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Chia Seeds Benefits | Weight Loss and more

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Chia seeds, also known as salvia hispanica, are known to have several health benefits due to the presence of important minerals and nutrients in them. Their role in assisting weight loss, improving bone health, and improving cardiovascular health, has prompted experts to deem this whole grain option a superfood.

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Chia Seeds Benefits

The abundance of nutrients in them means chia seeds have a host of health benefits. Here’s a list of 9 benefits of these seeds:

Assists in Weight Loss

When you eat food which is rich in protein and fiber, it will lead to weight loss. Fiber present in chia seeds makes you feel full, as it expands after absorbing large volumes of water from your body. They can absorb water up to 12 times their weight.

Also, these seeds provide high amounts of protein, another nutrient that decreases your appetite. Remember to complement the chia seeds in your diet with a healthy lifestyle, which makes it easier to lose weight.

chia seeds aid weight loss

Enhances Digestive Health

For every 28 grams of chia seeds, you get almost 11 grams of fiber, allowing you to get the required amount of this nutrient from a single serving. The dietary fiber, present in these seeds, has a positive impact on your bowel movement, while giving your stool a healthy appearance.

An interesting thing to note is that chia seeds create a substance which resembles gelatin, after consumption. They form this substance because of the presence of soluble fiber. It improves your digestive health by encouraging prebiotics to grow in your gut.

Full of Antioxidants

Studies show that antioxidants fight free radical production in your body. Free radicals are dangerous, as they damage your cells. As a result of this, they can cause diseases like cancer during the later stages of life. Also, they are responsible for ageing and cognitive decline.

The antioxidant content in chia seeds can protect your cells from these dangers. Keep in mind that obtaining antioxidants from natural sources is better than consuming supplements.

Great Source of Omega-3 Fatty Acids

Chia seeds are also rich in omega-3 fatty acids. Therefore, they manage and prevent heart diseases, by reducing blood pressure. It also decreases the fat in your liver, improves joint and bone health, prevents your skin from ageing prematurely, and increases the quality of sleep.

By eating chia seeds, your body gets the required amounts of Alpha Linolenic Acid (ALA). Consume fish oil, DHA supplements, or fatty fish along with them so that your body can convert ALA into its more active and useful forms, DHA and EPA.

There was a study published in the Journal of Molecular Biochemistry, which examined the impact of ALA on cervical and breast cancer. The researchers found that ALA destroys cancer cells while keeping the healthy ones out of harm’s way. There needs to be more research on the impact of ALA on other types of cancer. However, it is good to know that it can help fight some variants.

High Nutrient Density

One of the main reasons why chia seeds are gaining popularity all around the world is because of its high nutrient density. By eating two tablespoons of chia seeds, you get calcium, carbohydrates, fat, fiber, magnesium, manganese, phosphorus, protein, and vitamin A. It also provides small amounts of copper, potassium, and zinc.

Improves Dental Health

Nutrients such as zinc, phosphorus, calcium, and vitamin A are great for your teeth. The presence of calcium in chia seeds helps strengthen your teeth, making them great for dental health. At the same time, zinc keeps tartar at bay, by preventing plaque from building up. Also, due to its antibacterial effects, the germs responsible for bad breath cannot sustain themselves. Phosphorus and vitamin A keep your mouth healthy and add to the strength of your teeth.

helps improve dental health

Improves Bone Health

A single serving of chia seeds can account for about 18% of your daily calcium requirements. This mineral is an important nutrient for bone health, as it maintains their mass and strength. They also contain boron, which further improves your bone health. It is responsible for metabolising phosphorus, magnesium, calcium, and manganese, which promotes healthy growth in your bones.

Prevents Spike in Sugar Levels

Chia seeds are a great source of fiber, due to which your body doesn’t need to increase the amount of blood sugar to digest them. As a result of this, your pancreas doesn’t have to increase its production of insulin. When you consume food with high amounts of fiber, it will stabilise your blood sugar.

A study conducted by National Institute of Medicine has shown what happens when you consume a diet which has 14 grams of fiber out of 1,000 calories. There is a considerable reduction in the risk of type 2 diabetes. There was another study, which showed the positive effects of these tiny seeds on diabetes patients. For 12 weeks, 20 patients got either wheat bran or chia seeds. The researchers found out that the patients who ate chia seeds were showing signs of improvement in health markers such as vWF, hs-CRP, and blood pressure.

Improves Cardiovascular Health

According to certain recent studies, dietary fiber can help regulate the immune system and inflammation. Therefore, eating more chia seeds could decrease the risk of inflammation-related conditions such as diabetes, obesity, cardiovascular diseases and cancer.

A higher fiber intake has been known to lower blood pressure and cholesterol levels. A review consisting of 67 different controlled trials showed that a modest 10-gram increase in fiber intake everyday reduced LDL or “bad cholesterol”, as well as total cholesterol levels in the body. Therefore, the consumption of chia seeds can help bring cholesterol levels under control.

How to eat Chia Seeds?

There are several ways you can consume these healthy seeds. To ensure that your body can absorb all the nutrients, you should soak or grind them, before consumption.

Although there is a lot of debate about whether you should eat them raw or soaked, there is no difference in either. However, when you soak the seeds, it removes the protective “enzyme inhibitors.”

If you plan on soaking them, mix one and a half tablespoons of chia seeds with a single cup of water. By following this procedure, the mixture doesn’t become watery. Allow the seeds to settle in the water for at least 30 minutes before consuming them. If you grind the seeds, make sure that you store it in a sealed container, kept inside the refrigerator. Here are a few things you can do to consume chia seeds:

Add it to Muffins, Waffles, Homemade Granola Bars, and Pancakes

If you find it hard to stay away from food such as pancakes, homemade granola bars, muffins, waffles, and pancakes, you can add chia seeds, and make them nutritious. Its neutral flavour ensures that these dishes remain just as delicious.

Combine it with Vegetables, Meat, or Fish

Improve the nutritional value of vegetables, meat, or fish, by simply adding chia seeds to them. This would also result in an extra layer of crunchiness.

Make a Jam

You can replace pectin with chia seeds, as they can soak up water from your jam. At the same time, pectin is quite bitter, due to which, you have to add a lot of sugar, to make your jam sweet. For example, heat water and blueberries on a pan, till they become soft. Pulverise the berries with the help of a potato masher, before adding cinnamon, honey, and lemon juice. Stop heating the mixture and add chia seeds. Transfer the mixture into a bowl and store it in the refrigerator till it gets the consistency of a jam. If you don’t like blueberries, you can replace them with plums, peaches, or any other fruit of your choice.

Make a Pudding

As chia seeds can absorb large quantities of liquid, you can soak them in milk or water overnight. The next day, they will transform this mixture into a pudding-like texture. You can convert this into a delicious pudding by adding cacao/cocoa powder, maple syrup, almond milk/regular milk, and vanilla extract. Blend all these items together till the texture becomes creamy and smooth. Store this pudding in the refrigerator for at least three to five hours, before consumption.

Top off Oatmeal or Yoghurt

Adding chia seeds to oatmeal would require minimal effort. You can also add it as a topping for your yoghurt. If you find the gelatinous texture weird, add the chia seeds just before you consume these dishes.

Make a Smoothie

You can also choose to drink these seeds in the form of a Green Chia Smoothie. Simply put together 2 cups of spinach, 1.5 cups of water, and 2 tablespoons of chia seeds, and blend them. You can then add a peeled orange, a cup of frozen blueberries, and one cup of strawberries, before blending again.

Chia Seeds Side Effects

While they are a predominantly healthy snack, a few health risks have been observed to be associated with this superfood. A few potential side effects of consuming chia seeds are listed below:

  • While fiber is important for one’s health, excessive intake can cause abdominal pain, constipation and bloating. Eating too many chia seeds can lead to digestive problems if not consumed correctly. However, these negative symptoms can be prevented or regulated by increasing fiber intake slowly, and drinking a lot of water to help it pass through the body.
  • While they may be safe to most people, the consumption of chia seeds comes with the risk of choking. One must always consume these seeds carefully, especially if they have problems swallowing. This risk is due to the fact that chia seeds swell up and can absorb 10-12 times their weight when they are exposed to water.
  • Chia seeds are known to contain a good amount of Alpha Linolenic Acid (ALA). Some studies say that excessive ALA intake may be associated with an increased risk of prostate cancer.
  • Although uncommon, people have been known to be allergic to chia seeds. Symptoms of the allergy may include vomiting, diarrhea and itching of the lips and the tongue.

Summary

Chia seeds have several incredible benefits, ranging from aiding weight loss to improved bone and cardiovascular health. Include these tiny seeds in your favourite dish, or have them as a part of dessert. Simply make sure that chia seeds are a part of your diet in order to reap their many benefits.

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Omron Healthcare CEO Ranndy Kellogg on the company’s collaborative approach to innovation

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Omron Healthcare is one of the leading companies within the blood pressure monitoring space, but hasn’t been content to rest on its laurels.

The company has continued to innovate through partnerships that driven new lines of business and new products meant to bring Omron closer to its overarching goal of reducing heart attacks and stroke.

One of the Omron’s recent key product development collaborations has been with AliveCor, the Mountain View-based company known for their line of portable EKG Monitors.

The company co-led AliveCor’s $30 million Series D funding in 2017 and Omron Healthcare CEO Ranndy Kellogg sits on the startup’s board of directors. While early efforts served to integrate AliveCor EKG data into Omron’s cardiac health app, the two companies released their first hardware collaboration this month.

Omron’s new Complete device serves as both an at-home blood pressure monitor as well as an EKG monitor to provide a more holistic picture of a person’s cardiac health. In order to steer away from data overload, Omron allows the healthcare provider or clinician to set up parameters with when they’re notified about a patient’s health status.

“We work with physicians to find out what data they would like to see and how would they like to see it and we know they don’t want all your blood pressure readings and they don’t want all your EKG readings, so we can help triage what readings you get,” Kellogg said during an interview at the AdvaMed Digital MedTech Conference in San Francisco.

“It gets them more involved in the process so now they’re actually wanting to see the data as it enables them to better treat the patient and then obviously get paid for that work that they do.”

Eventually, the hope is to integrate Omron’s readings directly into the EHR to create even more seamless data sharing.

Earlier this year the company began selling its HeartGuide smartwatch, which retails for $500 and has the ability to measure blood pressure through the wrist, as well perform fitness and sleep tracking functions.

Kellogg said the smartwatch was an important step for the company in responding to customer demand and removing the stigma and burden to regularly check blood pressure among high risk patient populations.

According to Kellogg demand for the product has been strong, and the company has been playing catch-up with manufacturing, as evidenced by the projected September shipping date for new units on the company’s website.

The HeartGuide put a new medical-grade wearable on the market with a differentiated feature set outside of the scope of wearables manufacturers like Apple, Garmin and Fitbit. It also creates a more consistent health touchpoint with users, leading to new potential business opportunities.

On this end, Omron may look to Fitbit as a potential model. Under competitive pressure, the wearables company has tried to diversify its business model past device sales and into more recurring revenue sources like health coaching and health data analytics services.

The company’s Fitbit Care business line pairs on body wearable sensors with human health coaches to help users meet fitness and health goals through in-app, over the phone and in-person meetings

Kellogg said with its new wearable product, Omron is also weighing potentially developing their own health-oriented service models. Currently, Omron partners with other chronic disease management companies like Livongo, Omada and Lark as they’ve moved into hypertension.

“We are absolutely looking at whether there are new service models we should bring forward and have pilots at several institutions to see what might work,” Kellogg said.

The company has also benefited from increasing reimbursement for chronic care management, which has driven the use of their products as remote monitoring devices.

Kellogg said the next-generation of the HeartGuide watch would take a page from the Complete and incorporate the ability to perform EKG as well as more advanced sleep tracking features.

“At the top of our list is EKG or rhythm issues. There are other issues within that realm that you could detect. For example an electrophysiologist might want some specific heart rate measurements alongside an EKG,” Kellogg said.

The entrance of traditional consumer technology players into the medical monitoring and healthcare space could pose a challenge for incumbents like Omron, but Kellogg positioned the company’s knowledge of the regulated space as one competitive advantage, alongside its lower price point.

We welcome them coming in and it certainly draws attention to the market and the category. Our sales go up every time they make an announcement,” Kellogg said.

“We have to make sure as an industry though that all these products are really medical devices. We strongly believe that they all should be FDA reviewed and cleared or PMA or something, so that the consumer and the physician can trust the information they get from them.”

Another collaboration has been with Amazon to integrate Omron health functionalities into the company’s Alexa system.

Kellogg said the company considers the voice-enabled features – which can be used to set reminders and highlight higher than normal readings – as a product differentiator and eventually as a possible pathway toward a full remote monitoring system.

Our real initiative is in partnerships. How do we partner more with other companies to allow sharing of data to give a better picture of the consumer’s health?” Kellogg said.

“We know we can’t bring in all the data, so if there was a condition that required your blood glucose, could we partner with Medtronic for example and bring in the blood glucose data into our app and present in a way that allowed the patient to take action that they might not have taken before?”

Picture: Omron Healthcare

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TytoCare joins Epic App Orchard to expand reach of its telehealth service

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Online tele medicine isometric concept. Medical consultation and treatment via application of smartphone connected internet clinic.

Digital health startup TytoCare has joined the Epic App Orchard, a marketplace where providers can browse apps made by third-party software developers, according to a news release.

Through the integration, healthcare organizations using Epic can offer TytoCare’s telehealth service to their patients and providers.

In responses sent via email, TytoCare vice president of product and implementation Ophir Lotan said Epic customers must first request access to the TytoCare App Orchard app and customize their telehealth workflow to include TytoCare.

“Once this is done, patients will be able to initiate TytoCare telehealth visits from within MyChart and care providers can launch the Tyto Clinician Dashboard from Epic’s HyperSpace desktop application to initiate the telehealth exam and visit,” he said.

For instance, patients using the Epic MyChart tool can initiate a live or scheduled TytoCare telehealth visit, which will be launched from MyChart directly into the Tyto app.

Healthcare providers can launch the Tyto Clinician App from Epic’s HyperSpace desktop application to remotely join the telehealth visit. During the visit, the provider can control the TytoCare device to examine the patient and capture temperature readings, skin images and recordings of the throat and ears. When the visit wraps up, all the exam data is transferred to Epic’s EHR.

“We strive to make both patients and healthcare providers’ access to telehealth
services simpler and EHR integrations are an important component in this effort,” said Lotan.

He added that his company “is actively working with customers on various EHR integration capabilities.”

Other offerings in the Epic App Orchard include apps from Teladoc, Zocdoc, Healthgrades, Apple, GE Healthcare and AccessOne, a patient financing company that joined the App Orchard earlier this month.

TytoCare, which has offices in New York City and Netanya, Israel, offers a handheld exam kit and app.

In April, the company signed its first major retail partnership with Best Buy. Through it, the startup’s TytoHome product will be offered online through BestBuy.com and in brick-and-mortar stores in Minnesota. At the time of the announcement, TytoCare said availability is coming soon to Best Buy stores in California, North Dakota, South Dakota and Ohio.

Picture: Andrey Suslov, Getty Images

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FDA approves Novartis gene therapy Zolgensma for spinal muscular atrophy

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The Food and Drug Administration has given another approval to a gene therapy, this time for a rare disease that causes paralysis.

Swiss drugmaker Novartis announced the approval of Zolgensma (onasemnogene abeparvovec-xioi) for spinal muscular atrophy (SMA) in children younger than 2 who have biallelic mutations in the SMN1 gene. The original developer of Zolgensma was AveXis, which Novartis acquired last year for $8.7 billion.

The therapy is an adeno-associated viral vector-based therapy. The first gene therapy approved by the FDA was Spark Therapeutics’ Luxturna (voretigene neparvovec-rzyl), for biallelic RPE65 mutation-associated retinal dystrophy, a genetic disease that causes blindness, in December 2017.

In a conference call with reporters Friday, AveXis President Dave Lennon noted that the therapy would cost $2.125 million, paid in installments over five years at $425,000 per year, under a partnership with the specialty pharmacy Accredo. AveXis is negotiating with payers to create five-year, outcomes-based agreements for the therapy.

Ahead of the approval, reports had emerged that the therapy would cost as much as $5 million, but Novartis CEO Vas Narasimhan told reporters at an event Wednesday that it would be priced “far lower” than that, according to Reuters. In the Friday conference call, Lennon said the price point would be below the costs of current chronic treatment for SMA and for extremely rare, genetic diseases in children.

The company further noted that the price point would be 50 percent below the Institute for Clinical and Economic Review’s cost-effectiveness threshold for ultra-rare diseases, with a cost of about $250,000 per quality-adjusted life year.

The company is ready to launch the product immediately, having set up a production site in Illinois, with plans for additional sites as well.

Another approved therapy for SMA is Biogen’s Spinraza (nusinersen). However, Lennon pointed out that the two products will not necessarily compete, given the different indications. Spinraza, an antisense oligonucleotide drug, is approved for SMA in children and adults.

At the Veeva Summit in Philadelphia last week, Spark CEO Jeff Marrazzo said installment payments could potentially be used across the gene therapy space, but that policies at the Centers for Medicare and Medicaid Services had been slow to adapt. Novartis has a deal with Spark to market Luxturna outside the US. Another Swiss drugmaker, Roche, agreed to acquire Philadelphia-based Spark for $4.8 billion in February.

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Why precision medicines for oncology demands precision engagement

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Life sciences companies overwhelmed with large volumes of information and data available – both in terms of therapies and patient-reported outcomes – must establish a more efficient, bi-directional communication model with care teams to succeed.

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How a focus on food can move the needle to cost avoidance in healthcare

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L to R: moderator Dr. Thomas Hawes, managing director for Sandbox Industries; Rick Born, CEO of Aetna Better Health of Louisiana; Dr. Julia Jenkins, medical director of UnityPoint Accountable Care; Dr. Jennifer Avegno, Director of the New Orleans Department of Health; Dr. Sarah Hallberg, medical director of Virta Health; Dr. Timothy Harlan, executive director of the Goldring Center for Culinary Medicine

These days, everyone’s talking about the social determinants of health. Startups and large health systems alike are tackling examples like housing, education and transportation issues. And then there’s food insecurity. A lack of access to affordable and nutritious food can greatly impact an individual’s health.

At the MedCity INVEST Pop Health conference in New Orleans on May 22, panelists discussed why we should shift our dollars toward working on food access issues.

Dr. Sarah Hallberg, medical director of Virta Health, noted that we have typically approached disease by paying for patients’ medicines and working to ensure medication adherence. This, she said, is “because medicines are profitable.”

But she posed a question: “What is going to be the most cost-efficient thing — to continue to prescribe medications that we’re all going to bear the cost of (especially in the underserved population) or to give them food … to prevent the disease?”

Rather than sending patients home with a bunch of prescriptions, she asked, what if we sent them home with a food delivery option?

This idea of feeding patients healthy options could help us avoid costs. “We have to really switch our focus to this whole idea of cost avoidance,” Hallberg said.

Fellow panelist Dr. Timothy Harlan has a tie to food as well. In addition to serving as associate dean for clinical services at Tulane University School of Medicine, he is the executive director of the Goldring Center for Culinary Medicine, a teaching kitchen operated by Tulane.

Harlan also said that we can save money through food. We can help people of a lower socioeconomic status get nutritious food or teach and others them how to eat healthier.

But food issues don’t only impact people of a certain socioeconomic status.

“I think the answer for food is it touches pretty much every patient we see in some manner and fashion and we just have not well-equipped ourselves from a resource management standpoint but also an intellectual and educational standpoint to deal with that,” Harlan said.

Photo: Twitter user Jeanette R. Weiland (@JeanetteWeiland)

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Report: Amazon developing emotion-sensing wearable device

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Amazon has a health-oriented wearable in the works that has the potential to use voice recognition technology to sense emotional states, according to a report from Bloomberg.

The product (codenamed Dylan) is being developed by Amazon’s hardware development team Lab126 and its Alexa division. Designed to be worn on the wrist, the device seemingly has a form factor similar to a smartwatch.

According to documents and sources cited by Bloomberg, Amazon is currently beta-testing the technology which has built in speakers to pick up vocal inflections and commands.

While these capabilities seems more like science fiction, the technology is grounded in research about vocal biomarkers that can pick up issues like depression or anxiety or function as a diagnostic aid. Startups like San Francisco-based Ellipsis Health and Boston-based Sonde Health are operating in a similar space.

With the increased popularity of its Amazon Echo smart speaker devices, the e-commerce giant has expanded the use of voice skills across a variety of applications and has embedded its voice recognition in hardware ranging from its Fire video streaming sticks and its Echo Auto dashboard device.

One key example was the rollout of HIPAA-compliant skills for Alexa that facilitates the secure exchange of patient information through voice-based apps.

Paddy Padmanabhan, CEO of healthcare consultancy Damo Consulting, pointed to the new technology as the next step in the company’s combination of consumer-facing voice technology and health.

“Even though this is being positioned as wellness app, this could become a clinical app in future once the evidence of its effectiveness is available,” Padmanabhan said. “We already know that voice can be analyzed for detecting early onset of Parkinson’s, so it’s not hard to extend that same application to other conditions as well.”

Amazon has remained mum on the report, but Bloomberg pointed to previous patent filings by the company for voice software technology that can used vocal patterns to discern “joy, anger, sorrow, sadness, fear, disgust, boredom, stress, or other emotional states.”

A wearable would also extend the company’s data collection apparatus outside of its ecosystem with a device that is directly on a user’s body, presumably collecting and tracking information during the person’s daily life and providing an even closer touchpoint with Amazon’s growing retail and health network.

Of course, not all of the company’s forays into hardware have been lucrative. The Amazon Fire smartphone was unveiled with great fanfare in 2014 and discontinued a little more than a year later.

The company faces similar competitive pressure if it decides to enter the crowded industry dominated by incumbents like Apple and Fitbit.

Sam Hanna, an associate dean at American University and longtime healthcare advisor and consultant, said new emotional-sensing capabilities would serve to make Amazon’s products even more integral to users. He pointed to Alexa suggesting a purchase if the software senses sadness in their user.

“The intent is for us to rely and depend on Alexa to help us navigate our needs – whether we know them or not – and to provide us with solutions and options,” Hanna said.

“If you are sick and you sound raspy, it can recommend a special meal recipe to make or a dish to order from your favorite restaurant. It may even suggest you order some Claritin or Sudafed and have it delivered.”

It is still unclear, however, if Amazon’s technology will function as pure research effort or whether the product will eventually be commercialized. So it may be some time before we have a digital shoulder to cry on (and provide retail therapy in the process).

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FDA is looking for new companies to test out its pre-cert pilot program

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The Food and Drug Administration has put out a call for volunteer companies to test out the its digital health pre-certification program for software as a medical device (SaMD) technologies.

FDA’s plan is meant to broaden the test cases for the program to small and large software development companies building a range of SaMD products. The regulator is opening up the program to 510(k) submissions, instead of its initial focus on companies moving through the De Novo regulatory pathway.

The organization launched a pilot of its pre-cert program in 2017 with nine companies: Apple, Fitbit, J&J, Pear Therapeutics, Roche, Phosphorus, Samsung, Tidepool and Verily.

The pre-cert program is meant to provide a different approach to regulating digital health technology in a pathway that is better aligned with the software development cycle.

Instead of approving products in a piecemeal manner, pre-certification program participants would be given a “Excellence Appraisal” which could streamline much of the quality requirements necessary under the traditional regulatory pathway.

Additionally, companies would be required to include a plan to monitor and evaluate real-world performance of the technology.

“No regulator in the world could keep with with the volume of new software being created,” FDA’s digital health lead Bakul Patel said at the MedCity News INVEST conference last month.

“The pre-certification is really taking the oversight in two different directions. One is upstream and understanding where the company is and how excellent they are. Two is how do you move from this concept of quality systems and compliance to excellence?”

While the FDA touts the program as a way to fast-track innovation within the space, not everyone is so convinced.

Skepticism abounds from lawyers and regulatory experts about whether the pre-cert plan can be put into action without additional legislative support to expand the organization’s authorities.

Industry groups have also expressed concern about the disconnect between the US regulatory framework and the risk classification structure established by the International Medical Device Regulators Forum.

Still, being involved with the FDA’s program at an early stage could give companies a leg-up on competitors.

Potential new applicants for the program should be planning to submit a SaMD product for De Novo or 510(k) clearance prior to 2020 and must be in good standing without any outstanding FDA compliance actions.

The prospective companies must also be willing to open access to performance data, collect and share real-world post market data, take part in the Excellence Appraisal process and provide info about the company’s quality management system.

Important to note is that the FDA does not intend to provide precertification for companies during the testing in 2019. Interested companies will be accepted into the program on a rolling basis.

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Scott Gottlieb returns to NEA – this time with some valuable regulatory experience under his belt

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One of the largest venture capital firms in the world is adding an enviable member to its healthcare investment team: the man who just stepped down as commissioner of the Food and Drug Administration.

New Enterprise Associates – which has locations in Chevy Chase, Maryland, Menlo Park, California, and others – said Wednesday that it had rehired former FDA Commissioner Scott Gottlieb as a special partner. Gottlieb had previously served as venture partner at the firm from 2007 until 2017, when he was appointed as the country’s top drug regulator. He stepped down as FDA commissioner in March, and Ned Sharpless – former director of the National Cancer Institute – currently serves in his place as acting commissioner. Following his resignation, Gottlieb also returned to another prior position, as a fellow at conservative think tank the American Enterprise Institute.

Gottlieb returns to NEA with significant experience under his belt that he didn’t have during his previous time at NEA. He oversaw the FDA’s approval of the first CAR-T cell therapies for cancers – Novartis’ Kymriah (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel). On his watch, the FDA also approved the first gene therapy, Spark Therapeutics Luxturna (voretigene neparvovec), and the first RNA-interference therapy, Alnylam Pharmaceuticals’ Onpattro (patisiran).

At AEI, Gottlieb plans to focus on the issue of rising drug costs and what he has called the market failures that are keeping drug prices high. Drug prices were a focus for him as FDA commissioner as well, albeit within the limited scope of his authority to address the issue. While at the agency, he promoted competition as a way for the FDA to play a more active role in combating high drug prices – which is technically outside the agency’s purview – including by promoting more generic and biosimilar competition and publicizing complaints from generic drugmakers about branded drug companies that sought to make it harder to obtain product samples necessary for developing generics.

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MIT researcher, alleged to have copied antibody research Otsuka acquired, evaluating potential legal action

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Last year, Japanese drugmaker Otsuka Pharmaceutical paid $430 million to acquire Waltham, Massachusetts-based Visterra, a firm that combines computational and experimental technologies to develop monoclonal antibodies for kidney disease, infectious and other indications. Now, a group of executives at another firm allege that Visterra’s research was ripped off from them.

In a paper published Monday in the journal mAbs, executives from Lebanon, New Hampshire-based Adimab – led by CEO Tillman Gerngross – presented what they called evidence that Visterra’s monoclonal antibody for influenza, VIS410, is essentially the same drug as Adimab’s Ab044. The paper, titled “Connecting the sequence dots: shedding light on the genesis of antibodies reported to be designed in silico,” took aim at the work of Massachusetts Institute of Technology researcher Ram Sasisekharan and his team, including publications in two journals in 2015 and 2018.

In an email, sent through a spokesperson, Sasisekharan denied the allegations and wrote that he has consulted a legal team and a number of industry experts and was evaluating next steps, including potential legal action.

“Searching the patent database with the VIS410 sequences produces exact matches to an earlier US patent publication from 2013 describing AB044 with a similar inventorship group,” the Adimab executives wrote. They pointed to a comparison of tables from the two sources that they assert “confirms that VIS410 and AB044 are in fact the same antibody.”

The paper went on to point out what it called a “remarkable similarity” between an antibody for Zika virus from Sasisekharan’s lab, ZAb FLEP, and another antibody against the same virus, EDE1 C8.

Shares of Otsuka fell 1.6 percent, from 3,953 to 3,890 yen, on the Tokyo Stock Exchange Monday. They opened Thursday morning at 3,804 yen, but subsequently began to rise again. Otsuka acquired Visterra last July.

Sasisekharan dismissed the paper as an “opinion piece” that was “founded on a baseless conjecture and filled with entirely false claims.” He further wrote that it was accepted within two days of submission and was not peer-reviewed, and that he only learned about it from another journalist, having not been contacted either by the authors of the journal’s editors. “In short, the accusations are false, intentionally damaging, and commercially driven,” he wrote. “Authors did not make appropriate attempts to utilize accepted channels to investigate the facts prior to public publication and distribution.”

Sasisekharan disputed two key claims in the paper. In particular, he wrote that while he was an author on a study of VIS410 and its activity against the flu strain H7N9, he was not an inventor, and neither he nor MIT has claimed ownership. In addition, he wrote there are “fundamental differences” between ZAb FLEP and EDE1 C8, “which are the result of how the antibody was designed to bind to a ‘Zika-specific’ mutationally constrained epitope.”

In a phone interview, Gerngross said he and his team were not making an accusation. “We put out a paper that documented facts, and we interpreted those facts in a particular way,” he said, adding that if there was anything wrong in the paper, it would be immediately corrected and that he was willing to debate what was presented in the paper. “If [Sasisekharan] wants to take legal action in court, we’re happy to do it in court.”

Requests for comment from Otsuka and MIT were not immediately returned at the time of publication.

Photo: ClaudioVentrella, Getty Images

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