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Posts Tagged ‘Clinical Trials’


Llama inspired “AeroNabs” to strangle COVID-19 with an inhaler 

Reporter : Irina Robu, PhD

Llama and other camelids fight off pathogens like viruses with tiny antibodies called nanobodies. A USCF team used protein engineering to make a synthetic nanobody that prevents the spike protein on the surface of SARS-CoV-2 from binding to healthy cells and infecting them. The team indicates promising preclinical results for aerosol formulation and can be used as a self-administered form of protein against the virus.

According to the UCSF team, an aerosolized form of nanobody exhibit SARS-CoV-2 incapable of binding to the ACE2 receptor on healthy cells that line airways. The synthetic nanobody stays functional after it was freeze-dried, exposed to heat and aerosolized.

The researchers ongoing screening a library of synthetic nanobodies, ultimately landing on 21 that banned the spike-ACE2 interaction. The scientists decided that in order to be truly efficient, a nanobody based treatment with interact with all three of the receptor binding domains on the spike protein that attaches to ACE2.  Their solution was to engineer a molecular chain that connects three nanobodies together, which would ensure that when one of the nanobodies attached to RBD, the others would link to the two remaining RBD. This molecular chain resulted in a drug candidate proved to be 200,000 times more potent than a single antibody.

At the same time, ExeVir Bio is also developing an aerosolized COVID-19 treatment inspired by llamas and is currently trying to advance its candidate into clinical trials by the end of the year. Their main candidate, VHH-72Fc was considered to bind to an epitope that is found both in SARS-CoV-2 and SARS-CoV. Yet, the llama inspired treatments are still behind antibody efforts like that of Regeneron.

Even though, there are multiple vaccines in development, researchers at UCSF believe that AeroNabs can be used as a sort of personal protective equipment until vaccines become available. The same researchers are planning human trials and are in discussion with partners who can provide manufacturing and distribution backing.

SOURCE

https://www.fiercebiotech.com/research/ucsf-engineers-develop-llama-inspired-aeronabs-to-strangle-covid-19-inhaler

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Bioresorbable Stent Clinical Trials with New Esprit Below-the-knee Scaffold

Reporter: Irina Robu, PhD

Abbott announced on September 3, 2020, the beginning of the LIFE-BTK clinical trial to evaluate effectiveness and safety of  the Esprit BTK Everolimus Eluting Resorbable Scaffold System. The Esprit BTK System consists of a thin strutted scaffold made of poly-L-lactide, a semi-crystalline bioresorbable polymer engineered to resist vessel recoil and provide a platform for drug delivery. The scaffold is coated with poly-D, L-lactide (PDLLA) and the cytostatic drug, everolimus.

This trial is the first Investigational Device Exemption in the US to assess a fully bioresorbable stent to treat blocked arteries below the knees, also known as critical limb ischemia in people battling advanced stages of peripheral artery disease. For people with CLI, blocked vessels weaken blood flow to the lower extremities, which can lead to severe pain, wounds, and in severe cases, limb amputation.

At this time, the standard of care for patients battling critical limb ischemia is balloon angioplasty, which depend on on a small balloon delivered via a catheter to the blockage to compress it against the arterial wall, opening the vessel and restoring blood flow. Yet, blockages treated only with balloon angioplasty have poor short- and long-term results, and in many cases the vessels become blocked again, lacking additional treatment.

Patients treated with balloon angioplasty often require several procedures on treated arteries, and  a drug eluting resorbable device is if at all possible suited to provide mechanical support, decrease the chance of the vessel re-narrowing and then slowly disappear over time. At this time, there are no drug eluding stents, drug coated balloons or bare metal stents approved for use below the knee. Since, there is a limited number of options for stents below the knee, the FDA has granted Esprit BTK breakthrough device designation, which simplifies review and pre-market approval timelines.

According to Abbott, Espirit BTK System is not a permanent implant, but it does provide support to an artery right after a balloon angioplasty, stopping the vessel from reclosing. As soon as it is implanted, the scaffold distributes a drug over a few months that encourages healing and keeps the artery open. The scaffold is naturally resorbed into the body over time, like dissolving sutures, and eventually leaves only a healed artery behind.

The LIFE-BTK trial is the first Investigational Device Exemption trial in the U.S. to evaluate a fully dissoluble device to treat critical limb ischemia in people battling advanced stages of peripheral artery disease (PAD). The trial will be run by principal investigators Brian DeRubertis, M.D. (vascular surgeon, UCLA), Sahil Parikh M.D., (interventional cardiologist, New York-Presbyterian/Columbia University Irving Medical Center.

SOURCE

https://www.dicardiology.com/article/abbott-restarts-bioresorbable-stent-clinical-trials-new-esprit-below-knee-scaffold

 

 

 

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Artificial pancreas effectively controls type 1 diabetes in children age 6 and up

Reporter: Irina Robu, PhD

A new trial funded by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institute of Health created a clinical trial at four pediatric diabetes centers in the US of a new artificial pancreas system, which monitors and regulates blood glucose levels automatically. The artificial pancreas technology, the Control-IQ system has an insulin pump programmed with advanced control algorithms based on a mathematical model using the person’s glucose monitoring information to automatically adjust the insulin dose, and it was originally developed at University of Virginia (UVA), Charlottesville with funding support from NIDDK.

The artificial pancreas closed-loop control is all in one diabetes management system which monitors and tracks blood glucose levels using a continuous glucose monitor and at the same time delivers the insulin when needed via an insulin pump. The system is not only useful in children age 6 and up, but it also replaces reliance on testing by fingerstick or delivering insulin via injection multiple times a day.

The study contains 101 children between ages of 6 and 13 and the children are assigned either to the control or experimental group. The control group uses a standard injection method and separate insulin pump and the experimental uses the artificial pancreas system. Data was conducted every week for four months, while the participants continue on daily lives.

The results of the study showed that using an artificial pancreas system has a 7% improvement in keeping blood glucose in range during the daytime, and a 26% improvement in nighttime control compared to the control group. However, night time control group is important in people with type 1 diabetes, since unchecked hypoglycemia can lead to seizure, coma or even death. The artificial pancreas system shows about 11 % improvement to the standard method and it shows that the improvement in blood glucose control is impressive and safer for kids. No severe case of hypoglycemia or diabetic ketoacidosis occurred during the study, only some minor issues with the equipment.

After the clinical trial and based on the data received, Tandem Diabetes Care has received clearance from the U.S. FDA for use of the Control-IQ system in children as young as age 6 years.

SOURCE
https://www.nih.gov/news-events/news-releases/artificial-pancreas-effectively-controls-type-1-diabetes-children-age-6

 

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Black doctors’ group creates panel to vet Covid-19 vaccines

Reporter : Irina Robu, PhD

A group of black physicians have been working on creating their own expert task force to vet regulators’ decisions about COVID-19 drugs and vaccines, due to the fact that the trust in federal agencies has weakened over the last few months.

According to the president of NMA, Leon McDougle, the new task force will address the suspicion around COVID-19 vaccines. The fear is that the vaccines might not be safe or properly tested before they are approved which makes it the reason some patients of color are wary about taking part in the clinical trials.  The task force will evaluate how well the clinical trials participants characterize demographic breakdown of American population and the fairness of the federal plans to distribute a vaccine to Black, Latino and Native American communities.

The leaders of the black community task force are still figuring out how it will work and what happens if FDA authorizes the use of product without releasing the full data to support it. As past president of the NMA, Dr. Rodney Hood knows that the organization has in its ranks the kind of expertise that could analyze clinical trial data along with expertise in epidemiology and infectious disease.

The black community task force hopes that they are able to tell their patients about the scientific findings regarding COVID-19 vaccine with full transparency and disclosure.

SOURCE

https://www.statnews.com/2020/09/21/black-doctors-group-creates-panel-to-vet-covid19-vaccines/?utm_source=STAT+NewslettersTop of Form

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“Repurposing” Off-patent Drugs offers big hopes of New Treatments

Reporter: Irina Robu, PhD

Given the substantial costs and the slow pace of drug discovery and development, repurposing old drugs has become a practice, partly because it involves the use of already developed compounds. Yet, there is lack of clinical interest in repurposing off patent drugs.

However, the scale of the opportunity for drug repurposing is huge. Initially approved for one disease, these drugs went off-patent and now show potential in other diseases. Even so, many non-profit groups see promise in supporting trials into drug repurposing. There is a huge untapped medicine chest of generic drugs with unexploited uses. These generic drugs are often cheap, already approved, off-patent and relatively quick to develop, whereas new drugs can cost millions of dollars to develop, test and 45% of the drugs fail in clinical trials.

However, numerous non-profit groups see potential in supporting trials into drug repurposing. Epidemiological data can offer enticing leads. Yet, clinical trials for these drugs are costly, but the benefits can be huge. The Drugs for Neglected Diseases Initiative, a Swiss non-profit research group, supported research into fexinidazole, which was abandoned by a pharma at an early stage. The drug showed to have antiparasitic qualities. However, after years of work in January 2020, it was approved for sleeping sickness in the Democratic Republic of Congo. It is the first oral medicine for the disease, and works for all stages of it.

Up till now, when it comes to cancer the most promising generic pills are known. Cancer Research, a UK based charity is testing aspirin to see if can stop cancer from recurring; metformin in a large prostate-cancer trial; and an anti-fungal medication to treat bowel cancer. At the same time, the Anticancer Fund in Brussels hopes that propranolol in treating cancers of the inner lining of blood vessels and pancreatic cancer. Propranolol is a generic 1960s beta-blocker used for a wide range of ailments such as hypertension, anxiety and migraine. If approved for cancer, its cost would be negligible in comparison the tens of thousands of dollars a month usually charged for cancer medicines.

Money seems the crucial constraint with these drugs, in addition to the clinical trials needed to have these drugs updated and relabeled. Only the makers or original developers of a drug are permitted to adjust its label. Sanofi, based in Paris, was the firm that requested regulatory review of fexinidazole for sleeping sickness, while the research was a charitable effort. But drug firms are not forced to support non-commercial efforts to repurpose drugs. And outside the industry it is tough to find the legal expertise to be able to do the  necessary paperwork.

As non-profits make progress in repurposing, corporate interest may be rising. In terms of achieving new treatment options, this is good news. But it will not bring cheaper medicines in areas traditionally neglected by the drug industry. Firms will focus on finding ways to patent the new uses and charge high prices for the finished product.

If governments need cheaper drugs, non-profits will need financial incentives and a cooperative regulatory framework. They include making regulators give free advice and waive approval fees, and a public fund to support repurposing. Yet, when drugs are approved, investors are paid back by the public health service, which makes savings by using the newly approved generic drugs.

SOURCE

https://www.economist.com/international/2019/02/28/repurposing-off-patent-drugs-offers-big-hopes-of-new-treatments?fsrc=scn/tw/te/bl/ed/crosspurposesrepurposingoffpatentdrugsoffersbighopesofnewtreatmentsinternational

 

Other related articles published in this Online Scientific Open Access Journal include:

 

The Castleman Disease Research Network publishes Phase 1 Results of Drug Repurposing Database for COVID-19

Reporter: Stephen J. Williams, PhD

https://pharmaceuticalintelligence.com/2020/06/27/the-castleman-disease-research-network-publishes-phase-1-results-of-drug-repurposing-database-for-covid-19/

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Blood Clots Tied to Coronavirus Problems

Reporter: Irina Robu, PhD

Frequent complications of COVID-19 include purple rashes, swollen legs, clogged catheters and sudden death. Anyone with a severe illness is at risk of developing clots, but hospitalized patients with COVID-19 appear to be more susceptible. Blood clots in the deep veins of the body can occur due to injury/damage, inactivity, surgery, chemotherapy for cancer. Injuries like bone fractures or muscle tears can cause damage to blood vessels, leading to clots. Yes, due to long periods of inactivity, gravity causes blood to stagnate in the lowest areas of your body.

Yet, blood clots can form a variety of reasons. One of the most known blood clots that form in veins is pulmonary embolism caused by deep vein thrombosis. In some cases, a pulmonary embolism can be difficult to diagnose when you have an underlying lung or heart condition. It is possible that anything that gets in the bloodstream and then lodges in the smaller pulmonary arteries can be a pulmonary embolism.

Research from Netherlands and France suggest that clots appear in 20% to 30% of critically ill COVID-19 patients. Researchers have a few credible hypotheses to explain the phenomenon and they are starting to launch studies aimed at gaining mechanistic visions. But with the death toll rising, they are also scrambling to test clot-curbing medications. Common anticoagulant blood thinners such as warfarin and enoxaparin don’t reliably avert clotting in people with COVID-19 and young people are dying of strokes caused by the blockages in the brain. It is indicated that patients in the hospital have extremely elevated levels of a protein fragment called D-dimer, which is generated when a clot breaks down. High levels of D-dimer appear to be a powerful predictor of mortality in hospitalized patients infected with coronavirus.

Jeffrey Laurence, a hematologist at Weill Cornell Medicine in New York City studied lung and skin samples from three people infected with COVID-19 and found that the capillaries were clogged with clots. Even with all the research, how clotting occurs is still a mystery. One probability is that SARS-CoV-2 is unswervingly attacking the endothelial cells that line the blood vessels, which harbor the same ACE2 receptor that the virus uses to enter lung cells. This is confirmed by researchers from University Hospital Zurich in Switzerland and Brigham and Women’s Hospital in Boston, Massachusetts, who observed SARS-Cov-2 in endothelial cells inside kidney tissue.

Clotting can also be affected by the virus effects, because in some people COVID-19 prompts immune cells to release a torrent of chemical signals that ramps up inflammation. As the virus appears to activate the complement system, it then sparks clotting which acts a defense mechanism. People with the COVID-19 disease who become hospitalized usually have a number of risk factors for clotting such as high blood pressure, diabetes and/or genetic predisposition to clotting.

While researchers initiate how clotting occurs in people with COVID-19, they’re hurrying to test new therapies meant at preventing and busting clots. Blood-thinning medications are usually the standard of care for patients in the intensive-care unit and patients with COVID-19 are no exception. Similar trials are planned for scientists at Beth Israel Deaconess Medical Center have started enrolment for a clinical trial to evaluate an even more powerful clot-busting medication, tissue plasminogen activator. TPK is a drug more potent that carries higher risks of serious bleeding than do blood thinners. Scientists anticipate that these trials and others will deliver the data required to help physicians to make difficult treatment decisions.

SOURCE

https://www.scientificamerican.com/article/blood-clots-are-mysteriously-tied-to-many-coronavirus-problems/?fbclid=IwAR2SsBh00fkPjSqgCYyFpwCu6FlZbmnsYtSDYHqZ7xW_Dw2yP7f9HaLUhTE

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Sepsis Detection using an Algorithm More Efficient than Standard Methods

Reporter : Irina Robu, PhD

Sepsis is a complication of severe infection categorized by a systemic inflammatory response with mortality rates between 25% to 30% for severe sepsis and 40% to 70% for septic shock. The most common sites of infection are the respiratory, genitourinary, and gastrointestinal systems, as well as the skin and soft tissue. The first manifestation of sepsis is fever with pneumonia being the most common symptom of sepsis with initial treatment which contains respiratory stabilization shadowed by aggressive fluid resuscitation. When fluid resuscitation fails to restore mean arterial pressure and organ perfusion, vasopressor therapy is indicated.

However, a machine-learning algorithm tested by Christopher Barton, MD from UC-San Francisco has exceeded the four typical methods used for catching sepsis early in hospital patients, giving clinicians up to 48 hours to interfere before the condition has a chance to begin turning dangerous. The four standard methods were Systemic Inflammatory Response Syndrome (SIRS) criteria, Sequential (Sepsis-Related) Organ-Failure Assessment (SOFA) and Modified Early Warning System (MEWS). The purpose of dividing the data sets between two far-flung institutions was to train and test the algorithm on demographically miscellaneous patient populations.

The patients involved in the study were admitted to hospital without sepsis and all had at least one recording of each of six vital signs such as oxygen levels in the blood, heart rate, respiratory rate, temperature, systolic blood pressure and diastolic blood pressure. Even though they were admitted to the hospital without it, some have contracted sepsis during their stay while others did not. Researchers used their algorithm detection versus the standard methods applied at sepsis onset at 24 hours and 48 hours prior.
Even though sepsis affects at least 1.7 million adults mostly outside of the hospital settings, nearly 270,000 die. Researchers are hoping that the algorithm would allow clinicians to interfere prior to the condition becoming deadly.

SOURCE
https://www.aiin.healthcare/topics/diagnostics/sepsis-diagnosis-machine-learning

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Real Time @BIOConvention #BIO2019:#Bitcoin Your Data! From Trusted Pharma Silos to Trustless Community-Owned Blockchain-Based Precision Medicine Data Trials

Reporter: Stephen J Williams, PhD @StephenJWillia2
Speakers

As care for lifestyle-driven chronic diseases expands in scope, prevention and recovery are becoming the new areas of focus. Building a precision medicine foundation that will promote ownership of individuals’ health data and allow for sharing and trading of this data could prove a great blockchain.

At its core, blockchain may offer the potential of a shared platform that decentralizes healthcare interactions ensuring access control, authenticity and integrity, while presenting the industry with radical possibilities for value-based care and reimbursement models. Panelists will explore these new discoveries as well as look to answer lingering questions, such as: are we off to a “trustless” information model underpinned by Bitcoin cryptocurrency, where no central authority validates the transactions in the ledger, and anyone whose computers can do the required math can join to mine and add blocks to your data? Would smart contracts begin to incentivize “rational” behaviors where consumers respond in a manner that makes their data interesting?

Moderator:  Cybersecurity is extremely important in the minds of healthcare CEOs.  CEO of Kaiser Permenente has listed this as one of main concerns for his company.

Sanjeey of Singularity: There are Very few companies in this space.  Singularity have collected thousands of patient data.  They wanted to do predictive health care, where a patient will know beforehand what health problems and issues to expect.  Created a program called Virtual Assistant. As data is dynamic, the goal was to provide Virtual Assistant to everyone.

Benefits of blockchain: secure, simple to update, decentralized data; patient can control their own data, who sees it and monetize it.

Nebular Genetics: Company was founded by Dr. George Church, who had pioneered the next generation sequencing (NGS) methodology.  The company goal is to make genomics available to all but this currently is not the case as NGS is not being used as frequently.

The problem is a data problem:

  • data not organized
  • data too parsed
  • data not accessible

Blockchain may be able to alleviate the accessibiltiy problem.  Pharma is very interested in the data but expensive to collect.  In addition many companies just do large scale but low depth sequencing.  For example 23andme (which had recently made a big deal with Lilly for data) only sequences about 1% of genome.

There are two types of genome sequencing companies

  1.  large scale and low depth – like 23andme
  2. smaller scale but higher depth – like DECODE and some of the EU EXOME sequencing efforts like the 1000 Project

Simply Vital Health: Harnesses blockchain to combat ineffeciencies in hospital records. They tackle the costs after acute care so increase the value based care.  Most of healthcare is concentrated on the top earners and little is concentrated on the majority less affluent and poor.  On addressing HIPAA compliance issues: they decided to work with HIPAA and comply but will wait for this industry to catch up so the industry as a whole can lobby to affect policy change required for blockchain technology to work efficiently in this arena.  They will only work with known vendors: VERY Important to know where the data is kept and who are controlling the servers you are using.  With other blockchain like Etherium or Bitcoin, the servers are anonymous.

Encrypgen: generates new blockchain for genomic data and NGS companies.

 

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Live Conference Coverage Medcity Converge 2018 Philadelphia: Clinical Trials and Mega Health Mergers

Reporter: Stephen J. Williams, PhD

1:30 – 2:15 PM Clinical Trials 2.0

The randomized, controlled clinical trial is the gold standard, but it may be time for a new model. How can patient networks and new technology be leveraged to boost clinical trial recruitment and manage clinical trials more efficiently?

Moderator: John Reites, Chief Product Officer, Thread @johnreites
Speakers:
Andrew Chapman M.D., Chief of Cancer Services , Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
Michelle Longmire, M.D., Founder, Medable @LongmireMD
Sameek Roychowdhury MD, PhD, Medical Oncologist and Researcher, Ohio State University Comprehensive Cancer Center @OSUCCC_James

 

Michele: Medable is creating a digital surrogate biomarker for short term end result for cardiology clinical trials as well as creating a virtual site clinical trial design (independent of geography)

Sameek:  OSU is developing RNASeq tests for oncogenic fusions that are actionable

John: ability to use various technologies to conduct telehealth and tele-trials.  So why are we talking about Clinical Trials 2.0?

Andrew: We are not meeting many patients needs.  The provider also have a workload that prevents from the efficient running of a clinical trial.

Michele:  Personalized medicine: what is the framework how we conduct clinical trials in this new paradigm?

Sameek: How do we find those rare patients outside of a health network?  A fragmented health system is hurting patient recruitment efforts.

Wout: The Christmas Tree paradigm: collecting data points based on previous studies may lead to unnecessary criteria for patient recruitment

Sameek:  OSU has a cancer network (Orion) that has 95% success rate of recruitment.  Over Orion network sequencing performed at $10,000 per patient, cost reimbursed through network.  Network helps pharma companies find patients and patients to find drugs

Wout: reaching out to different stakeholders

John: what he sees in 2.0 is use of tech.  They took 12 clinic business but they integrated these sites and was able to benefit patient experience… this helped in recruitment into trials.  Now after a patient is recruited, how 2.0 model works?

Sameek:  since we work with pharma companies, what if we bring in patients from all over the US.  how do we continue to take care of them?

Andrew: utilizing a technology is critically important for tele-health to work and for tele-clinical trials to work

Michele:  the utilization of tele-health by patients is rather low.

Wout:  We are looking for insights into the data.  So we are concentrated on collecting the data and not decision trees.

John: What is a barrier to driving Clinical Trial 2.0?

Andrew: The complexity is a barrier to the patient.  Need to show the simplicity of this.  Need to match trials within a system.

Saleem: Data sharing incentives might not be there or the value not recognized by all players.  And it is hard to figure out how to share the data in the most efficient way.

Wout: Key issue when think locally and act globally but healthcare is the inverse of this as there are so many stakeholders but that adoption by all stakeholders take time

Michele: accessibility of healthcare data by patients is revolutionary.  The medical training in US does not train doctors in communicating a value of a trial

John: we are in a value-driven economy.  You have to give alot to get something in this economy. Final comments?

Saleem: we need fundamental research on the validity of clinical trials 2.0.

Wout:  Use tools to mine manually but don’t do everything manually, not underlying tasks

Andrew: Show value to patient

2:20-3:00 PM CONVERGEnce on Steroids: Why Comcast and Independence Blue Cross?

This year has seen a great deal of convergence in health care.  One of the most innovative collaborations announced was that of Cable and Media giant Comcast Corporation and health plan Independence Blue Cross.  This fireside chat will explore what the joint venture is all about, the backstory of how this unlikely partnership came to be, and what it might mean for our industry.

sponsored by Independence Blue Cross @IBX 

Moderator: Tom Olenzak, Managing Director Strategic Innovation Portfolio, Independence Blue Cross @IBX
Speakers:
Marc Siry, VP, Strategic Development, Comcast
Michael Vennera, SVP, Chief Information Officer, Independence Blue Cross

Comcast and Independence Blue Cross Blue Shield are teaming together to form an independent health firm to bring various players in healthcare onto a platform to give people a clear path to manage their healthcare.  Its not just about a payer and information system but an ecosystem within Philadelphia and over the nation.

Michael:  About 2015 at a health innovation conference they came together to produce a demo on how they envision the future of healthcare.

Marc: When we think of a customer we think of the household. So we thought about aggregating services to people in health.  How do people interact with their healthcare system?

What are the risks for bringing this vision to reality?

Michael: Key to experience is how to connect consumer to caregiver.

How do we aggregate the data, and present it in a way to consumer where it is actionable?

How do we help the patient to know where to go next?

Marc: Concept of ubiquity, not just the app, nor asking the provider to ask patient to download the app and use it but use our platform to expand it over all forms of media. They did a study with an insurer with metabolic syndrome and people’s viewing habits.  So when you can combine the expertise of IBX and the scale of a Comcast platform you can provide great amount of usable data.

Michael: Analytics will be a prime importance of the venture.

Tom:  We look at lots of companies that try to pitch technologies but they dont understand healthcare is a human problem not a tech problem.  What have you learned?

Marc: Adoption rate of new tech by doctors is very low as they are very busy.  Understanding the clinicians workflow is important and how to not disrupt their workflow was humbling for us.

Michael:  The speed at which big tech companies can integrate and innovate new technologies is very rapid, something we did not understand.  We want to get this off the ground locally but want to take this solution national and globally.

Marc:  We are not in competition with local startups but we are looking to work with them to build scale and operability so startups need to show how they can scale up.  This joint venture is designed to look at these ideas.  However this will take a while before we open up the ecosystem until we can see how they would add value. There are also challenges with small companies working with large organizations.

 

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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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Blood Pressure Lowering

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

Data analysis and publication of landmark NIH blood pressure study confirm that lower blood pressure target can reduce cardiovascular disease, deaths

http://www.nih.gov/news-events/news-releases/data-analysis-publication-landmark-nih-blood-pressure-study-confirm-lower-blood-pressure-target-can-reduce-cardiovascular-disease-deaths

 

NIH-supported researchers are reporting more details on a landmark study that announced preliminary findings in September showing a lower blood pressure target can save lives and reduce the risk of cardiovascular disease in a group of non-diabetic adults 50 years and older with high blood pressure. Results of the Systolic Blood Pressure Intervention Trial (SPRINT) appear in the current online issue of the New England Journal of Medicine and were discussed today at the American Heart Association 2015 Scientific Sessions in Orlando.

The study confirms that, in adults 50 years and older with high blood pressure, targeting a systolic blood pressure of less than 120 millimeters of mercury (mm Hg) reduced rates of cardiovascular events, such as heart attack and heart failure, as well as stroke, by 25 percent. Additionally, this target reduced the risk of death by 27 percent—as compared to a target systolic pressure of 140 mm Hg.

“SPRINT is part of a proud legacy of NIH-funded clinical trials that will change clinical practice and save lives for decades to come. These results reinforce the compelling public health importance of enhancing the awareness, treatment and control of hypertension in this country and around the world,” said Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI), the primary sponsor of SPRINT.

The SPRINT study, which began in the fall of 2009, included more than 9,300 participants age 50 and older, recruited from about 100 medical centers and clinical practices throughout the United States and Puerto Rico. About 36 percent of participants were women, 58 percent were white, 30 percent were African-American, and 11 percent were Hispanic. The SPRINT study did not include patients with diabetes, prior stroke, or polycystic kidney disease, as other NIH trials were studying those particular populations. Approximately 28 percent were 75 or older and 28 percent had chronic kidney disease. The study tested a strategy of using blood pressure medications to achieve the targeted goals of less than 120 mm Hg (intensive treatment group) versus 140 mm Hg (standard treatment group). The NIH stopped the blood pressure intervention in August—a year earlier than planned—after it became apparent that this more intensive intervention was beneficial.

“When the benefits of the stronger intervention became apparent in SPRINT, we made a commitment to rapid public health communication and peer-reviewed publication of the study results,” Dr. Gibbons said. “We are pleased to present the details of the study’s potentially lifesaving findings at this time.”

In their report, investigators provided detailed data showing that both cardiovascular deaths and overall deaths were lower in the intensive treatment group.

Certain types of serious consequences were more common in the intensive group, including low blood pressure, fainting, electrolyte abnormalities, and acute kidney damage. However, other serious adverse events associated with lower blood pressure, such as slow heart rate and falls with injuries, did not increase in the intensive group. In patients with chronic kidney disease, there was no difference in the rate of serious decline in kidney function between the two blood pressure goal groups.

“The benefits of more intensive blood pressure lowering exceeded the potential for harm, regardless of gender or race/ethnicity,” said study co-author Paul Whelton, M.D., of Tulane University School of Public Health and Tropical Medicine in New Orleans, Louisiana. He is chair of the SPRINT Steering Committee.

In addition to its primary cardiovascular outcome, the study continues to examine kidney disease, cognitive function, and dementia among the SPRINT participants; however, these results are not yet available as additional information will be collected and analyzed over the next year.

“Although the study provides strong evidence that a lower blood pressure target saves lives, patients and their health care providers may want to wait to see how guideline groups incorporate this study and other scientific reports into any future hypertension guidelines. In the meantime, patients should talk to their health care providers to determine whether this lower goal is best for their individual care,” said study co-author Lawrence Fine, M.D., Chief, Clinical Applications and Prevention Branch at NHLBI.

“It’s also important to remember that healthy lifestyle changes can make a difference in controlling high blood pressure,” Dr. Fine added. He emphasized the importance of following a healthy diet, being physically active, maintaining a healthy weight, as well as learning to check your blood pressure.

In addition to primary sponsorship by the NHLBI, SPRINT is co-sponsored by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging.

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at http://www.nhlbi.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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Landmark NIH study shows intensive blood pressure management may save lives

Embargoed for Release:

September 11, 2015, 10:30 AM EDT

Lower blood pressure target greatly reduces cardiovascular complications and deaths in older adults

More intensive management of high blood pressure, below a commonly recommended blood pressure target, significantly reduces rates of cardiovascular disease, and lowers risk of death in a group of adults 50 years and older with high blood pressure. This is according to the initial results of a landmark clinical trial sponsored by the National Institutes of Health called the Systolic Blood Pressure Intervention Trial (SPRINT). The intervention in this trial, which carefully adjusts the amount or type of blood pressure medication to achieve a target systolicpressure of 120 millimeters of mercury (mm Hg), reduced rates of cardiovascular events, such as heart attack and heart failure, as well as stroke, by almost a third and the risk of death by almost a quarter, as compared to the target systolic pressure of 140 mm Hg.

“This study provides potentially lifesaving information that will be useful to health care providers as they consider the best treatment options for some of their patients, particularly those over the age of 50,” said Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI), the primary sponsor of SPRINT. “We are delighted to have achieved this important milestone in the study in advance of the expected closure date for the SPRINT trial and look forward to quickly communicating the results to help inform patient care and the future development of evidence-based clinical guidelines.”

High blood pressure, or hypertension, is a leading risk factor for heart disease, stroke, kidney failure, and other health problems. An estimated 1 in 3 people in the United States has high blood pressure.

The SPRINT study evaluates the benefits of maintaining a new target for systolic blood pressure, the top number in a blood pressure reading, among a group of patients 50 years and older at increased risk for heart disease or who have kidney disease. A systolic pressure of 120 mm Hg, maintained by this more intensive blood pressure intervention, could ultimately help save lives among adults age 50 and older who have a combination of high blood pressure and at least one additional risk factor for heart disease, the investigators say.

The SPRINT study, which began in the fall of 2009, includes more than 9,300 participants age 50 and older, recruited from about 100 medical centers and clinical practices throughout the United States and Puerto Rico. It is the largest study of its kind to date to examine how maintaining systolic blood pressure at a lower than currently recommended level will impact cardiovascular and kidney diseases. NIH stopped the blood pressure intervention earlier than originally planned in order to quickly disseminate the significant preliminary results.

The study population was diverse and included women, racial/ethnic minorities, and the elderly.  The investigators point out that the SPRINT study did not include patients with diabetes, prior stroke, or polycystic kidney disease, as other research included those populations.

When SPRINT was designed, the well-established clinical guidelines recommended a systolic blood pressure of less than 140 mm Hg for healthy adults and 130 mm Hg for adults with kidney disease or diabetes. Investigators designed SPRINT to determine the potential benefits of achieving systolic blood pressure of less than 120 mm Hg for hypertensive adults 50 years and older who are at risk for developing heart disease or kidney disease.

Between 2010 and 2013, the SPRINT investigators randomly divided the study participants into two groups that differed according to targeted levels of blood pressure control. The standard group received blood pressure medications to achieve a target of less than 140 mm Hg. They received an average of two different blood pressure medications. The intensive treatment group received medications to achieve a target of less than 120 mm Hg and received an average of three medications.

“Our results provide important evidence that treating blood pressure to a lower goal in older or high-risk patients can be beneficial and yield better health results overall,” said Lawrence Fine, M.D., chief, Clinical Applications and Prevention Branch at NHLBI. “But patients should talk to their doctor to determine whether this lower goal is best for their individual care.”

The study is also examining kidney disease, cognitive function, and dementia among the patients; however, those results are still under analysis and are not yet available as additional information will be collected over the next year.  The primary results of the trial will be published within the next few months.

In addition to primary sponsorship by the NHLBI, SPRINT is co-sponsored by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging.

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