Podcasts about The KLF

Selv små influenter med en lille følgerskare – eller mikro-influencere, som de også kaldes – kan være en god forretning som reklamekanal. Det får vi en snak om med Frederik Nikolai Kruchov, som er medejer af bureauet Inmix, der fungerer som bindeled mellem virksomheder og influenter. De mindre influenter får måske mange af os til at sænke paraderne en anelse mere, fordi vi føler os tættere på, mere i øjenhøjde og tryggere ved en lille – måske lokal – influent. Det kan være en af forklaringerne på, at virksomheder har held med at bruge mikroinfluencere som reklamesøjle. Lyt med, når vi tager sidste interview i temaet om influencere med Frederik Nikolai Kruchov fra Inmix – og vender det i KLF-studiet, hvor nogle bagsider ved skærmbrug (bl.a. de fysiske) bliver debatteret. Og hvorfor har vi egentlig så travlt med at forsvare teknologien hver gang, vi nævner ulemperne? Misforståelser opstår let, når mennesker kommunikerer – men nogle bliver til sejlivede myter. Derfor griber vi fat i nogle af dem, der er dukket op flere gange i vores arbejde i KLF, Kirke & Medier. Måske du også bliver klogere af at få udredt et par af dem her? Medvirkende: Medstifter af bureauet Inmix Frederik Nikolai Kruchov og KLFs generalsekretær Mikael Arendt Laursen. Vært: Malene Tonnung. EKSTRAMATERIALE Vi har allerede tabt en generation til skærmen – interview med David Madsen: https://klf.dk/vi-har-allerede-tabt-en-generation-til-skaermen-interview-med-david-madsen/ Hvem har magten over skærmen – interview med Camilla Mehlsen: https://klf.dk/hvem-har-magten-over-skaermen-interview-og-updates-fra-klf-lige-nu/ 3 råd: Sæt rammer for din brug af nyhedsmedier: https://klf.dk/3-raad-saet-rammer-for-din-brug-af-nyhedsmedier/ Send meget gerne dine reaktioner ind her: https://klf.dk/reager/  Vil du gerne have et KLF-møde i kalenderen i din kirke eller forening? Så besøg http://book.klf.dk/ Hvis der er emner, du synes, at vi skal tage op i podcasten, er du velkommen til at sende en mail på podcast@klf.dk Hvis du har lyst til at støtte KLFs podcast og KLFs arbejde i det hele taget, kan det ske på Mobilepay: 76540. På forhånd tak for enhver gave! Hvis du ikke er medlem af KLF, er du meget velkommen: https://klf.dk/bliv-medlem/

Ja, det kommer såmænd også til at handle om clickbait i denne udgave af Lyt til KLF, men der er så meget andet på menuen, før vi når dertil. I anledning af DRs 100 års jubilæum spørger vi nemlig os selv på KLF, hvor gift vi er med DR? For der er ingen tvivl om, at Danmarks største public service-kanal fylder meget i vores bevidsthed og i vores gøremål. Vi fortsætter vores interviewrække om influencere – denne gang med et interview med biskop Peter Birch, som fortæller om en kampagne sidste år, hvor flere fik det i den gale hals, at influencere satte fokus på dåben. Dk4 sætter med en ny programrække med en lang række personligheder fra medier, politik og kultur fokus på, hvilke egenskaber DRs nye generaldirektør skal have. Det har fået KLF til at stille et par spørgsmål til værten Morten Hesseldahl. Bliv også klogere på vores analysearbejde på clickbait og bliv opdateret fra KLF-studiet.   Medvirkende: KLFs generalsekretær Mikael Arendt Laursen, tv-vært Morten Hesseldahl, biskop Peter Birch og analyseformidler Andreas Jensen. Vært: Malene Tonnung.   EKSTRAMATERIALE Dk4 kommer med forslag til DRs nye generaldirektør: https://klf.dk/dk4-kommer-med-forslag-til-drs-nye-generaldirektoer/ DR og KLF: En fortælling om et venskab: https://klf.dk/dr-og-klf-en-fortaelling-om-et-venskab/ 3 råd: Sæt rammer for din brug af nyhedsmedier: https://klf.dk/3-raad-saet-rammer-for-din-brug-af-nyhedsmedier/   Send meget gerne dine reaktioner ind her: https://klf.dk/reager/  Vil du gerne have et KLF-møde i kalenderen i din kirke eller forening? Så besøg http://book.klf.dk/ Hvis der er emner, du synes, at vi skal tage op i podcasten, er du velkommen til at sende en mail på podcast@klf.dk Hvis du har lyst til at støtte KLFs podcast og KLFs arbejde i det hele taget, kan det ske på Mobilepay: 76540. På forhånd tak for enhver gave! Hvis du ikke er medlem af KLF, er du meget velkommen: https://klf.dk/bliv-medlem/  

En agosto de 1994, dos músicos británicos llegaron a una isla escocesa con un maletín y un encendedor. Su misión: quemar un millón de libras esterlinas, todo lo que habían ganado con su exitosa carrera. En este episodio de Días Extraños exploramos la fascinante y perturbadora historia de The KLF y su radical performance, pero también el curioso fenómeno cultural de quemar dinero a lo largo de la historia: desde los rituales funerarios chinos hasta la "Church of Burn", pasando por las ceremonias de iniciación de la élite británica y las icónicas escenas del Joker. ¿Arte provocador, ritual mágico o simple desprecio por lo que otros tanto anhelan? Descubre la extraña psicología detrás de quienes deciden convertir su fortuna en cenizas. Escucha el episodio completo en la app de iVoox, o descubre todo el catálogo de iVoox Originals

Dokumentarer bruger greb fra portrætprogrammer og reality-genren, mens vi har større tillid til influencere og naboen end til medier og politikere. Jagten på sandheden er blevet en ujævn sti at betræde – især når følelserne står i vejen i faglighed og saglighed. Vi har besøg i KLFs studie af landsformand Peter Larsen, som hjælper os med at sætte ord på tidens udfordringer – og så starter vi et helt nyt tema op om influencere, som digital medieanalytiker Camilla Mehlsen giver os en introduktion til. Influencerne er nemlig blevet små udgivere eller medier, som vi ikke kommer uden om, når vi taler tendenser, holdninger og verdensopfattelser. Men uden ansvarshavende redaktører, som står som garanter for objektivitet og etik. Disse forhold tager vi op i denne podcast, som også kommer omkring skærmfri ophold, dårlige egenreklamer på tv og medlemmernes yndlings-udsendelse på tv for tiden. Medvirkende: KLFs generalsekretær Mikael Arendt Laursen, landsformand Peter Larsen og digital medieanalytiker og forfatter Camilla Mehlsen. Vært: Malene Tonnung.   EKSTRAMATERIALE Sociale medier: Bærer medierne ansvaret for en del af den hårde tone?: https://klf.dk/sociale-medier-baerer-medierne-ansvaret-for-en-del-af-den-haarde-tone/ Gud er din læge-dokumentar vinkler hårdt på ulykkelig sag: https://klf.dk/gud-er-din-laege-dokumentar-vinkler-haardt-paa-en-ulykkelig-sag/ Hvem har magten over skærmen? Interview med Camilla Mehlsen fra 2024: https://klf.dk/hvem-har-magten-over-skaermen-interview-og-updates-fra-klf-lige-nu/ Send meget gerne dine reaktioner ind her: https://klf.dk/reager/  Vil du gerne have et KLF-møde i kalenderen i din kirke eller forening? Så besøg http://book.klf.dk/ Hvis der er emner, du synes, at vi skal tage op i podcasten, er du velkommen til at sende en mail på podcast@klf.dk Hvis du har lyst til at støtte KLFs podcast og KLFs arbejde i det hele taget, kan det ske på Mobilepay: 76540. På forhånd tak for enhver gave! Hvis du ikke er medlem af KLF, er du meget velkommen: https://klf.dk/bliv-medlem/  

Hoy en La Gran Travesía, con motivo del aniversario del cuarto trabajo de KLF, White Room (3 de marzo de 1991) tenemos un especial dedicado a este dúo de auténticos lunáticos de la música británica. También recordaros que ya podéis comprar La gran travesía del rock, un libro interactivo que además contará con 15 programas de radio complementarios, a modo de ficción sonora... con muchas sorpresas y voces conocidas... https://www.ivoox.com/gran-travesia-del-rock-capitulos-del-libro_bk_list_10998115_1.html Jimi y Janis, dos periodistas musicales, vienen de 2027, un mundo distópico y delirante donde el reguetón tiene (casi) todo el poder... pero ellos dos, deciden alistarse al GLP para viajar en el tiempo, salvar el rock, rescatar sus archivos ocultos y combatir la dictadura troyana del FPR. ✨ El libro ya está en diversas webs, en todostuslibros.com Amazon, Fnac y también en La Montaña Mágica, por ejemplo https://www.mdemagica.es/libro/gran-travesia-del-rock-la_53628 ▶️ Y ya sabéis, si os gusta el programa y os apetece, podéis apoyarnos y colaborar con nosotros por el simple precio de una cerveza al mes, desde el botón azul de iVoox, y así, además podéis acceder a todo el archivo histórico exclusivo. Gezkurra, Tete García, Jose Angel Tremiño, Marco Landeta Vacas, Oscar García Muñoz, Raquel Parrondo, Javier Gonzalez, Eva Arenas, Poncho C, Nacho, Javito, Alberto, Tei, Pilar Escudero, Utxi 73, Blas, Moy, Juan Antonio, Dani Pérez, Santi Oliva, Vicente DC,, Leticia, JBSabe, Huini Juarez, Flor, Melomanic, Arturo Soriano, Gemma Codina, Raquel Jiménez, Francisco Quintana, Pedro, SGD, Raul Andres, Tomás Pérez, Pablo Pineda, Quim Goday, Enfermerator, María Arán, Joaquín, Horns Up, Victor Bravo, Fonune, Eulogiko, Francisco González, Marcos Paris, Vlado 74, Daniel A, Redneckman, Elliott SF, Guillermo Gutierrez, Sementalex, Jesús Miguel, Miguel Angel Torres, Suibne, Javifer, Matías Ruiz Molina, Noyatan, Estefanía, Iván Menéndez, Niksisley y a los mecenas anónimos.

Onze huiscartoonist Lectrr vertelt hoe The Simpsons ervoor zorgden dat hij begon met tekenen, waarom hij de 16e-eeuwse kunstschilder Albrecht Dürer het liefst van al een pak slaag zou geven, en hoe de chaos van de Britse band The KLF hem inspireert om hetzelfde te doen. See omnystudio.com/listener for privacy information.

Onze huiscartoonist Lectrr vertelt hoe The Simpsons ervoor zorgden dat hij begon met tekenen, waarom hij de 16e-eeuwse kunstschilder Albrecht Dürer het liefst van al een pak slaag zou geven, en hoe de chaos van de Britse band The KLF hem inspireert om hetzelfde te doen. See omnystudio.com/listener for privacy information.

If nothing happens on Swans Crossing does anyone even notice unless you make someone watch it who has never seen an episode before?

Hoy en La Gran Travesía viajamos hasta la década de los años 90 donde podréis escuchar a Goo Goo Dolls, Redd Kross, Prodigy, Happy Mondays, KLF, Auteurs, Chemical Brothers, Bush, Kyuss, Monster Magnet, Hole, Gomez, dEUS,... y muchos más. También recordaros que ya podéis comprar La gran travesía del rock, un libro interactivo que además contará con 15 programas de radio complementarios, a modo de ficción sonora... con muchas sorpresas y voces conocidas... https://www.ivoox.com/gran-travesia-del-rock-capitulos-del-libro_bk_list_10998115_1.html Jimi y Janis, dos periodistas musicales, vienen de 2027, un mundo distópico y delirante donde el reguetón tiene (casi) todo el poder... pero ellos dos, deciden alistarse al GLP para viajar en el tiempo, salvar el rock, rescatar sus archivos ocultos y combatir la dictadura troyana del FPR. ✨ El libro ya está en diversas webs, en todostuslibros.com Amazon, Fnac y también en La Montaña Mágica, por ejemplo https://www.mdemagica.es/libro/gran-travesia-del-rock-la_53628 ▶️ Y ya sabéis, si os gusta el programa y os apetece, podéis apoyarnos y colaborar con nosotros por el simple precio de una cerveza al mes, desde el botón azul de iVoox, y así, además podéis acceder a todo el archivo histórico exclusivo. Muchas gracias también a todos los mecenas y patrocinadores por vuestro apoyo: Jose MMB, Gezkurra, Tete García, Jose Angel Tremiño, Marco Landeta Vacas, Oscar García Muñoz, Raquel Parrondo, Javier Gonzar, Eva Arenas, Poncho C, Nacho, Javito, Alberto, Tei, Pilar Escudero, Utxi 73, Blas, Moy, Juan Antonio, Dani Pérez, Santi Oliva, Vicente DC,, Leticia, JBSabe, Huini Juarez, Flor, Melomanic, Noni, Arturo Soriano, Gemma Codina, Raquel Jiménez, Francisco Quintana, Pedro, SGD, Raul Andres, Tomás Pérez, Pablo Pineda, Quim Goday, Enfermerator, María Arán, Joaquín, Horns Up, Victor Bravo, Fonune, Eulogiko, Francisco González, Marcos Paris, Vlado 74, Daniel A, Redneckman, Elliott SF, Guillermo Gutierrez, Sementalex, Jesús Miguel, Miguel Angel Torres, Suibne, Javifer, Matías Ruiz Molina, Noyatan, Estefanía, Iván Menéndez, Niksisley y a los mecenas anónimos.

In the world of lucha libre, a parejas increíbles match is when two rivals team up against another team of rivals in an attempt to put aside their differences for the sake of winning. We often see unusual collaborations in the world of music as well. On this episode, Andrew and returning guest Fred Morlan (The Good, The Bad & The Hungee) play songs that feature artists of different backgrounds, genres, and vibes coming together to make great music. These incredible pairs include The Lonely Island and Michael Bolton, Anthrax and Public Enemy, Tom Jones and The Cardigans, The KLF and Tammy Wynette, Beyoncé and Miley Cyrus, Daft Punk and Paul Williams, and many more. It doesn't matter if you're a técnico or a rudo, you can still enjoy this fun episode!Theme song: "Hemispheres" by Silent PartnerBluesky: @MusicoftheMat / @justandrew / @FlagrantStatsListen to Fred's radio show: radiolex.usAll VOW podcasts, articles, previews, and reviews: VoicesofWrestling.comJoin the VOW Discord to discuss Music of the Mat and other shows/topics: VoicesofWrestling.com/DiscordDonate to Music of the Mat and other VOW podcasts: VoicesofWrestling.com/DonateAdvertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy

Episode 734: February 2, 2025 playlist: Susan Alcorn, "The Heart Sutra" (And I Await the Resurrection of the Pedal Steel Guitar) 2006 Olde English Spelling Bee Edith Frost, "Hold On" (In Space) 2025 Drag City La Securite, "Ketchup" (Ketchup / Detour) 2024 Mothland Park Jiha, "Blown Leaves" (All Living Things) 2025 Glitterbeat great area, "light decline" (light decline) 2024 Relaxin Hekla, "Graminn" (Turnar) 2025 Pantom Limb Nah, "Please Allow Me To Begin Again" (Totally Recalled) 2024 Viernluvier Kinski, "Experimental Hugs" (Stumbledown Terrace) 2025 Comedy Minus One the fun years, "auto show day of the dead" (baby it's cold inside) 2008 Barge / 2025 Keplar Monoparts, "Fear" (Soothsayers) 2025 A Strangely Isolated Place Gez Varley, "Tax Trouble" (Tony Montana) 1997 !K7 Dead Bandit, "Glass" (Dead Bandit) 2025 Quindi Halima, "Samantha (DONIS Remix)" (EXU (Deluxe)) 2025 drink sum wtr The KLF, "No More Tears" (The White Room (1989 Director's Cut)) 2021 KLF Communications Email podcast at brainwashed dot com to say who you are; what you like; what you want to hear; share pictures for the podcast of where you're from, your computer or MP3 player with or without the Brainwashed Podcast Playing; and win free music! We have no tracking information, no idea who's listening to these things so the more feedback that comes in, the more frequent podcasts will come. You will not be put on any spam list and your information will remain completely private and not farmed out to a third party. Thanks for your attention and thanks for listening.

Three Letters K L FNuff SaidA night to remember in Redfern with my best mate and some Fish Stew, Donuts and Video gamesGreater Dub - Severed Heads1991Used with the permission of Tom Ellard Support the show

In this episode of No Filter with Kobo, we continue our three-part series exploring Kobo's global trends within the beauty and cosmetics industry for 2025. Gabby and Elsie are back with a collaborative discussion of the next two exciting trends: ‘Modern Nostalgia' and ‘Brighten Your World.' Special guests Nicole Young, Kobo's Marketing Coordinator, and Urmi Dhamnaskar, App Lab Chemist from Kobo UK, share their expertise to offer a deep dive into these trends and the innovative Kobo formulas that align with them. Tune in to hear how Kobo's cutting-edge formulas reflect these trends and discover the latest the trends that can influence your next projects for 2025! Special thanks to Nicole and Urmi for sharing their insights into these trends. Stay tuned for Part 3 of our series coming in February, where we'll explore the trends ‘Sensorial Beauty' and ‘One Ingredient Wonder!' Check out the links below to learn more about each formula mentioned and its ingredients: ·KBL-043-EU Jelly Glow Last-All-Day Blush: https://www.koboproductsinc.com/formulations/KBL-043-EU.pdf ·KLF-366-EU Luminous Glow Foundation: https://www.koboproductsinc.com/formulations/KLF-366-EU.pdf     ABOUT US: Since 1987 Kobo has provided innovative, technology-based raw materials to the cosmetic industry. The product range includes Surface Treated Pigments, Microspheres, Suncare and Color Dispersions, Silicone Fluids, Specialties, Natural Ingredients, Effect Pigments, Boron Nitride and Delivery Systems. Kobo has five locations, USA (Corporate Headquarters), France, Japan, Brazil, and UK and is represented globally by independent agents. Learn more at: https://www.koboproductsinc.com

Subscriber-only episodeIn this episode, Darshan explores how artificial intelligence (AI) is transforming clinical trial design, with a focus on using real-world data (RWD). The episode dives into the FDA's recognition of AI's potential to enhance clinical trials by using data from electronic health records (EHRs), medical claims, and disease registries. AI's ability to analyze large data sets enables identification of patterns that can predict chronic disease progression, leading to more personalized and effective treatments.Key benefits discussed include AI's role in continuous monitoring of trial subjects, real-time data analysis, and ensuring data accuracy through cleaning and curation, such as identifying duplicate entries and filling data gaps. AI's capacity to identify EHR phenotypes and group patients based on relevant characteristics allows for targeted and efficient trials, paving the way for precision medicine.Despite its advantages, the “black-box” problem of AI, where decision-making processes aren't fully transparent, remains a challenge. However, with regulatory oversight and consistent monitoring, AI is poised to revolutionize clinical trials, making them more efficient and inclusive. Subscribe for more insights on pharmaceuticals and medical devices.

The stem cell industry is growing rapidly but faces heightened regulatory scrutiny, particularly regarding marketing practices. Recent events highlight this issue: Rebecca Tushnet's blog on state "Little FTC Acts" emphasizes their enforcement power against deceptive marketing, and the guilty plea of a stem cell product manufacturer's CEO for fraud underscores the stakes involved. Key Considerations for M&A Buyers:1. Legal Landscape: Understanding state and federal regulations is crucial to avoid penalties.2. Marketing Due Diligence:   - Review Materials: Scrutinize marketing content for truthful claims.   - Compliance Assessment: Ensure alignment with legal standards.   - Investigate Regulatory History: Look into past regulatory actions for potential liabilities.   - Evaluate Testimonials: Verify authenticity and compliance with FTC guidelines. Role of Life Science Attorneys:- Risk Mitigation: Guide clients on due diligence and indemnification clauses.- Regulatory Navigation: Educate clients on compliance and coordinate audits.- Post-Acquisition Support: Develop compliance programs to address deficiencies.- Litigation Preparedness: Prepare clients for regulatory inquiries and potential lawsuits.Why Partner with Kulkarni Law Firm:The Kulkarni Law Firm specializes in navigating M&A legal complexities in the life sciences sector, offering expertise in regulatory compliance, comprehensive due diligence, tailored compliance solutions, and robust litigation defense.In conclusion, while the stem cell industry offers significant opportunities, it also poses substantial risks. M&A buyers must conduct thorough evaluations to avoid legal liabilities, making partnership with experienced life science attorneys essential. Reach out to the Kulkarni Law Firm today to safeguard your investments.Support the show

In this episode, Darshan reacts to how at the start of each year, pharmacists often face the challenge of informing patients that their medications are no longer covered due to formulary changes managed by Pharmacy Benefit Managers (PBMs). PBMs, who work for insurance companies, negotiate drug prices and determine which medications are covered, often based on profitability. Surprisingly, PBMs may prioritize brand-name drugs over generics because of the rebates they receive, which can lead to sudden changes in coverage.While PBMs claim to help reduce drug costs, they are currently under scrutiny, with the Federal Trade Commission and several state attorneys general investigating their pricing practices and potential anti-competitive behaviors. On the other side, pharmaceutical companies and PBMs often shift blame onto each other, sparking debates about who's responsible for rising drug prices. Ultimately, clearer communication with doctors about medication costs could improve patient care, though the current system's complexity makes this challenging for both doctors and pharmacists.Support the show

In this episode, Edye Edens and Darshan Kulkarni discuss the evolving landscape of IRB oversight in 2024, including the roles of HRPP, AAHRPP, and OHRP, and the need for greater federal agency involvement. They also cover the impact of new guidance, the Trump administration, and the FDA's relationship with IRBs.We discuss: 1. The FDA's Finalized Guidance on Decentralized Clinical Trials (DCTs): The recent FDA guidance formalizing decentralized elements in clinical trials raises critical questions for Institutional Review Boards (IRBs). While DCTs have existed for years, the official guidance now provides a framework for utilizing healthcare providers (HCPs), remote modalities, and flexible patient engagement. IRBs must consider:Approval Implications: How decentralized elements affect risk-based assessments and informed consent.Data Validity: Whether varying patient experiences impact trial control and data integrity.Protocol Design: Increased complexities in evaluating sponsor protocols that integrate hybrid or decentralized approaches.2. Human Research Protection Programs (HRPPs): IRBs are components of broader HRPPs, which also encompass research compliance, conflict of interest management, and quality auditing. Accreditation bodies like AAHRPP (gold standard for HRPPs) demand higher standards, which could necessitate additional adjustments to align with FDA guidance.3. Regulatory Overlap and Harmonization Challenges: IRBs must navigate overlapping jurisdiction from the FDA and other entities like the Office for Human Research Protections (OHRP). The lack of harmonized regulations between these agencies creates confusion for researchers and inefficiencies in clinical trial oversight.4. FDA Audits and Oversight of IRBs: While the FDA does not directly regulate IRBs, it audits them and issues warning letters or Form 483 observations. IRBs must remain vigilant about FDA compliance, especially with decentralized elements becoming more common.5. Decentralization's Efficiency Debate: There is no blanket conclusion about whether decentralized trials increase efficiency or diversity. IRBs must assess the appropriateness of decentralized approaches on a case-by-case basis, particularly for complex studies like oncology trials or early-phase research requiring hospital stays.6. Calls for Streamlining Oversight: There is growing discussion about reducing redundancy across regulatory bodies to enhance efficiency and lower costs for patients. However, skepticism remains about whether eliminating overlap would ensure adequate protection for trial participants.7. Future Considerations:Adaptation: IRBs must adapt to increased DCT submissions while maintaining rigorous risk-based evaluations.Consistency: Balancing flexibility in decentralized models with the need for consistent oversight practices.Policy Evolution: Ongoing dialogue on whether accrediting bodies like AAHRPP or agencies like OHRP should develop complementary guidance to align with FDA standards.In 2024, IRBs face a critical moment to address these challenges while ensuring that decentralized innovations do not compromise participant safety or trial integrity.Support the show

Drillenisser, julenisser, gårdnisser. Fylder nisserne for meget i julen? Er tiden løbet fra eventyr og fantasivæsener? Handler julen for lidt om kristendommen? Du kan blande dig i debatten ved at ringe ind fra 12:15-13:30 på 7021 1919 eller send en sms til 1212. Medvirkende: Bubber, Niels Christian Meyer, tidl. børne tv-vært, Christiane Bjørg, skuespiller, "Kandis", Bertel Haarder (V) tidl kirke- og kulturminister, Mikael Arendt Laursen, generalsekretær for KLF, Kirke & Medier, Mai Mercado (K), drillenisse og politiker, Henrik L. Kristiansen, Oldermand Dansk Julemands Laug og Sofie Moesgaard, Folketingskandidat for Venstre, elsker nisser. Tilrettelægger: Gitte Hansen. Vært: Mathias Pedersen.

The polio vaccine, credited with eradicating a crippling disease in the U.S., faces renewed scrutiny after attorney Aaron Siri, linked to Robert F. Kennedy Jr., petitioned the FDA to revoke its approval. Kennedy, nominated as Health and Human Services Secretary, has distanced himself from the "anti-vaccine" label but calls for further vaccine studies. Public health officials, including Senator Mitch McConnell, stress the vaccine's proven safety and life-saving impact.While President-elect Trump has suggested openness to revisiting vaccine policies, the FDA operates independently, guided by rigorous scientific evidence. Any changes to the polio vaccine's status would require substantial justification and political will. Trust in science and regulatory safeguards remains critical during this ongoing debate.Support the show

FDA has changed its mind about off label marketing. Today, we're diving into how drug and device companies can effectively engage with payers and providers, exploring recent updates and guidelines. Let's start with the basics: FDA Regulations and the First Amendment. The FDA's ability to impose restrictions on speakers and content is limited by the First Amendment, which protects commercial speech. While the FDA can regulate marketing to prevent false or misleading claims, it must balance this with constitutional protections.Next, we discuss the CFL Guidance—focused on medical device and product communications consistent with FDA-required labeling. This guidance helps evaluate whether communications about approved products align with FDA labeling, including considerations for patient populations, usage directions, and potential harm. Despite its existence for six years, companies still face challenges due to high penalties for non-compliance and a lack of concrete steps for implementation.We'll also cover the FDAMA 114 Guidance, which clarifies how manufacturers can share healthcare economic information with payers about both approved and unapproved products. This guidance aims to ensure that communications are truthful, non-misleading, and based on competent and reliable scientific evidence.Additionally, the PIE Act (Prescription Drug and Medical Device Pre-Approval Information Exchange Act) facilitates communication about investigational drugs, allowing for early planning and budgeting by providing data on clinical trial phases and anticipated approval timelines.Finally, we'll touch on the SIUU Guidance, which focuses on communications from firms to healthcare providers about unapproved uses of approved products. This guidance is designed to ensure that such communications are truthful and separate from promotional content, despite the complexities and scrutiny involved.The key takeaways for medical affairs teams are to develop strategies that ensure compliance with these diverse guidelines, addressing both regulatory and legal aspects of communication. For robust support, contact the Kulkarni Law Firm, where we provide expert guidance to navigate these complex issues and ensure compliance.Support the show

Subscriber-only episodeToday, we're discussing the FDA's use of artificial intelligence (AI) to transform clinical trials.AI is emerging as a cornerstone in clinical research, with the FDA recognizing its potential in several key areas. First, predictive modeling allows AI to optimize pharmacokinetic profiles, streamlining dosing regimens and enhancing trial efficiency. Additionally, AI can create counterfactual simulations, enabling researchers to predict outcomes without putting real patients at risk.AI also improves adherence through tools like smartphone alerts and electronic medication tracking, ensuring participants remain engaged. By automating administrative tasks and optimizing workflows, AI enhances operational efficiency, significantly reducing the time and costs associated with trial management.Moreover, AI boosts participant recruitment and diversity by improving insight selection and engagement strategies, while AI-driven chatbots provide real-time support, predicting potential dropouts and improving retention. However, it's essential to implement proper training and safeguards to prevent overreliance on AI tools.AI further aids in monitoring safety and predicting adverse events by detecting clusters of symptoms, allowing for timely interventions. Additionally, it streamlines the submission process by automating data analysis and report generation, ensuring compliance and speeding up approvals.The integration of AI into clinical trials promises to make research more efficient, inclusive, and safe. 

The FDA's current approach to AI in healthcare highlights significant gaps in regulatory preparedness. Although the FDA has approved thousands of AI-enabled tools, it still lacks the resources, clear guidelines, and enforcement power necessary to address the rapid advancements and risks of AI effectively. The agency has issued frameworks and adopted some risk-based approaches, but these efforts fall short, leaving companies in limbo and patient safety at risk. AI in healthcare demands consistent oversight, yet the FDA's “wait-and-watch” approach, often leading to delayed action, hinders industry progress and creates uncertainty for innovators. Addressing these issues requires urgent congressional support, funding, and global regulatory collaboration. At the Kulkarni Law Firm, we help guide companies through this complex regulatory landscape to ensure compliance and safety. For more insights, subscribe to our podcast or reach out today.Support the show

In this episode, guest host Kate Woods and Darshan Kulkarni delve into current healthcare issues, including the unsettling news of the CEO of United Healthcare being shot. They discuss the broader implications of this event, questioning how it reflects the state of the healthcare system and whether CEOs in troubled companies are becoming targets. The conversation shifts to potential solutions for the healthcare crisis, considering options like Medicare for All and the inefficiencies in drug pricing, where American consumers often subsidize global drug costs. The duo also explores innovation in healthcare, such as adaptive clinical trials, and the role of AI in improving quality and efficiency. They touch on the impact of private equity in healthcare, emphasizing that funding can improve care quality and support staff livelihoods. Overall, the discussion centers on fixing a broken system with a focus on practical changes, accountability, and innovation.Support the show

Robert F. Kennedy Jr. has announced plans for a presidential mandate to restore federal agencies, including the FDA, to the "gold standard" of scientific review. This bold proposal has significant implications for the life sciences industry, affecting drug advertisers, clinical researchers, and M&A attorneys.Key Takeaways by SectorFor Drug AdvertisersExpect stricter scrutiny on advertising claims, requiring robust, data-driven evidence.Collaborations between marketing, regulatory, and legal teams will become critical to avoid severe penalties for non-compliance.Flashy, minimally substantiated claims are likely to face rejection, reshaping advertising strategies.For Clinical ResearchersEnhanced focus on data integrity, transparency, and protocol adherence is anticipated.While this could slow down approvals, it will boost study credibility and public trust.Researchers must align closely with sponsors to meet these stringent new expectations.For M&A AttorneysDue diligence processes will become more complex, requiring careful navigation of stricter regulatory demands.Potential impacts include delays, valuation adjustments, and new transaction structures.Attorneys must stay ahead of regulatory shifts to guide buyers and sellers effectively.The OpportunityFor companies that embrace these changes, the mandate offers a chance to differentiate themselves as trusted, compliant players in the life sciences arena.If you're preparing for the challenges and opportunities of this regulatory shift, The Kulkarni Law Firm is here to help navigate these hurdles. Let's talk about how to adapt and thrive under the new gold standard.Support the show

Last Christmas, we gave you a Christmas special, and this year we're doing the same because we're not very imaginative. This year, to save you from tears, we're doing Paul Feig's Wham-inspired romantic comedy Last Christmas. It was poorly received on its 2019 release, but as was generally the case with 2019 we didn't know how good we all had it. Now, it's settling in to become a Christmas favourite, with all the cheesy appeal of a Netflix or Hallmark movie filtered through two key talents - Feig and screenwriter Emma Thompson - who actually know what they're doing. Join Graham, Mark and show favourite Dexter (Mark's dog) as they discuss George Michael's legacy, the recent documentaries about him, the connection between the former Yugoslavia and the KLF, and how this film gets the most out of its often-miscast stars Emilia Clarke and Henry Golding. Plus appreciations of supporting player Ritu Arya and Jason Statham, the latter of whom isn't in this movie but I dunno, the conversation just went that way. If you want to help us audition for the big ice show, you can donate to our Patreon, where you'll get a bonus episode of this show every month - the next one comes out tomorrow, and it's about Santa Claus Conquers the Martians - plus weekly articles on The Twilight Zone, Red Dwarf and The X-Files and our end-of-month miscellany podcast Last Night..., which is gearing up for its own Christmas special. Follow us on Instagram, Twitter and Facebook for more.

Do we need a complete rethink of the rituals we use to mark the end of life? This week Andrew talks to undertaker and author RU CALLENDER about what he's learnt over the course of his career.  Ru Callender became an undertaker in order to offer people a more honest experience than the stilted formality of traditional ‘Victorian' funerals. Driven by raw emotion and the unresolved grief of losing his own parents, Ru brought an outsider, ‘DIY' ethos to the business of death.  Ru has carried coffins across windswept beaches, sat in pubs with caskets on beer-stained tables, helped children fire flaming arrows into their father's funeral pyre, turned modern occult rituals into performance art and, with the band members of the KLF, is building the People's Pyramid of bony bricks in Liverpool – all in the name of creating truly authentic experiences that celebrate those who are no longer here and those who remain. Subscriber Content This Week  If you're a subscriber to The Meaningful Life (via Apple Podcasts, Spotify or Patreon), this week you'll be hearing:  How to design a ritual Three things Ru Callender knows to be true. AND subscribers also access all of our previous bonus content - a rich trove of insight on love, life and meaning created by Andrew and his interviewees. Follow Up Get Andrew's free guide to difficult conversations with your partner: How to Tell Your Partner Difficult Things  Take a look at Andrew's new online relationship course: My Best Relationship Tools  Read Ru Callender's book, What Remains? Life, Death and the Human Art of Undertaking Follow Ru Callender on X/Twitter @wayswithweirds Andrew offers regular advice on love, marriage and finding meaning in your life via his social channels. Follow him on Twitter, Facebook and YouTube @andrewgmarshall   

This morning I sat in my house, took a twenty pound note from my wallet, lit a match and set the note on fire. Why? How did I feel as I watched it burn? Was it a waste, an immoral or stupid thing to do - or was it a deeply countercultural act? Jon Harris, came to the Bureau to talk about his life - as a pornographer, as a rock 'n' roll tour manager, as a bankrupt - and, most importantly, as The High Priest of The Church of Burn. We try to understand what money is, what it might be and what burning it can mean. We hear of Jon's own history of burning money and of the rites of The Church of Burn. Of course The KLF get a mention, as does Serge Gainsbourg and Youth of Killing Joke as we explore the history of the intentional sacrificial destruction of somethign that mainstream culture seems built around and compleltey obsessed with. The Church of Burn Jon's substack ---- I have often been asked about the music that plays during the Bureau episodes. Most of it is from two albums by The Real Tuesday Weld: 'Junskshop Melodies' (which will be released in 2025) and 'Songs For Crow' which has just been released. Detaisl HERE #money #moneyburning #cash #currency #churchofburn #daisycampbell #johnhiggs #youth #killingjoke #klf #theklf #thekfoundation #sergegainsbourg   

In this reaction video, Darshan responds to claims about the effectiveness of prescribed medications. While patients often expect their drugs to work, a statement suggesting that only 20% of people benefit from these medications is misleading. Darshan emphasizes that the FDA focuses on ensuring drugs are not harmful and assesses efficacy based on their effectiveness for a sufficient number of individuals, rather than a simplistic percentage. He discusses the growing field of personalized medicine, which aims to tailor treatments to individual genetic makeups, but notes that predicting a drug's effectiveness for a specific person remains complex. Concepts like digital clones and genetic design offer hope for the future, but he advises viewers to approach these ideas with caution. Ultimately, Darshan encourages understanding the intricacies of drug efficacy while maintaining realistic expectations.Support the show

Subscriber-only episodeWe explore the rapidly evolving role of artificial intelligence (AI) in clinical trial research design. He discusses how AI is reshaping the pharmaceutical landscape and highlights key areas identified by the FDA where AI is expected to make a significant impact.Darshan delves into the transformative power of digital health technologies, which enable real-time patient monitoring and enhance adherence to treatment protocols. These technologies not only improve patient safety but also provide critical data that can refine trial outcomes. The episode also emphasizes the benefits of decentralized clinical trials, which allow participants to engage from home, expanding recruitment and increasing diversity in research.Furthermore, Darshan explains the importance of real-world data, which can uncover valuable insights into drug effectiveness and safety outside traditional trial settings. However, he raises concerns about privacy and data interoperability, particularly for smaller trial sites that may lack advanced technologies.Ultimately, the integration of AI into clinical trials promises a more efficient, inclusive, and accurate research process, leading to faster therapy development and improved patient outcomes. Darshan concludes by reminding listeners to stay informed about these advancements and their regulatory implications.If you enjoyed this episode, be sure to subscribe, rate, and leave a review for more insights into the evolving trends in pharmaceuticals and clinical research.

The Supreme Court's ruling in Loper Bright Enterprises v. Raimondo significantly impacts off-label marketing for pharmaceutical and medical device companies by challenging the FDA's authority to restrict off-label speech. This decision is poised to reshape the regulatory landscape that has traditionally limited such communications.Key Legal Context:- Historically, the FDA has prohibited off-label promotion based on misbranding statutes, which require drug and device labeling to specify only FDA-approved uses. This has left off-label uses outside compliant labeling.- The FDA's argument that promoting off-label uses changes a product's "intended use" has been questioned in previous court cases, highlighting First Amendment concerns when promotions are truthful and not misleading.Impact of Loper Bright:- The ruling challenges the Chevron doctrine, which previously allowed courts to defer to agency interpretations of statutes. Courts are now instructed to interpret statutes independently, potentially weakening the FDA's ability to enforce a broad ban on off-label communications.- This shift could reduce legal risks for companies engaging in off-label promotion, particularly when the communications are scientifically accurate.FDA Guidance and Company Strategies:- The Loper Bright decision undermines the FDA's enforcement of existing guidance on off-label communications, making it crucial for companies to reassess their promotional strategies.- Companies should conduct thorough risk assessments, update internal policies, and engage with the FDA to understand the agency's post-ruling enforcement intentions.Conclusion:The Loper Bright ruling presents both challenges and opportunities for life sciences companies. By seeking expert legal counsel, such as from the Kulkarni Law Firm, companies can navigate the evolving landscape of off-label marketing, ensuring their strategies remain compliant and competitive.Support the show

Artificial intelligence (AI) is transforming the life sciences sector, offering groundbreaking advancements in areas like drug discovery, clinical trials, and personalized patient care. As AI-driven technologies become more integrated into these processes, the allure of acquiring AI-powered companies grows stronger. However, the complexities that come with AI introduce significant risks, especially when it comes to mergers and acquisitions (M&A). Life sciences attorneys must move beyond just understanding AI technology—they need to be deeply familiar with the regulatory, ethical, and legal intricacies that AI introduces in these transactions.At the heart of successful M&A due diligence involving AI companies lies a deep dive into regulatory compliance. Life sciences is one of the most heavily regulated industries globally, and AI technologies operating within this space must comply with laws such as FDA guidelines, GDPR for data privacy, and HIPAA for patient data protection. Failing to evaluate the target company's compliance with these regulations can lead to severe penalties and jeopardize the entire deal. Attorneys must ensure that AI systems are compliant to avoid unexpected liabilities post-acquisition.Another critical area is intellectual property (IP). AI-driven companies typically possess valuable assets, such as proprietary algorithms and data models, but ownership of these assets is not always clear-cut. Life sciences attorneys need to thoroughly review the IP portfolio to ensure full ownership and absence of any disputes or pending litigation. Overlooking these issues can result in future challenges, potentially devaluing the acquisition. Partnering with experienced IP counsel during the due diligence process is crucial to securing a clean and clear transfer of assets.Data integrity and security are also paramount in AI-driven life sciences companies. AI is only as good as the data it is trained on, and flawed or biased data can lead to catastrophic outcomes, especially in critical areas like patient care. Attorneys must assess the quality, source, and security of the data, ensuring that robust security measures are in place to protect sensitive patient information. This is non-negotiable in a sector where data breaches or flawed AI outcomes can lead to massive financial and reputational damage.Lastly, ethical considerations must be part of the M&A conversation. AI systems in life sciences raise issues of transparency, accountability, and bias, and attorneys must evaluate whether the target company adheres to ethical standards. This includes ensuring human oversight over AI decisions and preventing biased outcomes that could lead to discriminatory practices. Failing to address these ethical considerations could harm the acquiring company's reputation and market standing in a sector where trust is paramount.In conclusion, while AI holds immense potential in life sciences, the risks associated with acquiring AI-driven companies cannot be ignored. Thorough due diligence—covering regulatory compliance, intellectual property, data integrity, and ethical considerations—is essential to a successful M&A transaction. The Kulkarni Law Firm, with its deep understanding of both AI technology and the life sciences regulatory landscape, is uniquely positioned to guide companies through these complex processes, ensuring that all risks are identified and managed effectively. For those seeking expert legal advice on AI-driven M&A, the Kulkarni Law Firm is your trusted partner. Reach out to us today to safeguard your business objectives and ensure a smooth and compliant acquisition.Support the show

Subscriber-only episodeHealthcare and life sciences are on the brink of transformative change, fueled by a combination of technological innovation, ideological shifts, and evolving regulations. Visionaries like Elon Musk, Vivek Ramaswamy, and RFK Jr. are advocating for decentralization in healthcare, pushing for more personal control over patient data. While decentralization promises to reduce federal oversight, potentially lowering compliance costs and streamlining operations, it also raises serious concerns about the security and privacy of health data. Weakened federal regulations like HIPAA could lead to increased risks of data breaches and misuse, and state laws may not be enough to fill the gaps.Elon Musk's innovations, such as integrating Neuralink with blockchain technology, could pave the way for patient-owned data systems, allowing individuals to control and even monetize their health information. However, this could create a divide between tech-savvy individuals who benefit from these systems and others who remain vulnerable due to a lack of access or understanding. RFK Jr.'s approach to decentralization could shift more power to states and private entities, resulting in a patchwork of privacy standards. While this could encourage innovation, it could also complicate compliance, increase disparities, and challenge the interoperability of health data across states.The move towards decentralization and innovation comes with significant risks. Who will ensure AI systems process patient data securely, without bias, and in compliance with regulations? How will healthcare and pharmaceutical companies maintain accountability in a less-regulated environment? The balance between fostering innovation and protecting patient rights is critical. Companies in this sector must stay ahead of these changes with strategic legal guidance to ensure compliance and safeguard patient interests in this rapidly evolving landscape. 

Subscriber-only episodeIn this episode, we're diving into the intersection of technology and healthcare, specifically the role of Artificial Intelligence (AI) in clinical trials. As a Food and Drug lawyer, Darshan has seen firsthand how AI is revolutionizing drug development and testing. The FDA is closely monitoring this shift, recognizing the potential of AI to enhance patient outcomes, improve trial efficiency, and reduce costs.However, it's not all smooth sailing. AI can help identify the right patients for specific treatments, but it's crucial to address potential biases in AI algorithms, which could affect diversity in clinical trials. AI can also streamline trial processes, but the “black box” nature of how decisions are made raises concerns about transparency and fairness. Cost reduction is often touted, yet we're still waiting to see if AI will truly lower expenses in the long run.Data privacy and security are also big considerations. With AI relying on massive data sets, how can we ensure patient privacy is protected? And who truly owns the data? Algorithmic bias is another serious concern—especially when it comes to underrepresented patient populations. The FDA is working on issuing guidance for AI in clinical trials, but we're still in the early stages. They are encouraging collaboration between industry, academia, and other stakeholders to develop best practices. Plus, the FDA is investing in research to better understand both the benefits and risks of AI in healthcare.In the end, AI's potential is enormous, but we need to be careful about how it's implemented. What do you think are the biggest challenges when using AI in clinical trials? Drop your thoughts in the comments!And if you're a drug or medical device company looking to leverage AI, reach out to us at Kulkarni Law Firm for legal guidance through the complex regulatory landscape. Visit our website for more info.

This is the free half of a full talk which can be obtained by subscribing to JaysAnalysis at the Paypal links at the site. Musician and researcher John Adams joins me to divulge new details in relation to his series with researcher Nino on the secret history of punk music. Arising from the psychedelic genre and the 60s counter-culture (so-called) movements, punk became an iconic sub-genre that would have a tremendous impact on "youth culture" through the 70s, 80s, 90s and into today. The real question, however, is whether there is a deeper occult agenda to punk music, as well as a social engineering aspect to this "scene." We explore these questions, as well as topics such as: Henry Rollins, Riot Girl, feminism, GG Allin, Iggy Pop, situationism, Fugazi, The Sex Pistols and "spectacle," performance art, deep state connections, Genesis P-Orridge and transgender agendas, the Stone Roses, Lou Reed and Blavatsky, The KLF and the rise of electronica, Discordianism, techno and rave culture, and the power of pop culture to mind control mass populations. Send Superchats at any time here: https://streamlabs.com/jaydyer/tip Get started with Bitcoin here: https://www.swanbitcoin.com/jaydyer/ The New Philosophy Course is here: https://marketplace.autonomyagora.com/philosophy101 Set up recurring Choq subscription with the discount code JAY44LIFE for 44% off now https://choq.com Lore coffee is here: https://www.patristicfaith.com/coffee/ Orders for the Red Book are here: https://jaysanalysis.com/product/the-red-book-essays-on-theology-philosophy-new-jay-dyer-book/ Subscribe to my site here: https://jaysanalysis.com/membership-account/membership-levels/Become a supporter of this podcast: https://www.spreaker.com/podcast/jay-sanalysis--1423846/support.

Katie Graham and I discuss various aspects of FDA and FTC regulations, including ad promo, the Chevron decision, and the evolving role of compliance in the pharmaceutical industry.Key topics include:What is Ad Promo?Chevron decision's influence on FDA/FTCShould administrative agencies cite letters? Can the FDA establish rules after someone challenges them?Uncertainty of Compliance White SpaceIs regulatory medical advice now just seen as a risk?Support the show

Training your research site staff is critical. Despite regulations requiring Principal Investigators (PIs) to ensure proper training for research staff, recent cases reveal significant lapses. PIs are responsible for certifying that all associates, colleagues, and employees involved in the research are adequately trained and informed. However, instances have emerged where this responsibility was neglected.In one notable case, PIs were prosecuted due to inadequate training and oversight of research staff. Study coordinators, often without relevant research experience and from low-wage backgrounds, were left to manage studies without proper guidance. This lack of training led to errors and potential fraud, highlighting a crucial gap in compliance.Ensuring that all research staff are properly trained is essential for the integrity of clinical trials. If you need help developing a robust clinical research program, reach out to me. Support the show

DOJ filed criminal charges against 193 defendants, including 76 medical professionals for telemedicine violation. This alarming crackdown reveals the vulnerabilities within telemedicine, as illegal kickbacks and brief consultations have led to significant fraud, particularly in Medicare claims.Among the troubling cases highlighted, one psychiatrist was accused of billing for telehealth visits lasting only 10 to 30 seconds, falsely classified as legitimate patient consultations. The DOJ's focus on these practices serves as a critical reminder that telehealth providers must adhere to stringent federal and state regulations to avoid legal repercussions, including criminal charges and loss of medical licenses.Healthcare practitioners are urged to ensure their telehealth practices are not only clinically sound but also compliant with legal standards. For those in the telehealth space, seeking legal guidance is paramount to safeguarding their practices and upholding patient care standards. The Kulkarni Law Firm is available to assist healthcare professionals in navigating these challenges and avoiding potential fraud schemes.As the telemedicine landscape evolves, it's vital to consider whether the convenience of remote consultations outweighs the increased scrutiny and risks associated with them. Join the conversation by sharing your thoughts on the future of telehealth in the comments below.Support the show

Nature and Vox highlight the severe consequences of research fraud and its widespread impact on sectors like marketing, clinical research, medical affairs, regulatory compliance, and legal practices. Fraud can manifest in various ways, such as fabricating data or manipulating results, and its effects are far-reaching.The Nature article stresses that fraudulent research erodes public trust in science and endangers patient safety, especially in the pharmaceutical and medical device industries, where fraud can lead to legal issues, financial losses, and reputational damage. For marketers and medical affairs teams, relying on invalid clinical data can result in severe regulatory penalties and brand damage.Clinical researchers and physicians face additional risks, as relying on faulty research for treatment decisions could harm patients, leading to legal liabilities. Regulatory professionals and life sciences attorneys must stay vigilant in identifying red flags in research to advise clients on avoiding compliance pitfalls.At Kulkarni Law Firm, we focus on FDA regulatory compliance, clinical research, and pharmaceutical advertising law. Reach out to us today to ensure your work remains compliant and beyond reproach.Support the show

Influencers are NOT KOLs. We discuss using key opinion leaders (KOLs) and influencers in pharmaceutical and medical device marketing. Key Takeaways:- Influencers vs. KOLs: Influencers have large social media followings and can engage younger demographics, while KOLs are respected experts whose endorsements are based on scientific evidence.- Benefits and Risks: Influencers can create relatable content but risk non-compliance, while KOLs offer credibility but may deliver more conservative messages.Best Practices:  - Align with influencers and KOLs who match your target audience.  - Ensure understanding of regulatory requirements.  - Conduct thorough vetting and provide training.  - Establish clear contracts and monitor content for compliance. For Life Sciences Attorneys:It's vital to review contracts, monitor content, and collaborate with marketing teams to protect company interests.For more insights, subscribe to our podcast and reach out to the Kulkarni Law Firm for guidance on navigating influencer campaigns while minimizing legal risks.Support the show

Subscriber-only episodeIn this episode, we're diving into a crucial topic: the role of artificial intelligence in clinical research and the evolving landscape of data privacy laws that will impact every step of the process.In this episode, we'll be unpacking insights from Dr. ElZarrad, the FDA's Deputy Director for the Office of Medical Policy, on how AI is shaping clinical trial design and research. We'll also explore how AI can speed up trials, enhance patient recruitment, and even predict outcomes with greater accuracy. But with these advancements comes a significant responsibility, especially when it comes to patient data privacy. We'll talk about how laws like HIPAA, GDPR, CCPA, and others play a crucial role in safeguarding sensitive patient data at every step of AI development.If you're as passionate about the future of clinical research as we are, hit **like, subscribe, and share—it really helps grow the channel!Now, let's start from the beginning: Why is AI such a game-changer in clinical research? Well, it enables researchers to analyze vast datasets quickly, allowing for more tailored, personalized therapies. It's a breakthrough for precision medicine and personalized healthcare, and if we get this right, it could transform the entire industry. Dr. Dr. ElZarrad from the FDA highlights how AI can identify eligible patients more effectively and analyze real-time data, speeding up clinical trials significantly. AI also supports the rise of decentralized trials, where patients can participate remotely, making trials more accessible and diverse. This shift will be crucial, especially given the recent clinical trials guidance and the growing role of telemedicine.Of course, with this technological power comes the critical need for transparency and patient consent. AI relies heavily on sensitive data like medical histories, genetic information, and treatment responses. We'll also dive into the different layers of privacy laws—from data collection to tracking and communication regulations—and discuss why ensuring compliance at every stage is essential for maintaining trust and avoiding major legal pitfalls.Stay tuned as we break down these complexities and offer practical tips for staying compliant in this ever-evolving space.

Eli Lilly's changed its opinion on Off-Label uses! Eli Lilly, a company that makes a diabetes drug, is now urging people not to use it for weight loss, a common off-label use, despite not raising concerns about off-label uses in the past. Off-label use, where a drug is used for something other than its original purpose, is a normal part of healthcare, and the FDA acknowledges this practice. However, Lilly's sudden stance seems driven by a shortage of the drug, which they want to prioritize for diabetes patients. This shift appears more about supply management than safety. It's crucial that companies and regulatory bodies maintain consistent messaging to avoid confusion and ensure patient care remains a priority. Let's continue advocating for what's best for patients.Support the show

Today we're delving into the evolving role of artificial intelligence (AI) in drug development and clinical trial design. We'll explore the key concerns raised by the FDA and insights from Dr. ElZarrad on integrating AI into clinical research.AI has the potential to transform clinical trials by enhancing efficiency, accuracy, and outcomes. However, several challenges must be addressed to ensure its effective and ethical use. The FDA has highlighted six primary concerns:Bias: Variability in data quality and representativeness can introduce bias, affecting the reliability of AI-driven results.Data Quality and Relevance: AI models may be ineffective if they rely on irrelevant or incomplete data.Fitness of AI Models: The applicability and robustness of AI models in diverse clinical scenarios are crucial.Transparency: The complexity of AI methods can lead to challenges in interpreting and trusting AI-driven decisions.Uncertainty: Difficulties in interpreting AI models can create uncertainty in clinical trial decision-making.Performance Degradation: AI models may experience performance issues or data drift over time.To address these concerns, it's vital to use diverse, high-quality data for training AI models, implement rigorous validation processes, enhance transparency through interoperable algorithms, and continuously monitor model performance.Understanding and tackling these challenges will help harness AI's potential to improve clinical research. Stay tuned for more discussions on the latest developments in drug and medical device law from the Kulkarni Law Firm.Support the show

In this episode, we discuss key risks a life sciences company should consider during an acquisition with Kenneth White. We also explore the role of insurers in managing these risks. Support the show

Pharmacists often use a process of elimination to decipher doctors' handwritten prescriptions. Pharmacists rely on clues like drug names and doses, this method isn't foolproof. If the handwriting is unclear, identifying the correct medication can be challenging, leading to potential errors. The shift to electronic prescribing has improved accuracy and reduced confusion. For more insights on this topic, check out my video linked below. Support the show

In this episode, we are joined by Istvan Fekete to have a discussion over tech transfer offices, IP, and more. The video explains what tech transfer offices are, their significance in the research ecosystem, and why they might be the best place to negotiate equity stakes in intellectual property (IP) created by investigators, especially when funded by charitable organisations. We discuss the pros and cons of sponsors seeking a return on investment (ROI). Additionally, the video delves into the interest of physicians in the outputs, offering a comprehensive overview of how to navigate these complex relationships and interests effectively.Support the show

Darshan was asked to explain why drug names can be so complicated, and the answer lies in the fact that each drug typically has at least three distinct names. First, there's the chemical name, which is a technical identifier describing the drug's molecular structure—these names are often long and complex, like “acetylsalicylic acid,” and are more for scientific use. Next, there's the generic name, which is what most people are familiar with, such as “penicillin” or “aspirin.” These names are standardized and easier to remember. Finally, there's the brand name, which is where the complexity often comes into play.While pharmaceutical companies aim to create brand names that are simple and easy to remember, there are several critical factors they must consider. The FDA mandates that brand names be unique and not easily confused with other existing drug names. This is crucial because a mix-up at the prescribing stage could lead to serious health risks if a patient receives the wrong medication. To prevent this, companies must ensure their drug names don't look or sound too similar to any others on the market.In addition to FDA requirements, there are also intellectual property concerns. A drug's trademark must be unique, which means it can't infringe on existing trademarks. Balancing these various interests often results in drug names that are more complex than they might otherwise be. Some companies even go so far as to purchase a pre-approved drug name, sometimes paying millions of dollars, to avoid delays in bringing their drug to market. Every day a drug isn't on the market can result in significant financial losses, making it worthwhile to invest in a unique, approved name.In summary, the complexity of drug names is the result of a careful balancing act between FDA guidelines, intellectual property laws, and marketing considerations. The goal is to create a name that is distinctive, memorable, and safe to use in the healthcare setting. Darshan's insight into this process sheds light on the intricate considerations behind something as seemingly simple as a drug's name.Support the show

In this episode, Istvan Fekete joins us to discuss the intricacies of Congruency Reviews. We will explore the common mistakes individuals may encounter during these reviews and examine effective strategies for handling these errors. Additionally, we will delve into the processes that can be implemented to mitigate risks associated with congruency reviews. The discussion will also cover the potential benefits of involving third-party to ensure the accuracy and integrity of the review process.Points Discussed:•What are the biggest mistakes made in Congruency Reviews?  •What would a CAPA consist of? •Do institutions want to allocate funds for additional quality checks? •Do contracts need IRB congruency checks?•Who should do a Congruency Review?•What errors occur in congruency reviews besides human error?  Support the show

Jez Willis in conversation with David Eastaugh http://utahsaints.com/ Utah Saints were described as "the first true stadium house band" by the KLF's Bill Drummond, though their music is difficult to place into one genre. The dance group originally met as music promoters and DJs for the Mix Nightclub in Harrogate in the early 1990s. They began as MDMA, featuring two former The Cassandra Complex members Jez Willis and Keith Langley, along with Bobby Rae and guitarist Martin Scott. Willis started The Utah Saints with the addition of Tim Garbutt

On No Tags 25, we meet Jonny Banger: T-shirt hustler, avant-bootlegger, visionary rabble-rouser, DJ battle champ and bossman of the anarchic anti-fashion brand Sports Banger.From a certain angle, it can seem like the clothes are the main event at Sports Banger, from the original Free Tulisa tee and bootlegged NHS logos to wearable inflatables and a Chanel toilet seat headpiece. Naturally, Jonny has been asked a lot of questions in previous interviews about his designs and his philosophical take on bootlegs and infringement. But there's another side to the Banger story that hasn't been excavated: obviously, the music.Flipping through Sports Banger: Lifestyles of the Poor, Rich and Famous, the book that charts the first decade of the project, you can find musical references on almost every page: pilfered record label logos, Skepta in a postie's hi-viz jacket, descriptions of his studio's fine-tuned sound systems, playlists of tunes that inspired the Sports Banger runway shows, and even allusions to Jonny's previous life in the UK rap scene.We invited Jonny to go deep into the musical side of his story, from tape packs to free parties to the “shit mix jar” that collected fines in the first Sports Banger studio. He told us about his teenage years as a scratch DJ, his previous life as a club booker on Brick Lane, his ravey links with Swamp 81, School Records, Shangri-La and his own Heras label, and how he finally fell in love with free parties. And, most exciting for our resident KLF dweeb, he gave us a hint of what to expect from Sports Banger's forthcoming collaboration with K2 on the People's Pyramid.It's been a wild ride, and he's got the stories to prove it.If you enjoyed this big fat interview episode of No Tags then we implore you to press all the buttons and like, rate, review or subscribe on your podcast app of choice. You can also support us in a material manner via our paid tier. It's £5 a month, and it helps us keep doing whatever it is we're doing. Get full access to No Tags at notagspodcast.substack.com/subscribe