Indian With World’s 1st Patent for ‘Digital Vaccines’ Shares How They Work

For the previous 12 years, Bhargav Sri Prakash and his crew at FriendsLearn — a bio and well being tech startup with places of work in Chennai and San Francisco — have envisioned methods to make use of frontier applied sciences for a singular trigger.

Machine learning-deep studying, neurocognitive computing (AI), neural networks, gamification, AR/VR (metaverse) and cell app expertise — Bhargav’s enterprise has harnessed these to non-invasively induce a neural response, physiological consequence, and an immune response that’s constructing proof to show tips on how to decrease the chance of illness, scale back signs, and reduce hospitalisation for younger youngsters.

“Known as Digital Vaccines, they’ve been proven to work by stimulating the brain-gut-immune system on the mobile biomarker stage to decrease the chance of a variety of ailments; non-communicable ones like diabetes, heart problems, hypertension, and most cancers; cognitive ailments corresponding to ADHD, dementia; and, not too long ago, infectious ailments like COVID-19,” says Bhargav, CEO and founding father of FriendsLearn, in a dialog with The Higher India.

These Digital Vaccines fall underneath an rising science referred to as digital therapeutics, which seeks to ship medical care via smartphones, tablets, and comparable gadgets by effecting behavioural change at scale utilizing evidence-backed software program options. (Above photos courtesy Bhargav Sri Prakash and Mother or father Map)

“A baby experiences the whole lot like digital actuality gamified content material. That gamified content material is delivered by way of a cell app referred to as Fooya! This app could have a college grade applicable assortment of content material, which is a compilation of neurocognitive coaching mechanisms,” he says.

In layperson phrases, it’s a approach by which we’re capable of message or pulse the mind with stuff that they see. “We don’t do that in an invasive approach, however use sensory pathways like sight, contact, and listening to. These are major sign pathways and we’re capable of create sure patterns of neural response within the mind via this gamified content material,” explains Bhargav.

Professor Rahul Ladhania, a college member on the College of Michigan Faculty of Public Well being, says, “A key precept behind the idea of digital vaccines is of neuro-stimulation resulting in transference — whereas the gamified content material neuro-cognitively trains youngsters to make more healthy selections within the digital world, do the kids then go on to the true world and begin making more healthy selections?”

He provides, “Illustrating this with a easy instance, say, a toddler’s digital kind enters the sport. By that digital expertise, the kid’s mind is directed — via digital rewards and penalties — to keep away from aerated mushy drinks that might lead to way of life ailments like weight problems. These video games purpose to carry out neuro-cognitive coaching on the kid’s mind, and the speculation is that this leads them to keep away from mushy drinks in actual life. Moreover, this idea additionally has scope for AI-driven personalisation of those rewards and penalties. Youngsters aren’t alike, and their brains may reply differentially to those incentives”

These more healthy selections have an effect on their intestine and the microbes that reside inside them over a time period. Additionally they influence their blood parameters. So their blood sugar and ldl cholesterol numbers, amongst different biomarkers, begin altering over a time period.

One factor that trendy science is waking as much as is that our mind and intestines are literally linked. The intestines are residence to trillions of micro organism and viruses. The well being of that ecosystem is definitely the bedrock of our immune system and likewise impacts our thoughts, temper, ideas, and so forth.

Receiving a patent

FriendsLearn was based within the US in 2013. The foundational analysis started throughout Bhargav’s fellowship with the Kauffman Basis in 2011. FriendsLearn is at present working with colleges all over the world that may apply to change into companions of the Digital Vaccine Challenge at Carnegie Mellon College. Because of a extremely selective and rigorous technique of qualification, they’re working with a dozen colleges all over the world, and one in India.

“Greater than half one million youngsters all over the world have been safely digitally vaccinated via our platform, and we purpose to develop that quantity to a whole bunch of hundreds of thousands within the coming years. FriendsLearn has been self-funded to this point, together with grants from the Kauffman Basis, Remala Basis, Richard King Mellon Basis, and so forth. We at the moment are rising profitably based mostly on the commercialisation of our platform,” claims Bhargav.

The scientific and biomedical crew at FriendsLearn is led by Professor Rema Padman at Carnegie Mellon College’s (CMU) Digital Vaccine Challenge. She is a Trustees Professor of Administration Science and Healthcare Informatics on the Heinz Faculty of Info Programs and Public Coverage at CMU, and an skilled in AI and medication. They work in shut collaboration with different eminent researchers, scientists, and clinicians on the Bloomberg Faculty of Public Well being at Johns Hopkins College, College of Michigan Faculty of Public Well being, Baylor Faculty of Medication, Kansas Medical Heart, College of Oxford, Stanford College Faculty of Medication, and VHS Hospital in Chennai, amongst others. The programme was instituted in 2019.

Final month, Bhargav was awarded a patent by the US Patent and Trademark Workplace for the ‘techniques and strategies for digital vaccine’, which he developed as a part of Carnegie Mellon College’s Digital Vaccine Challenge. That is additionally the world’s first patent for a Digital Vaccine.

The patent has helped FriendsLearn safe broad mental property (IP) protection for his or her skill to non-invasively induce organic outcomes on the mobile and biomarker stage, via using metaverse AR (augmented actuality)/VR (digital actuality) and AI.

“The patent covers facets of our strategies to stimulate the mind and intestine non-invasively, that are on the core of our skill to unlock the self-healing mechanisms of the brain-gut axes and the immune system. Whereas the US was the primary nation to grant us approval for the authorized safety of this innovation and mental property, the appliance can be pending in India, Europe, China, Canada, Australia, New Zealand, and different international locations,” explains Bhargav.

Man behind the metaverse expertise

Bhargav, a 45-year-old biomedical tech entrepreneur, grew up in Chennai in a middle-class household. His mom, Sheila Sri Prakash, is broadly thought to be a pioneering architect and sustainability skilled. His late father, M V Sri Prakash, was an entrepreneur and ran a enterprise manufacturing patented modern merchandise within the sanitation infrastructure house.

“I started my profession as knowledgeable tennis participant. I went to Faculty of Engineering, Guindy for my undergraduate diploma in Mechanical Engineering, and went for graduate research in Automotive Engineering as a result of I had a ardour for racing vehicles. I went on a analysis fellowship to the College of Michigan in Ann Arbor,” he remembers.

His analysis in powertrain simulations from graduate college was incubated via the Enterprise Faculty on the College of Michigan in 1999-2000. The corporate, CADcorporation, was bought in 2005, after which he based Vmerse within the VR house to cater to American universities. After promoting Vmerse in 2009, he spent a while working within the fields of finance and investments earlier than his eyes turned towards digital therapeutics.

“I grew to become targeted on the well being of youngsters after turning into a mum or dad, seeing my daughter being influenced by commercials from processed meals firms and the way that weakened her well being. I additionally grew to become disillusioned that trendy medication has a a lot larger give attention to cashing in on our illness, somewhat than prevention,” he says.

The mission started when he was a fellow of the Kauffman Basis in 2010-2011. There, he was launched to Dr Amanda Bruce at Kansas Medical Heart, who was doing pioneering work on the examine of neural responses in youngsters. Primarily based on these elementary discoveries, “they developed gamified VR expertise for non-invasive neuromodulation in youngsters”.

The primary human randomised managed trials have been undertaken by Dr Jennette Moreno and Dr Craig Johnston on the Baylor Faculty of Medication’s Baby Diet Analysis Heart in 2013.

What roles can digital vaccines play within the course of of kid improvement?

Digital Vaccines are based mostly on Neuroplasticity (the mind’s skill to alter and adapt because of expertise) throughout the behavior formation levels of mind and intestine biome improvement. They’ve been developed to guard a toddler’s well being by decreasing their lifelong threat of illness. This, in flip, is finished by empowering their foundational immune system throughout the behavior formation stage via strategies of stimulating neurocognitive responsiveness, intestine microbiome and immune system. The core expertise is being delivered as a part of a curricular Ok-12 (kindergarten to twelfth grade within the American college system) well being programme via choose colleges.

“Our associate colleges are recognised as a DVx SCHOOL. The rigorously designed randomised subject trials purpose to ascertain scientific proof that youngsters who’re digitally vaccinated could have the data and behavioural modifications to profit from lifelong threat discount for diabetes, heart problems, hypertension, and most cancers, in addition to infectious ailments like COVID-19 and the flu. Sooner or later, we hope to induce more healthy cognitive improvement and sort out psychological well being,” claims Prof Rema Padman.

“A vital step within the science of vaccine improvement and validation entails a requirement to quantify the long run security, in addition to well being influence, upon a lot of wholesome people. That is decided via massive scale human well being (section 3) trials. Moreover, additionally it is required to trace and quantify opposed occasions after the vaccine is given to hundreds of thousands of individuals. That is broadly how vaccines and the underlying science have been refined to eradicate devastating illness and defend societies from the chance of an infection. We use the identical scientific course of to ethically develop and quantify the protection and efficacy of Digital Vaccines,” she provides.

Behaviour modification, knowledge and stopping misuse

The potential for any highly effective expertise to be misused is an important query and one which we should take into consideration from a scientific and moral innovation perspective. That is particularly essential as a result of they cater to youngsters — a weak inhabitants from a bioethics perspective.

“From a biomedical analysis perspective, we’ve got to be completely certain that we all know the long run advantages and dangers for kids,” Bhargav says. “As such, we’ve got innovated a number of design options and guard rails inside our Digital Vaccine platform to make sure protocol pushed security, corresponding to dose limits on the length of publicity. The underlying subscription-only enterprise mannequin ensures a whole give attention to the well being of the kid and the household, by eliminating any battle of curiosity if our income was based mostly on promoting or display time. Additionally, knowledge use and privateness are completely sacrosanct within the improvement and continued monitoring of well being.”

If not harnessed with a strong framework to make sure security of the topic, these neuro-modulation applied sciences may cause critical hurt to the mind. Employed in a medical setting, it’s essential to gauge the correct amount and frequency of publicity. For instance, you can die from overdosing on crocin. However with the correct dosage, paracetamol may help you with a fever. The precise dose could possibly be 250mg, taken thrice a day and proper after your meals. These determinations are based mostly on medical trials and knowledge.

“By these processes, we’re capable of decide {that a} display time of 30 to 45 minutes in per week for the kid is proven to cut back the chance of diabetes by ‘so and so quantity’. That is how these protocols are created and dose responses are really helpful. A limitation of standard medication is commonly the idea that one measurement matches all. With expertise, we are able to personalise this course of additional in order that it’s particular to a person relying on their location, top and weight, whether or not they’re chubby, have allergic reactions, and so forth. With digital vaccines, all of that’s considered so it’s very exactly mapped to that one individual,” he explains.

Moral questions

To your common sceptic, digital vaccines seem to be a type of thoughts management for kids. However do youngsters actually have management over their selections? Or are these selections typically manipulated via promoting and advertising and marketing?

As a society, we have gotten increasingly sick. This illness is coming from an elevated presence of processed meals in our day by day diets. And this isn’t taking place by chance. What number of billions of {dollars} go into promoting all this processed meals? In truth, there’s a direct hyperlink between the rise in unhealthy diets and an explosion in all kinds of sicknesses and issues — from diabetes to most cancers, COVID-19, psychological well being sicknesses, and extra.

Based on a 2021 paper revealed in BMJ International Well being, “There’s an pressing want for efficient motion to handle the over 10 million annual deaths attributable to unhealthy diets [globally].”

It provides, “Unhealthy diets are a significant threat issue for non-communicable ailments (NCDs) corresponding to coronary heart illness, type-2 diabetes, and most cancers. Limitations to progress embrace opposition of highly effective business actors, notably the multinational ultra-processed meals and beverage trade, which we outline as companies concerned within the manufacture or sale of ultra-processed meals and sugar-sweetened drinks.”

Going additional, the WHO stated that roughly 2 billion adults are chubby, of whom 650 million are thought-about to be affected by weight problems.

There are flavour enhancers, preservatives and colors in processed meals. The physique’s equipment is breaking down due to the extent of unnatural issues we’re permitting to enter the system via processed meals. And all this begins with the thoughts of youngsters.

“The US invented these methods of doing it, and now the place do you suppose their development markets are? I left India within the late Nineteen Nineties. That was the time when Coca-Cola and Pepsi have been coming into the nation. They’d taglines like ‘Yehi Hai Proper Selection, Child’, following which you had different massive celebrities endorsing mushy drinks,” says Bhargav.

these commercials, most Indians suppose these are the ‘selections’ of the brand new technology. However what occurs to diabetes 20 years down the street? India is deemed because the world’s capital of diabetes — the nation’s diabetic inhabitants is near hitting 80 million by 2030.

“So, the position we’re enjoying is attempting to actually be an promoting engine for meals which can be wholesome. We don’t promote any product however are simply promoting objects in the perfect curiosity of the kid’s well being. We use science, perceive what’s wholesome for kids based mostly on exhausting proof, and attempt to get them extra favourably inclined in direction of it. That was the unique thesis, however the ethics of this was actually dissected once we began working medical-grade medical trials,” says Prof Padman.

Sitting in entrance of institutional ethics committees, Bhargav remembers being requested questions starting from the medical dangers of accelerating blood stream to the mind, moral issues over free will, and ‘brainwashing’ to justifying the sedentary behaviour induced by time spent watching a display.

“All these moral issues are vetted by ethics and scientific assessment committees. We’ve carried out a number of randomised management trials, revealed our findings in prime journals, and proven that via this non-invasive intervention, we are able to scale back the chance of most cancers, diabetes or COVID-19. There’s a transparent established proof base to say that advantages far outweigh dangers,” he claims.

Elementary to any endeavour relating to Digital Vaccines is making certain knowledge privateness. From a bioethics and biomedical perspective, youngsters are thought-about a weak inhabitants. They can’t make totally knowledgeable choices. “From a bioethics perspective, the whole lot is designed with the privateness of the kid in thoughts. There are very stringent guidelines about what knowledge we are able to accumulate, what is totally anonymised and the way these neural networks work,” he provides.

There’s knowledge in the true world that FriendsLearn collects as youngsters use the Fooya! app. However there’s additionally knowledge they accumulate from these randomised managed trials run by scientists at Carnegie Mellon, Johns Hopkins College, Stanford College, and so forth. These are all protocol-driven and IRB (institutional assessment board)-approved. IRBs are scientific and ethics assessment boards figuring out what knowledge you accumulate, how lengthy you possibly can retailer it, what servers are they held in, what evaluation is carried out utilizing the information and what data is revealed extra broadly.

“After a given cut-off date, that knowledge might be utterly destroyed. That is additionally the place science and the protocols require us to by no means have the ability to single out anybody particular person. So, nobody is personally identifiable. This expertise has been developed within the Western market, the place we’ve got to abide by very stringent rules like Normal Knowledge Safety Regulation (GDPR-a EU regulation), Youngsters’s On-line Privateness Safety Rule (COPPA-a US regulation) and Well being Insurance coverage Portability and Accountability Act (HIPAA – a US regulation),” explains Prof Padman.

Regardless of the intent of ventures like FriendsLearn to undertake strict knowledge privateness measures, there are actual issues concerning the misuse of this expertise in much less mature democracies or autocracies. India, for instance, doesn’t but have a contemporary knowledge safety regulation regime.

There are already makes an attempt at commercialising Digital Vaccines. However received’t the method of commercialisation create conflicts that can have critical implications down the road? In spite of everything, that is very treasured and precious knowledge for main companies.

“We’re utterly self-funded and never backed by any buyers. We don’t generate Re 1 of revenue from promoting. That eliminates a large battle as a result of solely advertising-supported providers push the boundaries when it comes to with the ability to promote and monetise that knowledge,” Bhargav says.

He provides, “Our income mannequin is applied in colleges. The mother and father pay via the college. It’s a subscription-based service. Our total worth proposition is targeted on the well being of the kid. This removes choices of attempting something with the information that isn’t within the curiosity of the kid’s well being,” claims Bhargav.

Wanting Forward

“In partnership with progressive governments, in addition to aligned funders and buyers, we purpose to undertake state-wide and/or nationwide Digital Vaccination proof based mostly programmes. That is to decrease the incidence of a large spectrum of ailments as the important thing step in direction of constructing extra resilient societies, whereas decreasing the price of healthcare,” he says.

(You may click on right here to study extra about Fooya! and FriendsLearn. Additionally click on right here or right here to obtain the app.) 

Further Sources:

‘Can AI-powered’ Digital Vaccines’ open the door for innovation?’ by Anjali Raja Ok; Printed on 10 Could 2022 courtesy INDIAai

Lauber Ok, Rutter H, Gilmore AB; ‘Huge meals and the World Well being Group: a qualitative examine of trade makes an attempt to affect global-level non-communicable illness coverage’; BMJ International Well being 2021;6:e005216.

‘Prevalence of Weight problems’ courtesy World Weight problems

‘International well being leaders to handle drivers of unhealthy meals techniques’; Printed on 10 December 2021 courtesy College of Sydney

Kato-Lin, Yi-Chin & Kumar, Uttara & Prakash, Bhargav & Prakash, Bhairavi & Varadan, Vasini & Agnihotri, Sanjeeta & Subramanyam, Nrutya & Krishnatray, Pradeep & Padman, Rema. (2020); Influence of Pediatric Cellular Recreation Play on Wholesome Consuming Habits: Randomized Managed Trial. JMIR mHealth and uHealth. 8. e15717. 10.2196/15717.

(Edited by Divya Sethu)

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