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The Pediatrix and Obstetrix Medical Group Reports Surge in Critically Ill Pregnant Patients with the COVID-19 Delta Variant – Business Wire

Posted: October 5, 2021 at 7:45 pm

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--The Pediatrix and Obstetrix Medical Group, affiliates of Mednax, Inc. (NYSE: MD) and leading providers of maternal-fetal medicine (MFM) and obstetric (OB) services, reports that its affiliated clinicians are treating more pregnant women critically ill with COVID-19 than at any point in the pandemic. Pregnant patients remain largely unvaccinated, despite a strong endorsement from the Centers for Disease Control and Prevention (CDC), The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM).

Obstetrix comprises nearly 550 clinicians who provide specialized maternal care through 1,900 MFM visits and more than 400 attended deliveries daily in over 300 facilities across the country. The national network of MFM specialists, obstetrician-gynecologists and OB hospitalists are collaborating to share experiences and improve outcomes for critically ill pregnant women and their unborn babies.

Nationwide, we are seeing a troubling number of sick patients who have been adversely affected by the Delta variant, most of whom are unvaccinated, said Alan Fishman, M.D., MFM specialist and specialty medical officer. The patients we treat are high-risk to begin with, so to add severe COVID-19 infection on top of that, typically requiring hospitalization and sometimes admission into the intensive care unit for respiratory support, has resulted in some truly dire situations, including maternal death and premature birth.

As a leader in clinical research, Mednax-affiliated clinicians regularly publish studies related to the care of women and children. Early on in the pandemic, the research team studied the effect COVID-19 could have on pregnant women, and this continues to be monitored. The team has also examined the effects of COVID-19 on neonatal intensive care units. In addition, non-Mednax studies are regularly monitored and shared through multispecialty forums for clinician discussion.

A new study on COVID-19 severity in pregnant women in India shows that the Delta variant was identified in India as early as last December, said Reese Clark, M.D., vice president of clinical research for the Mednax Center for Research, Education, Quality and Safety. It swept rapidly through that country and Great Britain before reaching the U.S., where it is now the predominant variant. This report provides valuable insights about what we are seeing in our practices and allows us to anticipate adverse events and implement preventative strategies.

Mednax strongly supports the CDC, ACOG and SMFM vaccine recommendation. We urge all of our patients to get vaccinated, as early on in their care as those who are trying to conceive and not yet pregnant, said Brian Gilpin, M.D., OB hospitalist and specialty medical officer. The Delta variant is making pregnant women notably sicker, and severe illness is preventable. We now have the data that validates the safety of the vaccine, which also protects babies with vital antibodies. The risk of life-threatening complications from infection is far greater than the risk of vaccination.

To learn more about Mednaxs maternal-fetal and obstetric services, visit Obstetrix online. For the latest information about Mednax and womens and childrens health care topics, read the Mednax blog and follow us on Facebook and Twitter.

ABOUT MEDNAX

Mednax, Inc. is a national medical group comprised of the nations leading providers of physician services. Physicians and advanced practitioners practicing as part of Mednax are reshaping the delivery of care within their specialties and subspecialties, using evidence-based tools, continuous quality initiatives, clinical research and telehealth programs to enhance patient outcomes and provide high-quality, cost-effective care. The Company was founded in 1979, and today, through its affiliated professional entities, Mednax provides services through a network of more than 2,300 physicians in 39 states and Puerto Rico. Additional information is available at http://www.mednax.com.

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5 Common ER Visit in the Fall – Articles and Videos, Emergency Medicine, Featured, Health Topics – Hackensack Meridian Health

Posted: October 5, 2021 at 7:45 pm

September 30, 2021

As the seasons change and temperatures begin to drop, you may find yourself getting under the weather, and sometimes accidents do happen.

Beena Mathaikutty, M.D., MPH, director of the Emergency Department at Pascack Valley Medical Center, offers five of the most common reasons that people visit the emergency room during the fall season.

Upper respiratory diseases, colds and seasonal flu, oh my! Flu season is right around the corner, and typically lasts from October to May. With lingering COVID-19 variants, its even more important this year to get your flu shot. Avoid touching your mouth, nose and eyes with unwashed hands, and continue following the latest mask guidance.

Flu season can be especially challenging for children in school or daycare. This falland into the winterbe mindful of their hygiene habits to prevent them from bringing germs and viruses back home. Take the time to teach them to stay safe and healthy by washing hands and covering their mouths when coughing and sneezing. These preventative measures will help keep the whole family healthy, Dr. Mathaikutty says.

What seem like simple household chores can potentially cause you injury. A lot of people will prepare for the fall by raking leaves, doing yard work or preparing their homes for the winter, Dr. Mathaikutty says. Its essential to take caution with bending and heavy lifting as to avoid back spasms, sciatica or arthritis exacerbations. If you experience chest pain or shortness of breath while doing yard work, or during any other exertion, you should seek medical evaluation immediately.

Approximately 24 million Americans suffer from seasonal allergies, while about 25 million live with asthma. With the change in seasons, most people find themselves increasingly indoors, where things like dust and pet dander can aggravate the symptoms of these conditions. Dr. Mathaikutty says to be sure to continue taking any medication you have been prescribed to manage your symptoms. In addition, control indoor allergens by changing air filters often, vacuuming regularly and considering an air-purification device.

Slips and falls are one of the top reasons that send people to the emergency room year-round. Take extra steps to avoid letting your fun fall festivities turn into a trip to the hospital. People will be hiking and apple or pumpkin picking, so its ideal to wear the right gear to avoid falls, strains and sprains, Dr. Mathaikutty says. And if the weather is chilly, be sure you have on warm enough clothing.

To stay warm when temperatures drop, many people invest in space heaters for their home or gas-powered/kerosene heaters for their outdoor activities. Be careful when you are using these types of devices. If not used properly, heaters can cause burns and carbon monoxide poisoning. They can also potentially lead to fires, which can result in a life-threatening situation. As a part of your fall and winter home prep, install and maintain your carbon monoxide and smoke detectors.

Dr. Mathaikutty notes that during the fall and winter, the elderly typically do not go out as often. Be sure you are checking in on your elderly loved ones for their well-being during this time, she says. Many people also feel isolated or have seasonal affective disorder in the fall or winter, so checking in with your own mental health and seeking help if you need it is always important, too.

She says there is usually a decrease in physical activity in the fall and winter months, which can contribute to weight gain and a health decline. It is important to find other ways of staying active like exercising indoors and eating healthier, she recommends.

The material provided through HealthU is intended to be used as general information only and should not replace the advice of your physician. Always consult your physician for individual care.

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UPDATED: Merck’s oral COVID-19 antiviral slashes hospitalizations, prevents deaths in phase 3, sparking race to file with FDA – FierceBiotech

Posted: October 5, 2021 at 7:45 pm

The wait for an oral antiviral against COVID-19 may almost be over. Friday, Merck reported its prospect halved the risk of hospitalization and death in phase 3, spurring an early end to the study and a race to get emergency use authorization.

An effective oral treatment for mild to moderate COVID-19 is one of the big remaining gaps in the pandemic drug arsenal. Vaccines are stopping many people from developing symptomatic disease altogether, and treatment of severe COVID-19 has improved throughout the pandemic. But options for recently infected, high-risk people are limited to relatively expensive and logistically challenging anti-SARS-CoV-2 antibodies.

Molnupiravir could be a cheaper, oral way to stop people developing severe COVID-19. Merck, which is developing the drug with Ridgeback Biotherapeutics, has interim data from 762 mild to moderate patients who had at least one risk factor associated with poor disease outcomes.

In the molnupiravir cohort, 7.3% of participants were hospitalized or died through Day 29, compared to 14.1% of people who received placebo. There were eight deaths in the placebo group. None of the 385 recipients of molnupiravir died. Delta, gamma and mu variants accounted for almost 80% of the cases.

RELATED: U.S. injects $3B-plus into COVID-19 research to develop antiviral pill within a year

The strength of the efficacy data led the independent monitoring committee to recommend the trial be stopped early. Merck, in consultation with the FDA, has stopped enrollment in the trial. While the interim analysis took place halfway to the original recruitment target, the study was around 90% enrolled when Merck pulled the plug.

Merck is now racing to get the clinical data ready for submission to the FDA to support emergency use authorization. In parallel, the company is continuing to make molnupiravir with a view to being able to ship 10 million courses of treatment this year. The U.S. government has already placed an order for 1.7 million courses.

With the top-line safety data coming in clean, Merck looks well set to bring molnupiravir to market but is yet to share a detailed look at the results. The safety of molnupiravir will likely be scrutinized as it works differently from established antivirals, and the limited contribution of U.S. sites may be a point of discussion. Ex-U.S. countries accounted for 93% of participants, despite more than 30 of the 167 sites being located in the U.S.

Even so, the news sent Merck's shares skyward by nearly 10% to $82.43 around 10:22 a.m. ET on Oct. 1. Big Pharma shares tend to remain pretty stable, so a jump like this is notable.

RELATED:Pfizer tests oral COVID-19 antiviral for preventing infection in people living with patients

Merck's "impressivemolnupiravir data could help alter the course of the pandemic,"RBC Capital Markets analyst Brian Abrahams said.

"We believe that the availability of an effective oral drug that can be given in the outpatient setting can blunt the risks associated with breakthrough infections, and reduce mortality in the unvaccinated, which can begin to move the nation out of the pandemic and hasten reopening,"Abrahams said.

Merck is also working on a trial ofmolnupiravir as a preventative medicine with a read out sometime in the first half of 2022. This trial could help reduce the risk of exposure to COVID-19, especially for those who are immuno-compromised or healthcare workers,Abrahams noted.

Jefferies pointed out that Merck's results compare to existing antibodies, which achieve about a 70% reduction in hospitalization but are much more onerous to administer.

RELATED:Roche and Atea's small, early data peek sees experimental COVID drug slash viral load in hospital patients

Merck's results are also a good read through for Pfizer and Roche, which have oral COVID-19 treatments in the works, Jefferies added. Data is due for Pfizer's candidate by the end of the year while Roche is expected to drop data in the first half of 2022.

One odd side effect of an effective treatment for COVID-19 is that people could be less likely to get first vaccines or boosters, both Jefferies and RBC said. This could have a smalleffect down the road for Moderna.

Editor's note: This story was updated at 10:45 a.m. ET on Oct. 1 to include analyst commentary.

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Learn About Different Types Of Morning Glory For The Garden – vermontpressbureau.com

Posted: October 5, 2021 at 7:45 pm

Morning glories are a genus in the family Convolvulaceae. There are about 150 species of this genus, and many hybrids as well. The flowers have five petals that form an open star shape when they bloom.

Some people call them Mexican morning glories because these flowers were used by Aztecs for medicinal purposes as well as decoration in their rituals and ceremonies. This article will describe some of the most common types of morning glory, including sky blue, white, purple and pink varieties.

Also known as Ipomoea tricolor, the Mexican morning glory is a very well-known species of morning glory. Its scientific name means three colors, referring to its white, pink and purple petals forming an open star shape. It grows in thick clusters on vines that can reach up to 12ft long.

The stems of this plant have large leaves that can grow to 6 inches long with jagged edges. The flowers are tubular in shape and it has a yellow corona within the star of the flower that ranges from 5-20 mm (0.2 0.8 inches) in diameter depending on the variety. It only takes about 60 days for this plant to bloom and the blooms typically last in full color for just a few days.

Mexican morning glories are generally seen as an invasive plant because it is known to grow rapidly on other plants and can spread via seeds, but the Mexican government has been trying to control its growth by combating wildfires that would often occur during the dry season.

The name Ipomoea alba refers to the 6 white petals of this flower that form an open star shape. Although it comes from Mexico, it is now grown in different parts of the world, including South America and California. This flower does not have a thick stem or grow on vines; instead, its stems are thin and woody with smaller leaves that overlap each other. The flowers bear yellow seeds inside their pods when they bloom, but these natural seedpods can be dried and used to decorate flower arrangements. It takes about 2 months to bloom, and its petals will fall off after 48 hours of being in full color.

The Skyblue morning glory does not have a lot of commercial uses or benefits when compared to other types of morning glories, but their seeds are used as natural dyes for clothes and hair among certain groups of people. In addition, it has been seen that the flowers of this variety look very attractive when attached to hair in ponytails or pigtails.

The scientific name for purple morning glory is Ipomoea purpurea, and it is called such because of its dark purple petals forming an open star shape. This variety is the most common on North American soil with over 20 species within the genus. It grows in thick stems that can reach up to 150 centimeters (5 feet) long and has large leaves that are green with yellow veins. These flowers bloom in clusters, but they do not flower all at once. The purple morning glory is known to have a strong and unpleasant odor that can be smelled from afar.

This variety has beautiful dark red petals that grow on stems reaching up to 7 foot in height. It takes about 60 days for this plant to bloom, and it is commonly used as an ornamental plant due to its large size and striking appearance.

Because of its rapid growth rate, the purple morning glory is often seen as a weed that interferes with other plants, but it can be used as an ornamental plant as described above. In addition, the stems of this variety are often hollow and airtight when they are fresh. This means that purple morning glories are filled with oxygen that was produced by the photosynthesis process a few cuttings from the stem of this plant can be placed inside the shoes of people with foot issues or who have difficulty walking.

Seeds from the purple morning glory are known to be poisonous, but this is not a problem since they are normally removed before being eaten. In addition, the large leaves and stems can be used as a food source for livestock in need of some greens.

Blue Ridge morning glory is a variety of morning glory that is native to the Eastern United States. It has flowers with blue petals and white tips, but it can sometimes have pink or purple shades as well. The scientific name for this plant is Ipomoea turpethum. This type of morning glory grows on vines reaching up to 10 feet in length, and its stems are very thick.

The blue ridge variety blooms for over 6 weeks from June to August, but it can also bloom into the early fall season. The seeds of this plant are used as a spice in dishes like fried chicken or spicy sauces when they ripen. When these seeds are roasted before use, the seeds can be ground into a powder or crushed to use as a spice. The large leaves of this plant are also edible and are usually cooked before being eaten; they are known for having a strong flavor when consumed raw.

Blue Ridge morning glory is the best variety of morning glory in terms of medicinal benefits, since its stems contain many fibers that can be used as an organic fertilizer. This plant also contains chemicals that inhibit the growth of other plants, which means that dried and chopped stems released into the soil will prevent weeds from growing in a certain area.

Grandpa Otts morning glory is the best variety of morning glory when it comes to medicinal benefits, since it contains 10-hydroxy-pteroyloxazin-I acid (HPXA), which is an anticancer compound. In addition, the leaves and seeds of this plant are very good sources of electrolytes and protein.

This variety is commonly used as an ornamental plant in gardens, since it has red or purple flowers and is resistant to pests. It blooms from late spring through early fall, but the seeds need about 70 days before they are ready for planting. The scientific name for this plant is Ipomoea hederacea.

This variety of morning glory was named after a man called Grandpa Ott, who found and cultivated it on his farm in Louisiana. Grandpa Ott passed away recently at the age of 87, but this type of morning glory will live on forever because the scientific community has decided to name it after him.

The researchers who studied Grandpa Otts morning glory claim that it causes weight loss by stimulating chemical reactions in the body, which leads to fat being burned faster for energy. They also claim that the chemical HPXA can stimulate the immune system and ward off infections, as well as prevent birth defects. Only time will tell whether or not this information is true after more clinical trials are performed.

When picked fresh in early summer, Grandpa Otts morning glory has a bright red flower with purple tips on top. The plant can grow to be up to 3 feet in height, and its leaves are usually dark green with red or purple veins. It is resistant against many types of pests, but it does not have any substance that can inhibit the growth of other plants.

The seeds from Grandpa Otts morning glory are used for decorative purposes such as jewelry making. They can also be used to create painted art work and mosaics, which is why this plant is often called a living paintbrush by many artists.

Baby blue morning glory is the best variety of morning glory when it comes to medical benefits, since it contains a compound that can boost the immune system and make people feel stronger. It also contains many beneficial chemicals that have anti-inflammatory properties and can help people who suffer from asthma or allergies.

This plant has very low levels of calories, carbohydrates, and fats, which is why it has gained notoriety among people who want to lose weight.

Although this plant does contain a substance that can alleviate the symptoms associated with an allergic reaction, such as sneezing or runny nose, it will not prevent the same episode from occurring in the future. The scientific community acknowledges this fact, since they have determined that baby blue morning glory can only reduce the symptoms of an allergic reaction without preventing it from happening.

The leaves, stems, and roots of this plant are used to create medicines, although the entire plant can be used in some scenarios. The root is usually dried before being crushed into powder form for medicinal use.

The state of Illinois is known as the baby blue morning glory capital of the world because that is where most of these plants are grown. People from other states in the country tend to export this product to Illinois, and then local residents collect it for sale on a daily basis.

This variety of morning glory was developed by a woman named Connie Sue in the state of Tennessee. She created it in her own garden near an oak tree, which is why many people call it the double blue morning bloom under an oak.

The scientific community has not yet determined whether or not this strain of morning glory can increase the lifespan of human beings, but it is true that this plant grows faster than normal morning glories and produces a lot of flowers.

The leaves on Connie Sues double blue morning glory tend to be deep green in color with purple veins running through them. The flowers are typically light-blue and smell like candy. This plant can be used to create medicinal products, as well as art or jewelry.

A common use for this type of morning glory is to grow it on fences in order to conceal the existing fence while adding color and beauty. People who are unable to find the time to garden also benefit from growing this flower near their homes because it requires very little maintenance.

This variety of morning glory is usually blue to purple in color. Its flowers are small and appear similar to the other varieties found throughout North America, but mauve morning glories tend to be smaller than the average plant. It has a higher resistance against pests.

This plants leaves contain a very potent toxin that can poison humans. Some people have died after ingesting just one leaf because it contains enough poison to kill an adult human being.

This plants leaves and stems are used to create medicines that help people who suffer from asthma or allergies. However, some botanists believe it would be more effective to use mauve morning glories as a preventative medicine than as a curative one.

Mauve morning glories are often used as a preventative medicine for allergies and asthma. People who suffer from these conditions should consult with their doctor before trying mauve morning glory, however. This plant contains effective ingredients that can cure the symptoms associated with a severe allergic reaction or asthma attack, but it can also cause serious damage to human organs.

The root bulb on an improved white morning glory contains up to 78% more starch than the average morning glory. It is used to create medicinal products, as well as medicines that help people who suffer from diabetes or high blood pressure.

This plant can be difficult to grow in warmer climates because it needs a lot of water and sunlight. However, people who live in areas with an average temperature below 75 degrees Fahrenheit will enjoy growing improved white morning glories in their vegetable gardens.

Like most other varieties of morning glory, improved white morning glories are toxic to the touch and should never be handled by human beings without gloves on.

This plant is also known as double white. People who grow it often do so because it is more effective at curing a diabetics symptoms than other varieties. This plant can reduce the effects of diabetes, but it needs to be consumed in high quantities so its effects are felt by human beings.

Improved white morning glories usually grow up to ten inches tall and have a bloom period that typically lasts five weeks. During this time, they produce flowers that look similar to irises.

People who grow improved red morning glories believe it is easier to maintain than other varieties. Its blooms are typically crimson in color, but they do not appear as bright or vibrant as those on a typical Texas wildflower. Improved red morning glories also contain more starch than other varieties do.

This plant can grow up to three feet tall in some areas of the United States, but people who live in warmer climates might have difficulty growing it because it needs a lot of water and sunlight to survive. It is also difficult to maintain as a houseplant or inside an office building unless its owner has access to a large amount of indoor sunlight.

Improved red morning glories can be used to create jewelry or other trinkets that can be sold at local craft fairs throughout the state of Texas as well. People who intend to use it as an ornamental plant usually grow it on their front lawns or in other public spaces where it can be admired by others.

Improved red morning glories can also be used to create healing products that help people who suffer from diabetes or high blood pressure manage their symptoms. If you harvest the flower of an improved red morning glory after it has bloomed, then it will contain more starch than a typical mauve morning glory does.

This plant is toxic to the touch and should not be handled by human beings who are not wearing protective clothing. People should also wash their hands thoroughly if they happen to come into contact with an improved red morning glory while working in their vegetable gardens or when harvesting some of it for medicinal purposes.

Improved red morning glories usually grow up to twelve inches tall, but it is possible for them to grow up to twenty inches tall in some areas of the United States. Its bloom period typically lasts six weeks.

Pink morning glories are typically easy to grow because they require little maintenance and can adapt well to new environments. However, a person who attempts to grow them in a colder environment needs to know how to prepare the soil correctly so that it retains moisture long enough for these plants to survive.

If a person plants the seeds of a pink morning glory in soil that contains too much sand, then these seeds will not germinate. The most effective kinds of soil for growing this plant are those that contain lots of humus and other organic materials that can retain moisture as well as feed it to its roots.

Pink morning glories produce flowers that are typically pink in color, but they can also produce flowers that look white or violet from time to time. This is why the most common names for this plant are Morning Glory and Wake-Robin.

Pink morning glories need to be watered when the soil feels dry to the touch because it can wilt easily. If it is left in a puddle of water after its soil has become saturated, then the roots of this plant will rot.

Pink morning glories typically attract butterflies and other insects when they are healthy, so a person can place some of them around the garden to help with pollination. However, bumblebees might pollinate them too aggressively.

Morning Glories are climbing vines that bloom during the day and therefore they are flowers. They are also known as bindweed (because they wrap around their host plants) and scarlet climber. The name Morning Glory refers to their tendency to bloom as the sun rises; they are not related to the potato plant which is also called a Morning Glory.

Well, yes and no. They can be weeds if you consider them undesirable in your yard or garden. But they also have benefits: birds eat their seeds, people use them for medicinal purposes, and morning glories have been used as food. It depends greatly upon your point of view and how you would like your garden to look.

Morning Glory flowers come in white, blue, lavender, purple, pink or even red colors. The leaves are thick and veiny. They have large, heart-shaped leaves. The vines are green and wiry with small tendrils at the end of each leaf that help it climb.

Morning Glories dont usually grow as flowers in the ground. If you have morning glory growing in your ground, you dont need to remove it. It is spreading out by sending out seeds so if you decide to pull it up, you are essentially uprooting their seedlings.

Morning Glories grow best in moist, fertile soil and they do just fine without fertilizer. If you need to fertilize your morning glory, use compost or other organic materials.

Morning Glories can bloom all year but usually bloom in spring and summer depending on where you live. They also make good cut flowers.

Morning glories are beautiful flowers that anyone can grow. They are easy as long as you know how to take care of them. You really dont need to do anything else besides water them when the soil is dry and add some organic matter every now and then in order to make sure your morning glories stay healthy for a long time.

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Cell Therapy – Hoag

Posted: October 5, 2021 at 7:43 pm

Cell therapy is a type of immunotherapy, or immuno-oncology, where a patients own immune system helps fight and destroy cancer cells. Hoags Cell Therapy Program will conduct a number of cell therapy clinical trials, contributing to the development of promising new therapies for some of cancers most advanced diseases.

Hoag is the first hospital in Orange County to offer cell therapy for solid tumors.

Cell therapy at Hoag studies the use of NK cells, or natural killer cells. These cells are the first responders that help the immune system recognize cancer and initiate a large immune response, resulting in the development of antibodies to fight a patients cancer. These NK cells can stay active in the body much longer than traditional chemotherapy drugs.

NK cells are a type of lymphocyte (a white blood cell) and part of the innate immune system. NK cells play a major role in immunity again viruses and the immunity surveillance of tumors. NK cells express various types of immunoreceptors that are designed to detect changes in cells.

NK cell therapy is the newest immunotherapy, following the introduction of CAR T cell therapy. However, unlike CAR T cell therapy, NK cell therapy has shown to be less toxic, resulting in less side effects. NK cell therapy at Hoag is also used for solid tumors, as opposed to blood cancers, where CAR T cell therapy has typically been applied.

Immunotherapy in the treatment of cancer is here to stay. Cancer experts have seen a number of cell therapy trials that are now meaningfully expanding todays cancer therapeutics, said Burton Eisenberg, M.D., executive medical director, Hoag Family Cancer Institute and the Grace E. Hoag Executive Medical Director Endowed Chair. Hoag is joining the fight and pushing forward on some of the most deadly and challenging cancers to find new trials and therapies to provide new hope to our patients.

For more information on immunotherapy trials at Hoag, please call 866-257-6700 or email clinicalresearch@hoag.org.

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Cell Therapy Manufacturing Shifts to Automatic

Posted: October 5, 2021 at 7:43 pm

As the cell therapy industry continues to grow, it must face the challenge of creating products that are not only safe and effective, but also affordable. Currently, the prices for approved products ($0.42 million) are too high for most patients, largely because of labor costs, which account for about 50% of the cost of goods in cell therapy manufacturing.

Fully automated cell therapy manufacturing processes could significantly reduce manual intervention and human errors, supporting robust processes, improving product quality, speeding product delivery, and reducing costs. In this article, we will discuss how automated cell therapy manufacturing processes may be achieved with new bioreactor and sensor technologies.

Bioreactors are vessels that permit the careful control of parameters like pH, dissolved oxygen, and temperature to ensure that cells are optimized for cell growth. Bioreactors should culture cells at sufficiently large scales to address the need for cell therapies that can deliver 10810 cells/dose.

In 1944, de Becze and Liebmann created the first bioreactor for compressed yeast production. The first bioreactor designs were large stainless-steel tanks, the bases of which were connected to pipes that could introduce air. Subsequent designs introduced impellers that could facilitate mixing and air bubble dispersal. Eventually, designs were modified to address the requirements of the food and biopharmaceutical industries. For example, designs began to incorporate antiseptic features and real-time monitoring.

Today, various types of bioreactors with special features are commercially available. Bioreactors that are commonly utilized for cell manufacturing include rocking bed, stirred tank, packed bed, and rotating wall vessel bioreactors.

The most commonly used bioreactor for bioprocessing is the stirred tank bioreactor, which is capable of scaling to large volumes (maximum volume: 20,000 L) of cell culture. However, in the stirred tank bioreactor, cell cultures are homogenized using an impeller that turns so vigorously it can affect biological processes. For example, turbulent flows and large shear forces have been found to induce the undesirable, spontaneous differentiation of stem cells.

To minimize the effects of shear forces in bioreactors, researchers developed the rocking bed bioreactor. It uses wave-like motions to ensure low shear stress and to achieve efficient nutrient diffusion. Low shear stress, researchers have found, is crucial for maintaining high cell quality.

Another bioreactor that has similar advantages for culturing sensitive primary cell lines but typically in smaller volumes (<10 L) is the rotating wall vessel bioreactor. As the name suggests, the cells are cultured inside a vessel that is rotated to produce a free-falling state. However, this system requires a complex control system to create precise rotation speeds to induce a free-falling state for continually growing cell populations. For both rocking bed and rotating wall vessel bioreactors, scalability is a challenge.

The aforementioned bioreactors are suitable for culturing non-adherent cells such as immune cells for cancer immunotherapy, but when it comes to adherent stem cells, microcarriers are required. However, the need to completely remove dissolvable microcarriers in the later stages of bioprocessing can lead to technical challenges and regulatory difficulties. To avoid these problems, the packed bed bioreactor has been designed for scalable culture of adherent-dependent cells. For example, this kind of bioreactor has been used to culture muscle cells in synthetic meat applications.

In the packed bed bioreactor, cells are seeded on a fixed bed that consists of a hollow tube with immobilized surfaces such as scaffolds, microcarriers, or porous fibers. Fresh culture media can then continuously circulate within the system to supply oxygen and nutrients. Due to the large surface area, high-density cell culture and cost efficiency can be achieved. Culture media volumes can be smaller, and operations can be less troublesome. However, the high cell densities and difficulty in effectively introducing detachment supplements into the beds can make cell harvesting challenging.

Although the bioreactor types discussed thus far present advantages such as scalability and low shear stress, they all lack the kind of automation that can reduce labor expenses, lower contamination risks, and enhance compliance with Good Manufacturing Practices. Also lacking is automation that could leverage robotics technologies. If robotics could be integrated with modular bioreactors, it would be possible to accelerate and reduce the costs of cell manufacturing.

An example of an automated system is Miltenyi Biotecs CliniMACS Prodigy. It allows users to perform cell activation, transduction, and harvesting in a completely closed and turnkey fashion. Another example is Lonzas Cocoon, a modular cell therapy manufacturing platform. Technologies to automate bioreactors are being pursued not just by individual companies, but by industry consortia such as Autostem, a multidisciplinary mix of engineers, regenerative medicine scientists, and high-technology companies.

One of the greatest needs for cell therapy automation is in autologous manufacturing, says Gregory Russotti, PhD, chief technology officer at Century Therapeutics, a biotechnology company that develops natural killer and T-cell therapies derived from induced pluripotent stem cells. Since every patient requires his or her own batch in an autologous setting, there is no way to scale up processes to produce multiple doses for different patients in larger single batches. Better methods for scale-out are therefore required, in which parallel batches can be processed more efficiently.

One approach would be to automate the processes to reduce labor needs. Automated systems could be configured to process multiple batches at the same time, thereby improving processing efficiencies and driving down the cost of goods.

One of the challenges with designing automated systems for autologous processes is that different cell therapy developers use different processes; therefore, automated methods would need to be customized to each individual process. As the field matures, it is possible that cell therapy developers will converge on some of the process steps, potentially providing the opportunity for standardized automated systems.

Automating these platforms could help reduce the risk of contamination, adds Frank Barry, PhD, professor of cellular therapy at the National University of Ireland, Galway. There are two sources of contamination in the processing of tissue-derived cell productsthe tissue itself and the operators, Barry points out. He adds that most contamination events can be traced to operator actions, such as those involving breaches in the clean room environment. Contamination events due to operators could be reduced through the use of automated robots, which permit hands free procedures and which may be subjected to sterilization.

Automated bioreactor systems are usually designed for small-scale processes, such as the generation of immune cells for personalized cancer immunotherapies. The advantage of such systems is that the cells of individual patients can be manufactured in modular bioreactors. Small, modular, and automated bioreactors can be installed in hospitals rather than remote cell manufacturing factories. This can reduce logistical complexity due to double transportation of cells and minimize cell death due to long cryopreservation periods.

When attempting to enter the clinic, you should not overinvest in technologies or process scales that are not needed for Phase I studies, Russotti advises. Simpler systems at smaller scale will typically enable you to have your process ready for clinical studies more quickly.

However, you should be thinking ahead to what the commercial scale needs to be and have a strategy as to how you will change platforms (that is, bioreactor types) and scale-up your process so that you have a commercially viable process by the time it is needed. Taking this approach inevitably requires process changes which must be carefully planned to minimize the chance of comparability failures.

Sensors are installed in bioreactors to monitor key parameters like pH, temperature, and dissolved oxygen for quality control. One of the most common sensors utilized is the probe-based electrochemical sensor, which can be produced inexpensively and works by detecting changes in electrical potential due to chemical reactions. In general, probe-based sensors can take a wide range of measurements and deliver readings quickly. However, current sensors are typically large and invasive devices. Also, they are fragile and susceptible to electronic interference.

To minimize invasiveness and improve installation flexibility, optical chemosensor systems have been developed that can detect changes in optical properties such as photoluminescence intensity and absorption due to changes in analyte concentration. These systems comprise a light source, indicator dye, optical fiber, and a light detector. Disposable sensor patches can even be placed outside of a bioreactor to minimize the risk of contamination.

Other bioreactor sensors for quality control include spectroscopic sensors. They assess interactions involving molecular bonds and electromagnetic waves to measure key variables such as biomass and abundance of cell debris. Spectroscopic sensors are noninvasive and can measure multiple variables simultaneously with near instantaneous signal delivery. However, the measurements taken with these sensors can be compromised by scattered light. To avoid this problem, the sensors are used in glass reactors.

Unfortunately, most sensor technologies are probe based and incompatible with automated, closed-system, and single-use bioreactors. Moreover, apart from spectroscopic sensors, most sensors are designed to measure a single parameter. The use of multiple invasive sensors necessitates repeated exposure of bioreactor content to the environment, heightening contamination risk.

Multiple parameters can be monitored in real time, however, with capsule technology, which is a combination of autonomous sensor technology and wireless data transmission technology. With capsule technology, wireless sensors, or capsules, are presterilized and precalibrated before they are added to cell cultures, where they float freely. It is also possible to improve the accuracy and resolution of measurements by deploying multiple capsules within the bioreactor.

Automating the monitoring of cell processing will reduce costs, increase efficiency, and improve compliance with Good Manufacturing Practices. According to Mary Murphy, PhD, professor of regenerative medicine at the National University of Ireland, Galway, automated monitoring can allow technicians to control processes remotely. That is, a process occurring inside a facility can be controlled through computer interfaces that are located outside that facility.

Cell culture is one of the most resource-consuming steps of cell manufacturing, and it relies heavily on bioreactors for scalable cell production. Fortunately, bioreactors have come a long way since they were invented for compressed yeast fermentation. They now possess features such as rocking motion technology, which can minimize shear stresses while enhancing cell viability.

However, we can anticipate that the demand for cell-based therapeutic products will increase, and that we will need to automate cell culturing and sensing technologies. Doing so will allow us to rely less on human labor and more on robust processes that will, in turn, allow us to deliver innovative cell-based treatments to patients more quickly, safely, and affordably.

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Longeveron Successfully Advancing its Cell-Based Therapy …

Posted: October 5, 2021 at 7:43 pm

Research and development of stem cell-based therapies, where a patients own cells, or those from a donor, are used to fight injury and disease, is one of the fastest growing areas in the biotech space. Longeveron Inc. (NASDAQ: LGVN), a clinical-stage biotechnology company in the thick of clinical development, continues to advance its investigational therapeutic, Lomecel-B, for chronic, aging-related and life-threatening conditions.

The company recently announced the results of its randomized, blinded and placebo-controlled Phase 2 trial to evaluate the safety and efficacy of its proprietary Lomecel-B infusion in frail, older patients between 70 and 85 years old. The trial, which was partially funded by the National Institute on Aging, evaluated a single intravenous infusion of 4 different doses of Lomecel-B cell therapy compared to placebo on the change in the distance a person could walk in 6 minutes (a test known as the 6-minute walk test). Results showed that a single infusion of Lomecel-B resulted in an increase in walk distance of approximately 50 meters (164 feet) at 6 and 9 months after infusion, while the placebo-treated subjects showed minimal improvement at 6 months and a deterioration by 9 months.

Lomecel-B is a proprietary allogeneic product comprised of medicinal signaling cells (MSCs) from the bone marrow of adult donors, which are culture-expanded in Longeverons current good manufacturing practice cell-processing facility. According to trial results so far, Lomecel-B, and MSCs in general, may be injected or infused into an unrelated recipient without triggering a harmful reaction (rejection) due to the biochemical properties of these specialized cells. This is in part what makes this class of biologic so intriguing for use as a regenerative therapeutic.

A growing global trend is for biotech companies to direct their services to the cell and gene therapy industry and moving to expand into a new branch of the pharmaceutical contract development and manufacturing organization world.

The U.S. Food and Drug Administration (FDA) has approved a small number of cell and gene therapy drugs. Still, a new product pipeline is fighting for the agencys attention with approximately 1,200 experimental therapies more than half in Phase 2 clinical trials. The annual sales growth estimates for cell therapies are projected to reach 15%.

Longeveron has also initiated a Phase 2 trial evaluating the safety and efficacy of Lomecel-B injection into the heart of children born with hypoplastic left heart syndrome (HLHS), a rare and often fatal congenital heart defect.

Longeveron believes that using the same cells that promote tissue repair, organ maintenance and immune system function can develop safe and effective therapies for some of the most challenging diseases and conditions associated with aging.

We continue to make steady progress advancing our Lomecel-B clinical research programs forward, Longeveron CEO Geoff Green said. We have encouraging top-line results from our Aging Frailty program, and anticipate initiating a Phase 2 trial in Alzheimers disease later this year.

Longeveron shared their review of the Aging Frailty trial data with independent frailty experts, with the objective of planning the next steps for the program. The company presented clinical data at the 2021 International Conference on Frailty & Sarcopenia Research on Sept. 29 during a round-table presentation.

Learn more about Longeveron at http://www.longeveron.com.

2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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Longeveron Successfully Advancing its Cell-Based Therapy ...

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Cell and gene therapy: Biopharma portfolio strategy | McKinsey

Posted: October 5, 2021 at 7:43 pm

The potential importance of cell and gene therapy (CGT) to healthcare and the biopharma industry seems clear. CGT accounts for just 1 percent of launched products in major markets, with treatment of the vast majority of diseases still using small-molecule drugs. Yet those productswhich include cell therapies, such as chimeric antigen receptor (CAR) T-cell therapy for aggressive B-cell lymphomas, and gene therapiesto treat a range of monogenic rare diseaseshave proved transformative for patients. And there are many more in development. As of February 2020, CGT products account for 12 percent of the industrys clinical pipeline and at least 16 percent of the preclinical pipeline, but as most manufacturers do not disclose their preclinical assets, the true figure may be considerably higher (Exhibit 1).

Exhibit 1

New CGT products will surely emerge from this pipeline upon the continuing discovery of indications that CGT can address and the growing industry understanding of the genetic drivers and determinants of more complex, multifactorial diseases. Indeed, the pace of CGT-asset development is similar to that of monoclonal-antibody (mAb) assets in that modalitys early years, and mAb therapy went on to transform the biopharma market (see sidebar, Cell and gene therapy: Mirroring monoclonal-antibody therapy).

Exciting clinical results are helping to propel this pace. Success rates for CGT products are higher than those for small-molecule products, probably because CGT tends to target specific disease drivers rather than the broad targets (with potential for off-target effects) of small-molecule therapy. The sample size of launched CGTs is small, so comparisons may change as the market evolves. Nevertheless, there is a marked difference thus far. Between 2008 and 2018, the R&D success rate from Phase I to launch for small-molecule products was 8.2 percent; for CGT products, it was 11 percent.

Recognizing CGTs potential, 16 of the worlds largest (by revenue) 20 biopharmacos now have CGT assets in their product portfolios. Yet most companies are moving cautiouslyonly two of the top 20 have CGT assets making up more than 20 percent of their pipelines. They are still considering whether, when, and how to reposition their portfolios. In the meantime, biotech companies remain leaders in CGT innovation.

As of February 2020, only a small percentage of launched CGT assets either originated from or are owned by a top 20 biopharmacoin both cases, only 15 percent of launched assetsindicating how much opportunity there is for such companies to increase their exposure to CGT assets (Exhibit 2).

Exhibit 2

The figures are not altogether surprising, given that biopharmacos expertise often lies in disease areas, not in the development of the technology platforms that generate CGT products. More often than not, the original research behind new platforms is conducted by academics (who go on to set up their own biotech companies) and investors (whose models include company origination because of the potential financial gains and the concentrated technical risk that platform investments carry). Venture-capital firms are more comfortable than established biopharmacos with such risks.

Nevertheless, given the growth potential of CGT and the promise it holds for patients, most large biopharmacos are considering increasing their presence in the market. This article is intended to help guide their decisions, describing the key considerations when assessing investment opportunities and the various entry strategiesas well as the trade-offs to be made when choosing among them.

There are many technology platforms in development that seek to address different challengesassociated with CGT. In cell therapy, work is afoot to improve the manufacture of autologous therapies to reduce the cost of goods sold or vein-to-vein time, enable breakthrough efficacy in solid tumors, and improve the patient or customer experience. In gene therapy, there are investment opportunities in platforms that aim to overcome the limitations of current vectors (such as the size of the transgene, suboptimal tropism, or the triggering of an immune response) that enable nonviral delivery methods, reduce manufacturing costs, and expand manufacturing capacity.

The decision, therefore, is about not only whether to increase investment in CGT but also which technology platforms or assets to back. Companies should thus assess each investment opportunity by both strategic fit and technology attractiveness. Strategic considerations on a CGT platform or asset include whether it complements a companys disease areas of focus, the internal pipeline would benefit from diversification with new modalities, and the company has the required capabilities, capital, and conviction.

A host of questions need to be asked to gauge the attractiveness of the technology. Has it demonstrated proof of concept? What risks remain? Does the company have enough understanding of the underlying mechanisms? Does the technology enable first-mover advantage? What are the intellectual-property considerations? Is the platform differentiated from competing platforms? And given the rapid pace of innovation in CGT, what is the risk that the technology platform quickly becomes obsolete?

CAR T-cell therapy, whereby a patients T cells are genetically engineered to express a chimeric antigen receptor that targets a specific tumor antigen, illustrates the potential risk. In a relatively short time, the field has progressed from an initial set of constructs to a second generation that has given rise to two FDA-approved products, YESCARTA and KYMRIAH, even as third- and fourth-generation products are in development.

Investment opportunities that have a strong strategic fit and high-potential technologythose that fall into the top-right quadrant shown in Exhibit 3will be attractive. For example, a CAR T-cell or T-cell-receptor platform would fall in the top right for many oncology-focused companies. In the absence of such opportunities, those in the top-left or bottom-right quadrants may still be worthwhile as a means of gaining exposure to CGT, perhaps through an early-stage investment. For example, next-generation, unproven gene-editing technologies may fall in the bottom-right quadrant for companies focused on rare diseases with known genetic drivers. Companies would have to be prepared to tolerate the associated risks, however, and not all will conclude that now is the time to make a move.

Exhibit 3

Once a manufacturer has decided that it makes strategic sense to invest in CGT and has identified an attractive technology, it must choose an entry strategy. There are three main options: build a proprietary platform, buy an existing platform or one or more of its assets, or form a partnership to gain access to assets on platforms developed by others (Exhibit 4). The three options have different profiles in the capital required, changes to the operational model needed, and risk (as measured by the degree of diversification offered across different technologies).

Exhibit 4

Companies that build a platform or platforms from scratch enjoy full control over development efforts and retain all the financial rewards of successful assets. They also get the chance to build their own CGT capabilitiesscientific, clinical, and commercialand have the freedom to adapt as the technology evolves. In return, they have to commit significant resources to internal R&D and will, in effect, be placing big, early bets on a single or very limited number of platforms. Additionally, they may need to make significant changes to operating models designed for traditional modalities.

Buying a developed platform or late-stage asset carries less technical risk (assuming robust early data), though invariably a price premium too. This means that few, if any, companies will be able to acquire a large number of them, so companies continue to bet on a single or limited number of platforms.

The third optionforming a partnership to gain access to assets on platforms that others have developedlies between these two extremes in investment cost and risk. Because partnerships in the still-nascent CGT sector are relatively cheap, biopharmacos can afford to spread their bets on where future success might lie through establishing several partnerships.

Accordingly, most biopharmacos to date have followed the partnership route when placing a stake in CGT. Between 2010 and 2014, there were a total of 16 M&A deals in the CGT space. That rose to more than 60 between 2015 and 2019. However, even in 2019, when M&A activity was strongest, partnerships accounted for more than 80 percent of total transaction activity (Exhibit 5).

Exhibit 5

Nearly all of the top 20 biopharmacos have formed at least one partnership, while ten have made an acquisition. Just one has built its own platform. Exhibit 6 details this, along with the impact that the deals have had on the composition of company pipelines.

Exhibit 6

Partnerships come in three main varieties: those that give a biopharmaco access to a single asset, those that give it access to all assets in selected therapeutic areas that might emerge from a platform, and those that give it access to all platform assets, regardless of the therapeutic area or indication.

Partnerships structured to give a biopharmaco access to a single asset are the simplest way to enter the CGT market and are often chosen by companies that have a strong focus on certain indications and believe that their competitive advantage lies in owning multiple therapies across modalities in that space. A single-asset partnership also minimizes the investment required. However, this kind of partnership may leave a biopharmaco having to introduce a new operating model for a single asset.

Partnerships structured to give a biopharmaco access to all assets from a platform in certain therapeutic areas can help companies with a strong strategic focus on a given therapeutic area strengthen their portfolios and build more expertise in that area. In addition, more assets in a new modality means more opportunity to build the relevant development and commercial expertise.

The third option, partnering to win access to all the assets in a particular modality generated by a platform, tends to be the partnership of choice for biopharmacos that believe future competitive advantage lies in access to the best technology, no matter what may be the associated indication or therapeutic area. Through such a partnership, a company can follow the science, developing the technology for the indications in which it can provide the most clinical benefit. Such a strategy requires more investment than other forms of partnership, however, and so carries more concentrated technology risk. Companies may also find themselves developing products for therapeutic areas in which they have no expertise and thus are at a competitive disadvantage.

In addition to these three kinds of partnerships with biotech companies, some biopharmacos are considering more innovative ways to allocate their limited resources across multiple CGT technologies in a manner that also boosts their chances of keeping pace with rapid innovation. By partnering with venture-capital firms or biotech originators to launch new assets, new platforms, or even new companies or by collaborating with large academic institutions to license multiple new technologies, they are making much earlier-stage bets on where future success might lie.

The CGT era is an exciting one for healthcare, and all biopharmacos will want to reassess their portfolio strategies to decide whether and to what extent to diversify their pipelines. Most big biopharmacos have chosen partnerships to explore CGT initially, though the likelihood is that many will use a combination of strategies to increase their exposure and access to several technologies as the market evolves. Yet whether a company is still testing the water or is ready to commit, it will need to think carefully about how it builds its exposure to the CGT market and be fully aware of how to assess each investment opportunity, the range of possible entry strategies, and the different advantages and risks that each carries.

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Global Gene and Cell Therapy (GCT) Markets, 2016-2020 …

Posted: October 5, 2021 at 7:43 pm

Dublin, Oct. 05, 2021 (GLOBE NEWSWIRE) -- The "Global Gene and Cell Therapy (GCT) Market - Analysis By Vector, Application, By Region, By Country (2021 Edition): Market Insights, Pipeline, Forecast with Impact of COVID-19 (2021-2026)" report has been added to ResearchAndMarkets.com's offering.

The Global Gene and Cell Therapy (GCT) Market is estimated at USD 2504.2 Million in the year 2020

Growth in the historic period in the cell and gene therapy market resulted from increase in investments in cell and gene therapies, growth in research and development, advances in cancer drug discovery, rise in public-private partnerships, strong economic growth in emerging markets, increased healthcare expenditure, and rising in pharmaceutical R&D expenditure.

Companies in the gene and cell therapy for oncology market are increasing their product innovation through strategic collaborations. To sustain in the increasingly competitive market, organizations are developing innovative products as well as sharing skills and expertise with other such enterprises.

While oncology drug companies have long collaborated with each other as well as with academic and research institutions in this market by way of partnerships, in or out licensing deals, this trend has been increasing over the recent years.

Further, the market was restrained by inadequate reimbursements, challenges due to regulatory changes, low healthcare access, and limited number of treatment centers.

Going forward increasing prevalence of cancer and chronic diseases, rising geriatric population, rising geriatric population, rising focus on cell and gene therapy, and rise in healthcare expenditure will drive the growth in the gene and cell therapy market.

Factors that could hinder the growth of the market in the future include high costs of therapy, stringent regulations, reimbursement challenges, and coronavirus pandemic.

The report tracks competitive developments, strategies, mergers and acquisitions and new product development. The companies analysed in the report include F. Hoffman-La Roche Ltd., Novartis, Sanofi, Alnylam Pharmaceuticals Inc., Pfizer, BlueBird Inc., Sarepta Therapeutics, Voyager Therapeutics, Orchard Therapeutics Plc, AnGes Inc.

Story continues

Key Topics Covered:

1. Report Scope and Methodology1.Report scope & Methodology1.1 Scope of the Report1.2 Research Methodology1.3 Executive Summary

2. Strategic Recommendations

3. Gene and Cell Therapy Market: Product Outlook

4. Global Gene and Cell Therapy Market: Sizing and Forecast4.1 Global Gene and Cell Therapy Market Size, By Value, Year 2016-2026

5. Global Gene and Cell Therapy Market Segmentation - By Vector, By Application5.1 Competitive Scenario of Global Gene and Cell Therapy Market: By Vector5.1.1 Lentivirus - Market Size and Forecast (2016-2026)5.1.2 AAV - Market Size and Forecast (2016-2026)5.1.3 Retrovirus & Gammaretrovirus - Market Size and Forecast (2016-2026)5.1.4 Others - Market Size and Forecast (2016-2026)5.2 Competitive Scenario of Global Gene and Cell Therapy Market: By Application5.2.1 Oncology - Market Size and Forecast (2016-2026)5.2.2 Neurological Disorders - Market Size and Forecast (2016-2026)5.2.3 cardiovascular disorders - Market Size and Forecast (2016-2026)5.2.4 Others - Market Size and Forecast (2016-2026)

6. Global Gene and Cell Therapy Market: Regional Analysis6.1 Competitive Scenario of Global Gene and Cell Therapy Market: By Region

7. North America Gene and Cell Therapy Market: An Analysis (2016-2026)7.1 North America Gene and Cell Therapy Market: Size and Forecast (2016-2026), By Value7.2 North America Gene and Cell Therapy Market - Prominent Companies7.3 Market Segmentation By Vector (Lentivirus, AAV, Retrovirus & Gammaretrovirus and Others)7.4 Market Segmentation By Application (Oncology, Neurological Disorders, cardiovascular disorders and Others)7.5 North America Gene and Cell Therapy Market: Country Analysis7.6 Market Opportunity Chart of North America Gene and Cell Therapy Market - By Country, By Value, 20267.7 Competitive Scenario of North America Gene and Cell Therapy Market: By Country7.8 United States Gene and Cell Therapy Market: Size and Forecast (2016-2026), By Value7.9 United States Gene and Cell Therapy Market Segmentation - By Vector, By Application (2016-2026)7.10 Canada Gene and Cell Therapy Market: Size and Forecast (2016-2026), By Value7.11 Canada Gene and Cell Therapy Market Segmentation - By Vector, By Application (2016-2026)

8.Europe Gene and Cell Therapy Market: Segmentation: An Analysis (2016-2026)

9.Asia Pacific Gene and Cell Therapy Market:: An Analysis (2016-2026)

10.Global Gene and Cell Therapy Market Dynamics10.1 Drivers10.2 Restraints10.3 Trends

11.Market Attractiveness11.2 Market Attractiveness Chart of Global Gene and Cell Therapy Market - By Vector, 202611.3 Market Attractiveness Chart of Global Gene and Cell Therapy Market - Application, 202611.4 Market Attractiveness Chart of Global Gene and Cell Therapy Market - By Region, 2026

12.Competitive Landscape12.1 Major Technological Innovations, Mergers & Acquisitions and Role of Manufacturers12.2 Product Pipeline of Leading Gene Therapy Companies12.3 Market Share Analysis

13.Company Analysis13.1 F. Hoffman-La Roche Ltd.13.2 Novartis13.3 Sanofi13.4 Alnylam Pharmaceuticals Inc.13.5 Pfizer13.6 BlueBird Inc.13.7 Sarepta Therapeutics13.8 Voyager Therapeutics13.9 Orchard Therapeutics Plc13.10 AnGes Inc.

For more information about this report visit https://www.researchandmarkets.com/r/7ixaxq

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Global Gene and Cell Therapy (GCT) Markets, 2016-2020 ...

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FDA-approved CAR T-cell Therapies | UPMC Hillman

Posted: October 5, 2021 at 7:43 pm

Chimeric antigen receptor (CAR) T-cell therapy is a type of immunotherapy that uses a patients own genetically modified T cells to find and kill cancer. UPMC Hillman Cancer Center currently offers two types of FDA-approved CAR T-cell therapy.

UPMC Hillman Cancer Center was one of the first in the United States certified to provide ABECMA (idecabtagene vicleucel) for adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an antidCD38 monoclonal antibody.

Hillman was the first of 10 centers in the United States to offer BREYANZI (lisocabtagene maraleucel), an FDA-approved CAR T-cell therapy for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including:

UPMC Hillman Cancer Center is the first in western Pennsylvania to provide TECARTUSTM (brexucabtagene autoleucel), an FDA-approved CAR T-cell therapy for patients with relapsed or refractory mantle cell lymphoma.

UPMC Hillman Cancer Center is part of the network of certified treatment centers providing KYMRIAHTM(tisagenlecleucel), an FDA-approved CAR T-cell therapy for:

UPMC Hillman Cancer Center is the first center in western Pennsylvania providing YESCARTATM (axicabtagene ciloleucel), the first FDA-approved CAR T-cell therapy for adult patients with certain types of B-cell lymphoma.

The FDA has approved this treatment for patients with the following conditions that have either not responded to or have relapsed following two or more lines of systemic therapy:

Patients will undergo an extensive evaluation to determine their eligibility for this highly specialized treatment. To learn more, please call 1-833-UPMC-CART.

Patients who are approved for CAR T-cell therapy will undergo the following treatment process:

To refer a patient for evaluation for one of these clinical trials, please call 1-833-876-2227 (1-833-UPMC-CART).

If you think you might be a candidate for one of these clinical trials, please call 1-833-876-2227 (1-833-UPMC-CART).

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FDA-approved CAR T-cell Therapies | UPMC Hillman

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