T therapies market in China.

Chapter 8 provides detailed profiles of marketed and mid to late stage CAR-T therapies (phase I/II or above). Each profile features an overview of the therapy, its mechanism of action, dosage information, details on the cost and sales information (wherever available), clinical development plan, and key clinical trial results.

Chapter 9 provides detailed profiles of the mid to late stage TCR therapies. Each profile features an overview of the therapy, its mechanism of action, dosage information, details on the cost and sales information (wherever available), clinical development plan, and key clinical trial results.

Chapter 10 provides detailed profiles of the mid to late stage TIL therapies. Each profile features an overview of the therapy, its mechanism of action, dosage information, details on the cost and sales information (wherever available), clinical development plan, and key clinical trial results.

Chapter 11 identifies the most commonly targeted therapeutic indications, including hematological cancers and solid tumors and features brief discussions on the T-cell therapies being developed against them. The section also highlights key epidemiological facts and the currently available treatment options for each indication.

Chapter 12 provides a list of technology platforms that are either available in the market or under designed for the development of T-cell immunotherapies. A detailed discussion on innovative technology platforms that are being used for the development of T-cell therapies, along with profiles of key technology providers, and a relative competitiveness analysis of different gene editing platforms (used for the development of T-cell therapies), based on various parameters, such as ease of system design, cost of technology, level of toxicity and efficiency of technology.

Chapter 13 features an elaborate discussion and analysis of the various collaborations and partnerships that have been inked amongst players in this market, in the past few years. Further, the partnership activity in this domain has been analyzed on the basis of the type of partnership model (R&D collaborations, license agreements (specific to technology platforms and product candidates), product development and commercialization agreements, manufacturing agreements, clinical trial collaborations, product supply management agreements and others), companies involved, type of therapy, prominent product candidates involved and regional distribution of the collaborations.

Chapter 14 provides details on the various investments and grants that have been awarded to players focused on the development of T-cell immunotherapies. It includes a detailed analysis of the funding instances that have taken place in the period between 2000 to 2020, highlighting the growing interest of venture capital (VC) community and other strategic investors in this domain.

Chapter 15 features details of other novel T-cell based therapies, apart from CAR-Ts, TCRs and TILs, which are currently being investigated. It presents a detailed analysis of the approved / clinical products in this domain, including information on current phase of development, target therapeutic areas, type of cells, and source of T-cells. Additionally, we have provided a brief overview of the upcoming therapies, along with details on their mechanisms of action.

Chapter 16 provides insights on cell therapy manufacturing, highlighting the current challenges that exist in this domain, and the pre-requisites for owning and maintaining cell therapy manufacturing sites. It includes a detailed list of various cell therapy manufacturers, covering both contract manufacturing organizations and companies with in-house manufacturing capabilities. For the players mentioned in the chapter, we have included details on location of various manufacturing facilities, the products being manufactured, scale of operation and compliance to cGMP standards.

Chapter 17 highlights our views on the various factors that must be taken into consideration while deciding the prices of cell-based therapies. It features discussions on different models / approaches that a pharmaceutical company may choose to follow to decide the price at which their T-cell based immunotherapy product can be marketed. Additionally, we have provided a brief overview of the reimbursement consideration for T-cell immunotherapies and a case study on the National Institute for Health and Care Excellence (NICE) appraisal of CAR-T therapy.

Chapter 18 features an elaborate discussion on the future commercial opportunity offered by T-cell therapies. It provides a comprehensive market forecast analysis for molecules that are approved or are in phase I/II, phase II and phase III of development, taking into consideration the target patient population, existing / future competition, likely adoption rates and the likely price of different therapies. The chapter also presents a detailed market segmentation on the basis of [A] type of therapy (CAR-T, TCR and TIL), [B] target indications (acute lymphoblastic leukemia, non-Hodgkins lymphoma, melanoma, bladder cancer, lung cancer, head and neck cancer, multiple myeloma, sarcoma, chronic lymphocytic leukemia, ovarian cancer, esophageal cancer, colorectal cancer, nasopharyngeal carcinoma, hepatocellular carcinoma, acute myeloid leukemia, and renal cell carcinoma), [C] target antigens (CD19, BCMA, CD19/22, EGFR, NY-ESO-1, gp100, p53, EBV, MUC1, WT-1 and others) and [D] key geographies (North America (US and Canada), Europe (UK, Germany, France, Italy, Spain and rest of EU), Asia Pacific (China, Japan, Australia), Latin America, Latin America, Middle East and North Africa and rest of the world).

Chapter 19 highlights the key promotional strategies that are being implemented by the developers of the marketed products, KYMRIAH and YESCARTA. The promotional aspects covered in the chapter include details that are provided on the product website (covering key messages for patients and healthcare professionals), patient support offerings and informative downloadable content.

Chapter 20 includes brief company profiles of the leading players in the T-cell immunotherapy market. Each company profile includes an overview of the developer and brief description of the product portfolio specific to CAR-T, TCR and TIL therapies, technology portfolio (if available), recent developments related to T-cell immunotherapies and manufacturing capabilities of the companies. Additionally, we have provided details of the strategic / venture capital investments made in these companies.

Chapter 21 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 22 is a collection of transcripts of interviews conducted with key stakeholders in the market. In this chapter, we have presented the details of our conversations with Tim Oldham (Chief Executive Officer, Cell Therapies), Wei (William) Cao (Chief Executive Officer, Gracell Biotechnologies), Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR), Miguel Forte (Chief Operating Officer, TxCell), Adrian Bot (Vice President, Scientific Affairs, Kite Pharma), Vincent Brichard (Vice President, Immuno-Oncology, Celyad), Peter Ho (Director, Process Development, Iovance Biotherapeutics), Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing), Aino Kalervo (Competitive Intelligence Manager, Strategy & Business Development, Theravectys), Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital), Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado) and Patrick Dougherty (SVP, Strategy, Planning and Operations, Windmil Therapeutics)

Chapter 23 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 24 is an appendix, which contains the list of companies and organizations mentioned in the report.Read the full report: https://www.reportlinker.com/p06020739/?utm_source=GNW

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Global T-Cell Therapy Market by Type of Therapy, Target Indications, Target Antigens, Key Players and Key Geographies Global Forecast 2020-2030 -...

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