trans All-Trans-Retinal (ATR, 100 mM) By cshprotocols.cshlp.org Published On :: 2024-11-01T06:46:10-07:00 Full Article
trans Evaluation of the Importance of Capsule Transparency in Dry Powder Inhalation Devices [Research Briefs] By www.annfammed.org Published On :: 2024-09-23T14:00:14-07:00 The aim of this work is to test whether the use of a transparent capsule affects the residual capsule weight after inhalation as a surrogate of the inhaled delivered dose for patients with non-reversible chronic airway disease. Researchers conducted an observational cross-sectional study with patients using a single-dose dry powder inhaler. The weight of the capsule was measured with a precision microbalance before and after inhalation. Ninety-one patients were included, of whom 63 (69.2%) used a transparent capsule. Inhalation with a transparent capsule achieved a weight decrease of 30.1% vs 8.6% for devices with an opaque capsule (P <0.001). These data reinforce the need to provide patients with mechanisms that verify the correct inhalation technique. Full Article
trans Pulmonary complications of bone marrow transplantation By breathe.ersjournals.com Published On :: 2024-10-01T10:05:24-07:00 Bone marrow transplantation, now often known as haematopoietic stem cell transplantation (HSCT), is a complex choreographed procedure used to treat both acquired and inherited disorders of the bone marrow. It has proven invaluable as therapy for haematological and immunological disorders, and more recently in the treatment of metabolic and enzyme disorders. As the number of performed transplants grows annually, and with patients enjoying improved survival, a knowledge of both early and late complications of HSCT is essential for respiratory trainees and physicians in practice. This article highlights the spectrum of respiratory complications, both infectious and non-infectious, the timeline of their likely occurrence, and the approaches used for diagnosis and treatment, keeping in mind that more than one entity may occur simultaneously. As respiratory issues are often a leading cause of short- and long-term morbidity, consideration of a combined haematology/respiratory clinic may prove useful in this patient population. Full Article
trans Spatial lung imaging in clinical and translational settings By breathe.ersjournals.com Published On :: 2024-10-01T10:05:24-07:00 For many severe lung diseases, non-invasive biomarkers from imaging could improve early detection of lung injury or disease onset, establish a diagnosis, or help follow-up disease progression and treatment strategies. Imaging of the thorax and lung is challenging due to its size, respiration movement, transferred cardiac pulsation, vast density range and gravitation sensitivity. However, there is extensive ongoing research in this fast-evolving field. Recent improvements in spatial imaging have allowed us to study the three-dimensional structure of the lung, providing both spatial architecture and transcriptomic information at single-cell resolution. This fast progression, however, comes with several challenges, including significant image file storage and network capacity issues, increased costs, data processing and analysis, the role of artificial intelligence and machine learning, and mechanisms to combine several modalities. In this review, we provide an overview of advances and current issues in the field of spatial lung imaging. Full Article
trans Global tech to transform over 3 weeks By www.theaustralian.com.au Published On :: Tue, 26 Aug 2014 00:54:00 GMT THE world’s tech will undergo a transformation over just three weeks with a bonanza of new phones, tablets, smart watches and OLED 4K TVs. Full Article
trans Search for alien transmissions in promising star system draws a blank By www.newscientist.com Published On :: Thu, 26 Sep 2024 19:00:49 +0100 Astronomers listened for radio signals emanating from planets in the TRAPPIST-1 system, but found no evidence of any interplanetary communications Full Article
trans We need transparency from the companies disseminating misinformation By www.newscientist.com Published On :: Wed, 04 Sep 2024 19:00:00 +0100 As misinformation about the upcoming US elections rockets across social media, creating chaos, companies need to be honest about where this content is coming from, says Annalee Newitz Full Article
trans Musical AI harmonises with your voice in a transcendent new exhibition By www.newscientist.com Published On :: Wed, 23 Oct 2024 19:00:00 +0100 What happens if AI is trained to write choral music by feeding it a specially created vocal dataset? Moving new exhibition The Call tackles some thorny questions about AI and creativity – and stirs the soul with music Full Article
trans How VPNs shield your identity and secure your financial transactions from theft By www.foxnews.com Published On :: Sun, 10 Nov 2024 10:00:09 -0500 A virtual private network is a service that encrypts your internet connection, ensuring your online activity remains private and secure. Full Article 84af7ed4-6441-5599-8486-c667456675f6 fnc Fox News fox-news/tech fox-news/tech/topics/security fox-news/us/personal-freedoms/privacy fox-news/tech/topics/cybercrime fox-news/tech/topics/hackers fox-news/us fox-news/tech article
trans The Arsenal star who features in the top ten Premier League players for increased transfer value By www.sport.co.uk Published On :: Wed, 09 Oct 2019 11:02:00 +0000 One Arsenal star is on the list of the top ten Premier League players for increased transfer value in 2019. Full Article
trans Transgender athletes in women's competition: A sport-by-sport guide to rules and regulations By www.telegraph.co.uk Published On :: Tue, 22 Mar 2022 21:00:18 GMT Full Article topics:organisations/ioc topics:events/tokyo-olympics-2020 structure:sport structure:swimming structure:cycling structure:football structure:womens-sport storytype:standard
trans Tom Daley 'furious' at transgender ban from swimming and diving competitions By www.telegraph.co.uk Published On :: Sun, 26 Jun 2022 18:59:59 GMT Full Article topics:things/Transgender topics:people/tom-daley structure:sport structure:swimming storytype:standard
trans British Athletics want 'open' category for transgender women to compete with men By www.telegraph.co.uk Published On :: Fri, 03 Feb 2023 14:09:41 GMT Full Article topics:organisations/uk-athletics structure:sport storytype:standard
trans Women in Sport issue call to protect women's sport at every level from transgender athletes By www.telegraph.co.uk Published On :: Fri, 03 Nov 2023 18:24:28 GMT Full Article topics:things/Transgender structure:womens-sport storytype:standard
trans Parkrun event director quits over ‘inclusive policy’ as CEO pleads to ‘turn heat down’ on trans row By www.telegraph.co.uk Published On :: Fri, 09 Feb 2024 19:10:59 GMT Full Article topics:things/running topics:organisations/uk-athletics structure:sport structure:athletics storytype:standard
trans Stem cell transplant gives hope for treating age-related sight loss By www.newscientist.com Published On :: Thu, 03 Oct 2024 17:08:51 +0100 A monkey that performed poorly on vision tests did much better after having a stem cell transplant to patch up holes in its retina Full Article
trans New Carrier Fluid Makes Hydrogen Way Easier to Transport By spectrum.ieee.org Published On :: Thu, 31 Oct 2024 12:00:03 +0000 Imagine pulling up to a refueling station and filling your vehicle’s tank with liquid hydrogen, as safe and convenient to handle as gasoline or diesel, without the need for high-pressure tanks or cryogenic storage. This vision of a sustainable future could become a reality if a Calgary, Canada–based company, Ayrton Energy, can scale up its innovative method of hydrogen storage and distribution. Ayrton’s technology could make hydrogen a viable, one-to-one replacement for fossil fuels in existing infrastructure like pipelines, fuel tankers, rail cars, and trucks.The company’s approach is to use liquid organic hydrogen carriers (LOHCs) to make it easier to transport and store hydrogen. The method chemically bonds hydrogen to carrier molecules, which absorb hydrogen molecules and make them more stable—kind of like hydrogenating cooking oil to produce margarine. A researcher pours a sample of Ayrton’s LOHC fluid into a vial.Ayrton EnergyThe approach would allow liquid hydrogen to be transported and stored in ambient conditions, rather than in the high-pressure, cryogenic tanks (to hold it at temperatures below -252 ºC) currently required for keeping hydrogen in liquid form. It would also be a big improvement on gaseous hydrogen, which is highly volatile and difficult to keep contained.Founded in 2021, Ayrton is one of several companies across the globe developing LOHCs, including Japan’s Chiyoda and Mitsubishi, Germany’s Covalion, and China’s Hynertech. But toxicity, energy density, and input energy issues have limited LOHCs as contenders for making liquid hydrogen feasible. Ayrton says its formulation eliminates these trade-offs.Safe, Efficient Hydrogen Fuel for VehiclesConventional LOHC technologies used by most of the aforementioned companies rely on substances such as toluene, which forms methylcyclohexane when hydrogenated. These carriers pose safety risks due to their flammability and volatility. Hydrogenious LOHC Technologies in Erlanger, Germany and other hydrogen fuel companies have shifted toward dibenzyltoluene, a more stable carrier that holds more hydrogen per unit volume than methylcyclohexane, though it requires higher temperatures (and thus more energy) to bind and release the hydrogen. Dibenzyltoluene hydrogenation occurs at between 3 and 10 megapascals (30 and 100 bar) and 200–300 ºC, compared with 10 MPa (100 bar), and just under 200 ºC for methylcyclohexane.Ayrton’s proprietary oil-based hydrogen carrier not only captures and releases hydrogen with less input energy than is required for other LOHCs, but also stores more hydrogen than methylcyclohexane can—55 kilograms per cubic meter compared with methylcyclohexane’s 50 kg/m³. Dibenzyltoluene holds more hydrogen per unit volume (up to 65 kg/m³), but Ayrton’s approach to infusing the carrier with hydrogen atoms promises to cost less. Hydrogenation or dehydrogenation with Ayrton’s carrier fluid occurs at 0.1 megapascal (1 bar) and about 100 ºC, says founder and CEO Natasha Kostenuk. And as with the other LOHCs, after hydrogenation it can be transported and stored at ambient temperatures and pressures.Judges described [Ayrton's approach] as a critical technology for the deployment of hydrogen at large scale.” —Katie Richardson, National Renewable Energy LabAyrton’s LOHC fluid is as safe to handle as margarine, but it’s still a chemical, says Kostenuk. “I wouldn’t drink it. If you did, you wouldn’t feel very good. But it’s not lethal,” she says.Kostenuk and fellow Ayrton cofounder Brandy Kinkead (who serves as the company’s chief technical officer) were originally trying to bring hydrogen generators to market to fill gaps in the electrical grid. “We were looking for fuel cells and hydrogen storage. Fuel cells were easy to find, but we couldn’t find a hydrogen storage method or medium that would be safe and easy to transport to fuel our vision of what we were trying to do with hydrogen generators,” Kostenuk says. During the search, they came across LOHC technology but weren’t satisfied with the trade-offs demanded by existing liquid hydrogen carriers. “We had the idea that we could do it better,” she says. The duo pivoted, adjusting their focus from hydrogen generators to hydrogen storage solutions.“Everybody gets excited about hydrogen production and hydrogen end use, but they forget that you have to store and manage the hydrogen,” Kostenuk says. Incompatibility with current storage and distribution has been a barrier to adoption, she says. “We’re really excited about being able to reuse existing infrastructure that’s in place all over the world.” Ayrton’s hydrogenated liquid has fuel-cell-grade (99.999 percent) hydrogen purity, so there’s no advantage in using pure liquid hydrogen with its need for subzero temperatures, according to the company.The main challenge the company faces is the set of issues that come along with any technology scaling up from pilot-stage production to commercial manufacturing, says Kostenuk. “A crucial part of that is aligning ourselves with the right manufacturing partners along the way,” she notes.Asked about how Ayrton is dealing with some other challenges common to LOHCs, Kostenuk says Ayrton has managed to sidestep them. “We stayed away from materials that are expensive and hard to procure, which will help us avoid any supply chain issues,” she says. By performing the reactions at such low temperatures, Ayrton can get its carrier fluid to withstand 1,000 hydrogenation-dehydrogenation cycles before it no longer holds enough hydrogen to be useful. Conventional LOHCs are limited to a couple of hundred cycles before the high temperatures required for bonding and releasing the hydrogen breaks down the fluid and diminishes its storage capacity, Kostenuk says.Breakthrough in Hydrogen Storage TechnologyIn acknowledgement of what Ayrton’s nontoxic, oil-based carrier fluid could mean for the energy and transportation sectors, the U.S. National Renewable Energy Lab (NREL) at its annual Industry Growth Forum in May named Ayrton an “outstanding early-stage venture.” A selection committee of more than 180 climate tech and cleantech investors and industry experts chose Ayrton from a pool of more than 200 initial applicants, says Katie Richardson, group manager of NREL’s Innovation and Entrepreneurship Center, which organized the forum. The committee based its decision on the company’s innovation, market positioning, business model, team, next steps for funding, technology, capital use, and quality of pitch presentation. “Judges described Ayrton’s approach as a critical technology for the deployment of hydrogen at large scale,” Richardson says.As a next step toward enabling hydrogen to push gasoline and diesel aside, “we’re talking with hydrogen producers who are right now offering their customers cryogenic and compressed hydrogen,” says Kostenuk. “If they offered LOHC, it would enable them to deliver across longer distances, in larger volumes, in a multimodal way.” The company is also talking to some industrial site owners who could use the hydrogenated LOHC for buffer storage to hold onto some of the energy they’re getting from clean, intermittent sources like solar and wind. Another natural fit, she says, is energy service providers that are looking for a reliable method of seasonal storage beyond what batteries can offer. The goal is to eventually scale up enough to become the go-to alternative (or perhaps the standard) fuel for cars, trucks, trains, and ships. Full Article Hydrogen economy Hydrogen storage Clean energy Energy transition Liquid organic hydrogen carriers
trans Lefties ALWAYS Eat Their Own: Dem Rep. Seth Moulton Defends Trans Athlete Remarks (and He SHOULD) By twitchy.com Published On :: Tue, 12 Nov 2024 16:00:13 -0500 Full Article <![CDATA[boys]]> <![CDATA[CBS News]]> <![CDATA[daughter]]> <![CDATA[Democratic party]]> <![CDATA[father]]> <![CDATA[girl]]> <![CDATA[transgender]]> <![CDATA[women's rights]]> <![CDATA[trans kids]]>
trans Tufts University Denies It Cut Ties With Rep. Seth Moulton Over Trans Comments By twitchy.com Published On :: Tue, 12 Nov 2024 18:30:28 -0500 Full Article <![CDATA[college]]> <![CDATA[Lefties]]> <![CDATA[transgender]]> <![CDATA[trans women]]>
trans Green energy transition is ‘unstoppable’, says Ed Miliband By www.channel4.com Published On :: We spoke to energy secretary Ed Miliband and began by asking him what he thought of Donald Trump saying climate change is a hoax. Full Article
trans How to Transform Your Online Presence with a Custom Website By www.chartsattack.com Published On :: Tue, 01 Oct 2024 07:14:33 +0000 In today’s digital age, your website is more than just a virtual storefront—it’s the heart of your online presence. Whether you’re a small business, a growing startup, or an established brand, a custom-designed website can be the key to standing out in a crowded market. But what does it take to truly transform your digital […] The post How to Transform Your Online Presence with a Custom Website appeared first on Chart Attack. Full Article Business Custom Website Online presence User Experience web design agency
trans My Little Pony, Transformers, Phase 10 join the National Toy Hall of Fame By www.npr.org Published On :: Tue, 12 Nov 2024 15:31:52 -0500 The three 1980s staples are new National Toy Hall of Fame inductees. Hess Toy Trucks, the Pokémon Trading Card Game, the trampoline, and balloons were among the finalists. Full Article
trans Driving AI Transformation By gigaom.com Published On :: Wed, 23 Oct 2024 21:10:29 +0000 As we head into 2025, CEOs are focused on a clear set of priorities—AI-enabled growth, dynamic capacity, risk management, and human-machine integration. The post Driving AI Transformation appeared first on Gigaom. Full Article
trans Unleashing Transformation By gigaom.com Published On :: Wed, 30 Oct 2024 15:49:34 +0000 AI isn’t just another tool in the technology toolkit; it’s a revolution waiting to be led. As tech leaders, this is your The post Unleashing Transformation appeared first on Gigaom. Full Article
trans ‘Animal Crossing: Pocket Camp’ Shutting Down This November, New Paid Game Set To Release With Save Transfer By toucharcade.com Published On :: Thu, 22 Aug 2024 06:56:16 +0000 Nintendo just announced that Animal Crossing: Pocket Camp (Free) is shutting down on November 28th at 3 PM UTC. Animal … Continue reading "‘Animal Crossing: Pocket Camp’ Shutting Down This November, New Paid Game Set To Release With Save Transfer" Full Article Android Featured Free Games iPad Games iPhone games News Universal Upcoming Games Animal Crossing Animal Crossing Pocket Camp
trans Your Guide To Enjoying Transmasculine Sex By www.starobserver.com.au Published On :: Sun, 04 Aug 2024 02:40:01 +0000 I could be biased, but sex with transmasculine people is fantastic. A warning up front: this article is not safe for work, unless it’s your very first day at the ... The post Your Guide To Enjoying Transmasculine Sex appeared first on Star Observer. Full Article Healthy Living Life Life + Style News Bottom clitoris Consent intimacy non-binary Penis sex Trans Sex transmasculine Transmasculine sex Vagina
trans Free transit actually is a thing, and you might be surprised where By www.cbc.ca Published On :: Mon, 11 Nov 2024 04:00:32 EST While public transit in many Canadian cities is struggling with rising fares and falling ridership, one Ontario community has more than doubled its transit use in the past two years. Orangeville has made its buses free, joining a list of much larger communities that have gone fare-free. Full Article News/Business
trans The future of transport is utterly ridiculous By www.heraldsun.com.au Published On :: Tue, 10 Jan 2017 23:16:00 GMT YOU could avoid peak hour traffic congestion and overcrowded public transport by flying to work. Yes, flying. It’s something that could actually happen. Full Article
trans Pharmaceutical water systems in transformation mode with advanced processes & shift towards analytics By www.pharmabiz.com Published On :: Thursday, November 7, 2024 08:00 IST Indian and multinational pharma companies are leading the charge by investing in digital transformation and aligning Indian operations with global standards. Essentially, pharmaceutical water systems are Full Article
trans Transforming pre-surgical planning By www.medicalplasticsnews.com Published On :: Tue, 12 Nov 2024 17:30:00 -0000 Rob Pitts, sales manager at Tri-Tech 3D, UK provider of Stratasys 3D printing solutions, explores how additive manufacturing (AM) can help speed up surgical workflows and reduce costs by transforming anatomical modelling. Full Article
trans Best Practices for Successfully Transitioning a Patient Services Hub By feeds.feedblitz.com Published On :: Fri, 20 Sep 2024 10:30:00 +0000 Today’s guest post comes from Josh Marsh, Vice President and General Manager, Sonexus™ Access and Patient Support at Cardinal Health Josh discusses challenges manufacturers may face when outsourcing patient support programs. He outlines a process that smoothly transitions hubs and minimizes disruptions for patients and healthcare providers. To learn more, download the 3-step guide to patient hub transitions. Read on for Josh’s insights. Read more » Full Article Guest Post Sponsored Post
trans As MFP Approaches, Transparency Is More Important Than Ever By feeds.feedblitz.com Published On :: Fri, 11 Oct 2024 10:30:00 +0000 Today’s guest post comes from Angie Franks, Chief Executive Officer of Kalderos. Angie discusses how the Maximum Fair Price provision of the Inflation Reduction Act of 2022 will challenge providers, pharmacies, and manufacturers. She explains how Kalderos’ Truzo platform could reduce duplicate claims and address compliance issues. To learn more, register for Kalderos’ October 25 webinar Cracking the MFP Code: How Flexible Technology Helps You Navigate an Evolving Landscape. Read on for Angie’s insights. Read more » Full Article Guest Post Sponsored Post
trans If Plan Sponsors Are So Unhappy with Their PBMs’ Transparency, Why Won’t They Change the Model? By feeds.feedblitz.com Published On :: Tue, 15 Oct 2024 10:30:00 +0000 A new survey of plan sponsors sheds light on their satisfaction with transparency at large and small pharmacy benefit managers (PBMs). As you will see, clients remain slightly more satisfied with the perceived transparency of smaller PBMs compared with the Big Three PBMs—CVS Caremark, Express Scripts, and Optum Rx. However, plan sponsors are dissatisfied with transparency about how both large and small PBMs make money. Smaller PBMs have an edge, but it’s narrower than you might think. Perhaps PBMs’ clients are unable or unwilling to negotiate better deals, write more effective contracts, and switch to more satisfying relationships. Or maybe they don’t mind the current system, despite the challenges for patients. Some argue that transparency could swoop down to solve this problem. Riddle me this: Should we watch what plan sponsors say, or what they do? Read on to see what you think of my arguments below. Then, click here to share your thoughts with the Drug Channels community. Read more » Full Article Benefit Design Costs/Reimbursement Gross-to-Net Bubble PBMs
trans 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
trans Transforming healthcare: CinnaGen’s leadership in follow-on biologicals/ biosimilars development and market expansion By www.gabionline.net Published On :: Fri, 08 Nov 2024 13:18:16 +0000 <p> <b>Abstract</b><br />CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI<i> </i>(Generics and Biosimilars Initiative) about the company’s strategic focus, which includes expanding its product portfolio, entering highly regulated global markets, and advancing affordable treatments for conditions such as multiple sclerosis and immunological diseases—transforming healthcare in underserved regions.</p><p><b>Keywords</b>: Biosimilars, clinical development, commercialization, MENA</p> Full Article
trans Tell the UK’s research regulator to do more on clinical trial transparency By www.alltrials.net Published On :: Mon, 29 Jul 2019 13:41:09 +0000 The UK body that oversees health research is writing a new strategy on clinical trial transparency and it wants to hear opinions on it. The Health Research Authority (HRA) says its strategy aims to “make transparency easy, make compliance clear and make information public.” It has opened a public consultation on the strategy and some […] Full Article News
trans Can FDA's New Transparency Survive Avandia? By www.placebocontrol.com Published On :: Wed, 05 Jun 2013 03:53:00 +0000 PDUFA V commitments signal a strong commitment to tolerance of open debate in the face of uncertainty. I can admit to a rather powerful lack of enthusiasm when reading about interpersonal squabbles. It’s even worse in the scientific world: when I read about debates getting mired in personal attacks I tend to simply stop reading and move on to something else. However, the really interesting part of this week’s meeting of an FDA joint Advisory Committee to discuss the controversial diabetes drug Avandia – at least in the sense of likely long-term impact – is not the scientific question under discussion, but the surfacing and handling of the raging interpersonal battle going on right now inside the Division of Cardiovascular and Renal Products. So I'll have to swallow my distaste and follow along with the drama. Two words that make us mistrust Duke: Anil Potti Christian Laettner Not that the scientific question at hand – does Avandia pose significant heart risks? – isn't interesting. It is. But if there’s one thing that everyone seems to agree on, it’s that we don’t have good data on the topic. Despite the re-adjudication of RECORD, no one trusts its design (and, ironically, the one trial with a design to rigorously answer the question was halted after intense pressure, despite an AdComm recommendation that it continue). And no one seems particularly enthused about changing the current status of Avandia: in all likelihood it will continue to be permitted to be marketed under heavy restrictions. Rather than changing the future of diabetes, I suspect the committee will be content to let us slog along the same mucky trail. The really interesting question, that will potentially impact CDER for years to come, is how it can function with frothing, open dissent among its staffers. As has been widely reported, FDA reviewer Tom Marciniak has written a rather wild and vitriolic assessment of the RECORD trial, excoriating most everyone involved. In a particularly stunning passage, Marciniak appears to claim that the entire output of anyone working at Duke University cannot be trusted because of the fraud committed by Duke cancer researcher Anil Potti: I would have thought that the two words “Anil Potti” are sufficient for convincing anyone that Duke University is a poor choice for a contractor whose task it is to confirm the integrity of scientific research. (One wonders how far Marciniak is willing to take his guilt-by-association theme. Are the words “Cheng Yi Liang” sufficient to convince us that all FDA employees, including Marciniak, are poor choices for deciding matter relating to publicly-traded companies? Should I not comment on government activities because I’m a resident of Illinois (my two words: “Rod Blagojevich”)?) Rather than censoring or reprimanding Marciniak, his supervisors have taken the extraordinary step of letting him publicly air his criticisms, and then they have in turn publicly criticized his methods and approach. I have been unable to think of a similar situation at any regulatory agency. The tolerance for dissent being displayed by FDA is, I believe, completely unprecedented. And that’s the cliffhanger for me: can the FDA’s commitment to transparency extend so far as to accommodate public disagreements about its own approval decisions? Can it do so even when the disagreements take an extremely nasty and inappropriate tone? Rather than considering that open debate is a good thing, will journalists jump on the drama and portray agency leadership as weak and indecisive? Will the usual suspects in Congress be able to exploit this disagreement for their own political gain? How many House subcommittees will be summoning Janet Woodcock in the coming weeks? I think what Bob Temple and Norman Stockbridge are doing is a tremendous experiment in open government. If they can pull it off, it could force other agencies to radically rethink how they go about crafting and implementing regulations. However, I also worry that it is politically simply not a viable approach, and that the agency will ultimately be seriously hurt by attacks from the media and legislators. Where is this coming from? As part of its recent PDUFA V commitment, the FDA put out a fascinating draft document, Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making. It didn't get a lot of attention when first published back in February (few FDA documents do). However, it lays out a rather bold vision for how the FDA can acknowledge the existence of uncertainty in its evaluation of new drugs. Its proposed structure even envisions an open and honest accounting of divergent interpretations of data: When they're frothing at the mouth, even Atticusdoesn't let them publish a review A framework for benefit-risk decision-making that summarizes the relevant facts, uncertainties, and key areas of judgment, and clearly explains how these factors influence a regulatory decision, can greatly inform and clarify the regulatory discussion. Such a framework can provide transparency regarding the basis of conflicting recommendations made by different parties using the same information. (Emphasis mine.) Of course, the structured framework here is designed to reflect rational disagreement. Marciniak’s scattershot insults are in many ways a terrible first case for trying out a new level of transparency. The draft framework notes that safety issues, like Avandia, are some of the major areas of uncertainty in the regulatory process. Contrast this vision of coolly and systematically addressing uncertainties with the sad reality of Marciniak’s attack: In contrast to the prospective and highly planned studies of effectiveness, safety findings emerge from a wide range of sources, including spontaneous adverse event reports, epidemiology studies, meta-analyses of controlled trials, or in some cases from randomized, controlled trials. However, even controlled trials, where the evidence of an effect is generally most persuasive, can sometimes provide contradictory and inconsistent findings on safety as the analyses are in many cases not planned and often reflect multiple testing. A systematic approach that specifies the sources of evidence, the strength of each piece of evidence, and draws conclusions that explain how the uncertainty weighed on the decision, can lead to more explicit communication of regulatory decisions. We anticipate that this work will continue beyond FY 2013. I hope that work will continue beyond 2013. Thoughtful, open discussions of real uncertainties are one of the most worthwhile goals FDA can aspire to, even if it means having to learn how to do so without letting the Marciniaks of the world scuttle the whole endeavor. [Update June 6: Further bolstering the idea that the AdCom is just as much about FDA's ability to transparently manage differences of expert opinion in the face of uncertain data, CDER Director Janet Woodcock posted this note on the FDA's blog. She's pretty explicit about the bigger picture: There have been, and continue to be, differences of opinion and scientific disputes, which is not uncommon within the agency, stemming from varied conclusions about the existing data, not only with Avandia, but with other FDA-regulated products. At FDA, we actively encourage and welcome robust scientific debate on the complex matters we deal with — as such a transparent approach ensures the scientific input we need, enriches the discussions, and enhances our decision-making. I agree, and hope she can pull it off.] Full Article data quality drug safety Duke FDA GSK Tom Marciniak transparency
trans Enabling an Economic Transformation of Ukraine: Recovery, Reconstruction, and Modernization By www.belfercenter.org Published On :: Jan 10, 2023 Jan 10, 2023 The aim of the report is to focus specifically on the critical role of private sector investment in Ukraine’s economic reconstruction, and how the private sector, both within Ukraine and internationally, can enable Ukraine to win the peace. It provides a short overview of the economic challenges facing Ukraine, including governance, the sectors that will be critical to Ukraine's reconstruction, the roles and responsibilities for the G7, EU, IFIs, and DFIs, and then recommendations for how Ukraine and its partners can best attract private sector investment. Full Article
trans Local Start-ups Hold the Key to Transforming Africa's Seed Industry By www.belfercenter.org Published On :: Sep 2, 2015 Sep 2, 2015 "The seed industry in sub-Saharan Africa is informal in nature, with approximately 80% of farmers saving and replanting seeds from year to year. This gives them security of access. But improved varieties — including high-yielding and hybrid crops — will increase productivity and income. To get these seeds into the hands of farmers, a better marketing and distribution system is needed. Local small and medium-sized seed enterprises have a comparative advantage in reaching this underserved market due to their size and market reach." Full Article
trans Education, Research, and Innovation in Africa: Forging Strategic Linkages for Economic Transformation By www.belfercenter.org Published On :: Feb 8, 2016 Feb 8, 2016 Africa is a youthful continent: nearly 41% of its population is under the age of 18. To address the unique challenges of this demographic structure, the African Union (AU) hopes to reposition the continent as a strategic player in the global economy through improved education and application of science and technology in development. The paper proposes the creation of “Innovation Universities” that combine research, teaching, community service and commercialization in their missions and operations. They would depart from the common practice where teaching is carried out in universities that do little research, and where research is done in national research institutes that do not undertake teaching. Under this model, there is little connection with productive sectors. The idea therefore is not just to create linkages between those activities but to pursue them in a coordinated way under the same university structure. Innovation universities can be created in diverse fields such as agriculture, health, industry, services, and environment to advance sustainable development and inclusive growth. Full Article
trans If We Develop Africa's Bioeconomy It Will Be as Transformative for Us as Digital Has Been By www.belfercenter.org Published On :: Dec 13, 2016 Dec 13, 2016 "Unlike the digital revolution that relied on pre-existing technologies, the new bioeconomy will involve more local research, teaching and commercialization. This will require greater involvement of local universities, especially those with an entrepreneurial inclination." Full Article
trans Who Supports Gender Quotas in Transitioning and Authoritarian States in the Middle East and North Africa? By www.belfercenter.org Published On :: Mar 12, 2024 Mar 12, 2024 What are the drivers of citizens’ support for electoral gender quotas in transitioning and authoritarian states? Despite extensive research examining public support for women in politics in democracies, we know little about how the public perceives them in less democratic settings. To address this shortcoming, we use original survey data from authoritarian Morocco and transitioning Tunisia – two Arab countries hailed for their progressive gender policies. We argue that in these countries where citizens lack political information, they instead rely on their assessment of the government’s performance to form attitudes toward gender quotas. Furthermore, electoral legitimacy plays an important role in shaping citizens’ support for quotas, which are closely linked to how elections and legislatures operate. The findings offer strong support for our theoretical expectations and uncover important gender differences. Full Article
trans Zambia UN carbon market focus on VCM transition By www.argusmedia.com Published On :: 08 Nov 2024 13:04 GMT Full Article Emissions CO2 Voluntary carbon offset Zambia Net zero Demand Supply Climate change
trans Cop: UN chief reiterates economic force of transition By www.argusmedia.com Published On :: 12 Nov 2024 11:27 GMT Full Article Crude oil Electricity Emissions Natural gas Global Politics Net zero Investment and Financing Climate change
trans Transboundary Arctic Issues at Stake By www.belfercenter.org Published On :: Mar 28, 2024 Mar 28, 2024 Many issues in the Arctic are transboundary in nature and cannot be solved at the national level. A study group, led by Arctic Initiative Senior Fellow Margaret Williams, examined several key Arctic issues - maritime safety and security, commercial fisheries, and climate change and energy - and the difficulties of addressing them without Russian involvement. Full Article
trans Shaping Transatlantic Security: The EU’s Drive for a Stronger Defense Industry By www.belfercenter.org Published On :: Apr 22, 2024 Apr 22, 2024 On March 05, 2024, the European Commission unveiled its first-ever European Defense Industry Strategy (EDIS). This announcement comes at an unprecedented moment in history. In Ukraine, the situation remains a dire tactical stalemate, while belligerent Russia seems more threatening than ever to the European bloc. In the US, despite the efforts of the Biden administration, aid to Ukraine stalled for months and remains a contentious issue in Congress. Across Europe, EU Member States are trying to fill the gap in aid, but are struggling to supply Ukraine with the defense systems it urgently needs. On February 10, at a rally in South Carolina, former President and presidential candidate Donald Trump cast doubt on whether he would defend or surrender to Russia any European country that would fail to achieve NATO’s 2%-of-GDP target for defense spending. Full Article
trans Democratic Transitions and Conflict Zones: The Impact on Policy-Making in Africa By www.belfercenter.org Published On :: Mar 28, 2024 Mar 28, 2024 On March 26, the study group met for the first time to examine recent democratic progress and backsliding in African countries. The session focused on ongoing conflicts in different regions of Africa and examined their political underpinnings. Participants also discussed the role of third-party actors in supporting and facilitating conflict mediation and peacebuilding efforts in the continent. The study group counted with the presence of external expert guest Dr. Antje Herrberg, Chief of Staff of the European Union Capacity Building Mission in Niger (EUCAP Sahel Niger). Dr. Herrberg brings more than two decades of professional and personal experience in transition and conflict resolution, intractable conflict, and terrorism with a deep interest to alleviate the suffering of people. Furthermore, Florian Dirmayer, Master in Public Policy Candidate at Harvard Kennedy School, delivered a memo briefing on European Union Security Cooperation with Niger After the 2023 Military Coup. Full Article
trans It Doesn’t Make Sense: Why US Tariffs on Chinese Cleantech Risk the Green Transition By www.belfercenter.org Published On :: Jun 26, 2024 Jun 26, 2024 Global demand for renewable energy is surging so why make solar panels, wind turbines and EVs dearer for western consumers? Full Article
trans Sodium: An Alternative to the "White Gold" of the Energy Transition? By www.belfercenter.org Published On :: May 29, 2024 May 29, 2024 The energy transition is driving demand for critical minerals and metals, such as lithium, nickel, cobalt, graphite, and rare earth elements. Sodium-based batteries could provide a more secure, affordable alternative to lithium-ion batteries and highly concentrated lithium supply chains. Full Article
trans Event Debrief: Planning the Mid-Transition for Just and Sustainable Decarbonization By www.belfercenter.org Published On :: Jun 6, 2024 Jun 6, 2024 Emily Grubert, Associate Professor of Sustainable Energy Policy and of Civil and Environmental Engineering and Earth Sciences at the University of Notre Dame, discussed the dangers of an unplanned transition from a fossil-based energy system to a zero-carbon energy system during a talk at Harvard Kennedy School. Full Article