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Stem Cell Banking Market Scope, Consumption and Opportunities Analysis 2018 2028 – Cole of Duty

Posted: June 4, 2020 at 9:45 am

Global Stem Cell Banking Market: Overview

The demand within the global stem cell banking market is growing on account of advancements in the field of regenerative medicine. The medical fraternity has become extremely focused towards the development of artificial tissues that can infuse with the human body. Furthermore, medical analysis and testing has gathered momentum across biological laboratories and research institutes. Henceforth, it is integral to develop stem cell samples and repositories that hold relevance in modern-day research. The need for regenerative medicine emerges from the growing incidence of internal tissue rupture. Certain types of tissues do not recover for several years, and may even be damaged permanently. Therefore, the need for stem cell banking is expected to grow at a significant pace.

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In a custom report, TMR Research digs into the factors that have aided the growth of the global stem cell banking market. The global stem cell banking market can be segmented on the basis of bank size, application, and region. The commendable developments that have incepted across the US healthcare industry has given a thrust to the growth of the North America stem cell banking market.

Global Stem Cell Banking Market: Notable Developments

The need for improved regenerative medication and anatomy has played an integral role in driving fresh developments within the stem cell banking market.

Gallant has emerged as a notable market entity that has remained as the torchbearer of innovation within the global stem cell banking market. The company has recently launched stem cell banking for dogs, and has attracted the attention of the masses. As people become increasingly concerned about their pets, the new move by Gallant shall help the company in earning the trust of the consumers. Moreover, it can move several notches higher on the innovation index.

Cells4Life has also remained at the forefront of developments within the global stem cell banking market. After suffering backlash for its error in cord blood stem cell promotion, the company is expected to use effective public relation strategies to regain its value in the market.

Global Stem Cell Banking Market: Growth Drivers

Development of improved facilities for storage of stem cells has played an integral role in driving market demand. Furthermore, the unprecedented demand for improved analysis of regenerative medications has also created new opportunities within the global stem cell banking market. Medical research has attracted investments from global investors and stakeholders. The tremendous level of resilience shown by biological researchers to develop stem cell samples has aided market growth. Henceforth, the total volume of revenues within the global stem cell banking market is slated to multiply.

Commercialization of stem cell banks has emerged as matter of concern for the healthcare industry. However, this trend has also helped in easy storage and procurement of cells stored during the yester years of children. Presence of sound procedures to register at stem cell banks, and the safety offered by these entities, has generated fresh demand within the global market. New regional territories are opening to the idea of stem cell banking. Several factors are responsible for the growth of this trend. Primarily, improvements in stem cell banking can have favourable impact on the growth of the healthcare industry. Moreover, the opportunities for revenue generation associated with the development of functional stem cell banks has aided regional market growth.

The global stem cell banking market is segmented on the basis of:

Source

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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BeiGene Announces the Approval of BRUKINSA (Zanubrutinib) in China for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small…

Posted: June 4, 2020 at 9:44 am

First approvals for BRUKINSA in China and its first indication for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma

BEIJING, China and CAMBRIDGE, Mass., June 03, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that its BTK inhibitor BRUKINSA (zanubrutinib) has received approval from the China National Medical Products Administration (NMPA) in two indications the treatment of adult patients with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) who have received at least one prior therapy, and the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Both new drug applications (NDAs) were previously granted priority review by the Center for Drug Evaluation (CDE) of the NMPA.

BRUKINSA received accelerated approval from the U.S. Food and Drug Administration (FDA) as a treatment for MCL in adult patients who have received at least one prior therapy in November 2019.

The concurrent approvals of BRUKINSA in R/R CLL/SLL and R/R MCL are a tribute to the collective expertise and hard work of the BeiGene team. With two product approvals covering four indications in China and one in the United States in merely seven months, we continue to focus on execution in advancing our broad portfolio, commented John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene.

Following in the footsteps of tislelizumab, BRUKINSA is the second BeiGene internally-developed drug approved in China, another significant expansion in our growing commercial portfolio. These approvals would not have been possible without the many clinicians and patients who participated in our trials and the support of the health authorities, commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. We look forward to launching BRUKINSA in China, a potentially best-in-class BTK inhibitor with extensive global data from nine Phase 3 or potentially registration-enabling studies including a head-to-head comparison trial that was recently presented at the American Society of Clinical Oncology Annual Meeting.

The NMPA Approval in R/R CLL/SLL

The NMPA approval of BRUKINSA in patients with R/R CLL/SLL is based on results from a single-arm pivotal Phase 2 trial conducted in 91 patients (82 with R/R CLL; nine with R/R SLL) in China (NCT03206918; BGB-3111-205). Clinical efficacy data in the BRUKINSA label in China, as assessed by independent review committee (IRC) per iwCLL 2008 criteria for CLL and Lugano Classification 2014 for SLL, include an overall response rate (ORR) of 62.6%, including a complete response (CR) rate of 3.3%, a partial response (PR) rate of 59.3%, and the PR with lymphocytosis (PR-L) rate was 22%.

The most common adverse reactions reported in the label in China (10%) were neutropenia (68.1%), thrombocytopenia (40.7%), hematuria (35.2%), purpura (34.1%), anemia (23.1%), leukopenia (18.7%), pneumonia (18.7%), upper respiratory tract infection (15.4%), hemorrhage (14.3%), and rash (12.1%). The incidence of Grade 3 adverse reactions was 69.2%. The incidence of serious adverse reactions was 19.8%, and the most common serious adverse reaction was pneumonia (11.0%).

The approval of BRUKINSA will provide an important treatment option for Chinese patients with relapsed/refractory CLL/SLL. In addition to BRUKINSAs significant anti-tumor activity evidenced by an ORR of more than 60%, the drug demonstrated a favorable safety and tolerability profile, commented Jianyong Li, M.D., Professor and Director of the Department of Hematology and Director of the Pukou CLL Center at the First Affiliated Hospital of Nanjing Medical University.

The NMPA Approval in R/R MCL

The NMPA approval of BRUKINSA in patients with R/R MCL is based on results from a single-arm pivotal Phase 2 trial conducted in 86 patients in China (NCT03206970; BGB-3111-206). Clinical efficacy data in the BRUKINSA label in China, as assessed by IRC per Lugano Classification 2014, include the ORR of 83.7%, including a CR rate of 68.6% and a partial response PR rate of 15.1%.

The most common adverse reactions (10%) reported in the label in China were neutropenia (47.7%), rash (32.6%), leukopenia (31.4%), thrombocytopenia (30.2%), and anemia (11.6%). The incidence of serious adverse reactions was 15.1%, and common serious adverse reactions (2%) included pneumonia (8.1%), hemorrhage (2.3%), and thrombocytopenia (2.3%).

BRUKINSA has shown promise in hematologic malignancies including in patients with relapsed/refractory MCL. With robust results including a 68.6% CR rate in the MCL trial, we are optimistic and excited about the clinical benefits BRUKINSA can bring to these patients, said Jun Zhu, M.D., Ph.D., Professor and Director of the Department of Internal Medicine and Lymphoma, Peking University Cancer Hospital.

The recommended dose of BRUKINSA in Chinese Package Insert is 160 mg twice daily taken orally with or without food. The dose may be adjusted for adverse reactions, and reduced for patients with severe hepatic impairment and certain drug interactions.

About Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are forms of non-Hodgkin lymphoma, a type of blood cancer, that arise from B lymphocytes. CLL and SLL are essentially the same disease, with the only difference being the location where the cancer primarily occurs.i When most of the cancer cells are located in the peripheral blood and the bone marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL.ii According to epidemiological statistics, 88,200 patients are newly diagnosed with lymphoma each year in China, with NHL accounting for approximately 91%. Among all the NHL incidences, patients with B-cell NHL account for 66%, and CLL or SLL accounts for approximately 6.4% of all B-cell NHL incidences, indicating that the number of patients with CLL/SLL reaches approximately 3,390 in all patients (88,200) newly diagnosed with lymphoma each year.iii

About Mantle Cell Lymphoma

Lymphoma is a diverse group of cancers that originate from B-, T- or NK-cells. MCL is typically an aggressive form of non-Hodgkins lymphoma (NHL) that arises from B-cells originating in the mantle zone.iv According to epidemiological statistics, 88,200 patients are newly diagnosed with lymphoma each year in China, with NHL accounting for approximately 91%. Among all the NHL incidences, patients with B-cell NHL account for 66%, and MCL accounts for approximately 5% of B-cell NHL incidences, equivalent to over 2,600 newly diagnosed cases each year.v MCL usually has a poor prognosis, with a median survival of three to four years,vi and is often diagnosed at a later stage of disease.

About BRUKINSA (zanubrutinib)

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Brutons tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad pivotal clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

BRUKINSA was granted accelerated approval by the U.S. FDA to treat adult patients with MCL who have received at least one prior therapy in November 2019. This accelerated approval is based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. BRUKINSA was granted approval in China for the treatment of MCL in adult patients who have received at least one prior therapy and CLL or SLL in adult patients who have received at least one prior therapy in May 2020.

BRUKINSA is not approved for use outside of the United States and China.

IMPORTANT U.S. SAFETY INFORMATION FOR BRUKINSA (ZANUBRUTINIB)

Warnings and Precautions

Hemorrhage

Fatal and serious hemorrhagic events have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher bleeding events including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 2% of patients treated with BRUKINSA monotherapy. Bleeding events of any grade, including purpura and petechiae, occurred in 50% of patients treated with BRUKINSA monotherapy.

Bleeding events have occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Co-administration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 23% of patients treated with BRUKINSA monotherapy. The most common Grade 3 or higher infection was pneumonia. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (27%), thrombocytopenia (10%) and anemia (8%) based on laboratory measurements, were reported in patients treated with BRUKINSA monotherapy.

Monitor complete blood counts during treatment and treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 9% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was skin cancer (basal cell carcinoma and squamous cell carcinoma of skin), reported in 6% of patients. Advise patients to use sun protection.

Cardiac Arrhythmias

Atrial fibrillation and atrial flutter have occurred in 2% of patients treated with BRUKINSA monotherapy. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher events were reported in 0.6% of patients treated with BRUKINSA monotherapy. Monitor signs and symptoms for atrial fibrillation and atrial flutter and manage as appropriate.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for at least 1 week after the last dose. Advise men to avoid fathering a child during treatment and for at least 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Adverse Reactions

The most common adverse reactions in > 10% of patients who received BRUKINSA were neutrophil count decreased (53%), platelet count decreased (39%), upper respiratory tract infection (38%), white blood cell count decreased (30%), hemoglobin decreased (29%), rash (25%), bruising (23%), diarrhea (20%), cough (20%), musculoskeletal pain (19%), pneumonia (18%), urinary tract infection (13%), hematuria (12%), fatigue (11%), constipation (11%), and hemorrhage (10%). The most frequent serious adverse reactions were pneumonia (11%) and hemorrhage (5%).

Of the 118 patients with MCL treated with BRUKINSA, 8 (7%) patients discontinued treatment due to adverse reactions in the trials. The most frequent adverse reaction leading to treatment discontinuation was pneumonia (3.4%). One (0.8%) patient experienced an adverse reaction leading to dose reduction (hepatitis B).

Drug Interactions

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with moderate or strong CYP3A inducers.

Specific Populations

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

INDICATION

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Please see full U.S. Prescribing Information at beigene.com/PDF/BRUKINSAUSPI.pdf and Patient Information at beigene.com/PDF/BRUKINSAUSPPI.pdf

About the Zanubrutinib Clinical Trial Program

Clinical trials of zanubrutinib include:

About BeiGene

BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 3,800+ employees in China, the United States, Australia, and Europe are committed to expediting the development of a diverse pipeline of novel therapeutics for cancer. We currently market two internally-discovered oncology products: BTK inhibitor BRUKINSA (zanubrutinib) in the United States, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Srl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn more about BeiGene, please visit http://www.beigene.com and follow us on Twitter at @BeiGeneUSA.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGenes plans and expectations for the commercialization of BRUKINSA, the potential implications of clinical data for patients, and BeiGenes further advancement of, and anticipated clinical development, regulatory milestones and commercialization of BRUKINSA and its other products and product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGenes limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on the Companys clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled Risk Factors in BeiGenes most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

Investor Contact Media Contact

Craig West Liza Heapes or Vivian Ni

+1 857-302-5189 + 1 857-302-7596

ir@beigene.com media@beigene.com

__________________________i Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Fact Sheet, Lymphoma Research Foundation. Accessed at: https://www.lymphoma.org/wp-content/uploads/2018/04/LRF_FACTSHEET_CLL_SLL.pdf

ii Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Lymphoma Research Foundation. Accessed at: https://www.lymphoma.org/aboutlymphoma/cll/

iii Chen W, Zheng R , Baade P D , et al. Cancer statistics in China, 2015[J]. CA: A Cancer Journal for Clinicians, 2016, 66(2):115-132.

iv https://www.lls.org/sites/default/files/file_assets/mantlecelllymphoma.pdf

v Li, et al. Journal of Diagnostics Concepts & Practice, 2012,11(2): 111-115

vi Philip J. Bierman, James O. Armitage, in Goldman's Cecil Medicine (Twenty Fourth Edition), 2012.

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Hesperos Human-on-a-Chip System Used to Model Preclinical Stages of Alzheimers Disease and Mild Cognitive Impairment – Yahoo Finance

Posted: June 4, 2020 at 9:43 am

-- Peer-reviewed publication in Alzheimer's & Dementia: Translational Research & Clinical Interventions validates potential of drug discovery platform and ability to study early stages of disease pathology --

Hesperos Inc., pioneers of the Human-on-a-Chip in vitro system, today announced a new peer-reviewed publication that describes how the companys functional Human-on-a-Chip system can be used as a drug discovery platform to identify therapeutic interventions targeting the preclinical stages of Alzheimers disease (AD) and mild cognitive impairment (MCI). The manuscript, titled "A human induced pluripotent stem cell-derived cortical neuron human-on-a-chip system to study A42 and tau-induced pathophysiological effects on long-term potentiation," was published this week in Alzheimer's & Dementia: Translational Research & Clinical Interventions. The work was conducted in collaboration with the University of Central Florida and with David G. Morgan, Ph.D., Professor of Translational Neuroscience at Michigan State University, and expert in AD pathology.

To date, more than 100 potential therapeutics in development for AD have been abandoned or failed during clinical trials. These therapeutics relied on research conducted in preclinical animal studies, which often are unable to accurately capture the full spectrum of the human disease phenotype, including differences in drug metabolism and excretion between humans and animals. Therefore, there is a need for human models, especially those that accurately recapitulate the functional impairments during the preclinical phases of AD and MCI.

"Hesperos offers a breakthrough technology that provides a human cell-based assay based on cognitive function metrics to evaluate drugs designed to restore cognition at early stages of the Alzheimers continuum," said Dr. Morgan. "This system can serve as a novel drug discovery platform to identify compounds that rescue or alleviate the initial neuronal deficits caused by A1-42 and/or tau oligomers, which is a main focus of clinical trials."

In 2018, Hesperos received a Phase I Small Business Innovation Research (SBIR) grant from the National Institute on Aging (NIA) division within the US National Institutes of Health (NIH) to help create a new multi-organ human-on-a-chip model for testing AD drugs. Research conducted under this grant included a study to assess therapeutic interventions based on functional changes in neurons, not neuronal death.

In the recent Alzheimer's & Dementia publication, Hesperos describes its in vitro human induced pluripotent stem cell (iPSC)-derived cortical neuron human-on-a-chip system for the evaluation of neuron morphology and function after exposure to toxic A and tau oligomers as well as brain extracts from AD transgenic mouse models.

"Researchers are now focusing on biomarker development and therapeutic intervention before symptoms arise in AD and MCI," said James Hickman, Ph.D., Chief Scientist at Hesperos and Professor at the University of Central Florida. "By studying functional disruption without extensive cell loss, we now have a screening methodology for drugs that could potentially evaluate therapeutic efficacy even before the neurodegeneration in MCI and AD occurs."

The researchers found that compared to controls, treatment with toxic A and tau oligomers or brain extracts on the iPSC cortical neurons significantly impaired information processing as demonstrated by reduction in high-frequency stimulation-induced long-term potentiation (LTP), a process that is thought to underlie memory formation and learning. Additionally, oligomer and brain extract exposure led to dysfunction in iPSC cortical neuron electrophysiological activity, including decreases in ion current and action potential firing.

While exposure to the toxic oligomers and brain extracts caused morphological defects in the iPSC cortical neurons, there was no significant loss in cell viability.

"Clinical success for AD therapies has been challenging since preclinical animal studies often do not translate to humans," said Michael L. Shuler, Ph.D., Chief Executive Officer of Hesperos. "With our recent study, we are now one step closer in developing an AD multi-organ model to better evaluate drug metabolism in the liver, penetration through the blood-brain barrier and the effects on neuronal cells."

Story continues

About Alzheimers Disease/Preclinical Stage AD

AD is a progressive disease that is characterized by memory loss and deterioration of cognitive function. Preclinical AD is the first stage of the disease, and it begins long before any symptoms become apparent. It is thought that symptoms do not manifest until there is a significant death of neuronal cells, which is caused by the aggregation of toxic amyloid beta (A) and tau oligomers, typically during the earliest stages of the disease. Unfortunately, treatment after the diagnosis of MCI may be too late to reverse or modify disease progression.

To read the full manuscript, please visit https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.12029.

About Hesperos

Hesperos, Inc. is a leading provider of Human-on-a-Chip microfluidic systems to characterize an individuals biology. Founders Michael L. Shuler and James J. Hickman have been at the forefront of every major scientific discovery in this realm, from individual organ-on-a-chip constructs to fully functional, interconnected multi-organ systems. With a mission to revolutionize toxicology testing as well as efficacy evaluation for drug discovery, the company has created pumpless platforms with serum-free cellular mediums that allow multi-organ system communication and integrated computational PKPD modeling of live physiological responses utilizing functional readouts from neurons, cardiac, muscle, barrier tissues and neuromuscular junctions as well as responses from liver, pancreas and barrier tissues. Created from human stem cells, the fully human systems are the first in vitro solutions to accurately predict in vivo functions without the use of animal models. More information is available at http://www.hesperosinc.com.

Hesperos and Human-on-a-Chip are trademarks of Hesperos Inc. All other brands may be trademarks of their respective holders.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200529005128/en/

Contacts

Michelle LinnBioscribe774-696-3803michelle@bioscribe.com

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Molecular Genetics Company MiraDx Offers COVID-19 Viral Testing To U.S. Universities and Colleges – Business Wire

Posted: June 4, 2020 at 9:36 am

LOS ANGELES--(BUSINESS WIRE)--MiraDx, a Los Angeles-based molecular genetics company that transitioned its CLIA-certified lab to provide COVID-19 tests for essential workers, is now expanding access to its PCR viral testing to public and private universities and colleges across the country. MiraDx aims to enable students, faculty, and staff to resume on-campus education later this year in an environment that provides a clear framework and easy and comprehensive access to highly accurate testing for the COVID-19 virus.

MiraDx is able to develop testing programs customized to the needs of an individual institution. Notably, the MiraDx lab, which is now exclusively processing COVID-19 tests, has dedicated reserved capacity for college programs, both to optimize turnaround time and mitigate the backlog many other labs are currently experiencing. With specific days allocated to individual schools, MiraDx will be able to deliver test results back to school officials through a secure server within 48 hours of receipt at the lab.

Accurate and sensitiveCOVID-19 testing of all Americans is of the utmost importance, said Dr. Joanne Weidhaas, co-founder of MiraDx. As our company continues to provide testing for thousands of first responders and essential workers, we have also turned our attention to another matter of national importance: enabling our youth to continue their on-campus education as safely and as soon as possible. Our goal is to contribute in a meaningful way to institutions of higher learning to allow students, faculty, and staff to return to campus in good health and give parents peace of mind that their children are safe.

MiraDxs discussions with over 100 schools across the country, along with guidance from health officials, have helped to inform the development of emerging testing protocols, to include day one clearance testing of the entire student body and faculty, followed by repeat sentinel testing throughout the semester.

We are focused on delivering the highest quality, most sensitive and dependable testing programs possible, said Dr. Weidhaas, herself an educator at UCLA. We are only going to commit to programs today we know we can achieve in the fall we are not going to sell capacity we do not have, and in fact, we are building in a buffer of capacity in each college testing day.

MiraDx has a CLIA-certified lab with a high complexity molecular processing designation that allows it to conduct PCR testing, a highly sensitive approach that results in over 90 percent accuracy in COVID-19 testing and is considered the gold standard in testing. To determine whether an individual is infected with COVID-19, a sample is collected from a swab of the back of the throat, where the highest viral load exists for this coronavirus. The MiraDx test includes an air-tight vial, collection swab, a biohazard bag, and simple instructions for collecting the sample, which is collected under the supervision of a healthcare professional. MiraDxs analysis technique can identify as little as four copies of COVID-19 RNA in an individual sample, meaning that the virus can be detected even during the early stages of infection and/or in asymptomatic individuals. Non-PCR based testing approaches are either less sensitive (resulting in more false negatives) or do not tell patients when they are no longer contagious, which either leaves them in quarantine too long or presents the risk of them coming out of quarantine too soon.

MiraDxs COVID-19 test has been developed in line with the FDAs Emergency Use Authorization requirements.

About MiraDx

Dr. Joanne Weidhaas, MD, PhD, MSM is the co-founder of MiraDx and a professor and vice-chair in the department of radiation oncology at UCLA.

MiraDx is a Los Angeles-based molecular genetics company that identifies, validates, develops, and delivers novel germline biomarker tests for individualized cancer treatment, and now performs COVID-19 testing. Its goal is to improve human health and advance personalized medicine through the application of novel functional germline biomarkers. To learn more about MiraDx, please visit miradx.com. Please send inquiries to info@miradx.com

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In the race for a vaccine, children may be last to be vaccinated – ABC News

Posted: June 4, 2020 at 9:36 am

Even as scientists race to develop a COVID-19 vaccine, experts acknowledge that children could be among the last members of society to be vaccinated.

At least 10 vaccines are being tested in people across the globe, with the United States' top infectious disease doctor, Anthony Fauci, optimistically estimating we could have a viable vaccine by early 2021. While preliminary data on these vaccines has been encouraging, children have been excluded from early studies.

Fauci told ABC News it's possible that studies in children might "catch up" to those in adults, if they are done correctly.

"There is no reason not to believe that [a vaccine] wouldn't be available simultaneously for adults and children," Fauci said.

But other vaccine experts interviewed by ABC News said studies among children could take much longer to complete, and a hard look at the timeline of ongoing vaccine trials raises questions about whether families can expect their children to be vaccinated at some point in the upcoming academic school year.

"Children will be vaccinated, in time," said Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, who sits on the Food and Drug Administration's vaccine advisory committee.

"To date, my sense is that children are not part of these initial studies," Offit added. "It would be unfathomable giving children a vaccine that has not been adequately tested in children."

Work on a COVID-19 vaccine is underway at American biotechnology company Moderna in Massachusetts. Moderna plans to start phase II of its vaccine trials soon and phase III in the summer of 2020.

The process for testing a COVID-19 vaccine in children could take "extra months and maybe years longer," according to Paul Duprex, PhD, Director of the Center for Vaccine Research and professor of microbiology and molecular genetics at the University of Pittsburgh.

Throughout history, scientists have constantly been reminded that children are not simply small adults. Their bodies and immune systems work differently than adults, so they need to be studied separately -- preferably after safety has already been well-established in adults.

"Every person is special, but kids are especially special," said Duprex. "They are our charges. The emotional baggage that goes with something going wrong in clinical trials involving kids -- and I'm not saying adults are not important -- it's just different."

For now, vaccine trials remain laser-focused on members of society deemed to have the highest risk, such as front-line workers and adults. Although some groups have announced their intention to test vaccines in children, ABC News contacted four vaccine groups and none said they have actually started studies in children yet.

Typically, vaccines are tested in a stepwise approach: phase 1 for safety, phase 2 to start testing effectiveness and a massive phase 3 study with thousands of people.

The pharmaceutical company Pfizer told ABC News it will advance a vaccine into children once positive data from phases 1 and 2 is available in adults. Another company, Inovio said it plans "to assess pediatric populations in the future."

The University of Oxford, which has partnered with the pharmaceutical company AstraZeneca, is one of the few vaccine groups that has announced formal plans to start testing in children.

But a University spokesperson told ABC News that children will not be injected right away, and will only be given the vaccine once "all of the adults studies are moving along and have generated sufficient safety data."

In the United States, the National Institute of Allergy and Infectious Diseases (NIAID), which is collaborating with pharmaceutical companies for vaccine trials, told ABC News the agency would continue to work with CDC to better understand how the virus affects children.

In a statement, the agency said: "We will continue to plan for follow-on clinical trials to include younger age groups so such trials can commence if epidemiological CDC data indicate a need to test COVID-19 vaccines in children."

With vaccine skepticism on the rise, experts stressed that it will be important to proceed with caution. According to an ABC News/Washington Post poll, 27% of American adults said they were not inclined to get a vaccine -- even if it was available for free.

With any new vaccine, the ethical thing to do is test for safety in healthy adults first, and then begin testing it among people who need it the most, explained Jennifer Miller, Ph.D., an assistant professor at Yale School of Medicine and founder of Bioethics International and the Good Pharma Scorecard.

For COVID-19, that means older adults, front-line workers and people with underlying medical conditions. Children are far less likely to die of this disease.

"About 2% of the cases reported are in the pediatric population," said Dr. David Kimberlin, professor and co-director of the Division of Pediatric Infectious Diseases at the University of Alabama-Birmingham.

"It's about minimizing risks, it's about informed consent and it's about the population that needs it the most," Miller said.

Minimizing risk is important, especially when it comes to children and vaccines, experts agreed.

Very rarely have candidate vaccines caused a disease to become more severe when the individual is subsequently exposed to the natural infection.

This happened in 1966, when a chemically inactivated vaccine candidate for a childhood lung disease called RSV led to the death of several children. "That tragic event set the RSV vaccine field back decades," said Duprex. "In fact, there still is no licensed RSV vaccine."

Fauci proposed that children might be tested in a so-called "bridging study," in which children are studied in a Phase I trial to ensure the vaccine is safe, and then quickly folded into a large phase 3 study.

Other experts noted it's theoretically possible that studies in children could "catch up" to those in adults, though unprecedented. But even if we do not have a vaccine for children right away, that doesn't necessarily mean children will have to remain socially distant indefinitely.

Eventually, widespread vaccination of adults could end up protecting children thanks to "herd immunity," which is when enough people are vaccinated to snuff out an ongoing chain of infections.

"Usually it's the older way around -- vaccinating children protects older adults," Kimberlin said. But in the case of COVID-19, if we find a successful vaccine and most adults become immune to the virus, "parents could still very legitimately look at that as a win for children because it's a win for society."

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Western Pa. experts weigh chances of catching coronavirus from contaminated objects – TribLIVE

Posted: June 4, 2020 at 9:36 am

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Fears about catching coronavirus from contaminated surfaces have driven some people to become compulsive about cleaning countertops and wiping down their groceries. As the pandemic took hold, some poison centers even reported increased calls about excessive exposure to cleaning agents.

In recent weeks, the Centers for Disease Control and Prevention appeared to adjust its stance on surface transmission of the coronavirus. New language on its website was interpreted as deemphasizing concerns, creating some confusion about the risk of catching covid-19 from frequently touched objects.

Pittsburgh-based infectious disease and critical care physician Dr. Amesh Adalja said that while the contact spread of the virus can certainly occur, it is not responsible for the bulk of transmission.

Weve always known that there is a small contribution from contaminated surfaces. I think the CDC guidance reflects the fact that were trying to focus on the main route of how this virus gets from person to person. It is from another person directly, Adalja said. Our public health strategy needs to be focused on eliminating the person-to-person spread,and there can be less emphasis on contact spread.

After some news outlets ran with the idea that the CDC was no longer concerned about surface transmission, the agency issued a statement clarifying that contact with a contaminated surface is still one way to catch covid-19.

It may be possible that a person can get covid-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose or possibly their eyes. But this isnt thought to be the main way the virus spreads, the statement said. The change on the website was intended to make it easier to read, and was not a result of any new science.

Dr. Arvind Venkat, an Allegheny Health Network emergency physician, observed that we live in a hyper-connected world, and social media can create controversies that arent always there. So, the combination of not having consistent communication and an environment in which everything is so fragmented is a bad combination in a public health crisis.

Venkat also past president of the Pennsylvania College of Emergency Physicians said public health authorities must communicate carefully and accurately to maintain trust with the public.

Since this is a new virus, were still learning as we go along. The fact that there is contradictory and changing data is to be expected, Venkat said. So, when something changes, we need to make sure that we convey that in a systematic way so that it doesnt get perceived as going back and forth.

So, what are the chances of catching covid-19 from an object or surface laden with germs?

I think the relative risk of picking it up from common things given the precautions that everybody is taking is much lower, said Seema Lakdawala, assistant professor of microbiology and molecular genetics at the University of Pittsburgh School of Medicine.

But if you are a health care worker and you are working in a hospital setting with patients that are symptomatic and coughing and sneezing large volumes of the virus into their environment then, yes, the risk of catching it from a surface is much higher.

The feeling among medical experts who spoke with the Tribune-Review is people are unlikely to catch the virus from doing things like grocery shopping. Lakdawala, an expert in virus transmission, said she does not wipe down her groceries.

Everyone has their own comfort level. If somebody is taking the time to wipe down every single material three times, I would say that is a waste of their time, Lakdawala said. I think its important for the general public to understand, What kind of information do I need to make a risk assessment for myself?

Adalja said that while its important for people to continue to take protective action, they can be a little less concerned about contaminated surfaces they may have touched.

I think people can be less worried about making sure they scrub their groceries. Thats less likely to be impactful than other things, like washing your hands and trying to avoid crowded spaces and other social-distancing measures.

Paul Guggenheimer is a Tribune-Review staff writer. You can contact Paul at 724-226-7706 or pguggenheimer@triblive.com.

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Jono-on-the-spot – North East Times

Posted: June 4, 2020 at 9:36 am

June 1, 2020

Germanys footballing pantheon has yet to reserve a spot for Paderborn.

The Westphalian cathedral city may date back more than 1200 years, but its achievements on the countrys soccer pitches arent quite so historic.

Though SC Paderborn 07 formed from a merger in the 1980s dines among lavish contemporaries at Germanys top table, it remains slim pickings on the global stage.

The club might not yet have made an international impression, but someone with first-hand experience of the citys footballing journey is leaving an indelible mark on the world.

Prior to co-founding Newcastle-based life science company QuantuMDx Group, Jonathan OHalloran was enmeshed within Paderborns soccer fraternity.

Taken to Germany by his fathers British Army commitments, a pre-teen Jonathan known as Jono by those closest to him supplemented kickabouts among friends with more structured matches through the club.

A left winger with a strikers instinct, he was to tweak football commentator parlance a Jono-On-The-Spot figure, always in the right place at the right time to help his sides attacks.

Like a lot of youngsters, he harboured dreams of playing professionally, but when they failed to materialise, Jonathan found a new career outlet.

Instead of being a totemic figure on the pitch, he is now at the vanguard of next generation healthcare technology, which is leading the charge to transform disease detection and treatment.

At a time when the worlds medical services are battling against the coronavirus pandemic, Jonathan is, to return to that football phrase again, Jono-On-The-Spot.

Already known for work alongside Bill and Melinda Gates foundation to improve tuberculosis detection and treatment, and the development of a panel test to prevent the spread of sexually transmitted infections, QuantuMDx recently launched a coronavirus test for laboratory use.

Working with manufacturing partner Biofortuna Limited, QuantuMDx operating out of the Lugano Building, on Newcastles Melbourne Street says the test is able to deliver results in little more than an hour.

It has scaled up production capability to an initial two million tests a week, with capacity to slide that figure up to three million.

The test, known as a SARS-CoV-2 assay, has been developed using advanced bioinformatics, with its accuracy validated by use of 90 pre-extracted residual samples from Newcastle upon Tyne Hospitals NHS Foundation Trust.

Shown to be clinically equivalent to the comparator assay presently used in NHS hospitals, QuantuMDx is now translating the test and a respiratory panel on to its landmark Q-POC platform.

A cost-effective, portable and battery-operated molecular diagnostic tool, Q-POC can analyse patient DNA samples in depending on the complexity of a test as little as ten to 30 minutes.

Such expediency and portability mean QuantuMDxs coronavirus tests could potentially be analysed in as little as 15 minutes in hospitals, pharmacies, care homes, schools or immigration zones.

For governments around the world, the development stands quite literally as a life-changing intervention in their efforts to ramp up contact tracing of COVID-19.

With potential for use in airports to quickly test travellers, it could also help the global sporting landscape emerge from its coronavirus shutdown.

With Q-POC, people doing the contact testing can put it in their backpack, go and swab people, test them and get a result immediately, says chief executive Jonathan.

That is an obvious game-changer.

In airports, if someone comes through and theyve got a fever then they can be quickly tested.

It could be used in sporting environments and by the big banks and supermarkets, which want staff back safely but quickly, continues Jonathan, who reveals the company is now looking at honing its strategy again to deliver early testing for flu and SARS.

Weve got a device the world needs; it is a silver lining to a large global cloud.

Yet it could all have been so much different.

As a youngster, it was football, rather than genetics, that piqued Brightonian Jonathans interest.

The son of a Liverpool FC- supporting mother and a father whose family followed the fortunes of Millwall, he was always destined to fall for its charms.

But when he returned to the UK from Germany, the landscape began to shift.

I was in a bit of an Army bubble in Germany; I grew up on lots of different bases and remember playing lots of football, recalls Jonathan.

We moved back when I was 13 and I began at a private school in Lewes, east Sussex.

That was a bit of a culture shock; I went from an Army school to somewhere that was very prim and proper and even made us do homework!

When I was 16 or 17, I realised my dreams of professional football were not destined to succeed and that I needed to do something else, continues Jonathan, sipping tea from a Liverpool FC mug.

I was colour-blind, dyslexic and tone deaf, so I quickly found the arts were not for me, and instead I clicked with science.

I remember a teacher showing us an experiment one day and I got it immediately I was quicker than all of the smarter kids in the class to understand genetics.

From that point on, I knew what I wanted to do.

I looked at all of the universities for a straight genetics degree, but not of them did one, so instead I studied molecular genetics with biotechnology at Sussex University.

His academic journey continued when he was accepted into the esteemed Harvard University to study how mutations in DNA sequencing cause disease.

If his school science lesson prompted an interest in genetics, Jonathans time on the other side of the Atlantic truly crystallised his career path.

I benefited from an amazing education over there, but it became pretty obvious when I started writing my thesis that the academic life wasnt for me, he says.

At that time, I was reading a lot of books on epidemiology and about how viruses and plagues can wreak havoc globally.

I realised pretty early on that we needed to improve work on human diagnostics.

So I applied for jobs in laboratories and got one at Nuffield Health, in Tunbridge Wells, continues Jonathan.

That gave me exposure to a lot of pathology disciplines, and I got to play with a lot of devices.

After about four years in, I thought, I could build one of these.

And that is exactly what he did.

QuantuMDx began life not in a high-tech, modern laboratory, but in Jonathans Sussex garage.

Now backed by medical entrepreneur Elaine Warburton, who helped Jonathan co-found the venture, he began laying the research foundations that would set the business on its trail to present-day success.

It was also around this time that the company secured a grant from the Cape Biotech Trust, which saw Jonathan relocate to the southernmost tip of Africa.

The move albeit for a transitory period would prove to be another seminal moment in Jonathans professional life and the evolution of QuantuMDx.

While I was getting the data in my makeshift laboratory, Elaine who is now a non-executive director was raising money for the business on the back of that data, he recalls.

We received funding from Cape Biotech Trust and part of the deal was that we had to move to South Africas Tygerberg Hospital for two years so I packed up the garage and went.

We were based right next to the World Health Organisations tuberculosis laboratory.

On my coffee breaks I was having discussions with its scientists about tuberculosis.

I couldnt get my head around the disease. It was killing millions of people every year, so I started learning about genetic mutations that were stopping treatments from working.

When changes to funding requirements forced Jonathan and Elaine to return to the UK earlier than planned, the duo found a home in the North East.

Eminent geneticist Professor Sir John Burn who is now QuantuMDx vice-chairman and whose CV lists time at Londons Great Ormond Street Hospital offered the fledgling business initial space at Newcastles International Centre for Life.

Providing the company with a much-needed base, the residence close to like-minded operators and an ever-flowing stream of highly- skilled university graduates provided crucial momentum, which QuantuMDx has more than maintained from its Lugano Building site.

The quality of students and the catchment area we have is quite large, says Jonathan, who now counts more than 70 staff on QuantuMDxs books.

People from the North East want to stay here; they dont want to go off to Oxford or Cambridge, and that is such a huge benefit for us.

Furthermore, every time we put a call out to the universities for support, they all say yes, we can help, weve got a group doing that.

We have really meshed ourselves into the local life sciences sector.

Speaking as a soft southerner, he laughs, Brighton is supposed to be this wonderful city, but it is nothing compared to Newcastle.

This strong ecosystem and interest in QuantuMDxs ever-evolving revolutionary technology, leaves Jonathan in no doubt where his business is headed.

I always had a vision where this company would be, he says.

If we get the execution right, we are starting the commercial growth on a path towards becoming a unicorn [the term used to describe a privately-owned start-up company valued at more than $1 billion].

We have evolved our strategy for coronavirus; we have honed it and we are now doing it.

We are poised for rapid growth; it is going to be a very exciting time for us over the next 18 months.

We are going to be a different company again.

Jonathan OHalloran@BiotechRockstar

QuantuMDxwww.quantumdx.com@QuantuMDx

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All About the Twisted Story Behind Motive for Murder – E! NEWS

Posted: June 4, 2020 at 9:36 am

AP Photo/Crime Stoppers via Houston Chronicle, File

The case almost went cold for good.

On Jan. 15, 2012, Gelareh Bagherzadeh was sitting in the driver's seat of her silver Nissan Altima when she was shot twice in the head, point blank, from the passenger side of her car. She had been talking to a friend, who heard her scream, then silence, and called 911. Gelareh's cell phone was found at her feet. The car had smashed into the garage of a townhouse, one in a row behind The Galleria, an upscale mall in Houston, and the acrid smell of burnt tire rubber was thick in the air.

Her purse and wallet were there, seemingly intact, so it didn't appear to be a robbery. There were no signs of sexual assault.

It was a mystery, one thathad enough twists and turnsto end up the subject ofDateline and NBC News' latest true crime podcast, Motive for Murder.

"I'm no stranger to mystery, to secrets people are desperately trying to hide, and the things those people are willing to do to get what they want," Motive for Murderhost and longtimeDateline correspondent Josh Mankiewiczexplained as episode one got underway.

**This is documented real life, and Dateline covered the case in 2019,sothis isn't exactly a SPOILERalert, but there are major revelations about the case ahead.

An early theory that turned the story into national news was that perhaps Gelareh's outspoken political views had gotten her killed. Perhaps the Iranian government was involved.

The 30-year-old had moved to Houston from her native Iran for school and was studying molecular genetics at the University of Texas MD Anderson Cancer Center when she was killed. But she remained plugged in to the troubles at home andshe took part in protests in Houston supporting theIranian Green Movement, which disputed the legitimacyof then-President Mahmoud Ahmadinejad's re-election in 2009 and was demanding regime change.

Her activism certainly worried her parents, Ebrahim Bagherzadeh and Monireh Zangeneh, but they remembered their daughter being unafraid of any potential consequencesthough, according to the Houston Chronicle, she had asked that her name not be used when the paper posted a video from a 2010 protest on its website.

Friends in Gelareh's inner circle were skeptical, however, that the Iranian government would "waste their energy and time" by orchestrating the death of a student activist all the way in Texas. Though "if they had...they would take credit for it" to warn off other dissidents, observed Gelareh's close friend, Kathy Soltis.

Local police said early on that they didn't suspect either apoliticalmotive or that she was targeted because of her ethnicity.

Fingerprints found on the car, the bullets recovered at the scene, a cigarette butt on the ground outside the car doorall were sent to the lab for forensic testing.

Dead ends, the lot.

In the meantime, detectives started probing the possibility that the motive had something to do with one of three overarching motives for so many murders: love, money or pride.

Houston PD homicide investigator DetectiveRichard Bolton, now retired, recalled to Mankiewicz the inevitable part of the probe when they looked into the men in Gelareh's life, including her fairly new boyfriend, Cory Beavers, and the friend who said he heard a scream on the phone seemingly seconds before she was shot,Robeen Bandarwho also was her ex-boyfriend.

Bandar explained (to police and Mankiewicz) thatthey had had an amicable breakup and had mutually decided they would be better off just being friends.

Police asked why heheard a scream but didn't recallhearinga gun shot or screeching tires. Bandar said it was probably shock or denial of what he may indeed have heard.

Onto Gelareh's current boyfriend, Cory, the last known person to see her alive.

He told police that she had surprised him by showing up at his house, but he had a test to study for so they only hung out for awhile. When sheleft, he told her to text him when she got home to let him know she had arrived safely. He never heard from or saw her again.

Cory said he didn't know Gelareh was dead until he drove up to her house the next day and a reporter approached him and asked if he knew anything about "the girl who lived here."

He knocked on the door and Ibrahim answered, and he was the one to tell Cory that Gelareh was dead.

Police also looked intocrimes with similar M.O.s in the area, wondering if she was the victim of a carjacking gone wrong. They looked at a lawsuit her father was embroiled in at the time with a former employer.

More dead ends.

Four months after the murder, police announced that the family was offering a $200,000 reward for information that led to justice for Gelareh, the largest Crime Stoppers reward on offer in the country at the time.

The dozen or so tips that merited follow-up also led nowhere. But then there was another shooting that November.

The victim was Cory Beavers' identical twin brother, Coty. And homicide detectives don't put much stock in coincidences.

Coty Beavers' wife, Nesreen Irsan,had called 911 to report that her boyfriend had been shot. "Why did God do this to me?"she's heard wailing on the call.

She had found her husband's body in their apartment when she returned home from work. She told police she last saw Coty that morning, when he walked her down to her car to see her off, as he usually did. When police responded to her 911 call, it was apparent he had been dead for awhile. It was later determined that his wedding ring had been moved from his ring finger to the middle finger of his left hand.

Coty and Nesreen were newlyweds. According to Cory, Nesreenalso a student at MD Anderson, like Cory and Gelarehwas originally interested in him, but Cory was determined to keep his mind on his studies and introduced Nesreen to Coty. Nesreen was friends withGelareh, meanwhile, and she's the one who introduced her to Cory after he saw the two of them walking together at school. He was smitten immediatelyand after talkingto her more at a party not long after, they started dating.

By the time his newlywed brother was killed, Corystill reeling from the murder of his girlfriendwas fed up with what he felt was time wasted by the police looking at him as a suspect and any other activity that didn't get them any closer to finding Gelareh's killer.

Nesreen, meanwhile, had her own traumatic past. In the summer of 2011 she had run away from her strict Muslim household and her controlling father, whom she described as "violent and abusive," with only the clothes she was wearing. She climbed out of a window and went to a neighbor's house and asked for a rideto Coty and Cory's mom Shirley Beavers' house in Spring, Texas.

Nesreen had been dating Coty and keeping it a secret from her father, Ali Irsan, with the help of her sister Nadiawho would simultaneously cover for Nesreen but also threaten to tell on her.

When Ali Irsan found out about Nesreen and Coty, he barred his 23-year-old daughter from leaving the house.

Mayra Beltran/Houston Chronicle via AP

Police had no recourse to bring Ali's adult daughter back to their house if she didn't want to be there, so Ali showed up at Shirley's house himself (how he found out where they lived,whether the address was online or Nadia told him, or whatever, they didn't know). Ali knocked on their neighbors' doors, offering $100 for information on Coty's whereabouts. In the ensuing days, the Beavers would go outside in the morning to find that the air had been let out of their tires, so they had to start moving their cars. An order of protection Nesreen obtained against her father didn't stop himbut that at least paved the way for police to obtain a warrant to search the Irsan family's home, as well as two other properties Ali owned. They found a dismantled hand gun.

Cory recalled to Mankiewicz a fight he witnessed between Nadia and Nesreen during college, ostensibly over a petty issue,in which Nadia told her sister, "'I can't wait until my dad puts a bullet in your head.'"

"I believed her," Cory said.

Melissa Phillip/Houston Chronicle via AP, File

Going through boxes of documents they'd confiscated, police found paperwork that indicated Ali Irsan was committing multiple acts of fraud, such as falsely claiming disability benefits and opening credit cards in his kids' names.

Sothe Harris County Sheriff's Department brought in theFBI, and ultimately a task force thatcame to includethe Montgomery and Harris County sheriff offices, the FBI, the Houston Police Department, the Social Security Administration Office and Homeland Security got to work.

According to authorities, Irsan, a naturalized citizen, had first come to the U.S. from Jordan in 1978 and proceeded to marry a blind woman whom he physically and sexually abused, and had four children with. While still married, he brought a teenage bride, Shmou, over from Jordan, and they had eight more children, including Nesreen and Nadia.

In 2014, Irsan was chargedin federal court with conspiracy to defraud the United States, theft of public money and benefits fraud, and Shmou and Nadia were arrested, too. In April 2015, he pleaded guiltyto conspiracy to defraud and was sentenced to 45 months in prison; his wife and daughterwere convicted of providing false statements as part of the fraud schemeand were each sentenced to two years in prison.

But back to the double murder investigation.

Yet another thing discovered in the course of the investigation into Irsan was the revelation that he had been pulled over by a Texas State Trooper on the day of Gelareh's murder. His wife and one of his sons were also in the cara silver Toyota Camry.

Which, incidentally, matched the description given by a witness back in 2012 who told police she saw what looked to be a silver Camry speeding away from the site of the shooting. Nothing had ever come of it.

The location and timing of the traffic stop put Irsan's car exactly where it would have been had he driven away from the crime scene after the shooting. Dash-cam footage showed Ali barely able to stand, and he told the trooper hewas diabetic and suffering from low blood sugar, so he had been speeding on his way to find sugar.

There was no evidence that he was a diabetic.

It was almost a fluke that the trooper still had the dash-cam footage after two years. According to Mankiewiecz, the officer just had a funny feeling about the guy...

Furthermore, per authorities and Cory Beavers, it turned out that Gelareh and Alihad crossed pathstheir seeming lack of interaction having been a nagging issue when trying to connect Ali to both her murder and that of his son-in-law.

AfterNesreen fled her family's home in 2011, Ali started calling her classmates under the guise of simply being a concerned dad.

Gelareh wasn't having it, and told him she saw right through what he was trying to do.

Toward the end of the year, he called again. Gelareh called back and first talked to Nadia, who then passed the phone to her father, who asked (according to Cory), "Is this that Iranian bitch?" Gelareh proceeded to tell him off in Farsi. He hung up. A few weeks later she was dead.

In May 2014, Ali Irsan was charged with Gelareh's murder. That charge would be dropped for tactical reasons, because once authorities had connected him to both killings, Irsan was charged in 2015 with capital murder, for what has since been characterized as two so-called "honor killings."

Or make that three. In 1999, Irsan fatally shot his 29-year-old son-in-law Amjad Alidam. He told police Alidam had been abusing his daughter, and he killed him in self-defense. Authorities later said they couldn't build a case to prove otherwise.

In 2018, jurors spent 35 minutes deliberating before convicting him of themurders of Gelareh Bagherzadeh and Coty Beavers.

During the penalty phase of the trial, a former neighborsaidthat Ali Irsan hadbragged to him that he "got away with murder" inthe death of his other son-in-law."He said he invited his son-in-law to his house and shot him," the witness, Randy Wilkinson, testified. "He said he shot him with a 12-gauge shotgun and planted a gun on him."

His sonNasim Irsan, the one who was in the Camry with him, pleaded guilty in both murders as well and was sentenced last August to 40 years in prison. Ali Irsan iscurrently on death row in Texas.

The finale ofMotive for Murderwill be outThursday, June 4, wherever you get your podcasts.

(E! and NBC News are both members of the NBCUniversal family.)

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A lesson in race, for those who need it | News, Sports, Jobs – The Adirondack Daily Enterprise

Posted: June 4, 2020 at 9:36 am

This past semester I had the privilege of being an adjunct lecturer for a college-level general biology course. In my unit on human evolution, I taught about human diversity and skin color. At first I was intimidated; how was I going to talk about this incredibly complex topic with a class of 18- to 20-year-olds? I decided the best way to talk about race was to start with the bare facts of biology. I hope that the following (albeit reduced) explanation may help some readers understand why the ideals of white supremacy are both factually and morally wrong.

All human genes are a sequence of four different molecules. They are adenosine, thymine, cytosine and guanine. Every gene that a human being has and every living organism has, for that matter is made up of just these four molecules in different sequences. The human genome, the summation of these letter sequences, is 3 billion molecules long. If it were a book, it would have 200,000 pages in it, it would be as tall as the Washington monument (555 feet tall) and would take about 9.5 years to read aloud. Any given human is only 0.1% genetically different from another human. This means if we were to compare the 200,000-page books of sequences from two strangers, 200 pages of this book would vary (footnote 1).

In the eyes of biology, there is no such thing as race because it is a social construct. The reason we see such diversity in human skin color is because of environmental factors and slight changes in certain genes.

When the human species, Homo sapiens, first emerged in Africa 200,000 years ago, most individuals had dark skin. This was because they had a gene that resulted in their skin having lots of melanin, a pigment that helps protect skin cells from UV radiation. Living in equatorial Africa, this helped prevent skin cancer and early death. Individuals with lots of melanin could, theoretically, live longer and be able to reproduce, passing their genes onto their offspring because they were less likely to die of cancer at a young age.

As humans migrated across the planet and populations grew, individuals were born that had random small alterations, or mutations, in their melanin-producing gene. White skin, for example, is caused by having a mutation in the melanin gene which reduces its concentration in our cells. This mutation was more common in humans who had migrated away from the equator, to the north. At these higher latitudes, UV radiation is not as intense, thus the threat of skin cancer is not as great. It is also thought that having white skin in these more northern populations was advantageous because it helped individuals produce more vitamin D. Simply put, not having lots of melanin in these low-UV-radiation environments did not mean you would perish before producing offspring and actually helped you produce more vitamin D (2). This combination of random mutations and migration patterns in early humans is the basis for the modern-day concept of race.

When we look at what race is in the light of biology, the idea that one is superior to the other, that they should not mix, or that one must be conquered is meaningless. One race is not favored above the rest because there are no biologically defined races, just genetic diversity. Humans are 99.9% identical, no matter where they come from in the world, so why should 0.1% determine their worth? Why should a single change in a gene determine your socio-economic standing? Why should it mean you are more likely to be brutalized by others? Why cant that 0.1% difference be celebrated as the beauty and diversity that it really is? Its about time we start celebrating these differences in our appearances and start treating each other with the one thing we all share, our humanity.

Madeline Clark lives in Saranac Lake.

Footnotes:

1. Shuster, M., Vigna, J., Sinha, G., Tontonoz, M., and Kilburn, K.S. (2018). Biology for a changing world (3rd ed.). W.H. Freeman & Company.

2. Canfield, V.A., Berg, A., Peckins, S., Wentzel, S.M., Ang, K.C., Oppenheimer, S., and Cheng, K.C. (2013). Molecular Phylogeography of a human autosomal skin color locus under natural selection. G3: Genes|Genomes|Genetics, 3(11), 2059-2067. https://doi.org/10.1534/g3.113.007484

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A lesson in race, for those who need it | News, Sports, Jobs - The Adirondack Daily Enterprise

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Ferring and Igenomix Collaborate to Advance Care in Reproductive Medicine and Maternal Health – BioSpace

Posted: June 4, 2020 at 9:36 am

SAINT-PREX, Switzerland & VALENCIA, Spain--(BUSINESS WIRE)-- Ferring Pharmaceuticals and Igenomix today announced a two-year research collaboration aimed at the discovery of novel targets and disease mechanisms in infertility and pregnancy-related conditions, including preeclampsia, with the goal of developing innovative diagnostic and therapeutic strategies in these areas of high unmet need.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200603005784/en/

A new research hub will be created in Boston, bringing together scientists and expertise from both companies. The hub will focus on investigating molecular signatures, developing novel functional genomic systems and creating translational tools to study for embryo implantation, endometrial microbiome interaction and decidualization biology to drive innovative solutions for patients.

Today, 1 in 6 couples worldwide are affected by fertility issues, with embryo implantation being a critical step to improving success rates in assisted reproduction technologies (ART) such as IVF. Furthermore, between 3 and 5% of all pregnancies are affected by preeclampsia,1 a severe complication which increases the morbidity and mortality of both mother and baby, said Joan-Carles Arce, Senior Vice President of Reproductive Medicine and Maternal Health, Ferring. Through this collaboration, we aim to advance diagnostic testing and the discovery of candidate drug targets in these areas of high unmet need and ultimately help more people build healthy families worldwide.

This new research hub will connect Igenomixs unique diagnostic capabilities with Ferrings deep therapeutic expertise, said Professor Carlos Simn, Head of Scientific Board of Igenomix Foundation and Project Lead for the new hub. We believe this collaboration will accelerate scientific findings and improve conception rates at a time when significant progress is needed in preimplantation science to help more women and families experience healthy pregnancies.

ENDS

About Fertility Issues

The World Health Organization defines infertility as a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse. Today, 1 in 6 couples worldwide are affected by fertility issues. Assisted Reproductive Technologies (ART) such as In Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI) can help couples who have problems conceiving naturally.

About Preeclampsia

Preeclampsia is a common and severe complication of pregnancy characterised by high blood pressure and multiple organ failure. It affects between 3% and 5% of all pregnancies in the US.1 There is a significant unmet need for an effective treatment for preeclampsia; currently the only treatment is delivery of the baby.

Preeclampsia is responsible for approximately 20% of all preterm births2 and increases the morbidity and mortality of both mother and baby, especially in developing countries. An effective treatment would bring significant improvements in global infant and maternal health.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Learn more at http://www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.

About Igenomix

Igenomix is a biotech company based in Valencia, Spain, specialized in reproductive genetics. Its expertise in fertility and its advanced research capacity situates the company as a worldwide referent in this area. Igenomix has 23 laboratories across the world and employs more than 400 professionals. Since the company launch in 2010, Igenomix has published more than 450 scientific papers and its communications have taken place during high level congresses such as ESHRE (European Society of Human Reproduction) or ASRM (American Society for Reproductive Medicine). Igenomix researchers have received numerous awards recognizing research and many of them share their knowledge and knowhow in leading US universities such as Stanford or Harvard.

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