em Nvision Biomedical 3D-printed PEEK Interbody System receives FDA clearance By www.medicalplasticsnews.com Published On :: Thu, 31 Oct 2024 12:00:00 -0000 Nvision Biomedical Technologies and Invibio Biomaterial Solutions have announced that the FDA has granted clearance of the first 3D-Printed PEEK Interbody System made from PEEK-OPTIMA. Full Article
em The FemTech Series: How to fix inequality in healthcare By www.medicalplasticsnews.com Published On :: Mon, 11 Nov 2024 09:30:00 -0000 In this episode of The FemTech series Olivia Friett is joined by Jane Kennedy and Dr. MaryAnn Ferreux where we will discuss the inequality in women's health and how we can overcome the obstacles that come with this. Full Article
em Peytant Solutions granted FDA De Novo forAMStent Tracheobronchial Covered Stent System By www.medicalplasticsnews.com Published On :: Tue, 12 Nov 2024 13:00:00 -0000 Peytant has announced that the U.S. Food and Drug Administration (FDA) granted marketing authorisation (clearance to market in the United States as a Class II device) for the AMStent Tracheobronchial Covered Stent System, a therapy platform. Full Article
em The Climate and the Health of our Children Is on the Ballot on November 5 By www.scientificamerican.com Published On :: Thu, 31 Oct 2024 13:30:00 +0000 The 2024 presidential election will have enormous consequences for the climate, and the health and future of children Full Article
em Misinformation Really Does Spread like a Virus, Epidemiology Shows By www.scientificamerican.com Published On :: Wed, 06 Nov 2024 16:00:00 +0000 “Going viral” appears to be more than just a catchphrase when it comes to the rampant spread of misinformation Full Article
em Rainwater Could Help Satisfy AI’s Water Demands By www.scientificamerican.com Published On :: Thu, 07 Nov 2024 13:00:00 +0000 A few dozen ChatGPT queries cost a bottle’s worth of water. Tech firms should consider simpler solutions, such as harvesting rainwater, to meet AI’s needs Full Article
em Is Weight Really the Problem? By www.scientificamerican.com Published On :: Fri, 08 Nov 2024 11:00:00 +0000 Focusing on size in health care might be doing more harm than good. Full Article
em How Geometry Revealed Quantum Memory By www.scientificamerican.com Published On :: Tue, 12 Nov 2024 13:00:00 +0000 The unexpected discovery of a geometric phase shows how math and physics are tightly intertwined Full Article
em Phone Attachment for Pupil Measurements with Any Skin Tone By www.medgadget.com Published On :: Mon, 20 Nov 2023 22:43:00 +0000 A research team at the University of California San Diego have developed a smartphone attachment that can provide information on changes in pupil size, which can be used to assess neurological phenomena, such as traumatic brain injury and Alzheimer’s disease. Such changes in pupil size have been difficult to characterize in the past in those […] Full Article Ophthalmology UCSD
em Drug Channels News Roundup, September 2024: Inside JNJ’s Gross-to-Net Bubble, Optum Rx’s Private Label Biosimilars, Where Biosimilars Boom, Accumulators vs. Patients, and Steve Collis Retires By feeds.feedblitz.com Published On :: Tue, 24 Sep 2024 10:30:00 +0000 Autumn is here! Curl up with your favorite pumpkin-spiced blog and savor these acorns that we’ve squirrelled away for you: Johnson & Johnson Innovative Medicines gives a peek inside its $43 billion gross-to-net bubble Optum Rx joins the private label biosimilar bandwagon Biosimilars boom for provider-administered drugs Fresh evidence of how copay accumulators hurt patients Plus, words of wisdom from Cencora's soon-to-be-former CEO Steve Collis. P.S. Join my more than 58,000 LinkedIn followers for daily links to neat stuff along with thoughtful and provocative commentary from the DCI community. There’s still time to request an invite to the inaugural Drug Channels Leadership Forum. Attendance will be highly limited. We have already begun extending invitations, so apply now to be considered. Click here to view the full agenda. Read more » Full Article Benefit Design Biosimilars Buy-and-Bill Copay Accumulator Adjustment Gross-to-Net Bubble PBMs Specialty Drugs Wholesalers
em Informa Connect's Copay, Reimbursement and Access Congress By feeds.feedblitz.com Published On :: Mon, 30 Sep 2024 04:30:00 +0000 Informa Connect's Copay, Reimbursement and Access Congress November 18-20, 2024 | Hilton Penn’s Landing in Philadelphia, PA Drug Channels readers save 10% with code USAVE24* The access and affordability landscape is undergoing a seismic shift. Evolving legislation, disruptive market forces and the ever-growing complexities of cost sharing programs threaten patient adherence and commercialization strategies. Are you ready? A program driven by marketplace insights and led by industry trailblazers, Copay, Reimbursement and Access Congress is back November 18-20 and will deliver up-to-date insights necessary to enhance patient affordability, ensure program sustainability and navigate the regulatory landscape. In a time where remaining compliant has never been more complex and program innovation has never been more important, be sure to join your industry counterparts to drive adherence, access and commercialization forward. Why attend the Copay, Reimbursement and Access Congress? Keeping up with shifting market dynamics in the midst of maximizing access, while also meeting business objectives is a challenging task and brings about many questions for access professionals. Is your program sustainable and innovative to better support patients? Accumulators, maximizers, AFPs – What are your next steps to ensure effective reimbursement strategies? In an election year, what is the future of health policy? Experts will tackle these questions and more as the industry comes together to benchmark best practices to accelerate access and commercialization. Do not miss your chance to join seasoned leaders, your peers and leading solution providers as they navigate marketplace trends and dive into the impact coupons, benefit design, accumulators, maximizers, alternative funding programs and drug pricing legislation have on patient affordability and out-of-pocket costs. This is your chance to gain critical insights on industry standards, forward-thinking strategies to optimize your copay and cost sharing programs and so much more. Content highlights: Over 20 hours of content, including 7+ dedicated sessions to help decipher copay legislation Crucial perspectives from Pfizer, Sanofi, Janssen, Teva, Ascendis Pharma, Melinta Therapeutics, GSK, HIV + Hepatitis Policy Institute and more Insights direct from enforcement agents on the top trends and actions within the copay and patient services space Illuminating case study, Navigating the Patient Journey in a Shifting Copay Landscape from Spark Therapeutics 465 minutes of valuable in-person networking with colleagues and counterparts to expand your network and establish powerful partnerships Additional content access through Streamly, a platform that gives you 12-month access to all of the available conference content** to review at your leisure And more! Download the agenda and register today—Be sure to use your exclusive promo USAVE24 to save 10% off* of your registration See you there! *Cannot be combined with other offers, promotions or applied to an existing registration. Other restrictions may apply. **Pending speaker permissions The content of Sponsored Posts does not necessarily reflect the views of HMP Omnimedia, LLC, Drug Channels Institute, its parent company, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@DrugChannels.net). Full Article Sponsored Post
em Why PBMs and Payers Are Embracing Insulin Biosimilars with Higher Prices—And What That Means for Humira (rerun with an FTC update) By feeds.feedblitz.com Published On :: Tue, 01 Oct 2024 10:30:00 +0000 This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Last week, the Federal Trade Commission (FTC) released the redacted version of administrative complaint against the three largest pharmacy benefit managers (PBMs). The FTC rightly calls out how the gross-to-net bubble can raise patients’ out-of-pocket costs, while also acknowledging how rebates can reduce a plan's (but not the patient’s) costs. Apparently, the FTC believes that PBMs’ customers are pretty dumb, because PBMs are able to prevent plans from “appreciating” such healthcare financing dynamics. Section V.E. of the complaint (starting on page 23) focuses on the PBMs’ alleged unlawful conduct related to preferring high-list/high-rebate insulin products over versions with lower list prices. I thought it would therefore be fun to take the Wayback Machine to November 2021, when I wrote about this specific topic.Below, you can review my commentary about the warped incentives behind Viatris’ dual-pricing strategy for its interchangeable biosimilar of Lantus. Much of the FTC’s description of the drug channel aligns with my commentary. But before you fist pump too hard for Ms. Khan’s FTC, you should pause to reflect on the agency’s legal theories in light of plans’ revealed preferences. The Food & Drug Administration (FDA) recently approved the first interchangeable biosimilar insulin product: the insulin glargine-yfgn injection from Viatris. Read the FDA’s press release. Alas, I’m sad to report that the warped incentives baked into the U.S. drug channel will limit the impact of this impressive breakthrough. Viatris is being forced to launch both a high-priced and a low-priced version of the biosimilar. However, only the high-list/high-rebate, branded version will be available on Express Scripts’ largest commercial formulary. Express Scripts will block both the branded reference product and the lower-priced, unbranded—but also interchangeable—version. Meanwhile, Prime Therapeutics will place both versions on its formularies, leaving the choice up to its plan sponsor clients. Consequently, many commercial payers will adopt the more expensive product instead of the identical—but cheaper—version. As usual, patients will be the ultimate victims of our current drug pricing system. Below, I explain the weird economics behind this decision, highlight the negative impact on patients, and speculate on what this all could mean for biosimilars’ future. Until plan sponsors break their addiction to rebates, today’s U.S. drug channel problems will remain. Read more » Full Article Benefit Design Biosimilars Costs/Reimbursement Gross-to-Net Bubble PBMs
em No More Delays: Accelerating Therapy Starts by Embedding Hub Services in Provider Workflows By feeds.feedblitz.com Published On :: Fri, 25 Oct 2024 05:00:00 +0000 Today’s guest post comes from Shabbir Ahmed, Chief Commercial Officer at CareMetx. Shabbir explains the barriers that providers face when dealing with branded portals for multiple products. He then maintains that patients can access new therapies more quickly when the manufacturer relies on a brand-agnostic hub connected to a large network of providers and integrated with the systems those providers use daily. To learn more, download CareMetx’s new 2024 Patient Services Report: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage. Read on for Shabbir’s insights. Read more » Full Article Guest Post Sponsored Post
em How Field Reimbursement Services Help Overcome Coverage Barriers and Improve Patient Outcomes By feeds.feedblitz.com Published On :: Fri, 01 Nov 2024 11:00:00 +0000 Today’s guest post comes from Kimberley Chiang, Vice President of Biopharma Commercial Solutions at CoverMyMeds Kimberley highlghts the crucial roles of field reimbursement managers in removing access and reimbursement barriers. She then identifies the keys to successful implementation of field reimbursement services. To learn more, register for CoverMyMeds' November 13, 2024, webinar: Specialty Therapies & Field Reimbursement Services: Driving Better Outcomes for Brands and Patients. Read on for Kimberley’s insights. Read more » Full Article Guest Post Sponsored Post
em Transparency Shocker: Biosimilars Are Getting Cheaper—But Hospitals and Insurers Can Make Them Expensive By feeds.feedblitz.com Published On :: Mon, 04 Nov 2024 11:00:00 +0000 Here on Drug Channels, we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall. Novel transparency information reveals that this good news doesn’t always translate into savings. Below, we rely on a unique data set from Turquoise Health to examine how much four national commercial health plans—Aetna, Anthem, Cigna, and UnitedHealthcare—paid hospitals for Avastin and its two most significant biosimilar competitors. As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars. What’s more, plans can pay hospitals more for a biosimilar than for the higher-cost reference product. The U.S. drug channel system is warping hospitals’ incentives to adopt biosimilars, while simultaneously raising costs for commercial plans. The namesake of my alma mater once said: “Sunlight is said to be the best of disinfectants.” What would happen if we disinfected the entire channel? Read more » Full Article Average Sales Price (ASP) Biosimilars Buy-and-Bill Costs/Reimbursement Hospitals Specialty Drugs
em FDA reopens National Forensic Chemistry Center after expansion and renovation By www.flickr.com Published On :: Wed, 02 Oct 2024 13:40:56 -0700 The U.S. Food and Drug Administration posted a photo: Catherine Dasenbrock, director of the U.S. Food and Drug Administration’s National Forensic Chemistry Center, speaks to guests prior to officially reopening the center during a ribbon-cutting ceremony, Sept. 24, 2024, celebrating the completion of the 64,000-square-foot expansion and renovation of the facility in Cincinnati, Ohio. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices. FDA photo by Matthew MacRoberts Full Article
em FDA reopens National Forensic Chemistry Center after expansion and renovation By www.flickr.com Published On :: Wed, 02 Oct 2024 13:46:59 -0700 The U.S. Food and Drug Administration posted a photo: U.S. Food and Drug Administration officials and General Services Administration leaders officially reopen the National Forensic Chemistry Center during a ribbon-cutting ceremony, Sept. 24, 2024, highlighting the completion of the 64,000-square-foot expansion and renovation of the center in Cincinnati, Ohio. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices. (From left) Marie Maguire, Assistant Special Agent in Charge, Headquarters Operations, Office of Criminal Investigations, FDA James Sigg, Deputy Commissioner for Operations and Chief Operating Officer, Office of the Commissioner, FDA Catherine Dasenbrock, Director, National Forensic Chemistry Center, Office of Inspections and Investigations (OII), FDA Duane Satzger, Associate Director, Office of Medical Products and Specialty Laboratory Operations, OII, FDA Katy Kale, Deputy Administrator, GSA Douglas Stearn, Principal Deputy Associate Commissioner, OII, FDA FDA photo by Matthew MacRoberts Full Article
em FDA reopens National Forensic Chemistry Center after expansion and renovation By www.flickr.com Published On :: Wed, 02 Oct 2024 13:47:49 -0700 The U.S. Food and Drug Administration posted a photo: Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices. FDA photo by Matthew MacRoberts Full Article
em FDA reopens National Forensic Chemistry Center after expansion and renovation By www.flickr.com Published On :: Wed, 02 Oct 2024 13:48:25 -0700 The U.S. Food and Drug Administration posted a photo: Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices. FDA photo by Matthew MacRoberts Full Article
em FDA reopens National Forensic Chemistry Center after expansion and renovation By www.flickr.com Published On :: Wed, 02 Oct 2024 13:49:15 -0700 The U.S. Food and Drug Administration posted a photo: Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices. FDA photo by Matthew MacRoberts Full Article
em New On-Demand Training Platform By regulatoryrx.blogspot.com Published On :: Mon, 02 May 2022 12:00:00 +0000 I am pleased to announce the availability of on-demand training about FDA's regulation of advertising and promotion. So, you are now able to learn about the wonderful world of FDA ad-promo from the comfort of your home, office, or campsite. At PhillyCooke.Thinkific.com, you can see the courses that are currently available and sign up. In the video above, there's a special discount code to celebrate the launch of this new platform.If you are interested in providing access to the training for your full team, then please email me at DCooke@PhillyCooke.com or fill out the contact form on the website. I can provide all of the information about the corporate licensing. Every course comes with access for a full year. You can view, and review, the content as often as you like. In addition, every module on the platform is reviewed in its entirety at least twice per year. If something changes, new modules will replace the old ones, and students will be notified of the update. Those new modules will be available at no additional cost! That way you can rest assured that the information you are learning is always current with the latest developments in the world of ad-promo. Full Article APLB FDA On-demand OPDP SEM SEO training
em FTC Finalizes “Click-to-Cancel” Rule to Make It Easier for Consumers to End Recurring Subscriptions and Memberships By cohealthcom.org Published On :: Fri, 18 Oct 2024 20:56:52 +0000 Sorry, but you do not have permission to view this content. Full Article Regulatory/FDA Federal Trade Commission final rule FTC Good Rx HBRN Jim Potter PHI privacy
em The Decline of Science In the Pandemic By www.cardiobrief.org Published On :: Wed, 16 Sep 2020 14:13:24 +0000 Early in the pandemic there was a widespread belief that science would be our salvation. With the help of science we would be spared the worst consequences, such as occurred during the 1918 Spanish flu pandemic. A vaccine would arrive, reliably, after a few hard months of research, and in short order the problem would...Click here to continue reading... Full Article Policy & Ethics COVID-19 pandemic science
em Cardiology Research: Business As Usual During the Pandemic By www.cardiobrief.org Published On :: Thu, 29 Oct 2020 16:33:14 +0000 At this moment in time the pre-pandemic cardiology research agenda needs to be completely reprioritized. There are two broad areas that now take precedence over all existing research concerns. On the one hand, researchers need to achieve a better understanding of the staggering incidence of deferred or delayed treatment of cardiovascular events and conditions as...Click here to continue reading... Full Article Epidemiology & Outcomes People Places & Events Policy & Ethics coronavirus COVID-19 pandemic research agenda
em Skeptics and the Pandemic By www.cardiobrief.org Published On :: Mon, 06 Sep 2021 13:31:09 +0000 I recently posted the following thread on Twitter: I am so disappointed by the large number of pre-pandemic medical skeptics who have now turned into mask/vaccine skeptics. I largely agreed with many of them back in the day. /1 Pre-pandemic they used their skills and intelligence to rightfully question whether, say, a stent should be inserted...Click here to continue reading... Full Article People Places & Events Policy & Ethics Prevention Epidemiology & Outcomes COVID-19 masks pandemic skeptics vaccines
em EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz By www.gabionline.net Published On :: Wed, 23 Oct 2024 08:39:24 +0000 <p>On 19 September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorization for two aflibercept biosimilars: Sandoz’s Afqlir and Samsung Bioepis’s Opuviz. These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.</p> Full Article
em Nearly 200 women were prescribed valproate during pregnancy between April 2018 and September 2020 By www.pharmaceutical-journal.com Published On :: Fri, 12 Feb 2021 15:47 GMT Some 180 women were prescribed valproate, a medicine used to treat epilepsy and bipolar disorder, during their pregnancy within a 2.5 year interval, NHS data has revealed. Full Article
em Everything you should know about the coronavirus pandemic By www.pharmaceutical-journal.com Published On :: Mon, 15 Feb 2021 11:25 GMT The latest information about the novel coronavirus identified in Wuhan, China, and advice on how pharmacists can help concerned patients and the public. Full Article
em Semaglutide effective for weight loss in non-diabetic adults, research suggests By www.pharmaceutical-journal.com Published On :: Mon, 15 Feb 2021 12:04 GMT The type 2 diabetes mellitus drug semaglutide is effective for weight loss in non-diabetic overweight or obese adults, when taken alongside a reduced-calorie diet and exercise, researchers have found. Full Article
em Overseas candidates will be allowed to sit registration assessment remotely, regulator says By www.pharmaceutical-journal.com Published On :: Tue, 16 Feb 2021 12:05 GMT The General Pharmaceutical Council has said most candidates living in countries with a two-hour or more time difference from the UK will be able to apply to sit the registration assessment at home. Full Article
em Chiesi launches postal asthma inhaler recycling scheme By www.pharmaceutical-journal.com Published On :: Wed, 17 Feb 2021 14:34 GMT The UK’s first postal inhaler recycling scheme has been launched by pharmaceutical company Chiesi to support a more sustainable way of living for people with respiratory illnesses. Full Article
em New drug cuts the risk of death in bladder cancer by 30% compared with chemotherapy, study suggests By www.pharmaceutical-journal.com Published On :: Thu, 18 Feb 2021 15:30 GMT A new type of drug that targets chemotherapy directly to cancer cells reduces the risk of death from the most common type of bladder cancer by 30%, a phase III trial in the New England Journal of Medicine has suggested. Full Article
em Medicinal Chemistry In The Age Of Artificial Intelligence By lifescivc.com Published On :: Mon, 05 Aug 2024 11:00:53 +0000 By Peter Tummino, CSO of Nimbus Therapeutics, as part of the From The Trenches feature of LifeSciVC “Over the next five to 10 years, our goal is to become a company that’s leading the world in personalized medicines, a company The post Medicinal Chemistry In The Age Of Artificial Intelligence appeared first on LifeSciVC. Full Article Drug discovery From The Trenches R&D Productivity
em Keeping It Simple: What Really Matters For Emerging Enterprises By lifescivc.com Published On :: Wed, 04 Sep 2024 11:00:46 +0000 By Ankit Mahadevia, chairman of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC A common theme in startup literature is that by cutting a range of unnecessary tasks, a step-change in results will follow. I’ve found The post Keeping It Simple: What Really Matters For Emerging Enterprises appeared first on LifeSciVC. Full Article Bioentrepreneurship Biotech startup advice Corporate Culture From The Trenches
em Reflections On My Experience As A Board Member By lifescivc.com Published On :: Wed, 18 Sep 2024 11:00:01 +0000 By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC In an industry where boom and bust cycles occur regularly and 90 percent of drug candidates fail to reach the market, an outstanding The post Reflections On My Experience As A Board Member appeared first on LifeSciVC. Full Article Boards and governance From The Trenches Leadership
em AllTrials guide to asking academic institutions about missing results By www.alltrials.net Published On :: Fri, 17 Jan 2020 11:29:12 +0000 When university and hospital trusts were called to the UK parliament last year to answer questions on why they were not following the rules on reporting results, we saw how effective the questioning from politicians was. Those of you who watched the parliamentary session saw the pressure the university representatives were put under. Because the politicians asked […] Full Article News
em These Words Have (Temporarily) Relocated By www.placebocontrol.com Published On :: Tue, 18 Mar 2014 14:17:00 +0000 Near the end of last year, I had the bright idea of starting a second blog, Placebo Lead-In, to capture a lot of smaller items that I found interesting but wasn't going to work up into a full-blown, 1000 word post. According to Murphy’s Law, or the Law of Unintended Consequences, or the Law of Biting Off More Than You Can Chew, or some such similar iron rule of the universe, what happened next should have been predictable. First, my team at CAHG Trials launched a new blog, First Patient In. FPI is dedicated to an open discussion of patient recruitment ideas, and I’m extremely proud of what we've published so far. Next, I was invited to be a guest blogger for the upcoming Partnerships in Clinical Trials Conference. Suddenly, I've gone from 1 blog to 4. And while my writing output appears to have increased, it definitely hasn't quadrupled. So this blog has been quiet for a bit too long as a result. The good news is that the situation is temporary - Partnerships will actually happen at the end of this month. (If you’re going: drop me a line and let’s meet. If you’re not: you really should come and join us!) My contributions to FPI will settle into a monthly post, as I have a fascinating and clever team to handle most of the content. In case you've missed it, then, here is a brief summary of my posts elsewhere over the past 2 months. First Patient In How to Catalyze a Clinical Trial - My inaugural post introducing the blog and its purpose Video: Predicting Referral Conversion in Clinical Trial Advertising - A somewhat technical but very important topic, how to visualize and model the “real time” results of recruitment advertising at the sites. The Crystal Ball is on the Fritz - What to do with a broken enrollment feasibility process, and how asking will never be as good as measuring Partnerships in Clinical Trials The New Breed of Clinical Trial Matchmakers - A (hopefully pretty complete, thanks to knowledgeable commenters) listing of services looking to match interested patients to clinical trials Rethinking Patient Enrollment, in One Graphic - The perils of predictability in site-based enrollment Seize the Data! Will Big Data Save Us from Ourselves? - My take on what I consider to be the large and serious obstacles in the way of “Big Data” solutions for patient recruitment Please take a look, and I will see you back here soon. [Photo credit: detour sign via Flikr user crossley] Full Article Big Data metrics patient engagement patient recruitment site relationship management
em REMOTE Redux: DTP trials are still hard By www.placebocontrol.com Published On :: Tue, 23 May 2017 17:44:00 +0000 Maybe those pesky sites are good for something after all. It's been six years since Pfizer boldly announced the launch of its "clinical trial in a box". The REMOTE trial was designed to be entirely online, and involved no research sites: study information and consent was delivered via the web, and medications and diaries were shipped directly to patients' homes. Despite the initial fanfare, within a month REMOTE's registration on ClinicalTrials.gov was quietly reduced from 600 to 283. The smaller trial ended not with a bang but a whimper, having randomized only 18 patients in over a year of recruiting. Still, the allure of direct to patient clinical trials remains strong, due to a confluence of two factors. First, a frenzy of interest in running "patient centric clinical trials". Sponsors are scrambling to show they are doing something – anything – to show they have shifted to a patient-centered mindset. We cannot seem to agree what this means (as a great illustration of this, a recent article in Forbes on "How Patients Are Changing Clinical Trials" contained no specific examples of actual trials that had been changed by patients), but running a trial that directly engages patients wherever they are seems like it could work. The less-openly-discussed other factor leading to interest in these DIY trials is sponsors' continuing willingness to heap almost all of the blame for slow-moving studies onto their research sites. If it’s all the sites’ fault – the reasoning goes – then cutting them out of the process should result in trials that are both faster and cheaper. (There are reasons to be skeptical about this, as I have discussed in the past, but the desire to drop all those pesky sites is palpable.) However, while a few proof-of-concept studies have been done, there really doesn't seem to have been another trial to attempt a full-blown direct-to-patient clinical trial. Other pilots have been more successful, but had fairly lightweight protocols. For all its problems, REMOTE was a seriously ambitious project that attempted to package a full-blown interventional clinical trial, not an observational study. In this context, it's great to see published results of the TAPIR Trial in vasculitis, which as far as I can tell is the first real attempt to run a DIY trial of a similar magnitude to REMOTE. TAPIR was actually two parallel trials, identical in every respect except for their sites: one trial used a traditional group of 8 sites, while the other was virtual and recruited patients from anywhere in the country. So this was a real-time, head-to-head assessment of site performance. And the results after a full two years of active enrollment? Traditional sites: 49 enrolled Patient centric: 10 enrolled Even though we’re six years later, and online/mobile communications are even more ubiquitous, we still see the exact same struggle to enroll patients. Maybe it’s time to stop blaming the sites? To be fair, they didn’t exactly set the world on fire – and I’m guessing the total cost of activating the 8 sites significantly exceeded the costs of setting up the virtual recruitment and patient logistics. But still, the site-less, “patient centric” approach once again came up astonishingly short. Krischer J, Cronholm PF, Burroughs C, McAlear CA, Borchin R, Easley E, Davis T, Kullman J, Carette S, Khalidi N, Koening C, Langford CA, Monach P, Moreland L, Pagnoux C, Specks U, Sreih AG, Ytterberg S, Merkel PA, & Vasculitis Clinical Research Consortium. (2017). Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study. Journal of medical Internet research, 19 (2) PMID: 28246067 Full Article direct to patient DTP patient recruitment research sites site relationship management trial delays
em Patrick Dempsey aims to raise awareness of cancer disparities and encourage screening By www.npr.org Published On :: Mon, 11 Nov 2024 05:18:50 -0500 NPR's Leila Fadel talks with actor Patrick Dempsey about his efforts to raise money for cancer treatment and prevention. Full Article
em Remarkably resilient refugees: A teen on his own, a woman who was raped By www.npr.org Published On :: Tue, 12 Nov 2024 07:57:31 -0500 Sudan's civil war has displaced 10 million citizens. Here are profiles of two young people from the most vulnerable groups: an unaccompanied minor caring for twin brothers, a woman who was raped. Full Article
em Stretchy Wearables Can Now Heal Themselves By spectrum.ieee.org Published On :: Tue, 24 Sep 2024 11:00:03 +0000 If you’ve ever tried to get a bandage to stick to your elbow, you understand the difficulty in creating wearable devices that attach securely to the human body. Add digital electronic circuitry, and the problem becomes more complicated. Now include the need for the device to fix breaks and damage automatically—and let’s make it biodegradable while we’re at it—and many researchers would throw up their hands in surrender. Fortunately, an international team led by researchers at Korea University Graduate School of Converging Science and Technology (KU-KIST) persevered, and has developed conductor materials that it claims are stretchable, self-healing, and biocompatible. Their project was described this month in the journal Science Advances. The biodegradable conductor offers a new approach to patient monitoring and delivering treatments directly to the tissues and organs where they are needed. For example, a smart patch made of these materials could measure motion, temperature, and other biological data. The material could also be used to create sensor patches that can be implanted inside the body, and even mounted on the surface of internal organs. The biocompatible materials can be designed to degrade after a period of time, eliminating the need for an invasive procedure to remove the sensor later. “This new technology is a glimpse at the future of remote healthcare,” says Robert Rose, CEO of Rose Strategic Partners, LLC. “Remote patient monitoring is an industry still in its early stages, but already we are seeing the promise of what is not only possible, but close on the horizon. Imagine a device implanted at a surgical site to monitor and report your internal healing progress. If it is damaged, the device can heal itself, and when the job is done, it simply dissolves. It sounds like science fiction, but it’s now science fact.” Self-healing elastics After being cut a ribbonlike film was able to heal itself in about 1 minute.Suk-Won Hwang The system relies on two different layers of flexible material, both self-healing: one is for conduction and the other is an elastomer layer that serves as a substrate to support the sensors and circuitry needed to collect data. The conductor layer is based on a substance known by the acronym PEDOT:PSS, which is short for Poly(3,4-ethylenedioxythiophene) polystyrene sulfonate. It’s a conductive polymer widely used in making flexible displays and touch panels, as well as wearable devices. To increase the polymer’s conductivity and self-healing properties, the research team used additives including polyethylene glycol and glycol, which helped increase conductivity as well as the material’s ability to automatically repair damage such as cuts or tears. In order to conform to curved tissues and survive typical body motion, the substrate layer must be extremely flexible. The researchers based it on elastomers that can match the shape of curved tissues, such as skin or individual organs. These two layers stick to each other, thanks to chemical bonds that can connect the polymer chains of the plastic films in each layer. Combined, these materials create a system that is flexible and stretchable. In testing, the researchers showed that the materials could survive stretching up to 500 percent. The self-healing function arises from the material’s ability to reconnect to itself when cut or otherwise damaged. This self-healing feature is based on a chemical process called disulfide metathesis. In short, polymer molecules containing pairs of linked sulfur atoms, called disulfides, have the ability to reform themselves after being severed. The phenomenon arises from a chemical process called disulfide-disulfide shuffling reactions, in which disulfide bonds in the molecule break and then reform, not necessarily between the original partners. According to the KU-KIST researchers, after being cut, their material was able to recover conductivity in its circuits within about two minutes without any intervention. The material was also tested for bending, twisting, and its ability to function both in air and under water. This approach offers many advantages over other flexible electronics designs. For example, silver nanowires and carbon nanotubes have been used as the basis for stretchable devices, but they can be brittle and lack the self-healing properties of the KU-KIST materials. Other materials such as liquid metals can self-heal, but they are typically difficult to handle and integrate into wearable circuitry. As a demonstration, the team created a multifunction sensor that included humidity, temperature, and pressure sensors that was approximately 4.5 square centimeters. In spite of being cut in four separate locations, it was able to heal itself and continue to provide sensor readings. Implant tested in a rat To take the demonstration a step further, the researchers created a 1.8-cm2 device that was attached to a rat’s bladder. The device was designed to wrap around the bladder and then adhere to itself, so no adhesives or sutures were required to attach the sensor onto the bladder. The team chose the bladder for their experiments because, under normal conditions, its size can change by 300 percent. The device incorporated both electrodes and pressure sensors, which were able to detect changes in the bladder pressure. The electrodes could detect bladder voiding, through electromyography signals, as well as stimulate the bladder to induce urination. As with the initial demonstration, intentional damage to the device’s circuitry healed on its own, without intervention. The biocompatible and biodegradable nature of the materials is important because it means that devices fabricated with them can be worn on the skin, as well as implanted within the body. The fact that the materials are biodegradable means that implants would not need a second surgical procedure to remove them. They could be left in place after serving their purpose, and they would be absorbed by the body. According to Suk-Won Hwang, assistant professor at KU-KIST, a few hurdles remain on the path to commercialization. “We need to test the biocompatibility of some of the materials used in the conductor and substrate layers. While scalable production appears to be feasible, the high cost of disulfide derivatives might make the technology too expensive, aside from some special applications,” he says. “Biocompatibility testing and material synthesis optimization will take one to two years, at least.” Full Article Biodegradable devices Implanted sensors Selfhealing conductor Wearable devices Biodegradable electronics
em Pregnant and Empowered: Why Trust is the Latest Form of Member Engagement By medcitynews.com Published On :: Thu, 07 Nov 2024 14:18:00 +0000 Three ways health plans can engage, connect with, and delight their pregnant members to nurture goodwill, earn long-term trust, and foster loyal relationships that last. The post Pregnant and Empowered: Why Trust is the Latest Form of Member Engagement appeared first on MedCity News. Full Article Daily MedCity Influencers Patient Engagement Payers health plans maternity member engagement pregnancy trust
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