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Live Conference Coverage @Medcitynews Converge 2018 Philadelphia: Early Diagnosis Through Predictive Biomarkers, NonInvasive Testing

Posted in Alzheimer's Disease, Big Data, Big Data & Analytics, BioBanking, Biomarkers & Medical Diagnostics, Cancer and Current Therapeutics, Cancer Informatics, Cancer Screening, Diagnostics and Lab Tests, Meta-analysis of transcriptome data, Pharmaceutical Industry Competitive Intelligence, Pharmacotherapy and Cell Activity, Scientific & Biotech Conferences: Press Coverage, Transcriptomics, Uncategorized, tagged AD biomarkers, cancer biomarkers, clinical trial 2.0, innovations in cancer detection, multiple schlerosis, oncoproteomics, Predictive Cancer Biomarkers, Proteomics, Transcriptomics on July 11, 2018| Leave a Comment »

5:00 – 5:45 PM Early Diagnosis Through Predictive Biomarkers, NonInvasive Testing

Reporter: Stephen J. Williams, Ph.D.

 

Diagnosing cancer early is often the difference between survival and death. Hear from experts regarding the new and emerging technologies that form the next generation of cancer diagnostics.

Moderator: Heather Rose, Director of Licensing, Thomas Jefferson University
Speakers:
Bonnie Anderson, Chairman and CEO, Veracyte @BonnieAndDx
Kevin Hrusovsky, Founder and Chairman, Powering Precision Health @KevinHrusovsky

Bonnie Anderson and Veracyte produces genomic tests for thyroid and other cancer diagnosis.  Kevin Hrusovksy and Precision Health uses peer reviewed evidence based medicine to affect precision medicine decision.

Bonnie: aim to get a truth of diagnosis.  Getting tumor tissue is paramount as well as properly preserved tissue.  They use deep RNA sequencing  and machine learning  in their clinically approved tests.

Kevin: Serial biospace entrepreneur.  Two diseases, cancer and neurologic, have been diseases which have been hardest to get reproducible and validated biomarkers of early disease.  He concentrates on protein biomarkers.

Heather:  FDA has recently approved drugs for early disease intervention.  However the use of biomarkers can go beyond patient stratification in clinical trials.

Kevin: 15 approved drugs for MS but the markers are scans looking for brain atrophy which is too late of an endpoint.  So we need biomarkers of early disease progression.  We can use those early biomarkers of disease progression so pharma can target those early biomarkers and or use those early biomarkers of disease progression  for endpoint

Bonnie: exciting time in the early diagnostics field. She prefers transcriptomics to DNA based methods such as WES or WGS (whole exome or whole genome sequencing).  It was critical to show data on the cost savings imparted by their transcriptomic based thryoid cancer diagnostic test for payers to consider this test eligible for reimbursement.

Kevin: There has been 20 million  CAT scans for  cancer but it is estimated 90% of these scans led to misdiagnosis. Biomarker  development  has revolutionized diagnostics in this disease area.  They have developed a breakthrough panel of ten protein biomarkers in serum which he estimates may replace 5 million mammograms.

All panelists agreed on the importance of regulatory compliance and the focus of new research should be on early detection.  In addition they believe that Dr. Gotlieb’s appointment to the FDA is a positive for the biomarker development field, as Dr. Gotlieb understands the potential and importance of early detection and prevention of disease.  Kevin also felt Dr. Gotlieb understands the importance of incorporating biomarkers as endpoints in clinical trials.  Over 750 phase 1,2, and 3 clinical trials use biomarker endpoints but the pharma companies still need to prove the biomarkers clinical relevance to the FDA.They also agreed it would be helpful to involve advocacy groups in putting more pressure on the healthcare providers and policy makers on this importance of diagnostics as a preventative measure.

In addition, the discovery and use of biomarkers as disease endpoints has led to a resurgence of Alzheimer’s disease drug development by companies which have previously given up on these type of neurodegenerative diseases.

Kevin feels proteomics offers great advantages over DNA-based diagnostics, especially in cancer such as ovarian cancer, where a high degree of specificity for a diagnostic test is required to ascertain if a woman should undergo prophylactic oophorectomy.  He suggests that a new blood-based protein biomarker panel is being developed for early detection of some forms of ovarian cancer.

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Please see related articles on Live Coverage of Previous Meetings on this Open Access Journal

LIVE – Real Time – 16th Annual Cancer Research Symposium, Koch Institute, Friday, June 16, 9AM – 5PM, Kresge Auditorium, MIT

Real Time Coverage and eProceedings of Presentations on 11/16 – 11/17, 2016, The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

Tweets Impression Analytics, Re-Tweets, Tweets and Likes by @AVIVA1950 and @pharma_BI for 2018 BioIT, Boston, 5/15 – 5/17, 2018

BIO 2018! June 4-7, 2018 at Boston Convention & Exhibition Center

https://pharmaceuticalintelligence.com/press-coverage/

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Top 10 Medical Innovations for 2018, 2020 and 2021 by Cleveland Clinic

Posted in Hospital-based Medical Innovations, tagged Distance Health, Enhanced Recovery After Surgery, Gene Therapy for Inherited Retinal Diseases, Next Generation Vaccine Platforms, Scalp Cooling on July 10, 2018| Leave a Comment »

Top 10 Medical Innovations for 2018, 2020 and 2021 by Cleveland Clinic

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 12/26/2020 from

OCTOBER 6, 2020 / NEWS RELEASES

Cleveland Clinic Unveils Top 10 Medical Innovations For 2021

Top clinicians and researchers present transforming medical advancements and new award to recognize healthcare innovation

https://newsroom.clevelandclinic.org/2020/10/06/cleveland-clinic-unveils-top-10-medical-innovations-for-2021/

Here, in order of anticipated importance, are the Top 10 Medical Innovations for 2021:

1. Gene Therapy for Hemoglobinopathies

Hemoglobinopathies are genetic disorders affecting the structure or production of the hemoglobin molecule – the red protein responsible for transporting oxygen in the blood. The most common hemoglobinopathies include sickle cell disease and thalassemia – which combined affect more than 330,000 children born worldwide every year and more than 100,000 patients with sickle cell disease in the United States alone. The latest research in hemoglobinopathies has brought an experimental gene therapy, giving those who have the condition the potential ability to make functional hemoglobin molecules – reducing the presence of sickled blood cells or ineffective red blood cells in thalassemia to prevent associated complications.

2. Novel Drug for Primary-Progressive Multiple Sclerosis

In individuals with multiple sclerosis (MS), the immune system attacks the fatty protective myelin sheath that covers the nerve fibers – causing communication problems between the brain and the rest of the body that can result in permanent damage or deterioration and eventual death. Approximately 15 percent of people with MS experience a disease subset known as primary-progressive, characterized by gradual onset and steady progression of signs and symptoms. A new, FDA-approved therapeutic monoclonal antibody with a novel target is the first and only MS treatment for the primary-progressive population.

3. Smartphone-Connected Pacemaker Devices

Implantable devices like pacemakers and defibrillators deliver electrical impulses to the heart muscle chambers to contract and pump blood to the body. They are used to prevent or correct arrhythmias – heartbeats that are uneven, too slow or too fast. Remote monitoring of these devices is an essential part of care. Traditionally, remote monitoring of this device takes place through a bed-side console that transmits the pacemaker or defibrillator data to the physician. Though millions of patients have pacemakers and defibrillators, many lack a basic understanding of the device or how it functions and adherence to remote monitoring has been suboptimal. Bluetooth-enabled pacemaker devices can remedy these issues of disconnection between patients and their cardiac treatment. Used in conjunction with a mobile app, these connected devices allow patients greater insight into the health data from the pacemakers and transmit the health information to their physicians.

4. New Medication for Cystic Fibrosis

Today, more than 30,000 people in the United States are living with cystic fibrosis (CF) – a hereditary condition characterized by thick, sticky mucus that clogs airways and traps germs, leading to infections, inflammation and other complications. CF is caused by a defective cystic fibrosis transmembrane conductance regulator (CFTR) protein. A class of drugs called CFTR modulators correct the protein’s action, but medications developed prior to last year had only been effective in a subset of people with certain mutations. A new combination drug, FDA approved in October 2019, provides relief for patients with the most common CF gene mutation (F508 del) – estimated to represent 90 percent of individuals living with the disease.

 5. Universal Hepatitis C Treatment

Classified as a “silent epidemic” by the CDC, hepatitis C has emerged as a major public health issue in the U.S. Infection with the hepatitis C virus can lead to serious, life-threatening health problems like liver failure, cirrhosis and liver cancer. With no vaccine for the virus, patients have been limited to medication, but many treatments were accompanied by adverse side effects or only effective for certain genotypes of the disease. A new, approved fixed-dose combination medication has vastly improved hepatitis C treatment. More than 90 percent effective for hepatitis C genotypes one through six, the therapy represents an effective option for a wider scope of patients.

6. Bubble CPAP for Increased Lung Function in Premature Babies

Underweight and frail, babies born prematurely often require specialized care – including ventilation for those with infant respiratory distress syndrome (IRDS). For IRDS, infants are commonly administered surfactant during mechanical ventilation, a practice that can cause lasting lung injury in preterm infants and contribute to the development of chronic lung disease. Unlike mechanical ventilation, b-CPAP is a non-invasive ventilation strategy – delivering continuous positive airway pressure to newborns to maintain lung volumes during exhalation. The oscillating, rather than constant pressure, plays a role in its safety and efficacy, minimizing physical trauma and stimulating lung growth when administered over a prolonged period.

7. Increased Access to Telemedicine through Novel Practice and Policy Changes

COVID-19 saw increased adoption of telemedical practices as clinicians needed to conduct patient visits online. An increasingly virtual care model and increased consumer adoption came by way of fundamental shifts in policy at both the government and provider level. Since March, state and federal regulators have moved quickly to reduce barriers to telehealth, understanding that these new tools can speed access to care while protecting healthcare workers and community members. These measures opened the floodgates for telehealth, allowing for new programs and the expansion of existing networks.

8. Vacuum-Induced Uterine Tamponade Device for Postpartum Hemorrhage

Characterized as excessive bleeding after having a baby, postpartum hemorrhage is a devastating complication of childbirth, affecting from one to five percent of women who give birth. Mothers experiencing postpartum hemorrhage  may require blood transfusions, drugs which may cause dangerous side effects, long uncomfortable procedures, and even emergency hysterectomy with loss of fertility. Non-surgical interventions directed at the site of bleeding has been limited to balloon devices that expand the uterus while compressing the site of bleeding. But the newest advancement is that of vacuum-induced uterine tamponade – a method that uses negative pressure created inside the uterus to collapse the bleeding cavity causing the muscle to close off the vessels. The vacuum-induced device represents another minimally invasive tool for clinicians as they treat the complication and provides a low-tech solution that is potentially translatable to developing countries with low resource availability.

9. PARP Inhibitors for Prostate Cancer

About one man in nine will be diagnosed with prostate cancer in his lifetime. While there has been progress in the last decade, the disease remains the second-leading cause of cancer death among men in the U.S. PARP inhibitors – pharmacological inhibitors for cancer treatment – block proteins called PARP that help repair damaged tumor DNA in people with BRCA1 and BRCA2 gene mutations. Though known for their success in women’s cancers, two PARP inhibitors have been demonstrated to delay the progression of prostate cancer in men with refractory cancer and DNA repair pathway mutations. Both were approved for prostate cancer in May 2020.

10. Immunologics for Migraine Prophylaxis

Migraines affect more than 38 million people in the U.S. – an estimated 12 percent of the adult population. For some time, multi-purpose drugs like blood pressure medications, antidepressants, anti-seizure drugs and Botox injections have been used to prevent attacks. However, not developed specifically for migraines, these methods have been met with mixed results. In 2018, new medications were developed to help head off migraine pain. The class of drugs works by blocking the activity of a molecule called calcitonin gene-related peptide (CGRP), which spikes during a migraine. Actively prescribed in 2020, this new FDA-approved class of medication is the first to be specifically designed for the preventive treatment of migraine, marking a new era of migraine therapeutics.

At next year’s Medical Innovation Summit, in addition to the annual Top 10 list, Cleveland Clinic will present a new award in honor of its rich history of innovation and advancements in healthcare delivery. The inaugural prize will be awarded to a team, organization or individual who has made a significant contribution to healthcare delivery with a focus on one or more defined areas. Details will be released in early 2021.

For more information on the annual Top 10 Medical Innovations list including descriptions, videos, and year-by-year comparisons, visit Cleveland Clinic’s Top 10 Medical Innovations page.

OCTOBER 23, 2019 / NEWS RELEASES

Cleveland Clinic Unveils Top 10 Medical Innovations for 2020

A panel of top doctors and researchers presents the medical advancements with the power to transform healthcare in the next year

https://newsroom.clevelandclinic.org/2019/10/23/cleveland-clinic-unveils-top-10-medical-innovations-for-2020/

1. Dual-Acting Osteoporosis Drug

Osteoporosis is a condition in which bones become weak and brittle, effectively increasing their risk of breaking. With osteoporosis, the loss of bone occurs silently and progressively – often without symptoms until the first fracture. Providing more bone-strengthening power, the recent FDA approval of a new dual-acting drug (romosozumab) is giving patients with osteoporosis more control in preventing additional fractures.

2. Expanded Use of Minimally Invasive Mitral Valve Surgery

The mitral valve allows blood flow from the heart’s left atrium to the left ventricle. But in about 1 in 10 individuals over the age of 75, the mitral valve is defective causing the action of regurgitation. Expanding the approval of a minimally invasive valve repair device to a population of patients who have failed to get symptom relief from other therapies provides an important new treatment option.

3. Inaugural Treatment for Transthyretin Amyloid Cardiomyopathy

A disheartening cardiovascular disorder, ATTR-CM is a progressive, underdiagnosed, potentially fatal disease in which amyloid protein fibrils deposit in, and stiffen, the walls of the heart’s left ventricle. But a new agent to prevent misfolding of the deposited protein is showing a significantly reduced risk of death. Following Fast-Track and Breakthrough designations in 2017 and 2018, 2019 marked the FDA approval of tafamidis, the first-ever medication for treatment of this increasingly recognized condition.

4. Therapy for Peanut Allergies

It’s a terrifying reality for 2.5 percent of parents – the possibility that at any moment, their child might be unable to breathe due to an allergic reaction. Though emergency epinephrine has reduced the severity and risk of accidental exposure, these innovations are not enough to quell the ever-present anxiety. But development of a new oral immunotherapy medication to gradually build tolerance to peanut exposure holds the opportunity to lend protection against attack.

5. Closed-Loop Spinal Cord Stimulation

Chronic pain is a terribly frustrating condition, and a large reason for prescription of opioid medication. Spinal cord stimulation is a popular treatment for chronic pain through which an implantable device provides electrical stimulus to the spinal cord. But unsatisfactory outcomes due to subtherapeutic or overstimulation events are common. Closed-loop stimulation is allowing for better communication between the device and the spinal cord providing more optimal stimulation and relief of pain.

6. Biologics in Orthopaedic Repair

After orthopaedic surgery, the body can take anywhere from months to years to recover. But biologics – cells, blood components, growth factors, and other natural substances – have the power to replace or harness the body’s own power and promote healing. These elements are finding their way into orthopaedic care, allowing for the possibility of expedited improved outcomes.

7. Antibiotic Envelope for Cardiac Implantable Device Infection Prevention

Worldwide, roughly 1.5 million patients receive an implantable cardiac electronic device every year. In these patients, infection remains a major, potentially life-threatening complication. Antibiotic-embedded envelopes are now made to encase these cardiac devices, effectively preventing infection.

 

8. Bempedoic Acid for Cholesterol Lowering in Statin Intolerant Patients

High cholesterol is a major concern for nearly 40 percent of adults in the U.S. Left untreated, the condition could lead to serious health problems like heart attack and stroke. Though typically managed with statins, some individuals experience unacceptable muscle pain with statins. Bempedoic acid provides an alternative approach to lowering of LDL-cholesterol while avoiding these side effects.

9. PARP Inhibitors for Maintenance Therapy in Ovarian Cancer

PARP, or poly-ADP ribose polymerase, inhibitors block repair of damaged DNA in tumor cells which increases cell death, especially in tumors with deficient repair mechanisms.  One of the most recent important advances ovarian cancer treatment, PARP inhibitors have improved progression-free survival and are now being approved for first-line maintenance therapy in advanced stage disease. Several additional large-scale trials are underway with PARP inhibitors set to make great strides in improving outcomes in cancer therapy.

10. Drugs for Heart Failure with Preserved Ejection Fraction

Heart failure with preserved ejection fraction (HFpEF) – also known as diastolic heart failure – is the condition in which the ventricular heart muscles contract normally, but do not relax as they should. With preserved ejection fraction, the heart is unable to properly fill with blood – leaving less available to be pumped out to the body. Currently, recommendations for this treatment are directed at accompanying conditions and mere symptom relief. But SGLT2 inhibitors, a class of medications used in the treatment of type 2 diabetes, is now being explored in HFpEF – alluding to a potential new treatment option.

For more information on the annual Top 10 Medical Innovations including descriptions, videos, and year-by-year comparisons visit: https://innovations.clevelandclinic.org/Summit/Top-10-Medical-Innovations

SOURCE

https://newsroom.clevelandclinic.org/2019/10/23/cleveland-clinic-unveils-top-10-medical-innovations-for-2020/

Top 10 for 2018

#1 Hybrid Closed-Loop Insulin Delivery System

This approach has not just made T1D management easier than ever, it is also getting praise for stabilizing blood glucose at an unprecedented level.

Read More

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#2 Neuromodulation to Treat Obstructive Sleep Apnea

While C.P.A.P. is the gold standard treatment for OSA, the risk of misuse or discontinued use has created an opportunity for innovators to search for a less intrusive way to treat it. The result is ne

Read More

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#3 Gene Therapy for Inherited Retinal Diseases

In 2018 gene therapy is expected to make its comeback with expected FDA approvals for a variety of inherited retinal diseases (“IRDs”).

Read More

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#4 The Unprecedented Reduction of LDL Cholesterol

These new drugs are taking cholesterol to low levels never seen before.

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#5 The Emergence of Distance Health

In 2018, the prevalence of connectivity enables distance health.

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#6 Next Generation Vaccine Platforms

In 2018, innovators will be upgrading the entire vaccine infrastructure to support the rapid development of new vaccines (a concept that was #1 on the Top 10 Medical Innovations for 2015).

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#7 Arsenal of Targeted Breast Cancer Therapies

For breast cancer patients that are BRCA1 or BRCA2 positive, there is new hope for a targeted therapy that is already seeing success in the ovarian cancer market.

Read More

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#8 Enhanced Recovery After Surgery

After seeing substantial growth in hospital readmissions and an opioid epidemic spiraling out of control, it is clear that physicians need to overhaul the post-surgery strategies currently in use.

Read More

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#9 Centralized Monitoring of Hospital Patients

Centralized monitoring has emerged as the answer, as part of a “mission control” operation in which off-site personnel use advanced equipment monitor patients.

Read More

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#10 Scalp Cooling for Reducing Chemotherapy Induced Hair Loss

The practice of “Scalp Cooling” has been shown to be highly effective for preserving hair in women receiving neoadjuvant or adjuvant chemotherapy for early-stage breast cancer.

Read More

SOURCE

http://innovations.clevelandclinic.org/Summit/Top-10-Medical-Innovations/Top-10-for-2018.aspx

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