FDA and CTTI to host a public workshop on AI in drug & biological product development

https://duke.zoom.us/webinar/register/WN_YisPhfadR7iWGHfxhF8TOg?_x_zm_rtaid=4t9UNAfBRWqYTfTRF-GBgw.1722436969908.c70a34ebcd7ebab00505fc7c473e63f5&_x_zm_rhtaid=870#/registration On Tuesday August 6, 2024 from 10 AM to 5:30 PM EDT, FDA and the Clinical Trials Transformation Initiative are hosting a free hybrid public workshop on artificial intelligence (AI) in drug and biological product development. Please join us as we explore the guiding principles being applied by innovators and regulators to ensure AI is used responsibly. AI holds great potential to transform how drugs are developed, manufactured, and used. Participants may attend virtually or in-person in the FDA Great Room located at 10903 New Hampshire Avenue, Silver Spring, MD 20993.

New Data Management and Sharing Reporting Requirement Starts October 1, 2024 July 29, 2024

https://www.nccih.nih.gov/research/blog/new-data-management-and-sharing-reporting-requirement-starts-october-1?nav=govd In October 2020, the National Institutes of Health (NIH) issued the Final NIH Policy for Data Management and Sharing (DMS), effective for competing applications with due dates on or after January 25, 2023, to promote the sharing of scientific data. In a 2022 post on this blog, my colleagues Drs. D. Craig Hopp and Emmeline Edwards announced new web resources to help applicants understand the policy. Today, I’ll answer a few questions we are often asked at the National Center for Complementary and Integrative Health (NCCIH) Office of Grants Management and highlight a new implementation requirement taking effect October 1, 2024.

The Promise of Synthetic Cells: Revolutionary New Drugs, Outer Space Explorers and Pushing Beyond the Limits of Evolution July 31, 2024

https://www.nist.gov/blogs/taking-measure/promise-synthetic-cells-revolutionary-new-drugs-outer-space-explorers-and For over a decade, scientists have made extraordinary progress on the long-held dream of fabricating an entire cell from nonliving molecules and materials. Such synthetic (or “engineered”) cells would behave similarly to the ones in our bodies, though they would also have built-in safeguards that ensure safety and ethics. By studying them, we could transform our understanding of the rules of life. They could also be used to manipulate living organisms and achieve astounding breakthroughs in medicine and science.

2024 CBER Patient and Care Partner Listening Meetings Date: Friday, September 20 Time: 11:00 a.m.–4:30 p.m. ET Location: This free virtual listening meeting will be hosted on Zoom.

https://www.fda.gov/news-events/2024-cber-patient-and-care-partner-listening-meetings?utm_medium=email&utm_source=govdelivery On September 20, 2024, the FDA Center for Biologics Evaluation and Research (CBER) is hosting a public patient listening meeting to better understand patient and care partner perspectives on safety considerations and long-term follow-up for approved gene therapy treatments for rare diseases. The objectives of this listening meeting are to hear from patients and care partners on their perspectives on short-term and long-term risks of approved gene therapy products, to learn what types of information patients would find helpful in their decision-making when considering gene therapy, to learn about their considerations and experience with participating in long term post-market studies, and to help inform patient-centered protocols for long-term studies that include gene therapy outcomes. The meeting will be divided into two sessions and patients, advocates, and caregivers are encouraged to request to speak during the registration process. The deadline to request to speak is Friday, August 30, 2024, at 11:59 p.m. ET.

Ecosystem engineers: The intriguing ways humans are still evolving Lauren Leffer | Popular Science | July 26, 2024

https://geneticliteracyproject.org/2024/07/26/ecosystem-engineers-the-intriguing-ways-humans-are-still-evolving/?mc_cid=c522817a55&mc_eid=b73600b7ac We know that humans have altered our environment in innumerable ways–changing the very air, water, and soil that we rely on as the most successful “ecosystem engineers” on Earth. It can be easy, amid all that change, to assume that we’ve conquered biology and eliminated the effects of evolution and natural selection on our species. But that’s not what the science says.

50 colorful examples of how genetics programs human diversity Akvile Petraityte | MSN | July 29, 2024

https://geneticliteracyproject.org/2024/07/29/50-colorful-examples-of-how-genetics-programs-human-diversity/?mc_cid=c522817a55&mc_eid=b73600b7ac Human DNA is programmed to be unique. Your body contains about 20,000–25,000 genes responsible for giving you brown hair instead of red or a small forehead instead of a big one. They define your height or lactose tolerance, your risk of heart disease, and how fast you can run.

Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older July 2024

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drugs-treatment-partial-onset-seizures-extrapolation-efficacy-adults-pediatric-patients-1-month-age?utm_medium=email&utm_source=govdelivery FDA Announces Availability of a Revised Final Guidance on Extrapolating Efficacy Data to Treat Partial Onset Seizures in Pediatric Patients On July 15, 2024, the FDA announced the availability of a revised final guidance for industry entitled Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older, replacing the 2019 final guidance which discussed extrapolation to pediatric patients 4 years of age and older. This revised final guidance provides recommendations to sponsors on the clinical development of drugs for the treatment of partial onset seizures (POS) in pediatric patients. Specifically, this guidance addresses FDA’s current thinking regarding clinical development programs that can support extrapolation of the efficacy of drugs approved for the treatment of POS in adults to pediatric patients 1 month of age and older. This guidance discusses formulation development, efficacy and safety considerations, and clinical pharmacology and dosing considerations. This guidance does not address the development of drugs to treat other types of seizures. Historically, efficacy for the treatment of POS in pediatric patients was established by performing one or more adequate and well-controlled clinical studies in pediatric patients. However, efficacy can be extrapolated from adults to pediatric patients when it is reasonable to assume that children, compared with adults, have a similar progression of disease, similar response of disease to treatment, and similar exposure-response relationship. Initial systematic and quantitative analyses conducted by FDA, using data from clinical studies of drugs with a variety of putative mechanisms of action approved for the treatment of POS in both adults and pediatric patients, have shown that the relationship between exposure and response (reduction in seizure frequency) is similar in adults and pediatric patients 4 years of age and older. Subsequent evaluation by FDA determined that POS are readily identifiable in pediatric patients down to 1 month of age and are phenomenologically and pathophysiologically very similar to those in older patients. These analyses and observations have allowed FDA to conclude that the efficacy of drugs approved for the treatment of POS can be extrapolated from adults to pediatric patients 1 month of age and older.

7 Things To Know About Complementary Health Approaches for Headache and Migraine

https://www.nccih.nih.gov/health/tips/things-to-know-about-complementary-health-approaches-for-headache-and-migraine?nav=govd A variety of complementary health approaches have been studied to see whether they might be helpful for migraines or other types of headaches. There’s limited evidence that a few dietary supplements—including coenzyme Q10, the herb feverfew, the mineral magnesium, and the B vitamin riboflavin—might help reduce the frequency of migraines, but additional rigorous research is needed. Studies suggest that relaxation techniques, such as self-hypnosis paired with guided imagery or autogenic training with or without biofeedback, may help reduce headache pain. Acupuncture may help relieve headache pain, but much of its benefit may be due to nonspecific effects, including expectation, beliefs, and placebo responses, rather than specific effects of needling.

Measles cases surge to triple last year's — with 5 months to go Approximately 85% of cases this year have been individuals without a Measles, Mumps, and Rubella (MMR) vaccination By Timothy H.J. Nerozzi Fox News Published July 27, 2024 10:17am EDT | Updated July 27, 2024 12:24pm EDT

Measles cases surge to triple last year's — with 5 months to go Approximately 85% of cases this year have been individuals without a Measles, Mumps, and Rubella (MMR) vaccination By Timothy H.J. Nerozzi Fox News Published July 27, 2024 10:17am EDT | Updated July 27, 2024 12:24pm EDT https://www.foxnews.com/health/measles-cases-surge-triple-last-years-with-5-months-go

Stay fresh in the heat of summer with 5 hygiene trends from dermatologists From special skin care to sleep tips and more, these health hacks could help you stay cool in the hottest months By Brittany Kasko Fox News Published July 28, 2024 10:47am EDT

Stay fresh in the heat of summer with 5 hygiene trends from dermatologists From special skin care to sleep tips and more, these health hacks could help you stay cool in the hottest months By Brittany Kasko Fox News Published July 28, 2024 10:47am EDT https://www.foxnews.com/health/stay-fresh-heat-summer-5-hygiene-trends-dermatologists

Blood tests for Alzheimer's may be coming to your doctor's office: What to know Researchers at the Alzheimer’s Association International Conference in Philadelphia said the testing can be highly accurate Associated Press Published July 29, 2024 7:18am EDT

Blood tests for Alzheimer's may be coming to your doctor's office: What to know Researchers at the Alzheimer’s Association International Conference in Philadelphia said the testing can be highly accurate Associated Press Published July 29, 2024 7:18am EDT https://www.foxnews.com/health/blood-tests-alzheimers-doctors-office

‘Pickleball saved my sight,’ says Florida woman, 79: ‘I was really worried’ Avid player first noticed symptoms of eye disease while involved in her favorite sport Melissa Rudy By Melissa Rudy Fox News Published July 29, 2024 4:00am EDT

‘Pickleball saved my sight,’ says Florida woman, 79: ‘I was really worried’ Avid player first noticed symptoms of eye disease while involved in her favorite sport Melissa Rudy By Melissa Rudy Fox News Published July 29, 2024 4:00am EDT https://www.foxnews.com/health/pickleball-saved-sight-florida-woman-really-worried

Bavarian Nordic and CEPI partner to advance Mpox vaccination in Africa

https://cepi.net/bavarian-nordic-and-cepi-partner-advance-mpox-vaccination-africa?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9SVSeP-TfsthPx7greS7SI17IICP_FjsGqqxb9L9eXFBC_QsR1JfthYITb51YA4MgdVuv7dwSjLyHCXGv3LWSjfRLF4A&_hsmi=317667934&utm_content=317667934&utm_source=hs_email Mpox vaccine trial to start in three African countries Researchers from McMaster University in Canada are planning a clinical trial to test whether receiving Bavarian Nordic’s mpox vaccine can protect people who’ve been exposed to the infection from getting sick or reduce the severity of the illness. The trial will launch next month in the Democratic Republic of Congo and will later include participants in Uganda and Nigeria. The researchers received $4.9 million (U.S.) from the Coalition for Epidemic Preparedness Innovations and the Canadian Institutes of Health Research, per a CEPI press release. The trial’s results could be critical to combat mpox in the DRC, which has seen 11,000 cases and 443 deaths this year already, with children making up the majority of both, the press release noted. The study will invite over 1500 participants over the age of 10 from households with a confirmed mpox infection to participate. CEPI and Bavarian Nordic also have a separate clinical trial that will launch later in the year testing the mpox vaccine in children ages 2-12. Mpox Our latest coverage of the unprecedented mpox outbreak spreading across multiple continents. https://www.statnews.com/topic/mpox/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9X2KAp2V9OjqRVt3V-3wIKAvJn2-uPT6YxDQQ9IAMc_tB657zuOefe46qPuGombDzj8-btEKr4IYrsGSaNK2Hz7rs3tQ&_hsmi=317667934&utm_content=317667934&utm_source=hs_email

US State Restrictions and Excess COVID-19 Pandemic Deaths

https://jamanetwork.com/journals/jama-health-forum/fullarticle/2821581?utm_term=072624&utm_campaign=ftm_links&utm_medium=referral&_hsenc=p2ANqtz--Fru3Bty3b2C4jO8k4Nqo-rEieBhPRYMzf89-ZSNsXr5gDZmV_MzePRF3DjwJrTlamShOnZw0UnuIFa1KNfKIFU_QIDg&_hsmi=317667934&utm_source=For_The_Media Stronger Covid restrictions saved lives, per study If every state in the U.S. had imposed Covid policies like those in the 10 most restrictive states, deaths from the virus would have been 10-21% lower between July 2020 and June 2022, according to a study published Friday in JAMA Health Forum. State policies were largely similar in the first few months of the pandemic, but began to diverge in the second half of 2020. Study analysis found that mask requirements (especially in schools) and vaccine mandates were associated with lower rates of excess deaths. On the flip side, a lack of mandates was associated with higher excess deaths. The analysis can’t conclusively identify causation, only associations. Still, the results suggest that strong Covid restrictions saved lives, the authors wrote.

Bird flu snapshot: Upstart manufacturers in low- and middle-income countries to start early vaccine work Helen Branswell By Helen Branswell July 29, 2024

Bird flu snapshot: Upstart manufacturers in low- and middle-income countries to start early vaccine work Helen Branswell By Helen Branswell July 29, 2024 https://www.statnews.com/2024/07/29/bird-flu-snapshot-h5n1-vaccine-mrna-argentina-who/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_A7N6KV-FNRmB5b1CoH4fXRBR5mk9GnKCUtFxUqYRton0DCgZNJoGQHQYkyX2AvW9kYfdJVxpebkdb-aUcfvhXlOVt1A&_hsmi=317667934&utm_content=317667934&utm_source=hs_email More and more dairy cow herds are becoming infected with H5N1 bird flu, and the need to stop transmission is pressing — if not for the cows, then for us. As the virus travels among mammals, it’s possible that it could adapt to become better equipped to transmit to, and among, humans. Multiple animal vaccine manufacturers are at work trying to develop a bird flu vaccine for cows. But would a vaccine actually help stop the spread? Experts who spoke to STAT’s Helen Branswell are divided on the idea. There are still questions about whether vaccinating cows would be an effective solution in the first place. And some experts wonder whether farmers would be willing to absorb the costs of vaccines, or to agree to stringent post-vaccination surveillance. Read more from Helen on the debate. And after a week that saw the human count of bird flu cases hit 13 and the cumulative number of infected herds climb to 172, don’t miss today’s bird flu snapshot on all the latest developments. Could cow vaccines help halt the spread of bird flu in U.S. herds? Experts are divided Helen Branswell By Helen Branswell July 29, 2024 https://www.statnews.com/2024/07/29/bird-flu-vaccine-for-cows-research-ongoing-many-scientists-urge-biosecurity-first/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_SPpFwZf_WASM9k846MSw61RbHHbBH1Myk0u2ooFyfnNBx78TPxZm1KfpSzujynzO8zSfFDGo8HDfbkulJCdNe4yxakA&_hsmi=317667934&utm_content=317667934&utm_source=hs_email

AAIC | Alzheimer's Association International Conference

https://www.thelancet.com/events/conferences/alzheimers-association-international-conference The following content was published by The Lancet Group and presented at the most recent Alzheimer's Association International Conference.

Science Shouldn’t Be This Much Fun…But It Was on the Star Talk Podcast! Director’s Page Helene M. Langevin, M.D.

https://www.nccih.nih.gov/about/offices/od/director/past-messages/science-shouldnt-be-this-much-funbut-it-was-on-the-star-talk-podcast?nav=govd I recently had the pleasure of joining a lively discussion on the StarTalk podcast, hosted by Neil deGrasse Tyson alongside Chuck Nice and Gary O’Reilly. We covered so much ground—from complementary medicine and health trends to discussing inflammation, acupuncture, vitamins, and whether there is a right “dose” of stretching. It was not only informative but also a lot of fun—we laughed our way through some serious science. While I encourage you to watch the entire episode, I want to bring your attention to a few highlights from our discussion: We explored the mysteries of the placebo effect—how something as deceptively simple as a sugar pill can influence our health outcomes. We also tackled the concept of resilience, diving into how cold therapy and other physiological stressors can potentially bolster our ability to bounce back from illness and injury. And of course, we couldn’t ignore the pressing question: Is sitting as detrimental to our health as smoking?

CAR SEATS: BEWARE KNOCKOFFS, FAKES AND COUNTERFEITS!

Car Seats: Beware Knockoffs, Fakes And Counterfeits! By Ivanhoe Broadcast News on August 3, 2024 https://www.ivanhoe.com/?p=33823&preview=1&_ppp=68ab66d629

HELP YOUR CHILD THRIVE: BACK-TO-SCHOOL HOMEWORK STRATEGIES

Help Your Child Thrive: Back-To-School Homework Strategies By Ivanhoe Broadcast News on August 1, 2024 https://www.ivanhoe.com/?p=33817&preview=1&_ppp=546d9b82d9

A PATH TO REDUCE THE NUMBER OF PRE-EMPTIVE MASTECTOMIES

A Path to Reduce the Number of Pre-Emptive Mastectomies By Ivanhoe Broadcast News on July 30, 2024 https://www.ivanhoe.com/?p=33797&preview=1&_ppp=b3e9b7f83b

viernes, 26 de julio de 2024

Drug Trials Snapshots: SOHONOS (palovarotene)

Fibrodysplasia ossificans progressiva (FOP) is a rare genetic disease in which there is abnormal growth of bone tissue (heterotopic ossification or HO) within muscles, tendons, and other soft tissues, which restricts mobility and can be disabling. SOHONOS is a retinoid drug that is indicated to reduce the amount (measured as volume) of new HO in patients with FOP who are aged 8 years and older for females and 10 years and older for males. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-sohonos

FDA Approves HPV Tests That Allow for Self-Collection in a Health Care Setting

https://www.cancer.gov/news-events/cancer-currents-blog/2024/fda-hpv-test-self-collection-health-care-setting?cid=eb_govdel On May 14, the Food and Drug Administration (FDA) expanded the approvals of two tests that detect cancer-causing types of human papillomavirus (HPV) in the cervix. Both tests are used as part of screening for cervical cancer.

Call for Papers: Supplemental Issue of Prevention Science Structural Approaches to Youth Violence Prevention: Addressing Racism and Discrimination Released: May 31, 2024 Letters of intent due: September 30, 2024

https://nimhd.nih.gov/about/publications/call-for-papers-supplemental-issue-of-prevention-science.html?utm_medium=email&utm_source=govdelivery Submit Your Letter of Intent by September 30, 2024 NIMHD is inviting researchers to contribute to an upcoming supplemental issue of the journal Prevention Science. This supplemental issue will focus on youth violence prevention interventions that address structural racism and discrimination, and other structural factors and social determinants. Topics of Interest: Empirical research on the impact of interventions on individual, community, social, and structural factors. Prospective intervention studies and natural policy experiments at local, state, regional, or national levels. Conceptual papers that describe current challenges and viable solutions to implementing sustainable multilevel, multisectoral interventions that address social and structural factors that place youth at highest risk for violence as well as those that address disparities in youth violence. Authors interested in contributing should submit a letter of intent by September 30, 2024.

Epigenetic Editor Silences Toxic Proteins in the Mouse Brain, Offering Promising Path to Treat Deadly Prion Diseases Posted on July 25th, 2024 by Dr. Monica M. Bertagnolli

https://directorsblog.nih.gov/2024/07/25/epigenetic-editor-silences-toxic-proteins-in-the-mouse-brain-offering-promising-path-to-treat-deadly-prion-diseases/ Prion diseases are fatal neurodegenerative disorders caused by a malfunction of the prion protein in the brain. Exposure to a misfolded version of the protein triggers normal proteins of the same type in the brain to misfold, forming clumps that produce infectious disease and fatal brain damage over time. There are currently no treatments, preventive vaccines, or cures for prion diseases, which can be acquired, like mad cow disease, or inherited, like fatal familial insomnia. But an encouraging new study in mice suggests a potentially promising path for developing a treatment for people with these deadly conditions. https://www.niaid.nih.gov/diseases-conditions/prion-diseases Findings from an NIH-supported study reported in Science show that the key to this approach is a molecular tool capable of silencing prion protein throughout the brain using epigenetic editing. Unlike gene editing approaches, which change the sequence of genes, epigenetic editing can turn gene expression off with the addition of a chemical tag that prevents genes from being translated into proteins. Such a strategy may be able to deliver modifying tools to the brain or other parts of the body to silence specific toxic or disease-causing genes, including the one encoding the prion protein, without the risks associated with altering DNA sequences. https://pubmed.ncbi.nlm.nih.gov/38935715/

Can bacteria in your gut make you want to exercise?

https://magazine.medlineplus.gov/article/can-bacteria-in-your-gut-make-you-want-to-exercise?utm_medium=email&utm_source=govdelivery Have you ever wondered why some people enjoy exercise while others find it unbearable? New research hints at a surprising connection: the gut microbiome! You read that right—the trillions of tiny organisms, or microbes, that live in our digestive system may play a role in whether we feel like exercising. We know that the bacteria in our guts are important for our digestion and overall health. Recent research suggests that

Multiple Sclerosis and Psychological and Physical Approaches

https://www.nccih.nih.gov/health/multiple-sclerosis?nav=govd Multiple sclerosis is a disease of the central nervous system. Its symptoms may include muscle weakness, tingling and burning sensations, numbness, chronic pain, fatigue, and coordination problems. People with multiple sclerosis may also feel depressed and have trouble thinking clearly. Research has shown that several psychological and physical complementary health approaches (mind and body practices) may help people with multiple sclerosis manage their symptoms. Practicing yoga may help with fatigue and mood, but not with mobility or thinking ability. Reflexology (applying pressure to the soles of the feet) may reduce burning or prickling sensations; however, larger studies are needed to provide a reliable conclusion. A few studies of acupuncture for multiple sclerosis symptoms have suggested that it may be helpful.

Risky Drinking Can Put a Chill on Your Summer Fun

Risky Drinking Can Put a Chill on Your Summer Fun Summer is typically a wonderful season for outdoor activities and spending additional time with family and friends. For some people, these activities include drinking beverages containing alcohol. This summer, take measures to protect your own health and that of your loved ones. https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/risky-drinking-can-put-chill-on-your-summer-fun

jueves, 25 de julio de 2024

11 tips for adults age 65 and over to ‘live well’ over time, according to gerontologists From sleep to socializing to a sense of purpose, here’s how seniors can optimize their health, experts say Melissa Rudy By Melissa Rudy Fox News Published July 25, 2024 5:19am EDT

11 tips for adults age 65 and over to ‘live well’ over time, according to gerontologists From sleep to socializing to a sense of purpose, here’s how seniors can optimize their health, experts say Melissa Rudy By Melissa Rudy Fox News Published July 25, 2024 5:19am EDT https://www.foxnews.com/health/tips-adults-age-65-live-well-age-gerontologists

Doctors react after Biden’s live address to the nation: A concerning ‘lack of emotion’ It's a 'very emotional time for him and he isn't showing it,' said one doctor, also perceiving a 'lack of conviction' Melissa Rudy By Melissa Rudy Fox News Published July 24, 2024 10:01pm EDT

Doctors react after Biden’s live address to the nation: A concerning ‘lack of emotion’ It's a 'very emotional time for him and he isn't showing it,' said one doctor, also perceiving a 'lack of conviction' Melissa Rudy By Melissa Rudy Fox News Published July 24, 2024 10:01pm EDT https://www.foxnews.com/health/doctors-react-bidens-live-address-nation-lack-emotion

Hepatitis C and Dietary Supplements: What the Science Says

https://www.nccih.nih.gov/health/providers/digest/hepatitis-c-and-dietary-supplements-science?nav=govdcd Several dietary and herbal supplements have been studied for hepatitis C, and substantial numbers of people with hepatitis C have tried herbal supplements. The most commonly used supplement for hepatitis C is silymarin (an extract from milk thistle). However, no dietary supplement has been shown to be efficacious for hepatitis C. This issue provides information on what the science says about several dietary supplements studied for hepatitis C.

Symptom Clusters in Cancer (PDQ®)–Health Professional Version

https://www.cancer.gov/about-cancer/treatment/side-effects/cancer-symptom-clusters-hp-pdq?cid=eb_govdel#top A symptom cluster is two or more concurrent symptoms with the following properties:[1,8] The concurrent symptoms within the cluster are stable (i.e., the same symptoms that comprise clusters are identified at different time points throughout the cancer care trajectory). The symptoms within a cluster may share underlying mechanisms. The symptoms within a cluster may share outcomes. The symptom cluster may have a temporal dimension (i.e., the severity of the symptoms within the cluster may shift together over time).

Training Institute for Dissemination and Implementation Research in Genomics and Precision Public Health (TIDIR-GPPH) Facilitated Course

https://orise.orau.gov/genomics-precision-public-health/tidir-gpph.html From the website: "The Training Institute for Dissemination and Implementation Research in Genomics and Precision Public Health (TIDIR-GPPH) Facilitated Course is being offered in 2024 and is open to all current ORISE fellows and mentors! The course is intended to provide participants with a thorough grounding in conducting dissemination and implementation (D&I) research with a specific focus on genomics and precision public health. TIDIR-GPPH will be a hybrid course including training through open access modules with assigned reading material and office hours and culminating with a 2-day in-person event (September 5-6, 2024)."

High-throughput screen identifies non inflammatory small molecule inducers of trained immunity

https://www.pnas.org/doi/10.1073/pnas.2400413121?utm_campaign=+61510452&utm_content=&utm_medium=email&utm_source=govdelivery&utm_term= NIAID-supported scientists have identified small molecules that trigger trained immunity, a form of innate immune-system memory, without a pathogen or host molecule activating innate immunity first. These newly identified compounds surprisingly include steroids, which are usually immunosuppressive. Also, unlike the few previously identified molecules that trigger trained immunity, the new ones are easy to make and deliver, the scientists say. These findings could help researchers develop new or improved vaccines and treatments.

Where the Sugars and the Proteins Play: Q&A With Mia Huang by Abbey Bigler-Coyne

https://biobeat.nigms.nih.gov/2024/07/where-the-sugars-and-the-proteins-play-qa-with-mia-huang/?utm_medium=email&utm_source=govdelivery Mia Huang, Ph.D., studies sugar-coated proteins and how they interact with other proteins to help our cells function. She hopes that by better understanding these interactions, researchers can find ways to disrupt those involved in diseases such as cancer. In this Q&A, Dr. Huang shares not only her work, but also her thoughts on the role of creativity in science and why she became a researcher. Could a Spoonful of Sugar Be a Medicine? by Abbey Bigler-Coyne https://biobeat.nigms.nih.gov/2021/09/could-a-spoonful-of-sugar-be-a-medicine/?utm_medium=email&utm_source=govdelivery Nearly every aspect of biology involves sugars, and researchers have only begun to explore these molecules’ complexities and potential uses. In this post, three NIGMS-supported scientists describe how their work with sugars could help fight bacterial infections, treat cholera, and more.

Ayurveda in the 21st Century

https://www.news-medical.net/health/Ayurveda-in-the-21st-Century.aspx Ayurveda, which means "science of life" or "knowledge of life" in Sanskrit, is an ancient holistic healing approach that originated in India. Millions of people have been practicing Ayurveda for over 2,000 years to live a balanced life and maintain optimal health. This ancient Indian medical system relies on a natural and holistic approach to promote a healthy lifestyle and treat diseases with minimal side effects.

A human autoimmune organoid model reveals IL-7 function in coeliac disease

https://www.nature.com/articles/s41586-024-07716-2?utm_campaign=+61507613&utm_content=&utm_medium=email&utm_source=govdelivery&utm_term= NIAID-supported researchers have created an organoid model of celiac disease that enabled them to identify a potential treatment target: an immune-system protein called interleukin 7 (IL-7). The model is unique because it has the tissue structure and immune features of the human intestine, and it mimics celiac disease when exposed to gluten. Scientists hope the model will advance their understanding of how celiac disease develops, which could lead to new treatments. The findings were published today in the journal Nature.

Urine test identifies high-risk prostate cancers

https://www.nih.gov/news-events/nih-research-matters/urine-test-identifies-high-risk-prostate-cancers At a Glance Researchers developed a urine-based test that can distinguish between slow-growing prostate cancers that pose little risk and more aggressive cancers that need treatment. The test could help some patients avoid unnecessary biopsies and other tests that carry potential risks.

Research in Context: Movement after paralysis

https://www.nih.gov/news-events/nih-research-matters/research-context-movement-after-paralysis From electrical stimulation to robotics NIH-funded researchers have been working to restore movement to people living with paralysis. This special Research in Context feature explores the different experimental approaches scientists are developing to allow people without control of their body’s movements to become more independent and improve their quality of life.

How excess niacin may promote cardiovascular disease

https://www.nih.gov/news-events/nih-research-matters/how-excess-niacin-may-promote-cardiovascular-disease At a Glance A metabolite of niacin (vitamin B3) was associated with elevated risk of heart attack and stroke, likely due to inflammation in arteries. The findings suggest new measures that may prevent or treat cardiovascular disease and raise concerns about the health effects of too much niacin.

Developing treatments for prion diseases

https://www.nih.gov/news-events/nih-research-matters/developing-treatments-prion-diseases At a Glance Researchers developed a novel method to turn off prion protein production in mice. The technique could lead to treatments for prion diseases such as mad cow disease.

Gene variant slows form of inherited Alzheimer’s disease

https://www.nih.gov/news-events/nih-research-matters/gene-variant-slows-form-inherited-alzheimer-s-disease At a Glance In a family with an inherited form of Alzheimer’s disease, those who carried a gene variant called APOE3Ch had a delay in cognitive impairment and dementia. More research is needed to see whether APOE3Ch has a protective effect in people beyond this family and to understand how it exerts its protective effect.

Testing transmission and infection of H5N1 from cows

https://www.nih.gov/news-events/nih-research-matters/testing-transmission-infection-h5n1-cows At a Glance Researchers found that an H5N1 flu virus from cows could infect mice and ferrets, but airborne transmission wasn’t very efficient. The findings increase our understanding of whether the H5N1 outbreak in cows could lead to a human pandemic.

In the News: Diamond Shruumz-Brand Chocolate Bars, Cones, and Gummies

https://www.nccih.nih.gov/health/in-the-news-diamond-shruumz-brand-chocolate-bars-cones-and-gummies?nav=govd The U.S. Food and Drug Administration (FDA) is investigating serious illnesses linked to Diamond Shruumz brand chocolate bars, cones, and gummies marketed as containing a proprietary mushroom blend. Symptoms include seizures, confusion, abnormal heart rates, and nausea. The exact cause of the illnesses is still under investigation. Edible products containing psychoactive compounds such as cannabis or mushroom are increasing in availability. Reactions to these products can vary among individuals. In addition, the products might contain undisclosed ingredients, including illicit substances, other adulterants, or potentially harmful contaminants that are not approved for use in food. The Centers for Disease Control and Prevention (CDC), FDA, and America’s Poison Centers are continuing to monitor cases of illness reported to poison centers nationwide. Any suspected adverse effects after consuming any Diamond Shruumz brand products should be reported to the Poison Help Line (1-800-222-1222).

Whole Person Health: What You Need To Know

https://www.nccih.nih.gov/health/whole-person-health-what-you-need-to-know?nav=govd Much of our work at the National Center for Complementary and Integrative Health centers around the concept of whole person health. Whole person health involves looking at all aspects of a person—not just separate organs or body systems— considering multiple factors that promote either health or disease. It means helping and empowering individuals, families, communities, and populations to improve their health in multiple areas—biological, behavioral, social, and environmental. And it means not just treating specific diseases but also focusing on restoring health, promoting resilience, and preventing diseases across the lifespan.

One size does not fit all when to comes to dieting

https://www.news-medical.net/news/20240723/One-size-does-not-fit-all-when-to-comes-to-dieting.aspx In a recent study published in the journal Nutrients, researchers in the United States investigated the effects of low-fat and lower-carbohydrate diets on weight loss using the Preventing Overweight by Novel Dietary Strategies (POUNDS) Lost study.

The burden of cirrhosis mortality by county, race, and ethnicity in the USA, 2000-19: a systematic analysis of health disparities

https://pubmed.ncbi.nlm.nih.gov/39004094/ The burden of cirrhosis mortality by county, race, and ethnicity in the USA, 2000-19: a systematic analysis of health disparities Cirrhosis is responsible for substantial health and economic burden in the USA. Reducing this burden requires better understanding of how rates of cirrhosis mortality vary by race and ethnicity and by geographical location. This study describes rates and trends in cirrhosis mortality for five racial and ethnic populations in 3110 US counties from 2000 to 2019. Author: Hasan Nassereldine, Kelly Compton, Zhuochen Li, Mathew M. Baumann, Yekaterina O. Kelly, Wichada La Motte-Kerr, Farah Daoud, Erik J. Rodriquez, George A. Mensah, Anna M. Nápoles*, Eliseo J. Pérez-Stable*, Christopher J. L. Murray, Ali H Mokdad, Laura Dwyer-Lindgren Journal: The Lancet - Public Health, July 11

Multiple chronic diseases and psychological distress among adults in the United States: the intersectionality of chronic diseases, race/ethnicity, immigration, sex, and insurance coverage

https://pubmed.ncbi.nlm.nih.gov/39017703/ Multiple chronic diseases and psychological distress among adults in the United States: the intersectionality of chronic diseases, race/ethnicity, immigration, sex, and insurance coverage Psychological distress significantly contributes to the burdens of morbidity and mortality in the United States, but the understanding is limited with regards to the risk factors associated with psychological distress. Researchers used nationally representative data to examine (1) the comorbidities of chronic diseases and their risks for psychological distress and (2) the ways in which chronic diseases combine with demographic factors such as sex, race/ethnicity, immigration status, and health insurance coverage to affect the patterning of psychological distress. Author: David Adzrago*, David R. Williams, Faustine Williams* Journal: Social Psychiatry and Psychiatric Epidemiology, July 17

Restoring color vision with gene therapy | Drug Discovery News

Restoring color vision with gene therapy | Drug Discovery News: People with achromatopsia have never seen color. Restorative gene therapies have had mixed success, leaving researchers wondering why.

What will it take to make precision health a global reality

https://www.nature.com/articles/s41591-024-03163-8 From the article: "In this special issue, we ask what it means to deliver precision health — that is, tailoring preventive or treatment approaches to groups of people or individual people on the basis of certain characteristics — in different geographical and clinical contexts. Alongside the big questions addressing infrastructure, capacity, policy and access, our ‘Turning points’ articles zoom in on researchers’ personal stories of what precision health means to them, and how they came to dedicate their careers to this cause. "

Advancing Genomic Cancer Medicine in Rural and Underserved States

https://jamanetwork.com/journals/jamaoncology/article-abstract/2821206 From the article: "In the evolving landscape of oncology, the integration of powerful genomic technologies into practice has ushered in a new era of precision cancer medicine. Complex genomic information such as mutational analyses, transcriptional signatures, and polygenic risk scores have become key diagnostics guiding therapeutic decisions and management of inherited cancer risk. However, the expertise to interpret these data for clinical decision-making remains constrained and is a significant challenge for community oncologists, especially those in rural regions and in medically underserved areas. While physical access to these tests is readily available, poor access to interpretive expertise has become the key limiting factor. "

FDA Rare Disease Innovation Hub to Enhance and Advance Outcomes for Patients

https://www.fda.gov/news-events/fda-voices/fda-rare-disease-innovation-hub-enhance-and-advance-outcomes-patients?utm_medium=email&utm_source=govdelivery From the website: "An estimated 10,000+ rare diseases affect more than 30 million people – approximately one out of every 10 people – in the U.S., and about half of these people are children. Many rare conditions are life threatening, and most do not have approved treatments. Fundamental to the mission of the U.S. Food and Drug Administration is to engage patients and caregivers – to understand their unique perspectives and experiences and keep these front of mind as we review medical products for rare disease patients. "

Circular RNA: a new era in therapeutics | Drug Discovery News

Circular RNA: a new era in therapeutics | Drug Discovery News: The durability and capacity to boost protein expression of circular RNA makes it a promising candidate for next-generation vaccines and gene therapies.

Mini-retinas model human disease in a dish | Drug Discovery News

Mini-retinas model human disease in a dish | Drug Discovery News: Researchers use retinal organoids to screen drugs and hope to transplant them into the eyes of people with blindness in the coming years.

The Rising Tide: Trends and Challenges of Lung Cancer in Asia Published: July 8, 2024

Lung cancer is a significant public health issue in Asia, representing one of the leading causes of cancer-related mortality. The incidence of both non-small cell lung cancer and small-cell lung cancer in this region is high, driven by high rates of smoking, air pollution, and specific genetic mutations. Despite ongoing research and health-care efforts, the rising incidence and mortality rates of lung cancer pose an urgent challenge for health-care systems across Asia. In this Series of three Review articles published in eClinicalMedicine, The Lancet Regional Health – Western Pacific, and The Lancet Regional Health – Southeast Asia, Roselle de Guzman and colleagues explore the impact of climate change on lung cancer rates in the region, including screening, early detection, management, and treatment; Yi-Long Wu and colleagues highlight the development of genetic testing technology in the Western Pacific region; and Kumar Prabhash and colleagues examine the unique factors that are associated with lung cancer in Southeast Asian population. https://www.thelancet.com/series/lung-cancer-asia?dgcid=hubspot_update_feature_infocusoncology_lungcancerasia24_lansea&utm_campaign=update-lansea&utm_medium=email&_hsenc=p2ANqtz-96Coj3hok4mknkNShplGx3lQvPTmVvt6XHdMJbKyQgFUFLUJe7-WVKcmSrQsCwvrGjorQLLvYXXQXRJgOr27aJMSb_4Q&_hsmi=316670270&utm_content=316447178&utm_source=hs_email

IAPAC-Lancet HIV Commission on the future of urban HIV responses

Cities are home to a disproportionate number of many countries’ population of people living with HIV. The future of urban HIV responses is therefore crucial to the future of the global HIV epidemic. The Commission report offers cities and their communities an equity-centred, rights-based framework to guide the future direction of urban HIV responses in line with Sustainable Development Goal (SDG) 3.3 of ending the HIV epidemic by 2030. https://www.thelancet.com/infographics-do/urban-hiv-responses?dgcid=hubspot_email_conferencealerts_lanhivftc24&utm_campaign=conferencealerts&utm_medium=email&_hsenc=p2ANqtz--0Bxqx5CdG9mO7hDYtR89lgcuQz0ZRQCVXk3FbNhs-OqIlnifXmkiFh__xkDmXNoPYHcgWBvHs1qTfDbXPG6P1Y6tvFg&_hsmi=316285152&utm_content=316285152&utm_source=hs_email

The IAPAC–Lancet HIV Commission on the future of urban HIV responses Published: July 20, 2024

With urbanisation trends projecting more than twice as many people in the world will be living in urban versus rural settings by 2050, cities have an increasingly important role to play in achieving the health-related Sustainable Development Goals (SDGs), including ending the HIV epidemic by 2030 (SDG 3.3). The International Association of Providers of AIDS Care (IAPAC)–Lancet HIV Commission on the Future of Urban HIV Responses report centres health equity in urban HIV responses, with cross-cutting recommendations made across intersectional domains. Among these domains are the right to health, health system resilience, syndemic conditions and comorbidities, social determinants of health, and data-driven accountability. The report also proposes opportunities to accelerate progress towards SDG 3.3, and more broadly SDG 10 (making cities inclusive, safe, resilient, and sustainable), with the aim of guiding local, national, and international stakeholders in their efforts to optimise urban HIV responses. https://www.thelancet.com/commissions/urban-hiv-responses?dgcid=hubspot_email_conferencealerts_lanhivftc24&utm_campaign=conferencealerts&utm_medium=email&_hsenc=p2ANqtz-83ILwGKcuP14L-PTkoz0ojfFgNC6b3JOlRCn6YLAZdQSJrNEjcMnluuAoVVAywDj8ej6USKfaPGhjWV4Lo6ZSKRwqtrg&_hsmi=316285152&utm_content=316285152&utm_source=hs_email

Three generations of nurses deliver hope at Children's National Hospital NICU

https://wjla.com/news/local/childrens-national-hospital-washington-dc-nursing-nurses-family-sister-mother-daughter-nicu-baby-patients-premature-preemie-kelly-hartge-chrissy-marsh-carmen-blake Three generations of nurses deliver hope at Children's National Hospital NICU nursing runs in the family for several team members at Children’s National. Chrissy Marsh and Kelly Hartge are two sisters who currently work in the NICU, inspired by their mom, Carmen Blake, who spent five years working with them in the same unit until her retirement in 2020. (ABC 7)

AI Analysis of Large Registries Identifies New Risk Factors for Perinatal Stroke

https://journals.lww.com/neurotodayonline/fulltext/2024/06060/ai_analysis_of_large_registries_identifies_new.7.aspx AI analysis of large registries identifies new risk factors for perinatal stroke Sarah Mulkey, M.D., Ph.D., prenatal-neonatal neurologist, explains how an artificial intelligence (AI) model that identifies new risk factors for perinatal arterial ischemic stroke (PAIS) is helpful. (Neurology Today)

‘Healthy moms equal healthy babies': Children's National offers maternal health care

https://www.nbcwashington.com/news/health/healthy-moms-equal-healthy-babies-childrens-national-offers-maternal-health-care/3604243/?_branch_match_id=1288163324046319662&utm_medium=share&_branch_referrer=H4sIAAAAAAAAA8soKSkottLXz0tKLk8szsjMSy%2FJz9NLLCjQy8nMy9Y3za4M9PW3LEnxSgIAgusMfCoAAAA%3D Catherine Limperopoulos, Ph.D., director of the Center for Prenatal, Neonatal and Maternal Health Research and director of research for the Zickler Family Prenatal Pediatrics Institute, explains the new DC Mother-Baby Wellness Program at Children’s National and how it provides mothers with medical, social and mental health support in the same place where their babies get checkups.

Pandemic stress in pregnant mothers may affect anxiety regions of babies’ brains

https://innovationdistrict.childrensnational.org/pandemic-stress-in-pregnant-mothers-may-affect-anxiety-regions-of-babies-brains/ A critical part of the brain linked to risks for anxiety later in life – the left amygdala – was significantly smaller by volume in babies of mothers who reported stress during the COVID-19 pandemic, according to a new manuscript published in JAMA Network Open.

Supporting breakthroughs in at-home pediatric monitoring

https://innovationdistrict.childrensnational.org/supporting-breakthroughs-in-at-home-pediatric-monitoring/ Children’s National was part of a clinical trial that helped advance Gabi SmartCare, an innovative monitoring device that recently achieved Food and Drug Administration clearance. The device features a tiny, lightweight, wearable band that enables at-home monitoring of a patient’s vital signs.

First-of-its-kind study on impacts of Lyme disease in pregnancy and infant development

https://innovationdistrict.childrensnational.org/lyme-disease-in-pregnancy-and-infant-development/ First-of-its-kind study on impacts of Lyme disease in pregnancy and infant development Understanding the effects of Lyme disease on the developing fetal brain is essential to ensure timely prenatal and postnatal treatments to protect the fetus and newborn. In response to this need, Children’s National Hospital is leading a pilot study to establish the groundwork needed for a larger study to determine the effect of in utero exposure to Lyme disease on pregnancy and early childhood neurodevelopmental outcomes.

Treating sex and gender differences as a continuous variable can improve precision cancer treatments

https://bsd.biomedcentral.com/articles/10.1186/s13293-024-00607-1 The significant sex and gender differences that exist in cancer mechanisms, incidence, and survival, have yet to impact clinical practice. One barrier to translation is that cancer phenotypes cannot be segregated into distinct male versus female categories. Instead, within this convenient but contrived dichotomy, male and female cancer phenotypes are highly overlapping and vary between female- and male- skewed extremes. Thus, sex and gender-specific treatments are unrealistic, and our translational goal should be adaptation of treatment to the variable effects of sex and gender on targetable pathways.

Browsing: Positive Parenting

Positive Parenting is a collaboration between the Child Trends Hispanic Institute, a Child Trends initiative, and Ivanhoe Broadcast News, a syndicated news company. Child Trends received a grant from the National Science Foundation to support this work as well as the Institute of Education Sciences (IES). https://www.ivanhoe.com/channels/positive-parenting/

KATIE KICKS CANCER WITH A FIRST

Katie Kicks Rare Cancer with A First By Ivanhoe Broadcast News on July 17, 2024 https://www.ivanhoe.com/medical-breakthroughs/katie-kicks-rare-cancer-with-a-first/ BALTIMORE, MD (Ivanhoe Newswire) – Almost two million people will be told they have cancer this year. More than 200,000 of those will be considered a rare cancer. The rarer it is, the harder it is to find ways to not just treat it, but also get the right diagnosis. That’s why one woman is sharing her journey in hopes of giving patients like her a fighting chance to survive it.

CATCHING GUM DISEASE EARLY SAVES TEETH LATER

Catching Gum Disease Early Saves Teeth Later By Ivanhoe Broadcast News on July 19, 2024 https://www.ivanhoe.com/medical-breakthroughs/catching-gum-disease-early-saves-teeth-later/ INDIANAPOLIS, IN (Ivanhoe Newswire) – Periodontal disease is a common and a growing issue. About 40% of adults ages 30 and over have some form of it. That number increases to 70% for people over age 65. Here are some of the symptoms to look for and why it’s so important to catch gum disease early.