Xtalks is taking a look at some of the major stories and innovations of the year in the life sciences, many of which were driven by emerging new technology innovations.
The year continued to be dominated by COVID-19, and the second year of the pandemic was all about vaccines. With Pfizer-BioNTech and Moderna leading with their innovative mRNA-based COVID-19 vaccines, the first mRNA vaccines of any kind, other vaccine makers like AstraZeneca and Johnson & Johnson suffered more setbacks than anticipated with their viral vector vaccines over problems of rare blood clots.
And while over 8 billion doses of vaccines have been administered worldwide, billions more are still needed. Achieving global vaccine parity is imperative to getting everyone vaccinated in order to get out of this pandemic.
While COVID-19 vaccines were the highlight of the year, other vaccine milestones were also achieved, including a new malaria vaccine, the first the world has seen in over three decades.
In the medtech space, neuromodulation was a big area. The year saw approvals for new neuromodulatory devices for the treatment of conditions ranging from depression to chronic pain. While neuromodulation like deep brain stimulation is not a novel concept, it has seen a revival in recent years with innovations driving new and improved methods and applications.
And in healthcare and health research, trends towards increased digitization continued, including remote monitoring in clinical trials, use of wearable technologies and AI-based approaches to data collection, management and analysis. The year 2021 was all about continuing innovations in the life sciences.
COVID-19: The Pandemic and the Vaccines
The second year of the COVID-19 pandemic was the year of COVID-19 vaccines. Vaccines were the much-needed and much-awaited tool in the arsenal against COVID-19. And the mRNA COVID-19 vaccines were one of the most significant life science innovations in recent years.
Having two stellar working vaccines based on new mRNA technology was a significant and historic feat achieved in less than a year. Viral vector vaccines also represented a new type of vaccine technology used for the first time in widespread vaccinations. Given the rapid development of the vaccines and the relative unfamiliarity of new technologies like mRNA technology among the public, vaccine hesitancy has been an ongoing issue that has hindered vaccine uptake in some cases. Vaccine hesitancy must be met with solid vaccine education and communication.
According to the New York Times vaccine tracker, there are currently 111 different COVID-19 vaccines in clinical trials. This shows that the handful of vaccines that went on to receive regulatory authorizations and approvals were a true success in the global fight against COVID-19.
With just over half of the world vaccinated (56.8 percent), the push for vaccines will continue well into 2022. As of December 13, 8.47 billion vaccine doses have been administered worldwide, which amounts to over 4.41 billion people having received at least one dose of a COVID-19 vaccine.
The United Arab Emirates (UAE) has led in vaccinations, with over 90 percent of its population being fully vaccinated and almost 99 percent having received at least one COVID-19 vaccine dose. This is largely credited to strong vaccination campaigns spearheaded by the government and health officials in the country.
The COVAX Facility, a program being led by Gavi, the Vaccine Alliance, along with the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI), was formed to help deliver vaccines to poorer countries. Their initial target was to deliver 2 billion doses worldwide by the end of 2021. However, it had to pare down that goal by 25 percent to 1.4 billion because of delays in regulatory authorizations/approvals, production and supply chain deliveries as well as global export bans. COVAX has supplied over 650 million vaccine doses to 144 countries so far.
Richer countries have been criticized by the WHO for hoarding vaccines. G7 countries have bought over a third of the world’s vaccine supply while they make up only 13 percent of the global population. The US committed to donating about 1.1 billion doses this year, 500 million more than its initial donation. The US had donated 140 million vaccine doses as of September to at least 93 countries.
As Moderna’s first ever commercial product, the company wasn’t positioned for large-scale manufacturing of its COVID-19 Spikevax vaccine. As such, it struck manufacturing partnerships with the likes of Thermo Fisher, Samsung Biologics in Korea and contract development and manufacturing organizations (CDMOs) including Lonza, as well as other contract research organizations (CROs).
Companies like Pfizer and Moderna have also drawn criticism over patent waivers and reluctance to share their COVID-19 vaccine formulas so that other countries can produce them domestically and not have to wait on the companies for them. Now, both companies appear to have eased on their initial stance and willing to cooperate. Last week Pfizer struck a deal with South African biomanufacturer Biovac to produce its vaccine, and Australia entered an agreement with Moderna to begin producing its vaccine in Melbourne once construction of a vaccine manufacturing facility is completed there in 2024.
While there are concerns of decreasing effectiveness of the vaccines amid the emergence of new SARS-CoV-2 variants like Delta and Omicron, they continue to provide protection against severe disease and death due to infection from any of the variants, according to the WHO. According to the latest data from the Centers for Disease Control and Prevention (CDC), unvaccinated individuals have a 5.8 times higher chance of contracting COVID-19 and 14 times greater risk of dying from COVID-19 compared to fully vaccinated people.
Vaccines Versus Variants: Omicron
If 2020 was the race for a working COVID-19 vaccine, 2021 was the race of those vaccines against variants. And by the looks of it, the vaccine versus variants race will continue into early- and mid-2022. The need for vaccines will not be going away any time soon given waning immunity and in the face of new coronavirus variants.
On November 26, 2021, the World Health Organization declared Omicron (B.1.1.529) as a new SARS-CoV-2 variant of concern (VOC). Initially detected in South Africa, owing to their sophisticated infectious diseases infrastructure, the variant spread rapidly in the country to become the dominant variant, and a similar story is unfolding around the world. While researchers are still learning more about Omicron, what we know is that it has the ability to spread quickly, has over 30 mutations in its spike protein and can impact the effectiveness of current vaccines. Initial lab studies, including one from South Africa, show that vaccine-induced antibodies may be less effective at neutralizing Omicron.
Early lab data also shows that Omicron can be more effectively neutralized with three doses of the Pfizer vaccine, and that two doses provides only about 70 percent protection against hospitalization. Pfizer also revealed data that shows individuals who received two doses of the current Pfizer COVID-19 vaccine had 25-fold reduced neutralization antibody titers against the Omicron variant compared to wild-type, and that a third booster dose increased titers by 25-fold. However, Pfizer said that since the “vast majority of epitopes targeted by vaccine-induced T cells are not affected by the mutations in Omicron, the companies believe that vaccinated individuals may still be protected against severe forms of the disease and are closely monitoring real-world effectiveness against Omicron, globally.”
Both Pfizer and Moderna are also working on boosters specifically targeting Omicron and other potential variants.
Along with vaccines in the COVID-19 arsenal, there were a few COVID-19 treatments that were
Life Science Innovations: Malaria and Influenza Vaccines
While the COVID-19 vaccines stole much of the limelight this year, there were several other notable vaccine developments this year. This included two milestones on the malaria vaccine front, one being trial results for the first new vaccine for malaria developed in over 30 years by researchers at the University of Oxford, and the second was backing of an existing malaria vaccine (RTS,S/AS01, known by its trade name Mosquirix) by the World Health Organization (WHO) for children at high risk of the infection, namely in sub-Saharan Africa and other regions with moderate to high malaria transmission.
The Oxford vaccine candidate, named R21/Matrix-M (MM), demonstrated an efficacy of 77 percent in a Phase II trial involving young children in Burkina Faso. Young children are most affected by the deadly disease in the continent of Africa. Developing a highly effective vaccine against malaria has been technically challenging because malaria has a large and complex genome, and it’s why it’s generally more difficult to develop a vaccine against parasites than smaller viruses and bacteria. This is why the Oxford vaccine represented a major breakthrough, as it took over three decades to develop a malaria vaccine that met the WHO’s set benchmark of 75 percent efficacy mark for a malaria vaccine.
Although Mosquirix was developed in the 1980s by SmithKline Beecham Biologicals, now GlaxoSmithKline (GSK) Vaccines, it only got the green light in 2015 for a pilot implementation from the WHO, likely because of its low efficacy of 55.8 percent. Following the pilot, the vaccine was administered in Kenya and Ghana in 2019 and in October of this year, and the WHO finally gave it the green light for administering to children in areas with high malaria transmission. In 2020, 95 percent of malaria cases and 96 percent of malaria deaths occurred in the African region, with 80 percent of the deaths among children under the age of five. Given the significant unmet need, the WHO’s decision on Mosquirix, and Oxford’s new malaria vaccine offered much hope this year in the fight against malaria.
Leveraging the success of the mRNA technology used for its COVID-19 vaccine, Moderna developed the first mRNA-based vaccine against influenza this year. The company recently released data from an early-stage trial evaluating the vaccine, which showed that it has a good safety profile and elicits immune responses against four strains of influenza. The results are promising and Moderna is set to go ahead with its planned Phase II trial for the vaccine. The biotech company is also developing a combination vaccine against COVID-19, influenza and respiratory syncytial virus (RSV).
It was also a significant year in the medical device space, particularly in the area of neuromodulation. While neuromodulation has been around for several decades, it has seen a revival in recent years.
Neuromodulation involves altering the activity of nerves through pharmacological or physical stimuli i.e., through neurostimulation. Neuromodulation can be electrical or magnetic, and can treat neurological conditions such as Parkinson’s disease, depression, chronic pain and migraines. The best-known applications of neuromodulation are spinal cord stimulation for chronic pain and deep brain stimulation for Parkinson’s disease.
The global neuromodulation market is currently valued at $5.8 billion and is expected to grow to $8.8 billion by 2025, at a compound annual growth rate (CAGR) of 8.6 percent. This is largely due to increased awareness and the growing incidence of neurological conditions like depression, chronic pain and neurodegenerative disorders.
This year, several neuromodulation companies received breakthrough device designations from the US Food and Drug Administration (FDA) for their neuromodulatory devices. This included Magnus Medical’s Magnus System for the treatment of major depressive disorder (MDD). The device is a personalized, rapid-acting neurostimulation system for treating patients that have not responded sufficiently to antidepressants or other treatments. The device delivers personalized transcranial magnetic stimulation in high doses by pairing it with digital scanning to identify target areas.
A randomized control trial of the system revealed that 79 percent of individuals with severe depression who were treated with the device entered remission after just five days of treatment.
Xtalks spoke to the CEO of Magnus Medical who explained that the device targets the prefrontal cortex, which is typically underactive in depression, and the subgenual cingulate, a deeper part of the cortical network that is overactive in depression. By using functional magnetic resonance imaging (fMRI), the technology figures out what the “sweet spot” is in the left dorsolateral prefrontal cortex (on the left side of the forehead) that is most connected to the deeper structures implicated in symptoms of depression.
“By stimulating that at a personalized target and with a dosing pattern that leverages all of the underlying neuroscience around how do you stimulate, what pattern, what timing and so on, it has a really rapid-acting, profoundly effective result in the treatment of major depression,” Dr. Wingeier said.
When asked about how he has seen the field of neuromodulation grow in the past two decades and how he sees it moving forward, Dr. Wingeier said neuromodulation has been held back, partly because there is so much we still don’t understand about the brain.
In addition, the technology used to stimulate the brain are ones that have been around for decades and have just been repurposed, he said. “It’s hard to technologically innovate because this is a field where to bring an innovation forward, you have to have clear signals from great clinical research that your new coil or new electrodes are going to be a real win for the patient and the system. One of the answers to this is personalization, it’s respecting the fact that every brain is different.”
“I feel fortunate that this came together for Magnus’ technology because the imaging and our understanding of those networks got to a point where we could make something that’s really profoundly effective. Going forward, hopefully the types of data that we can gather from imaging, from other signals, from people suffering from disease, we just get better and better at using that to understand how to stimulate, where to stimulate, what patients are going to benefit from one thing versus another, and the technology, the interface with the brain, whether it’s magnetic or electrical or other means, just keeps getting better and better.”
Neurotech company Flow Neurosciences is also developing neurostimulation devices to treat depression. To expand development, the company acquired neurostimulation technology from fellow neurotech company Halo Neurosciences. Flow Neurosciences plans to use the technology to improve its current medically certified transcranial direct current stimulation (tDCS) headset for the treatment of depression.
Neuromodulation can also be an ideal, non-invasive alternative to medications for chronic pain, many of which can often be addictive. NeuraLace’s peripheral nerve stimulation system received 501(k) FDA clearance this year for the treatment of chronic pain. The device stimulates peripheral nerves damaged due to injuries, burns or loss of a limb. The 510(k) FDA clearance means the device has the go-ahead to be marketed after a successful pre-market submission.
Companies like Nerivio also focus on neuromodulatory technologies for the treatment of migraines. Nerivio has the first FDA-cleared and CE-marked smartphone-controlled prescription wearable device for acute migraine treatment.
Currently, there are 68 neurotech companies around the world developing neuromodulation technologies for pain treatment.
There are also bigger players in the neuromodulation space such as Medtronic and Boston Scientific, which is working on deep brain stimulation for the treatment of Parkinson’s disease as well as a spinal cord stimulator for personalized pain relief.
The increasing introduction of digital technologies in healthcare has been a growing trend in the past few years, and the COVID-19 pandemic significantly accelerated the trend.
The clinical trial space was highly impacted by lockdowns and closures due to the pandemic and had to rapidly adopt to decentralized and hybrid models as a result. This involved implementing digital technologies that allowed for remote monitoring and electronic data capture and analysis. Decentralized trials offer patients greater convenience, accessibility and can foster greater inclusion and diversity as decentralization allows trials to be more patient-centric rather than site-centric. And decentralized trials are here to stay post-pandemic given the success of remote models and methodologies.
The digital transformation of healthcare involves the use of both existing and innovative new technologies such as telemedicine, artificial intelligence (AI), virtual reality and blockchain electronic health records are just several examples. For example, AI-based approaches are being used in areas like pathology and imaging to extract higher-level data. And virtual reality-based medical devices are being seen to help treat neurological conditions like depression and pain. In fact, the FDA approved the first virtual reality system for the treatment of chronic lower back pain this year; the approval was granted to virtual reality medtech company AppliedVR that developed the device.
Digital approaches are remodeling interactions between healthcare professionals, data capture and data sharing as well as leveraging that data to make more informed and robust decisions about treatment and care.
Digital solutions in healthcare also change interactions between patients and healthcare providers. Patients and providers can connect more readily at any time through connected devices, which can include simple cell phones in telemedicine, to more sophisticated wearable technology for applications like health monitoring. Healthcare providers can also readily connect with each other to share information and seek advice on cases.
Digitization of lab spaces in the scientific research world is also an emerging area, as labs try to build efficiencies into many of their dated procedures. This includes connecting lab devices, automated and digital lab notebooks that enable better record and data keeping as well as automated procedures built into devices with appropriate checks and alerts.
Innovation is key to digital solutions. From AI-powered technologies to virtual reality, once new and unfamiliar technologies are now leading the era of digital transformation in the life sciences.
Despite the continuing challenges of the pandemic, 2021 was a year of continuous innovations. The year sets the stage for what is to come in the next year and beyond, with pharma, biotech and medical device focused on the ultimate goal of providing innovative solutions to help improve the lives of patients.