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Oxnard, CA’s FORMAT Medical Research Secures Two Big Clinical Trials with Regeneron Investigating REGN-COV2

The Study

Now, Format Medical Research takes on two high profile clinical trials involving the antibody cocktail known as REGN-COV2. Garnering national attention, this investigational therapy targeting COVID-19 has receive a lot of attention. The Ventura County Star reports that the SMO will commence the first study, representing one of 150 sites in North and South America, this Friday. The goal: determine if the antibody medicine offers a safe and effective treatment for those who tested positive for SARS-CoV-2.

The second study focuses on those participants who are actually healthy but “at risk” of the virus. In this study, the participants will take the therapy to determine if there are prevention properties and the sponsor seeks up to 2,000 participants.

Although perhaps not a household name among big pharmaceutical sponsors perhaps that may change as FORMAT Medical Research in Oxnard, California, recently secured a major contract with Regeneron to participate in their highly watched, Operation Warp Speed-funded REGN-COV2 double antibody COVID-19 clinical trial. The Southern California-based research organization starts two trials with the New York State-based sponsor chief, Nicholas Focil, who now faces “the most important study of my career.”

The SMO

The Oxnard-based research company “facilities clinical trials.” The “Integrated Research Organization” also known as a “Site Management Organization” (SMO) was profiled as part of the TrialSite’s global SMO survey back in early December, 2019. An independent operation, Format Medical Research has aligned with the hyperCORE International, a “Super Site Network” that purports to standardize systems and processes including business development. With over a decade of experience conducting Phase 1 to 4 clinical trials across a variety of therapeutic areas, they offer SMO and site services for up to 50 sites, SMO employs between 25 and 50 employees. Format claims to have in its network over 10 million patients it can access for studies.

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Boosting immune system a potential treatment strategy for COVID-19

But new findings from a team of researchers led by scientists at Washington University School of Medicine in St. Louis point to another theory and suggest that become ill because their immune systems can’t do enough to protect them from the virus, landing them in intensive care units. They suggest that boosting immunity could be a potential treatment strategy for COVID-19.

Such a strategy has been proposed in two recently published papers, one published online in JAMA Network Open and the other published online in the journal JCI Insight.

“People around the world have been treating patients seriously ill with COVID-19 using drugs that do very different things,” said senior investigator Richard S. Hotchkiss, MD, professor of anesthesiology, of medicine and of surgery. “Some drugs tamp down the immune response, while others enhance it. Everybody seems to be throwing the kitchen sink at the illness. It may be true that some people die from a hyperinflammatory response, but it appears more likely to us that if you block the too much, you’re not going to be able to control the virus.”

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Why Japanese Businesses Are So Good at Surviving Crises

On March 11, 2011, a 9.1-magnitude earthquake triggered a powerful tsunami, generating waves higher than 125 feet that ravaged the coast of Japan, particularly the Tohoku region of Honshu, the largest and most populous island in the country.nnNearly 16,000 people were killed, hundreds of thousands displaced, and millions left without electricity and water. Railways and roads were destroyed, and 383,000 buildings damaged—including a nuclear power plant that suffered a meltdown of three reactors, prompting widespread evacuations.nnIn lessons for today’s businesses deeply hit by pandemic and seismic culture shifts, it’s important to recognize that many of the Japanese companies in the Tohoku region continue to operate today, despite facing serious financial setbacks from the disaster. How did these businesses manage not only to survive, but thrive?nnOne reason, says Harvard Business School professor Hirotaka Takeuchi, was their dedication to responding to the needs of employees and the community first, all with the moral purpose of serving the common good. Less important for these companies, he says, was pursuing layoffs and other cost-cutting measures in the face of a crippled economy.nn

As demonstrated after the 2011 earthquake and tsunami, Japanese businesses have a unique capability for long-term survival. Hirotaka Takeuchi explains their strategy of investing in community over profits during turbulent times.

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Bill Gates is spending $150 million to try to make a coronavirus vaccine as cheap as $3

Gates has been among the foremost leaders on vaccine production over the last two decades, spending $4 billion on the global vaccine development effort known as Gavi. And for months, the billionaire has expressed profound worries that while rich countries may fare okay at surviving the coronavirus, that the pandemic will devastate poor countries that can’t afford to administer the treatment, whenever it arrives.

Pay more attention to what Gates is doing overseas than what he’s saying about the United States.

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NSD2 shapes the program of cell senescence [image] Science News

NSD2 is the fourth protective factor of cellular senescence that our team has identified,” said Professor Mitsuyoshi Nakao. “With the discovery that NSD2 protects against cellular senescence, this study clarifies a basic mechanism of aging.

Researchers from Kumamoto University in Japan have used comprehensive genetic analysis to find that the enzyme NSD2, which is known to regulate the actions of many genes, also works to block cell aging. Their experiments revealed 1) inhibition of NSD2 function in normal cells leads to rapid senescence and 2) that there is a marked decrease in the amount of NSD2 in senescent cells. The researchers believe their findings will help clarify the mechanisms of aging, the development of control methods for maintaining NSD2 functionality, and age-related pathophysiology.

As the cells of the body continue to divide (cell reproduction), their function eventually declines and they stop growing. This cellular senescence is an important factor in health and longevity. Cell aging can also be stimulated when genomic DNA is damaged by physical stress, such as radiation or ultraviolet rays, or by chemical stress that occurs with certain drugs. However, the detailed mechanisms of aging are still unknown. Cell aging can be beneficial when a cell becomes cancerous; it prevents malignant changes by causing cellular senescence. On the other hand, it makes many diseases more likely with age. It is therefore important that cell aging is properly controlled.

Although senescent cells lose their proliferative ability, it has recently become clear that senescent cells secrete various proteins that act on surrounding cells to promote chronic inflammation and cancer development. Since senescent cells are more active than expected, cellular aging is thought to be responsible for whole body aging. This idea has been supported by reports of systemic aging suppression in aged mice after removal of accumulated senescent cells. In other words, if you can control cell aging, you may be able to control the progression of aging throughout the body.

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Doctors experiment with stem cell therapy on COVID-19 patients

Doctors are hoping stem cell therapy could be a weapon in the fight against coronavirus. On Friday, regenerative medicine company Mesoblast announced a 300-person trial to determine whether stem cell treatments will work in COVID-19 patients suffering from severe lung inflammation.

One hospital in New York tried it as an experiment with 12 patients, 10 of whom were able to come off of ventilators.

“What we saw in the very first patient was that within four hours of getting the cells, a lot of her parameters started to get better,” Dr. Karen Osman, who led the team at Mount Sinai, told CBS News’ Adriana Diaz.

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Programmable synthetic materials

Artificial molecules could one day form the information unit of a new type of computer or be the basis for programmable substances. The information would be encoded in the spatial arrangement of the individual atoms—similar to how the sequence of base pairs determines the information content of DNA, or sequences of zeros and ones form the memory of computers.

Researchers at the University of California, Berkeley, and Ruhr-Universität Bochum (RUB) have taken a step towards this vision. They showed that atom probe tomography can be used to read a complex spatial arrangement of ions in multivariate metal-organic frameworks.

Metal-organic frameworks (MOFs) are crystalline porous networks of multi-metal nodes linked together by organic units to form a well-defined structure. To encode information using a sequence of metals, it is essential to be first able to read the metal arrangement. However, reading the arrangement was extremely challenging. Recently, the interest in characterizing metal sequences is growing because of the extensive information such multivariate structures would be able to offer.

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4 Palliative Canadians approved for end of life psilocybin therapy through section 56(1) ; First legal medical exemptions for psilocybin in Canada since 1970’s

Four Canadians battling incurable cancer have been approved by the Minister of Health, Patty Hajdu, to use psilocybin therapy in the treatment of their end-of-life distress. These 4 patients mark the first publicly-known individuals to receive a legal exemption from the Canadian Drugs and Substances Act to access psychedelic therapy, and the first known patients to legally use psilocybin since the compound became illegal in Canada in 1974. The decision comes after over 100 days of waiting for a response.

“ I would like to personally thank the Hon. Minister Hajdu and the team at the Office of Controlled Substances for the approval of my section 56 exemption. This is the positive result that is possible when good people show genuine compassion. I’m so grateful that I can move forward with the next step of healing” says Thomas Hartle, one the section 56 applicants battling cancer, from Saskatoon Saskatchewan.

Laurie Brooks, another applicant from British Columbia facing end-of-life distress states: “I want to thank the Health Minister and Health Canada for approving my request for psilocybin use. The acknowledgement of the pain and anxiety that I have been suffering with means a lot to me, and I am feeling quite emotional today as a result. I hope this is just the beginning and that soon all Canadians will be able to access psilocybin, for therapeutic use, to help with the pain they are experiencing, without having to petition the government for months to gain permission. Thanks also to TheraPsil for helping the four of us in this fight. To Thomas Hartel and the other two patients – I think of you often and wish you only good things, especially good health!”

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