Category Archives: Molecular Medicine

When exploring the history of the Joyce Murtha Breast Care Center and the Windber Research Institute now the Chan Soon-Shiong Institute for Molecular Medicine Windber you see numerous phenomena that contributed to the amazing technological capabilities that came together to produce such a world-class operation.

The following is a depiction of one such unlikely scenario that combined not only happenstance, but also serendipity and, Im sure, some divine intervention.

The key connector in this story was Gen. Joseph M. Cosumano, whose business card read something like this: Supreme Commander of the Worlds Air and Space Missile Defense Command for the United States Army.

Anyone seeing that title for the first time had to have been impressed and humbled. This individual was in charge of missile defense for not only the continental United States, but for the entire world.

As a breast cancer survivor, Gen. Cosumanos wife, Lydia, was a passionate advocate and supporter of the Clinical Breast Care Project and the work that then Dr. Col. Craig Shriver was undertaking at both the previous Walter Reed Army Hospital and the research institute and breast center in Windber.

She often spoke at the off-site retreats held by Shriver during which the scientists, physicians and staff of both facilities would be apprised of the current research and updated on new treatments and surgical procedures that were substantiated by the discoveries being made by the more than 100 Ph.D.s, doctors and clinical providers working in the program.

Because of Shrivers clinical relationship with Lydia Cosumano, he was invited to a holiday party at the Cosumano home, where he mingled among the guests, both civilian and military. It was during one of those casual interactions that Shriver introduced himself to a senior engineer who is now an honoree of the U.S. Air, Space and Missile Defense Distinguished Civilian Wall of Fame Jess Granone.

Granone was the director of the U.S. Army Space and Missile Defense Technical Center and, as the story goes, he casually said to Shriver, I am in charge of Star Wars.

That was the initiative that had been touted by President Ronald Reagan as a means of protecting the United States from a nuclear attack by any enemy.

After that brief introduction, Granone said to Shriver, What do you do?

At that point, Shriver replied, Im in charge of the Clinical Breast Care Project at Walter Reed.

That resulted in Granone taking a step back and becoming very serious while he explained to Shriver that his sister-in-law had recently died prematurely from breast cancer and how completely devastated the family was over this loss.

He went on to further explain that every day, he sat in front of multiple computer monitors watching simulations of a nuclear attack where hundreds of missiles were flying toward the United States, some with warheads and some as decoys.

He explained that the scientists and engineers under him were responsible for creating algorithms that would sort through the images of these missiles to attempt to determine which of them had the lethal-tipped hydrogen explosives.

This is when things became somewhat more intense.

Granone looked Shriver directly in the eye and said, I came to realize searching for these killer warheads was very much like what a radiologist must have been dealing with while exploring a digital mammography image.

After a short pause, he said, I will get as many of these algorithms declassified as possible and make them available to you for use in your research.

Months later, at a breast conference, the digital image of a mammogram was placed on a screen, and as the algorithms were applied to this image, unusual or potentially dangerous cells and lumps were identified.

Shriver and the teams at both Windber and Walter Reed went on to work with General Electric and the Space and Missile Defense Command in an attempt to perfect what was, in effect, a spell-check for mammography, a program that would double check the scan to ensure not even one malignant cell would be overlooked.

None of this, not one single part of this, could have been possible without the vision, commitment and dedication to our military that emanated from the late Rep. John P. Murtha.

At a ceremony recognizing an anniversary of the Windber Research Institute, when this program was explained, Murtha jokingly took a jab at one of his Republican friends by saying, Well, Im glad that trillion dollars from Star Wars finally resulted in something positive.

And indeed, positive it was as hundreds of thousands of breast cancer screens are now double-checked by the same algorithms used to find and stop nuclear missiles.

It was a partnership that will have a long-lasting impact.

Nick Jacobs, of Windber, is a health care consultant and author of the book Taking the Hell Out of Healthcare.

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Breast Cancer Awareness | Nick Jacobs | An unlikely partnership: The United States Army Space and Missile Defense Command and the Joyce Murtha Breast...

DALLAS Oct. 3, 2022 Expected to be diagnosed in 2% of men and 1% of women in the U.S., kidney cancer has traditionally been one of the most challenging cancers to treat. Until 2005, only one drug had been approved by the Food and Drug Administration (FDA) to treat kidney cancer, which is resistant to both chemotherapy and conventional radiation. Since then, discoveries about its biology have led to a flurry of targeted and immune therapies. But despite these advances, still today, most patients succumb to the disease once the cancer has spread.

Discovered at UTSouthwestern Medical Center (UTSW), theHIF2 protein is the most important driver of kidney cancer, which has traditionally been regarded as undruggable. UTSW scientists identified avulnerability in the HIF2 protein structure and identifiedchemicals blocking HIF2. Licensed to Peloton Therapeutics in the UTSW BioCenter, these chemicals set the foundation for the development of PT2977 (also called belzutifan), which receivedFDA approval for the treatment of hereditary kidney cancer in 2021, and is currently being evaluated against nonfamilial kidney cancer in multiple phase 3 clinical trials by Merck, which acquired Peloton.

However, studies inmice and subsequently inpatients have shown that kidney tumors develop resistance. Resistance arises as a result of mutations, including mutations that block the attachment of the drug to HIF2.

James Brugarolas, M.D., Ph.D.

For the last seven years, scientists in theBrugarolas lab at UTSW have partnered withArrowhead Pharmaceuticals to develop a second-generation inhibitor with activity not only against unmodified but also mutated HIF2. Using the sameplatform of patient tumors transplanted in mice that provided the first evidence ofanti-cancer activity by Pelotons HIF2 blocking drugs, the authors now showthat this second-generation drug is also active against kidney cancer. Proof of principle of activity is also provided in humans from thephase 1 trial led by James Brugarolas, M.D., Ph.D., Professor of Internal Medicine and Director of theKidney Cancer Program at theHarold C. Simmons Comprehensive Cancer Center of UTSW.

Like the FDA-approved Pfizer-BioNTech and Moderna COVID-19 vaccines, this second-generation HIF2 inhibitor (ARO-HIF2) is an RNA-based drug. ARO-HIF2 is a dsRNA drug that blocks the production of HIF2 in cancer cells. A particular advantage of ARO-HIF2 is the presence of a "homing device" that specifically targets it to cancer cells by interacting with a protein on their surface.

Downregulation of HIF2 by ARO-HIF2 in patient tumor biopsies. Courtesy of Dr. Payal Kapur

RNA-based medicines hold promise to treat many different diseases, as evidenced by a recent string of new FDA approvals. However, the unsolved challenge in cancer is delivery. Developing delivery systems to target tumor cells, something that was accomplished with ARO-HIF2, is an area of expanding research, said Daniel Siegwart, Ph.D., Associate Professor of Biochemistry at UTSW and a member of the Simmons Cancer Center.

These studies were supported by Arrowhead Pharmaceuticals as well as the National Cancer Institute through a Specialized Program of Research Excellence (SPORE) award. Dr. Brugarolas has previously served as a consultant for Arrowhead Pharmaceuticals and has several patent applications pertaining to HIF2.

Dr. Brugarolas holds The Sherry Wigley Crow Cancer Research Endowed Chair in Honor of Robert Lewis Kirby, M.D. Dr. Siegwart holds the W. Ray Wallace Distinguished Chair in Molecular Oncology Research.

About UTSouthwestern Medical Center

UTSouthwestern, one of the nations premier academic medical centers, integrates pioneering biomedical research with exceptional clinical care and education. The institutions faculty has received six Nobel Prizes, and includes 26 members of the National Academy of Sciences, 17 members of the National Academy of Medicine, and 14 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 2,900 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UTSouthwestern physicians provide care in more than 80 specialtiesto more than 100,000 hospitalized patients, more than 360,000 emergency room cases, and oversee nearly 4 million outpatient visits a year.

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Tackling resistance to HIF2 drugs with an RNA-based therapy - UT Southwestern

Saveetha Institute of Medical and Technical Sciences (SIMATS) organized the induction ceremony to welcome the Second batch of students who have joined the M.Tech/M.Sc programme in Molecular Medicine for the session 2022-24 was held recently.

Prof. (Dr) Suresh Kumar Rayala, Chairman of GATE/JAM and Professor Department of Biotechnology, IIT Madras, Chennai was the chief guest on the occasion. The Induction ceremony was felicitated by Dr. Sheeja Varghese, Registrar, SIMATS and Dr Aravind Kumar, Dean, Saveetha Dental College and Hospitals, Chennai.

SIMATS started this programme in 2021 for the first time in the state of Tamil Nadu. This course in Molecular Medicine is an interdisciplinary programme with an emphasis on 12 months of dissertation/research work. The programme expands upon the scientific and medical knowledge acquired in bachelor programmes and explores in-depth molecular aspects of medicine.

It should enable students to engage in independent and creative research at the crossroads of medicine and basic science. This year students from diverse fields including graduates and postgraduates in Medicine, Dentistry, Life sciences and Allied Health Sciences joined the programme.

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SIMATS organizes Induction Ceremony - Afternoonnews - Afternoon News

SOUTHLAKE, Texas--(BUSINESS WIRE)--OncoNano Medicine, Inc. today announced positive interim clinical results from an ongoing Phase 2 study of its lead clinical development candidate, pegsitacianine, for the detection of residual disease following cytoreductive surgery (CRS). Study results were presented by Patrick Wagner, MD, Department of Surgical Oncology, Allegheny Health Network Cancer Institute, during an oral presentation at the World Molecular Imaging Congress (WMIC) in Miami, FL on September 29th. The interim results from this trial provide evidence that pegsitacianine could offer surgeons a real-time optical imaging capability that enhances their ability to detect residual cancerous tissue that would otherwise be left behind from their standard of care process for cytoreductive surgery of peritoneal metastases.

We are encouraged by the Phase 2 study results for pegsitacianine in the detection of residual disease for both mucinous and non-mucinous metastatic nodules across multiple cancer types and look forward to further exploring the clinical utility of this novel molecular imaging agent in cancer surgery, said Patrick Wagner, MD, one of the lead investigators on the trial.

The Phase 2 study (NCT04950166) remains open to enrollment and is designed to evaluate the ability of pegsitacianine, a micellar fluorescence agent, to detect residual malignancies following CRS, an operation to completely resect peritoneal metastases. As an adjunct to tactile and visual cues for detecting residual disease, pegsitacianine may allow surgeons a more accurate evaluation of the completeness of surgery, or potentially to augment the results by removing additional lesions. A total of 27 patients were administered pegsitacianine at a dose of 1 mg/kg, proceeded to surgery with intra-operative imaging occurring between 24- and 72-hours post-dose, and completed pathology examination of resected specimens. The data presented revealed that 15 patients (55%) have demonstrated a clinically significant detection of pathology-confirmed residual disease following the completion of intended surgery. In this ongoing study, pegsitacianine continues to be well-tolerated with no observed drug-related serious adverse events. The most common adverse event observed with the use of pegsitacianine has been infusion-related reactions that have been mild to moderate and self-resolving.

About Pegsitacianine

Pegsitacianine is an intraoperative fluorescence imaging agent under development by OncoNano Medicine for the detection of cancerous tissue in patients undergoing surgical resection. Relying on an ultra pH-sensitive activation mechanism of OncoNanos ON-BOARD platform, pegsitacianine exists in a fluorescently dark Off state at physiological pH but transitions rapidly to a fluorescently On state in the presence of the elevated acidic tumor microenvironment. Pegsitacianines unique mechanism of action provides it with the potential for intraoperative near infrared imaging across a variety of solid tumor types. Pegsitacianine has previously been studied in Phase 1 and 2 clinical trials where breast, head and neck, colorectal, and esophageal cancers were successfully imaged following an intravenous dose of pegsitacianine.

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immune-oncology therapeutics that activate and guide the bodys immune system to target cancer.

OncoNanos lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ONBOARD platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNanos second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at http://www.OncoNano.com.

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OncoNano Medicine Announces Positive Phase 2 Data for Pegsitacianine as an adjunct to Cytoreductive Surgery of Peritoneal Carcinomatosis - Business...

Madeline Mayday, BS, a fourth-year Experimental Pathology graduate student in the Laboratory of Diane Krause, MD, PhD, was recently awarded a 2022 National Institute of Diabetes and Digestive and Kidney Diseases Hematology Centers Program Type B Pilot and Feasibility grant for her project entitled, Investigation of RBM15 and the m6A Epitranscriptome in Megakaryopoiesis.

The NIDDK is an institute within the National Institutes of Health. The NIDDK Hematology Centers Program provides a novel support mechanism for researchers to pursue new directions in benign hematology. The grants are designed to support innovative pilot research projects in benign hematology, including the generation of preliminary data for larger research grants.

Madeline is a PhD candidate in the Department of Pathology and is part of the Medical Research Scholars Program. She is originally from Muskoka, Ontario, and graduated with a BS in Cell and Molecular Biology from San Francisco State University. She then worked as a Research Associate at UCSF to develop a protocol for detection of pathogens causing respiratory failure in pediatric HSC transplant patients.

Madeline began her graduate studies in the Translational Molecular Medicine, Pharmacology and Physiology (TMMPP) program at Yale in Fall 2019 and joined the Krause Lab in May 2022 with an interest in translational research and hematopoiesis.

Submitted by Terence P. Corcoran on September 20, 2022

Link:
ExPath Grad Student Madeline Mayday Awarded Grant from the NIDDK Cooperative Centers of Excellence in Hematology - Yale School of Medicine

VIENNA & OXFORD, England--(BUSINESS WIRE)--Exscientia (Nasdaq: EXAI), ETH Zurich, the Medical University of Vienna, and the Center for Molecular Medicine (CeMM) today announced a new publication in Blood Cancer Discovery, a journal of the American Association for Cancer Research, titled Deep Morphology Learning Enhances Precision Medicine by Image-Based Ex Vivo Drug Testing from the laboratory of Prof. Berend Snijder. This post-hoc analysis builds on the transformative work of the EXALT-1 trial, published in Cancer Discovery, by using deep learning algorithms to classify complex cell morphologies in patient cancer tissue samples into disease morphotypes.

EXALT-1 was the first prospective trial to demonstrate significantly improved outcomes for late-stage haematological cancer patients using an AI-supported precision medicine platform to guide personalised treatment recommendations as compared to physicians choice of treatment. In EXALT-1, 40% of patients experienced exceptional responses lasting at least three times longer than expected for their respective disease. The post-hoc analysis published today in Blood Cancer Discovery shows that combining the technology as used in EXALT-1 with new deep learning advancements that take advantage of cell-specific features in high-content images revealed a potential to further increase these patient outcomes.

Following results of the EXALT-1 study, these findings continue to validate that our AI-guided precision medicine platform has the ability to identify highly actionable clinical treatment recommendations for blood cancers, deepening our insights and enhancing the clinical predictive power of the platform to help patients, said Gregory Vladimer, Ph.D., VP Translational Research at Exscientia and co-inventor of the platform technology. Cell morphology, or assessing the characteristics of cells, is fundamental to the diagnosis of cancer. Within this research, we were able to utilise deep learning within the platform to improve our ability to identify personalised cancer treatments, leading to improved clinical outcomes for patients. At Exscientia, we are excited to expand the platforms applications in order to bring personalised medicine to broader populations.

We believe performing drug screens directly in tumour tissues of cancer patients is a great step forward in understanding tumour complexity compared to traditional cell model systems. The fact that we can now harness the power of deep learning to turn these terabytes of images into actionable insights is very exciting indeed, added Prof. Berend Snijder, Principal Investigator at the Institute of Molecular Systems Biology of the ETH Zurich in Switzerland.

The impact of deep learning on the clinical predictive power of ex vivo drug screening was assessed in a post-hoc analysis of 66 patients over a period of three years in a combined data set of 1.3 billion patient cells across 136 ex vivo tested drugs across haematological diagnoses including acute myeloid leukaemia, T-cell lymphomas, diffuse large B-cell lymphomas, chronic lymphocytic leukaemia and multiple myeloma. Patients receiving treatments that were recommended by the platforms immunofluorescence analysis or deep learning on cell morphologies showed an increased rate of achievement of exceptional clinical response, defined as a progression free survival period that lasted three times longer than expected for each patients respective disease. Post-hoc analyses confirmed that the clinical predictions became more accurate when also considering the drug toxicity on the healthy cells within the tested patient sample.

Exscientias precision medicine platform uses custom deep learning and computer vision techniques to extract meaningful single-cell data from high content images of individual patient tissue samples. This analysis generates clinically-relevant insights into which treatments will deliver the most benefit to an individual patient. Further evaluation of individual patient results through Exscientias genomics and transcriptomics capabilities may help Exscientia further understand which other patients may benefit from similar treatments. The underlying technology was developed by Dr. Gregory Vladimer and Prof. Berend Snijder while working in the laboratory of Giulio Superti-Furga at the CeMM Research Center for Molecular Medicine in Austria.

About Exscientia

Exscientia is an AI-driven pharmatech company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting. Our internal pipeline is focused on leveraging our precision medicine platform in oncology, while our partnered pipeline broadens our approach to other therapeutic areas. By pioneering a new approach to medicine creation, we believe the best ideas of science can rapidly become the best medicines for patients.

Exscientia is headquartered in Oxford (England, U.K.), with offices in Vienna (Austria), Dundee (Scotland, U.K.), Boston (Mass., U.S.), Miami (Fla., U.S.), Cambridge (England, U.K.), and Osaka (Japan).

Visit us at https://www.exscientia.ai or follow us on Twitter @exscientiaAI.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements with regard to Exscientias expectations with respect to the progress of development of candidate molecules, timing and progress of, and data reported from, preclinical studies and clinical trials of Exscientias product candidates, and Exscientias expectations regarding its precision medicine platform and AI-driven drug discovery platform. Words such as anticipates, "believes," expects, "intends," "projects," "anticipates," and "future" or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the uncertainties inherent in predicting future results and conditions, including the scope, progress and expansion of Exscientias product development efforts; the initiation, scope and progress of Exscientias and its partners clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; and those inherent in the process of discovering, developing and commercialising product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such product candidates. Exscientia undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

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Blood Cancer Discovery Publication Further Validates Exscientia's AI Precision Medicine Platform for Improving Patient Outcomes - Business Wire

During the 2021-22 fiscal year, 13 startup companies executed agreements to access foundational intellectual property and commercialize new technologies developed at the University of California, Davis.

The bold pursuit of novel solutions through research at UC Davis often results in new technologies and services aligned with a commercial pathway for impact, said Prasant Mohapatra, vice chancellor for research at UC Davis. In most cases those innovations are licensed to existing companies, but many also become the foundation for emerging startups. We are thrilled to see the success of this pathway continue at UC Davis.

The process for connecting innovations from the university to commercial impact is managed by the Innovation and Technology Commercialization division, which is part of the Office of Research. During the 2021-2022 fiscal year, the division processed 132 new records of invention and executed 48 license agreements.

The divisions Venture Catalyst unit focuses on advancing potential technologies with proof-of-concept funding and facilitating startup formation.

The University of California system of campuses ranks first in the world for the number of U.S. utility patents according to a recent report from the National Academy of Inventors and the Intellectual Property Owners Association.

Venture Catalyst, which was launched in 2013, provides resources to help campus innovators advance technologies and launch new companies, said Janine Elliott, interim director Venture Catalyst. It is exciting to see the results of these efforts and the broad range of solutions being advanced.

In the last 10 years Venture Catalyst assisted 130 startups with foundational intellectual property. The 13 emerging startups over the past year are focused on developing technology to meet needs in food, health and agriculture.

One of the startups,Eunicera is developing novel therapeutics to treat and cure advanced drug-resistant prostate cancer. Co-founded by Allen Gao, a professor in the Department of Urology, the companys proprietary, orally bioavailable small molecules targeting both AKR1C3 and androgen receptor variants either work alone or in combination with current therapies to overcome and prevent treatment resistance.

Another company, Optimized Foods is propelled by innovations in the food technology and cultivated meat sectors. By using a novel approach in mycelium technology, the team is creating nutritious, sustainable foods, starting with cultured caviar. Minami Ogawa, a graduate student in the Department of Food Science, discovered how the innovation could be harnessed as an ideal proprietary scaffold for cell cultivation. In parallel, Ruihong Zhang, a professor in the Department of Biological and Agricultural Engineering, and her lab had been developing foundational elements of the platform for food applications. The companys platform is focused on making the dream of cultivated meat a reality, and improving human, animal and planetary health.

Peak B is commercializing natural alternatives to synthetic food colorants with superior color qualities, stability and potency. The UC Davis-led startup hasdiscovered a cyan blue color, solving one of the biggest challenges in the food industrys search to source natural food colorants. The researchers examinedanthocyanin, a water-soluble pigment thats found in many familiar fruits and vegetables, giving them their vibrant red, purple, pink and blue hues. A specific anthocyanin was discovered in red cabbage thatdisplayed the desired blue properties. Since the amount of anthocyanin is small in red cabbage, they used an enzyme-based process to turn its other anthocyanins into blue.Co-founded byJustin Siegel,an associate professor in chemistry, biochemistry and molecular medicine, the companys patented enzyme-based process now turns extracts from natural sources into blue and green colorants that can be used in a variety of food applications.

Additional companies that executed agreements to access the foundational intellectual property from UC Davis during the 2021-22 fiscal year are highlighted below. Three companies have chosen to remain in stealth mode for competitive reasons and are not listed.

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New Startups Built From UC Davis Innovations Drive Solutions in Food, Health and Agriculture - University of California, Davis

University of Gothenburg Researchers have identified a procedure that was not known to scientists in the past which can be used to control cancer growth. The new research has hinted at the direction of possible new drugs with lesser side effects in near future.

The study was published in the journal Nature Communications. The study focuses on the protein that binds the genetic material and controls the conditions that lead to tumor development. The properties that promote tumor growth are neutralized, paving the way for the development of drugs, says Chandrasekhar Kanduri, one of the research leaders behind the study. Drugs can be manufactured in the future to neutralize the effect of protein that promotes tumor growth.

Drugs come with their own side effects. But a recent study shows that controlling the protein responsible for tumors can be done without posing any danger. The mechanism has the potential to become a more attractive cancer treatment option, with fewer side effects, says Meena Kanduri, Associate Professor of Molecular Medicine.

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Scientists Discover New Cancer Treatment - The Morning News

Precision medicine places the patient at the center of healthcare, using a variety of tools to develop tailored and targeted therapeutics and diagnostics.

Promised to revolutionize the landscape of modern medicine, precision medicine requires an in-depth knowledge of the molecular underpinnings of healthy and diseased states. Advances in molecular biology techniques and bioinformatic platforms are helping to provide such knowledge, equipping researchers and physicians with the tools to implement precision medicine approaches across different disease areas.

Thus far, oncology the field of cancer research and treatment has arguably seen the most benefit from precision medicine. However, the pharmaceutical and biotechnology company AstraZeneca believes that precision medicine will rewrite the textbook for the diagnosis and treatment of chronic diseases. Technology Networks recently had the pleasure of speaking with Mark Fidock, vice president for Diagnostic Development, Precision Medicine at AstraZeneca, to find out how the company is rising to the challenge of delivering precision medicines for chronic diseases.

Molly Campbell (MC): Can you talk about some of the ways in which AstraZeneca is actively pursuing precision medicine?

Mark Fidock (MF): I think an interesting metric is that, when we look at our portfolio, over 90% of it has a precision medicine strategy. Precision medicine as a strategy and as a discipline really does encompass the full spectrum of drug research and development. That includes finding new targets which requires the use of cutting-edge methods that are available advancing and pioneering new technologies and of course, driving for better patient outcomes and a more sustainable healthcare system.

One of the areas in which we've made major advances is oncology. AstraZeneca has already achieved over 50 regulatory-approved companion diagnostics across a variety of indications and across a variety of different sample types. This has enabled innovative targeted therapies to be developed and benefit millions of cancer patients worldwide.

The work and success we have achieved in oncology has almost produced a framework for which we can develop precision medicine approaches for chronic diseases. However, we need to recognize that chronic disease is biologically complex and very heterogenous in origin, so a key priority in this space is to investigate the ways in which precision medicine can be deployed and used that increases our disease understanding and leads to better patient outcomes.

The opportunity in the precision medicine space is huge, especially for chronic diseases. Were now in an era where, through precision medicine, we are rewriting the textbook for many indications, and changing the way in which we ultimately treat patients.

MC: Lets talk more about the tools and technologies used. What are the key technological developments that are helping us to understand the biology behind diseases, and harness that information to tailor treatments?

MF: One of the key technology areas (in which AstraZeneca is a leader) is genomics research. Our in-house Centre for Genomics Research intends to sequence 2 million genomes by 2026 which of course, isnt all that far away now. Using very innovative bioinformatics analysis methods, the groups behind this project are looking for rare variants associated with diseases. Through doing so, they are uncovering new biological insights into disease, discovering new therapeutic targets and describing the diseases at a much more granular almost molecular or genetic, way.This creates opportunities for the development of targeted therapies for different segments of a particular disease.

Key examples include the discovery of novel targets in respiratory and immunology diseases, cardiovascular research and renal and metabolic diseases. One of AstraZenecas areas of interest is pulmonary fibrosis, and the group has previously published the discovery of a gene called SPDL1 identified in idiopathic pulmonary fibrosis.

The SPDL1 gene encodes a protein known as Spindly which is responsible for signaling during cell division. Previously, this gene had not been described in relation to idiopathic pulmonary fibrosis. The identification of a novel mechanism underpinning the disease opens the door for novel therapeutic discoveries.

In cardiomyopathy, the group also published a finding relating to the TTN gene. Both examples are key illustrations of how genomic techniques can be used to inform our understanding of a disease. These publications have been shared widely amongst the scientific community.

The TTN gene encodes a protein called titin. Truncated variants of the gene contribute to approximately 1525% cases of nonischemic dilated cardiomyopathy, a condition where the left ventricle becomes enlarged.

MC: Can you talk about the importance of biomarkers in precision medicine? How are they used to identify patients and develop targeted therapies?

MF: I think the opportunity space for precision medicine across all disease indications that AstraZeneca is exploring is huge. It will enhance our ability to rewrite the medical textbooks that physicians are using to understand, diagnose and treat disease.

How do we do this? A core aspect of precision medicine is identifying predictive biomarkers, which is achieved through the insights gathered using genomic studies and other means. Predictive biomarkers provide the opportunity to include the right patients in our clinical trials and to develop targeted companion diagnostics and treatment approaches most appropriately.

In those disease areas where we already have multiple targeted treatment options available, we also have identified biomarkers for selecting patients. One example is in non-alcoholic steatohepatitis (NASH) where A second example is IL33 a cytokine that is seen and raised in many different indications, from asthma to diabetic kidney disease and even in COVID-19.

These are areas whereby the biomarker and the scientific research surrounding the biomarker is helping us to identify the right patients, which allows us to direct where our targeted therapeutics will have the most beneficial clinical outcomes.

MC: Can you talk about the importance of collaboration in the precision medicine space? How is AstraZeneca pursuing collaborative projects?

MF: AstraZeneca works in a very collaborative way, with many collaborations established across each of the different research spaces in which we choose to operate.

We must develop companion diagnostics that are scalable and have global reach, so they're aligned not only to our targeted treatments, but they're also analytically and clinically validated and demonstrate patient benefit. We've built global partnerships to deliver these tests that can be commercialized, which really does enable maximal access to patients. It also ensures these diagnostics are used consistently within the regulatory requirements across whichever part of the world that they will be used.

Through one of our collaborations with Almac, we are developing and validating companion diagnostic tests for patient selection across a variety of different clinical trials for a range of therapeutic areas, such as chronic kidney disease, NASH and respiratory diseases. This is a robust framework that we can adapt for use with other ongoing collaborations, such as our work with Roche diagnostics, among others.

In terms of challenges, when you're innovative, leading in a space and you are creating information that is rewriting rulebooks and rewriting the ways in which treatments are being derived, of course there are going to be some challenges. I think we can all agree that health is a fundamental right that we should all have access to, and that it should be inclusive and tailored to the individual. We think that precision medicine will be a vital part of this offering, it will improve health and it will improve health equality. We need to have discussions to ensure that all healthcare systems can fully adopt this approach into clinical practice, which is achieved through interactions, partnerships and engaging in symposiums and summits. We recently spoke at the World Health Summit, and AstraZeneca aims to bring together panels of external leaders across different diagnostic organizations, to talk through policy and to look at ways in which we can help to bring novel approaches to the clinical community and healthcare structures.

MC: Looking to the future of precision medicine, what are the key priorities in precision medicine for AstraZeneca? What do you envision that this space is going to look like in, say, 1015 years?

MF: The more that we use precision medicine within the chronic disease space, and the more that science really begins to uncover how these complex chronic diseases are derived and their etiology, the more we can look to develop new therapeutic modalities. We can identify the right patient populations for diagnostics to target treatments and ultimately, this will deliver much better outcomes for patients in the long term.

What will it look like in the future? I think that a key focus is asking: how do we bring in novel diagnostics into clinical practice? How do we bring precision medicine to the patient? The future is about patient convenience. One day, it would be fantastic to be able to introduce molecular diagnostic devices to the home, so that patients can monitor their diseases as they are happening. This will involve bringing digital advancements such as progress in artificial intelligence (AI) into the different areas of precision medicine. How do we do this? How do we use digital mediums to derive actionable diagnostic data, where patients can take a diagnostic test in their own environment, that data is then shared with their treating physician enabling decisions and discussions to be held for the patients benefit? These will be important considerations.

A big part of the future is looking to further develop the scientific understanding of chronic disease and bringing together all the learnings that we've had in precision medicine and maximizing the outcome for patients. The future of precision medicine is about having a deep understanding of chronic disease at a molecular, genetic or metabolic level, in such a way that we're able to really make sure that the patient is at the heart of everything, and that they can have the benefit and the convenience of precision medicine in the future.

Mark Fidock, VP for Diagnostic Development, Precision Medicine at AstraZeneca was speaking to Molly Campbell, Senior Science Writer for Technology Networks.

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Rewriting the Textbook for Precision Medicine - Technology Networks

In an interview with '60 Minutes', the president said the pandemic is over, but much work remains. Physicians rejected the assessment and noted hundreds are dying each day.

In a wide-ranging interview on the season premiere of 60 Minutes Sunday night, President Biden surprised many health experts by saying, The pandemic is over.

Responding to a question from CBS journalist Scott Pelley, Biden also said, We still have a problem with COVID. We're still doing a lotta work on it. It's-- but the pandemic is over. if you notice, no one's wearing masks. Everybody seems to be in pretty good shape. And so I think it's changing. (Heres the transcript of the interview.)

Many healthcare experts cringed at the presidents assessment.

Esther Choo, an emergency physician and researcher, wrote on Twitter, The pandemic is not over, and acting like it is harming its ability to *ever* be over. Just last week, she wrote in a piece for MSNBC, The pandemic is marching along quite robustly.

While COVID-19 deaths and hospitalizations are well below the peaks of last winter, the virus continues to take a toll.

After Bidens interview aired, Eric Topol, a physician, author and professor of molecular medicine at Scripps Research, said on Twitter, Wish this was true. What's over is @POTUS's and our government's will to get ahead of it, with magical thinking on the new bivalent boosters.

Topol added Bidens statement ignores the reality of long Covid, the likelihood of new variants, and our current incapability for blocking infections and transmission.

Gavin Yamey, director of global health and public policy at Duke University, disagreed with the president in a piece for Time magazine. The headline: Biden is wrong, the COVID-19 pandemic isnt over. Yamey said the pandemic will end, but were not at the finish line.

The major problem with the President saying the pandemic is over is that it could impede our efforts to reach low endemic levels, Yamey wrote. For example, Congress is less likely to renew funding for COVID-19 measures if the pandemic has ended.

Hospitals have been urging Biden and Congress to approve more federal aid. While acknowledging federal aid helped sustain hospitals in the pandemic, they also say they havent received aid for the influx of COVID-19 patients infected with the Delta and Omicron variants.

Rick Pollack, president of the American Hospital Association, has urged the president and lawmakers to support American hospitals. More than half of U.S. hospitals could end 2022 in negative margins as hospitals are losing billions, the AHA said in a report last week. Hospitals and health systems are also anxious to continue waivers for key services, including telehealth, that are tied to the COVID-19 public health emergency.

In a media call last week, Pollack also pointed out the fight against COVID-19 hasnt ended. Hospitals continue to treat COVID-19 patients, along with a host of patients who deferred care in the pandemic and are now requiring longer hospital stays.

Hundreds are dying each day due to COVID-19 (the 7-day average is 410, The Washington Post reports). The 7-day average of COVID-19 hospitalizations is just over 24,000, according to the U.S. Centers for Disease Control and Prevention.

Jorge Caballero, who co-founded Coders Against COVID, a collaborative to address data gaps in the pandemic, said on Twitter that he feared saying the 'pandemic is over' will directly lead to preventable illness and death.

The Biden administration sought to clarify the messaging on the pandemic.

Sarah Lovenheim, a spokeswoman for the U.S. Department of Health and Human Services, reiterated Monday that the COVID-19 public health emergency remains in effect.

HHS will provide a 60-day notice to states before any possible termination or expiration, Lovenheim posted on Twitter. As weve done previously, well continue to lean on the science to determine the length of the PHE.

Health officials are also urging the continuation of the public health emergency so millions won't lose health coverage. When the emergency declaration expires and Medicaid's continuous enrollment provision ends, the health department projects as many as 15 million Americans could lose coverage.

Anthony S. Fauci, the federal governments chief expert on infectious diseases, told The Washington Post, We still have a lot of work to do to get it down to a low enough level that we would feel comfortable with it.

Im not comfortable with 400 deaths per day, Fauci said in the interview.

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Biden says 'The pandemic is over,' but health experts disagree - Chief Healthcare Executive