Health experts unsure COVID-19 antibodies protect against reinfection

Health experts unsure COVID-19 antibodies protect against reinfection

  • August 3, 2020

As an increasing number of people across the country get tested for COVID-19 antibodies, health experts are cautioning that much is still unknown about what the results mean — including if antibodies provide protection from catching the virus again, how strong that protection might be and how long it may last.

A COVID-19 antibody test, also known as a serology test, aims to detect the presence of antibodies in the blood specific to SARS-CoV-2, the virus that causes COVID-19.

A positive test result is presumed to mean that a person was exposed to the virus at some point in the past and their immune system produced proteins called antibodies to fight it off. The tests are different from nasal swab tests and do not indicate whether a person is currently infected with the virus.

The Centers for Disease Control and Prevention, in a June 30 update, said it does not know if people who recover from COVID-19 can get infected again. It also said even with a positive test for antibodies, people “still should take preventive measures to protect yourself and others.”

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Dr. Raymond Kiser, medical director of hospital care physicians at Columbus Regional Health, said antibody testing is “probably not that helpful” for most people because it won’t tell them if a particular bout of illness in the past was COVID-19 or if they are currently immune to the virus.

Additionally, Kiser said he is “nervous” that people who test positive for COVID-19 antibodies may be lulled into a false sense of security and “think they’re protected and they may not be.”

“We have no idea if you develop (COVID-19) antibodies, does that confer immunity, and if it does, for how long,” he said. “…When people ask me, ‘Should I get antibody tested,’ in all honesty, I usually tell them no. It’s not going to answer the question you really want to know and that is ‘Are you protected from this virus?’ And the answer is, ‘I don’t know’ — even if you have antibodies I won’t know the answer to that.”

Studies underway

Currently, numerous studies are underway to better understand the protective role of antibodies against the novel coronavirus, but just months into the pandemic much still remains unknown.

Health experts say antibodies usually confer at least partial immunity against some viruses, but the length and level of protection varies.

The antibodies produced in response to an infection of certain viruses, like the one that causes measles, are believed to provide lifetime immunity, while antibodies generated against other viruses, like the ones that cause the common cold, tend to offer shorter-lived protection. For some viruses, however, antibodies provide nearly no protection at all.

Most health experts, including Kiser, suspect that COVID-19 antibodies may offer some level of protection against the virus in the short-term, but nobody knows for sure where those antibodies fall on the spectrum.

The strongest evidence so far for short-term immunity comes from a study done on monkeys infected with the novel coronavirus, and it’s not yet clear the extent to which those results will hold true for humans, Kiser said.

“The only data that we really have for that is a study done on primates where they actually exposed them to the SARS-CoV-2 virus and those who had antibodies didn’t get re-infected at 30 days. But we don’t really know if that applies to humans,” Kiser said.

CRH, for its part, does have COVID-19 antibody tests in-house, hospital officials said.

As of mid-July, CRH had administered 106 antibody tests, but only one of them had come back positive, Kiser said.

In June, the U.S. Food and Drug Administration released performance results of 21 antibody tests, including the Siemens Healthineers total antibody test, which is the antibody test that CRH uses, according to hospital officials.

The FDA started requiring companies to submit testing data and apply for emergency authorization to remain on the market in May after reports of faulty results and fraud emerged, The Associated Press reported.

The accuracy of antibody tests is measured by their “sensitivity,” or their ability to identify if someone has COVID-19 antibodies in their blood, and their “specificity,” which is their ability to determine who does not have the antibodies, according to the FDA.

The tests are also described by their positive predictive value, which measures how likely it is that a person who receives a positive result from a test truly has COVID-19 antibodies based on the test’s sensitivity, specificity and assumptions about the prevalence of the virus in a community, according to the FDA.

“Every test returns some false positive and false negative results” and some people may need more than one antibody test to ensure accurate results, according to the FDA’s website.

The test CRH uses was shown to be 100% sensitive and 99.8% specific and has a positive predictive value of at least 96.5% depending on how prevalent the virus is in a given community, according to the FDA’s performance data.

That means that the test is expected to correctly identify the presence of COVID-19 antibodies at least 96.5% of the time, according Siemens Healthengineers.

“We have not seen a lot of positive (antibody) testing here so far,” Kiser said. “With regards to the tests, especially the ones that we are using, we do believe that they are very specific, which means that if you have this antibody positive it means that you’ve definitely been exposed to the SARS-CoV-2 virus.”

Public health efforts

Though the protective role of antibodies against COVID-19 isn’t clear, antibody testing could provide valuable information for public health efforts, including studies seeking to determine how many people in a community have been exposed to the virus.

Researchers across the United States, including in Indiana, have embarked on such studies, aiming to use a representative sample of the overall population to shed light on the prevalence of COVID-19 in different areas of the country.

The hope, health experts say, is that these studies may help scientists and doctors measure the infection fatality rate of COVID-19, or the proportion of deaths from the virus compared to the total number of people diagnosed with the disease.

So far, initial results from several studies have found varying degrees of COVID-19 prevalence across the United States.

A study by the University of Southern California and the Los Angeles County Health Department found in May that an estimated 2.5% to 7% of adults in Los Angeles County had contracted the new coronavirus in May.

A similar study conducted by Massachusetts General Hospital and the Boston Public Health Commission found that roughly 10% of Boston residents tested positive for COVID-19 antibodies in May.

The prevalence of COVID-19 in Indiana, however, is believed to be much lower.

Last month, researchers at the Indiana University Richard M. Fairbanks School of Public Health at IUPUI and the Indiana State Department of Health released preliminary data from the second phase of their prevalence study, finding that a total of 1.5% of participants tested positive for COVID-19 antibodies, up from 1.1% in the first phase, according to preliminary findings.

“One of the big things we want to know about this virus is how many people have been infected,” Kiser said. “…If I know how many people in a general population have been exposed and I know how many people have died, then I can really tell you the information that you’re going to want to know, which is if everybody gets exposed, how many deaths can we expect?”

Scientists are getting closer to an answer, according to leading science journal Nature. Research so far suggests that COVID-19 is five to eight times deadlier than the seasonal flu, which kills hundreds of thousands of people around the world each year.

The seasonal flu has an infection fatality rate of around 0.1%, meaning that one out of every 1,000 people infected would be expected to die, Kiser said. By comparison, five to eight out of every 1,000 people infected with the SARS-CoV-2 virus would be expected to die.

In other words, if all of Indiana’s estimated 6.7 million residents were to be infected with COVID-19, an estimated 33,500 to 53,600 people would be expected to die, compared an estimated 6,700 estimated deaths from influenza.

“Influenza is probably one of our No. 1 infectious killers in the U.S., and this thing is five to eight times worse,” Kiser said.

In addition, antibody testing could help identify potential blood plasma donors for convalescent plasma therapy, which is an experimental treatment for COVID-19 currently in trials at numerous hospitals across the country, including Columbus Regional Hospital, where at least 54 patients have received the treatment, Kiser said.

Convalescent plasma therapy involves giving COVID-19 patients an infusion of blood plasma from people who have already recovered from the illness, CRH officials said.

Though it currently is not known precisely how COVID-19 antibodies work, researchers and doctors believe that plasma from COVID-19 survivors could boost the immune system’s response in a patient whose body is struggling to fight off the infection.

At this point, however, antibody testing is most useful for public health efforts and identifying potential plasma donors, Kiser said.

“Right now, the best use of antibody testing is public health,” Kiser said. “…I think on an individual basis, it’s probably not that helpful.”

Where to learn more

Anyone with concerns about COVID-19 is urged to call the health system’s Triage Resource Call Center, a phone resource line launched by CRH to handle calls from residents with questions and concerns about exposure or symptoms associated with COVID-19. The phone line is open daily from 7 a.m. to 8 p.m. and is staffed by registered nurses who will offer screening questions and potentially recommend a course of action for patients.

The phone resource line can be contacted at 812-379-4449.

Visit crh.org/news/2020/03/16/coronavirus-update-what-you-need-to-know for more information.

Visit the Community COVID-19 Task Force’s website at covid19communitytaskforce.org.

US coronavirus cases 'extraordinarily widespread': Live updates | News

US coronavirus cases ‘extraordinarily widespread’: Live updates | News

  • August 3, 2020

  • The United States is in a new phase of the novel coronavirus outbreak with infections “extraordinarily widespread” in rural areas as well as cities, a White House coronavirus experts said, as cases hit 4.6 million with more than 154,000 deaths reported.

  • Millions of COVID-19 tests able to detect the virus within 90 minutes will be rolled out in the UK to boost capacity in the coming months, the country’s health minister has announced, while cases nationwide surpassed 306,000, with more than 46,000 deaths.

  • Brazil has recorded 25,800 additional confirmed cases of the novel coronavirus and 541 deaths, bringing the total to more than 2.73 million and more than 94,000 deaths as of the end of Sunday, according to the country’s health ministry.

  • More than 17.96 million people around the world have been diagnosed with the new coronavirus. Almost 10.62 million patients have recovered and more than 687,000 have died, according to data from Johns Hopkins University.

Here are the latest updates:

Monday, August 3

01:15 GMT – Pope appeals to political leaders create jobs

Pope Francis has called on politicians to create jobs so that economies can relaunch from the lockdowns imposed to combat the coronavirus pandemic, according to the Associated Press news agency.

The pope, speaking after the traditional Sunday blessing, said that ’”without work, families and society cannot go forward. Let us pray for this, because this will be a problem in the post-pandemic period, the poverty and the lack of jobs. It requires lots of solidarity and lots of creativity to resolve this problem.”

The pontiff also wished the faithful “some days of rest, and contact with nature, to recharge also in the spiritual dimension.”

The pope’s remarks follow a week in which officials released statistics showing a record plunge in both the US and eurozone economies.

00:55 GMT – Italy’s tally of new virus cases down to 239

The number of new confirmed cases of the coronavirus in Italy nudged lower to 239 in the last 24 hours, while all eight deaths were recorded in Lombardy, the epicentre of the country’s epidemic.

That brings the total number of cases in Italy to 248,070 and deaths to 35,154, AP news agency reported early on Monday quoting the country’s health ministry.

The number of daily cases in Italy has hovered between 200-300 for weeks, mostly related to people arriving from outside of Italy, either foreign workers or migrants.

00:25 GMT – Britain to roll out millions of 90-minute coronavirus tests

UK - coronavirus

Britain’s healthcare system has come under severe strain during peaks in the country’s COVID-19 outbreak, which has killed more than 46,000 people, the fourth highest toll in the world [Andy Rain/EPA]

Millions of COVID-19 tests able to detect the virus within 90 minutes will be rolled out to British hospitals, care homes and laboratories to boost capacity in the coming months, Reuters news agency reported on Monday quoting the country’s health minister.

The tests will comprise 5.8 million tests using DNA and 450,000 swab tests. Neither will need to be administered by a health professional, said Matt Hancock.

Separately, the publicly-funded National Health Service said it would be offering “COVID-friendly” treatments to cancer patients, including drugs that do not have a big impact on the immune system.

Britain’s healthcare system has come under severe strain during peaks in the country’s COVID-19 outbreak, which has killed more than 46,000 people, the fourth highest toll in the world, according to a Reuters tally collated on Sunday.

00:15 GMT – Mexico reports 4,853 new coronavirus cases, 274 more deaths

Mexico’s health ministry has reported 4,853 new confirmed coronavirus cases and 274 additional fatalities, bringing the total in the country to 439,046 cases and 47,746 deaths, according to Reuters news agency.

The government has said the real number of infected people is likely significantly higher than the confirmed cases.

Mexico

Crematory workers are pictured next to a body bag containing the body of victim of the coronavirus disease (COVID-19) at a crematory in Mexico City on Sunday [Edgard Garrido/Reuters]

00:01 GMT – Brazil registers 25,800 new coronavirus cases, death toll tops 94,000

Brazil has recorded 25,800 additional confirmed cases of the novel coronavirus and 541 deaths from the disease caused by the virus in the past 24 hours, according to Reuters news agency quoting the country’s health ministry.

Brazil has registered more than 2.73 million cases of the virus since the pandemic began, while the official death toll has risen to 94,104 as of the end of Sunday, according to the ministry data.

_______________________________________________________________

Hello and welcome to Al Jazeera’s continuing coverage of the coronavirus pandemic. I’m Ted Regencia in Kuala Lumpur, Malaysia. 

For all the key coronavirus-related developments from yesterday, August 2, click here.


SOURCE:
Al Jazeera and news agencies

Little Black Book Of Health, Beauty And Wellness Practitioners

Little Black Book Of Health, Beauty And Wellness Practitioners

  • August 2, 2020

For so many of us, this period of mandated isolation has led to reflection. It has been a time to pause, ask questions and scrutinize our actions and routines. Ask almost any health and wellness expert, and they will tell you that being healthy and eating well, it’s really a lifestyle. And herein are a handful of skilled professionals, products and programs to help achieve balance and hopefully bring a little joy to your day-to-day.

Spanx Leggings At Selfridges

Designed with the flattering lift and sculpting that we’ve all come to expect of the Spanx brand, this collection is all about form and function. Designed with the perfect amount of stretch, the collection includes classic black designs, faux leather and a handful of bold prints, it’s an activewear collection that can be worn day-to-day as well as in the gym. The waistband-free design ensures each pair is outrageously comfortable and the additional features, like four-way stretch, breathability and an anti-odour finish, means you never want to take them off.

Detox Kitchen Happy Gut Package

The easiest way to keep healthy is to avoid temptation. And better yet, is when the available diet-friendly food is also delicious. The new happy gut package from Detox Kitchen in London, created in partnership with nutritional therapist Eve Kalinik, includes 10 days of gut-cleansing foods, with dishes such as a kimchi bowl, seed crispbread and super grains salad. Choose between a vegan, protein, or green with protein package. But perhaps the best part about this concept is that it’s not just about nutrition but also includes a series of supporting gifts, such as seven live-stream classes with Stretch London to get you moving and feeling more relaxed; a £50 voucher to spend online and cult activewear brand Ernest Leoty, as there’s no better motivator than a new pair of leggings; a Neom Organics SPF moisturiser, and a bag of pink Himalayan bath salts to press reset.

Susie Mermaid

Susie Mermaid is a new luxury wellness brand that aims to bring a wellness retreat into the home. The range consists of a capsule face and body products. Founded by holistic facialist and bodyworker Susie Mermaid, all the product formulations were inspired by her years hosting wellness retreats on the coasts of Italy and Swiss lakes—the scents are transportive and the products work to deliver spa-level facial results, at home.

Lisa Franklin

Award-winning facialist and skincare expert Lisa Franklin has launched her own at-home range. Lisa founded the line after witnessing the effects pollution and city life had on the skin. Combining the latest scientific knowledge and a holistic, clean approach, the result is a range of ultra-effective products. The brand has also been awarded the Positive Luxury Mark for its approach to sustainability.

Box Of Style By Rachel Zoe

Created and curated by A-list stylist Rachel Zoe, Box of Style offers customers a slice of happiness by post every season.”This summer edit has been curated with the hope that each piece will bring joy and, in some way, be part of lasting memories,” said Zoe.  “I can truly say that everything in this selection makes me happy, and that certainly means more to me now than ever before.” The box of luxury and lifestyle items includes a cream and caramel Henry + Lev weekender; a pair of Pansea beaded tassel earrings; a tube of rich and hydrating hand cream from Grown Alchemist; a Kosas colour and light illuminating palette; and a Peter Som Dream Floral Sarong available in Meteorite or Rose Quartz prints, both of which have been designed exclusively in partnership with Zoe. Delivered directly to consumers’ homes, it helps to fulfil a much-needed jet-set agenda and offers a reminder of Bohemian barefoot glamour, ideal for a summer night—even if it’s just at home.

Paul Edmonds

Paul Edmonds in Knightsbridge and Battersea Power Station offer a one-stop-shop to experience the world’s leading hair, beauty and nail experts. Paul Edmonds has long been considered one of the UK’s top hairdressers and colourists, counting Emma Thompson, Christina Hendricks and Sam Smith among his clients. Having now reopened, the salons were designed to feel more like a home, with its plush sofas and warm colour palette.

Bvlgari Spa Tips

With everything going on right now, self-care has never been more important. Therapists from Bvlgari Hotel London’s Spa have created a special series of at-home treatments. Some are designed to ameliorate the specific ailments and tensions that can arise from working and staying at home, while others provide indulgent care and escapism.

Immunity-Boosting At-Home Ritual

  1. Lie down in a quiet soothing environment, and carefully pour warm aromatherapy oil onto the centre of your body, spreading the oil across your abdomen from the base of your ribcage for ten clockwise circular motions.
  2. Use the flat surface of four fingers to apply gentle pressure to the area surrounding your belly button in clockwise circles, repeating the action all the way around your abdomen for three minutes. 
  3. Place the palm of your hand on your solar plexus below the centre of your ribcage and move in five slow, static anti-clockwise circles with very light pressure, and then repeat in the opposite direction. 
  4. Move your palm to your lower abdomen and repeat the same movement. These two steps focus on two of the seven chakras, the body’s energy centers. 
  5. End the ritual by stroking the palm of your hand in clockwise circular motions three times across your abdomen from the base of the ribcage. Be sure to rest and drink plenty of water afterwards.

ZeroDB

Of the comany, founder and CEO Gary LeBlanc explains that, “When creating Zero dB, it was imperative that our product was based on hard science, targeting actual benefits. Much of the anxiousness people experience today can be traced to the high volume of noise we have in our minds due, to our multi-tasking reality. People who have tried our beverages describe the benefit of feeling more focused, relaxed, and able to take on their next challenge. Whether it’s that critically important work presentation or even a golf game that requires a sharper edge, I like to describe our products as the world’s first noise-canceling beverages.”

Curate Beauty

Curate Beauty was founded by Samantha Freedman, an award-winning beauty journalist (who was previously the beauty editor of Grazia Magazine) and Margot Vitale, who has a background in retail, having worked for Sachs Fifth Avenue. A digital beauty wholesale marketplace for indie brands, Curate Beauty currently has over 80 indie brands on the site—covering all aspects of the industry—including skincare, makeup and hair. All brands on the site are curated by Samantha, who is always researching the latest indie beauty trends and innovations.

Green People Hand Sanitiser

Cult organic beauty brand Green People has extended its range with a new germ-fighting deep-cleansing hand foam that can be used with or without water. Made with naturally antibacterial actives, including a powerful tea tree extract and Manuka honey, the product is 91 percent organic and made without alcohol so it’s ideal for sensitive skin.

Sun.Day

Hackney-based sustainable home fragrance brand SUN.DAY of London was founded by fine artist Natasha Garbawi. The brand uses only the highest-quality aromatherapy-grade essential oils, a sustainable wax blend and pure-cotton wicks. The candles are handcrafted and housed in apothecary jars, which are produced in the UK and blended without any synthetic perfumes or paraffin.

111Skin Selfridges Pop-Up

111SKIN will be hosting a Master-Masking pop-up shop in the main Beauty Hall within Selfridges’ London flagship until August 12th. Customers will have the opportunity to select an assortment of targeted masks to address their skincare concerns. Following a purchase of four or more single sachets, customers will receive a complimentary Rose Gold Illuminating Eye Mask and branded silver bag to carry their products. The products and cult-favourite sheet masks are beloved by celebrities and supermodels alike, including Cate Blanchett, Margot Robbie and Priyanka Chopra. 

Alpha Glow Flash Facial By 001 London

A three-in-one product that acts as a serum, primer, facial, Alpha-Glow Flash Facial from 001 Skincare is made with nine specially selected ingredients to help target key skin concerns. The effective active ingredients include hyaluronic acid, salicylic acid, vitamin A and C, and aloe vera, which combine to hydrate, plump, brighten and soothe the skin, revitalising the skin’s tone, texture and glow.

Theragun

The Theragun was created in 2008 and officially launched in 2016 by chiropractor Dr. Jason Wersland after suffering a life-altering injury. Building on over a decade of research and development, the Theragun uses state-of-the-art technology to effectively reduce muscle tension, accelerate recovery and improve performance. Used by professional sports teams around the world, it remains the leader in at-home massage.

Eclat

Eclat Skin London is a luxury skincare brand that started out creating a 24-carat-gold anti-ageing collection. Behind the brand is the belief that combining natural extracts and oils with active-science-based ingredients is the most efficient way to create skincare formulations. The resulting products are nourishing with proven science-based actives that make a real difference to the skin. And specifically, the Collagen Day Moisturiser contains hydration-boosting hyaluronic acid and collagen amino acids.

Dr Jack Nourish Relax Supplement

London-based Dr. David Jack has built a reputation for being a considered and holistic practitioner in the field of aesthetic medicine. It is well known that stress, anxiety and insomnia can have major effects on the skin, both in terms of ageing and progressing adult acne. This is what led Dr. Jack to create a supplement that helps address some of these issues, using the most up-to-date natural and plant-based ingredients. Relax is a blend of 17 ingredients, each chosen for their relaxing and mood-boosting effects. Relax combines adaptogens, which are used in traditional Chinese and Ayurvedic medicine to regulate the effects of stressors on the body, including holy basil, maca, ashwagandha and liquorice root. It can be taken in the evening and comes as a naturally flavoured powder that is mixed with hot water to create a powerful fortified hot chocolate-like drink.

Eve And Keel

Vegan, cruelty-free, hand-crafted and organic, wherever possible Eve & Keel creates its products in recycled or recyclable packaging, particularly beautiful milk glass bottles. The balancing chakra rollers come in a range of seven scents, each which serves a particular purpose, encouraging creativity, clarity, stability and more. Roll the blend between your brow and around your temples to support well-being and encourage a sense of balance. The brand also makes body oil, hand creams and a reset facial mist.

Dermatica Subscription

Dermatica has created an affordable prescription skincare line formulated to treat all types of acne. Offering access to powerful prescription ingredients that are not available in over the counter products, this subscription-based brand promises powerful results. Whether you suffer from the occasional breakout, or more severe cystic acne, the brand offers personalised treatment plants for all skin types. To get started, simply fill out an online questionnaire and upload a few photograph of your skin, then a team of dermatologists and doctors provide a diagnosis and prescribes a customised treatment, which arrives through the post each month.

 Maapilim

Maapilim has a new US-based FDA- approved quick-absorbing hand sanitiser. The chic packaging and incredible-smelling formulation mean this product ticks all the boxes. The gel is boosted with an essential oil blend of bergamot, jasmine, and cedarwood that dries quickly with no stickiness. Most importantly, it kills 99.9 percent of germs and bacteria and has been formulated with aloe vera to keep the hands moisturised. 

Maya Njie

Born in Västerås Sweden, Maya Njie (pronounced ‘Maia En-jai’) moved to London in her late teens. Having studied design and photography at the University of the Arts London, Maya always had a sense she would later found a boutique brand. With its focus on quality, she founded Maya Njie Perfumes in 2016, creating artisanal scents that took influence from both her Swedish and West African heritage. Each batch is hand-bottled and all the scents, colourways and packaging has been designed by Maya. She even incorporates sepia-toned family photographs into the designs.

Aimee Victoria Long

Aimee Victoria Long takes the philosophy that training is all about nourishing the mind and the body. Fitness, food and beauty all go hand in hand, and Aimee has honed her Body Beautiful method with that in mind. After spending years obsessing over her weight, counting calories and following fad diets Aimee decided she’d had enough. Now one of London’s leading personal trainers, she has trained at top studios such as Bodyism and Heartcore. Mixing Pilates, strength and conditioning, her sessions are far from easy, but they are dynamic and help clients achieve the results they’ve always asked for and never-yet achieved.

Juni

Juni‘s hydrating lipsticks are plastic free, vegan and organic. The aluminium bullet case has been designed to be reused, and you can swap in any of the brand’s five dynamic lipstick shades each time you run out. The colours are bold, wearable and modern, while the formulas are nourishing and hydrating.

Axiology

These multi-purpose balmies from Axiology can be used on the eyes, lips and cheeks. Plastic-free they have been designed with no unnecessary packaging, you simply tear the outer paper as you use them. There are singles and sets, created in a range of bold and glossy colours. Packed with oils and antioxidants, such as elderberry, hemp and plum oil, they also nourish, heal, and hydrate the skin.

Glow Bar Elixirs

Glow Bar in London has recently introduced five new adaptogenic elixirs to its online store. Whisk or stir a small amount of the powder into your favourite drink and enjoy as part of your night-time routine. Reishi promises to deliver a good night’s sleep—something most adults struggle with. Reishi has been used in traditional Eastern medicine for centuries; it works to give the immune system a major boost and reduces fatigue.  

RMS Oil

Body oils are brilliant, offering the skin a highly concentrated dose of nourishing ingredients, including jojoba, buriti and organic coconut oils. As well as soothing and conditioning, RMS beauty body oil helps to balance the skin. Perfect for morning and night, it’s super concentrated, so just three or four drops are required for each application.

Fable & Mane

A clever new haircare brand, Fable & Mane is a haircare brand that uses plant-based ingredients and takes its inspiration from Indian traditions and heritage. The range includes a shampoo, conditioner and hair mask, all of which are beautifully packaged and designed.

Nourish Hair Formula

Nourish by SK Hair Formula has been formulated by an expert nutritionist who has put in years of research and experience. Specifically, the ingredients have been carefully selected and uniquely combined to support all rounded wellness and support the structure of healthy hair.

Cosmic Molecule

Cosmic Molecule Bone Broth Protein has been crafted from healthy grass-fed, pasture-raised cows. To make it, the bones are gently simmered to extract all the essential nutrients. The result is a broth, packed with collagen and 19 amino acids. The product works perfectly added to a morning coffee or tea, blended into a smoothie or mixed into a soup, stew or sauce.

Anatomē

Anatomē started to provide high-quality vitamins, supplements and therapeutic oils that have both physical and emotional benefits, all made using active natural botanical extracts, organic and scientifically proven ingredients. The range has been developed with the help of sports scientists, nutritionists and aromacologist. Anatomé products help the user to connect with their emotional and physical health, sleep better, manage stress, and support the immune system. 

Gyko

British sustainable swimwear brand Gyko is working to solve women’s swimwear struggles by creating form-flattering modular pieces. The London-based swimwear began after its founder Sophie Flora found herself unable to find the perfect fit in tops and bottoms of a bikini set. A self-professed bikini addict, Flora has always had a huge collection of swimwear, and she often found she liked a top from one set and the bottoms from another. Having been left some money by her grandmother and told to invest it into something that would make her happy, Sophie started researching the idea of creating her own swimwear line and launched in 2019, creating a brand where each top can be paired with any bottom to create the ultimate set. 

Overly Opulent

Founded in 2016 by Simman Dulay, Overly Opulent has become an established and highly sought-after luxury event planning service. Beauty is their speciality and before lockdown, Overly Opulent hosted a one-of-a-kind make-up masterclass series at The Dorchester. The day is comprised of a welcome breakfast, four-course luncheon, afternoon tea and a goody bag stuffed with premium beauty brand. They have been sponsored by over 40 different world-renowned brands, including: Balmain, Marc Jacobs, Huda Beauty, Beauty Blender, Tarte, Tatcha, Anastasia Beverly Hills, Patrick Ta, Elemis, Dermalogica, Rodial, and 111 Skin.

Ava Isa

Ava Isa Sun-è-Serum Drops SPF 35 is an all-mineral sunscreen that feels as lightweight and silky as your favourite serum. Transparent on all skin tones (Michelle Obama is a fan), it is vegan and cruelty-free.

Equi London

Created by women, for women, Equi London is an award-winning range of supplements backed by science and led by nature. Designed to restore inner and outer health and beauty, the brand uses adaptogenic herbs and medicinal mushrooms, vitamins, minerals, plant superfoods and probiotics, in order to help balance the body and optimise health, beauty and well-being.

Pat McGrath

British makeup artist Pat McGrath has been called the fashion world’s most important makeup artist. Born and raised in Northampton, McGrath consistently credits her Jamaican mother for introducing her to the world of hair, makeup, and fashion. McGrath has launched a new campaign to coincide with her Dark Star mascara and eyeshadow palette. The campaign by Meisel includes Naomi Campbell, who is already the global face of Pat McGrath Labs, and also Marisa Berenson, Irina Shayk and Damien Hurley among others. Each muse wears the ultimate mascara in the campaign.

Whole Story

Whole Story is committed to fixing the problem at its core. One thing that sets the brand apart, Whole Story owns all their formulas, uncommon in this industry and their team of cell biologists and chemists curate custom formulas using botanically rich ingredients that are cold-pressed at the time of harvest, ensuring a high quality of ingredients throughout the hard-working range.

 Yoga for Health Beauty, Immunity

 Yoga for Health Beauty, Immunity

  • August 2, 2020
‘Spread of Yogic education need of hour’
‘Spread of Yogic education need of hour’

Shahnaz Husain

How often do we consider yoga as a tool to enhance beauty, mental peace and boost our immune system? Our immune system is of utmost importance and plays a significant role in keeping us fit, beautiful and healthy.

While there are many ways to stay calm, healthy and look attractive this time of year, yoga has proven to be one of the best ways to not only avoid getting sick but to strengthen your overall immune system along the way.

Yoga helps us fight infections by boosting our immune system, reducing stress and strengthening our body’s functions and systems which leads to  healthy and attractive outlook.

As the country battles the Covid-19 pandemic on a war-footing, India’s traditional system of Yoga has been established as a means to boost immunity and improve overall health and well being. Yoga for immunity is a thing. A consistent yoga practice – along with certain poses in particular – can support and boost the immune system.

Lack of sleep, poor nutrition, and stressful life all lead to a weakened immune system and vulnerability to sickness.

In addition to the basic measures taken this time of year—getting enough sleep, eating whole foods, stressing less—yoga is a proactive way to take control of your health so you can feel cheerful, all year long.

In this fast-moving world where one hardly gets time to take care of himself, here we bring to you a complete yoga routine that you can follow to maintain your immunity.

. You do not have to be born beautiful. You can acquire  beautiful, supple, glowing and flawless  skin by treating     yourself from inside through selection of yoga poses and exercises rather than relying on expensive cosmetics and  time consuming salon treatments  .

You can  enhance your beauty with yoga   by  incorporating   strict guidelines  in your daily life. Regular yoga practice  pranayama, and meditation aid you in  reverse the signs of ageing including wrinkles, saggy skin, crow’s feet and fine lines amongst other .

Pranayam helps purifying the blood because of the increased intake of oxygen, which is very crucial for improving immunity.     Yoga is one of the most effective and time-tested natural immunity boosters that can lead to a healthy, sickness-free body.

Mindfulness meditation can have benefits for health and performance, including improved immune function, reduced blood pressure and enhanced cognitive function.

. Those who regularly practice yoga  and meditation have a certain glow about them that comes from within and radiates outward  .Yoga helps lower stress hormones that compromise the immune system, while also conditioning the lungs and respiratory tract, stimulating the lymphatic system to oust toxins from the body, and bringing oxygenated blood to the various organs to ensure their optimal function  whiich helps us to remain healthy  and attain inner beauty .

Mindfulness meditation can have benefits for health and performance, including improved immune function, reduced blood pressure and enhanced cognitive function. Meditation produces more antibodies in people. It  significantly increases left-sided, anterior brain activation (pattern indicating positive emotions) in meditators (compared to non-meditating controls) and that this activity was associated with the rise in antibodies

The practice of yoga may greatly aid in helping you look more youthful and more refresh.

I have always said that a strong immune system, good health and beauty are complimentary to each other . Unless you are healthy from the inside, you cannot reflect true beauty. For a flawless skin, shiny hair and a slim figure, good health must be on top of the list. In fact, I promoted the Ayurvedic principles of holistic health, with yoga as an integral part of the program. This concept of holistic beauty care was unique and caught on worldwide. In fact, I believe that yoga is very relevant to our modern lifestyle, in terms of both health and beauty. Personally, it has been a part of my life and I have experienced its numerous benefits.

The appeal of Yoga lies in the fact that it helps both body and mind. It not only works on all the muscle groups, but also increases vitality, tones the internal organs, stimulates the nerve centres, relieves stress and clears the mind which boost immunity and  gives  you attractive  personality and  beauty from within . Although it is an ancient Indian discipline, it has also gained relevance as a means of attaining a well-balanced personality and delaying the visible signs of ageing. The other important aspect of Yoga is that it involves breath control and specifies the inhalation and exhalation of breath during the exercises. Thus, it helps oxygenation  which boost immunity  imparts a feeling of physical and mental exhilaration. This is so important for beauty, because feeling good is an integral part of looking good.

Yoga improves blood circulation, including the circulation of blood to the skin surface. This is so important for the good health of the skin, as it helps to supply essential nutrients to the skin. It also promotes the removal of toxins through the skin which boost immunity. This is so important, especially in cases of skin congestion. It tones the skin, improves oxygenation to the skin, imparts a beautiful glow and keeps the skin youthful and free from problems. The same goes for the hair. Yoga helps to promote blood circulation and oxygenation to the scalp and hair follicles. This helps to supply nutrients in the bloodstream to the hair follicles. It promotes hair growth and keeps the scalp healthy.

When we talk of beauty, we do not talk only about the beauty of the face. It also includes the figure, giving it suppleness, good posture and grace. Where the appearance is concerned, a slim figure can take years off and helps in staying youthful for a longer time. It supplies oxygen to every tissue and this, itself makes way for both health and beauty. If you are leading a life that does not provide enough physical activity, you are actually encouraging ageing. Exercise is a potent remedy for pre-mature ageing, not only because it strengthens the body, but also keeps it looking trim ,fit and enhances immunity in body . The yogic asanas are designed to keep the spine and joints flexible and supple. They make the body strong and agile, tone the muscles, improves blood circulation, imparts vitality and enhances both beauty and good health .

Many beauty problems are triggered off by stress. Since yoga helps to induce relaxation and reduce stress, it certainly helps in dealing with stress-related conditions like acne, hair loss, dandruff, etc. Studies conducted on those who practice yoga have shown that positive changes also occur in the personality, in attitudes, emotional stability, self-confidence. It has a direct effect on the mind, emotions and mood. In fact, it is a regular stress-buster and puts the glow back on the skin. You will feel instantly rejuvenated and good about yourself.

Indeed, the benefits of Yoga reflect as external beauty. For a flawless skin, shiny hair and a slim, graceful figure, make yoga a part of your daily life . .

The author is beauty expert from India.

 

 

 

Kendall County Board, Health Department: Thanks for wearing your mask, social distancing

Kendall County Board, Health Department: Thanks for wearing your mask, social distancing

  • July 31, 2020

As a public service, Shaw Media will provide open access to information related to the COVID-19 (Coronavirus) emergency. Sign up for the newsletter here

Kendall County Board and Kendall County Health Department extended thanks in a press release Friday to county residents for wearing their masks, watching their distance and washing their hands amid the continuing COVID-19 pandemic.

“We recognize this is a tough time in our lives, and we need to draw on all the resources available to us to stay healthy. So, take good care of yourself and we’ll get through this together,” a statement in the press release reads.

The board and health department also encouraged county residents to maintain their health by boosting their immune systems by the following:

Move that body: When you exercise, not only do your muscles get stronger, you also prepare your cardiovascular system. Additionally, running or walking can release the chemicals that give your mood a boost, which can help you mentally as well.

Eat well: Add antioxidants and immune boosting foods to your diet. Making it ‘colorful’ with berries, avocados, nuts, carrots and other veggies and fruits will give you a full plate of vitamins and minerals. And don’t forget to add natural vitamin C – oranges are a great source but so are kiwis, red pepper and tomatoes.

Sleep: When you’re mostly at home, there is really no reason why you can’t get 7-8 hours of sleep. Sleep helps reboot our systems, and it can help release cytokines, a protein that can help the immune system fight off infections.

Go outside: The sun not only gives you Vitamin D, but it can also lift your mood which is good for your body.

Decrease your stress: Stress releases hormones that can impair our immune systems. Try to take a few minutes every day to do some deep breathing or meditation. Or listen to some calming music or listen to a podcast about something you enjoy. And turn off the news – it can contribute to anxiety.

The Kendall County Board, along with the Kendall County Health Department continue to be committed to the health and safety of the citizens of Kendall County. If you have any questions, please contact the Kendall County Health Department at (630)553-9100.

Building immunity with natural and ayurvedic herbs

The year of building health and immunity – lifestyle

  • July 31, 2020

A strong immune system could be the perfect solution to tackle COVID-19. Building the body’s defence through food and herbal concoctions became a top priority for most people during the ongoing pandemic.

From giloy juice and tulsi drops to turmeric milk, Indians have been flocking stores to buy honey, herbal teas, Amla based products, touted to improve immunity to fight diseases. Corona year has probably made each one of us more conscious than ever to take care of our health. And the onus has been majorly on the factors responsible to boost immunity.

Hamid Ahmed, CEO, Hamdard Laboratories- Food Division

Hamid Ahmed, CEO, Hamdard Laboratories- Food Division

Hamid Ahmed, CEO, Hamdard Laboratories- Food Division, says, “It’s very important to keep your immunity high during such times. Taking steam to keep viruses away is essential. Giloy, neem and amla juice work beautifully with warm water and should be taken regularly. Also, homemade kadhas and multivitamins help in building immunity. Consumption of vitamin C-rich fruits and vegetables should be encouraged to boost the immune system.”

Dimple Jangda, founder, Prana Ayurveda says, “The COVID-19 virus attacks the throat and the lungs. In Ayurveda, Kaphadosha, made of earth and water, is

dominant in the nose, throat, and chest region. When kapha is imbalanced, it leads to accumulation of thick fluids like mucus, a breeding ground for allergies, viruses, bronchial diseases.”

Hamid Ahmad suggests a set exercise regimen to fight off any viruses present in the air. He adds, “A simple walk or a jog would increase lung capacity which is essential to fight Covid-19.”

Dimple adds,”Kapha is heavy, dense, moist, sweet, sour, and salty in quality, and to balance this we must incorporate bitter, astringent, and pungent tastes in our diet. Cold-pressed juices allow your body to heal and
you will have more energy and less cravings thus building the balance that the body needs.”

The better your body’s immune system is, the better are your chances of successfully fighting off an infection like the novel coronavirus.

Pavleen Gujral

Pavleen Gujral

Pavleen Gujral, actor and nutritionist, says, “You can easily give your immunity a boost with ready-to-use immunity-booster products such as tulsi drops, amla juice, giloy-neem, and ashwagandha. They would help in the long-run. Also, one of my personal favourites to boost immunity is turmeric latte.” This beverage is a nutritional powerhouse. It is a cup full of antioxidant-rich spices that also happen to have anti-inflammatory properties. Have one glass of this at night before sleeping and you can considerably reduce the odds of getting sick.

Even Dimple echoes that tulsi, giloy, amla, neem, ashwagandha, turmeric, ginger and other herbs are antioxidants, have anti-inflammatory, anti-bacterial, anti-allergic, antiviral properties that help in strengthening bronchial health, reducing Kapha imbalance, and boosting immunity against most viruses. She adds, “This is the era of building immunity, and boosting it is the best prevention against all kinds of disorders and viruses.”

Bank on us to give you a list of vitamins and foods which you can inculcate in your diet to have a strong immune system and in turn, fight the infectious disease.

Ashwagandha

Improves antibody production that plays an essential role in fighting bacteria, viruses, and other pathogens

Increases nitric oxide production, which activates macrophage actions of the immune system and improves the ability to ingest invader cells

Promotes anti-inflammatory effects, thus help lower inflammation by reducing the number of C-reactive proteins in the body

Tulsi

It acts as an immunomodulator, which refers to agents that improve the functioning of the immune system

Helps to restore balance for healthy physiological and psychological functioning

Contains unique antioxidants and micronutrients that may provide powerful immune protection from free radical damage and increase the body’s capacity to fight against disease and infections.

Giloy

An antipyretic in nature, giloy can prevent the onset of recurrent fever

Strengthens immunity and is a source of biologically active compounds like alkaloids and lactones

Helps to reduce respiratory problems like frequent cough, cold, tonsils due

and tackle respiratory and breathing problems.

Helps to fight off free radicals and disease-causing germs

Amla is rich in Vitamin C

Amla is rich in Vitamin C

Amla

Rich in Vitamin C – a nutrient known to help boost immunity

Helps to repair the body, and keep the risk of diseases away

Boosts the production of white blood cells (WBC) in the body that help in fighting

several infections and disease

Turmeric latte

Turmeric latte

Turmeric

Curcumin present in turmeric has powerful antioxidant properties

Neutralises free radicals and stimulates the body’s antioxidant enzyme to avoid further damage

Curcumin inhibits inflammation, relieves congestion and pain and thus improves your breathing

Gynecological Cancers Not a Risk for Severe COVID-19: Study | Health News

Gynecological Cancers Not a Risk for Severe COVID-19: Study | Health News

  • July 30, 2020

(HealthDay)

THURSDAY, July 30, 2020 (HealthDay News) — Despite rampant fears that cancer patients are at higher risk of having severe cases of COVID-19, a new study suggests gynecologic cancers do not boost the chances of hospitalization or death.

“Our study should be reassuring for women with gynecologic cancers who are worried that having cancer increases their risk of becoming seriously ill if they go to the hospital because of COVID-19,” said lead investigator Olivia Lara, an oncology fellow at NYU Langone’s Perlmutter Cancer Center.

For the study, Lara’s team reviewed the medical records of 121 women, aged 51 to 63, being treated simultaneously for gynecologic cancers and COVID-19 in New York City between March and April.

The results, published online July 31 in the journal Cancer, revealed that these women had similar hospitalization rates and death as those who only had COVID-19.

More than half of the study patients required hospitalization, and among those hospitalized one-quarter died, amounting to a 14% death rate.

The death rate among this sample is comparable to the 21% death rate identified in another study, which included 5,700 hospitalized COVID-19 patients in the city, the study authors noted.

The study could potentially alter the theory that cancer patients face worse odds when infected with COVID-19.

A full 75% of the women with gynecological cancer experienced only a mild form of the disease, according to the report.

The women’s risk of dying from COVID-19 did not increase even if they had late-stage cancer, cancer surgery or high-dose chemotherapy, the study authors said in a New York University news release.

Still, one risk factor related to cancer treatment seemed to increase the odds of death.

Women receiving immunotherapy — treatment that uses a person’s own immune system to fight cancer — were three times more likely to die than women who received standard cancer treatments such as radiation, surgery or chemotherapy.

But only eight out of the 121 participants included in the study were treated with immunotherapy, prompting the study authors to stress that the sample was too small to make any conclusions based on this finding.

The results do underscore the importance of receiving cancer screenings and treatments, despite COVID-19 fears.

“The basic rules of cancer care have not changed during the pandemic,” study senior investigator Dr. Bhavana Pothuri said in the news release. “Early detection, screening and care lead to more people surviving what remains a leading cause of death among American women.”

Copyright © 2020 HealthDay. All rights reserved.

Nutritionist explains how to boost your immune system

Nutritionist explains how to boost your immune system

  • July 30, 2020

JACKSONVILLE, Fla. – We’ve all heard the phrase you are what you eat so while it is important to practice all of the recommended CDC guidelines to help prevent the spread of COVID-19 – it’s equally important that you pay attention to what foods you’re putting into your body during these times. 

“Keep it simple. If it grows from the earth or roams from the earth, this is safe to eat. If it comes from a plant eat it; if it’s made in a plant don’t,” said Zach Elkins, Nutritionist at Lean Impact Nutrition. 

It is always important to monitor what you eat, but it’s become even more critical during the coronavirus pandemic. 

“We need to start focusing internally on our health. The higher your immune system is the more you’re going to be able to fight off diseases, because your body needs macro and micronutrients to perform at its’ best. When you eat highly processed, sugary food you feel that; you feel tired; you feel sluggish,” Elkins said. 

Simplicity can be the key when it comes to a myriad of healthy eating tips, diet, fads, and etc. 

“Fruits and vegetables are going to give you your most bang for your buck when it comes to immunity and antioxidants, micronutrients, your minerals, your vitamins, so what I always tell people is to keep it simple,” said Elkins. 

PRO-TIP: Avoid using vegetable and canola oils when possible. Substitute olive and coconut oils instead.

When it comes to increasing your intake of vitamin C, reconsider what you think you know about the immune-boosting vitamin. Elkin said most people go-to oranges for an extra punch of immune health, but not as many people know there’s a vegetable with far more nutrients to offer.

“What people don’t realize is red pepper has more vitamin C than an orange. Start incorporating bright colors with your peppers. In your lettuce decision-making, choose keep them dark and leafy options– that’s going to be your kale (which is a superfood), spinach, and broccoli,” he said.

Another rule of thumb to follow, try to get 80% of your calories from whole nutrient foods. Start small instead of going all out. Make one meal a week in accordance with the rule, and gradually increase the dietary changes as you progress and feel more confident.

Simple Meal Plans To Get You Started

  1. A piece of salmon, pan-seared with zucchini. Looking for more food? Add squash and roast red peppers with kale. Kale is a superfood and probably one of the best greens you can eat, according to Elkins. 
  2. For carb lovers, this one is for you. Have a burger with and fresh broccoli crowns. sweet potatoes. Elkins said be selective with your meat purchase. “When you pick your burger you want to try to get the leanest possible, so 90% or higher is going to be the least amount of fat, least amount of calories,” Elkins said. 
  3. Keep it really simple with a salad. Elkins said keep it colorful too by incorporating kale, fresh tomatoes, carrots, and zucchini spears. Add a small amount of chicken breast for some protein or keep it veggies only.

Eating healthy is not only difficult but expensive. If you can’t afford fresh vegetables and fruits, try to choose processed foods that are low in sugar and trans fat.

Copyright 2020 by WJXT News4Jax – All rights reserved.

Immunity claims proliferate in new product launches | 2020-07-30

Immunity claims proliferate in new product launches | 2020-07-30

  • July 30, 2020

ARNHEM, THE NETHERLANDS — Products carrying an immunity claim, already on the rise before the coronavirus (COVID-19) pandemic, have continued picking up steam.

“From 2015 to 2019 … you’re looking at almost a doubling of new product innovation globally for food and beverage launches with an immune health claim,” said Tom Vierhile, vice president of strategic insights, North America, at Innova Market Insights. “You’re also seeing more products directly reference immunity or the immune system right on the font of product packaging.”

Two-thirds of millennials and a third of baby boomers said they were increasing their consumption of functional food and beverage products in 2019, Mr. Vierhile said. Those numbers have shifted in recent months, with around half of consumers worldwide consuming more immunity-boosting products after the onset of the pandemic.

Four Sigmatic chaga mushroom beverage mixImmunity has been a focus in dairy innovation, Mr. Vierhile said.

“Dairy products are definitely benefiting from the fact that many contain probiotics, especially items like yogurt,” he said.

An example is the recently launched fermented buttermilk with strawberries from Farmi Piimatoostus Ltd., an Estonian dairy company. The product features vitamins B6 and B12, which contribute to immune and nervous system performance, and Selenium, a mineral that protects cells from oxidative stress.

Hot drinks, especially tea, have emerged as another key area of new product innovation.

“The reason tea is trending is that many tea products, especially herbal tea products, contain ingredients that may be high in nutrients like vitamin C, maybe orange peel and other ingredients like ginger,” Mr. Vierhile said.

Examples include the new Chaga mushroom drink mix from Los Angeles-based Four Sigmatic. The drink mix features Chaga mushrooms, which offer a host of antioxidant properties to support the immune system and overall health, along with Rose Hip, which is high in vitamin C.

once upon a farm dairy-free smoothiesImmunity also is trending in plant-based products. The number of new launches carrying both a plant-based and an immunity claim nearly tripled between 2015 and 2019, according to Innova Market Insights.

“You’re seeing companies being more forthcoming about the fact that their products are plant based,” Mr. Vierhile said. “You’re seeing references to plant-based content and plant-based ingredients right on the front of the packaging.”

An example is new dairy-free smoothies from Once Upon A Farm, Berkeley, Calif., which contain added probiotics for gut and immune health.

 

What’s next for immunity

Future directions for immune health may include CBD and foodservice, Mr. Vierhile said.

“We’re seeing a lot of new opportunities for innovation when it comes to immune health products, and CBD is one area that’s beginning to break out a little bit,” he said.

Innovation has focused on combining CBD with other compounds and minerals to promote a variety of health benefits. Vancouver-based BevCanna recently launched Lev, a line of fruit-forward CBD-infused sparkling spring waters. The products contain a fulvic and humic mineral formulation that promotes immune system health. Other benefits include improved cognitive function, metabolism support and digestive health.

BevCanna Lev CBD sparkling water“Foodservice is definitely not the first place you look for new immunity product innovation, but that may be changing,” Mr. Vierhile said.

The Kerry Group, Tralee, Ireland, is exploring adding functional ingredients to the foodservice sector with GanedenBC30, a natural probiotic ingredient that provides beneficial bacteria known to support the digestive and immune systems.

“That particular ingredient is especially resistant to extremes of heat, cold and pressure, which enables it to be used in a broad range of products, including pizza, coffee and all kinds of food and beverage products,” Mr. Vierhile said. “The idea is that it can be used as an ingredient for everyday products that consumers may be purchasing at fast-food outlets or white tablecloth restaurants.”

Personalized nutrition may be another area ripe for innovation. Santa Monica, Calif.-based Vejo recently launched a portable blender designed for customized functional beverages. The pod-based system delivers doctor-formulated nutrition blends tackling issues like immunity, stress reduction and sleep.

Another customized beverage tool is NesQino from Nestle China, Beijing, which launched in April. The product allows consumers to create a variety of nutritionist-designed smoothies, oat shakes and milkshakes. One variety is Glowing Shield, an immunity blend featuring mango, carrot and acerola cherries.

“You have the option of having a cold drink or a hot beverage to create kind of a customized superfood product,” Mr. Vierhile said. “There are many different formulations that consumers can enjoy with this particular item. It’s one to watch.”

Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy

Human microbiomes in health and disease: Strategic options for regulatory science and healthcare pol

  • July 30, 2020
This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding diligent regulatory science and policy action to ascertain confidence and trust among consumers, patients, and healthcare providers. The authors discuss why establishing harmonized processes and standards to better understand the baseline healthy microbiota is essential to development of strategies for nutrition and clinical applicability. They conclude that, given the complexity of issues, a well-orchestrated, multistakeholder approach is advisable for the best chance of success.
 
Introduction
Traditional paradigms for healthcare product development are significantly challenged as we enter an era of new tools (e.g., CRISPR, RNAi, ‘omics’ diagnostic technologies, in silico trials, digitization, apps, and wearables) and face new or shifting targets, such as human microbiota/microbiomes, consumer-patient continuum, and shifts from disease management to health-preserving strategies. In addition to current population-based approaches, rapidly evolving science and technologies provide the potential for personalizing nutrition and medicine, leading toward highly individualized, precision therapies and preventive medicine. These developments are opening new avenues to tackle rare (orphan) and common noncommunicable and communicable diseases.1-3
 
Targeting microbiomes on and in humans as part of developing health- and disease-focused solutions for the human organism opens a broad perspective for preventative, as well as therapeutic, interventions. The human microbiota ‒ at times considered a virtual organ constituted of eubacteria, as well as archaea, filamentous fungi, yeasts, protozoa, viruses ‒ cohabits our bodies and may hold the key to many aspects of maintaining good health. These aspects include having an impact on digestion and boosting the immune system, cognitive functions, and even longevity. Multiple facts and causalities have yet to be established or refined because it is still not clear what defines a healthy microbiome and what causal relationships exist between diet, health, disease, and respective disturbances.4,5
 
These opportunities and challenges require significant and acute out-of-the-box rethinking, as well as open communication and sharing of, and access to, data. It requires collaboration between multiple stakeholders from regulatory authorities, academia, manufacturers, healthcare professionals, payers, and patients to establish, interpret, and implement appropriate regulations and healthcare policies.6
 
Innovating regulatory science
Evolving scientific and innovative technological tools, processes, and respective terminologies, allow us to study and establish new personalized, precision, tailored, or bespoke approaches to preventing and treating diseases. All those elements will result in increased intervention efficiency compared with a more general, less precise population-based approaches. With a focus on the human microbiome, a thorough knowledge of the types and ratios of microbes is needed before microbiome science can be incorporated into routine clinical practice.7 There have been multiple efforts to establish the baseline(s) and standards for comparison of an individual’s microbiome or metagenome to expand the knowledge base of what a ’normal’ microbiome constitutes. These efforts still focus mostly on specific subsets of the issue, such as the Genomic Standards Consortium8 on reporting (meta)genomic sequences, the Critical Assessment of Metagenomic Interpretation on computational tools used in metagenomic research,9 or the International Human Microbiome Standards on standardization of procedures to study the gut microbiome.10 Standardization is shown to be an issue for all microbiome research, as evidenced recently by MicrobiomeSupport on food systems microbiomes.11-13
 
It is essential to define which factors determine a healthy state of a particular microbiome and its resilience. Study results may lead to divergent conclusions, depending on the kinds of methods or procedures used. For example, various DNA extraction methods or the relative abundance of species (i.e., eubacteria, archaea, filamentous fungi, yeasts, protozoa, viruses) may favor different organisms and bias outcomes. Hence, agreements on human reference microbiomes and standardization of the various steps in microbiome analyses are needed for analyses linked to health, disease, or gender, or for comparing the clinical effects related to nutrition or drugs. More accurate, higher-throughput data accrual, and the ability to organize, store, access, and share data sets via comparable bioinformatics pipelines are needed to increase comparability and reproducibility of results.14,15
 
Standardization of the microbiome research field starts with the general adoption of standardised reference reagents. The UK’s National Institute for Biological Standards and Control for microbiome analysis by next-generation sequencing DNA reference reagents were used to develop a first set of reference reagents and a four-measure framework for evaluating bioinformatics tool and pipeline bias. These can act as global working standards and will be evaluated as candidate World Health Organization International Reference Reagents.16
 
There has been progress in defining reference genomes reflecting the human gastrointestinal microbiome. A unified sequence catalog of more than 200,000 genomes and 171 million protein sequences of the human gut microbiome have been generated. Of note is that more than 70% of the species in the catalog have not yet been cultured, and 40% of the proteins have unknown functions. The catalog will be instrumental in gaining a deeper mechanistic understanding of the human gut microbiomes.17
 
With further standardization and the identification of reference metagenomes, the overall aim of a planned European coordination and support action18 is to structure the field of microbiome research as related to human health and to reach global agreement, among scientific institutions, regulatory authorities, industry, and funders, on human reference microbiomes in an effort to:
 

  • standardize the different steps in human microbiome studies
  • define healthy states in and on the human body
  • contribute to collaborative synergistic collection of microbiome data to improve coherence and reduce overlap
  • integrate metagenomics and human microbiome references into other multilateral cooperation areas or personalised medicine approaches

     

There is a strategic role and potential of the human microbiome in personalizing health and disease management. A growing body of evidence suggests that noncommunicable diseases (NCDs) are associated with unbalanced dietary patterns and subsequent disturbances in the gut microbiome (dysbiosis), now recognized as an important biological interface between human genetics, lifestyle, and environmental conditions. With new research insight as a result of high throughput “omics” technologies in the current postgenomic era, there is growing interest in the functioning of the gut microbiome and the potential for developing innovative applications and personalized health solutions that target the microbiome.19,20
 
There is a need for diligent regulatory and policy action, considering the rapid pace of science and technology development and the application potential of these fields. A range of microbiome-related, or pre- and probiotics-based, products and derived active compounds (postbiotics) are already available, ranging from certain foods, to food supplements, including fermented foods or fermentation products, to fecal microbiota transplants (FMT). As with all healthcare-related products for nutritional or medicinal purposes, quality, safety, efficacy, and fitting the intended use or health claim must be demonstrated. However, current regulatory guidance is limited, because no consolidated national or global regulatory frameworks are applicable.21 The need for an international dialogue between multiple stakeholders has been recognized for harmonizing the scientific standardization and technological development, as has the need for microbiome product regulation.22 There is an ongoing dialogue among the Intestinal Microbiome-based Medicines European Task Group,23 the International Probiotics Association,24 and the Microbiome Therapeutics Innovation Group.25
 
The US Food and Drug Administration (FDA) has published guidance dedicated to FMT26 and live-biotherapeutic products.27 To further microbiome-related discussion and research, an interagency Microbiome Working Group was created as well, with FDA and National Institutes of Health experts. As Rousseau and colleagues have noted,28 FMTs illustrate the variety of regulatory statuses potentially applicable to microbiome-related health products, some of which may conflict with existing regulations applicable to tissues and cells as defined in the EU and the US as “human material.”29,30 When administered for difficult-to-treat, potentially life-threatening Clostridium difficile infection, FMT meets the US definition of a biological product.31 The EU Commission, without a specific framework, considers FMT as substances of human origin,32 whereas some EU member states regulate FMT under tissues and cells standards and others as medicinal, non-ATMP products, or as foods.33
 
The nonclinical to clinical translation for microbiome-based products provides specific development challenges not typically encountered with other types of regulated healthcare products.34 Given a large variety and mode of action, as well as the need for microbial characterization, a case-by-case product development approach is typical. Rousseau and colleagues35 have described a vast spectrum of available microbiome-adapted nonclinical models, some of which are already well developed and continuously improving. Moreover, the regulatory framework for computer-based, in silico modelling and simulation, is starting to evolve and will eventually provide additional “digital evidence” to complement nonclinical and clinical studies. Rousseau and colleagues had also reviewed the potential use of in silico analyses in the microbiome field to investigate the interactions and role of the host microbiome on the host health,36 explore the microbiomes’ impact on the immune system, or identify personalized microbiota.37,38
 
Meeting the challenges of translating nonclinical models to the human situation, that is, moving models from bench to bedside, requires understanding of what determines a healthy microbiome, what a healthy reference microbiome is, and how microbiomes react to drugs and stimuli. Most drugs directly target a patient’s cells or tissues, whereas microbiome-based products aim to modify, are modified by, or interact with the patient’s microbiota. By the same token, microbiome‒drug interactions and the resulting clinical responses linked to different gut microbiomes composition must be considered.39 An integrative approach is advisable in regard to chemistry, manufacturing, and controls, or CMC, whereas nonclinical and clinical product development must align findings and increase their relevance toward expected human treatment outcomes.40
 
The food- and nutrition-related regulatory science framework for microbiome-based products is significantly less developed than it is for personalized, precision, or bespoke medicine. Beyond fulfilling potential novel food approval requirements for innovative components, “prebiotic,” “probiotic,” and “postbiotic” statements are considered implicit references to general, nonspecific benefits of the nutrient or food for overall good health or health-related well-being. They face the challenge of being accompanied by a specific, authorized health claim in the EU.41,42
 
The foremost mandate for regulatory science is to ensure consumer and patient safety in our volatile, uncertain, complex, ambiguous environment. Novel, rapidly evolving science and diagnostic technologies, of particular relevance for the microbiome, require regulatory science to enable a pragmatic shift of past paradigms.43 Indeed, as ‘omics’ technologies blur the traditional segmentation between consumers (health) versus patients (disease), disease prevention versus treatment, and nutrition versus drug, the regulatory framework should adopt this development as part of a new concept that approaches health holistically. In addition, although it is necessary to address the increased complexity of understanding and defining ”where health ends and disease starts,” practical solutions should include a certain level of uncertainty, while ensuring safety and efficacy of interventions.44
 
It is a challenge to provide healthcare solutions as rapidly as possible to citizens who need them urgently and would otherwise suffer unduly. Meeting the challenge requires a pragmatic rethinking and refinement of healthcare development and access approaches, involving diverse stakeholders from science, the healthcare profession, and industry, as well as payers and politicians. Recognizing this raises the question of what policymaking would be required to ensure a clinically beneficial and cost-efficient healthcare environment for the individual and the population.45
 
Innovating healthcare policy
Schneeman46 has argued that, although science is necessary for developing policy, it is not always sufficient. For instance, challenges associated with disease prevention or global malnutrition problems will have to be addressed through multidisciplinary approaches. There have been multiple efforts to review current policies and the need to adapt to fast-moving, innovative areas, such as personalizing healthcare,47 making sense of dietary guidelines,48,49 creating and improving the evidence for nutrition,50,51 and understanding and targeting the microbiome.52,53
 
Given the developmental speed of new data and technologies, and the complexity and importance of nutrition products for life and healthcare, it might be necessary to factor in a certain amount of risk when building evidence for nutrition products ‒ as well as the microbiota.54,55 While justifying potential risk, the principle safety and utility of nutrition products for the prevention and management of diseases compared with other available healthcare options, cannot be overly emphasized.
 
Key issues expected to be addressed by the European coordination and support action referred to previously in this article, are essential for society and necessitate sound and rapid regulatory answers. In addition to the question of what constitutes a healthy state microbiome, we need to understand how to define health and disease in general, and, in that context, how to define who is a consumer and who is a patient. The new tools in science, as well as societal needs, such as NCD prevention or healthcare cost efficiency, require deeper investigation, which could result in some existing models and paradigms being questioned and having to be re-conceptualized or revised.56 There is proven precedence in healthcare – for example, with the Orphan Disease Act – to create incentives to treat rare diseases, as with the development and approval pathways to respond to treatment challenges in the early days of the HIV/AIDS crisis, or with biotechnological versus small-entity chemical drugs.57 New tools, targets, and an increasing cost burden, require similar action as quickly as possible.
 
The Organisation for Economic Co-operation and Development has clearly stated the key policy challenges for innovation in the microbiome through diet.58 There is accumulating scientific evidence that the gut microbiome can be altered to generate greater health and well-being, offer better protection and resilience against NCDs, and even cure conditions such as type 2 diabetes and Clostridium difficile infections. Yet, to lead to innovative applications, science and innovation policies must be improved in five areas:
 

  • science policy
  • enabling translational science
  • public‒private collaboration
  • regulatory frameworks
  • skills, communication, and public awareness

 
The same principles should apply to the other microbiomes in and on the human body, even if less is known about them, compared with the gut, and they are not as widely researched.
 
Hence, beyond continuing to corroborate the foundation of well-known, population-based approaches, establishing the right framework conditions is essential when targeting the microbiome as part of personalized and preventive healthcare. A reliable and trustworthy science base is a major criterion for healthcare systems to support novel interventions or to take up in novel dietary guidelines. These should be supported by regulatory systems that accept the concept of a continuum between health and disease and food or drug and address these issues with a holistic approach. Creating awareness and value for citizens and healthcare providers is essential. However, it is important to not encourage the “hype” currently associated with areas of personalized nutrition and the microbiome (Table 1).59

Ruthsatz_TABLE.png

Given the strong evidence that microbiomes play an important role in human health and have clear links to many of the major NCDs, and possibly even in infectious diseases, it is of paramount importance that information is gathered, disseminated, and translated into policy solutions as quickly as possible. Due to their intrinsic complexities, these issues are best addressed through a well-managed, multistakeholder approach. The approach should be global, as well as regional and local, where advisable.

 

Multistakeholder campaigns60

Changes in science and technology are moving at unprecedented speed. Science is entrenched in thematic “silos” and struggling to cope with change, but it is needed for guiding regulatory and policymaking decisions.61 The stakes are high for the ambitious goal of including the microbiome in our global healthcare approaches as soon as possible, and strengthening nutrition and personalized medicine as a beneficial and cost-effective way to prevent and/or treat NCDs. For sustained impact, a science-based, multistakeholder collaboration is the most promising and systematic way of finding comprehensive solutions to characterize the microbiota on a global scale and discern what determines a healthy microbiome in terms of aging, gender, and ethnicities. Given the enormity of the task and the many factors that can affect its trajectory, single-sector or stakeholder actions are unlikely to effectively influence all aspects of microbiome research in a coordinated fashion.62,63

 

Working together will maximize impact. Aligning goals, resources, and working in a coordinated manner, can multiply the impact of individual stakeholders. Exploring mutually beneficial linkages across stakeholders and programs can build organizational capacity. A multistakeholder approach, aligned with straightforward goals and a clear path to implementation, means pooling limited resources and allowing the collaboration to maximize financial and technical expertise. By working together, stakeholders can draw on collective core competencies to create a more comprehensive set of capabilities.64

 

The multistakeholder initiatives outlined in the preceding section, “Innovating regulatory science,” provide insight into the state of research on the human microbiome and its links to health and certain diseases. In the best case scenario, they ultimately will establish a “community of practice” incorporating science, regulatory and industry experts, funders, and political leaders from around the globe, all addressing the need for standardization and agreeing on reference human microbiomes (in and on the human body) and how they relate to health, different disease areas, nutrition, gender differences, populations, and ethnicities.

 

Key will be to translate this knowledge from bench to bedside, thereby ensuring that the human microbiome awareness and information will reach healthcare professionals and the broader audience for rapid implementation. The Optimal Nutrition Care for All, or ONCA, multistakeholder campaign, spearheaded by the European Nutrition for Health Alliance, showcases a successful way forward in its efforts to tackle the costly malnutrition epidemic by implementing routine nutrition risk screening, increasing education campaigns to raise public awareness, and implementing proper science-based nutrition care for patients in 18 countries.65,66 As an African proverb advocates: “If you want to go fast, go alone, if you want to go far, go together.”67

 

Conclusion

The human microbiota and microbiomes play a strategic role in general population-based approaches as well as personalizing health and disease management. New evidence and the scourge of NCDs are demanding diligent regulatory science and rapid policy action to translate knowledge, disseminate, and implement solutions rapidly to consumers, patients and healthcare providers. Given the intrinsic complexity of challenges, issues are best being addressed by a well-orchestrated, multi-stakeholdessr approach. While multiple analytical approaches are currently employed by researchers worldwide, establishing basic harmonized processes and standards to better compare and understand the baseline healthy microbiota is essential for developing strategies for nutrition, personalized and preventive interventions, and clinical applicability.

 

References

All websites accessed on 23 July 2020, unless otherwise noted.

 

  1. Roach S. Bespoke therapies – Opportunities, challenges and hope. Regulatory Focus. May 2020. Regulatory Affairs Professionals Society. https://www.raps.org/news-and-articles/news-articles/2020/5/bespoke-therapies-opportunities-challenges-and-hop.
  2. Meskó B. The Future of Digital Health. Top 10 Technologies We Are Excited About. Published 9 December 2019 on LinkedIn. https://www.linkedin.com/newsletters/the-future-of-digital-health-6501324601757442048/.
  3. D’Hondt K, Kaput J, Ruthsatz M. Personalized nutrition for better health: Targeting the human microbiome. Regulatory Focus. July 2019. Regulatory Affairs Professionals Society. https://www.raps.org/news-and-articles/news-articles/2019/6/personalized-nutrition-for-better-health-targetin.
  4. OECD. The microbiome, diet and health ‒ Toward a science and innovation agenda. OECD Science, Technology and Industry Policy Papers, No. 42, OECD Publishing, Paris. Published 22 September 2017. https://doi.org/10.1787/d496f56d-en.
  5. Valdes AM, Walter J, Segal E, Spector TD. Role of the gut microbiota in nutrition and health. BMJ. 2018;361:k2179. https://www.bmj.com/content/361/bmj.k2179.
  6. Ruthsatz M. Role of nutritional therapy in healthcare innovation: The need for reshaping regulatory paradigms. Réalités Industrielles ‒ A series of Annales des Mines. 2017:80-85.
  7. King CH, Desai H, Sylvetsky AC, et al. Baseline human gut microbiota profile in healthy people and standard reporting template. PLoS ONE. 2019;14(9):e0206484. https://doi.org/10.1371/journal.pone.0206484.
  8. Genomic Standards Consortium website. https://press3.mcs.anl.gov/gensc/.
  9. Sczyrba A, Hofmann P, Belmann P, et al. Critical assessment of metagenome interpretation ‒  A benchmark of metagenomics software. Nat Methods. 2017;14:1063-71.   https://doi.org/10.1038/nmeth.4458.
  10. International Human Microbiome Standards (IHMS) website. www.microbiome-standards.org/.
  11. MicrobiomeSupport. Defining standards in microbiome research – Day 1 of workshop series on methodology. March 2020. https://www.microbiomesupport.eu/defining-standards-in-microbiome-research-day-1-of-workshop-series-on-methodology/.
  12. Berg G, Rybakova D, Fischer D, et al. Microbiome definition re-visited: Old concepts and new challenges. Microbiome. Published online 30 June 2020. https://doi.org/10.1186/s40168-020-00875-0.
  13. IS_MIRRI21 website. https://ismirri21.mirri.org/.
  14. European Commission. Coordinating and supporting research on the human microbiome in Europe and beyond. Conference call (reference H2020-SC1-HCO-17-2020). 2019. https://ec.europa.eu/eip/ageing/funding/horizon-2020/coordinating-and-supporting-research-human-microbiome-europe-and-beyond_en.
  15. Op cit 7
  16. Amos GCA, Logan A, Anwar S, et al. Developing standards for the microbiome field. Microbiome. Published online 26 June 2020. https://doi.org/10.1186/s40168-020-00856-3.
  17. Almeida A, Nayfach S, Boland M, et al. A unified catalog of 204,938 reference genomes from the human gut microbiome. Nat Biotechnol. Published online 20 July 2020. https://doi.org/10.1038/s41587-020-0603-3.
  18. Op cit 14
  19. Kaput J, Draper C, Descombes P, et al. Targeted (personalized) nutrition. Regulatory Focus. August 2016. Regulatory Affairs Professionals Society. http://www.raps.org/regulatoryDetail.aspx?id=25724.
  20. Op cit 3
  21. Rousseau CF, Desvignes C, Kling F, et al. Microbiome product toxicology: Regulatory view on translational challenges. In: Reichl FX, Schwenk M (eds). Regulatory Toxicology. Springer, Berlin, Heidelberg, 2020. https://doi.org/10.1007/978-3-642-36206-4_140-1.
  22. Op cit 4
  23. Pharmabiotic Research Institute website. IMM-ETG [Intestinal Microbiome-based Medicines European Task Group]: A new European initiative for intestinal microbiome medicinal products. 20 May 2019. https://www.pharmabiotic.org/2019/05/20/imm-etg-a-new-european-initiative-for-intestinal-microbiome-medicinal-products/.
  24. International Probiotics Association website. http://internationalprobiotics.org/.
  25. Microbiome Therapeutics Innovation Group website. https://microbiometig.org/.
  26. Food and Drug Administration. Enforcement policy regarding investigational new drug requirements for use of fecal microbiota for transplantation to treat Clostridium difficile infection not responsive to standard therapies. Draft for Industry. March 2016. Last updated 29 January 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-regarding-investigational-new-drug-requirements-use-fecal-microbiota-0. Accessed 29 July 2020.
  27. Food and Drug Administration. Early clinical trials with live biotherapeutic products: Chemistry, manufacturing, and control information. Guidance for industry. June 2016. Last updated 16 August 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/early-clinical-trials-live-biotherapeutic-products-chemistry-manufacturing-and-control-information. Accessed 29 July 2020.
  28. Op cit 21
  29. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Official Journal of the EU. L102:48-58.
  30. Food and Drug administration. Code of Federal Regulations Title 21, Vol. 8. Revised as of 1 April 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.3.
  31. Op cit 26
  32. European Commission Directorate General for Health and Food Safety. Competent authorities on substances of human origin expert group (CASoHO E01718): Meeting of the competent authorities for tissues and cells, 13-14 May 2019. Summary minutes. https://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/ev_20190513_sr_en.pdf.
  33. European Commission. Commission staff working document. Executive summary of the evaluation of the Union legislation on blood, tissues and cells. Dated 10 October 2019. https://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/swd_2019_375_summary_en.pdf.
  34. Ruthsatz M, Chiavaroli C, Cassar MA, Voisin E. Biomolecules versus smaller chemicals in toxicology. ICH, EU, and US recommendations. In: Reichl FX, Schwenk M (eds). Regulatory Toxicology. Springer, Berlin, Heidelberg, 2020. https://doi.org/10.1007/978-3-642-36206-4_57-2.
  35. Op cit 21
  36. Moorthy AS, Eberl HJ. compuGUT: An in silico platform for simulating intestinal fermentation. SoftwareX. 2017;6:237-42.
  37. Rousseau CF, Crozatier C, duVerle DA, et al. A regulatory landscape shift for in silico clinical trials. Regulatory Rapporteur. 2019;16(11):18-21.
  38. Op cit 21
  39. Guthrie L, Kelly L. Bringing microbiome-drug interaction research into the clinic. EbioMedicine. Published online 1 June 2019. https://doi.org/10.1016/j.ebiom.2019.05.009.
  40. Op cit 21
  41. Ibid
  42. Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. Official Journal of the EU. L404: 9-25.
  43. Op cit 6
  44. EFSA Scientific Committee. Guidance on uncertainty analysis in scientific assessments. EFSA Journal. Published online 24 January 2018. https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5123.
  45. Ruthsatz M, Candeias V. Non-communicable disease prevention, nutrition and aging. Acta Biomed. Published online 11 May 2020. https://www.mattioli1885journals.com/index.php/actabiomedica/article/view/9721.
  46. Schneeman BO. Linking science and policy. Nutrition Today. 2014;49(4):167-73.
  47. Ciriello Pothier K. Personalizing precision medicine: A global voyage from vision to reality. 1 1st ed. Wiley; 2017.
  48. European Food Information Council website. Make sense of dietary guidelines. 2020; Brussels. www.eufic.org.
  49. Schneeman BO. Impact of changing scientific recommendations on nutrition policies. Regulatory Focus. July 2018. Regulatory Affairs Professionals Society. https://www.raps.org/news-and-articles/news-articles/2018/7/impact-of-changing-scientific-recommendations-on-n.
  50. Magni P, Bier DM, Pecorelli S, et al. Perspective: Improving nutritional guidelines for sustainable health policies – Current status and perspectives. Adv Nutr. 2017;8:532-45. https://pubmed.ncbi.nlm.nih.gov/28710141/.
  51. Laville M, Segrestin B, Alligier M, et al. Evidence-based practice within nutrition: What are the barriers for improving the evidence and how can they be dealt with? Trials. Published online 11 September 2017. https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2160-8.
  52. Op cit 4
  53. D’Hondt K, Sanz Y, Ruthsatz M. Microbiome, diet, health and disease: Policy needs to move forward. Regulatory Focus. October 2017. Regulatory Affairs Professionals Society. https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/11/microbiome,-diet,-health,-and-disease-policy-needs-to-move-forward.
  54. Op cit 44
  55. Op cit 45
  56. Matthews R. Regulatory Focus, June issue: Nutrition in health and disease management. Regulatory Focus. July 2020. Regulatory Affairs Professionals Society. https://www.raps.org/news-and-articles/news-articles/2020/7/raps-regulatory-focus-june-issue-nutrition-in-heal. Accessed 29 July 2020.
  57. Fundamentals of International Regulatory Affairs. 4th ed. Regulatory Affairs Professionals Society; 2017.
  58. Op cit 4
  59. Op cit 3
  60. World Economic Forum. Multistakeholder collaboration for healthy living: Toolkit for joint action. March 2013. http://www3.weforum.org/docs/WEF_HE_HealthyLiving_Toolkit_2013.pdf.
  61. Šucha V, Sienkiewicz M (eds.). Science for policy handbook. Copyright 2020 European Union. Published by Elsevier Ltd; 2020. https://doi.org/10.1016/C2018-0-03963-8.
  62. Op cit 45
  63. Op cit 60
  64. Ibid
  65. De Man F, Smit C, Ruthsatz M. Innovating patient driven nutritional care in Europe: The Optimal Nutrition Care for All (ONCA) multi-stakeholder initiative. Regulatory Focus. October 2017. Regulatory Affairs Professionals Society. https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/10/innovating-patient-driven-nutritional-care-across-europe-the-optimal-nutritional-care-for-all-(onca. Accessed 29 July 2020.
  66. De Man F, Barazzoni R, Garel P, et al. Towards optimal nutritional care for all: A multi-disciplinary patient centred approach to a complex challenge. Clin Nutr. 2020;39:1309-14.
  67. Op cit 45

 
About the authors
Manfred Ruthsatz, PhD, RAC, FRAPS, is the executive director of Nutrition+HealthCARE, Connecting Advocacy, Regulatory, and Empathy. His healthcare regulatory experience, rounded out by quality, safety, vigilance, health economics, and reimbursement, spans more than 30 years in diverse healthcare industry settings, FDA CDER’s Division of Antiviral Drug Products, and NIH’s National Cancer Institute, working on human papilloma viruses. His publishing and speaking activities in Europe, the US, Asia, and Latin America include an array of regulatory- and policy-related healthcare topics, with a focus on nutrition in health and disease prevention and treatment, the human microbiome, and healthy longevity. He is a member of the IS_MIRRI21 advisory board and the RAPS editorial advisory committee. He can be contacted at ManfredRuthsatz@gmail.com.
 
Emmanuelle Voisin, PhD, is the CEO of Voisin Consulting Life Sciences, providing global strategic advice on interactions with the FDA and European Medicines Agency, as well as health technology assessment bodies in Europe, for the development, registration, and launch of innovative medical technologies. Her experience spans more than 30 years in diverse healthcare industry settings, the FDA’s CDER and the NIH’s National Institute of Mental Health. Her expertise lies in nonconventional drug development strategies and maximizing the use of regulatory mechanisms to bring new technologies to patients, with a particular interest in microbiome and the in silico clinical development. She is author of various articles covering innovative drug development as well as the global challenges facing the biotechnology industry. She leads the policy working group of the Avicenna Alliance. She can be contacted at voisin@voisinconsulting.com.
 
Nelson Lima, PhD, is full professor and researcher at the Centre of Biological Engineering of University of Minho and executive director of MycoTec Lda. He is visiting professor at several international universities and professor honoris causa at the University Federal of Pernambuco (Recife, Brazil); director of the fungal culture collection Micoteca da Universidade do Minho; coordinator of the EU project, IS_MIRRI21; coordinator of the Portuguese node of MIRRI-PT; and responsible for establishing the MIRRI European headquarters at University of Minho. He is past president of the European Culture Collections’ Organisation. Lima’s teaching, publishing, and communicating activities include topics related to food, environmental and clinical mycology, ex situ microbial resources preservation, and science and environmental education. He can be contacted at nelson@ie.uminho.pt.
 
Kathleen D’Hondt, PhD, trained as a molecular cell biologist in both academia and industry. She earned her doctorate at the University of Ghent and spent several years as a postdoc in Belgium, the Netherlands (WAU), and the Biozentrum in Basel. In 2006, she joined the Department of Economy, Science and Innovation of the Flemish government as a policy analyst, and in 2013, joined the Organisation for Economic Co-operation and Development as a policy analyst in the Working Party on Bio, Nano, and Converging Tech (BNCT). Since 2016, she has been back at the Department of Economy, Science and Innovation of the Flemish government. She is a work-package leader in MicrobiomeSupport on food systems microbiomes and bioeconomy, as well as coordinating SAPHIRe on personalised health in regions (both EU H2020 CSA projects started end of 2018). She can be contacted at kathleen.dhondt@vlaanderen.be.
 
Acknowledgment The authors would like to express special thansks and recognition to Cécile Rousseau and Clara Desvignes, of Voisin Consulting Life Sciences, for their valuable contributions to this paper, cited via the publication, Microbiome Product Toxicology: Regulatory View on Translational Challenges, as noted in Reference 21 of this article.s
 
Disclaimer This article reflects the personal opinion and experience of the authors. It should not be construed as an official position by any organization with which the authors are affiliated.
 
Citation Ruthsatz M, Voisin E, Lima N, D’Hondt K. Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy. Regulatory Focus. July 2020. Regulatory Affairs Professionals Society.
 

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