header logo image


Page 186«..1020..185186187188..200210..»

Precigen CEO Envisions a Transformative 2021 with Precision Medicine Therapy – BioSpace

April 4th, 2021 6:47 am

Precigen Chief Executive Officer Helen Sabzevari pictured above.

The year 2020 and the COVID-19 pandemic created a number of challenges for individuals and companies. Despitethese hurdles, Maryland-based Precigen still managed to achieve its clinical milestones in oncology.

The company is advancing its UltraCAR-T cell therapy approach to treating cancer that Chief Executive Officer Helen Sabzevari believes will be transformative to the personalized cell therapy landscape for cancer patients.

This is what precision medicine in the twenty-first century should look like, Sabzevari told BioSpace in an interview.

Sabzevari joined Precigen in 2017after undergoing a rebranding effort that included a name change from Intrexon Corporation, as well as the divestiture of non-healthcare assets, such as AgBiotech and Intrexon Produce Holdings. The company now focuses on the development of next-generation gene and cell therapies that have potential to change the treatment paradigm in immuno-oncology, autoimmune disorders and infectious diseases.

While there are multiple companies pursuing programs of these types, Sabzevari said Precigen can differentiate itself through a unique precision medicine approach that could simultaneously impact different types of genetic expressions on cancer cells, both hematological and solid tumors. Additionally, Precigen believes its UltraCAR-T immunotherapies can be developed with fewer toxicity issues and manufactured at a lower cost than currently available CAR-T treatments.

She added the company has the most differentiated platform in cell and gene therapy compared to other companies in the space.

The company is developing two UltraCAR-T platforms. The first, PRGN-3005 UltraCAR-T, is a first-in-class investigational therapy currently being assessed in a Phase I/Ibclinical study for the treatment of advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer.

In December, Precigen reported preliminary data from the study that showed a favorable safety profile with no dose-limiting toxicities (DLTs), neurotoxicity or cytokine release syndromes. What may be most important of all, Sabzevari said the study showed the UltraCAR-T treatment generated expansion and persistence after low dose IP infusion without lymphodepletion.

Precigen intends to begin a dose expansion of this study in the second half of the year. For the first time, Sabzevari said, they were able to show clinical efficacy in a solid tumor. Approximately 50% of patients showed a decrease in tumor lesions.

Precigen is also developing PRGN-3006 UltraCAR-T, a first-in-class investigational therapy currently under clinical evaluation in a Phase I/Ibstudyfor the treatment of patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes (MDS).

Preliminary Phase I data reported in December showed a favorable safety profile with no DLTs or neurotoxicity. Encouraging expansion and persistence of PRGN-3006 UltraCAR-T was observed in both lymphodepletion and non-lymphodepletion cohorts and across all dose levels. PRGN-3006 treatment indicated clinical activity as evidenced by reduction in AML tumor blast levels, the company said. Data from the PRGN-3006 study also revealed that UltraCAR-T cells persisted for more than seven months after a very low dose of 24 million total UltraCAR-T cells in a patient. Sabzevari said this highlights the difference between Precigens UltraCAR-Ts and other CAR-T programs, which introduce hundreds of millions of CARs in to patients during an infusion. Those CARs also have a shorter life than the Precigen assets, which means they can have a sustainable impact on cancer.

Following the revelation of the preliminary data, the U.S. Food and Drug Administration awarded PRGN-3006 with Orphan Drug Designation for AML.

While CAR-T therapies are not yet considered front-line defenses in cancer, Sabzevari predicted that cell and gene therapies will eventually move to first-line options.

Checkpoint inhibitors have become frontline therapies and thats the vision for CAR-T and cell therapies, she said.

Sabzevari likened the possibilities of Precigens UltraCAR-T therapies to antibiotics. If a doctor prescribes one and it does not produce the desired therapeutic effect, there will be another type available from the companys library that could treat the cancer.

If one target, for whatever reason isnt sufficient, you can switch overnight to change it with another. In our vision, a patient can come in and an oncologist could identify the indication of the cancer through screening, order a treatment from our UltraCar-T library and get it done, infuse the patient, Sabzevari said.

Because of the potential Precigens UltraCAR-T program has in oncology, Sabzevari believes the companys stock is significantly undervalued. In January, Precigenraised about $130 million. She believes the stock could go much higher and noted that Precigens market cap has tripled in the past year.

2021 promises to be another transformative year for our company with important data readouts and trial initiations anticipated for our key programs. We have a very good stretch of growth in front of us, Sabzevari said.

Excerpt from:
Precigen CEO Envisions a Transformative 2021 with Precision Medicine Therapy - BioSpace

Read More...

What Are the Evolving Opportunities for the Players in the Precision Medicine Market? The Courier – The Courier

April 4th, 2021 6:47 am

According to P&S Intelligence, the precision medicine market generated $203.5 billion in 2019 and it is expected to reach $738.8 billion by 2030, progressing at a CAGR of 12.1% during the forecast period (20202030). This growth can be driven by the rising government support, escalating awareness regarding personalized treatments, rising number of approved personalized medications, increasing use of artificial intelligence (AI) in clinical trials related to precision medications, surging number of regulatory approvals, soaring cases of chronic and genetic diseases, and flourishing medical tourism industry.

Request to Get the Sample Pages at: https://www.psmarketresearch.com/market-analysis/precision-medicine-market-outlook/report-sample

Governments across the globe are taking several initiatives to develop personalized treatment, thereby, playing a vital role in the precision medicine market growth. According to the World Economic Forum, Argentina introduced a Precision Medicine Initiative Grant, in 2017, to start the scientific procedures needed to introduce investigational precision medicine approaches into clinical practices. Similarly, the U.S. administration under its Personalized Medicine Coalition announced its plan, in July 2019, to bring down the costs of drugs in the country, to make them comparable with international rates.

Make Enquiry Before Buying the Report: https://www.psmarketresearch.com/send-enquiry?enquiry-url=precision-medicine-market-outlook

Globally, the North America held the largest share in 2019, and it is expected to continue its dominance during the forecast period. This is due to the rising incidence of lifestyle-associated and chronic diseases, like CVDs and diabetes, burgeoning healthcare spending, and increasing number of government initiatives in the form of awareness programs and funding for precision medicine. Whereas, the Asia-Pacific (APAC) market will register the highest growth in the forecast years, owing to the increasing healthcare expenditure, presence of players developing precision medicines, and growing awareness about these medicines.

Thus, the rising frequency of critical trials and the magnifying government support will propel the market growth in the coming years.

This study covers

Read the rest here:
What Are the Evolving Opportunities for the Players in the Precision Medicine Market? The Courier - The Courier

Read More...

Global Nanomaterials in Personalized Medicine Market 2021 by Manufacturers, Regions, Type and Application, Forecast to 2026 The Bisouv Network – The…

April 4th, 2021 6:47 am

MarketandResearch.biz has produced a research report titled, Global Nanomaterials in Personalized Medicine Market 2021 by Company, Regions, Type and Application, Forecast to 2026 consists of an overall market scenario with prevalent and future growth prospects. The report speaks about potential development openings that exist in the worldwide market. The report elaborates insights associated with the market diversification, exhaustive information about new products, and recent developments, competitive assessment for the 2021 to 2026 forecasted time-frame. It describes the profile, as well as the analysis of market prices and the characteristics of the value chain. An extensive analysis of key growth strategies, drivers, opportunities, key segments, and competitive landscape has been given in the global Nanomaterials in Personalized Medicine market report. The complete market report is further bifurcate into company profiles, countries, and different segments for the competitive landscape study.

Global Growth Trends:

Various important factors such as market trends, revenue growth patterns market shares, and demand and supply are included in the market research report for every industry. The report focuses on industry trends where market drivers and top market trends are highlighted. It highlights provides exclusive vital statistics, data, information, trends and competitive landscape details relate to the market. The comprehensive research report offers decisive conclusions concerning growth factors and determinants, eventually influencing the holistic growth of the global Nanomaterials in Personalized Medicine market.

NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

DOWNLOAD FREE SAMPLE REPORT: https://www.marketandresearch.biz/sample-request/173174

Top companies covered in this research report:

Market segment considering production, revenue (value), price trend by type:

Market segment by consumption growth rate and market share by application:

Geographically, the market report is categorized into many major regions covering:

Regional Analysis of Market:

Major companies are working on distributing their products and services across different regions. This report indicates the region and segment that is expected to witness the fastest growth as well as to dominate the market. Market analysis by geography highlights the consumption of the product/service in the region as well as indicates the factors that are affecting the market within each region. It analyzes the changing nature of the economies within the geographies that are influencing the global Nanomaterials in Personalized Medicine market.

ACCESS FULL REPORT: https://www.marketandresearch.biz/report/173174/global-nanomaterials-in-personalized-medicine-market-2021-by-company-regions-type-and-application-forecast-to-2026

The Key Areas That Have Been Focused On The Report:

Customization of the Report:

This report can be customized to meet the clients requirements. Please connect with our sales team ([emailprotected]), who will ensure that you get a report that suits your needs. You can also get in touch with our executives on +1-201-465-4211 to share your research requirements.

Contact UsMark StoneHead of Business DevelopmentPhone: +1-201-465-4211Email: [emailprotected]Web: http://www.marketandresearch.biz

Original post:
Global Nanomaterials in Personalized Medicine Market 2021 by Manufacturers, Regions, Type and Application, Forecast to 2026 The Bisouv Network - The...

Read More...

How COVID-19 Will Help Denver Doctors Revolutionize Health Care – 5280 | The Denver Magazine

April 4th, 2021 6:47 am

The COVID-19 pandemic has spawned collaborations in the Denver medical community that could help usher in a new golden age of medicine.

As the medical director of the Medical Intensive Care Unit at Denver Health, Dr. Ivor Douglas knows better than most how devastating a toll COVID-19 has taken. Weve lost 400,000 people, which is as many Americans as were lost in the Second World War, he says. (The number topped 520,000 in early March.) And weve done it in a year.

At the same time, Douglas understands that the unwelcome arrival of the novel coronavirus presents an opportunity to advance health care at an unprecedented rate. Absolutely its going to have long-term effects on human health and scientific discovery, Douglas says. He believes such rapid progress will occur because, well, hes seen it happen.

For about 20 years, Denver Health has been treating acute respiratory distress syndrome (ARDS)when fluid builds up in the tiny air sacs in the lungs, limiting the air they can holdby rotating ventilated patients from lying on their backs to the prone position, on their stomachs, for prolonged periods of time. Although the practice seems counterintuitive (doesnt breathing on your stomach appear constrictive?), Denver Health and other hospitals believed the practice increased oxygen levels while decreasing ventilator-induced lung injuries. But because there hadnt been a consensus on the effectiveness of the procedure, and its cumbersome to move intubated patients from supine to prone (three to six people are required), few hospitals regularly performed the technique.

Then COVID-19 began causing ARDS in severe cases. A number of studies promptly affirmed that proning such patients was a potentially life-saving decision. Further, research co-authored by Douglas lent credence to the safety of prolonged proning, in which patients remain in the position for days at a timemore than 20 in some cases. Once the pandemic is over, doctors around the world will use that information to treat people suffering from ARDS caused by bacterial pneumonia or viral influenza.

Similar COVID-19-spawned symbioses are not rare in Colorado. Rival health systems have banded together; thousands of patients have donated their DNA to scientific research; and specialists have rebuilt relationships with community doctors. While the trauma of COVID-19 will endure for years, its lessons could inspire benefits that last for generations.

When confusion reigned, Colorados largest health care providers united to chart a course through the pandemic.

When COVID-19 first arrived in the United States, the Centers for Disease Control and Prevention advised that Americans who werent sick didnt need to wear masks. Back then, even experts didnt understand the best ways to combat the disease. No one knew what was going on, says Dr. JP Valin, chief clinical officer at SCL Health, and that includes the health care providers of Colorados seven largest hospital networks. So we just said, Lets work on this together, Valin says. Physician executives of SCL Health, UCHealth, HealthOne, Centura Health, Denver Health, Boulder Community Health, and Banner Health began meeting virtually every weekday (and some weekends) to share data, discuss best practices, and manage the local distribution of personal protective equipment. By the end of July, the networks had collaboratively cared for 98 percent of the COVID-19-related hospitalizations in Colorado, and according to a study about the partnership published in the New England Journal of Medicine Catalyst, they boasted lower mortality, lengths of stay, and mechanical ventilation rates than the national averages. The collaboration later became a model for other states. We cant lose this after the fact, Valin says. This is something special, and weve done some really cool things.

How the rival networks worked together to ensure Coloradans got the care they needed during COVID-19.Back to Top

Perspective: Before the state instituted a COVID-19 tracking system, the partnership recognized early outbreaks. In March and April 2020, Banner began seeing a spike in positive tests in Weld County. When UCHealths hospitals in Weld reported a similar flare-up, they traced the surge to patients employer: the JBS USA Greeley beef plant. The group notified the state and county, which closed the plant (although a Denver Post story questioned the speed with which Weld responded).

Patient advocacy: Many hospitals and clinics in rural areas are affiliated with a larger providerbut some are not, and more than 60 percent of U.S. rural hospitals dont have a single ICU bed. So the collaborative worked through the Colorado Hospital Association to set up partnerships between rural hospitals and larger ones. The relationships included dispensing advice and accepting patients if they required emergency care. In 48 hours, Valin says, we were able to quell a lot of unease in rural areas.

Partnership: When hospitals were allowed to perform elective surgeries again in late April, SCL Health developed an algorithm to assess the health of incoming patients, and it shared this with the other systems. So every patient in the state of Colorado who was getting an elective procedure followed that exact same protocol, Valin says, rather than patients and doctors being confused [about precautions], or one hospital being safer than another. We wanted there to be confidence in all of us.

Peer support: An unexpected benefit of the partnership was the partnership itself. Physician executives are often isolated from their peers (both from other doctors and other C-suite suits). Through working with execs at other systems, they enjoyed support, workforce development ideas, and, in late August, a happy hour. We went to the Lowry Beer Garden, where its all these picnic tables, Valin says. There was a lot of trust generated very quickly because we could say, Were doing the right thing.

Childrens Hospital Colorados virtual town halls became a must-listen for a pediatric community that needed healing.Back to Top

For most of Childrens Hospital Colorados 113 years, community doctors tended to the facilitys patients. But as the economics of medicine changed, fewer physicians could afford to leave their practices to spend time at the hospital. Specialists became primary caregivers for inpatients. As a result, says Dr. David Brumbaugh, chief medical officer of Childrens, the hospitals relationship with the local pediatric community grew distant. Then COVID-19 struck. To help terrified local doctors who needed concrete answers, Childrens began hosting virtual town halls. Eventually, about 500 providers began tuning in on Thursday nights to listen to Childrens docs review the latest science. The fringe benefit: The town halls began to rebuild the connection between the hospital and community providers. We spoke with some of Childrens most avid weekly audience members to hear how.

Dr. David Brooks | Valley View Hospital, Glenwood SpringsWe reached out to Dr. Sean OLeary [a pediatric infectious disease specialist at Childrens] and he presented a Zoom conference [on virtual learning] to about 200 people in the Roaring Fork Valley. After that, pediatricians here helped re-establish in-person learning. Im not sure we would have progressed to that point without the town halls.

Dr. Sharisse Arnold Rehring | Kaiser Permanente, DenverI think I personally received several face shields from Childrens in the mail because I didnt have any, and I wasnt sure we were going to get them at Kaiser Permanente. We did, but Childrens Hospital didnt ask any questions except, Whats your address?

Dr. Sharon Sagel | Southeast Denver PediatricsAt the beginning you felt like this very small fish in this really big pond. How do we practice? We felt like we were reinventing the wheel every day. And then all of a sudden youre connected to a whole community of pediatricians who are all in the same situation. I dont know what the future will look like, but I think there is this sense that were all better when we work together.

Dr. Matt Dorighi | Cherry Creek PediatricsThese town halls have certainly created the environment where you have that confidence to do new things, like telehealth. Its such a great format for getting information on new ideas. Itll be interesting to see what topics they shift to after the pandemic. But its been a really efficient way to affect change in the community.

Thanks to the telehealth boom, UCHealths Biobank connected with more patients than ever.Back to Top

Personalized medicinealso called precision or individualized medicinetailors treatment to the specific indicators locked away in our unique DNA (and other molecules). The discipline could help improve the outcomes of pharmacology and even predict future diseases, such as breast cancer, based on cellular variances. In order for personalized medicine to work, however, it needs data. Lots of data. The more DNA collected, the more connections that can be made. The University of Colorado Anschutz Medical Campus Colorado Center for Personalized Medicine launched its Biobank in 2016 to become the repository of such info for UCHealth. It has since signed up more than 173,000 patientsbut owes its biggest surge in outreach to COVID-19.

Biobank asks UCHealth patients to participate through the systems online patient portal, My Health Connection. Before the pandemic, though, fewer than half of the networks patients used the portal to, say, schedule appointments. When the pandemic forced UCHealth to switch primarily to telehealth visits, patients were suddenly required to use their portalsand, thus, interact with the Biobank consent form. Weve actually been able to reach out to more potential volunteers for the Biobank than we ever could have done before, says Kathleen Barnes, director of the center. Which means a global pandemic could play a part in helping make Coloradans healthier than theyve ever been before.

The pandemic has felt particularly isolating to new parents. Maybe thats not such a bad thing.Back to Top

In August 2020, three months before she was due, Aliesa Pope-Hodge gave birth to her second son, Reign, at the Medical Center of Aurora. Weighing one pound and eight ounces, Reign was immediately placed on a ventilation system that filled his underdeveloped lungs with about 360 breaths per minute. He looked like he was vibrating, Pope-Hodge says. She estimates she got to see Reign for 20 seconds before hospital staff ushered the baby into an ambulance for the 10-mile trip to Presbyterian/St. Lukes (PSL) Medical Centers newborn intensive care unit (NICU), a Denver facility qualified to serve the most acutely ill infants.

There, Pope-Hodge and her husband, Diamond Taylor, donned masks, scrubbed and washed their hands, and were screened for fevers every time they visited Reign. Neither family nor friends were allowed to join them. But the restrictions were nothing compared to Pope-Hodges own feelings of separation. While practicing skin-to-skin contact to encourage bonding between mother and child, Reign would often cry. His heart rate and oxygen levels would dropa common occurrence for preemies experiencing touch for the first timeand alarms would shriek. I felt scared to touch him, Pope-Hodge says. Like I was going to hurt him. Maybe I stress him out? I felt detached from Reign for a very long time.

Detachment might be the official emotion of the pandemicparticularly for new parents. Even though nascent research suggests COVID-19 is uncommon in newborns, even among those with COVID-19-positive mothers, most local hospitals and birthing centers have restricted access during birth to the parents (or mom and one support person, such as a doula). Once a baby heads home, many doctors recommend limiting visitation there as well.

While this has thwarted the ambitions of cheek-pinching grandparents, seclusion hasnt been all bad for parents. You arent trying to cater to extended family and keep them updated, says Dr. Anna Zimmermann, a neonatologist at PSLs Rocky Mountain Hospital for Children. It pares the experience down to the parents and allows them to just get to know their baby.

Research on the benefits of pandemic-induced alone time is minimal so far, but one study did test its impact on familial bonds. During April 2020, 70 pregnant women in Ireland participated in a survey that sought to quantify the emotional effects of social distancing. Of those whose relationships with their partners had not deteriorated (only three had), 34.3 percent said theyd grown closer, 28.4 percent said they talked more, and 20.9 reported exercising together.

Pope-Hodge and Taylor finally brought a five-pound Reign home from PSL in November and promptly barred visitorsa difficult decree considering they live with Taylors mother. She held him on Christmas, Pope-Hodge says. Other than that, she hasnt touched him, which is really hard for her. She feels stripped of the gift of being a grandmother.

The isolation, though, has allowed Pope-Hodge to form a connection with Reign that she never imagined possible at the NICU. [Our eldest son] King had his grandma and his aunties, and everyone else around him that gave him love, Pope-Hodge says. With Reign, I feel proud that I am, with Diamond, the ones who are taking care of him. Everything that he gets is from me. I feel really proud of that.

Confronting the connections between public health and health care in our local communities.Back to Top

More than any other disease, COVID-19 has drawn attention to the tether between social ills and physical illness. The pandemic has just brought it to the fore in ways that, frankly, diabetes didnt, kidney disease didnt, [and] high blood pressure didnt, says Dr. Jandel Allen-Davis, the president and CEO of Craig Hospital in Englewood. To illustrate the connection between COVID-19 and public health issues, Colorado Health Institute (CHI), a Denver-based public health advocacy group, created a Social Distancing Index (SDI). CHI gave each Colorado census tract a score from one to 10 based on its comparison to other tracts in the state in three areas: population density, overcrowded housing, and proportion of essential workers. The index is the average of a tracts three scores. The higher the score, the more vulnerable a tracts population is to the spread of COVID-19and, as noted below, a range of social inequities.

College ViewMore than 40 percent of children under 18 in College View live in poverty, compared to 18 percent countywide.

WestwoodThe four U.S. census tracts that make up the Westwood neighborhood are all at least 80 percent populated by people of color.

HilltopThe wealthiest tract in Denver County is in the Hilltop neighborhood (median household income: $209,000). It is 86.6 percent white.

MontbelloThis tract in the Montbello neighborhood is one of the 25 USDA-identified food deserts in Denver County, all but six of which have SDIs above the county median of 3.1.

East ColfaxAccording to the U.S. Department of Housing and Urban Development, the percentage of low- to moderate-income residents (those who earn less than 80 percent of the metro area median income) in this part of East Colfax ranges from 61.2 to 87.7 percent.

WindsorThe per capita income in this tract is $26,341, about three-fifths of Denver Countys per capita of $43,770.

Hampden SouthIn the tract with the lowest SDI, only 4.7 percent of residents live below the poverty line, compared to 12.9 percent across the county.

Bioethicist Matthew Wynia speaks out about the mortal dilemmas of the pandemicand how COVID-19 could forever guide our moral compass.Back to Top

Who gets a ventilator and who doesnt? Should everyone be forced to wear a mask? Which demographics deserve to receive the COVID-19 vaccine first? These are the questions the pandemic forced Dr. Matthew Wynia and other bioethicists to wrestle with as they attempted to guide the health care system through a stark market of supply and demand. Director of the University of Colorado Anschutz Medical Campus Center for Bioethics and Humanities, Wynia not only advised on state policy, but also helped oversee the UCHealth triage team as it made critical decisions. In the early stages of the vaccine rollout in Colorado, 5280 spoke with Wynia to better understand how local hospitals came to some very difficult decisions.

5280: Were the choices about, say, who would get ICU beds already determined before COVID-19 came along?Matthew Wynia: Not exactly. We had a framework because weve had prior pandemicsthe 2009 H1N1 influenza pandemic had generated a lot of interest in these issues. But it hadnt been adapted to COVID. So that was the initial work. Pull that off the shelf, open it up, and start making adjustments based on COVID. Very early on, we were already seeing that there might be a problem with blood clotting. Well, thats not a normal problem with influenza. How does that affect the clinical decision-making?

How does it?Those factors get put into your risk calculation for how likely a patient is to die if theyre really sick with COVID. Because if you think theyre going to die no matter what, youre better off not allocating them scarce resources. Also, if you think they might be able to pull through if they dont get the scarce resource, you similarly dont want to put them on the scarce resource.

So if a patient has a history of blood clots, no ICU?Well, Id be careful about that, because there are about 30 things in our calculation.

This is a question typically reserved for supervillains, but how did you sleep at night?I am famous in my family for being able to sleep anytime, anywhere. Thats my superpower. In March, for the first time in my life, I was tossing and turning, because we thought Colorado was going to get hit hard, and we were going to end up implementing our triage teams. The thing [we] do not want is the bedside doctor to be the one deciding who receives these resources and who doesnt. Number one, your bedside doctor should be your advocate. And number two, the bedside doctor does not have great situational awareness of what else is going on around the hospital or the region.

Yeah, but that means you have to make that decision.Yes, but based on better information than that individual doctor has.

Because of all the tough choices doctors had to make during the pandemic, do you think bioethics has evolved?If we make good decisions that clearly prioritize equity, we could come out of this with greater levels of trust in the health care system among racial and ethnic minority populations that havent always trusted the health care systembecause they didnt have a lot of good reasons to trust the health care system. Watching leaders in health care really struggle with how to do this right, so that we dont disadvantage this community, that can be a cohesion-building experience.

Spencer Campbell writes features and edits service packages.

More:
How COVID-19 Will Help Denver Doctors Revolutionize Health Care - 5280 | The Denver Magazine

Read More...

Perspectum: High Liver Fat (Hepatic Steatosis) Linked to Increased Risk of Hospitalization in COVID-19 Patients With Obesity – Business Wire

April 4th, 2021 6:47 am

OXFORD, England--(BUSINESS WIRE)--New research published this month in Frontiers in Medicine (Gastroenterology) reveals that individuals with both obesity and severe fatty liver are five times more likely to require hospitalization for the illness. The non-invasive liver imaging technology Perspectums LiverMultiScan was used to gather MRI scans for the study.

Obesity is often associated with fat accumulation in the liver, which can lead to liver disease, and emerging data suggests that patients with obesity are at an increased risk of becoming seriously ill with COVID-19. The World Obesity Federation summarizes recent reports suggesting in the US almost 50 percent of people hospitalized with COVID-19 were also affected by obesity. A new report from the CDC (Centers for Disease Control and Prevention, U.S.A.) indicates 78 percent of people who were hospitalized, placed on a ventilator or died from COVID-19 were overweight or obese.

The results of the imaging study, which explored whether having excess liver fat could influence severity of COVID-19 in obese individuals, showed that individuals with both obesity as well as fatty liver were five times more likely to require hospitalization for COVID-19. Notably, individuals with obesity and normal liver fat were not at increased risk of being hospitalized.

Some individuals with obesity have a normal level of liver fat and some non-obese individuals have high levels of liver fat. It is pertinent to establish whether pre-existing liver disease increases the risk of severe COVID-19 and how this relates to obesity, says Adriana Roca-Fernandez, first author and scientist at Perspectum, the company developing LiverMultiScan. Measurement of liver fat and detection of liver disease can be achieved using non-invasive imaging methods such as Perspectums well-validated, magnetic resonance imaging (MRI) technology to help identify patients with COVID-19 who are at increased risk of severe disease.

Understanding the contribution of liver fat to COVID-19 risk and outcomes is important for clinical understanding and management of COVID-19 and long COVID. The study, Hepatic Steatosis Rather Than Underlying Obesity Increases Risk of Infection and Hospitalization for COVID-19, Roca-Fernandez et al., 2021, also confirmed some previously reported risk factors for contracting COVID-19, such as being a male and having a lower socio-economic status. In addition, this study showed that the participants who had tested positive for COVID-19 were more likely to have higher liver fat. The MRI data were acquired before the COVID-19 pandemic by the UK Biobank, one of the largest biomedical databases in the world, and included 4,458 people who had later been tested for COVID-19.

According to Dr. Arun Sanyal, Virginia Commonwealth University, one of the authors of the study, The current study demonstrates pre-existing fatty liver disease is an independent risk factor for development of severe disease in those with COVID-19. This raises important questions about the role of hepatic steatosis and related liver injury as a disease modifying factor. These data highlight the public health relevance of NAFLD beyond cardiovascular, cancer and liver outcomes and provide a strong rationale for future studies to evaluate whether de-fatting the liver will reduce the likelihood of severe COVID-19 in affected individuals.

Determining all risk factors for increased severity of COVID-19 is crucial to help shape public policy measures to protect these high-risk individuals, such as social distancing, prioritization of people for vaccinations, and access to personalized medicine to guide clinical and lifestyle interventions, adds Roca- Fernandez.

Perspectum, a global medical technology company with offices in the U.K., the U.S. and Singapore, delivers leading digital technologies that help clinicians provide better care for patients with liver disease, diabetes and cancer. With a strong focus on precision medicine using advanced imaging and genetics, our vision is to empower patients and clinicians through quantitative assessments of health enabling early detection, diagnosis, and targeted treatment. With a diverse team of physicians, biomedical scientists, engineers and technologists, Perspectum offers a way to manage complex health problems at scale. For more information, visit perspectum.com.

Excerpt from:
Perspectum: High Liver Fat (Hepatic Steatosis) Linked to Increased Risk of Hospitalization in COVID-19 Patients With Obesity - Business Wire

Read More...

Foundation Medicine Appoints Brian Alexander, M.D., M.P.H., as Chief Executive Officer – Business Wire

April 4th, 2021 6:47 am

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. today announced the appointment of Brian Alexander, M.D., M.P.H., as chief executive officer, effective April 6, 2021. Dr. Alexander previously served as Foundation Medicines chief medical officer since 2019 and brings with him years of experience as a radiation oncologist at Dana-Farber/Brigham and Womens Cancer Center and an Associate Professor at Harvard Medical School. He succeeds Cindy Perettie, who has taken on a new role within Roche Diagnostics.

Brian has been instrumental in leading Foundation Medicine in its mission to rapidly advance personalized medicine for cancer patients on a global scale, said Severin Schwan, CEO, Roche Group. As an oncologist, he is uniquely positioned to help the company become an ever-more-essential partner for patients, physicians, and the researchers developing new cancer medicines by providing them with the insights they need to support critical decisions.

Dr. Alexander joined Foundation Medicine as senior vice president of clinical development in September 2018 and was promoted to Chief Medical Officer the following year. He has directed Foundation Medicines decision insights strategy to help more oncologists, both in community and academic settings, determine the right treatment, at the right time, for each unique patient. Under his leadership, Foundation Medicines medical team has expanded its molecular tumor board program to include over 90 leading oncology centers globally, launched a cross-functional genomics and health disparities effort, and has developed hundreds of studies and publications to advance the clinical utility of genomic profiling.

I am proud to be part of a team that has delivered groundbreaking innovations catalyzed by our unparalleled insights into cancer genomics, said Dr. Alexander. I am grateful to Cindy for her leadership and mentorship during such a transformative time for the company, and Im excited to lead the next chapter for this remarkable organization as we work to enable better therapeutic decision making and help our pharmaceutical and biotech partners advance the breakthrough therapies of tomorrow.

Dr. Alexander was the founding director of the Program in Regulatory Science at the Dana-Farber Cancer Institute and the Harvard/MIT Center for Regulatory Science. He also co-founded the Global Coalition for Adaptive Research, a non-profit organization focused on clinical trial innovations to accelerate the discovery and development of cures for patients with rare and deadly diseases and served as chair of the FDA/Project Datasphere task force on external control arms. He previously co-authored a book on the interpretation of diagnostic tests for medical decision making. Dr. Alexander is an is an affiliated researcher at the MIT Laboratory for Financial Engineering and affiliated faculty of the Harvard Kennedy School Healthcare Policy Program. He was named to Boston Magazines Top Doctors List in 2019, 2020, and 2021.

Previously, Dr. Alexander served as a White House fellow and Special Assistant to the Secretary of Veterans Affairs, where he helped prepare the VA for the transition of administrations, worked to develop a public reporting system for quality, and served as a health policy advisor to the Secretary. Dr. Alexander organized the standup of the VAs Coordinating Council on National Health Reform and directed the activities of its multi-team Health Reform Working Group. He was also a member of the Institute of Medicines Committee on the Governance and Financing of Graduate Medical Education.

Dr. Alexander received his B.A. from Kalamazoo College, M.D. from the University of Michigan Medical School, and M.P.H. from the Harvard School of Public Health. He completed his training in radiation oncology at the Harvard Radiation Oncology Program.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patients cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicines molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine is a registered trademark of Foundation Medicine, Inc.

Source: Foundation Medicine

Excerpt from:
Foundation Medicine Appoints Brian Alexander, M.D., M.P.H., as Chief Executive Officer - Business Wire

Read More...

New Clinical Trial Studies Pancreatic Cancer Tumor Traits To Uncover Better Treatment Options – PRNewswire

April 4th, 2021 6:47 am

NEW YORK, March 30, 2021 /PRNewswire/ -- A new team of pioneering pancreatic cancer researchers has been formed to predict which treatments might work best for individual pancreatic cancer patients based on the molecular traits of tumors. The Pancreatic Cancer Convergence Dream Team is funded by the Pancreatic Cancer Collective, an initiative of the Lustgarten Foundation and Stand Up To Cancer (SU2C), SU2C Canada and Pancreatic Cancer Canada.

The team will be led by Jennifer Knox, MD, the Lewitt Chair in Pancreatic Cancer Research at the Princess Margaret Cancer Centre, part of University Health Network, and professor of medicine at the University of Toronto in Canada, and Elizabeth Jaffee, MD, a professor of oncology and deputy director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland.

"This team's cutting-edge work to better understand the makeup of pancreatic cancers will benefit tens of thousands of cancer patients in the United States and around the world," said Nobel Laureate Phillip A. Sharp, PhD, chair of the SU2C Scientific Advisory Committee, co-chair of the SU2C Canada Scientific Advisory Committee and Institute professor at the David H. Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology. "Pancreatic Cancer Collective-supported research has already contributed to a 2013 FDA approval of a combination therapy for advanced pancreatic cancer; the work of this Dream Team is an important next step in determining if that treatment, or another leading treatment, will work best for different pancreatic cancer subtypes."

Pancreatic cancer is the third leading cause of cancer-related death in both the United States and Canada and is exceptionally difficult to treat. The five-year survival rate for pancreatic cancer is around 10% in the United States and 8% in Canada. Additionally, Black people in the U.S. and Canada are more likely to develop pancreatic cancer than whites. In the U.S., the incidence of pancreatic cancer is 19% higher in Black men compared to white men, and 36% higher in Black women compared to white women. The Dream Team hopes to address this disparity by making recruitment of diverse patients a top priority in their research.

The Dream Team recently opened a phase II clinical trial entitled Pancreatic Adenocarcinoma Signature Stratification for Treatment (PASS-01) Trial looking more closely at the two leading treatments for advanced pancreatic cancer. One of those treatments is Modified FOLFIRINOX, which is a combination of four chemotherapy drugs. The other treatment is a combination of chemotherapy drugs gemcitabine and nab-paclitaxel. The U.S. Food and Drug Administration approved that treatment in 2013 based, in part, on the work of a previousSU2C Pancreatic Dream Team, which was a part of the Pancreatic Cancer Collective portfolio.

The two treatments are helpful for some pancreatic cancer patients but have little effect for other patients. The goal of the PASS-01 trial is to uncover more about how the two treatments work. Currently, precision medicine for pancreatic cancer patients includes a comprehensive evaluation of the tumor's genomic profile. But, doctors still don't know enough about the different types of pancreatic cancer to determine whether either treatment will help an individual patient, and if so, which treatment might work best. Building on the findings from a pancreatic cancer clinical trial conducted by the Ontario Institute for Cancer Researchwhich also is a collaborator on the PASS-01 trialpotential predictors of patient response to chemotherapy will be further tested by Knox and Jaffee and their Dream Team colleagues. They also hope the trial will help them learn more about biomarkers within patients' tumors. Their goal is to be able to identify specific biomarkers that indicate whether a pancreatic cancer will respond better to one treatment versus the other.

At the same time, the clinical trial will explore another promising method in fighting pancreatic cancer by uncovering the unique characteristics of individual patients' tumors. Collaborators at Cold Spring Harbor Laboratory in Cold Spring, New York, will create patient-derived organoids (PDOs) from biopsies of trial participants' tumors. The miniature 3-D structures are grown in lab dishes from tiny bits of tumors taken from patients. Scientists then see how the PDOs react to different types of cancer drugs. This work may lead to more effective individualized treatments for pancreatic cancer.

"We have brought together some of the finest pancreatic cancer researchers in North America; the time is right to dig in much deeper to help understand pancreatic cancer," Knox said. "We need to stop assuming one size fits all and instead advance the field by gaining a better understanding of every tumor. We believe our work can help doctors treat patients optimally today while providing a better understanding of this deadly disease into the near future."

"There is a critical need to identify ways that medicine can better treat pancreatic cancers," Jaffee said. "We believe by identifying and learning more about these biomarkers, we can help make that happen. We can give patients more hope that their cancers can be treated effectively."

"Personalized medicine has been a game changer in the treatment of many other cancers and this trial is a significant step toward offering this type of individualized care to metastatic pancreatic cancer patients," said David Tuveson, MD, PhD, chief scientist for the Lustgarten Foundation and director of the Lustgarten Foundation Pancreatic Cancer Research Lab at Cold Spring Harbor Laboratory where pancreatic cancer organoids were co-developed. "The international partnership between these organizations is a great example of collaboration between labs to help physicians make faster, better informed decisions in efforts to provide patients with better outcomes."

Knox and Jaffee have already begun enrolling clinical trial participants at Princess Margaret Cancer Centre and Johns Hopkins. The team hopes to enroll 150 patients in the trial, with four additional locations throughout the United States and Canada opening soon, including Memorial Sloan Kettering Cancer Center in New York City, Northwell Health in Long Island, Dana Farber Cancer Institute in Boston and BC Cancer in Vancouver, B.C.

# # #

Media Contact:Mirabai Vogt-JamesStand Up To Cancer[emailprotected]

About Stand Up To CancerStand Up To Cancer (SU2C) raises funds to accelerate the pace of research to get new therapies to patients quickly and save lives now. SU2C, a division of the Entertainment Industry Foundation, a 501(c)(3) charitable organization, was established in 2008 by media and entertainment leaders who utilize these communities' resources to engage the public in supporting a new, collaborative model of cancer research, to increase awareness about cancer prevention, and to highlight progress being made in the fight against the disease. As of 2021, more than 1,950 scientists representing more than 210 institutions are involved in SU2C-funded research projects.

Under the direction of our Scientific Advisory Committee, led by Nobel laureate Phillip A. Sharp, Ph.D., SU2C operates rigorous competitive review processes to identify the best research proposals to recommend for funding, oversee grants administration, and ensure collaboration across research programs.

Current members of the SU2C Founders and Advisors Committee (FAC) include Katie Couric, Sherry Lansing, Kathleen Lobb, Lisa Paulsen, Rusty Robertson, Sue Schwartz, Pamela Oas Williams, and Ellen Ziffren. The late Laura Ziskin and the late Noreen Fraser are also co-founders. Sung Poblete, Ph.D., R.N., serves as SU2C's CEO. For more information, visitStandUpToCancer.org.

About the Pancreatic Cancer CollectiveThe Pancreatic Cancer Collective is an initiative of Lustgarten Foundation and Stand Up To Cancer to improve pancreatic cancer patient outcomes. Together, these leading cancer research organizations have funded 26 projects for a total of more than $108 million and are attracting new collaborators; employing big data to improve diagnosis of pancreatic cancer; finding new treatments for pancreatic cancer; and supporting the next generation of pancreatic cancer investigators. Engaging thought leaders, researchers, institutions, and companies, the Collective is innovating and accelerating research on the edge of science. For more information, visit PancreaticCancerCollective.org.

About the Lustgarten FoundationThe Lustgarten Foundation is the largest private funder of pancreatic cancer research in the world. Based in Woodbury, N.Y., the Foundation's mission is to cure pancreatic cancer by funding scientific and clinical research related to the diagnosis, treatment, and prevention of pancreatic cancer; providing research information and clinical support services to patients, caregivers and individuals at high risk; and increasing public awareness and hope for those dealing with this disease. Since its inception, the Lustgarten Foundation has directed more than $200 million to research and has assembled the best scientific minds with the hope that one day, a cure can be found. Thanks to separate funding to support administrative expenses, 100 percent of your donation funds pancreatic cancer research. For more information, visit Lustgarten.org.

About Stand Up To Cancer CanadaStand Up To Cancer Canada is a Canadian registered charity (Reg: # 80550 6730 RR0001), launched by the U.S.-based Entertainment Industry Foundation in 2014. Stand Up To Cancer Canada (SU2C Canada) raises funds to support collaborative cancer research teams, as well as education and awareness programs conducted in Canada.

Under the direction of our SU2C Canada Scientific Advisory Committee, co-led by Alan Bernstein, Ph.D., president of the Canadian Institute for Advanced Research (CIFAR) and Nobel laureate Phillip A. Sharp, Ph.D., SU2C Canada operates rigorous competitive review processes to identify the best research proposals to recommend for funding, oversee grants administration, and ensure collaboration across research programs. SU2C Canada currently supports three "signature" Dream Teams engaging dozens of the best and brightest researchers in different disciplines from 15 institutions across the country.

In addition to a board of leading Canadian broadcaster representation, SU2C Canada is guided by the SU2C Council of Founders and Advisors (CFA) including Katie Couric, Sherry Lansing, Kathleen Lobb, Lisa Paulsen, Rusty Robertson, Sue Schwartz, Pamela Oas Williams, and Ellen Ziffren. The late Laura Ziskin and the late Noreen Fraser were also co-founders. Sung Poblete, Ph.D., RN serves as SU2C CEO. The CFA includes entertainment industry leaders who utilize these communities' resources to engage the public in supporting this new, collaborative model of cancer research, to increase awareness about cancer prevention, and to highlight progress being made in the fight against the disease. For more information on Stand Up To Cancer Canada, visitStandUpToCancer.ca.

About Pancreatic Cancer CanadaPancreatic Cancer Canada is fighting to raise survival rates for the world's toughest cancer investing in targeted research, increased awareness and patient support, community activation and advocacy. We have taken on one of the world's deadliest cancers a disease with virtually no progress in survival in the past 40 years and a 92% mortality rate. We are aggressively fighting it with investments in research aimed at greater understanding of this cancer and better treatment options. At the same time, we are working to educate physicians about faster diagnosis and with patients/families to support them as they face the realities of this cancer in their lives. To learn more, please visitwww.pccf.ca.

SOURCE Stand Up To Cancer

Homepage

Read the original post:
New Clinical Trial Studies Pancreatic Cancer Tumor Traits To Uncover Better Treatment Options - PRNewswire

Read More...

Natera and Tesis Labs Announce Strategic Collaboration on Prenatal Genetic Testing – PRNewswire

April 4th, 2021 6:47 am

AUSTIN, Texas, March 31, 2021 /PRNewswire/ --Natera, Inc.(NASDAQ: NTRA), a pioneer and global leader in non-invasive genetic testing and analysis of cfDNA, and Tesis Labs, a US multi-region lab services provider with labs in Colorado, Texas and Arizona, announced a strategic partnership in the field of prenatal genetic testing.

The collaboration will allow Tesis to broaden its portfolio of genetic testing offerings and participate in the fast growing screening market for over 4 million pregnancies in the United States. Tesis's state-of-the-art and highly scalable genetics laboratory in Lafayette, Colorado can serve many regions of the U.S. including Texas, Arizona and Colorado.

"Natera is pleased to partner with Tesis Labs to improve patient testing access and convenience in a number of critical regional markets for both Natera and Tesis," said Ramesh Hariharan, General Manager of Natera's Women's Health business.

"We are honored to partner with Natera," said Tesis Labs CEO Ron King. "Working together will offer new opportunities for early screening, allowing more informed treatment and care decisions for women and their families. Our combined expertise and technology will play a major role in helping patients."

About Tesis Labs

Tesis Labs' genetically integrated medical platform has revolutionized targeted genetic sequencing. Our mission is to change medicine by providing physicians, hospitals, and researchers with the tools to help patients treat and overcome major chronic conditions such as heart disease, lung disease, cancer, and diabetes through advanced genetic testing. Tesis offers healthcare providers, and physicians' access to our unique genetic testing and precision medicine, enabling them to create personalized care plans for treating chronic diseases individually and across generations. We also enable medical device companies and pharmaceuticals to bring new products to market and create a robust repository of genetic data and research. Visitwww.tesislabs.comto learn more.

Media Contact: Kim Warth, Amendola Communications303-918-9205[emailprotected]tingpr.com

About Natera

Naterais a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at http://www.natera.com/investors and http://www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350

Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., [emailprotected]

SOURCE Natera, Inc.

Read more here:
Natera and Tesis Labs Announce Strategic Collaboration on Prenatal Genetic Testing - PRNewswire

Read More...

Outlook on the Biomarkers Global Market to 2025 – Rising Incidence of Diseases Presents Opportunities – GlobeNewswire

April 4th, 2021 6:47 am

Dublin, April 02, 2021 (GLOBE NEWSWIRE) -- The "Biomarkers: Technologies and Global Markets 2021" report has been added to ResearchAndMarkets.com's offering.

This new report, Biomarkers: Technologies and Global Markets, provides a comprehensive analysis of the biomarkers market in a global context, including market forecasts and sales through 2025. The report analyzes the market, segmenting it into various product offerings (i.e., instruments, consumables [reagents, kits and panels], services and software). Segmentation also provides analysis by popular technology type (genomics, proteomics and metabolomics, imaging and bioinformatics).

This study surveys the biomarker market by therapeutic area (cancer, cardiovascular and metabolic diseases, infectious diseases, neurodegenerative diseases, autoimmune diseases and others. End-users include academic institutes, pharma and biotechnology companies, clinical research organizations, hospitals and diagnostics. Geographic regions include North America, Europe and Emerging markets. Emerging markets include countries like India, China, Korea, Taiwan, Africa, Australia, New Zealand, Canada, Latin America, etc.

This report features new product developments and patents that are boosting global growth in this market.

This report provides comprehensive profiles of market players in the industry. The industry structure chapter focuses on changing market trends, market players and leading products. This chapter also covers mergers and acquisitions and other collaborations or partnerships that are expected to shape the industry.

Strengths, weaknesses, threats and opportunities are expected to play a role in the diagnostic biomarkers market. These are evaluated in detail.

The scope of the report excludes in vitro diagnostic products and regulatory aspects. Digital biomarkers are not covered in this report.

Report Includes:

Biomarkers, the biological indicators of health and disease, have come a long way, from being used as simple measurements of clinical diagnosis, to becoming essential tools in the clinical space and drug discovery and development. The utility of biomarkers has been expanding over the last couple of decades, due to the potential for predicting disease diagnosis and prognosis, treatment response, pharmacokinetics of drugs and monitoring therapy. During the COVID-19 pandemic, boosted R&D for novel diagnostics led to the approval of many biomarker-based diagnostic tests for early and rapid detection of the SARS-CoV-2 virus.

Pharmaceutical and biopharmaceutical drug developers struggle to overcome escalating cost barriers and high drug attrition rates in late-stage clinical trials. Biomarkers are promising tools to address drug development challenges. offering the prediction of drug toxicity and efficacy in early stages. The 21st Century Act allowed the Food and Drug Administration (FDA) to publish guidelines for Biomarker Qualification for use in drug development programs, paving the way for biomarker inclusion into drug development through either the drug approval process or the Biomarker Qualification Program.

Biomarkers are extremely useful in clinical trials, increasingly used to identify populations for a study, monitor therapeutic response and identify side effects. There is an emerging market of clinical research organizations (CROs) carrying out clinical trial recruitment and other services, while expanding technical expertise in bioanalytical and biomarker development. This enables pharmaceutical clients access to biomarker discovery and development.

The global biomarkers market is growing at a significant pace, driven by an explosion of publications and clinical trials. Enhanced analytical methods and the development of new, sophisticated and sensitive multiplex methods in gene expression analysis, proteomics, metabolomics and transcriptomics bring huge momentum to this market. The development of multi-biomarker assays, novel immunoassays and multi-modal imaging and mass spectrometry methods further drive market growth.

Collaborations and strategic partnerships, mergers and acquisitions and other deals between private and public players are on the rise. Companies are strengthening technical know-how and expanding product portfolios in order to offer enhanced services and new offerings to the biomarker research community. Precision medicine, particularly in the field of cancer, has contributed tremendously to an interest in biomarkers, with growing adoption of biomarkers in companion diagnostics and selecting targeted patient populations for high-value drugs. Other therapeutic areas, such as cardiovascular, neurodegenerative and autoimmune diseases are getting noticeable attention in biomarker research.

Challenges for this market, remain in the form of disparity in biomarker definitions at an international level and lack of any defined regulatory guidance for use in R&D. There is still a need to develop sensitive and robust methods of analysis for low concentration analytes via methods that can be validated. Lack of skilled manpower and the high cost of technology are other challenging factors.

Positive approaches in biomarker research, effective dialogue and collaborations between all stakeholders is expected to address challenges and take this market forward in coming years.

Key Topics Covered:

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Market and Technology Background

Chapter 4 Market Breakdown by Product Type

Chapter 5 Market Breakdown by Technology Type

Chapter 6 Market Breakdown by Therapeutic Area

Chapter 7 Market Breakdown by End User

Chapter 8 Industry Structure

Chapter 9 Clinical Trials

Chapter 10 Patent Analysis

Chapter 11 Analysis of Market Opportunities

Chapter 12 Company Profiles

Chapter 13 Appendix: Abbreviations/Acronyms

For more information about this report visit https://www.researchandmarkets.com/r/xjd6q0

Read the original here:
Outlook on the Biomarkers Global Market to 2025 - Rising Incidence of Diseases Presents Opportunities - GlobeNewswire

Read More...

Cerba healthcare to welcome EQT as new shareholder to foster innovation and continue to meet the healthcare challenges – PRNewswire

April 4th, 2021 6:47 am

Cerba Healthcare, headquartered in France and firmly established in Europe and Africa through its historical routine and specialty biology expertise, also operates globally through its clinical trials business unit for the validation of new compounds and vaccines. It stands as a unique group in the diagnosis market, covering the needs for diagnostic tools and expertise for patients, physicians, hospitals and the pharmaceutical industry.

With this new partnership, Cerba HealthCare reinforces its capital structure with its existing shareholders -more than 400 long-time biologists and managers- and its long-term partner, PSP Investments, to sustain the Group's development strategy and current transformation.

Catherine Courboillet, CEO, Cerba HealthCare, states: "Over the past four years, Partners Group has shown a comprehensive understanding of our market and unwavering support in sustaining Cerba HealthCare's growth strategy. In order to continue to fulfill the Group's long-term development, we are excited to welcome a partner that shares the same vision and values, as well as a strong understanding of the importance of cutting-edge, personalized services. It is critical to keep on investing heavily in innovation, IT security and talents in order to drive further and faster our on-going transformationtowards better healthcare services for patients. With EQT, we have chosen an experienced partner that will strengthen our European positioning while helping us expand into new markets."

Nicolas Brugre, Partner, Investment Advisor at EQT Partners and Head of EQT France, comments:"EQT has followed Cerba HealthCare for a long time and we are deeply impressed with the company's unique platform for medical diagnoses and superior scientific expertise. Cerba HealthCare is a purpose-driven company with a culture that is well-aligned with EQT's values and we are happy to partner with its management team and with PSP Investments. EQT Private Equity is committed to invest in and future-proof Cerba HealthCare for the long-run to best serve patients and healthcare professionals."

Kim Nguyen, Partner, Private Equity Services, Partners Group, adds: "Cerba HealthCare operates in an important sector and we are proud to have successfully contributed to the sustainable growth strategy of the Company over the last four years. In line with Partners Group's focus on positive stakeholder impact and entrepreneurial governance, Cerba HealthCare has not wavered in its commitment to responding to the COVID-19 crisis. During our holding period, the Company has transformed into a market leader, penetrating new international markets, including in Africa and Italy, further consolidating its expertise in clinical trials and securing leadership in the veterinary biology sector. We are convinced Cerba HealthCare is poised for lasting success and that, after our strong and collaborative partnership, it is the right time and opportunity for all stakeholders that the Company move into its next phase of growth."

Simon Marc, Senior Managing Director and Global Head of Private Equity, PSP Investments, said: "Since our initial partnership with Cerba HealthCare in 2017, the company has gone from strength to strength, and we are excited to continue supporting Catherine and her talented management team as long term-partners. We look forward to welcoming EQT who has been one of PSP Investments core partners for many years, and who brings tremendous expertise in European healthcare. Together, we will provide the long-term strategic capital to support Cerba HealthCare in achieving its full potential through its next phase of development as a European leader in medical diagnostics."

Following the completion of the deal, which is subject to administrative notifications and regulatory approvals, EQT Private Equity and PSP Investments will work with Cerba HealthCare's management team, led by CEO Catherine Courboillet, to support the numerous growth opportunities of the business. These include the continuation of the Company's highly successful M&A strategy on a global scale, as well as the acceleration of organic growth and development in other segments.

About Cerba HealthCareCerba HealthCare, a leading player in medical diagnosis, aims to support the evolution of health systems towards more prevention. It draws on more than 50 years of expertise in clinical pathology to better assess the risk of diseases development, detect and diagnose diseases earlier, and optimize the effectiveness of personalized medicine.

Every day, on 5 continents, the Group's 8500 employees sustain the transformation of medicine, driven by one deep conviction: to advance diagnosis is to advance health.Cerba HealthCare, enlightening health.

About PSP InvestmentsPSP Investments is one of Canada's largest pension investment managers with approximately $169.8 billion of net assets as of March 31, 2020. It manages a diversified global portfolio of investments in public financial markets, private equity, real estate, infrastructure, natural resources and private debt. Established in 1999, PSP Investments manages net contributions to the pension funds of the federal Public Service, the Canadian Forces, the Royal Canadian Mounted Police and the Reserve Force. Headquartered in Ottawa, PSP Investments has its principal business office in Montreal and offices in New York, London and Hong Kong. For more information, visit investpsp.com or follow PSP Investments on Twitter and LinkedIn.

About Partners GroupPartners Group is a leading global private markets firm. Since 1996, the firm has invested over USD 145 billion in private equity, private real estate, private debt and private infrastructure on behalf of its clients globally. Partners Group is a committed, responsible investor and aims to create broad stakeholder impact through its active ownership and development of growing businesses, attractive real estate and essential infrastructure. With over USD 109 billion in assets under management as of 31 December 2020, Partners Group serves a broad range of institutional investors, sovereign wealth funds, family offices and private individuals globally. The firm employs more than 1,500 diverse professionals across 20 offices worldwide and has regional headquarters in Baar-Zug, Switzerland; Denver, USA; and Singapore. It has been listed on the SIX Swiss Exchange since 2006 (symbol: PGHN). For more information, please visit http://www.partnersgroup.comor follow us on LinkedInor Twitter.

About EQT EQT is a purpose-driven global investment organization with more than EUR 84 billion in raised capital and over EUR 52 billion in assets under management across 17 active funds. EQT funds have portfolio companies in Europe, Asia-Pacific and North America with total sales of more than EUR 27 billion and approximately 159,000 employees. EQT works with portfolio companies to achieve sustainable growth, operational excellence and market leadership.More info: http://www.eqtgroup.com Follow EQT on LinkedIn, Twitter, YouTube and Instagram

Press contacts: Cerba Healthcare, Emmanuelle Saby, +33 6 09 10 76, [emailprotected]; PSP Investments, Maria Constantinescu, 1 844 525 3795, [emailprotected]; EQT, Brunswick Paris: Benoit Grange, (+ 33 6 14 45 09 26); Hugues Boton, (+33 6 79 99 27 15), [emailprotected]; Press contact EQT: [emailprotected]- +46 8 506 55 334; Partners Group, Jenny Blinch, +44207575 2571, [emailprotected]

Logo - https://mma.prnewswire.com/media/1477637/PSP_Investments_Cerba_healthcare_to_welcome_EQT_as_new_sharehold.jpg

http://www.investpsp.ca/

SOURCE PSP Investments; Cerba Healthcare

View post:
Cerba healthcare to welcome EQT as new shareholder to foster innovation and continue to meet the healthcare challenges - PRNewswire

Read More...

City of Hope Receives $50 Million Gift From Lennar Foundation to Build the Future of Cancer Care – BioSpace

April 4th, 2021 6:47 am

IRVINE, Calif.--(BUSINESS WIRE)-- World-renowned cancer research and treatment center City of Hope has received a $50 million gift from Lennar Foundation, the charitable arm of homebuilder Lennar Corporation. This transformational gift of hope is the largest single philanthropic contribution to City of Hope Orange County. It will expedite the health care organizations bold plans to invest $1 billion to develop and operate a comprehensive cancer campus in Irvine, California, and establish an Orange County network of advanced cancer care and research that will speed groundbreaking treatments directly to a community with growing needs.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210331005094/en/

Lennar Foundation Cancer Center, opening in 2022 (Photo: City of Hope)

The future 190,000-square-foot Lennar Foundation Cancer Center at City of Hope Orange County will be located on 11 acres at Five Points Great Park in the heart of Irvine. It will bring best-in-class cancer care, pioneering research and lifesaving treatments to the countys 3.2 million residents. Construction is already underway on the comprehensive cancer center, which will open in 2022. In addition, Orange Countys only hospital dedicated exclusively to treating and curing cancer will open at City of Hope Irvine in 2025.

City of Hopes presence in Orange County offers local access to City of Hopes National Cancer Institute-designated comprehensive cancer center with world-renowned cancer physicians and researchers who are singularly focused on finding better treatments and cures.

Lennar Foundation Cancer Center at City of Hope Orange County will bring to the region a host of distinguishing services, including:

As the country emerges from the COVID-19 pandemic, Lennar Foundations extraordinary contribution underscores the importance of investing in local health care resources and increasing access to leading-edge care. For Orange County, it is a reminder that cancer does not stop, and that City of Hopes mission is more important than ever.

Lennar has a long history in Orange County of developing thriving communities, including helping form the vision for a world-class recreation and lifestyle destination. This gift is an extension of this longstanding commitment to improving lives in the regions Lennar helps shape. A portion of the gift to City of Hope is designated to support clinical translational research between City of Hope and the Sylvester Comprehensive Cancer Center of the University of Miami, thus uniting two organizations supported by Lennars generosity who share similar goals in developing new treatments and cures for patients with cancer.

City of Hope and Sylvester Comprehensive Cancer Center serve two of the most diverse areas in the United States. Both organizations are committed to conducting high-impact research that addresses the cancer burden in their communities. This gift will enable collaborative, translational science that will drive innovation and catalyze timely and necessary progress towards health equity.

Lennar Foundations gift to City of Hope is a generous continuation of Lennars longstanding support of the comprehensive cancer center. Jon Jaffe, co-chief executive officer and co-president of Lennar Corporation, is a member of City of Hopes Construction Industries Alliance Leadership Advisory Council, which raises funds for cancer treatment and research. In recognition of his contributions, Jaffe was awarded City of Hopes highest honor The Spirit of Life Award in 2004.

City of Hope Newport Beach, the first phase of City of Hope Orange Countys expansion, opened in early 2020, providing Orange County residents first-time local access to world-renowned physicians backed by the powerful City of Hope network. City of Hope plans to open other clinical network locations across the region.

Supporting quotes

Robert Stone, president and CEO, City of HopeHelen and Morgan Chu Chief Executive Officer Distinguished Chair

This is the start and it is a monumental start to show the nation that our work in Orange County will catalyze incredible achievements in health care. Visionary donors and volunteers have been foundational to City of Hopes 108-year history, and we are deeply grateful to the Lennar Foundation for their extraordinary contributions and longstanding support. With this gift, we will achieve the nexus of unsurpassed medical expertise, future-focused communities, groundbreaking technology and innovation, all for the single purpose of saving lives. This partnership supports a system of care delivery that provides state-of-the-art treatments, the latest scientific and medical discoveries, and unprecedented access that will serve as a model across the country.

Stuart Miller, executive chairman, Lennar Corporation

At Lennar, we are committed to building communities, and we are pleased to support City of Hope to help build the future of cancer care. Together, we are building a state-of-the-art center for advanced cancer care and research that will make a difference in the lives of so many by turning science into practice and hope into reality.

Nicole Petersen Murr, grateful Orange County patient

City of Hope saved my life. My family and I will be forever grateful to my doctor and care team. Anyone who has heard the words You have cancer knows how those words change your life and affect every piece of it. I want everyone who hears those words to have the same compassionate care and access to the latest treatments that I had. Having City of Hope in Orange County changes everything for cancer patients present and future. Im so grateful to have this world-renowned care in my own community.

Annette M. Walker, president, City of Hope Orange County

This generous gift of hope is a historic moment for City of Hope. Thank you to Lennar Foundation, which is united in our vision and understands the urgency of our work, helping us ensure that our promise to Orange County will be fulfilled. We are building a place of hope and healing that will serve residents of Orange County and beyond for generations to come. Every one of us has been touched by cancer and we want all who are impacted by this disease to know we are here for you, your family, friends and neighbors.

Jon Jaffe, co-chief executive officer and co-president, Lennar Corporation

City of Hope is a leader in the treatment of and race to find a cure for cancer, and its gratifying to know that, with this gift, we will make a positive impact by expanding access to care and advancing the research that will treat, prevent and ultimately eliminate cancer we hope this contribution will encourage other philanthropic leaders to support City of Hope in the fight against cancer.

Kristin J. Bertell, chief philanthropy officer, City of Hope

This important contribution is a clear demonstration of the power of philanthropy to accelerate positive changes in health care delivery, spur advances in science, research and treatment, and give real hope to patients, families and communities. Lennar Foundations generosity continues a long philanthropic legacy that is the cornerstone of our history. There is no doubt that this gift will have a long-lasting impact, and we look forward to engaging the community to make the vision for Orange County and the future of cancer care a reality.

For more information on the progress of City of Hopes Orange County expansion and its first clinical network location in Newport Beach, please visit CityofHope.org/OC.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hopes translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies, and numerous breakthrough cancer drugs are based on technology developed at the institution. Translational Genomics Research Institute (TGen) became a part of City of Hope in 2016. AccessHope, a wholly owned subsidiary, was launched in 2019, dedicated to serving employers and their health care partners by providing access to City of Hopes exceptional cancer expertise. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nations Best Hospitals in cancer by U.S. News & World Report. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

About Lennar Corporation

Lennar Corporation, founded in 1954, is one of the nation's leading builders of quality homes for all generations. Lennar builds affordable, move-up and active adult homes primarily under the Lennar brand name. Lennar's Financial Services segment provides mortgage financing, title and closing services primarily for buyers of Lennar's homes and, through LMF Commercial, originates mortgage loans secured primarily by commercial real estate properties throughout the United States. Lennar's Multifamily segment is a nationwide developer of high-quality multifamily rental properties. LENX drives Lennar's technology, innovation and strategic investments. For more information about Lennar, please visit http://www.lennar.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210331005094/en/

Continue reading here:
City of Hope Receives $50 Million Gift From Lennar Foundation to Build the Future of Cancer Care - BioSpace

Read More...

UM School of Medicine Dean Announces He Will Transition From The Deanship In 2022 After Completing 16-Year Tenure – PRNewswire

April 4th, 2021 6:47 am

BALTIMORE, March 31, 2021 /PRNewswire/ --University of Maryland School of Medicine (UMSOM) Dean E. Albert Reece, MD, PhD, MBA, a widely recognized visionary leader who elevated the UMSOM into a top-tier biomedical research and patient-focused academic center, announced that he will complete his 16-year tenure as Dean, at the end of the next academic year. He will return to the UMSOM faculty where he will lead a new Center, and continue research and teaching.

Dr. Reece, who is also Executive Vice President for UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor, was appointed as the UMSOM's 30th Dean in 2006. Over the course of his Deanship, he led the UMSOM through a period of unprecedented, record-breaking growth and achievements across all its areas of operation, enabling the UMSOM to reach major milestones in research, clinical care, reputation, and global impact. He is considered to be one of the most successful Deans in the U.S., as well as in our institution's rich 214-year history.

Under his leadership:

Dr Reece commented, "I deem it a distinct honor and privilege to have led the UMSOM over several years. Much of the accomplishments and successes in the UMSOM are due to the excellent team I have been blessed to work with, and the support of the UMB leadership over the years. The support from the UMSOM Board of Visitors, the alumni, Directors, Chairs, Dean's senior staff, and assistants have been truly invaluable." He continued, "I am most pleased to pass the baton to a new Dean who undoubtedly will take the UMSOM to new heights."

A leading physician-scientist, and member of the prestigious National Academy of Medicine (NAM), Dr. Reece has served on the NAM's Governing Council and the Executive Committee. He holds faculty appointments as Professor in the Departments of Obstetrics and Gynecology, Medicine, and Biochemistry & Molecular Biology. During his entire Deanship, Dr. Reece remained active in his NIH multi-million-dollar research laboratory group, studying the bio-molecular mechanisms of diabetes-induced birth defects. This laboratory was transitioned to become the Center for Birth Defects Research. Dr. Reece promoted his mentee and lab associate, Peixin Yang, PhD, Professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences, to direct the Center with him. The Center is now supported by seven NIH RO1 grants. Notably, Dr. Reece and his colleagues have unraveled the molecular mechanism into the causation of diabetes-induced birth defects, and have identified and patented molecular targets to be used in preventive and therapeutic strategies.

At the national level, Dean Reece is well known among medical school deans for his mentoring of faculty across the U.S. who aspired to leadership positions. Through his active participation in the AAMC's Dean's Fellowship Program, many senior faculty members have "shadowed" Dean Reece during his tenure and received valuable mentoring from him.

Dean Reece has served on many medical, governmental and civic organization committees, including serving as Chair of the Council of Deans of the Association of American Medical Colleges (AAMC). He currently serves on the board of Research America, and has been recently named to the Board of the Lasker Foundation. During his career, he has served additional organizations, agencies, and cultural/educational institutions, including the Secretary of Health & Human Services Committee on Infant Mortality, The March of Dimes Birth Defects Foundation, the Harvard/ Massachusetts General Hospital Scientific Advisory Committee, and the Baltimore Symphony Orchestra.

Dr. Reece is a sought-after Visiting Professor and Lecturer at numerous institutions both nationally and internationally. He has published extensively in the scientific literature-12 books including revisions and more than 500 publications.

He has received from various universities and government organizations numerous special awards, citations, and honorary degrees in recognition of his distinguished leadership, lifetime achievement, and major contributions to science and medicine.

"I was heavily involved in the recruitment of Dean Reece when he came to UMSOM as Dean," said former University System of Maryland (USM) Chancellor "Brit" Kirwan, PhD. "I consider his appointment to be one of the most important efforts I was involved in as Chancellor of the University System of Maryland. Under Dr. Reece's leadership, our School of Medicine has soared to new heights of excellence as a powerhouse in medical research, a highly regarded institution for training the next generation of doctors, and a valued source of community engagement. His irrepressible commitment to excellence in all aspects of the School's mission has been transformative. He leaves a legacy of accomplishment that will endure for the benefit of generations to come," he said.

A Leader in Service

As Dean, Dr. Reece has also been a prominent leader in the local business and health care community as well. He has been a visible member of the local community and a familiar face to residents who attend the UMSOM's various community programs. Each year at Thanksgiving, Dean Reece has been a fixture at "Project Feast," where he serves dinner and engages with community residents. He is also well known by the hundreds of participants (both and adult and children) who are "students" in UMSOM's highly successful and longstanding "Mini-Med School" and "Mini-Med School for Kids" programs. At each Mini-Med School Graduation Ceremony, Dean Reece greets and delivers special completion certificates to each community participant.

With a new charter and new leadership, the UMSOM's Program in Health Equity and Population Health, Directed by Erin Hager, PhD, Associate Professor of Pediatrics, and Deputy Director Laundette Jones, PhD, MPH, Associate Professor of Epidemiology & Public Health, now combines research, education, and service to advance health equity by addressing the critical health issues often influenced by the social determinants of health. In recent years, the Program has generated 331 active grants with funding of $128 million.

Bruce E. Jarrell, MD, FACS, president of the University of Maryland, Baltimore, said,"I wish to thank Dean Reece for his outstanding leadership in creating an even stronger medical school and wish him all the best as he transitions out of the deanship. Dean Reece leaves the School of Medicine in an excellent position for a new leader to take the school into a post-COVID world."

Growth of the Academic Enterprise

During his Deanship at UMSOM, Dr. Reece presided over dramatic growth of an academic enterprise that now totals 45 academic units, including 25 departments and 20 research centers, institutes, and programs. He expanded the UMSOM's academic facilities to 17 buildings, covering more than 2.5 million square feet of research and academic space, and led the planning and construction of a 430,000 square foot, state-of-the-art advanced research facility. Subsequently, he launched a nationwide investigator recruitment effort, resulting in 30 teams of top NIH-funded scientists from leading institutions across the country, joining the UMSOM's faculty of more than 3,500 physicians and scientists. He also led the complete renovation of Leadership Hall into an elegantly designed 700-seat theatre-style structure that now hosts major conferences and special events.

Over the past five years, Dean Reece has successfully recruited a new generation of department chairs with the appointment of top physicians and scientists from both inside and outside the UMSOM.

From the beginning of his tenure as Dean, Dr. Reece was keenly focused on elevating the UMSOM's leadership position in biomedical research, building on the foundation laid by his predecessor, a visionary leader, Dean Emeritus Donald Wilson, MD.Dean Reece laid out a specific plan to focus on "Big Science Research," with the goal of fundamentally changing the health care landscape and making a lasting and direct impact on patients' health and well-being.

Soon after joining UMSOM as Dean, Dr. Reece and Dr. Bruce Jarrell ( who served as the UMSOM Executive Vice Dean), successfully recruited two well-known and highly accomplished scientists and their research teams to the UMSOM: Claire Fraser, PhD, who established a new Institute for Genome Sciences (IGS), and Robert Gallo, MD, who transitioned the Institute of Human Virology (IHV) to the UMSOM. In the ensuing years, Dean Reece launched additional centers, such as STAR (Shock Trauma, Anesthesiology Research Center), and the Center for Epigenetic Research in Child Health & Brain Development, the Center for Blood Oxygen Transport and Hemostasis, and others, now totaling 20. He also significantly expanded the Center for Vaccine Development & Global Health.

In 2013, in the midst of a challenging economy and a dearth of commercial construction, Dean Reece embarked on an ambitious plan to construct a new world-class research facility for UMSOM. Despite significant challenges, Dean Reece, along with then-University System of Maryland Chancellor, Brit Kirwan, PhD, and with former UMB Presidents, the late Dr. David Ramsay, and Jay Perman, MD (now USM Chancellor), relentlessly pursued, and successfully implemented, a multi-faceted plan to make the new facility a reality.

In December, 2017, the UMSOM opened its new 430,000 square-foot research building Health Sciences Research Facility III (HSRF III), becoming the largest building ever constructed in the University System of Maryland, and setting a new standard of excellence in biomedical research, innovation, and discovery. Working in HSRF III's state-of-the art laboratories with cutting edge genomic technology, faculty physicians and scientists are now working together on breakthrough treatments for cancer, diabetes, and heart disease.

In 2013, Dr. Reece launched Accelerating Innovation and Discovery in Medicine (ACCEL-Med), a major UMSOM initiative designed to increase the pace and scope of clinical and basic sciences research. The Accel-Med initiative was launched with the first UMSOM "Festival of Science," which has become an annual full-day symposium highlighting the breakthrough research being conducted by UMSOM faculty. A cornerstone of Accel-Med was the Dean's formation of the UMSOM's first "Scientific Advisory Council" (SAC) to review and evaluate the UMSOM's research efforts on an annual basis. The Council, which included preeminent scientists, Nobel laureates and National Academy members, continues today.

At the inaugural Festival of Science, Dean Reece announced the opening of new core biomedical research facilities with funding from National Institutes of Health (NIH), called the Center for Innovative Biomedical Resources (CIBR). It was the first time that the UMSOM had established a center of excellence for state-of-the-art technologies, high-tech instrumentation, and expertise to support biomedical research, clinical practice, and health care. Dean's Challenge Awards were also established to provide seed funding to UMSOM scientists and encourage collaborations across departments. In 2021, the UMSOM has climbed to the top tier of medical schools in federal research funding.

"Dean Reece's mark on the School of Medicine is unmistakable; he's been integral to its enormous success," said University System of Maryland Chancellor Jay A. Perman, MD. "It's fitting that Dean Reece leaves the deanship at a time when the school is enjoying such well-deserved acclaim, nationally and internationally. I wish him all the best as he transitions into a role that gives him the same personal and professional satisfaction as have his 15 years leading the UMSOM."

Major National Designation and Clinical Expansion

Dean Reece led significant growth of the UMSOM's clinical practices across the State of Maryland during his tenure as Dean:

Added Cynthia Egan, current Chair of the UMSOM Board of Visitors: "There are many grateful patients whose care and cures have come from the exemplary leadership of the School of Medicine under Dean Reece. His relentless focus for excellence in research, academics, and developing extraordinary faculty and practitioners have advanced UMSOM to be a powerful force in delivering the best of medicine. It has been and will continue to be a true privilege to work with Dean Reece."

Commitment to Diversity, Equity and Inclusion

Dean Reece is known by faculty, staff, and colleagues for his "relentless pursuit of excellence" mantra, and his sincere dedication to making an impact on people's lives every day. He has been recognized for initiating a long-term school-wide culture transformation in diversity, equity, and inclusion. Through his leadership and close collaboration with faculty, students, and staff, the Culture Transformation Initiative (CTI) has become a top priority for the institution, with new programs aimed at ensuring equity in opportunity, recruitment, promotion, and compensation.

Dr. Reece's commitment to increasing diversity across the UMSOM has ignited positive changes and has resulted in growing numbers of women (40-60 percent) and under-represented minorities among senior leadership, faculty, and students. Specifically, women now make up more than 40 percent of UMSOM's senior leadership; the percentage of women faculty has increased to 40 percent, with under-represented minorities making up 11 percent. In the UMSOM student body, 60 percent of students are now women, and 25 percent are under-represented minorities.

Shaping the Future of Medical Education

Dr. Reece, as a scholar and educator, shaped the future of medical education in significant ways. He launched the first program for MD students in the nation on the Foundations of Research and Critical Thinking (FRCT), ensuring that the new generation of physicians would be equipped with the problem-solving and decision-making skills required for the future. Dr. Reece himself has consistently taught in the course. To further provide MD students with experience in data analysis and personalized medicine, the UMSOM was also the first medical school to offer pharmaco-genetic testing to all of its MD students to determine individualized responses to medication.

In 2020, despite the challenges posed by the COVID-19 pandemic that restricted in-class instruction for MD students, Dr. Reece and his team in Academic Affairs successfully renewed and launched a new innovative MD program of medical study and training -- the Renaissance Curriculum. Developed over several years, this fully integrated curriculum takes a systems-based, holistic approach to learning, combining instruction in both the health and disease processes of the body related to major organ systems. Given its optimized format, the Renaissance Curriculum also allows students to enter the clinical portion of medical school earlier.

He has overseen the significant growth of UMSOM's Community Education Pipeline Program. The program, directed by two biomedical scientists, Greg Carey, PhD, Associate Professor Microbiology and Immunology and Director of Student Summer Research and Community Outreach in the Office of Student Research, and Bret Hassel, PhD, Professor of Microbiology and Immunology and Assistant Director for Training & Education. They have established education programs for undergraduate and high school students, as well as educational opportunities for STEM research and mentoring of students from a wide variety of backgrounds.

Michael Cryor, President of the Cryor Group, who served with Dean Reece for 10 years as Chair of the UMSOM's Board of Visitors, said, "As Chair Emeritus of the medical school's Board of Visitors, I have been witness to many facets of unparalleled growth at the medical school under Dean Reece's leadership-increased research funding, pivotal roles in vaccine development here and around the world and an increasing focus on student education. I was a member of the search committee to select the candidate who would follow the celebrated tenure of Dr. Donald Wilson. We were convinced Dean Reece was the right choice. His successful tenure is proof positive that we made the right selection," he said.

The Power of Partnership

Dean Reece's career at the University of Maryland has been marked by a collaborative approach to leadership and management at every level.

His close collaboration with the University of Maryland Medical System was highlighted as a national model in a 2012 article that he co-authored with former UMMS President & CEO Robert Chrencik, MBA, CPA, in the journal, Academic Medicine. The article, entitled, Fully Aligned Academic Health Centers: A Model for 21st-Century Job Creation and Sustainable Economic Growth, described the unique and highly effective alignment established between UMSOM and UMMS. Dr. Reece and Mr. Chrencik coined the phrase, "The Power of Partnership," noting that alignment of the clinical and research missions resulted in significant economic benefits for the State of Maryland.

The close partnership Dean Reece established between UMSOM and UMMS also resulted in expanded UMSOM faculty clinical practice locations in UMMS hospitals as well. New multi-specialty locations were established in Harford, Howard, and Prince George's County, with state-of-the-art facilities for urgent care, vascular surgery, trauma, orthopaedics, and other specialties.

Mohan Suntha, MD

"Throughout his tenure as Dean of the University of Maryland School of Medicine, Dr. Reece has been an unabashed champion of discovery-based medicine," said UMMS President and CEO Mohan Suntha, MD, MBA."His relentless focus has led to incredible advances and recognition for the university while simultaneously advancing our patient care mission. I have been truly blessed to call him a friend, mentor, and colleague throughout his 15 years at the helm of the School of Medicine."

Added Bert W. O'Malley, MD, President and CEO, University of Maryland Medical Center (UMMC). "From working with Dean Reece, and knowing of his many accomplishments, it is clear that he has a unique combination of visionary talent along with the ability to execute with surgical precision and exceed all expectations. I've greatly enjoyed our partnership in advancing the mission of academic medicine and look forward to continuing to work with him during his transition and in his new role."

Dean Reece also prioritized opportunities for UMSOM's collaboration with other universities in the USM, and with other schools at UMB. During his tenure, there was a significant increase in collaborative research efforts across the USM, with marked growth of interdisciplinary funding between UMSOM-both with the other schools at UMB, as well as with other USM campuses.

About the University of Maryland School of Medicine

Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 45 academic departments, centers, institutes, and programs; and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1.2 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic and clinically based care for nearly 2 million patients each year. The School of Medicine has more than $563 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 student trainees, residents, and fellows. The combined School of Medicine and Medical System ("University of Maryland Medicine") has an annual budget of nearly $6 billion and an economic impact more than $15 billion on the state and local community. The School of Medicine, which ranks as the 8th highest among public medical schools in research productivity, is an innovator in translational medicine, with 600 active patents and 24 start-up companies. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit http://www.medschool.umaryland.edu.

SOURCE University of Maryland School of Medicine

http://www.medschool.umaryland.edu

The rest is here:
UM School of Medicine Dean Announces He Will Transition From The Deanship In 2022 After Completing 16-Year Tenure - PRNewswire

Read More...

Health Logic Interactive Inc., Acquires Next-Generation Lab-On-Chip Medical Diagnostic Technology – PRNewswire

April 4th, 2021 6:47 am

TSX.V: CHIP.H

CALGARY, March 29, 2021 /PRNewswire/ -Health Logic Interactive Inc. ("Health Logic" or the "Company") (TSX.V: CHIP.H),is pleased to announce its wholly owned operating subsidiary, My Health Logic Inc. ("My Health Logic"), has entered into a license agreement (the "License Agreement")with an arm's length third party (the "Licensor") pursuant to which My Health Logic has a worldwide, exclusive license to the UAL-Chip, a patent pending lab-on-chip ("LOC") technology that has the potential to be used in a smartphone connected, hand-held device to provide rapid point-of-care ("POC") diagnosis of Chronic Kidney Disease ("CKD").

CKD is a life-changing chronic condition that is harmful for patients and extremely expensive to treat unless caught early. Over 850 million people globally and 37 million people in the United States have CKD, and total healthcare costs for treatment of CKD in the US exceed $120B per year. The key to preventing the major harms from CKD, such as kidney failure, kidney dialysis, and death, is early testing and treatment; however, approximately 90% of those afflicted by CKD do not realize they have it. We believe that providing patients and caregivers a low-cost, accessible tool for early diagnosis and treatment is an opportunity to help millions of at-risk patients and start to bend the cost curve for health systems worldwide.

UAL-Chip technology has the potential to drive a much-needed disruption of the legacy systems used for CKD testing and accelerate the trend towards automation, digitization and personalization in the healthcare industry. The UAL-Chip can utilizemicrofluidic technology to test for the albumin levels in urine and deliver rapid results to a users' smartphone and their healthcare practitioner. Currently, <50% of at-risk patients are tested; we expect that introducing digitally connected home testing solutions would increase this number by removing one of the current barriers to testing, being attendance at a central lab, and would also provide My Health Logic with the opportunity to develop a robust platform for continuous digital patient monitoring and care for CKD of all stages.

"CKD is common, costly and harmful for patients and communities. It is also under-recognized. Bringing the CKD diagnosis into the home is a disruptive approach that could bridge the screening gap for millions of patients, allowing early detection and treatment, preventing harms for millions, and reducing health costs by billions" Dr. Claudio Rigatto, Co-Inventor, Seven Oaks General Hospital

"Our lab-on-chip platform can give accurate results rivalling central laboratories in precision but in an accessible, low cost and rapid form usable in the home, fulfilling the dream of true point-of-care diagnosis and personalized medicine." Dr. Francis Lin, Lead Inventor

Highlights of the Market:

Highlights of the Technology:

The Technology was invented by the world-renowned team of nephrologists at Seven Oaks General Hospital including Dr. Navdeep Tangri, Dr. Paul Komenda, and Dr. Claudio Rigatto, and biomedical engineering LOC expert Dr. Francis Lin. The team of inventors are expected to play an active role in the ongoing development of the lab-on-chips, and MATLOC device as we pursue regulatory approvals with Health Canada and the US Food and Drug Administration ("FDA") via an accelerated 510K pathway. In addition to the ongoing guidance from the inventors, the Company plans to on board and engage strategic industry thought leaders and experts to best guide My Health Logic through the development process to successful commercialization, for which there is no guarantee.

My Health Logic's obligations under the License Agreement include: (a) developing, manufacturing and selling products that incorporate the licensed technology ("Licensed Products"); (b) marketing Licensed Products in the US and Canada within 6 months of receiving regulatory approval; (c) reasonably filling market demand for Licensed Products following marketing; (d) obtaining all necessary governmental approvals for the activities in (a); and (e) spending at least $650,000 on the development of Licensed Products during the first four years of the License Agreement. As consideration for the license and other rights under the License Agreement, My Health Logic will pay Licensor annual royalties on net sales of Licensed Products, cover past patent costs, pay annual license maintenance fees and make certain payments upon the occurrence of milestone events in the regulatory approval process with respect to Licensed Products.

The Company is also pleased to announce that it plans to conduct a non-brokered private placement for gross proceeds of up to $1.4M, subject to approval of the TSX Venture Exchange.

About the Company

Health Logic Interactive, through its wholly owned operating subsidiary My Health Logic, is developing and commercializing consumer focused handheld point-of-care diagnostic devices that connect to patient's smartphones and digital continued care platforms. The Company plans to use their patent pending lab-on-chip technology to provide rapid results and facilitate the transfer of that data from the diagnostic device to the patient's smartphone. The Company expects this data collection will allow it to better assess patient risk profiles and provide better patient outcomes. Our mission is to empower people with the ability to get early detection anytime, anywhere with actionable digital management for chronic kidney disease. For more information visit us at:www.healthlogicinteractive.com

Neither the TSX Venture Exchange nor its regulation services provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward Looking Statements

Cautionary Note Regarding Forward-Looking Statements: This release includes certain statements and information that may constitute forward-looking information within the meaning of applicable Canadian securities laws. Forward-looking statements relate to future events or future performance and reflect the expectations or beliefs of management of the Company regarding future events. Generally, forward-looking statements and information can be identified by the use of forward-looking terminology such as "intends" or "anticipates", or variations of such words and phrases or statements that certain actions, events or results "may", "could", "should", "would" or "occur". This information and these statements, referred to herein as "forwardlooking statements", are not historical facts, are made as of the date of this news release and include without limitation, statements regarding discussions of future plans, estimates and forecasts and statements as to management's expectations and intentions with respect to, among other things: development, manufacture and sale of Licensed Products; performance of obligations under the License Agreement; plans to engage the inventors and other experts to assist with regulatory approval and commercialization of Licensed Products; plans for and expected benefits of the licensed technology; and the Offering.

These forwardlooking statements involve numerous risks and uncertainties and actual results might differ materially from results suggested in any forward-looking statements. These risks and uncertainties include, among other things: My Health Logic's ability to develop, manufacture and sell the Licensed Products, perform its obligations under the License Agreement and otherwise implement its business strategies; My Health Logic's ability to obtain regulatory approval of Licensed Products; and the Company's ability to obtain regulatory approval of the Offering and complete the Offering on the proposed terms.

In making the forward looking statements in this news release, the Company has applied several material assumptions, including without limitation, that: My Health Logic will be able to develop, manufacture and sell the Licensed Products, perform its obligations under the License Agreement and otherwise implement its business strategies; My Health Logic will be able to obtain all necessary regulatory approvals with respect to Licensed Products; and the Company will be able to obtain all necessary regulatory approvals with respect to the Offering, and the Company will be able to complete the Offering on the proposed terms.

Although management of the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Readers are cautioned that reliance on such information may not be appropriate for other purposes. The Company does not undertake to update any forward-looking statement, forward-looking information or financial out-look that are incorporated by reference herein, except in accordance with applicable securities laws. We seek safe harbor.

SOURCE Health Logic Interactive Inc.

Home

Read this article:
Health Logic Interactive Inc., Acquires Next-Generation Lab-On-Chip Medical Diagnostic Technology - PRNewswire

Read More...

Seventure Partners: New Report Reveals Links Between Covid-19 and the Microbiome – Business Wire

April 4th, 2021 6:47 am

PARIS--(BUSINESS WIRE)--Seventure Partners, one of Europes leaders in financing innovation and a world leader in life science microbiome investment, has published an analysis highlighting the close links between Covid-19 and the individuals microbiome.

The report titled Understanding the potential to monitor and modulate the COVIBIOME to improve patient resilience and outcome analyses a number of features of Covid-19 that are believed to have links to the microbiome, including:

In recent years, we have seen an increasing amount of data that indicate that the microbiome is likely to have strong links with our immune system and our immune health. As our understanding steadily grows on how Covid-19 affects our body, it also gives us an opportunity to understand how our microbiome is affected and how we can use this knowledge to improve treatments or enhance protection. Our report reveals a series of scientific findings on the connection between the virus and our microbiome, said Isabelle de Cremoux, CEO and Managing Partner, Seventure Partners, who led Health for Life Capital fund raising and microbiome strategy and author of the report.

To request a copy of the report, please email contact@seventure.fr

-ENDS-

Notes to Editors

About Seventure Partners

With 850m net commitments under management as of the end of 2020, Seventure Partners is a leading venture capital firm in Europe. Since 1997, Seventure Partners has been investing in innovative businesses with high growth potential in two fields: Life sciences across Europe, Israel, Asia and North America, and Digital technologies in France and Northern Europe.

In life sciences, the main areas of focus include classic approaches such as biotechnology and pharmaceuticals, diagnostic and medtech, industrial biotechnology, as well as beyond the pill approaches such as MICROBIOME-linked innovations, nutrition, foodtech, digital/connected health, wellbeing and personalized medicine & personalized nutrition.

About Health for Life Capital

Seventure Partners launched Health for Life Capital, the first venture capital fund focused mainly on investments beyond the pill in the microbiome and nutrition space. Europe is the primary focus of the fund, but it also invests in North America, Asia and Israel.

The 160m first fund launched in 2014 has invested in 20 companies at the forefront of their fields, such as Enterome, Vedanta Biosciences, MaaT Pharma, Eligo Bioscience, Ysopia Bioscience, TargEDys, A-Mansia Biotech, BiomX, Microbiotica, LiMM Therapeutics, Siolta Therapeutics, DayTwo, Zipongo (renamed Foodsmart), Cambrooke, Mdoloris Medical Systems, MycoTechnology, etc.

In 2019 it launched second fund Health for Life Capital II with a target fund size of over 200m which invested in Axial Therapeutics, BCD, Citryll, Dermala, Ervaccine, Federation Bio, Galecto, etc.

Both first fund and second fund attracted strategic investments from prestigious organizations including Danone, Novartis, US based global food ingredient providers (to be disclosed), Lesaffre, Tornier, Tereos, Unigrains and Bel, as well as financial institutions, family offices and entrepreneurs.

Read the original:
Seventure Partners: New Report Reveals Links Between Covid-19 and the Microbiome - Business Wire

Read More...

Cell and Gene Therapy Drug Delivery Devices Market, 2030 – Market Opportunities in the Strong Pipeline of Cell and Gene Therapies – PRNewswire

April 4th, 2021 6:46 am

DUBLIN, March 30, 2021 /PRNewswire/ -- The "Global Cell and Gene Therapy Drug Delivery Devices Market: Focus on Product Type, Commercialized Drug Delivery Devices, Country Data (16 Countries), and Competitive Landscape - Analysis and Forecast, 2020-2030" report has been added to ResearchAndMarkets.com's offering.

The global cell and gene therapy drug delivery devices market was valued at $55.75 thousand in 2019, and is expected to reach $375.13 thousand by 2030, registering a CAGR of 16.61% during the forecast.

Cell and gene therapy drug delivery industry is a transformative industry whose full potential is only just beginning to emerge. Cell and gene therapy involves the extraction of cells, protein, or genetic material (DNA) from the donor, and altering them to provide highly personalized therapy. Cell and gene therapies may offer longer-lasting effects than traditional medicines.

One of the significant drugs of the cell and gene therapy industry is CAR-T cell-based medicines, which include both cell therapy and gene therapy. Various market players are actively investing in the research and development of the cell and gene therapy industry. The players are offering improved and new products, which meet the critical needs of patients.

The growth is attributed to major drivers in this market such as the increasing prevalence of cancer and chronic diseases, increased funding in the cell and gene therapy market, rising need to develop novel treatment options for rare diseases, and rising biopharmaceutical R&D expenditure, and rising number of the FDA approvals of cell and gene therapies & clinical trials. The market is expected to grow at a significant growth rate due to various potential opportunities of growth that lie within its domain, which include drug approvals and strong pipeline of cell and gene therapies.

Various new cell and gene-based therapy approaches use biological engineering to improve the immune system's capacity to fight disease while sparing healthy tissues in the body. For instance, there are antibody-based therapies that can make T-cells more effective by increasing their interactions with cancer cells. Other modifications, such as adding complexity to the CAR-T and cancer cell interaction, which can further sharpen T-cells' cancer-targeting ability by reducing damage to normal cells.

The increase in the geriatric population and an increasing number of cancer cases, and genetic disorders across the globe are expected to translate into significantly higher demand for cell and gene therapy drug delivery devices market.

Furthermore, the companies are investing huge amount in research and development of cell and gene therapies and associated drug delivery devices products. The clinical trial landscape of various genetic and chronic diseases has been on the rise in the recent years, this will fuel the cell and gene therapy drug delivery devices market in future.

Within the research report, the market is segmented based on product type, commercialized drugs, and region. Each of these segments covers the snapshot of the market over the projected years, the inclination of the market revenue, underlying patterns, and trends by using analytics on the primary and secondary data obtained.

Competitive Landscape

The exponential rise in the application of precision medicine on a global level has created a buzz among companies to invest in the development of novel cell and gene therapy drug delivery devices.

Due to the diverse product portfolio and intense market penetration, Novartis AG, Kite Pharma Inc., and Dendreon Pharmaceuticals LLC. have been the pioneers in this field and been the major competitors in this market.

The other major contributors of the market include companies such as Vericel Corporation, Amgen Inc., Bausch & Lomb Incorporated, Spark Therapeutics, Inc., and Becton, Dickinson and Company.

Based on region, North America holds the largest share of cell and gene therapy drug delivery devices market due to substantial investments made by biotechnology and pharmaceutical companies, improved healthcare infrastructure, rise in per capita income, early availability of approved therapies, and availability of state-of-the-art research laboratories and institutions in the region. Apart from this, Asia-Pacific region is anticipated to grow at the fastest CAGR during the forecast period.

Key Topics Covered:

1 Technology Definition

2 Research Scope

3 Key Questions Answered in the Report

4 Research Methodology

5 Market Overview5.1 Introduction5.2 Cell and Gene Therapies and Drug Delivery Devices Industry5.3 Cell and Gene Therapy Drugs and Their Clinical Importance5.4 Cell and Gene Therapy Drug Delivery Devices Market: Current Scenario5.5 Cell and Gene Therapy Drug Delivery Devices Market: Future Perspective

6 Global Cell and Gene Therapy Drug Delivery Devices Market and Growth Potential, 2020-20306.1 Overview6.2 Pipeline Analysis6.2.1 Drug Delivery Systems in Development: Current Scenario6.2.1.1 Ongoing Clinical Trials of Drug Delivery Systems6.2.1.2 Limitations of Cell and Gene Therapy Drug Delivery Devices6.2.1.3 Recent Advancements in Gene Therapy Drug Delivery6.3 Cell and Gene Therapy Drug Delivery Devices Market and Growth Potential6.4 Cell and Gene Therapy Drug Development and Commercialization Landscape6.5 Impact of COVID-19 on Cell and Gene Therapy Drug Delivery Devices Market6.5.1 Impact of COVID-19 on Global Cell and Gene Therapy Drug Delivery Devices Market Growth Rate6.5.2 Impact of COVID-19 on Supply Chain of Cell and Gene Therapy Drug Delivery Devices Market6.5.3 Clinical Trial Disruptions and Resumptions

7 Emerging Technology Landscape7.1 Potential Technologies in Cell and Gene Therapy Drug Delivery Devices Market7.2 Microchip Technology7.3 Nanotechnology-Based Drug Delivery Devices7.4 Lipid Nanoparticles in Gene Therapy

8 Market Dynamics8.1 Impact Analysis8.2 Market Drivers8.2.1 Increasing Prevalence of Cancer and Chronic Diseases8.2.2 Increased Funding of Cell and Gene Therapies8.2.3 Rising Number of FDA Approvals of Cell and Gene Therapies, and Clinical Trials8.3 Market Restraints8.3.1 Stringent Legal Requirements and Regulations8.3.2 Injuries and Infections Caused by Needles8.4 Market Opportunities8.4.1 Strong Pipeline of Cell and Gene Therapies

9 Industry Insights9.1 Regulatory Scenario of Cell and Gene Therapy Drug Delivery Devices Market9.1.1 Overview9.1.2 Risk Assessment of Medical Devices9.1.3 Regulation of Medical Devices in the U.S.9.1.4 Regulation of Medical Devices in Europe9.1.5 Regulation of Medical Devices in Asia-Pacific9.2 Pricing and Reimbursement of Cell and Gene Therapy Drug Delivery Devices

10 Patent Landscape

11 Global Cell and Gene Therapy Drug Delivery Devices Market (by Product Type)11.1 Overview11.2 Subretinal Injection Cannula11.3 Extension Tube11.4 Intravenous Catheter11.5 Sterile Insulin Syringe11.5.1 Sterile Insulin Syringe (Size 1.0 ML, 31-Gauge Needle)11.5.2 Sterile Insulin Syringe (Size 0.5 ML, 22 Gauge Needle)11.6 Pre-Filled Syringe11.6.1 Pre-Filled Syringe (Size 1.0 ML, 22-26 Gauge Needle)11.6.2 Pre-Filled Syringe (Size 4.0 ML, 22-26 Gauge Needle)11.7 Infusion Bags11.7.1 Infusion Bags (Size 10 ML to 50 ML)11.7.2 Infusion Bags (Size 68 ML)11.7.3 Infusion Bags (Size 60 ML)11.7.4 Infusion Bags (Size Up to 65 ML)

12 Global Cell and Gene Therapy Drug Delivery Devices Market (by Commercialized Drugs)12.1 Commercialized Drugs12.1.1 Luxturna12.1.2 Kymriah12.1.3 Provenge12.1.4 Zolgensma12.1.5 Yescarta12.1.6 Strimvelis

13 Global Cell and Gene Therapy Drug Delivery Devices Market (by Region)13.1 Overview

14 Competitive Landscape14.1 Key Developments and Strategies14.1.1 Overview14.1.2 Regulatory and Legal Developments14.1.3 Synergistic Activities14.1.4 M&A Activities14.1.5 Funding Activities14.2 Market Share Analysis

15 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/2mcxqt

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

http://www.researchandmarkets.com

Excerpt from:
Cell and Gene Therapy Drug Delivery Devices Market, 2030 - Market Opportunities in the Strong Pipeline of Cell and Gene Therapies - PRNewswire

Read More...

Legally blind Great Falls filmmakers share their vision in national challenge – Yahoo News

April 4th, 2021 6:46 am

The Daily Beast

Getty/Facebook Two weeks before he allegedly rammed his car into two police officers guarding the U.S. Capitol, killing one of them, Noah Green posted an article on his Facebook page titled, Lull Before the Storm.An Intro to the Honorable Elijah Muhammad and his divine warning to us all during these last days of our world as we know it. Satans rule over us is up, the 25-year-olds apocalyptic post said, linking to an article from Final Call, the official newspaper of the Nation of Islam.Greens social media posts suggest he was spiraling in the lead up to the attack on Friday. On the eve of his alleged assault, his brother, Brendan Green, told The Washington Post, he sent a worrying text after leaving the apartment where they lived together for the past few months.Im sorry but Im just going to go and live and be homeless. Thank you for everything that youve done. I looked up to you when I was a kid. You inspired me a lot, the text reportedly read. That messageand the deadly attack that occurred less than 24 hours latercapped off a period that was riddled with red flags. Officer Killed, Driver Fatally Shot After Ramming Into Capitol Building BarricadeAs congressional staff grabbed lunch on Friday, Green allegedly rammed his dark blue sedan into two officers guarding a barricade on a road outside the Capitol.He then jumped out of the car and lunged at officers with a knife, U.S. Capitol Police Chief Yogananda Pittman said, prompting them to fatally shoot him. A senior law enforcement official confirmed to The Daily Beast that Green was the suspect, though he has not yet been officially identified by police. One Capitol Police officer, William Billy Evans, died, and a second officer was left hospitalized. He was said to be in stable condition late Friday.Pittman said the suspect was not known to Capitol Police before the attack and there was no indication of any nexus to members of Congress. She also said there was no ongoing threat and the suspect didnt yell anything before being shot. She said that, while an investigation was ongoing, it did not appear to be terrorism-related.Greens social media posts last month described searching for a spiritual journey within the Nation of Islam, a religious Muslim sect that the Southern Poverty Law Center classifies as a hate group for its bizarre theology of innate black superiority over whites and deeply racist, antisemitic and anti-gay rhetoric.In a statement on Saturday, Greens family expressed sympathy for the officer who was killed on Friday, and said they were just as taken aback as the rest of the nation from this horrific event. Still, the family said, Green suffered from depression and potential mental illness, and had likely fell ill to the multitude of problematic situations that surround us in todays society. They also suggested head injuries he sustained playing football may have contributed to his mental state. Nothing indicated a clear motive for targeting the police, nor the U.S. Capitol building located hours from both the Indianapolis apartment he had recently lived in, and the semi-rural part of Virginia he grew up in.In two lengthy March 17 posts on Greens Facebook profile, which was taken down shortly after the incident, Green wrote about losing his job and being unwittingly drugged. He said it was a major goal to meet Nation of Islam leader Louis Farrakhan.There was no immediate indication that Fridays attack was religiously motivated, and the Nation of Islams Virginia branch and D.C. headquarters did not immediately respond to requests for comment.Green wrote about suffering unspecified setbacks in his life recently.To be honest these past few years have been tough, and these past few months have been tougher, he wrote in the March 17 post. I have been tried with some of the biggest, unimaginable tests in my life. I am currently now unemployed after I left my job partly due to afflictions, but ultimately, in search of a spiritual journey.Despite the lack of a job, he posted an image of a certificate that said hed donated $1,085 to the Nation of Islam as a Saviours Day 2021 gift.Greens brother, Brendan, told the Post that Noah had become paranoid in 2019 and accused football teammates of drugging him with Xanax. He moved out to his own apartment and then abruptly moved to Indianapolis, where he believed there were intruders getting into his apartment. It was around that time that Brendan said he flew out to see his brother and realized his mind didnt seem right.More recently, his brother said, Green up and moved to Botswana and suggested he had tried to take his own life by jumping in front of a car. After he returned home, Noah Green appeared to view the Nation of Islam as a way to keep himself anchored. In his most recent social media posts, Green wrote that he had been faced with fear, hunger, loss of wealth, and diminution of fruit in recent months, and was being sustained by faith centered on the belief of the Honorable Minister Louis Farrakhan as Jesus, the Messiah.He posted that he had graduated with distinction, landed a good job out of college, and pursued a graduate degree despite not growing up in the best of circumstances. He said he was on track to go into business, but his path was thwarted. Green wrote that he partially blamed his setbacks on the array of concerning symptoms he suffered as side effects of drugs I was intaking unknowinglyperhaps alluding to the alleged incident in 2019. Noah Green played football for Christopher Newport University and graduated in 2019. CNU Green played football in high school, and a bio from Christopher Newport University said he was born in Fairlea, West Virginia, and has seven brothers and two sisters. He grew up in a semi-rural area in Covington, Virginia. Calls to his siblings and parents went unanswered on Friday.Public records show he enrolled in a graduate course at Florida State University this year, after majoring in marketing at Glenville State College.In the Christopher Newport bio, he said his dream vacation spot was Jamaica and the person hed most like to meet was Malcolm X.Friends appeared shocked that the outgoing, football-playing, marketing student they knew was the same person they saw being stretchered from the Capitol on Friday.He was always super sweet to me and all of his friends loved him, we were all sad to see him leave Glenville, Alaina Funk, a friend of the suspect, told The Daily Beast.It was unclear from his Facebook page how recently he became involved with Nation of Islam. Older posts centered around football and college rather than religion. His grandmother, who died in 2019 from a long illness, was Baptist, her obituary said.But, by March, Greens posts appeared to be consumed by religious warnings about the end days.I encourage everyone to study Revelations, study the signs of the end times, study who the beast is, study who the anti-Christ is, study who the false prophet is, and study the created images during those times. The Minister is here to save me and the rest of humanity, even if it means facing death, he wrote on March 17, before ominously ending the post with, We have a little time.Court records in Indiana, where he temporarily lived in an Indianapolis apartment, show that he sought to change his name recently. In December 2020, he filed a petition to legally change his name to Noah Zaeem Muhammad. But after he failed to show up for a hearing earlier this week and the court apparently did not hear from him, the matter was dismissed and the case declared closed.with reporting by Pilar MelendezRead more at The Daily Beast.Get our top stories in your inbox every day. Sign up now!Daily Beast Membership: Beast Inside goes deeper on the stories that matter to you. Learn more.

More:
Legally blind Great Falls filmmakers share their vision in national challenge - Yahoo News

Read More...

Pfizer Announces Vaccine Is 100% Protective Against Coronavirus In Kids As Young As 12 – Yahoo News

April 4th, 2021 6:46 am

The Daily Beast

Getty/Facebook Two weeks before he allegedly rammed his car into two police officers guarding the U.S. Capitol, killing one of them, Noah Green posted an article on his Facebook page titled, Lull Before the Storm.An Intro to the Honorable Elijah Muhammad and his divine warning to us all during these last days of our world as we know it. Satans rule over us is up, the 25-year-olds apocalyptic post said, linking to an article from Final Call, the official newspaper of the Nation of Islam.Greens social media posts suggest he was spiraling in the lead up to the attack on Friday. On the eve of his alleged assault, his brother, Brendan Green, told The Washington Post, he sent a worrying text after leaving the apartment where they lived together for the past few months.Im sorry but Im just going to go and live and be homeless. Thank you for everything that youve done. I looked up to you when I was a kid. You inspired me a lot, the text reportedly read. That messageand the deadly attack that occurred less than 24 hours latercapped off a period that was riddled with red flags. Officer Killed, Driver Fatally Shot After Ramming Into Capitol Building BarricadeAs congressional staff grabbed lunch on Friday, Green allegedly rammed his dark blue sedan into two officers guarding a barricade on a road outside the Capitol.He then jumped out of the car and lunged at officers with a knife, U.S. Capitol Police Chief Yogananda Pittman said, prompting them to fatally shoot him. A senior law enforcement official confirmed to The Daily Beast that Green was the suspect, though he has not yet been officially identified by police. One Capitol Police officer, William Billy Evans, died, and a second officer was left hospitalized. He was said to be in stable condition late Friday.Pittman said the suspect was not known to Capitol Police before the attack and there was no indication of any nexus to members of Congress. She also said there was no ongoing threat and the suspect didnt yell anything before being shot. She said that, while an investigation was ongoing, it did not appear to be terrorism-related.Greens social media posts last month described searching for a spiritual journey within the Nation of Islam, a religious Muslim sect that the Southern Poverty Law Center classifies as a hate group for its bizarre theology of innate black superiority over whites and deeply racist, antisemitic and anti-gay rhetoric.In a statement on Saturday, Greens family expressed sympathy for the officer who was killed on Friday, and said they were just as taken aback as the rest of the nation from this horrific event. Still, the family said, Green suffered from depression and potential mental illness, and had likely fell ill to the multitude of problematic situations that surround us in todays society. They also suggested head injuries he sustained playing football may have contributed to his mental state. Nothing indicated a clear motive for targeting the police, nor the U.S. Capitol building located hours from both the Indianapolis apartment he had recently lived in, and the semi-rural part of Virginia he grew up in.In two lengthy March 17 posts on Greens Facebook profile, which was taken down shortly after the incident, Green wrote about losing his job and being unwittingly drugged. He said it was a major goal to meet Nation of Islam leader Louis Farrakhan.There was no immediate indication that Fridays attack was religiously motivated, and the Nation of Islams Virginia branch and D.C. headquarters did not immediately respond to requests for comment.Green wrote about suffering unspecified setbacks in his life recently.To be honest these past few years have been tough, and these past few months have been tougher, he wrote in the March 17 post. I have been tried with some of the biggest, unimaginable tests in my life. I am currently now unemployed after I left my job partly due to afflictions, but ultimately, in search of a spiritual journey.Despite the lack of a job, he posted an image of a certificate that said hed donated $1,085 to the Nation of Islam as a Saviours Day 2021 gift.Greens brother, Brendan, told the Post that Noah had become paranoid in 2019 and accused football teammates of drugging him with Xanax. He moved out to his own apartment and then abruptly moved to Indianapolis, where he believed there were intruders getting into his apartment. It was around that time that Brendan said he flew out to see his brother and realized his mind didnt seem right.More recently, his brother said, Green up and moved to Botswana and suggested he had tried to take his own life by jumping in front of a car. After he returned home, Noah Green appeared to view the Nation of Islam as a way to keep himself anchored. In his most recent social media posts, Green wrote that he had been faced with fear, hunger, loss of wealth, and diminution of fruit in recent months, and was being sustained by faith centered on the belief of the Honorable Minister Louis Farrakhan as Jesus, the Messiah.He posted that he had graduated with distinction, landed a good job out of college, and pursued a graduate degree despite not growing up in the best of circumstances. He said he was on track to go into business, but his path was thwarted. Green wrote that he partially blamed his setbacks on the array of concerning symptoms he suffered as side effects of drugs I was intaking unknowinglyperhaps alluding to the alleged incident in 2019. Noah Green played football for Christopher Newport University and graduated in 2019. CNU Green played football in high school, and a bio from Christopher Newport University said he was born in Fairlea, West Virginia, and has seven brothers and two sisters. He grew up in a semi-rural area in Covington, Virginia. Calls to his siblings and parents went unanswered on Friday.Public records show he enrolled in a graduate course at Florida State University this year, after majoring in marketing at Glenville State College.In the Christopher Newport bio, he said his dream vacation spot was Jamaica and the person hed most like to meet was Malcolm X.Friends appeared shocked that the outgoing, football-playing, marketing student they knew was the same person they saw being stretchered from the Capitol on Friday.He was always super sweet to me and all of his friends loved him, we were all sad to see him leave Glenville, Alaina Funk, a friend of the suspect, told The Daily Beast.It was unclear from his Facebook page how recently he became involved with Nation of Islam. Older posts centered around football and college rather than religion. His grandmother, who died in 2019 from a long illness, was Baptist, her obituary said.But, by March, Greens posts appeared to be consumed by religious warnings about the end days.I encourage everyone to study Revelations, study the signs of the end times, study who the beast is, study who the anti-Christ is, study who the false prophet is, and study the created images during those times. The Minister is here to save me and the rest of humanity, even if it means facing death, he wrote on March 17, before ominously ending the post with, We have a little time.Court records in Indiana, where he temporarily lived in an Indianapolis apartment, show that he sought to change his name recently. In December 2020, he filed a petition to legally change his name to Noah Zaeem Muhammad. But after he failed to show up for a hearing earlier this week and the court apparently did not hear from him, the matter was dismissed and the case declared closed.with reporting by Pilar MelendezRead more at The Daily Beast.Get our top stories in your inbox every day. Sign up now!Daily Beast Membership: Beast Inside goes deeper on the stories that matter to you. Learn more.

Continue reading here:
Pfizer Announces Vaccine Is 100% Protective Against Coronavirus In Kids As Young As 12 - Yahoo News

Read More...

Regenerative medicine is already changing the way drugs are discovered and tested – MedCity News

April 4th, 2021 6:45 am

Anthony Atala receives an award for his innovations in 3D printing to create human organs at the Smithsonian Magazines 2016 American Ingenuity Awards after at National Portrait Gallery on December 8, 2016 in Washington, DC. Photo credit: Leah Puttkammer, Getty Images

Regenerating a solid organ for transplant might be years away from reaching patients. But regenerative medicine technology as a tool for discovering and testing new drugs? Thats already happening.

In Winston-Salem, North Carolina, scientists are 3D printing miniature organs that replicate the anatomy and function of a heart, liver, lungs, even the brain, said Anthony Atala, a professor of urology at Wake Forest University. Their lifetimes last just months, but thats more than enough time to assess a drug in ways that lab tests or even animal tests cannot.

After tens of millions of dollars of investment, by the time a drug gets into a Phase 1 clinical trial through the FDA, 90% of those drugs end up failing, Atala said, speaking on March 24 during the Oracle Health Sciences Connect 2021 conference. Its due to the testing that is not really accurate. Therefore, the strategy is to create these miniature organs.

Atala is the director of the Wake Forest Institute for Regenerative Medicine (WFIRM), which is conducting research on about 40 different tissues and organs. So far, the institute has launched 15 technologies that use human cells to engineer tissues and organs.

The drug testing happens on organoids, an invitro system that stands in for an organ. These miniature organs can be made in both healthy and diseased states, Atala said. These chips can create the human equivalent of physiological responses. For example, scientists can prompt a heart attack or a stroke to assess what a drug would do to an organ affected by those conditions.

WFIRMs drug discovery research represents a convergence of technologies. This body-on-a-chip technology is used to screen libraries of compounds for both safety and efficacy ahead of animal studies and clinical trials, Atala said. Data are cataloged at every step of the process. Artificial intelligence can then be applied to find patterns in the data, improving predictive modeling for drug development.

The Wake Forest research is being conducted as part of the Humanoid Sensor Consortium, a partnership comprised of pharmaceutical companies, academic institutions, and government agencies. The WFIRMs own drug discovery collaborators include the Biomedical Advanced Research and Development Authority (BARDA), which has provided $25 million for research into potential countermeasures to chemical agents. The Defense Threat Reduction Agency (DTRA) has provided more than $26 million in funding for the development of countermeasures for nerve agents.

The technologies that are closest to helping patients are part of a new approach to personalized medicine. The miniature organs are used to help oncologists make treatment decisions. A patients own tissue is used create tumors on a chip, which is then used to test different chemotherapies. These chips are currently being evaluated in clinical trials.

Instead of trying out a treatment for six months and finding out it doesnt work, and then trying another regimen, by then the tumor might be too far gone, Atala said. We can now try to define what the best treatment is before the patient receives the first dose.

Regenerated organs are on the way, Atala said. Engineered skin products are entering the market. The next regenerative tissue products will be a bit more complex, taking on tubular structures. WFIRM has regenerated urethras by taking a small tissue sample from a patient and expanding those cells in a lab. Those cells populate a bioresorbable scaffold, which can then be implanted in the patient.

Solid organs pose the biggest challenge for regenerative medicine. These organs are comprised of many more cells that must be nourished by blood supply. WFIRMs research includes kidneys. A small tissue sample from a patient is expanded in a lab, yielding kidney units capable of producing urine. These kidney units can then be implanted in the patient. Atala said that this research is advancing to Phase 3 testing for patients in end-stage renal failure.

When WFIRM started in 2004, the scientists did not begin the research with an eye on which patients could be helped most by regenerative medicine technology, Atala said. But now, it seems the greatest area of need appears to be kidney transplant patients.

As you know, 80% of patients on the transplant wait list are actually waiting for a kidney, Atala said. So, if we can make a dent in that population, that would be a great thing.

See the original post here:
Regenerative medicine is already changing the way drugs are discovered and tested - MedCity News

Read More...

Aspect Biosystems and JSR Corporation Enter Collaboration to Develop Bioprinted Vascularized Tissues for Regenerative Medicine – BioSpace

April 4th, 2021 6:45 am

VANCOUVER, British Columbia--(BUSINESS WIRE)-- Aspect Biosystems, a privately held biotechnology company pioneering the development of bioprinted therapeutics, is pleased to announce a new joint development program with JSR Corporation, a global leader in advanced materials innovation. This collaboration builds on the existing partnership between the two companies and will see the combining of Aspects proprietary microfluidic 3D bioprinting platform with JSRs advanced materials technology to develop implantable vascularized tissues for kidney regeneration and other applications in regenerative medicine.

The vascularized implantable tissues we develop through this collaboration will enable the next generation of regenerative medicine solutions by supporting longer-term function of therapeutic cells in the body, said Tamer Mohamed, President and CEO of Aspect Biosystems. We are excited to work with JSRs innovative team based in Japan, a country at the forefront of regenerative medicine, and we look forward to continue making breakthroughs with our broadly applicable technology platform.

In our work through JSR Life Sciences, we are seeing the need for advanced, innovative materials continue to grow throughout the biosciences, said Toru Kimura, CTO of JSR Corporation. This joint development program with Aspect Biosystems is testament to that and an important step in enabling and accelerating highly impactful areas in regenerative medicine.

About Aspect Biosystems

Aspect Biosystems is a biotechnology company creating bioprinted therapeutics as medicines of the future. Aspect is applying its microfluidic 3D bioprinting technology internally to develop these advanced cell therapies and partnering with leading researchers and industry innovators worldwide to tackle the biggest challenges in regenerative medicine. Learn more at http://www.aspectbiosystems.com.

About JSR Corporation

JSR Corporation is a multinational company with research-oriented organization that pursues close collaborations with leading innovators in a number of industries that are a key to the present and future welfare of human society: life sciences, synthetic rubbers, electronic materials, display and optical materials. JSR Corporation conducts its global life sciences business through JSR Life Sciences LLC. JSR Life Sciences provides specialized materials, products and services to the biopharma and life sciences industries both directly and through its subsidiaries MEDICAL & BIOLOGICAL LABORATORIES CO., LTD, KBI Biopharma, Inc., Selexis SA, and Crown Biosciences. Learn more at http://www.jsr.co.jp/jsr_e/ and https://www.jsrlifesciences.com/

View source version on businesswire.com: https://www.businesswire.com/news/home/20210330005431/en/

See original here:
Aspect Biosystems and JSR Corporation Enter Collaboration to Develop Bioprinted Vascularized Tissues for Regenerative Medicine - BioSpace

Read More...

The Governments Watchful Eye on Fraud Stemming from Stem Cell Therapy – JD Supra

April 4th, 2021 6:45 am

Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell therapy, and the increasing government spend related to these novel techniques, have now caught the eye of federal regulators and prosecutors. In this client alert, we profile some brief context of stem cell therapy, the governments regulations governing these techniques, and some of the best practices for those interested in this emerging space.

Stem cells are cells from which all other cells with specialized functions are generated (i.e., the bodys raw materials). Stem cells may duplicate themselves to create more stem cells or they may generate cells with a specific function like blood or brain cells.

Stem cell therapy is used to repair or replace damaged tissue or cells within the body. Many in the medical community are hopeful that stem cell therapy can be used to treat a wide array of conditions and diseases from multiple sclerosis to vision loss to traumatic spinal cord injuries to Lou Gehrigs disease just to name a few.

The Food and Drug Administration (FDA) oversees and regulates stem cell therapy treatments. While the FDA has acknowledged that stem cell therapy has the potential to treat diseases or conditions for which few treatments exist, there are still only a few treatments that have actually been approved by the FDA. Many treatments are still only in early investigatory stages.

The FDA has recognized the massive potential that stem cell therapy has in allowing patients treatments for various conditions. Consequently, in 2017, the FDA issued guidance indicating its intent to exercise enforcement discretion as a means to support and expedite the development of regenerative medicine products. This enforcement discretion period was to allow innovators time to determine whether to submit an Investigational New Drug (IND) or marketing application and, if such an application is needed, to prepare and submit the application as appropriate. The FDA, however, has made clear its enforcement discretion policy only applies to products that do not raise potential significant safety concerns. What the FDA considers significant is debatable, creating uncertainty and ambiguity for those who might be relying on the FDAs enforcement discretion period.

Initially, the FDA stated that its enforcement discretion period would last through November 2020. But in July 2020, the FDA extended its enforcement discretion period through May 2021 a fast-arriving date. It remains unclear whether the FDA intends to extend the time period of its enforcement discretion any further, but either way, stem cell therapy providers would be well-served by planning for and expecting enforcement efforts to ramp up in the near future.

In 2019, the FDA went to great lengths to warn consumers of the potential fraud that may arise from what it called stem cell therapy hype, and encouraged consumers to make sure any stem cell therapy treatments were either approved or being studied as an IND. The FDAs concerns have led to multiple enforcement actions, including one just last month. On February 1, 2021, for example, the government announced the indictment of Ashton Derges, a healthcare provider in Missouri, who marketed stem cell shots as a successful treatment for various conditions, including COVID-19. According to the indictment, Derges was paid nearly $200,000 by patients for the stem cell shots, none of which actually contained stem cells at all. While this alleged fraud was not particularly sophisticated, it nonetheless marked a significant development: the governments first criminal prosecution of those touting stem cell therapies.

But blatant fraud is not the only type of stem cell therapy case the government has expressed interest in investigating. A primary concern of the government is the marketing and use of unproven stem cell treatments as miracle cures. A good case study of the risks associated with aggressive marketing of stem cell therapy is a case out of Florida involving US Stem Cell Clinic Inc. The clinic was marketing stem cell therapy to treat conditions and diseases such as Parkinsons disease, stroke, and brain injuries none of which were approved by the FDA. And, much of the marketing that US Stem Cell Clinic used promised almost miraculous results. As a result, last year, the FDA successfully permanently enjoined the US Stem Cell Clinic from selling or providing those stem cell therapy treatments. Notably, this case was pursued by the FDA despite the FDA explicitly stating its intent to be lenient with emerging stem cell therapy treatments.

Stem cell therapy is a groundbreaking medical tool with great possibilities to treat a plethora of diseases and conditions. As the industry continues to expand, so will the governments interest. Our firm continues to see an uptick in cases involving stem cell therapy treatments. And we have successfully assisted clients in avoiding unnecessary scrutiny by the FDA and other government regulators.

If you are in the stem cell therapy industry or are considering offering stem cell therapy treatments, we recommend that you:

View original post here:
The Governments Watchful Eye on Fraud Stemming from Stem Cell Therapy - JD Supra

Read More...

Page 186«..1020..185186187188..200210..»


2025 © StemCell Therapy is proudly powered by WordPress
Entries (RSS) Comments (RSS) | Violinesth by Patrick