UC Davis and Orgenesis Partner to Increase Access to Cell and Gene Therapies in California



UC Davis and Orgenesis Inc. today announced an agreement to implement Orgenesis Mobile Processing Units and Labs™ (OMPULs™) at multiple medical and academic institutions within the University of California. These OMPULs provide on-site development and manufacturing of cell and gene therapies, help reduce development costs, and increase access to therapeutics.

UC Davis is home to one of the largest Good Manufacturing Practice campus facilities in the United States

“We are very excited to move forward with this collaboration with Orgenesis,” said Jan Nolta, director of the UC Davis Stem Cell and Gene Therapy Center Program at the UC Davis Health Institute for Regenerative Care. “OMPULs will enable broader access to promising cell and gene therapies for patients in different regions of California, improving affordability and reducing health care disparities.”

The collaboration is the first step in bringing affordable therapies to patients in California. Defines a step-by-step approach to deploy and manage OMPUL using the Point-of-Care (POCare) services platform to produce cell and gene therapies on-site for clinical trials and hospital therapies.

UC Davis Health joined the Orgenesis POCare Network in 2020. It has used the platform to develop and deliver cell and gene products and therapies.

Access to cell and gene therapy through on-site manufacturing

Over the past three decades, the field of cell and gene therapies has transformed, with applications expanding every year. One example is chimeric antigen receptor T (CAR T) cell therapies. These have evolved from being experimental in 2012, with therapies available in only a few specialized academic centers, to FDA-approved marketed therapies now available to more patients.

CAR T cells are applied as first-line therapies to treat hematologic malignancies (blood cancer disorders). They give thousands of patients hope that their immune systems can be trained to successfully fight their lymphomas or leukemias for the rest of their lives.

“CAR T cell therapies are currently the best known cell and gene therapies,” said Gerhard Bauer, director of the Good Manufacturing Practice facility at UC Davis. “What is still missing, however, are CAR T-cell therapies that are widely available and affordable, so all patients, no matter where they are, could receive such curative treatments.”

UC Davis worked with Orgenesis on a paradigm shift to address these accessibility issues. Instead of a few large manufacturing centers, mobile cell manufacturing and gene therapy units will be able to deliver CAR T cell products to patients in locations far from major universities or medical centers.

Jan Nolta

OMPULs will enable broader access to promising cell and gene therapies for patients in different regions of California, improving affordability and reducing health care disparities. Jan Nolta, director of the stem cell program and gene therapy center at the Institute for Regenerative Care

The new partnership includes the creation and validation of the first OMPUL at UC Davis. This step would be followed by the commercialization and installation of OMPUL at other healthcare sites in California.

“We believe this partnership between Orgenesis, UC Davis and the University of California will become a model for decentralizing the development and manufacturing of cell and gene therapies while demonstrating the benefits of our OMPUL project for the US and international healthcare markets.” said Vered Caplan, CEO of Orgenesis. “Our shared goal is the widespread development of life-saving therapies for patients with a range of conditions, at a cost that can be borne by taxpayers and society at large.”

Stamina cells
The collaboration will help bring affordable gene and cell therapies to more patients in California

Morgenesis LLC., subsidiary of Orgenesis’ POCare service, will install OMPULs.

“Quality products for the treatment of blood cancers will become more available. The production will be carried out by highly qualified personnel and supervised by a centralized and sophisticated quality control unit, just like in large production centers,” said Bauer. “With OMPULs, it is possible to avoid cell storage and product shipping and reduce product production time. This leads to cost savings by making therapies more affordable and available to more patients.”

The new agreement with Orgenesis follows the renewal of an $8 million grant to UC Davis Health’s Alpha Stem Cell Clinic from the California Institute for Regenerative Medicine (CIRM). The grant allows the clinic to expand its clinical trial operations and advance toward on-site manufacturing of therapies.

Learn about the UC Davis Stem Cell Program

UC Davis’ Stem Cell program brings together physicians, researchers, biomedical engineers, and a range of experts and partners at its Institute for Regenerative Cures. The $62 million facility located on the University of Sacramento campus was supported by the California Institute for Regenerative Medicine (CIRM). It is the hub for team-driven, collaborative science that is driving breakthrough discoveries designed to bring stem cell therapies and cures to patients around the world. Learn more about the CIRM-funded Alpha Clinic at UC Davis Health.

About the Gene Therapy Center

The UC Davis Gene Therapy Center provides a unique, comprehensive, and well-established interdisciplinary network of experts and resources to lead the field of gene therapy through research, manufacturing, education, and policy. It offers expertise and state-of-the-art facilities and equipment, including one of the largest university Good Manufacturing Practice (GMP) facilities and a Viral Vector Core. Learn more about the Gene Therapy Center.

About Orgenesis

Orgenesis is a global biotechnology company working to unlock the full potential of cell and gene therapies (CGT) in an affordable and accessible format at the point of care. The POCare network brings together patients, physicians, industrial partners, research institutions and hospitals from around the world to achieve harmonized and regulated clinical development and manufacturing of therapies. Learn more about Orgenesis.

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Parkinson’s Foundation Receives Robert W. Woodruff Foundation Grant to Increase Access to Genetic Research in Georgia

Parkinson's Foundation Receives Robert W. Woodruff Foundation Grant to Increase Access to Genetic Research in Georgia

NEW YORK AND YOU LOVE ME, June 6, 2023 /PRNewswire/ — The Parkinson’s Foundation has received a grant from the Robert W. Woodruff Foundation to expand genetic testing, genetic counseling, and educational research opportunities for black and African Americans with Parkinson’s disease (PD). Through PD GENERATION: Mapping the future of Parkinson’s diseaseThe grant supports efforts to increase community participation in collaborative research with Morehouse School of Medicine In Atlanta.

“We are grateful for the generosity of the Woodruff Foundation in helping us expand the GENERation of PD and provide additional support to Black and African Americans in the Parkinson’s disease community,” said the Parkinson’s Foundation chief scientist James Beck, Ph.D. “PD GENEration is designed to be inclusive and accessible to all populations, and this grant allows us to elevate the scope of study through our partnership with Morehouse.”

The initiative will provide free genetic testing and genetic counseling to Black and African American participants with PD, conduct educational workshops introducing the role of genetics in PD, and further empower individuals with PD by determining eligibility for relevant clinical trials. No two people with PD are alike, so ensuring the diversity and inclusiveness of research participants is critical to accelerating discoveries toward a cure.

Through PD GENEration, the Parkinson’s Foundation works to increase the representation of marginalized population groups in research and aims to make free genetic testing accessible to people with PD. Work in collaboration with Chantale BransonMD, the first ever movement disorder specialist at Morehouse School of Medicinethe Parkinson’s Foundation is committed to improving health disparities in the PD community.

“By making genetic testing, counseling and education more accessible to Black and African Americans with PD through this partnership, we hope to significantly improve clinical outcomes and increase research participation,” Branson said.

PD GENEration is a global genetics initiative that offers genetic testing for clinically relevant PD-related genes and free genetic counseling for all people with PD. Genetic testing and counseling through PD GENEration is available in English and Spanish. Currently, participants are enrolled from all 50 US states, Puerto Rico and the Dominican Republic.

Rus Hardinpresident of the Robert W. Woodruff Foundation, said, “The Woodruff Foundation is pleased to support the Parkinson’s Foundation and Morehouse School of Medicine as they join forces to extend promising genetic research to more Parkinson’s patients Georgia.”

To learn more about PD GENERATION, call 1-800-4PD-INFO (1-800-473-4636) or email [email protected]. For questions about joining PD GENEration at Morehouse, email [email protected] or register directly by clicking here.

About the Parkinson Foundation
The Parkinson’s Foundation improves the lives of people living with Parkinson’s disease by improving care and promoting research for a cure. In everything we do, we draw on the energy, experience and passion of our global Parkinson’s community. Since 1957, the Parkinson’s Foundation has invested more than 425 million dollars in the research and clinical care of Parkinson’s. Connect with us at Parkinson.org, Facebook, ChirpingInstagram or call 1-800-4PD-INFO (1-800-473-4636).

Information about Parkinson’s disease
Affecting approximately one million Americans and 10 million worldwide, Parkinson’s disease is the second most common neurodegenerative disease after Alzheimer’s and is the fourteenth leading cause of death in the United States. It is associated with a progressive loss of motor control (eg, tremor or tremor at rest and lack of facial expression), as well as nonmotor symptoms (eg, depression and anxiety). There is no cure for Parkinson’s and 90,000 new cases are diagnosed each year in the United States alone.

Marissa Cruz
Parkinson Foundation
[email protected]

SOURCE Parkinson Foundation

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Carbon dioxide levels in the atmosphere mark a near-record increase

Carbon dioxide levels in the atmosphere mark a near-record increase

Despite growing awareness of global climate change and its devastating effects, carbon dioxide levels continue to walk in the wrong direction.

This year’s annual rise in CO2 levels is one of the largest on record, representing a buildup of heat-trapped gases not seen in millions of years, scientists at the Scripps Institution of Oceanography and the National Oceanic and Atmospheric Administration. The current amount of carbon dioxide in the atmosphere is now 50 percent higher than before the industrial era, NOAA and Scripps scientists said in a report.

The new figures offer further evidence that global climate efforts, including the transition from fossil fuels to cleaner energy, are falling short of what scientists say is needed to stem global warming.

Every year, we see the impacts of climate change in the heatwaves, droughts, floods, wildfires and storms that occur around us, NOAA Administrator Rick Spinrad said in a statement. While we will need to adapt to climate impacts we cannot avoid, we must make every effort to reduce carbon pollution and safeguard this planet and the life that calls it home.

Carbon dioxide levels in May averaged 424.0 parts per million (ppm), the fourth-largest annual increase since measurements began 65 years ago at NOAA’s Mauna Loa Observatory in Hawaii.

The highest mean monthly levels of CO2 peaks occur in May for the northern hemisphere, just after plants exude the gas before the growing season. The monthly average for May this year stood at 423.78 ppm, a 3.0 ppm increase from the May 2022 average.

The increases in carbon dioxide levels come as no surprise to climate scientists who have tracked them over time.

[The findings are] disappointing, but not surprising. We’re still seeing CO2 rising at the same rate it has in decades, Ralph Keeling, a geochemist at Scripps, told The Post.

Carbon dioxide that is generated from the burning of fossil fuels for transportation and electricity generation, cement production, deforestation, agriculture and many other practices traps heat from the planet’s surface that would otherwise escape into space. Carbon dioxide pollution, a key greenhouse gas, amplifies extreme weather events, such as heat waves, droughts and wildfires, as well as rainfall and floods.

Between January and April of this year, 12,972 wildfires burned more than 392,287 acres of land, according to NOAA. Atmospheric rivers, combined with snowmelt, hit the western United States with significant flooding that left hundreds of thousands without electricity.

Last year was declared the fifth or sixth warmest year on record by five different scientific organizations. Twenty-eight countries set national record annual averages last year, including Britain, Spain, France, Germany, China and New Zealand. Berkeley Earth reported that 850 million people experienced their hottest year ever.

Whatever we’re seeing weather-wise now is just the beginning of much bigger changes, Keeling said.

Scientists can monitor carbon dioxide in two ways. One is through direct measurements of CO2 levels in the atmosphere, as the Scripps scientists did at the Mauna Loa Observatory. The other method is the estimation of emissions from multiple sources of work conducted by the International Energy Agency.

In a March report, the IEA said global carbon dioxide emissions linked to energy generation rose 0.9 percent in 2022, reaching a new high of more than 36.8 billion tonnes.

As atmospheric carbon dioxide levels continue to rise, leaders around the world face mounting pressure to commit to more aggressive plans to reduce greenhouse gas pollution. Last year’s climate summit in Egypt, known as COP27, was widely seen as a disappointment on this score, with little progress being made on binding measures to cut emissions.

Scientists fear that the new El Nio cycle could increase the growth rate of CO2 in the atmosphere. El Nio, the opposite of La Nia, triggers warmer-than-normal surface waters in the tropical Pacific Ocean and is characterized by droughts in some regions.

During El Nio, drying tropical vegetation and savannahs contribute to higher C02 levels, Keeling said. The previous La Nia cycle contributed to slightly slower growth rates.

I expect next year’s news to look even worse, Keeling said.

#Carbon #dioxide #levels #atmosphere #mark #nearrecord #increase

Why climate change is fueling the increase in mosquito numbers in NC

A new study has found it "first" Mosquito days are on the rise in the Wilmington area and throughout North Carolina as climate change causes warmer temperatures.  STARNEWS FILE PHOTOS

A new study has found it "first" Mosquito days are on the rise in the Wilmington area and throughout North Carolina as climate change causes warmer temperatures.  STARNEWS FILE PHOTOS

They’re as much a part of summer in Southeast North Carolina as the sun, sand, and surf.

But the buzz generated by these kids isn’t one that anyone really appreciates, and a new study shows that North Carolina’s warm climate fueled by climate change is creating better living conditions for the region’s bloodsucking residents.

A recent analysis by Climate Central found that Wilmington had 11 more “mosquito days” for a total of 221 in 2022 than in 1979. The non-profit climate communication group defined mosquito days as having a relative humidity average of 42% or higher and daily minimum and maximum temperatures between 50 and 95 degrees. While Port City’s numbers are pointing in the wrong direction, it was better than what researchers found in Raleigh-Durham (+27 days), Greenville (+22 days), and Asheville (+22 days).

Last year Wilmington experienced 221 days considered favorable for mosquitoes, an 11-day increase from 1979.

TIMELESS TREESAncient NC trees have survived thousands of years. Will they be able to withstand climate change?

Overall, the study found that 173 locations, or 71 percent of the 242 U.S. locations analyzed, saw annual mosquito days increase by an average of 16 days. In 55 locations, annual mosquito days increased by 21 days or more. Leading the pack was Santa Maria, California, which saw an increase of 43 days, closely followed by San Francisco with 42 days. Unsurprisingly, the Southeast and South experience mosquito days more than half the year, the highest in the nation.

#climate #change #fueling #increase #mosquito #numbers

Alarm for the increase in the number of teenagers addicted to “smart drugs”.

Drug counselors said anxious students contacted them after becoming addicted to smart drugs to cope with the stress of studying for exams

A record number of students and schoolchildren are being treated for addiction to stimulant ‘smart drugs’ that put them at risk for severe anxiety and insomnia, experts have warned.

UK Addiction Treatment Group (UKAT), a leading addiction clinic, has responded to calls from thousands of young people seeking help after becoming addicted to tablet computers.

Smart drugs are an umbrella term for a number of concentration-enhancing drugs, including Ritalin, also known as methylphenidate, and Adderall, which contains four types of amphetamines. Both are used to treat the mental health condition attention deficit hyperactivity disorder (ADHD) by increasing activity in areas of the brain that help control attention and behavior.

However, they can increase energy and focus in people who don’t have ADHD, which is why they are often used by students, particularly during exams.

Doctors warn children are handing out these smart drugs to friends at school and have urged policymakers to tighten regulations that currently allow private clinics to prescribe the powerful drugs without a face-to-face consultation.

Drug counselors said anxious students contacted them after becoming addicted to smart drugs to cope with the stress of studying for exams

Drug counselors said anxious students contacted them after becoming addicted to smart drugs to cope with the stress of studying for exams

When taken as recommended, these drugs are not addictive. But many abusers take significantly larger doses or crush the pills and snort them, making them more potent. When taken this way, the drug can be addictive, while also increasing the risk of triggering sleep problems, anxiety, and even heart damage.

UKAT has seen an almost 80% increase in requests for help from students and young professionals addicted to smart drugs compared to before the Covid pandemic.

Studies show that the number of prescriptions for ADHD medications has increased nearly 70% since 2020 as a record number of people have been diagnosed with the disorder. While many will have a real need, experts believe this increase in ADHD is also being driven by private clinics that are overdiagnosing the condition.

As a result, there have also been intermittent shortages of some of these drugs, meaning those in need have been unable to get vital care.

Doctors have warned that students have been passing smart drugs to their friends at school

Doctors have warned that students have been passing smart drugs to their friends at school

“It’s concerning how easy it is for children to get their hands on these pills,” says Dr Mateen Durrani, a clinical psychiatrist at UKAT. “They’re often given out at school by kids who have prescriptions.”

Overuse of ADHD medication is not a new phenomenon, a survey conducted in 2020 found that around six per cent of UK university students had taken it to help them study.

Some experts believe that the sharp increase in cases of smart drug addiction is linked to the Covid pandemic, which has drastically reduced the time many students have spent face-to-face with teachers and has also led to the cancellation of exams. Now, they argue, these students are turning to drugs to help them perform.

“Since the pandemic, there’s been a lot of pressure on students to make up the learning they’ve lost,” says Dr. Durani. “But what often happens is that they will keep taking larger and larger amounts of these pills to maximize their concentration until they get hooked on the effect it has on the brain.”

Last month, a BBC investigation raised concerns that some private clinics were misdiagnosing people with ADHD and offering them medication without meeting them face-to-face. Some experts believe this relaxed approach to prescribing such strong pills could be linked to increasing addictions.

“There has been a massive increase in prescriptions since the pandemic,” says Professor Philip Asherson, professor emeritus of neurodevelopmental psychiatry at King’s College London. “It’s possible that this has led to the pills becoming more available in schools.”

Dr. Durrani agrees: “There is clearly very little regulation in the industry, and one of the impacts is that children are abusing drugs.”

But according to Dr. Durrani, such an addiction is treatable.

“We give patients a low-dose tranquilizer to combat the anxiety and agitation they often feel when they stop taking large doses of these drugs,” she says.

The need to address this issue is clear. In the short term, stimulants can trigger nausea, decreased appetite, sleep disturbances, and anxiety. It has also been linked to the condition Raynaud’s circulation, which causes fingers and toes to turn white or blue, as well as causing pain and numbness in the joints. But the pills can also raise blood pressure and heart rate. Experts say this could have dangerous long-term consequences.

“The long-term impacts of methylphenidate abuse are unclear because it’s still relatively new,” says Professor Asherson. “But taking very large amounts of this drug increases your risk of heart problems later in life.”

#Alarm #increase #number #teenagers #addicted #smart #drugs

Ozempic and Wegovy: FDA warns of increase in off-brand versions

A pharmacist is seen working.

A pharmacist is seen working.Share on Pinterest
The FDA has issued a warning against compound drugs similar to Ozempic and Wegovy that haven’t been tested for safety or efficacy. Terry Vine/Getty Images
  • The FDA has issued a warning on GLP-1 drugs similar to Ozempic and Wegovy.
  • These drugs differ from FDA-approved Ozempic and Wegovy because they are made by online pharmacies and other uncertified sources.
  • These compound drugs are made by mixing or altering drugs to create a semaglutide-like drug.
  • The health risks of the compound semaglutide are not yet known, but off-label versions of the drug may contain contaminants.
  • The FDA cannot verify the safety or efficacy of compound semaglutide drugs, especially those made with salt, that have not undergone rigorous testing.

The Food and Drug Administration (FDA) has issued a warning against modified glucagon-like peptide-1 (GLP-1) drugs, such as semaglutide, that are being sold.

The United States has experienced a shortage in both Ozempic, used to treat type 2 diabetes, and Wegovy, used to treat obesity, since early May 2023.

As a result, online pharmacies and uncertified sources sell GLP-1 drugs made with different ingredients than those used in approved drugs.

These drugs, called compound drugs due to mixing or altering ingredients to create a drug, are marketed as semaglutide.

Compound drugs aren’t approved by the FDA, and the agency doesn’t test compound drugs for safety or efficacy, the FDA said in his warning.

The FDA issued the warning after the agency received reports of people taking the compound semaglutide.

The compounded drugs may contain unwanted contaminants or have a different potency than FDA-approved drugs, Dr. Kelly Johnson-Arbor, a medical toxicologist and co-medical director of the National Capital Poison Center, told Healthline.

There have been incidents of people becoming very ill and even dying from other types of compound drugs, Johnson-Arbor said.

In some cases, the compound semaglutide drugs consisted of saline forms of semaglutide, including semaglutide sodium and semaglutide acetate, which are different from the FDA-approved versions of semaglutide sold under the brand names Ozempic and Wegovy.

According to the FDA, these salt versions have not been shown to be safe or effective.

It is also not clear what the health risks are.

Essentially, you’d be using an uncontrolled substance, possibly illegally imported into the United States, with no control over what’s in it, Dr. Dan Azagury, an associate professor of surgery at Stanford Healthcare, told Healthline.

The Alliance for Compounded Pharmacy released a statement last week saying the compound semaglutide is technically ineligible to be sold by compounding pharmacies.

Some compounding drugs may be legally prescribed by a licensed health care practitioner and sold by compounding pharmacies as they must meet stringent compounding standards.

For example, people with an allergy to a certain dye can get the drug without it, says Azagury.

But in this situation, the current semaglutide molecule is probably only produced by Novo Nordisk. If they don’t have enough, no one does, Azagury said.

David Lebo, PhD, a professor of pharmaceutical sciences at Temple University’s School of Pharmacy, explained to Healthline that compounding should never be used as a substitute for a commercial product, such as Ozempic, unless there are specific reasons such as adjustments to the dose, route of administration or to make the drug available to special populations.

To avoid buying a compound version of semaglutide, you should only get your prescription through a licensed healthcare professional and pick up your medications from a state-licensed pharmacy or facility registered with the FDA.

The APC has warned consumers to avoid unreliable online retailers.

If your doctor hasn’t written you a prescription for the compound semaglutide and mailed it to a legitimate, identifiable pharmacy, be wary of the seller of that substance, says the APC.

If you are buying your medications online, make sure that the retailer is licensed and regulated and that the medications are made by the drug manufacturer Novo Nordisk.

For tips on evaluating the legitimacy of your online retailer, visit the FDA website BeSafeRx.

Illegitimate versions of semaglutide tend to be cheaper.

When searching for semaglutide online, look for clues such as not for human use or laboratory use only to identify formulations of the drug that are intended for use only as research chemicals and are not approved by the FDA for use in the man, Johnson-Arbor said.

If you think you have taken or purchased compound semaglutide, report the incident to the FDA MedWatch Adverse Event Reporting.

A certified healthcare provider can help you get the drug in a supervised process with the right support, Azagury said.

If you can’t access semaglutide due to a shortage, there are several other drugs in this class, Lebo said.

Patients should have a conversation with their doctor or pharmacist about some of the options, Lebo noted.

The FDA has issued a warning against modified GLP-1 drugs, such as semaglutide, that are being sold.

There was a shortage in both Ozempic and Wegovy since May 2023, and some uncertified resellers are selling a modified version of the drug made with saline forms of semaglutide.

The salt versions haven’t been tested, so it’s unclear how safe and effective they are, and what the health risks are.

Health experts say you should not take fake or compounded semaglutide under any circumstances.

You are working on losing weight to improve your health so as not to endanger it by using these drugs, Azagury said.

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