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Helping Digital Health Companies Win Regulatory Approvals: Interview with Ruby Gadelrab, CEO of MDisrupt

Digital Health companies often face a struggle knowing where to begin on the road to regulatory approval. Issues such as conducting clinical validation…

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Digital Health companies often face a struggle knowing where to begin on the road to regulatory approval. Issues such as conducting clinical validation studies and finding the right regulatory experts to assist in their journey can all present major hurdles. These difficulties prompted Ruby Gadelrab to create MDisrupt, a digital health intelligence company based in California.

The company aims to assist early-stage digital health companies to pursue regulatory approvals by connecting them with a large network of experienced regulatory experts, including medical advisors, commercial strategists, and regulatory strategists. The company also assists firms with obtaining useful information on their technologies from early clinical adopters.

This helps companies to receive data on the real-world performance of their products in a healthcare setting. MDisrupt’s long-term plans include creating a benchmarking system for digital health technologies, allowing various stakeholders to compare products across different criteria.

Medgadget had the opportunity to speak with Ruby Gadelrab about MDisrupt and its plans.     

Conn Hastings, Medgadget: Please give us an overview of the struggles that digital health companies can face when pursuing regulatory approval for their technologies.

Ruby Gadelrab, MDisrupt: Digital health has the power to change how clinicians practice medicine, how they interact with their patients and how consumers and patients manage their health at home. Yet this area is one of the most difficult areas to innovate in as the regulatory processes have yet to catch up with the technology.  

Firstly, the lines between a medical claim (regulated) and a wellness claim are often blurry. It is hard for digital health innovators to clearly distinguish what constitutes each type of claim and the appropriate regulatory strategy to follow.

Secondly, the regulatory bodies have tried to regulate software, algorithms and AI in a similar way to how they have regulated traditional hardware-based medical devices. This approach is not well suited for the faster and more iterative processes required in software development.

Finally, the level of evidence and the studies required for regulatory submissions are much higher for regulated healthcare products than they are for consumer tech. This means that digital health innovators need to navigate how to do the appropriate technology and clinical validation studies which is often a very different skill set.

Engaging regulatory experts early and often in the process can be the key to navigating some of these challenges.

There is a constructive tension between digital health innovators who want to “go fast and break things” and the healthcare ethos of “do no harm.” At MDisrupt we believe that if we can partner digital health innovators with the appropriate health industry experts they can “Go fast responsibly.”

Medgadget: How does MDisrupt help early-stage digital health companies to secure regulatory approval?

Ruby Gadelrab: MDisrupt has amassed a network of over 500 health experts that are available on-demand to work with digital health companies. These experts include regulatory strategists that can help startups define the regulatory path and work directly with the regulatory bodies, medical advisors, and fractional chief medical officers that can help define and design the studies needed for regulatory submissions as well as commercial and reimbursement strategists that can enable widespread adoption and scale.

Medgadget: How does MDisrupt help digital health companies to obtain real-world data on the utility, advantages, and limitations of their products?

Ruby Gadelrab: A large part of MDisrupt’s health expert network consists of practicing clinicians who are considered to be technology early adopters. These clinicians are digital natives and eager to adopt and test digital health innovations in their practices. We call them clinical early adopters.

MDisrupt is able to take post-market digital health products and put them into the hands of a cohort of practicing clinicians to test with their patients and compare to the standard of care. We can systematically gather data from these clinicians on the product’s real-world performance, the provider and the physician experiences, the impact on health outcomes, and feedback on implementation into clinical workflows.

We call this concept clinical crowdsourcing. Clinicians get early access to technologies and have the opportunity to participate in the data generation for digital health innovations.

Digital health companies get valuable clinical user feedback which can inform future product feature development and can create clinical advocates for the innovation. In addition, the real-world performance data set generated can be used by other important stakeholders in healthcare including payors, health systems, employers and other providers.

Medgadget: Please give us an overview of your plans to establish a benchmarking system for digital health technologies. Who could benefit from this system?

Ruby Gadelrab: Our mission is to organize the world’s digital health products by performance through clinically crowdsourced data generation.

In the past 2 years, over $50B has been invested in the digital health industry. The digital health innovations of today will become the healthcare of the future. This was demonstrated during the pandemic when we relied on these technologies to deliver healthcare: this included telemedicine, at-home covid testing, at-home lab testing, remote patient monitoring and so much more.

The gap in the industry today is that there is no objective, data-driven, knowledge source that patients, providers and consumers can go to determine if a digital health product is good. Does it have evidence behind it? Who is the product suitable for? How does it compare to other products in the same category? What do clinicians think of it?

Our goal is to create a digital health intelligence platform where patients and providers can go to seek answers to these questions. And where more detailed datasets are available for payors to make reimbursement decisions, health systems and employers to make adoption and implementation decisions and for investors to make medically diligent investment decisions.

Medgadget: What inspired you to establish MDisrupt?

Ruby Gadelrab: After spending over 15 years in Silicon Valley and after leaving 23andMe in 2017 – I consulted for over 25 digital health companies over the span of 2.5 years. I saw some life-changing innovations in healthcare being developed and I met incredibly talented and passionate founders. All the founders I met had tech, commercial or finance backgrounds and they experienced the same three challenges as founders:

How do I find the right health experts to help me build my product?

How do I find the earliest clinical users of my product?

How do I generate the evidence I need for regulatory, provider adoption and scale?

These challenges were consistent irrespective of the health product being developed.

At the same time, there was a generation of clinicians who were looking to connect with the digital health industry and wanted to reduce clinical practice and participate in the development of digital health innovations.

It quickly became obvious that the very first part of building a digital health intelligence platform had to be an app that connected health experts and clinicians with the companies that needed their expertise. So, we bootstrapped the company for a couple of years until we had over 50 incredible clients all utilizing our health experts on demand.

Medgadget: Do you have any future plans for the company? Where do you see MDisrupt in five years?

Ruby Gadelrab: At MDisrupt we have built an incredible team of clinicians, scientists, engineers, technologists and commercial leaders. We have also built a thriving clinical community of experts and a client base. Our goal is to be the first point of call for any digital health innovator who wants to get their health product to market quickly and responsibly.

Within 5 years my hope is that we have organized the world’s digital health products by performance and created an objective standards system that every stakeholder in healthcare is using to make data-driven healthcare decisions.

Link: MDisrupt homepage…

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Pfizer vaults into sickle cell market as GBT deal confirmed

Pfizer’s reported interest in acquiring sickle cell disease specialist Global Blood Therapeutics (GBT)  has been confirmed, with the
The post Pfizer…

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Pfizer’s reported interest in acquiring sickle cell disease specialist Global Blood Therapeutics (GBT)  has been confirmed, with the $68.50-per-share deal valuing GBT at $5.4 billion.

As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.

Oxbryta is the main asset in the deal, with Evaluate predicting sales could reach $1.5 billion in 2028 – a leap forward from the $195 million it made last year and $127 million in the first half of 2022.

Pfizer is expecting big things from the takeover , predicting that the company’s SCD franchise will bring in combined peak sales of more than $3 billion.

The boards of both companies have recommended the deal to shareholders, and the two companies suggested it should close before the end of the year – assuming of course it doesn’t fall foul of any antitrust issues raised by financial regulators.

The GBT deal comes at a time when the market for SCD therapies is undergoing significant change, with multiple new drugs reaching the market after years of stagnation and progress also being made with genetic therapies from the likes of bluebird bio, Vertex Pharma/CRISPR Therapeutics and Precision Bio/Novartis.

Oxbryta came to market in 2019, a few days after Novartis’ injectable anti-P-selectin antibody Adakveo (crizanlizumab), which is also tipped for blockbuster sales but like Oxbryta has suffered from a slow rollout.

CRISPR Therapeutics and Vertex are also in the running with their gene-editing candidate CTX001, in phase 1/2 trials which are due to generate final results later this year. If those results are positive the partners have said they could file for approval in the US before year-end.

Meanwhile, bluebird bio’s one-time gene therapy  lovotibeglogene autotemcel is supposed to be heading for regulatory filing in the US next year, although it has been delayed by an FDA partial clinical hold implemented after a persistent case of anaemia was seen in one adolescent patient in a clinical trial.

GBT’s inclacumab – another P-selectin antibody that could encroach on Adakveo – is in a pair of phase 3 trials due to generate results next year.

Meanwhile, there are a couple of orally-active pyruvate kinase R activators from Forma Therapeutics and Agios – etavopivat and mitapivat, respectively – in mid-stage development, and Pfizer has its own SCD candidate in PF-07209326, an E-selectin anatomist in phase 1.

It’s worth noting that this isn’t Pfizer’s first deal in SCD. In 2011 it paid $340 million for rights to rivipansel, a pan-selectin antagonist developed by GlycoMimetics, which failed a phase 3 test in 2019 and was jettisoned by Pfizer the following year.

The deal is another example of Pfizer splashing out on business development thanks to windfall cash generated by its COVID-19 vaccine Comirnaty and oral antiviral therapy Paxlovid. It comes shortly after the group closed a $6.7 billion acquisition of Arena Pharma, bringing on board etrasimod in late-stage testing for ulcerative colitis, and made an $11.6 billion takeover bid for Biohaven and its migraine therapy Nurtec ODT (rimegepant).

The post Pfizer vaults into sickle cell market as GBT deal confirmed appeared first on .

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New COVID variants could emerge from animals or from people with chronic infections – but it’s not cause for panic

Animal reservoirs and people who experience chronic COVID infections could potentially see the emergence of new variants. But these variants aren’t necessarily…

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peterschreiber.media/Shutterstock

As the COVID pandemic rolls on, we’re becoming all too familiar with the continued emergence of new variants. Some can thwart immunity from vaccines and prior infections, increasing their capacity to disrupt our everyday lives. But where do new variants actually come from?

Variants develop through changes in the genetic code of the virus. This happens most commonly through mutations, essentially copy errors in the virus’ genetic information. Variants of concern are variants that have been identified to have a significant impact on transmissibility, severity of disease or immunity, likely to change the epidemiological situation of the pandemic.

Each time we’re infected with SARS-CoV-2 (the virus that causes COVID), our bodies produce a large number of virus particles with a range of genetic differences to the original infecting virus and to each other. Many of these mutations will have no effect on the virus.

Occasionally, however, mutations will occur that give the virus an advantage. For example, delta was more transmissible than earlier variants because of a mutation in its spike protein (a protein on the surface of SARS-CoV-2) allowing the virus to infect our cells more easily.

Even though we know a lot about how mutation occurs, it’s incredibly difficult to pinpoint where specific variants came from. But recent studies have investigated potential sources of new SARS-CoV-2 variants, including people who experience chronic COVID infections and animals.

Chronic infections

A chronic infection is where a person is actively infected with SARS-CoV-2 for a long period of time. This is different to long COVID, where symptoms persist well after the patient has recovered from the initial infection.

Chronic cases are rare and, to date, all documented cases have been in people with severely suppressed immune systems. These might be people undergoing treatment for cancer or following an organ transplant, for example.

Several studies have shown that the rate of mutation in these patients is higher than in those who are infected for a shorter time. Immunocompromised patients have a reduced immune response to infection and are often undergoing a range of treatments, both factors which are thought to allow a broader variety of mutations to develop. This is compounded by the longer period of time for which they may be infected.


Read more: Coronaviruses – a brief history


While new COVID variants do appear more likely to form in patients with chronic infections, the good news is they don’t seem to pose a significant threat.

In a recent study that looked at 27 chronically infected patients, there was no clear pattern of mutations. And when comparing mutations identified in the chronic patients with existing variants of concern, the chronic infections often lacked key mutations repeatedly identified in the variants of concern.

The researchers suggest the the majority of variants arising from chronically infected patients enhance virus replication, but are not characterised by improved transmission. This means they’re good at replicating in an infected person, but not as good at spreading from person to person.

The study demonstrated that there was no evidence of onward transmission from the patients with chronic infections to other people, which would be essential for a new variant to take hold and become a variant of concern. Although the authors note this may be due to human behaviour, rather than virus evolution, as immunosuppressed patients are likely to be confined to their homes.

That said, most variants of concern possess mutations that enhance transmission rather than replication, so it seems unlikely that these patients are significant sources of variants of concern.

Animal reservoirs

SARS-CoV-2 is likely to have been originally transmitted to humans via an animal market in China, and throughout the pandemic, we’ve learned that the virus can infect a variety of animals.

So another suggestion is that animals could be the source of new SARS-CoV-2 variants. The idea is they contract the virus from humans, which then mutates during infection in the animal host, before spreading back to humans.

A mink in the wild.
Could animals be a breeding ground for new COVID variants? An inspiration/Shutterstock

A species jump (or “zoonosis”) can only occur when multiple factors align. These include virological factors (for example, mutations that allow infection of human cells) and environmental factors (for example, close contact with infected animals). Zoonosis is not common, but is becoming more regular due to climate change and deforestation, which put more animals in contact with humans.

One study analysed the genetic code of omicron and showed high levels of similarity in the spike protein with that of mouse coronaviruses. The authors suggest the omicron variant may have occurred as a result of a human-to-mouse infection, mutation in the infected mouse, followed by transmission back to humans.

But often, when a virus infects a new host, such as a human, it’s unable to be transmitted further to other humans. The virus has to quickly adapt to allow it to thrive in the new host and go on to infect others. Indeed, where animal-to-human transmission of COVID occurred on Dutch mink farms, while we did see the virus mutate, there was no evidence of further transmission from the farm workers into the wider community.

Similarly, we’ve observed many instances of people infected with bird flu through prolonged close contact with birds. But there have been very few events of further transmission to other humans.

So although new variants may form in animals occasionally, it seems unlikely that they’re being re-transmitted back to humans and spreading.


Read more: Human catches COVID from a cat – here's why this new evidence is not cause for panic


While we can know geographically where new SARS-CoV-2 variants were first detected, it’s almost certain we’ll never know exactly where they come from. But as virus evolution is based on a combination of chance events such as mutation and human behaviour, it’s most likely that variants of concern are formed in a wide range of infected patients across the world.

With so many people being infected at once, many living in dense cities and travelling across the globe, the chances of viral evolution and onward spread of new mutants are increased. If large numbers of infections continue globally, more variants will continue to arise.

Grace C Roberts works at the University of Leeds and receives funding from the MRC.

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Norwegian Makes a Covid Change Royal Caribbean, Carnival Haven’t

Norwegian Cruise Line has announced a major change to its pandemic-era policies.

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Norwegian Cruise Line has announced a major change to its pandemic-era policies.

Since the Centers for Disease Control and Prevention stopped tracking covid on cruise ships, the major cruise lines have been making changes to their onboard pandemic-related policies. 

Now, since the government hasn't set industry standards, each cruise line is responsible for setting its own rules.

That may or may not be a problem, but it does mean that at least at the moment, Royal Caribbean International (RCL) - Get Royal Caribbean Group Report, Carnival Cruise Lines (CCL) - Get Carnival Corporation Report, and Norwegian Cruise Line (NCLH) - Get Norwegian Cruise Line Holdings Ltd. Report all have different policies. 

During the height of the pandemic, that was not the case. The CDC set rules under its mandatory conditional sail order, and later under a voluntary program that every major cruise line opted into.

Those rules may have been overly restrictive compared with how other travel and entertainment businesses were treated. But they did create a baseline for the industry.

Now, it's a free for all. Royal Caribbean and Carnival both have new polices that take effect in early August. 

And Norwegian has made what might be the most controversial change, effective Sept. 3.

Image source: Daniel Kline, TheStreet

Norwegian Makes Big Covid Changes

Once the CDC dropped its oversight of the pandemic's impact on cruise ships, Carnival and Royal Caribbean made similar changes. Both have dropped testing for vaccinated passengers on cruises less than six nights,

Both RCL and CCL allow a certain amount of passengers ages 11 and younger to sail without being vaccinated. But in all cases they require those passengers to provide negative covid tests taken no more than three days before their sailings. (That's a change since for many months the rule had been two days.)

The rules do vary based on destinations, but the two biggest cruise lines largely have the same ones in place.

Norwegian has adopted roughly the same policies as its rivals -- with one notable difference, which the company outlined on its website.

"Guests age 12 and over will be allowed to board unvaccinated. Unvaccinated guests age 12 and over will be required to show proof of a medically supervised negative PCR or antigen test taken no more than 72 hours prior to embarkation," the company said. "For guests age 11 years or younger, no additional protocols or testing requirements apply."

No More Vaccine Requirement on Norwegian

It's sort of buried in a lot of words, but Norwegian has dropped its vaccine requirement for all passengers. 

Unvaccinated passengers ages 12 and over will still need to provide a negative test taken no more than 72 hours before their cruises, while unvaccinated guests 11 and under don't even have to test.

“Our long-awaited revisions to our testing and vaccination requirements bring us closer in line with the rest of society, which has learned to adapt and live with covid-19, and makes it simpler and easier for our loyal guests to cruise on our three best-in-class brands," Norwegian Chief Executive Frank Del Rio said in a news release.

The CEO stressed that "health and safety is our top priority," a statement that might not perfectly match up with the rule change.

Royal Caribbean has decided to enable a limited number of unvaccinated passengers 12 and over, a change President Michael Bayley discussed  on social media.

"Unvaccinated guests will be required to take one test within three days of departure. We will also continue to operate highly vaccinated cruises with a vaccinated population greater than society and which continues to exempt kids 12 and [under. And] we will welcome unvaccinated guests over 12 and guests with a certificate of recovery within 90 days to travel, keeping in mind our ships will typically sail with 80%-plus vaccinated guests onboard," he said.

Norwegian did not say whether it has any limits on how many unvaccinated passengers can sail on each ship.

 

 

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