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Biomedical Research Leads Science’s 2021 Breakthroughs

Posted on January 4th, 2022 by Lawrence Tabak, D.D.S., Ph.D.

Hi everyone, I’m Larry Tabak. I’ve served as NIH’s Principal Deputy Director for over 11 years, and I will be the acting NIH director until a new permanent director is named. In my new role, my day-to-day responsibilities will certainly increase, but I promise to carve out time to blog about some of the latest research progress on COVID-19 and any other areas of science that catch my eye.

I’ve also invited the directors of NIH’s Institutes and Centers (ICs) to join me in the blogosphere and write about some of the cool science in their research portfolios. I will publish a couple of posts to start, then turn the blog over to our first IC director. From there, I envision alternating between posts from me and from various IC directors. That way, we’ll cover a broad array of NIH science and the tremendous opportunities now being pursued in biomedical research.

Since I’m up first, let’s start where the NIH Director’s Blog usually begins each year: by taking a look back at Science ’s Breakthroughs of 2021. The breakthroughs were formally announced in December near the height of the holiday bustle. In case you missed the announcement, the biomedical sciences accounted for six of the journal Science ’s 10 breakthroughs. Here, I’ll focus on four biomedical breakthroughs, the ones that NIH has played some role in advancing, starting with Science ’s editorial and People’s Choice top-prize winner:

Breakthrough of the Year: AI-Powered Predictions of Protein Structure

The biochemist Christian Anfinsen, who had a distinguished career at NIH, shared the 1972 Nobel Prize in Chemistry, for work suggesting that the biochemical interactions among the amino acid building blocks of proteins were responsible for pulling them into the final shapes that are essential to their functions. In his Nobel acceptance speech, Anfinsen also made a bold prediction: one day it would be possible to determine the three-dimensional structure of any protein based on its amino acid sequence alone. Now, with advances in applying artificial intelligence to solve biological problems—Anfinsen’s bold prediction has been realized.

But getting there wasn’t easy. Every two years since 1994, research teams from around the world have gathered to compete against each other in developing computational methods for predicting protein structures from sequences alone. A score of 90 or above means that a predicted structure is extremely close to what’s known from more time-consuming work in the lab. In the early days, teams more often finished under 60.

In 2020, a London-based company called DeepMind made a leap with their entry called AlphaFold. Their deep learning approach—which took advantage of 170,000 proteins with known structures—most often scored above 90, meaning it could solve most protein structures about as well as more time-consuming and costly experimental protein-mapping techniques. (AlphaFold was one of Science ’s runner-up breakthroughs last year.)

This year, the NIH-funded lab of David Baker and Minkyung Baek, University of Washington, Seattle, Institute for Protein Design, published that their artificial intelligence approach , dubbed RoseTTAFold, could accurately predict 3D protein structures from amino acid sequences with only a fraction of the computational processing power and time that AlphaFold required [1]. They immediately applied it to solve hundreds of new protein structures, including many poorly known human proteins with important implications for human health.

The DeepMind and RoseTTAFold scientists continue to solve more and more proteins [1,2], both alone and in complex with other proteins. The code is now freely available for use by researchers anywhere in the world. In one timely example, AlphaFold helped to predict the structural changes in spike proteins of SARS-CoV-2 variants Delta and Omicron [3]. This ability to predict protein structures, first envisioned all those years ago, now promises to speed fundamental new discoveries and the development of new ways to treat and prevent any number of diseases, making it this year’s Breakthrough of the Year.

Anti-Viral Pills for COVID-19

The development of the first vaccines to protect against COVID-19 topped Science ’s 2020 breakthroughs. This year, we’ve also seen important progress in treating COVID-19, including the development of anti-viral pills .

First, there was the announcement in October of interim data from Merck, Kenilworth, NJ, and Ridgeback Biotherapeutics, Miami, FL, of a significant reduction in hospitalizations for those taking the anti-viral drug molnupiravir [4] (originally developed with an NIH grant to Emory University, Atlanta). Soon after came reports of a Pfizer anti-viral pill that might target SARS-CoV-2, the novel coronavirus that causes COVID-19, even more effectively. Trial results show that, when taken within three days of developing COVID-19 symptoms, the pill reduced the risk of hospitalization or death in adults at high risk of progressing to severe illness by 89 percent [5].

On December 22, the Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for Pfizer’s Paxlovid to treat mild-to-moderate COVID-19 in people age 12 and up at high risk for progressing to severe illness, making it the first available pill to treat COVID-19 [6]. The following day, the FDA granted an EUA for Merck’s molnupiravir to treat mild-to-moderate COVID-19 in unvaccinated, high-risk adults for whom other treatment options aren’t accessible or recommended, based on a final analysis showing a 30 percent reduction in hospitalization or death [7].

Additional promising anti-viral pills for COVID-19 are currently in development. For example, a recent NIH-funded preclinical study suggests that a drug related to molnupiravir, known as 4’-fluorouridine, might serve as a broad spectrum anti-viral with potential to treat infections with SARS-CoV-2 as well as respiratory syncytial virus (RSV) [8].

Artificial Antibody Therapies

Before anti-viral pills came on the scene, there’d been progress in treating COVID-19, including the development of monoclonal antibody infusions . Three monoclonal antibodies now have received an EUA for treating mild-to-moderate COVID-19, though not all are effective against the Omicron variant [9]. This is also an area in which NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV ) public-private partnership has made big contributions.

Monoclonal antibodies are artificially produced versions of the most powerful antibodies found in animal or human immune systems, made in large quantities for therapeutic use in the lab. Until recently, this approach had primarily been put to work in the fight against conditions including cancer, asthma, and autoimmune diseases. That changed in 2021 with success using monoclonal antibodies against infections with SARS-CoV-2 as well as respiratory syncytial virus (RSV), human immunodeficiency virus (HIV), and other infectious diseases. This earned them a prominent spot among Science ’s breakthroughs of 2021.

Monoclonal antibodies delivered via intravenous infusions continue to play an important role in saving lives during the pandemic. But, there’s still room for improvement, including new formulations highlighted on the blog last year that might be much easier to deliver.

CRISPR Fixes Genes Inside the Body

One of the most promising areas of research in recent years has been gene editing, including CRISPR/Cas9, for fixing misspellings in genes to treat or even cure many conditions. This year has certainly been no exception.

CRISPR is a highly precise gene-editing system that uses guide RNA molecules to direct a scissor-like Cas9 enzyme to just the right spot in the genome to cut out or correct disease-causing misspellings. Science highlights a small study reported in The New England Journal of Medicine by researchers at Intellia Therapeutics, Cambridge, MA, and Regeneron Pharmaceuticals, Tarrytown, NY, in which six people with hereditary transthyretin (TTR) amyloidosis , a condition in which TTR proteins build up and damage the heart and nerves, received an infusion of guide RNA and CRISPR RNA encased in tiny balls of fat [10]. The goal was for the liver to take them up, allowing Cas9 to cut and disable the TTR gene. Four weeks later, blood levels of TTR had dropped by at least half.

In another study not yet published, researchers at Editas Medicine, Cambridge, MA, injected a benign virus carrying a CRISPR gene-editing system into the eyes of six people with an inherited vision disorder called Leber congenital amaurosis 10. The goal was to remove extra DNA responsible for disrupting a critical gene expressed in the eye. A few months later, two of the six patients could sense more light, enabling one of them to navigate a dimly lit obstacle course [11]. This work builds on earlier gene transfer studies begun more than a decade ago at NIH’s National Eye Institute.

Last year, in a research collaboration that included former NIH Director Francis Collins’s lab at the National Human Genome Research Institute (NHGRI), we also saw encouraging early evidence in mice that another type of gene editing, called DNA base editing, might one day correct Hutchinson-Gilford Progeria Syndrome, a rare genetic condition that causes rapid premature aging. Preclinical work has even suggested that gene-editing tools might help deliver long-lasting pain relief . The technology keeps getting better , too. This isn’t the first time that gene-editing advances have landed on Science ’s annual Breakthrough of the Year list, and it surely won’t be the last.

The year 2021 was a difficult one as the pandemic continued in the U.S. and across the globe, taking far too many lives far too soon. But through it all, science has been relentless in seeking and finding life-saving answers, from the rapid development of highly effective COVID-19 vaccines to the breakthroughs highlighted above.

As this list also attests, the search for answers has progressed impressively in other research areas during these difficult times. These groundbreaking discoveries are something in which we can all take pride—even as they encourage us to look forward to even bigger breakthroughs in 2022. Happy New Year!

References :

[1] Accurate prediction of protein structures and interactions using a three-track neural network . Baek M, DiMaio F, Anishchenko I, Dauparas J, Grishin NV, Adams PD, Read RJ, Baker D., et al. Science. 2021 Jul 15:eabj8754.

[2] Highly accurate protein structure prediction with AlphaFold . Jumper J, Evans R, Pritzel A, Green T, Senior AW, Kavukcuoglu K, Kohli P, Hassabis D. et al. Nature. 2021 Jul 15.

[3] Structural insights of SARS-CoV-2 spike protein from Delta and Omicron variants . Sadek A, Zaha D, Ahmed MS. preprint bioRxiv. 2021 Dec 9.

[4] Merck and Ridgeback’s investigational oral antiviral molnupiravir reduced the risk of hospitalization or death by approximately 50 Percent compared to placebo for patients with mild or moderate COVID-19 in positive interim analysis of phase 3 study . Merck. 1 Oct 2021.

[5] Pfizer’s novel COVID-19 oral antiviral treatment candidate reduced risk of hospitalization or death by 89% in interim analysis of phase 2/3 EPIC-HR Study . Pfizer. 5 November 52021.

[6] Coronavirus (COVID-19) Update: FDA authorizes first oral antiviral for treatment of COVID-19 . Food and Drug Administration. 22 Dec 2021.

[7] Coronavirus (COVID-19) Update: FDA authorizes additional oral antiviral for treatment of COVID-19 in certain adults . Food and Drug Administration. 23 Dec 2021.

[8] 4′-Fluorouridine is an oral antiviral that blocks respiratory syncytial virus and SARS-CoV-2 replication . Sourimant J, Lieber CM, Aggarwal M, Cox RM, Wolf JD, Yoon JJ, Toots M, Ye C, Sticher Z, Kolykhalov AA, Martinez-Sobrido L, Bluemling GR, Natchus MG, Painter GR, Plemper RK. Science. 2021 Dec 2.

[9] Anti-SARS-CoV-2 monoclonal antibodies . NIH COVID-19 Treatment Guidelines. 16 Dec 2021.

[10] CRISPR-Cas9 in vivo gene editing for transthyretin amyloidosis . Gillmore JD, Gane E, Taubel J, Kao J, Fontana M, Maitland ML, Seitzer J, O’Connell D, Walsh KR, Wood K, Phillips J, Xu Y, Amaral A, Boyd AP, Cehelsky JE, McKee MD, Schiermeier A, Harari O, Murphy A, Kyratsous CA, Zambrowicz B, Soltys R, Gutstein DE, Leonard J, Sepp-Lorenzino L, Lebwohl D. N Engl J Med. 2021 Aug 5;385(6):493-502.

[11] Editas Medicine announces positive initial clinical data from ongoing phase 1/2 BRILLIANCE clinical trial of EDIT-101 For LCA10 . Editas Medicine. 29 Sept 2021.

Structural Biology (National Institute of General Medical Sciences/NIH)

The Structures of Life (NIGMS)

COVID-19 Research (NIH)

2021 Science Breakthrough of the Year (American Association for the Advancement of Science, Washington, D.C)

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Posted In: News

Tags: 4'-fluorouridine , Accelerating COVID-19 Therapeutic Interventions and Vaccines , ACTIV , AI , AlphaFold , amino acids , artificial antibodies , artificial intelligence , biochemistry , Christian Anfinsen , Chronic Pain , computational biology , coronavirus , COVID pill , COVID-19 , CRISPR , CRISPR/Cas9 , DeepMind , Delta variant , Editas Medicine , EUA , gene editing , hereditary transthyretin amyloidosis , Hutchinson-Gilford progeria syndrome , Intellia Therapeutics , Leber congenital amaurosis , Merck , molnupiravir , monoclonal antibodies , Omicron variant , pandemic , Pfizer , progeria , protein structure , rare disease , Regeneron , RoseTTAFold , SARS-CoV-2 , Science Breakthrough of the Year , Science Breakthroughs of 2021 , structural biology

14 Comments

It would be remiss not to celebrate another NIH milestone in 2021: on March 1, 2021, the NIH finally took a stand against structural racism in biomedical research ( https://www.nih.gov/about-nih/who-we-are/nih-director/statements/nih-stands-against-structural-racism-biomedical-research ) — and given the rampant health inequities exposed by COVID-19 and also the profound issues of structural racism and economic adversity affecting the health and well-being of the US population, it is essential that this NIH breakthrough be celebrated, institutionalized, and supported with ample funding and leadership.

Biology is a fascinating thing. It’s amazing to think what a few nucleotides can do and how epigenetics can dictate very different outcomes. Something that is toxic in one species can be fairly benign in another. As the pandemic becomes endemic and there are other host animals (such as what is being seen with deer and certain zoo animals), one does have to ask about the evolutionary advantage of codon optimization and the value of pseudo-uridine. Perhaps there are lessons that can be gleaned from Gleevac?

Thank you for carrying on this important communication that I continue to share throughout my own circle. It is vital in combatting “qanonense” and more in our time.

Happy New Year Dr. Tabak, Congratulations on your important work in the NIH and thank you for this special explanation on medical advances being studied.

These goals deeply affect medical problems that are still difficult to manage, such as diseases of genetic origin. Even though they are sometimes rare diseases, we have to think that behind that statistical number is a face, a person, who begs for our help as doctors. I still remember today a young patient (visited decades ago) suffering from Leber’s congenital amaurosis who explained his tragedy to me: at the time I couldn’t find words to help him.

Looking at future treatments for chronic pain that is sometimes devastating to the affected person, it is encouraging to know that the CRISPR gene editing tool could help these patients. https://directorsblog.nih.gov/2021/04/01/could-crispr-gene-editing-technology-be-an-answer-to-chronic-pain/

Just yesterday, a patient who has been suffering from spinal damage for years, writes to me: he periodically updates me on the operations he is undergoing, unfortunately with poor results. Last planned, implantation of a medullary electro-stimulator. But the stress resulting from this situation also causes recurrent central serous chorioretinopathies, a source of serious fear for his sight.

I read tons of scientific ‘stuff’, mostly related to geo-hydromorphological, ecological and botanical, so reading outside these areas challenges my patience. I have to say, this presentation of accomplishments engages to most weary readers. So much of our science has become inaccessible from unnecessary jargon. Larry shows us how to reach out with clear, concise and understandable descriptions. It was a pleasure read! Thank you!

It’s delightful to read, and be reminded of the incredible work that’s been done over the past 2 years, with so much promise in the years soon to come.

Excellent, Dr. Tabak and colleagues….look forward to tracking this blog in the years ahead. Thank you from a colleague in the national and economic security world…

Science is a complicated thing to parlay to lay people without adequate training. The CDC serves to communicate public health concerns to the general public whereas the FDA serves as a regulatory body. Those with the background and training to make informed choices may make decisions that are different from the lay public. However with any of these organizations there needs to be a forum to communicate dissent without repercussion. If a non-majority voice is squashed either by intimidation or other measures, it hardly serves the purpose behind science. The difficult part lays in communicating the message to the majority of the “intended” population while respecting individual informed choices. Not an enviable position to be, and everyone should realize that. It’s like being given the job of a real time translator where nuances may have very different outcomes.

Welcome Larry Tabak. Best wishes for you & the NIH team.

I’m a hereditary TTR patient currently taking Tafamidis daily. My son is genetically positive. Good to read about advances. Need test subjects?

Biology is a fascinating thing. It’s amazing to think what a few nucleotides can do and how epigenetics can dictate very different outcomes.

Some solid-state metrology advances would improve medical equipment tools. I’ve been treating improving antenna design as replacing as much of its metal construction with solid-state lattice building processes, as is efficient. Before medical equipment, there is a need for metrology to improve. Solid-state mechanical reactions have no ground truth. X-ray diffraction, Raman Spectroscopy, NMR, XANES, manometry and thermometry, may all improve solid state manufacturing if improved. They can be improved themselves by solid state advances. This virtuous cycle will lead to soft medicine and now-metal equipment both being better prototyped by the above tools developed initially for solid state metrology. Seeing how many milli-seconds a ball bearing heats a mill surface will lead to the equipment will be quieter using more lattices than metals.

Sorry, I do not understand what the second sentence to stating. Please explain, restate. Thanks

My app was radar dishes and coils, improving them with better materials. The principle also works for say, a microscope. The eyepiece wheel on a Bruker Optics microscope is made of metal. Heavy enough to deaden some vibrations. Precision ground and buffed to have balance. Massive enough to take handling and minimize elastic forces handling wear as well as accidental impacts. But replace the metal with sapphire and 3/4 of the material properties improve with 1/4 being worse. Namely, a lighter microscope made in the shape of a hollow cell membrane will outperform CNC lasered metal or extruded plastic parts. Bigger lenses would throw the existing microscope off balance in months. Already I suggest making such equipment out of planetary mill constituents. I had a 1930s X-ray in 2007 and the machine took up 1/4 the room; consider how small baggage X-rays are now.

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December 22, 2021

2021 Research Highlights — Promising Medical Findings

Results with potential for enhancing human health.

With NIH support, scientists across the United States and around the world conduct wide-ranging research to discover ways to enhance health, lengthen life, and reduce illness and disability. Groundbreaking NIH-funded research often receives top scientific honors. In 2021, these honors included Nobel Prizes to five NIH-supported scientists . Here’s just a small sample of the NIH-supported research accomplishments in 2021.

Printer-friendly version of full 2021 NIH Research Highlights

20210615-covid.jpg

Advancing COVID-19 treatment and prevention

Amid the sustained pandemic, researchers continued to develop new drugs and vaccines for COVID-19. They found oral drugs that could  inhibit virus replication in hamsters and shut down a key enzyme that the virus needs to replicate. Both drugs are currently in clinical trials. Another drug effectively treated both SARS-CoV-2 and RSV, another serious respiratory virus, in animals. Other researchers used an airway-on-a-chip to screen approved drugs for use against COVID-19. These studies identified oral drugs that could be administered outside of clinical settings. Such drugs could become powerful tools for fighting the ongoing pandemic. Also in development are an intranasal vaccine , which could help prevent virus transmission, and vaccines that can protect against a range of coronaviruses .

202211214-alz.jpg

Developments in Alzheimer’s disease research

One of the hallmarks of Alzheimer’s is an abnormal buildup of amyloid-beta protein. A study in mice suggests that antibody therapies targeting amyloid-beta protein could be more effective after enhancing the brain’s waste drainage system . In another study, irisin, an exercise-induced hormone, was found to improve cognitive performance in mice . New approaches also found two approved drugs (described below) with promise for treating AD. These findings point to potential strategies for treating Alzheimer’s. Meanwhile, researchers found that people who slept six hours or less per night in their 50s and 60s were more likely to develop dementia later in life, suggesting that inadequate sleep duration could increase dementia risk.

20211109-retinal.jpg

New uses for old drugs

Developing new drugs can be costly, and the odds of success can be slim. So, some researchers have turned to repurposing drugs that are already approved for other conditions. Scientists found that two FDA-approved drugs were associated with lower rates of Alzheimer’s disease. One is used for high blood pressure and swelling. The other is FDA-approved to treat erectile dysfunction and pulmonary hypertension. Meanwhile, the antidepressant fluoxetine was associated with reduced risk of age-related macular degeneration. Clinical trials will be needed to confirm these drugs’ effects.

20210713-heart.jpg

Making a wireless, biodegradable pacemaker

Pacemakers are a vital part of medical care for many people with heart rhythm disorders. Temporary pacemakers currently use wires connected to a power source outside the body. Researchers developed a temporary pacemaker that is powered wirelessly. It also breaks down harmlessly in the body after use. Studies showed that the device can generate enough power to pace a human heart without causing damage or inflammation.

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Fungi may impair wound healing in Crohn’s disease

Inflammatory bowel disease develops when immune cells in the gut overreact to a perceived threat to the body. It’s thought that the microbiome plays a role in this process. Researchers found that a fungus called  Debaryomyces hansenii  impaired gut wound healing in mice and was also found in damaged gut tissue in people with Crohn’s disease, a type of inflammatory bowel disease. Blocking this microbe might encourage tissue repair in Crohn’s disease.

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Nanoparticle-based flu vaccine

Influenza, or flu, kills an estimated 290,000-650,000 people each year worldwide. The flu virus changes, or mutates, quickly. A single vaccine that conferred protection against a wide variety of strains would provide a major boost to global health. Researchers developed a nanoparticle-based vaccine that protected against a broad range of flu virus strains in animals. The vaccine may prevent flu more effectively than current seasonal vaccines. Researchers are planning a Phase 1 clinical trial to test the vaccine in people.

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A targeted antibiotic for treating Lyme disease

Lyme disease cases are becoming more frequent and widespread. Current treatment entails the use of broad-spectrum antibiotics. But these drugs can damage the patient’s gut microbiome and select for resistance in non-target bacteria. Researchers found that a neglected antibiotic called hygromycin A selectively kills the bacteria that cause Lyme disease. The antibiotic was able to treat Lyme disease in mice without disrupting the microbiome and could make an attractive therapeutic candidate.

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Retraining the brain to treat chronic pain

More than 25 million people in the U.S. live with chronic pain. After a treatment called pain reprocessing therapy, two-thirds of people with mild or moderate chronic back pain for which no physical cause could be found were mostly or completely pain-free. The findings suggest that people can learn to reduce the brain activity causing some types of chronic pain that occur in the absence of injury or persist after healing.

2021 Research Highlights — Basic Research Insights >>

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Revolutionising health care: Exploring the latest advances in medical sciences

Gehendra mahara.

1 Clinical Research Center, The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, China

4 Shantou University Medical College, Shantou, Guangdong, China

Cuihong Tian

2 Center for Precision Health, Edith Cowan University, Perth, Australia

3 Department of Cardiovascular Medicine, The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, China

5 Department of Infection Control, The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangzhou, China

Photo: Human heart, anterior view, artificial valve, coronary bypass. Illustration by Patrick J. Lynch. Source: Flickr, free to use under Creative Commons Attribution 2.5 License ( https://creativecommons.org/licenses/by/2.5/ ).

Recent years have seen a revolution in the domain of medical science, with ground-breaking discoveries changing health care as we once knew it [ 1 ]. These advances have considerably improved disease diagnosis, treatment, and management, improving patient outcomes and quality of life [ 2 - 5 ]. These innovations range from the creation of novel medications and treatments to the utilization of cutting-edge technologies. For instance, gene editing technologies like Clustered Regularly Interspaced Palindromic Repeats (CRISPR-Cas9) have opened up new treatment options for genetic illnesses [ 6 ], while the development of mRNA vaccines has offered a desperately needed response to the coronavirus disease 2019 (COVID-19) pandemic [ 7 ]. Moreover, wearable technology and telemedicine have improved accessibility, convenience, and personalization of health care, whereas 3D printing and nanotechnology breakthroughs have made it possible to create individualized implants and drug delivery systems [ 8 - 10 ]. This article examines some of the most recent developments in medical research and how they might completely change health care delivery.

The selection process for identifying the latest advances in medical sciences for this article was as follows. We aimed to showcase ground-breaking developments with the potential to revolutionise health care practices and significantly impact patient outcomes. We extensively searched reputable scientific journals, conferences, and reports from recognized health care organisations and institutes. We included the novelty and significance of the advancements, their ability to address existing health care challenges, the level of scientific evidence supporting their efficacy, and their potential for widespread adoption and implementation. By utilizing this process, we ensured that the selected advancements represent diverse medical fields and have the capacity to drive significant advancements in patient care, diagnostics, treatment modalities, and health care delivery.

REGENERATIVE THERAPY TREATMENT

Regenerative medicine is a rapidly growing field that seeks to restore, replace, or regenerate damaged tissues and organs using a variety of approaches, including cell therapy, tissue engineering, and gene therapy [ 11 ]. This field has the potential to revolutionise the treatment of many diseases and injuries that are currently incurable or difficult to treat. For example, stem cell therapy has been shown to be effective in treating spinal cord injuries [ 12 ], with several studies reporting significant improvements in motor function and sensory perception [ 13 ]. Tissue engineering approaches are being developed to replace damaged or diseased organs using 3D printing, such as the liver, pancreas, and heart [ 11 , 14 ]. Gene therapy is being used to target genetic disorders, such as sickle cell anaemia and cystic fibrosis, with promising results [ 15 ]. The development of regenerative medicine has the potential to transform the treatment of many diseases and injuries, providing hope for patients with conditions that are currently considered untreatable [ 16 - 18 ].

DEVELOPMENT OF IMPLANTABLE ARTIFICIAL ORGANS

Various replacement or augmentation devices for organs, such as the eyes, kidneys, heart, muscle, liver, skin, and brain, have been developed due to the creation of implantable artificial organs [ 4 ]. Artificial organs can be developed from a number of substances, such as polymers and biological tissues, and are intended to mimic the shape and functionality of actual organs [ 19 ]. For instance, the Wearable Artificial Kidney (WAK) has promise for enhancing the quality of life for individuals with end-stage of renal illness [ 20 ]. The creation of artificial hearts ( Figure 1 ), such as the Total Artificial Heart (TAH), has the potential to extend the lives of patients awaiting heart transplants [ 21 - 23 ].

Artificial Intelligence, Brain. Image by Gerd Altmann. Source: Pixabay, free to use under Content License ( https://pixabay.com/service/license-summary/ ).

Furthermore, scientists are developing artificial muscles, liver tissue replicas, skin grafts, and brain implants. For instance, a study by Kolesky et al. [ 24 ] reported the successful implantation of a 3D-printed artificial skin graft. Additionally, a study by White [ 25 ] and Weng et al. [ 26 ] revealed the development of a 3D-printed muscle tissue construct [ 26 ]. Although the research into implantable artificial organs is still in its infancy, it has the potential to transform how organ failure is treated and enhance patient outcomes [ 4 ].

ADVANCEMENTS IN NANOTECHNOLOGY IN HEALTH SCIENCE

Another fast-expanding and highly promising area of use for nanotechnology is in the field of medicine. Drugs and other therapeutic substances can be delivered directly to a disease site using nanoparticles because they can target particular cells or tissues in the body [ 27 ]. This technology may improve the efficacy of therapies, lessen their negative effects, and potentially enable the treatment of previously incurable diseases [ 28 ].

Current developments in nanotechnology have demonstrated considerable promise for the medical field. A study by Foglizzo and Marchio [ 10 ] created a multifunctional nano platform that delivered chemotherapeutic medication and an immunomodulatory substance to tumour cells, increasing antitumor activity and minimizing adverse effects. Using nanotechnology, a magnetic resonance imaging (MRI) contrast agent that can specifically target and image pancreatic cancer cells was created [ 29 ]. Moreover, nanotechnology has demonstrated promise in the treatment of diseases like brain tumours that were previously incurable. A study by Chen et al. [ 30 ] created a nano platform that specifically targeted and delivered medications to brain tumour cells, improving survival rates in a mouse model. These recent developments show how nanotechnology has the potential to enhance therapeutic efficacy, lessen adverse effects, and broaden the scope of diseases that can be treated [ 31 , 32 ].

DEVELOPMENT OF CRISPR-Cas9 GENE EDITING TECHNOLOGY

A rapidly developing technique called gene editing could revolutionise medicine by enabling researchers to change cells' genetic makeup. CRISPR-Cas9, a promising method for gene editing, allows for accurate targeting and editing of particular regions of the genome [ 33 ]. Genetic disorders like cystic fibrosis and sickle cell anaemia, which were once thought to be incurable, could potentially be cured because of this technique [ 34 , 35 ]. Also, scientists are looking at its therapeutic potential for a number of illnesses, such as Alzheimer’s disease, human immunodeficiency virus (HIV), and cancer [ 34 , 36 ].

Yet there are also moral questions raised by using gene editing on people, so it's important to use the technology sensibly and morally. Until the hazards and moral issues surrounding germline editing, which edits the genes that can be passed on to future generations, are better known, a group of scientists called for a moratorium on its clinical usage in 2019 [ 37 ].

ARTIFICIAL INTELLIGENCE (AI) FOR MEDICAL SCIENCE

Recent years have seen considerable advancements in the use of artificial intelligence (AI) and machine learning in the health care industry. In order to find trends and forecast health outcomes, AI systems can evaluate enormous amounts of medical data, including images, test results, and patient records [ 38 ]. This may result in more accurate diagnosis, individualized treatment strategies, and effective patient monitoring.

The promise of AI in health care has been proved by a number of studies. For instance, Esteva et al. [ 39 ], created an AI model with skin cancer detection accuracy on par with dermatologists. Rajkomar et al. [ 40 ] use of machine learning to forecast patient mortality and hospital readmission rates may aid health care professionals in identifying patients who need more care. Moreover, Chung et al. [ 41 ], created an AI algorithm that could anticipate the onset of psychosis in individuals who had clinical high-risk signs.

Predicting the risk of cardiovascular illness using AI has also shown promise. For example, Khera et al. [ 42 ] developed a model using machine learning to identify patients with a high risk of developing heart disease, potentially allowing for early intervention and preventative measures.

Yet, there are also issues with using AI in health care that need to be resolved, such as the requirement for strong data protection and ethical concerns with the use of AI algorithms to clinical decision-making [ 43 ].

CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELL THERAPY TO TREAT CANCER

Chimeric Antigen Receptor (CAR) T-cell therapy, a form of immunotherapy that employs T cells to recognize and target cancer cells, depends heavily on genetically transformed T cells [ 44 ]. Recent studies have demonstrated that CAR T treatment is very effective in treating a range of lymphoma types, including diffuse large B-cell lymphoma and mantle cell lymphoma [ 45 , 46 ].

Despite the positive outcomes, CAR T therapy has drawbacks, such as a high price and risk for toxicity. In order to increase the effectiveness and safety of CAR T treatment and broaden its use to treat additional cancer types, research is now being done by Ren et al. [ 47 ]. For instance, a recent study by Yang et al. [ 48 ] discovered that multiple myeloma, a kind of blood cancer, that has relapsed or become resistant to treatment, can be effectively treated with CAR T therapy that targets the B-cell maturation antigen (BCMA). Researchers are also investigating combination therapies, which couple CAR T therapy with additional medications, including checkpoint inhibitors, to enhance results [ 49 ].

DEVELOPMENT OF mRNA VACCINE

The development of mRNA vaccines has been a significant milestone in the fight against COVID-19 [ 50 ]. The Pfizer-BioNTech and Moderna mRNA vaccines have demonstrated remarkable efficacy and safety profiles in preventing COVID-19 infection and its complications [ 7 , 51 , 52 ]. The mRNA technology used in these vaccines has several advantages over traditional vaccine production methods, including faster development and manufacturing times, lower production costs, and greater flexibility in responding to emerging viral variants [ 53 , 54 ].

Clinical trials of the Pfizer-BioNTech and Moderna vaccines have shown high levels of protection against COVID-19. A study by Polack et al. [ 55 ] found that the Pfizer-BioNTech vaccine had an efficacy rate of 95% in preventing COVID-19 infection, while a study by Baden et al. [ 56 ] reported a similar efficacy rate of 94.1% for the Moderna vaccine. Additionally, real-world data has confirmed the high effectiveness of mRNA vaccines in preventing severe disease, hospitalization, and death caused by COVID-19 [ 57 ].

Another company that has been working on developing mRNA vaccines for COVID-19 is Novavax [ 58 ]. The company's vaccine candidate combines mRNA technology with nanoparticles to enhance the body's immune response [ 59 ]. In clinical trials, the vaccine demonstrated efficacy against both the original strain of COVID-19 and certain variants of the virus [ 60 ].

Companies such as Moderna and BioNTech are now exploring the potential of mRNA vaccines for a wide range of illnesses, including cancer and influenza [ 61 ]. The development of mRNA vaccines also holds promise for creating rapid responses to new and emerging infectious diseases, as the technology allows for quick adaptation to new viral strains [ 7 , 54 , 61 , 62 ].

Overall, the development of mRNA vaccines for COVID-19 represents a significant breakthrough in vaccine technology, with potential implications for future disease prevention and treatment [ 53 ].

ADVANCES IN 3D PRINTING FOR MEDICAL APPLICATIONS

The development of complex anatomical models, prostheses, implants, and drug delivery systems has been made possible by advances in 3D printing technology [ 8 ]. 3D printing has enabled the development of custom-made implants, reducing the need for invasive surgeries and improving patient outcomes. The successful implantation of 3D printed titanium-mesh implants for the repair of bone deformities was described in a study by Ma et al. [ 63 ]. Anatomical models that have been 3D printed have been proven to be useful for planning surgeries and advancing medical knowledge. The use of 3D printed models for surgical planning in complicated craniofacial patients was reported in a study by Charbe et al. [ 64 ]. The development of 3D printing technology has the potential to revolutionise the medical industry by enabling more individualized and efficient patient care [ 65 ].

TELEMEDICINE TO PROVIDE REMOTE CARE

Over the past few years, telemedicine – the use of technology to deliver medical treatments remotely – has grown in popularity, especially during the COVID-19 pandemic [ 66 ]. Telemedicine allows health care providers to offer virtual consultations, monitor patients remotely, and provide access to medical services in areas with limited health care resources [ 67 ]. Telemedicine was linked to better health care access and outcomes for patients with cardiovascular disease during the COVID-19 pandemic [ 9 ]. Telemedicine also has the potential to lower medical expenses and raise patient satisfaction. High levels of patient satisfaction with teleconsultations for dermatology services were observed in a study by Nicholson et al. [ 68 ]. Telemedicine use is anticipated to increase over the next few years, which might have a significant impact on how health care is delivered in the future [ 9 , 69 ].

VERTUAL REALITY IN MEDICAL TRAINING

Medical students can practice and hone their skills in a safe and controlled environment with the help of virtual reality (VR), which has grown in popularity in recent years [ 70 ]. Students can practice medical procedures and scenarios using VR technology, which helps them become more adept at diagnosing and treating patients [ 71 ]. According to a recent study by Yiasemidou et al. [ 72 ], medical students' performance and confidence improved when VR was used for surgical instruction. Moreover, using VR technology can replace animal or cadaveric models in training for less common medical operations. The effective use of VR technology in training for transesophageal echocardiography was described in a study by Arango et al. [ 73 ]. The use of VR in medical education has the potential to raise the standard of medical instruction and increase patient safety [ 74 ].

DEVELOPMENT OF WEARABLE DEVICES FOR HEALTH MONITORING

The development of wearable health monitoring technology has completely revolutionised how people track and manage their health [ 75 ]. Individuals can receive real-time feedback on their health state by using wearable devices, such as fitness trackers and smartwatches, which can gather data on physical activity, heart rate, blood oxygen saturation, sleep habits, and other health markers [ 76 ]. These devices capture data that can be analysed to find trends and patterns that can provide important information about a person's general health and well-being [ 77 , 78 ]. According to research by Patel et al. [ 79 ], adult users of wearable technology had increases in physical activity and weight loss. Moreover, wearable technology can be used to monitor patients with chronic illnesses remotely, enabling health care professionals to monitor patient progress and take appropriate action as needed. According to a study by Gautam et al. [ 80 ], wearable devices are useful for remotely monitoring patients with heart failure [ 80 , 81 ]. By encouraging early disease identification and prevention, wearable health monitoring technology has the potential to enhance health outcomes and save health care costs [ 78 ].

CONCLUSIONS

In conclusion, the most recent developments in medical science have the potential to completely revolutionise the way health care is provided and greatly enhance patient outcomes. With the advent of modern technologies like telemedicine, gene editing, and AI, doctors are now able to detect and treat illnesses more precisely and effectively. Moreover, the application of nanotechnology, 3D printing, and regenerative medicine is bringing about ground-breaking treatments for previously incurable diseases. The advances being made in medical science are genuinely astonishing and give hope for a healthier future, even though there are still obstacles to be addressed. In the years to come, we may anticipate even more interesting advances with ongoing innovation and investment.

Acknowledgements

We would like to acknowledge the support of Prof Xuerui Tan, from Shantou University Medical College. Additionally, we extend our gratitude to the clinical research center team at the first affiliated Hospital of Shantou University Medical College.

Funding: This work was funded by the Provincial Science and Technology Special Fund of Guangdong, China (2021123071-1).

Authorship contributions: GM and WW conceived the research idea. GM drafted the manuscript. CT and XX, collected information and reviewed the manuscript. WW, acting as the principal investigator, assisted in revising the manuscript. The final version of the manuscript was critically reviewed and approved by all authors.

Disclosure of interest: The authors have completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and disclose no relevant interests.

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Expert reviews the current state of retinoblastoma research

by Children's Hospital Los Angeles

Retinoblastoma is a rare pediatric cancer, with approximately 250–300 new cases per year in the United States and 8,000 worldwide. The cancer grows within the retina, a thin layer of cells at the back of the eye, and is usually treatable when diagnosed early. However, if undiagnosed, retinoblastoma can metastasize and lead to death.

Research has led to remarkable advances in the understanding of this disease over the past decade. David Cobrinik, MD, Ph.D., has contributed to many of these advances in his work at the Vision Center at Children's Hospital Los Angeles.

Recently, Dr. Cobrinik was invited to write an article about the current understanding of the development of retinoblastoma . The article was published in the New England Journal of Medicine .

Retinoblastoma occurs when there is a specific genetic mutation in a gene called RB1, a tumor-suppressing gene. RB1 tells the body to make a protein called pRB. Since the gene was identified (it was first cloned for study in the 1980s by CHLA researchers and others), research has revealed much about how RB1, and pRB, suppresses tumorigenesis.

"pRB basically puts the brakes on cell growth ," says Dr. Cobrinik, Principal Investigator in Ophthalmology at The Saban Research Institute. "However, further study of the pRB protein showed that it is normally expressed in almost all the cells of the body, so it was a mystery why children who carry an inactivated RB1 gene mainly develop tumors in the retina.

The Cobrinik Lab found that the retinal cell of origin for retinoblastoma is the cones—the color-sensing cells in the back of the eye. They then showed that the cancer occurs only when the cones are at a specific, intermediate stage of development—after the cones are immature but before they are fully developed and used for vision.

They found that these "maturing cones" are extremely sensitive to RB1 gene mutations. This was one of the first demonstrations that cancers can begin in a specific stage of cell development.

Their studies also showed that these cone cells form something called a premalignant lesion, considered a dormant precursor to cancer. This lesion can then convert into a cancer from the time the baby is born up until about 5 years of age. Moreover, after the retinoblastomas form, they acquire additional mutations that make the cancers more aggressive, harder to treat and more likely to metastasize.

All of the new understanding about how retinoblastomas develop has uncovered potential therapeutic targets for possible future treatment of the cancer . It has also coincided with the development of a new biopsy method that allows doctors to determine the stage of retinoblastoma before treatments begin, which was developed by the CHLA ocular oncology team of Jesse L. Berry, MD, and Liya Xu, Ph.D.

The expectation is that this new understanding of how tumors form combined with new diagnostic approaches will significantly improve retinoblastoma outcomes, especially for patients whose retinoblastoma tumors are only first detected in advanced stages.

For his numerous contributions to the understanding of the disease, Dr. Cobrinik was recently recognized by the International Society for Genetic Eye Disease and Retinoblastoma. "I felt very fortunate and honored to give the award lecture last summer," says Dr. Cobrinik. "We've learned a lot about this disease. And we can now envision a new paradigm for retinoblastoma treatment in the future."

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• Published: 07 December 2020

2021: research and medical trends in a post-pandemic world

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Goodbye 2020, a year of arguably too many challenges for the world. As tempting as it is to leave this year behind, the biomedical community is forever changed by the pandemic, while business as usual needs to carry on. Looking forward to a new year, experts share six trends for the biomedical community in 2021.

Summing up 2020, Sharon Peacock, director of the COVID-19 Genomics UK Consortium, says “we’ve seen some excellent examples of people working together from academia, industry, and healthcare sectors...I’m hopeful that will stay with us going into 2021.” Nonetheless, we have lost ground and momentum in non-COVID research, she says. “This could have a profound effect on our ability to research other areas in the future.”

The coronavirus SARS-CoV-2 has already revealed weaknesses in medical research and clinical capabilities, as well as opportunities. Although it is too soon to know when countries around the world will control the COVID-19 pandemic, there is already much to be learned.

To explore trends for 2021, we talked to experts from around the world who specialize in medical research. Here is what we learned.

1. The new normal

Marion Koopman, head of the Erasmus MC Department of Viroscience, predicts that emerging-disease experts will overwhelmingly remain focused on SARS-CoV-2, at least for the coming year.

“I really hope we will not go back to life as we used to know it, because that would mean that the risk of emerging diseases and the need for an ambitious preparedness research agenda would go to the back burner,” Koopman says. “That cannot happen.”

Scientists must stay prepared, because the virus keeps changing. Already, Koopman says, “We have seen spillback [of SARS-CoV-2] into mink in our country, and ongoing circulation with accumulation of mutations in the spike and other parts of the genome.”

Juleen R. Zierath, an expert in the physiological mechanisms of metabolic diseases at the Karolinska Institute and the University of Copenhagen, points out that the pandemic “has raised attention to deleterious health consequences of metabolic diseases, including obesity and type 2 diabetes,” because people with these disorders have been “disproportionally affected by COVID-19.” She notes that the coupling of the immune system to metabolism at large probably deserves more attention.

2. Trial by fire for open repositories

The speed of SARS-CoV-2’s spread transformed how scientists disseminate information. “There is an increased use of open repositories such as bioRxiv and medRxiv, enabling faster dissemination of study and trial results,” says Alan Karthikesalingam, Research Lead at Google Health UK. “When paired with the complementary — though necessarily slower — approach of peer review that safeguards rigor and quality, this can result in faster innovation.”

“I suspect that the way in which we communicate ongoing scientific developments from our laboratories will change going forward,” Zierath says. That is already happening, with many meetings going to virtual formats.

Deborah Johnson, president and CEO of the Keystone Symposia on Molecular and Cellular Biology, notes that while virtual events cannot fully replace the networking opportunities that are created with in-person meetings, “virtual events have democratized access to biomedical research conferences, enabling greater participation from young investigators and those from low-and-middle-income countries.” Even when in-person conferences return, she says, “it will be important to continue to offer virtual components that engage these broader audiences.”

3. Leaps and bounds for immunology

Basic research on the immune system, catapulted to the frontlines of the COVID-19 response, has received a boost in attention this year, and more research in that field could pay off big going forward.

Immunobiologist Akiko Iwasaki at the Yale School of Medicine hopes that the pandemic will drive a transformation in immunology. “It has become quite clear over decades of research that mucosal immunity against respiratory, gastrointestinal, and sexually transmitted infections is much more effective in thwarting off invading pathogens than systemic immunity,” she says. “Yet, the vast majority of vaccine efforts are put into parenteral vaccines.”

“It is time for the immunology field to do a deep dive in understanding fundamental mechanisms of protection at the mucosal surfaces, as well as to developing strategies that allow the immune response to be targeted to the mucosal surfaces,” she explains.

“We are discovering that the roles of immune cells extend far beyond what was previously thought, to play underlying roles in health and disease across all human systems, from cancer to mental health,” says Johnson.

She sees this knowledge leading to more engineered immune cells to treat diseases. “Cancer immunotherapies will likely serve as the proving ground for immune-mediated therapies against many other diseases that we are only starting to see through the lens of the immune system.”

4. Rewind time for neurodegeneration

Oskar Hansson, research team manager of Lund University’s Clinical Memory Research, expects the trend of attempting to intervene against neurodegenerative disease before widespread neurodegeneration, and even before symptom onset, to continue next year.

This approach has already shown potential. “Several promising disease-modifying therapies against Alzheimer’s disease are now planned to be evaluated in this early pre-symptomatic disease phase,” he says, “and I think we will have similar developments in other areas like Parkinson’s disease and [amyotrophic lateral sclerosis].”

Delving deeper into such treatments depends on better understanding of how neurodegeneration develops. As Hansson notes, the continued development of cohort studies from around the world will help scientists “study how different factors — genetics, development, lifestyle, etcetera — affect the initiation and evolution of even the pre-symptomatic stages of the disease, which most probably will result in a much deeper understanding of the disease as well as discovery of new drug targets.”

5. Digital still front and center

“As [artificial intelligence] algorithms around the world begin to be released more commonly in regulated medical device software, I think there will be an increasing trend toward prospective research examining algorithmic robustness, safety, credibility and fairness in real-world medical settings,” says Karthikesalingam. “The opportunity for clinical and machine-learning research to improve patient outcomes in this setting is substantial.”

However, more trials are needed to prove which artificial intelligence works in medicine and which does not. Eric Topol, a cardiologist who combines genomic and digital medicine in his work at Scripps Research, says “there are not many big, annotated sets of data on, for example, scans, and you need big datasets to train new algorithms.” Otherwise, only unsupervised learning algorithms can be used, and “that’s trickier,” he says.

Despite today’s bottlenecks in advancing digital health, Topol remains very optimistic. “Over time, we’ll see tremendous progress across all modalities — imaging data, speech data, and text data — to gather important information through patient tests, research articles or reviewing patient chats,” he says.

He envisions that speech-recognition software could, for instance, capture physician–patient talks and turn them into notes. “Doctors will love this,” he says, “and patients will be able to look a doctor in the eye, which enhances the relationship.”

6. ‘Be better prepared’ — a new medical mantra

One trend that every expert interviewed has emphasized is the need for preparation. As Gabriel Leung, a specialist in public-health medicine at the University of Hong Kong, put it, “We need a readiness — not just in technology platforms but also business cases — to have a sustained pipeline of vaccines and therapies, so that we would not be scrambling for some of the solutions in the middle of a pandemic.”

Building social resilience ahead of a crisis is also important. “[SARS-CoV-2] and the resulting pandemic make up the single most important watershed in healthcare,” Leung explains. “The justice issue around infection risk, access to testing and treatment — thus outcomes — already make up the single gravest health inequity in the last century.”

One change that Peacock hopes for in the near future is the sequencing of pathogens on location, instead of more centrally. “For pathogen sequencing, you need to be able to apply it where the problem under investigation is happening,” she explains. “In the UK, COVID-19 has been the catalyst for us to develop a highly collaborative, distributed network of sequencing capabilities.”

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May, M. 2021: research and medical trends in a post-pandemic world. Nat Med 26 , 1808–1809 (2020). https://doi.org/10.1038/s41591-020-01146-z

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DOI : https://doi.org/10.1038/s41591-020-01146-z

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Computer Science > Computer Vision and Pattern Recognition

Title: multimodal information interaction for medical image segmentation.

Abstract: The use of multimodal data in assisted diagnosis and segmentation has emerged as a prominent area of interest in current research. However, one of the primary challenges is how to effectively fuse multimodal features. Most of the current approaches focus on the integration of multimodal features while ignoring the correlation and consistency between different modal features, leading to the inclusion of potentially irrelevant information. To address this issue, we introduce an innovative Multimodal Information Cross Transformer (MicFormer), which employs a dual-stream architecture to simultaneously extract features from each modality. Leveraging the Cross Transformer, it queries features from one modality and retrieves corresponding responses from another, facilitating effective communication between bimodal features. Additionally, we incorporate a deformable Transformer architecture to expand the search space. We conducted experiments on the MM-WHS dataset, and in the CT-MRI multimodal image segmentation task, we successfully improved the whole-heart segmentation DICE score to 85.57 and MIoU to 75.51. Compared to other multimodal segmentation techniques, our method outperforms by margins of 2.83 and 4.23, respectively. This demonstrates the efficacy of MicFormer in integrating relevant information between different modalities in multimodal tasks. These findings hold significant implications for multimodal image tasks, and we believe that MicFormer possesses extensive potential for broader applications across various domains. Access to our method is available at this https URL

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Researchers develop a new way to safely boost immune cells to fight cancer

Cancer is the monster of our society. Last year alone, more than 600,000 people in the United States died from cancer, according to the American Cancer Society. The relentless pursuit of understanding this complex disease has shaped medical progress on developing treatment procedures that are less invasive while still highly effective.

Immunotherapy is on the rise as a possible solution. Immunotherapy involves harnessing the power of the body's immune system to fight against cancer cells. Researchers in the College of Engineering have found a way to revamp a treatment procedure into a groundbreaking practice.

Rong Tong, associate professor in chemical engineering, has teamed up with Wenjun "Rebecca" Cai, associate professor in materials science and engineering, to explore a cancer immunotherapy treatment that has long been of interest to researchers. In their newly published article in the journal Science Advances, Tong and Cai detailed their approach, which involves activating the immune cells in the body and reprogramming them to attack and destroy the cancer cells. This therapeutic method is frequently implemented with the protein cytokine. Cytokines are small protein molecules that act as intercellular biochemical messengers and are released by the body's immune cells to coordinate their response.

"Cytokines are potent and highly effective at stimulating the immune cells to eliminate cancer cells," Tong said. "The problem is they're so potent that if they roam freely throughout the body, they'll activate every immune cell they encounter, which can cause an overactive immune response and potentially fatal side effects."

Tong and Cai, in collaboration with chemical engineering and materials science and engineering graduate students, have developed an innovative approach to employ cytokine proteins as a potential immunotherapy treatment. Unlike previous methods, their technique ensures that the immune cell stimulating cytokines effectively localize within the tumors for weeks while preserving the cytokine's structure and reactivity levels.

Combining forces to take down cancer cells

Current cancer treatments, such as chemotherapy, cannot distinguish between healthy cells and cancer cells. When someone with cancer is treated with chemotherapy, the treatment attacks all of the cells in their body, which can lead to side effects such as hair loss and fatigue. Stimulating the body's immune system to attack tumors is a promising alternative to treat cancer. The delivery of cytokines can jump-start immune cells in the tumor, but overstimulating healthy cells can cause severe side effects.

"Scientists determined a while ago that cytokines can be used to activate and fight against tumors, but they didn't know how to localize them inside the tumor while not exposing toxicity to the rest of the body," said Tong. "Chemical engineers can look at this from an engineering approach and use their knowledge to help refine and elevate the effectiveness of the cytokines so they can work inside the body effectively."

The research team's goal is to find a balance between killing cancer cells in the body while sparing healthy cells.

To accomplish this goal, Tong and his students used their expertise to create specialized particles with distinctive sizes that help determine where the drug is going. These microparticles are designed to stay within the tumor environment after being injected into the body. Cai and her students worked on measuring these particles' surface properties.

"In the field of materials science and engineering, we study the surface chemistry and mechanical behavior of materials, such as the specialized particle created for this project," Cai said. "Surface engineering and characterization, along with particle size, play important roles in controlled drug delivery, ensuring prolonged drug presence and sustained therapeutic effectiveness."

To ensure successful drug delivery, Tong and his chemical engineering students designed a novel strategy that:

• Anchors cytokines to these new microparticles, limiting the harm of cytokines to healthy cells
• Allows the newly particle-anchored cytokines to jump-start immune systems and recruit immune cells to attack cancer cells

"Our strategy not only minimizes cytokine-induced harm to healthy cells, but also prolongs cytokine retention within the tumor," Tong said. "This helps facilitate the recruitment of immune cells for targeted tumor attack."

The next step in the process involves combining the new, localized cytokine therapy method with commercially available, Food and Drug Administration (FDA)-approved checkpoint blockade antibodies, which reactivate the tumor immune cells that have been silenced so they can fight back the cancer cells.

"When there is a tumor inside the body, the body's immune cells are being deactivated by the cancer cells," Tong explained. "The FDA-approved checkpoint blocking antibody helps "take off the brakes" that tumors put on immune cells, while the cytokine molecules "step on the gas" to jump-start the immune system and get an immune cell army to fight cancer cells. These two approaches work together to activate immune cells."

Combining the checkpoint antibodies with the particle-anchored cytokine proved to successfully eliminate many tumors in their study.

Engineering an impact on cancer treatment

Team members hope their impact on immunotherapy treatment is part of a greater movement toward cancer treatment approaches that are harmless to healthy cells. The new approach of attaching cytokines to particles also could be used in the future to deliver other types of immunostimulatory drugs, according to the team.

"Researchers are still looking for safer and more effective cancer treatments," said Tong. "This motivation is what drives us to develop new technologies in the field. The whole class of drugs that are employed to jump-start the immune system to fight cancer cells has largely not yet succeeded. Our goal is to create novel solutions that allow researchers to test these drugs with existing FDA-approved therapeutics, ensuring both safety and enhanced efficacy."

Cai said the nature of cancer treatment research requires expertise across engineering disciplines.

"I view this project as a perfect marriage between chemical engineering and materials science," Cai said. "The former focuses on the synthesis and drug delivery part, the latter on applying advanced materials characterization. This collaboration not only accelerates immunotherapy research, but also has the ability to transform cancer treatment."

• Immune System
• Brain Tumor
• Lung Cancer
• Prostate Cancer
• Colon Cancer
• Skin Cancer
• Immune system
• Chemotherapy
• Monoclonal antibody therapy
• Natural killer cell
• White blood cell
• Prostate cancer
• Endocrine system

Story Source:

Materials provided by Virginia Tech . Original written by Hailey Wade. Note: Content may be edited for style and length.

Journal Reference :

• Liqian Niu, Eungyo Jang, Ai Lin Chin, Ziyu Huo, Wenbo Wang, Wenjun Cai, Rong Tong. Noncovalently particle-anchored cytokines with prolonged tumor retention safely elicit potent antitumor immunity . Science Advances , 2024; 10 (16) DOI: 10.1126/sciadv.adk7695

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Reports highlight CDRH actions to advance medical device safety and innovation and build on these efforts this year.

FOR IMMEDIATE RELEASE April 17, 2024

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH)

Today, CDRH is issuing two companion reports that detail the Center's commitment to further advance our core pillars of safety and innovation. The CDRH 2024 Safety Report is an update to our 2018 Medical Device Safety Action Plan and features steps we have taken in recent years to assure the safety of medical devices keeps pace with the evolving technology. The CDRH 2024 Innovation Report highlights our work to advance innovation and the progress we have made to make the U.S. market more attractive to top device developers.

As we have long stated, safety and innovation are not polar opposites, but rather two sides of the same coin. Our focus on safety and innovation stems from our vision to protect and promote the public health by assuring that medical devices on the U.S. market are high-quality, safe and effective, and that patients and providers have timely and continued access to these devices.

Since 2009, CDRH has focused our efforts on advancing the development of safer, more effective medical devices that provide a significant benefit to the public health. As such, we enhanced our clinical trial and premarket review programs, including the 510(k) and De Novo pathways, and created new programs like the Breakthrough Devices Program , the Safety and Performance Based Pathway and the Safer Technologies Program to help reduce barriers for innovators. As a result of these actions and other past and ongoing efforts, the number of innovative medical devices authorized annually in the U.S. has increased five-fold since 2009.

In parallel, we took significant actions to improve device safety and enhanced our ability to identify and address new safety signals. We achieved an ambitious set of goals outlined in our 2018 Medical Device Safety Action Plan to help ensure patient safety throughout the Total Product Life Cycle (TPLC) of a medical device. We made improvements and updates to our medical device reporting programs, including updating the Manufacturer and User Facility Device Experience (MAUDE) database, vastly improved our recalls program, and took steps to ensure the timely communication and resolution of new or known safety issues.

And throughout, we partnered with patients and incorporated their voices into our work, including establishing our Patient Science and Engagement Program, because at the end of the day, improving the health and the quality of life of people is at the core of our public health mission.

We are proud of the progress we've made to advance innovation and improve the safety of medical devices, and we continue to build on these efforts, as resources and additional capabilities permit. One of the challenges we face, though, is the sheer volume of products and producers. Today there about 257,000 different types of medical devices on the U.S. market, made by approximately 22,000 manufacturing facilities worldwide, and CDRH authorizes roughly a dozen new or modified devices every business day. Despite that, the number of new or increased known safety issues involve only a small fraction of technologies and many can be addressed without any changes to the device itself. However, the impact to people can be significant, which is why we need to continuously take steps to advance both safety and innovation.

This year, we will take additional actions to help further ensure innovative, high-quality, safe, and effective devices are developed and marketed to U.S. patients. As further detailed in the 2024 Innovation Report, three actions we plan to take this year include: reimagining our premarket review program, expanding our footprint in geographical innovation centers, and launching a new home as a health care hub to extend first-class care into the home. Additionally, as detailed in the 2024 Safety Report, three actions we plan to take this year include: expanding a program to assist companies improve their device quality efforts, strengthening active surveillance, and enhancing the medical device recall process.

Through these new actions and the work detailed in the 2024 Safety and Innovation reports, CDRH remains committed to furthering our mission to protect and promote the public health and ensure our organization is well-positioned to meet the needs of all people and changes in the medical device ecosystem.

Additional Resources:

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