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2 episodes with drug trials
7 episodes with drug trials
2 episodes with drug trials
3 episodes with drug trials
2 episodes with drug trials
2 episodes with drug trials
2 episodes with drug trials
2 episodes with drug trials
3 episodes with drug trials
Steve Grzanich has the business news of the day with the Wintrust Business Minute. Shares of AbbVie have dropped sharply after disappointing trials for its drug to treat schizophrenia. The drug, emraclidine, failed to meet the primary goal of treating symptoms of the mental illness. The drug was part of two mid-stage trials which shows […]
Hadi Finnerty, Senior Manager of Education & Community Volunteers at Alzheimer’s Association Illinois Chapter, joins Lisa Dent to discuss the claims that Ozempic could lower the risk of Alzheimer’s. While the early studies aren’t exactly promising, the sample sizes aren’t large enough to give definitive results.
TODAY ON THE ROBERT SCOTT BELL SHOW: Heavy Metal School Lunches, Jane Durst-Pulkys & Cindy Kennedy, Metabolic Balance, Tuberculinum, Ty Bollinger, Hurricane Milton, FDA and Big Pharma, Pink Fraud Exposed, Bias in Drug Trials and MORE! https://robertscottbell.com/heavy-metal-school-lunches-jane-durst-pulkys-cindy-kennedy-metabolic-balance-tuberculinum-ty-bollinger-hurricane-milton-fda-and-big-pharma-pink-fraud-exposed-bias-in-drug-trials-and-more/
Being a part of a clinical drug trial can pay very well—up to several thousand dollars. And a lot of people need that cash and are desperate to take part. But when someone's desperate for that money, they'll cut a lot of corners: lie to be accepted, fail to report adverse reactions or other complicating factors and skip the mandatory recovery time between trials. When that happens, it can throw everything off, including the data that Health Canada may be relying on in order to approve these drugs for all of us to use...GUEST: Rob Cribb, director of the Investigative Journalism Bureau, investigative reporter at the Toronto Star We love feedback at The Big Story, as well as suggestions for future episodes. You can find us:Through email at hello@thebigstorypodcast.ca Or by calling 416-935-5935 and leaving us a voicemailOr @thebigstoryfpn on Twitter
¡Se filtró un episodio clasificado de Experimentos Legendarios! En 1969 se les enseño a un grupo de monos a usar drogas intravenosas como morfina y heroína para estudiar la adicción. Escucha todos los capítulos disponibles de Experimentos Legendarios exclusivamente en Podimo, haz clic en el link y recibe 30 días de prueba gratis: https://go.podimo.com/leyendas Learn more about your ad choices. Visit megaphone.fm/adchoices
¡Se filtró un episodio clasificado de Experimentos Legendarios! En 1969 se les enseño a un grupo de monos a usar drogas intravenosas como morfina y heroína para estudiar la adicción. Escucha todos los capítulos disponibles de Experimentos Legendarios exclusivamente en Podimo, haz clic en el link y recibe 30 días de prueba gratis: https://go.podimo.com/leyendas Learn more about your ad choices. Visit megaphone.fm/adchoices
Erika is joined by Quintin Maidment, a vice president at CTRx Pathways, to discuss why diversity is critical in clinical drug trials and what barriers stand in the way. In the Beyond the News segment, Nick and Shawn discuss the controversy around efforts by Johnson & Johnson to create a rebate program around 340B drug pricing.
Last month, the first psychedelic therapy treatment came before the Food and Drug Administration for a vote. It entailed using MDMA, also known as ecstasy or molly, to treat PTSD.MDMA therapy has looked promising as a treatment for PTSD and other mental health conditions in some studies. But the FDA scientific advisory panel that evaluated this treatment voted overwhelmingly against approving it.Many of the arguments against approval had less to do with MDMA itself than with the methodology of the clinical trials done by Lykos Therapeutics, formerly the Multidisciplinary Association for Psychedelic Studies, or MAPS. The FDA panel was presented with allegations of misconduct and incongruous data, including a letter by trial participant Sarah McNamee.McNamee, who joined the trial for treatment of PTSD, is also a licensed psychotherapist and researcher of trauma and psychotherapy at McGill University in Montreal. She joins guest host Rachel Feltman alongside Dr. Eiko Fried, a methodologist and psychologist at Leiden University in the Netherlands, to discuss the decision.If you or someone you know is struggling with PTSD or other mental health conditions, call 988 for the suicide and crisis lifeline.Transcripts for each segment will be available after the show airs on sciencefriday.com. Subscribe to this podcast. Plus, to stay updated on all things science, sign up for Science Friday's newsletters.
“I realize there's this massive disconnect in the business model whereby you've got governments and health insurers paying billions and billions of dollars for what might be a not very effective therapy, and then there's all these potential cures, even, and much better treatments out there.” - Savva Kerdemelidis Savva Kerdemelidis and Zan Lowe, of Public Good Pharma, joined me this week to talk about re-aligning the incentive structures for drug development. In our current system, drugs are often funded based on how much of their formula is patentable, and manufacturers will tweak the formulas in order to get new patents when they've run out. So how do we fix the system, for the public good? Savva's solution is to “self-fund” pharmaceutical trials, through employers. These trials can be used to determine if lower cost drugs have the same or better effect than more expensive, patented ones (which they often do), and also demonstrate huge cost-savings for employers. Join us as we take on “Big Pharma” this week on Self-Funded. Chapters: (00:00:00) Introducing Public Good Pharma (00:09:29) Our Profit-Driven Pharmaceutical Industry (00:12:16) Drug Development Challenges in Patent System (00:13:19) Patent Monopolies and “Evergreening” Pharmaceuticals (00:17:44) “Interventional Pharmacoeconomics” (00:19:32) Clinical Trials for Affordable Treatments (00:29:18) Employer Involvement in Lower-Cost Drug Trials (00:33:37) Cost-Effective Pharmaceutical Incentive Strategy (00:36:55) Revamping Healthcare Incentives (00:45:28) Affordable Pharmaceutical Alternatives Key Links for Social: @SelfFunded on YouTube for video versions of the podcast and much more - https://www.youtube.com/@SelfFunded Listen on Spotify - https://open.spotify.com/show/1TjmrMrkIj0qSmlwAIevKA?si=068a389925474f02 Listen on Apple Podcasts - https://podcasts.apple.com/us/podcast/self-funded-with-spencer/id1566182286 Follow Spencer on LinkedIn - https://www.linkedin.com/in/spencer-smith-self-funded/ Follow Spencer on Instagram - https://www.instagram.com/selffundedwithspencer/ Key Words: #PharmaIndustry #DrugPricing #PatentSystem #Evergreening #ValueBasedPricing #InterventionalPharmacoeconomics #FormularyDesign #InnovativeIncentives #FixTheSystem #CostReduction #PersonalizedMedicine #AIinHealthcare #selffunded #podcast Pharma Industry, Drug Pricing, Patent System, Evergreening, Value Based Pricing, Interventional Pharmacoeconomics, Formulary Design, Innovative Incentives, Fix The System, Cost Reduction, Personalized Medicine, AI in Healthcare, self funded, podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/spencer-harlan-smith/support
“I realize there's this massive disconnect in the business model whereby you've got governments and health insurers paying billions and billions of dollars for what might be a not very effective therapy, and then there's all these potential cures, even, and much better treatments out there.” - Savva Kerdemelidis Savva Kerdemelidis and Zan Lowe, of Public Good Pharma, joined me this week to talk about re-aligning the incentive structures for drug development. In our current system, drugs are often funded based on how much of their formula is patentable, and manufacturers will tweak the formulas in order to get new patents when they've run out. So how do we fix the system, for the public good? Savva's solution is to “self-fund” pharmaceutical trials, through employers. These trials can be used to determine if lower cost drugs have the same or better effect than more expensive, patented ones (which they often do), and also demonstrate huge cost-savings for employers. Join us as we take on “Big Pharma” this week on Self-Funded. Chapters: (00:00:00) Introducing Public Good Pharma (00:09:29) Our Profit-Driven Pharmaceutical Industry (00:12:16) Drug Development Challenges in Patent System (00:13:19) Patent Monopolies and “Evergreening” Pharmaceuticals (00:17:44) “Interventional Pharmacoeconomics” (00:19:32) Clinical Trials for Affordable Treatments (00:29:18) Employer Involvement in Lower-Cost Drug Trials (00:33:37) Cost-Effective Pharmaceutical Incentive Strategy (00:36:55) Revamping Healthcare Incentives (00:45:28) Affordable Pharmaceutical Alternatives Key Links for Social: @SelfFunded on YouTube for video versions of the podcast and much more - https://www.youtube.com/@SelfFunded Listen on Spotify - https://open.spotify.com/show/1TjmrMrkIj0qSmlwAIevKA?si=068a389925474f02 Listen on Apple Podcasts - https://podcasts.apple.com/us/podcast/self-funded-with-spencer/id1566182286 Follow Spencer on LinkedIn - https://www.linkedin.com/in/spencer-smith-self-funded/ Follow Spencer on Instagram - https://www.instagram.com/selffundedwithspencer/ Key Words: #PharmaIndustry #DrugPricing #PatentSystem #Evergreening #ValueBasedPricing #InterventionalPharmacoeconomics #FormularyDesign #InnovativeIncentives #FixTheSystem #CostReduction #PersonalizedMedicine #AIinHealthcare #selffunded #podcast Pharma Industry, Drug Pricing, Patent System, Evergreening, Value Based Pricing, Interventional Pharmacoeconomics, Formulary Design, Innovative Incentives, Fix The System, Cost Reduction, Personalized Medicine, AI in Healthcare, self funded, podcast --- Support this podcast: https://podcasters.spotify.com/pod/show/spencer-harlan-smith/support
In this episode of Discover Daily, we explored a range of topics that are shaping the future of technology, healthcare, and entertainment. We began by discussing the strategic partnership between Magic Leap and Google, which aims to push the boundaries of augmented reality (AR) and extended reality (XR) experiences. By combining Magic Leap's expertise in optics and manufacturing with Google's technological capabilities, this collaboration has the potential to deliver cutting-edge AR and XR solutions for various industries.Next, we looked into a groundbreaking development in the field of dentistry, as researchers at Kitano Hospital in Japan prepare to begin human trials for the world's first drug designed to regrow teeth. By targeting the USAG-1 protein, which normally inhibits tooth growth, this innovative treatment encourages the growth of new teeth through bone morphogenetic protein signaling. If successful, the drug could be commercially available by 2030, offering hope to millions of people with missing teeth.We also covered OpenAI's efforts to combat influence operations that misuse its AI tools, as well as the nostalgic Infobar-inspired Apple Watch case that transforms the modern device into a retro accessory. Finally, we discussed Sony Pictures Entertainment's embrace of artificial intelligence to reduce the costs associated with film and television production, highlighting the potential benefits and challenges of integrating AI into the creative process.From Perplexity's Discover feed:The Return of Magic Leaphttps://www.perplexity.ai/page/The-Return-of-4clL.ioDSIK94t.nrdoE3wWorld's First Tooth-Growing Drughttps://www.perplexity.ai/page/Worlds-First-ToothGrowing-NIMSIYlHTKCwe5wUdRbSkwOpenAI Wrestles with Influence Ops https://www.perplexity.ai/page/OpenAI-Wrestles-with-Vy8xUY1XS_ai_GBx7e1PzgInfobar-inspired Apple Watch Case https://www.perplexity.ai/page/Infobarinspired-Apple-Watch-wUafDGFeSiSxlH.JidnXEgSony Pictures Uses AI to Cut Film Costs https://www.perplexity.ai/page/Sony-Pictures-Uses-6_PDbvPzShW.L3pZw0v4sAPerplexity is the fastest and most powerful way to search the web. Perplexity crawls the web and curates the most relevant and up-to-date sources (from academic papers to Reddit threads) to create the perfect response to any question or topic you're interested in. Take the world's knowledge with you anywhere. Available on iOS and Android Join our growing Discord community for the latest updates and exclusive content. Follow us on: Instagram Threads X (Twitter) YouTube Linkedin
In the past few years pharmaceutical companies have developed a string of new Alzheimer's drugs called anti-amyloids, which target amyloid plaques in patients' brains. These plaques are one of the key biomarkers of the disease.The first of these drugs, Aduhelm, was approved by the FDA in 2021 amid enormous controversy. The FDA approved the drug despite little evidence that it actually slowed cognitive decline in patients. Biogen, the maker of Aduhelm, pulled the plug on further research or sales of the drug last month.In January 2023 The FDA approved another anti-amyloid medication from Biogen, lecanemab, sold under the brand name Leqembi. This time, there was much stronger evidence. Clinical trial results showed that the drug showed a modest improvement in cognitive decline in the early phases of the disease. But the drug comes with risks, including brain swelling and bleeding.Most recently, at the beginning of March, the FDA delayed approval of another anti-amyloid drug, donanemab, created by Eli Lilly. The FDA said it will be conducting an additional review to further scrutinize the study design and efficacy data.From the outside looking in, these Alzheimer's drugs appear to be mired in controversy. How well do they actually work? And why has there been so much back and forth with the FDA?To answer those questions and more, guest host Arielle Duhaime-Ross talks with Dr. Jason Karlawish, professor of medicine, medical ethics and health policy, and neurology at the University of Pennsylvania's Perelman School of Medicine, and co-director of the Penn Memory Center.Transcripts for each segment will be available after the show airs on sciencefriday.com. Subscribe to this podcast. Plus, to stay updated on all things science, sign up for Science Friday's newsletters.
In episode 2 of Dugout of History, Chrystal and Colleen dig into the Pittsburgh drug trials, the scandal that many people know because the Pirate Parrot mascot was implicated as a coke dealer, but that had far-reaching impacts across major league baseball, including shaping the sport's drug policy into the Steroid Era.For me (producer Jesse, writing the show notes), it's a very interesting episode because I was a little kid at the time. I remembered Rod Scurry as a Yankee, for instance, and remember him dying young – though I definitely didn't put it together as an 11-year-old that his death was drug-related. Lonnie Smith wound up having a very interesting second act with Atlanta, leading the National League in on-base percentage in 1989 and hitting three homers in the 1991 World Series before blundering on the basepaths in Game 7. Keith Hernandez, obviously, was and is Keith Hernandez.So, I knew some of the details for this one, remembered others, and learned plenty for the first time. The story of the Pittsburgh drug trials also echoes through the way baseball has dealt with subsequent scandals, including in the sport's powers that be making the same mistakes. Thank goodness that's all history, though, and vice-related scandals involving superstars are… ah, dang it. Hosted on Acast. See acast.com/privacy for more information.
In episode 2 of Dugout of History, Chrystal and Colleen dig into the Pittsburgh drug trials, the scandal that many people know because the Pirate Parrot mascot was implicated as a coke dealer, but that had far-reaching impacts across major league baseball, including shaping the sport's drug policy into the Steroid Era.For me (producer Jesse, writing the show notes), it's a very interesting episode because I was a little kid at the time. I remembered Rod Scurry as a Yankee, for instance, and remember him dying young – though I definitely didn't put it together as an 11-year-old that his death was drug-related. Lonnie Smith wound up having a very interesting second act with Atlanta, leading the National League in on-base percentage in 1989 and hitting three homers in the 1991 World Series before blundering on the basepaths in Game 7. Keith Hernandez, obviously, was and is Keith Hernandez.So, I knew some of the details for this one, remembered others, and learned plenty for the first time. The story of the Pittsburgh drug trials also echoes through the way baseball has dealt with subsequent scandals, including in the sport's powers that be making the same mistakes. Thank goodness that's all history, though, and vice-related scandals involving superstars are… ah, dang it. Hosted on Acast. See acast.com/privacy for more information. This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit willetspen.substack.com
In this episode of "From Our Neurons to Yours," we're taking a deep dive into the neuroscience of obsessive-compulsive disorder (OCD) and the recent discovery that the anesthetic ketamine can give patients a week-long "vacation" from the disorder after just one dose.Join us as we chat with Dr. Carolyn Rodriguez, a leading expert in the field, who led the first clinical trial of Ketamine for patients with OCD. She sheds light on what OCD truly is, breaking down the misconceptions and revealing the reality of this serious condition.Dr. Rodriguez, a professor of psychiatry at Stanford Medicine, discusses her research on ketamine for OCD, current hypotheses about how it works in the brain, and her approach to developing safer treatments. Listeners are encouraged to seek help if they or a loved one are struggling with OCD.Learn more:Rodriguez's OCD Research Lab (website)Rodriguez at the World Economic Forum (video - WEF)International OCD Foundation (IOCDF) (website)Rodriguez pioneers VR therapy for patients with hoarding disorder (video - Stanford Medicine)The rebirth of psychedelic medicine (article - Wu Tsai Neuro)Researcher investigates hallucinogen as potential OCD treatment (article - Stanford Medicine)Episode credits:This episode was produced by Michael Osborne at 14th Street Studios, with production assistance by Morgan Honaker. Our logo is by Aimee Garza. The show is hosted by Nicholas Weiler at Stanford's Wu Tsai Neurosciences Institute. Thanks for listening! Learn more about the Wu Tsai Neurosciences Institute at Stanford and follow us on Twitter, Facebook, and LinkedIn.
Explore the journey of breaking boundaries as QuantHealth secures $15M to drive AI-driven clinical drug trials in the United States. Delve into the innovative strategies that promise to reshape the future of healthcare research. Get on the AI Box Waitlist: AIBox.ai Join our ChatGPT Community: Facebook Group Follow me on Twitter: Jaeden's Twitter
Witness the catalyzation of change as QuantHealth secures $15M to drive AI-driven clinical drug trials in the United States. Explore how this funding is set to revolutionize the approach to healthcare research and drug development. Get on the AI Box Waitlist: AIBox.ai Join our ChatGPT Community: Facebook Group Follow me on Twitter: Jaeden's Twitter
ChatGPT: OpenAI, Sam Altman, AI, Joe Rogan, Artificial Intelligence, Practical AI
Dive into the future of healthcare research with QuantHealth, as their $15M funding fuels AI advancements in US clinical drug trials. Explore the transformative potential of AI in advancing the efficiency and accuracy of drug development. Get on the AI Box Waitlist: AIBox.ai Join our ChatGPT Community: Facebook Group Follow me on Twitter: Jaeden's Twitter
Witness the dawn of a new era as QuantHealth, AI pioneers, secures $15M in funding for groundbreaking clinical drug trials in the United States. Dive into the transformative impact of AI on reshaping the landscape of healthcare research. Get on the AI Box Waitlist: AIBox.ai Join our ChatGPT Community: Facebook Group Follow me on Twitter: Jaeden's Twitter
In this episode, we explore the impact of QuantHealth's remarkable achievement—a $15 million investment—focused on employing AI for clinical drug trials in the United States, discussing the implications for healthcare advancements. Invest in AI Box: https://Republic.com/ai-box Get on the AI Box Waitlist: https://AIBox.ai/ AI Facebook Community Learn more about AI in Video Learn more about Open AI
The fellas are joined again by Dr. Brian Koffman, a well-known doctor, educator, and clinical professor turned patient has dedicated himself to teaching and helping the Chronic Lymphocytic Leukemia (CLL) community since his diagnosis in 2005. Dr. Koffman believes that his dual status as a physician and patient provides a unique experience and understanding which allows him to provide clear explanations of complex issues and to advocate for his fellow patients and inform his fellow healthcare providers. This week Dr. Koffman joins the boys to chat about CAR-T Cell therapy and all the things you'd ever want to know about drug trials! Join the post-episode conversation over on Discord! https://discord.gg/expeUDN
The fellas are joined again by Dr. Brian Koffman, a well-known doctor, educator, and clinical professor turned patient has dedicated himself to teaching and helping the Chronic Lymphocytic Leukemia (CLL) community since his diagnosis in 2005. Dr. Koffman believes that his dual status as a physician and patient provides a unique experience and understanding which allows him to provide clear explanations of complex issues and to advocate for his fellow patients and inform his fellow healthcare providers. This week Dr. Koffman joins the boys to chat about CAR-T Cell therapy and all the things you'd ever want to know about drug trials! Join the post-episode conversation over on Discord! https://discord.gg/expeUDN
Police are ramping up their patrols this evening in an effort to catch those drinking and driving. MTA and the North County Transit District will be offering free rides anytime after 6:00 tonight. UC San Diego researchers and two local clinics are looking for participants to help in a new study for a drug geared toward fighting Alzheimer's disease. See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
Why is Ketamine being used to treat depression and anhedonia? In this science-y episode I'm going through the neuroscience of Ketamine and the brain, the chemical makeup of the drug, and why it's being used in many trials to treat people with treatment resistant depression and anhedonia. BRAIN FACT:ECT therapy – what is It, how does it work, what type of mental disorders is it used as a treatment for. Read more about ECT from the Mayo Clinic https://mayocl.in/3sfPN9W . EXTRA READING Read Understanding Anhedonia https://bit.ly/anhedonia-explained . Mandal S, Sinha VK, Goyal N. Efficacy of ketamine therapy in the treatment of depression. Indian J Psychiatry. 2019 Sep-Oct;61(5):480-485. doi: 10.4103/psychiatry.IndianJPsychiatry_484_18. PMID: 31579184; PMCID: PMC6767816. LISTENER QUESTION:rr I'm doing my PHD and have realised I don't think I want a career in the thing I'm studying. After listening to your episode on the Sunk Cost Fallacy (https://bit.ly/46TyOJs ) I'm looking for advice on whether or not I should finish the PHD or not. LINKS: Send your Listener question to info@dyfmpod.com Join DYFM + https://bit.ly/dyfm-membership . Subscribe to the DYFM 6 week course https://bit.ly/dyfm-course . Follow @dyfmpodcast on Instagram Follow @alexispredez on Instagram Join the DYFM Facebook Group https://bit.ly/dyfm-group . Follow @listnrentertainment on Instagram CREDITS Host: Alexis Fernandez Executive Producer & Editor: Elise CooperDigital Producer: Zoe Panaretos DYFM Social Producer: Shania MaguaManaging Producer: Sam Cavanagh Find more great podcasts like this at www.listnr.com/ See omnystudio.com/listener for privacy information.
AI Hustle: News on Open AI, ChatGPT, Midjourney, NVIDIA, Anthropic, Open Source LLMs
Join us in this episode as we delve into the groundbreaking world of AI-powered clinical drug trials. We sit down with the leaders at QuantHealth, who just secured $15 million in funding to revolutionize the landscape of drug research. Discover how AI is accelerating and optimizing the process, potentially bringing life-saving treatments to patients faster than ever before. Get on the AI Box Waitlist: https://AIBox.ai/Join our ChatGPT Community: https://www.facebook.com/groups/739308654562189/Follow me on Twitter: https://twitter.com/jaeden_ai
AI Chat: ChatGPT & AI News, Artificial Intelligence, OpenAI, Machine Learning
In this episode, we dive into QuantHealth's recent $15 million funding round and its ambitious plan to revolutionize clinical drug trials in the US using AI technology. Learn how the company aims to increase the efficiency and accuracy of trials, and what this could mean for the future of healthcare. Get on the AI Box Waitlist: https://AIBox.ai/ Facebook Community: https://www.facebook.com/groups/739308654562189/ Discord Community: https://aibox.ai/discord Follow me on X: https://twitter.com/jaeden_ai
Northwestern Medicine Chief Medical Officer Dr. Kevin Most joins the Steve Cochran Show to discuss a new smoking cessation drug that may be hitting the market soon, over-the-counter birth control that may be available as soon as 2024, and the potential long-term health implications associated with Ozempic usage. Dr. Kevin Most's Show Notes: Over-the-counter oral contraceptive pill FDA approved. On Thursday the FDA approved the first OTC birth control pill. Drastic change? There are 100 other countries that already have this in place, so we are lagging not cutting edge The drug named Opill has been safely used for years across the world The medication is expected to be available in January and will not have an age restriction Will be interesting to see the pricing and if insurance companies will cover the cost. The medication is sometimes called a “mini pill” it has progestin, it suppresses ovulation The FDA voted unanimously that the benefits outweigh the risks There is obviously the political as well as religious concerns It is not uncommon for a drug to go from prescription to OTC (Aleve, Nexium, Pepcid, Zyrtec) Drug for smoking cessation does well in clinical trial Smoking cessation has always been a difficult thing to accomplish Many things have been tried- nicotine patch, nicotine gum, antidepressants, acupuncture, hypnosis- most with little or no success Currently a Phase 3 study on a drug historically known as Cytisine being done at Mass General Results out in JAMA recently are very positive- effective and well tolerated Cytisine is a natural plant based compound that binds to the nicotine receptors in the brain that slow the urge to smoke This is better than the slow decline in nicotine replacement This was done at 17 sites with over 800 participants with the end goal being total stopping of smoking for a 4 week period Individuals in the trial noted a rapid and sustained decline in the craving and smoking urges in the first month Over the long term it continued to show great success at the 6 month mark Well tolerated with low rates of side effects Drug information- Drugs have a patent life where no generics can be made and a company has the exclusive rights to produce and sell the drug The patent life for a drug is 20 years from the date the patent was submitted, however there are extensions for antibiotics, some pediatric drugs, orphan drugs The patent does not mean that a company has 20 years of sales without a competitor as some of these drugs will take 10-15 years to go thru the trails necessary for approval There are 51 drugs coming off patent in 2023 including billion dollar drugs used to treat diabetes, depression, arthritis, ADHD If you are taking a brand name drug and want to see when it will come off patent Pharsight is a great resource Drug shortages- safety lapses- razor thin margins- tough competition Drug shortages in the US are at the highest level in 9 years Medications currently in short supply include Chemotherapy drugs, ADHD drugs and antibiotics Drug shortages are not where a drug is out 100% it is where the current supply exceeds the current need Chemotherapy shortages are the most detrimental as patients are on specific medications with specific dosing and alternates are not easy to find if even possible Chemotherapy in those cases is delayed, or lower doses are given Currently close to 2 dozen chemotherapy drugs and in shortage status Why is it occurring? Multi factorial – a factory in India, Intas Pharmaceuticals , that made about one half of Chemo used in the US, had quality issues and was shut down by the FDA last December, other companies did not step up and fill that void This has forced the FDA to allow for some chemo drugs to be imported from China Information on demand is not easy to get as drug companies often want to keep that private to minimize competition 90% of prescriptions are for generic medications- the goal is to keep prices down- encourage sufficient supplies – ensure the meds are safe and effective in generic format Those 3 goals are difficult to hit all at once the 3 pull at each other. Margin on generic drugs is small as companies had a race to the bottom as they tried to gain market share. Continuing to lower the price to knock out competitor but also shrinking margins Covid, inflation and work force shortages have impacted many generic drug manufacturers No perfect solution Medicare to finally negotiate pricing on medications- good or bad? We are all waiting to see the list of drugs that federal officials will target as they pen negotiations on pricing later this year. The new law, part of the Inflation Reduction Act, allowing for Medicare to negotiate on drug prices goes into effect in September of this year For the past 30 years this negotiation was not allowed by law The first round will focus on 10 drugs that are selected for being the most expensive with high use. The list is not yet decided on but a few expected include Embrel- for arthritis, Xarelto- a blood thinner, Januvia- a diabetes medication The price difference in different companies is ridiculous. An example- Xarelto the blood thinner, in the US a years prescription costs $6,240. While in Canada it cost just above $1,000 Now, don't expect any quick changes, the negotiations are scheduled for 2024 and 2025, with the negotiated price change going into effect Jan 1, 2026, however one drug has been impacted with Insulin having a $35 / month cap for Medicare patients that is now in effect. See omnystudio.com/listener for privacy information.
In this episode, we are joined by Dr. Lutz Harms. Lutz is a Senior Director at GW Pharma Germany and has over 20 years of experience in leading orphan drug and specialty businesses in Germany and Europe. He has a proven track record in delivering growth and performance turnarounds. With over 15 years of experience in leadership of orphan drug and specialist medicines businesses in Germany including market access (AMNOG process) and launches/relaunches. Topics: 1. Orphan Drug Trials 2. Launching Epidyolex 3. Market Access Requirements * Twitter - @TheCannabisRev2 * LinkedIn - @thecannabisreview * Episode Library - https://www.thecannabisreview.ie
Manal Abdelmalek, Jörn Schattenberg and Ian Rowe join Stephen Harrison, Louise Campbell and Roger Green to recap NAFLD and NASH-related insights from TLMdX 2021, the AASLD annual liver meeting. This conversation focuses on crafting the most robust efficient pathway to shift the gold standard of drug development from semi-quantitative biopsy reads to intelligent use on non-invasive techniques.Opinions diverge about everything from how easy it will be to replace biopsy to exactly what that pathway might look like. What is clear is that everyone in this discussion believes with a hot passion that biopsy is a critical impediment to getting drugs approved.
Everyone! Evade everyday errands with enjoyment in the ears! It's "E"! Justin talks about one of his favorite playwrights, Erika shows us a play about a drug trial gone romantic, and they both say Erika's name 20 times because...IT STARTS WITH "E". An exciting episode for everyone!Our small theatre shout out is Everyman Theatre in Baltimore, MD! Follow them on instagram @everymantheatre!Special thanks to Broadway Licensing for being a script supplier of the show and U92 for being our recording headquarters!If you like the show, feel free to subscribe and give us a five star review! Also, follow us on instagram @justinborak and @actualerikakuhn for any news and notes on upcoming episodes!
Rare diseases are also called ‘orphan diseases,' so named because they were long abandoned (or orphaned) by a profit-driven pharmaceutical industry.Rare diseases are also called ‘orphan diseases,' so named because they were long abandoned (or orphaned) by a profit-driven pharmaceutical industry. So why a book about orphan drugs, which by definition treat only rare diseases? Did they really trigger a revolution important enough to care about? And if so, why is that so little known? In fact, orphan drugs have revolutionized society, for reasons ranging from the deeply personal to the broader cultural and political.Rare diseases deserve our attention because they're merciless, causing families often far worse human suffering than common diseases. And unlike many common diseases, few can be prevented or treated by a good diet or exercise. Perhaps most importantly, a rare genetic disease could someday strike any family—and an orphan drug become of utmost urgency to anyone with a child or grandchild, niece or nephew.A biotechnology executive, Jim Geraghty has been a passionate participant in the orphan drug revolution since its inception. His book is in part a history, with eyewitness accounts of advances as they occurred and portraits of the pioneering scientists and physicians, tireless activists, and visionary business leaders who made the revolution happen. And it tells deeply personal stories of patients and parents willing to risk new, untried therapies. But Geraghty also uses his exceptional experience and vantage point to look forward, to the immense promise of the newest technologies like gene therapy and gene editing for the treatment of patients today and tomorrow.
Rare diseases are also called ‘orphan diseases,' so named because they were long abandoned (or orphaned) by a profit-driven pharmaceutical industry.Rare diseases are also called ‘orphan diseases,' so named because they were long abandoned (or orphaned) by a profit-driven pharmaceutical industry. So why a book about orphan drugs, which by definition treat only rare diseases? Did they really trigger a revolution important enough to care about? And if so, why is that so little known? In fact, orphan drugs have revolutionized society, for reasons ranging from the deeply personal to the broader cultural and political.Rare diseases deserve our attention because they're merciless, causing families often far worse human suffering than common diseases. And unlike many common diseases, few can be prevented or treated by a good diet or exercise. Perhaps most importantly, a rare genetic disease could someday strike any family—and an orphan drug become of utmost urgency to anyone with a child or grandchild, niece or nephew.A biotechnology executive, Jim Geraghty has been a passionate participant in the orphan drug revolution since its inception. His book is in part a history, with eyewitness accounts of advances as they occurred and portraits of the pioneering scientists and physicians, tireless activists, and visionary business leaders who made the revolution happen. And it tells deeply personal stories of patients and parents willing to risk new, untried therapies. But Geraghty also uses his exceptional experience and vantage point to look forward, to the immense promise of the newest technologies like gene therapy and gene editing for the treatment of patients today and tomorrow.
After a month of major Fatty Liver medical meetings, Jörn Schattenberg, Louise Campbell and Roger Green explore emerging stories that will shape the next 6-12 months in Fatty Liver disease. This conversation focuses on exciting data they anticipate for multiple different drugs. They also discuss the implications positive drug trials and anticipated approvals will have for NAFLD treatment.Roger starts by discussing the educational work Intercept was beginning before obeticholic acid received its complete response letter in 2020. He underlines the logic that doctors will be more eager to learn how to treat when given a reliable way to achieve results.Jörn expresses specific enthusiasm about the future of FGF-21s as implicated by the recent Akero Phase 2b results. Roger then notes the promising data and/or approvals on the horizon for four different modes of action. He suggests that with these, the ideas of combination therapy and disease regression or resolution may become real for the first time. Louise agrees about the promise of the medications. However, she expresses strong concern that the diagnostic and patient management structures will not be in place before the drugs arrive. This shortcoming will slow the ability to bring these benefits to patients. Jörn returns to the excitement about the drugs and the idea that significant amounts of data may come as soon as November's AASLD meeting. As the conversation ends, the group begins to explore where bottlenecks in getting drugs to patients might exist.
Jörn speaks about co-authoring an article, “The Nonalcoholic Steatohepatitis (NASH) drug development graveyard: established hurdles and planning for future successes.” In doing so, he discusses areas for improvement he feels clinical trial strategy and design will require. Joining the conversation is Stephen Harrison and Global Liver Institute Founder and CEO, Donna Cryer. Both Stephen and Donna approach the conversation from the patient and patient advocate perspectives. This episode From the Vault provides an amazing and complementary comparison to how far this topic has come in just two years. Notably, much has developed in the space of NITs since this paper in 2020. In this week's Surf, Season 3 - Episode 41, Roger, Louise, Stephan and Jörn reflect on what has improved in the intervening time period, what has not, and where this space is headed.
A look into the current state of science and regulations when it comes to using animals in research. In other news, San Diego County health officials held a monkeypox town hall yesterday, to discuss the virus with community members. Plus, some of the weekend arts events happening around San Diego.
A San Diego company is facing backlash for using Beagles in drug trials. In other news, repairs continue in Tijuana after a major sewage rupture last week. Plus, a new safe parking lot is open for homeless people sleeping in their cars in East County.
Our week of "Greatest Hits" episodes from the vault starts with Jörn's first featured episode, which we posted in November 2020. The episode focused on a recent article he co-authored looking at why so many NASH drug trials fail. One key issue: proper utilization of Phase 2 trials. At the time, we wrote:Jörn Schattenberg joins Stephen, Donna, Louise and Roger to discuss his recent article "The Nonalcoholic Steatohepatitis (NASH) drug development graveyard: established hurdles and planning for future successes." The discussion starts with lessons from failed trials, focusing on the importance of utilizing Phase 2 trials to test hypotheses and establish appropriate targets. From there, Surfers went on to discuss commercial and patient-focused definitions of what makes a clinical trial successful.
Surfing the NASH Tsunami posted on Buzzsprout for the first time on July 23, 2020. Over the past two years, NASH Tsunami has posted 132 episodes and close to 400 posts when we include both episodes and conversations. This week, Jörn Schattenberg and Roger Green review some of the podcast's high points and set the stage for a week of resharing "Greatest Hits" episodes and conversations from the Vault of old postings.The conversation starts with Jörn and Roger reminiscing about Jörn's first couple of appearances on the podcast, first helping to review the digital ILC 2020 and then coming on a couple of months later to discuss a paper Jörn had recently published looking at why NASH drug trials fail. Jörn and Roger discuss come of the lessons from the paper and how those have translated into changes in drug development and clinical trial strategies.One interesting side note: Roger asks Jörn about feedback from the original paper. He comments that the authors rarely get feedback, especially those who are not the correspondent author (which Jörn was not for this paper). He commented that he receives more feedback from the discussions on NASH Tsunami, either on the podcast or in subsequent conversations with friends and colleagues who have heard the episode. Roger goes on to note that while the "Why Trials Fail" paper touched on challenges around biomarkers and conditional endpoints, we were only at the beginning of learning how many flaws existed in the system of semi-quantitative reads. This serves as a bridge to the specific conversations NASH Tsunami will repost from the Vault during this anniversary week. They address topics ranging from stellate cell activation to the role of NITs to the importance of patient advocacy. As they move from post to post, Jörn and Roger provide context on where each one fits in the history of the podcast and what they learned or experienced as a result. Of course, a podcast without Stephen or Louise can provide only so much of the podcast's history and key moments, but for listeners, this episode will give you an opportunity to reflect on your own intellectual journey with NAFLD and NASH and to ask yourself which of the older episodes and conversations you might want to revisit. As we noted earlier, we will post two episodes and six conversations we like to revisit in the week ahead.
In the episode, "An Interview with Psychologist Dr. Roger McFillin, host of Radically Genuine Podcast, on Psych Meds, Drug Trials, Resilience & Recovery (S4, E4)," Licensed Psychologist Dr. Roger K. McFillin, who is the Executive Director of the Center for Integrated Behavioral Health in Bethlehem PA, joins the show. Also host of the podcast “Radically Genuine”, Roger is strongly committed to the use of evidence-based treatments and specializes in Cognitive-Behavioral Therapy (CBT) and Dialectical Behavior Therapy (DBT) for the treatment of post-traumatic stress, eating disorders & mood/anxiety related concerns.McFillin is extremely vocal about the fact that psych meds do not improve long-term outcomes and openly challenges the scientific basis to support their efficacy. He reveals how contrived the drug trials are explaining what data is actually published. Conducted by the pharmaceutical industry, these studies test efficacy for up to only 8 weeks, while patients are often prescribed them for life. In contrast he offers ample insight as to what proper mental health treatment looks like. With his belief in resilience and recovery, his message is that healing is possible in a variety of ways and that the human spirit has imbedded in it the potential to rise above obstacles in life. Criticizing the overriding reductionist materialist view in today's Western medicine, Dr. Roger McFillin shares how many of these historical cultural norms and narratives no longer serve us in our modern age. Although he has experienced some backlash in the mental health field for his openly critical assertions, particularly on his active Twitter platform (@DrMcFillin), Dr. McFillin is opening the conversation for those in the prescribed harm community and the psychiatric survivor movement, as he invites the ethical and open-minded players in the mental health professional arena to debate the problems openly on his Radically Genuine Podcast to discuss new change for the better. #prescribedharm #radicallygenuinepodcast #bigpharmaharms #ethicalscience #mentalhealth #therapy #mentalillness #westernpsychiatry #evidencebasedtreatment #psychiatricsurvivor #resilience #recovery #bipolarartist #PTSD #depression #anxiety #DSMlabels #mentalhealthpodcast #materialism #biomedicalmodel #humanexperience Follow Dr. Roger McFillin on:Twitter: @DrMcFillinIG and TikTok: @radgenpodEmail thoughts and questions to: radgenpod@gmail.comCheck out his website at: https://www.centerforibh.com/Listen to his Radically Genuine Podcast at any podcast locationDon't forget to subscribe to the Not As Crazy As You Think YouTube channel @SicilianoJenAnd please visit my website at: www.jengaitasiciliano.comConnect: Instagram: @ jengaitaLinkedIn: @ jensicilianoTwitter: @ jsiciliano
This week, we take a look at the biggest baseball scandal at the time, since the 1919 World Series fix. Seven of some of the biggest names in baseball, took the stand before a federal grand jury, to expose the incredible network of players using cocaine, as well as the local Pennsylvania baseball fans who would ultimately pay the price, for servicing the player's insatiable appetite for the drug. An enterprise so expansive, that even the Pirates' mascot, the Parrot, was conducting deals in the Pittsburgh clubhouse during games. #PeterUeberroth #JoaquinAndujar #DaleBerra #EnosCabbell #KeithHernandez #JeffLeonard #DaveParker #LonnieSmith #RodScurry #KevinKoch #CurtisStrong #DaleShiffman #JAAllen #AdamORenfro
This week, we take a look at the biggest baseball scandal at the time, since the 1919 World Series fix. Seven of some of the biggest names in baseball, took the stand before a federal grand jury, to expose the incredible network of players using cocaine, as well as the local Pennsylvania baseball fans who would ultimately pay the price, for servicing the player's insatiable appetite for the drug. An enterprise so expansive, that even the Pirates' mascot, the Parrot, was conducting deals in the Pittsburgh clubhouse during games. #PeterUeberroth #JoaquinAndujar #DaleBerra #EnosCabbell #KeithHernandez #JeffLeonard #DaveParker #LonnieSmith #RodScurry #KevinKoch #CurtisStrong #DaleShiffman #JAAllen #AdamORenfro
Clinical trials can save lives and provide new ways to treat disease. The industry estimates that 85% of all clinical trials face delays due to patient enrollment. Understanding that challenge and finding ways to minimize it is the pursuit of Jeeva Informatics. The company's founder and CEO, Dr. Harsha Rajasimha, joined Kevin Stevenson on I Don't Care to discuss the issue.Dr. Rajasimha has a long history of clinical research experience, working as a data scientist and software engineer. After several personal tragedies, he wanted to apply his knowledge to helping clinical research trials overcome logistical burdens to bring new treatments to market faster.“The biggest barrier in clinical trials is delays in the timeline associated with patient recruitment. Traditionally, those enrollees must be within 50 miles of the lab,” Dr. Rajasimha explained. That narrows down access considerably. “Only 1.2% of cancer patients in the U.S. are in a clinical trial.”The other challenge is the logistics. Patients must travel to sites for treatment or simply just exchanges with physicians. “It's a travel burden for patients and their caregivers,” Dr. Rajasimha noted.To change the clinical trial ecosystem, Dr. Rajasimha said that the paradigm of the four walls of the lab must evolve. “Clinical trials have been slow to adopt digital channels, but the pandemic forced this.”By digitizing and automating repetitive manual tasks, the burden of participation shrinks for the patient. “The pandemic showed that there is a demand for flexibility in decentralizing clinical trials. With the right tools, this is possible,” Dr. Rajasimha explained.By leveraging technology, clinical trial producers can maximize diversity, equity, and inclusion. With more communication and interaction, patients in trials are also more likely to adhere to medication instructions and be more trusting of the process
Jerry Fu was a former pharmacist that became a certified leadership coach specialized in conflict resolution. He gives his knowledge during the pandemic, why he switched and his expertise in general. For more information visit: www.adaptingleaders.com
Welcome to When It Goes Wrong, the podcast about disasters, accidents and when things fall apart. On this episode, I discuss drug trials which have gone wrong and resulted in catastrophic side effects for the participants. I discuss the Theraluzimab trial along with the current covid vaccine trials.Please subscribe and review for more! You can follow the podcast on instagram at https://instagram.com/whenitgoeswrongpod or email with your feedback and ideas to whenitgoeswrongpod@gmail.com.Sources:Drug development:https://mstrust.org.uk/a-z/drug-development-processhttps://en.wikipedia.org/wiki/Drug_developmenthttps://www.nhs.uk/conditions/clinical-trials/TGN:https://www.bbc.com/news/magazine-35766627https://en.wikipedia.org/wiki/Theralizumabhttps://www.reuters.com/article/us-drug-comeback-exclusive/exclusive-drug-that-caused-elephant-man-side-effect-makes-comeback-after-2006-disaster-idUSKBN0MK1SQ20150324https://www.huffingtonpost.co.uk/entry/the-drug-trial-bbc-examines-what-went-wrong-in-the-infamous-elephant-men-case_uk_58ac3bd1e4b07028b703c926The drug trial documentary on BBC / youtubeBIA:https://en.wikipedia.org/wiki/BIA_10-2474https://edition.cnn.com/2016/05/23/health/fatal-french-drug-trial-investigation/index.htmlhttps://www.theguardian.com/science/2016/mar/07/french-drug-trial-man-dead-expert-report-unprecidented-reactionhttps://www.reuters.com/article/us-health-france-test-idUSKCN0WI007Covid:https://theconversation.com/explainer-how-clinical-trials-test-covid-19-vaccines-146061https://theconversation.com/coronavirus-vaccine-understanding-trial-results-roll-out-and-what-happens-next-an-expert-guide-151971https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/https://www.swlstg.nhs.uk/news-and-events/latest-news/item/vaccine-safety-and-myths-bustinghttps://britishima.org/operation-vaccination/hub/covidmyths/https://www.nature.com/articles/d41586-020-03441-8
In this episode, we'll discuss what vaccine and drug trials are, how they work, and how this relates to the development of a COVID-19 vaccine. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app
COVID-19 drug trials for Blacks; BLM Breathe Act unveiled; Changes at Essence; FB meets rights orgs Support #RolandMartinUnfiltered via the Cash App ☛ https://cash.app/$rmunfiltered or via PayPal ☛https://www.paypal.me/rmartcinunfiltered #RolandMartinUnfiltered Partner: Ceek Be the first to own the world's first 4D, 360 Audio Headphones and mobile VR Headset. Check it out on www.ceek.com and use the promo code RMVIP2020 - The Roland S. Martin YouTube channel is a news reporting site covered under Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for "fair use" for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Learn more about your ad-choices at https://www.iheartpodcastnetwork.com See omnystudio.com/listener for privacy information.
On this episode, I review many possible treatments for COVID-19, including Ivermectin, Hydroxychloroquine/Azithromycin, Remdesivir, Vitamin C, and Ozone. I also get into some important elements of clinical trials. There are other proposed treatments out there, roughly 388 clinical trials going right now, so I may have missed a few things. hereswhaticansay@gmail.com Thanks for listening! Dr Greg
Welcome back to this week's #FridayReview where I can't wait to share with you the best of the week! I'm looking forward to reviewing: Bad news media Fuzzy California media math Mask safety recommendations Sabotaging Virus drug trials Colloidal Silver research benefits Elite Man podcast interview Your Own Magic podcast interview A Game Advantage podcast interview For all the details tune into this week's #CabralConcept 1533 - Enjoy the show and let me know what you thought! - - - Show Notes & Resources: http://StephenCabral.com/1533 - - - Dr. Cabral's New Book, The Rain Barrel Effect https://amzn.to/2H0W7Ge - - - Join the Community & Get Your Questions Answered: http://CabralSupportGroup.com - - - Dr. Cabral's Most Popular At-Home Lab Tests: > Complete Minerals & Metals Test (Test for mineral imbalances & heavy metal toxicity) - - - > Complete Candida, Metabolic & Vitamins Test (Test for 75 biomarkers including yeast & bacterial gut overgrowth, as well as vitamin levels) - - - > Complete Stress, Mood & Metabolism Test (Discover your complete thyroid, adrenal, hormone, vitamin D & insulin levels) - - - > Complete Stress, Sleep & Hormones Test (Run your adrenal & hormone levels) - - - > Complete Food Sensitivity Test (Find out your hidden food sensitivities) - - - > Complete Omega-3 & Inflammation Test (Discover your levels of inflammation related to your omega-6 to omega-3 levels)
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