Podcasts about regulatory

General term for rules, including delegated legislation and self-regulation

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Best podcasts about regulatory

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Latest podcast episodes about regulatory

FreightCasts
The Daily | Why Freight Brokers Lose $19 Per Load, CSX Layoffs & CA CDL Crackdown

FreightCasts

Play Episode Listen Later Jan 8, 2026 6:06


In this episode of The Daily, we uncover why many freight brokers are structurally losing roughly $19 on every load despite seemingly stable contract rates. We break down the "negative operating leverage trap" detailed in How are Freight Brokers Staying Afloat? that is forcing companies to burn cash while desperately chasing volume. The conversation shifts to the rail sector, where CSX lays off 5% of management staff, furloughs conductors in a move that signals a permanent shift toward leaner operations. These deep cuts reflect a broader industry trend of redrawing profitable baselines amidst challenging economic conditions and declining high-margin traffic. Regulatory pressure is also intensifying, as the DOT strips California of $160M over foreign truckers for failing to revoke thousands of unlawfully issued commercial driver's licenses. This systemic collapse in the state's licensing process threatens to tighten capacity further in the stressed West Coast freight market. We also examine compliance risks, highlighting a case where an air cargo contractor reimburses Postal Service for fraudulent billing after falsifying delivery scans to avoid late penalties. This recurring pattern of fraud underscores the rigorous compliance demands fleets must manage alongside financial pressures. Physical risks are escalating as well, with new analysis on Minneapolis, 1992, and What Fleets Need to Know About the Insurrection Act as state and federal tensions create volatile conditions for urban logistics. Fleet operators are urged to prioritize real-time visibility and safety training to navigate these potential disruptions effectively. Finally, we look at market data where U.S. Bank, DAT launch quarterly truck freight rates report showing that carrier capacity is quietly shrinking while contract rates hold steady. This disconnect raises the critical question of which sector will force a necessary margin reset in the coming year. Follow the FreightWaves NOW Podcast Other FreightWaves Shows Learn more about your ad choices. Visit megaphone.fm/adchoices

Supply Chain Now Radio
Adapting to Change: 2025 Lessons, Supply Chain Insights, & 2026 Predictions, featuring U.S. Bank's Gustav Khambatta

Supply Chain Now Radio

Play Episode Listen Later Jan 7, 2026 47:12 Transcription Available


As global supply chains navigate through cybersecurity threats and rapid technological integration, companies must rethink their strategies to stay competitive. Cybercriminals are increasingly targeting corporate systems through sophisticated tactics, such as email infiltration, to gain access to sensitive data, including bills of lading. This underscores the need for organizations to strengthen their cybersecurity and ensure their supply chains remain secure.In this episode of Supply Chain Now, Scott Luton and Karin Bursa sit down with Gustav Khambatta, SVP, Head of Freight Payment Sales at U.S. Bank, to explore key themes in supply chain management. They discuss the evolving role of cybersecurity, AI's impact on the industry, and the challenges posed by cargo theft and security breaches.They talk about the intersection of AI and cybersecurity, highlighting how technology is transforming business operations. AI is being integrated into supply chain processes, with use cases ranging from fraud prevention to streamlining document verification. However, as AI adoption accelerates, so does the potential for security vulnerabilities. The conversation underscores the importance of continuous adaptation in a rapidly changing supply chain landscape, where technology and security will play a central role in shaping the future.Jump into the conversation:(00:00) Intro(04:02) Sports talk: Patriots, Falcons, F1(06:19) Gustav's professional journey(08:01) US Bank Freight Payment Index insights(14:39) Cybersecurity in the corporate world(20:22) AI in supply chain and cybersecurity(23:28) AI and cybersecurity integration(24:08) Regulatory environment and leadership challenges(24:38) Supply chain evolution and technology(27:26) AI in supply chain management(29:35) Reflections on 2025(32:29) Energy demand and AI(37:02) Predictions for 2026Additional Links & Resources:Connect with Gustav Khambatta: https://www.linkedin.com/in/gustav-khambatta-384852/Learn more about U.S. Bank: https://www.usbank.com/index.htmlDownload the most recent edition of the U.S. Bank Freight Payment Index: bit.ly/scn-us-bankLearn more about Supply Chain Now: https://supplychainnow.comWatch and listen to more Supply Chain Now episodes here: https://supplychainnow.com/program/supply-chain-nowSubscribe to Supply Chain Now on your favorite platform: https://supplychainnow.com/join

Artificial Intelligence in Industry with Daniel Faggella
Reducing R&D Cycle Time in Pharma Without Increasing Regulatory Risk - with Vaithi Bharath of Bayer

Artificial Intelligence in Industry with Daniel Faggella

Play Episode Listen Later Jan 7, 2026 38:01


Today's guest is Vaithi Bharath, Associate Director of Data Science & AI Solutions at Bayer. Bharath joins Emerj Editorial Director Matthew DeMello to break down why clinical R&D timelines often slip for reasons that have little to do with model performance. Rather, delays compound when data moves across fragmented systems, teams rely on slow handoffs, and validation requirements turn minor adjustments into major cycle-time hits. He walks through where decision-making slows from data capture through database lock, and what it takes to accelerate workflows without replacing a validated environment. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on the 'AI in Business' podcast! This episode is sponsored by AnswerRocket.

Horses in the Morning
AHC: New Year New You, Resolutions and Intentions

Horses in the Morning

Play Episode Listen Later Jan 6, 2026 40:01


Get 2026 started of Right! Join us as we discuss what making a New Year's resolution really means and how to stay true to yourself and your intentions. For our Legislative and Regulatory update we're talking biosecurity, outbreaks, and where you should look for correct information. Happy New Year!HORSES IN THE MORNING Episode 3856 –Show Notes and Links:Your Hosts: Julie Broadway (President) and Emily Stearns (Health, Welfare, and Regulatory Affairs Liaison) of the American Horse CouncilGuest: Karen Chaton of the Endurance Rider PodcastGuest: Meghan Brady of the Galloping Getaways PodcastLink: USDA APHIS Equine DiseaseLink: Equine Disease Communication CenterLink: Find your state animal health official (via United States Animal Health Association)Sponsors: AHC Board of Trustees, AHC Committees and AHC Staff | AHC FoundationSubscribe to the American Horse Council Podcast - Search American Horse Council Podcast on your podcast player.Follow Horses In The Morning on FacebookFollow the American Horse Council on Facebook, Instagram and X (formerly Twitter)

All Shows Feed | Horse Radio Network
AHC: New Year New You, Resolutions and Intentions - Horses in the Morning

All Shows Feed | Horse Radio Network

Play Episode Listen Later Jan 6, 2026 40:01


Get 2026 started of Right! Join us as we discuss what making a New Year's resolution really means and how to stay true to yourself and your intentions. For our Legislative and Regulatory update we're talking biosecurity, outbreaks, and where you should look for correct information. Happy New Year!HORSES IN THE MORNING Episode 3856 –Show Notes and Links:Your Hosts: Julie Broadway (President) and Emily Stearns (Health, Welfare, and Regulatory Affairs Liaison) of the American Horse CouncilGuest: Karen Chaton of the Endurance Rider PodcastGuest: Meghan Brady of the Galloping Getaways PodcastLink: USDA APHIS Equine DiseaseLink: Equine Disease Communication CenterLink: Find your state animal health official (via United States Animal Health Association)Sponsors: AHC Board of Trustees, AHC Committees and AHC Staff | AHC FoundationSubscribe to the American Horse Council Podcast - Search American Horse Council Podcast on your podcast player.Follow Horses In The Morning on FacebookFollow the American Horse Council on Facebook, Instagram and X (formerly Twitter)

Smart Biotech Scientist | Bioprocess CMC Development, Biologics Manufacturing & Scale-up for Busy Scientists
217: Silkworm Biomanufacturing: From Ancient Silk Production to Phase I Vaccine Trials with Masafumi Osawa - Part 1

Smart Biotech Scientist | Bioprocess CMC Development, Biologics Manufacturing & Scale-up for Busy Scientists

Play Episode Listen Later Jan 6, 2026 25:29


For over 4,000 years, silkworms have connected civilizations through ancient trade routes. Now, KAICO Ltd., a Japanese biotech spin-off from Kyushu University, is transforming these creatures into living bioreactors capable of producing complex recombinant proteins and vaccine antigens—without the bioreactors, expensive media, or massive water consumption of conventional platforms.Masafumi Osawa, Business Development Lead at KAICO, brings an unconventional path to biotech. Trained in cultural anthropology with fieldwork experience in Indonesia, he witnessed firsthand the healthcare disparities that drive his current mission. After years in pharmaceutical business development at Towa Pharmaceutical, he joined KAICO to help scale a technology he believes could reshape global vaccine accessibility. His cross-cultural expertise now proves invaluable as KAICO expands internationally, with active partnerships in Vietnam and Thailand and growing interest from other regions.Episode highlights:Masafumi's transition from anthropology to biotech, and how cross-cultural expertise benefits global health collaborations. (04:15)The founding story of KAICO, spun out from Kyushu University and focused on recombinant proteins and vaccine antigen production (08:45)Step-by-step overview of the silkworm baculovirus expression system, including pupae handling and bioprocessing basics. (10:28)Practical differences between silkworms, E. coli, mammalian, and insect cell culture platforms—exploring advantages and drawbacks. (13:10)Strategies KAICO uses to control silkworm variability, including SPF grade sourcing, diet, environment, and documentation for pharmaceutical acceptance. (15:08)Production scalability: a single pupa can match 100–1000 ml of insect cell culture, with major implications for cost and environmental footprint. (16:42)Downstream harvesting and purification—how KAICO extracts and processes proteins from silkworm pupae, keeping methods largely familiar to traditional systems. (19:31)Regulatory and GMP challenges of using live organisms, and KAICO's approach to satisfying authorities and ensuring product consistency. (21:43)Whether you're curious about alternative biomanufacturing methods or want a transparent look at silkworm-based protein expression from research to the clinic, this episode delivers practical insights and thoughtful discussion.Connect with Masafumi Osawa:LinkedIn: www.linkedin.com/in/masa-osawaKAICO Ltd.: www.kaicoltd.jp/enNext step:Need fast CMC guidance? → Get rapid CMC decision support hereOne bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.Support the show

Alloutcoach Tim
DOSE OF OPTIMISM AND DUTY TO ADVANCE LONGEVITY MEDICINE

Alloutcoach Tim

Play Episode Listen Later Jan 6, 2026 53:14


Advancing longevity research is about honoring the value of life—and translating that respect into evidence-based prevention. If healthcare is judged by life expectancy + quality of life, longevity medicine may be one of the most meaningful metrics we can pursue: extending health span through early detection, validated biomarkers, and interventions that scale.This unforgettable Expert Panel from the 4th annual Medical Innovation Olympics (#MIO2025) convened all-star global leaders in Longevity and Preventive Medicine who separated hype from reality and outlined what it will take to bring longevity into mainstream care - rigorously, ethically, and accessibly.Topics include: breakthroughs (including epigenetic approaches pointing toward functional restoration of eyesight), biomarkers/endpoints as the “keystone” for faster trials, the TAME (Targeting Aging with Metformin) concept, and the role of standards, education, trust, and shared responsibility—keeping dignity central.Panelists:Dr. David Barzilai (Harvard Medical School; Geneva College of Longevity Science, GCLS) • Dr. Dominik Thor (President, GCLS) • Dr. Mishkat Shehata (Emirates Lifestyle & Longevity Medicine Society) • Keith Comito (Lifespan Research Institute) • Dr. Uma Senthilkumar (Three Five Revive)

Global Medical Device Podcast powered by Greenlight Guru
#440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory

Global Medical Device Podcast powered by Greenlight Guru

Play Episode Listen Later Jan 5, 2026 50:12


In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Our esteemed guest, Jennifer Mascioli-Tudor, CEO and founder of JMT Compliance Consulting, shares her wealth of experience from top MedTech companies, underscoring the importance of proactive quality management, project management skills, and the ability to influence and communicate within organizations.Key Timestamps:[00:00:50] Introduction to Jennifer Mascioli-Tudor and her extensive background in the MedTech industry.[00:03:30] Jennifer's origin story in quality and regulatory roles.[00:07:15] The pivotal learning moments in quality management and regulatory affairs.[00:10:45] Strategies for influencing business leaders and the importance of storytelling in quality and regulatory roles.[00:16:30] The significance of human factors in product design and learning from end-user feedback.[00:21:50] Project management skills for quality and regulatory professionals.[00:25:20] The concept of 'design freeze' in the MedTech space and its impact on product development.[00:29:55] Jennifer's insights on agility and adaptability in building a quality management system.Quotes:"A really good quality and regulatory professional needs to have really good project management skills." - Jennifer Mascioli-Tudor"It's not just about the design and about the product. It's about everything ancillary that feeds into that finished medical device." - Jennifer Mascioli-TudorMedTech Trends:An emphasis on proactive quality management to ensure patient safety and product efficacy.The rising importance of human factors and user-centered design in medical device development.The shift towards integrating software and digital solutions in medical devices.Practical Tips:Quality and regulatory professionals should hone their project management skills.Communication and storytelling are key in influencing business decisions and leadership.Always present solutions and alternatives when addressing compliance challenges.References:JMT Compliance ConsultingJennifer Mascioli-Tudor on LinkedInEtienne Nichols on LinkedInGreenlight Guru's platform for Quality Management & Clinical InvestigationsQuestions for the Audience:Discussion: "How do you envision MedTech changing the landscape of healthcare in the next decade?"Feedback:Love the episode? Have suggestions or topics you'd like to hear about? Email us at podcast@greenlight.guru and leave a review on iTunes!Sponsors:This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru's intuitive platform!

FreightCasts
The Daily | Waabi's Door-to-Door Autonomy, CA Enforcement Risks, and the 2026 Economy

FreightCasts

Play Episode Listen Later Jan 2, 2026 5:59


In this episode of FreightWaves' The Daily, we map out the critical operational shifts defining the 2026 supply chain landscape, focusing on risk management over pure technology. We examine how generative AI and OEM partnerships are accelerating Waabi's push for point-to-point autonomous trucking to solve the commercial inefficiencies of the "highway trap." Regulatory risks are rising as a massive budget deficit in California threatens to disrupt federal, leading to significant compliance volatility for carriers. An internal audit highlights systemic weaknesses in the state's safety programs that could make roadside inspections and protocols increasingly unpredictable. On the macro front, a robust 4.3% GDP growth rate in Q3 signals a healthier economic foundation driven by strong consumer spending and exports rather than just import fluctuations. This economic shift is prompting industry leaders to stop designing for certainty and start building supply chains for adaptability to better handle market disruptions. We also discuss how this renewed focus on efficiency is setting the stage for a resurgence in large carrier M&A, including the anticipated spin-off of FedEx Freight. Finally, we analyze the urgent need to harden networks against sophisticated criminal rings that are exploiting commercial freight channels to smuggle narcotics and stolen vehicles across borders. Learn more about your ad choices. Visit megaphone.fm/adchoices

FinPod
Corporate Finance Explained | Corporate Spin Offs: Why Companies Break Up to Unlock Value

FinPod

Play Episode Listen Later Jan 1, 2026 13:46


Corporate success is often measured by growth and diversification, but for many conglomerates, being too big leads to a "conglomerate discount." This is the moment when the boardroom turns to corporate separation—the strategic process of intentionally breaking a business apart to create massive new shareholder wealth.In this episode of Corporate Finance Explained on FinPod, we break down why companies spin off divisions, how finance teams manage the disentanglement, and the real-world consequences of these billion-dollar maneuvers.What is a Corporate Spinoff?A spinoff occurs when a parent company takes a business unit or division and separates it into a brand-new, independent, publicly traded company.The Mechanism: Existing shareholders of the parent company automatically receive shares in the new entity.The Tax Benefit: These deals are typically structured to be tax-free for both the corporation and the investor, making it a premier tool for reorganization.The 5 Strategic Drivers: Why Break Up?Eliminating the "Conglomerate Discount": The market often penalizes highly diversified firms because analysts struggle to value a mix of slow-growth and high-growth assets. A spinoff creates a "Pure Play" company that the market can value more accurately.Strategic Focus: Different businesses have conflicting needs. Separation allows a management team to focus purely on their unique product cycles and R&D requirements (e.g., J&J spinning off Kenvue to separate stable consumer goods from high-risk pharma).Capital Structure Optimization: A spinoff allows for a customized balance sheet. A high-growth unit can start with a clean, debt-free slate to fund expansion, while the mature "cash cow" parent can take on more leverage.Regulatory & Activist Pressure: Antitrust concerns or pressure from activist investors often force management to divest units that are perceived as dragging down the total valuation.Preparation for Sale: It is significantly easier to sell a clean, standalone company than a messy division tangled in a larger corporate structure.The Operational Challenge: Assessing the "Carve-Out"Executing a spinoff is an incredibly complex process that often takes years of financial engineering:Carve-Out Financials: Finance teams must reconstruct what the business would have looked like if it had always been independent, projecting standalone revenue, margins, and cash flow.Stranded Costs: These are expenses the parent company is stuck with after the spinoff departs (e.g., half-empty headquarters or oversized software licenses). If not managed, these can destroy the expected value unlock.Transition Service Agreements (TSAs): Temporary lifelines where the parent provides HR or IT support to the new company for a fee until the spinoff can build its own infrastructure.Tax Risks (The Morris Trust): Strict IRS rules dictate that the spinoff must remain independent for a specific period. If the new company is acquired too quickly, it can trigger a catastrophic tax bill for the parent company.Case Studies: Billions UnlockedeBay and PayPal: PayPal was a high-growth fintech innovator being valued like a slow online marketplace. Once spun off, its market cap skyrocketed as it gained the freedom to partner with eBay's competitors like Amazon. IBM and Kyndryl: By spinning off its slow-growing legacy infrastructure business, IBM transformed into a "cleaner" tech growth play focused on Cloud and AI. DowDuPont: A massive "merger to split" strategy where the giants merged with the explicit goal of then breaking into three focused companies: Agriculture (Corteva), Materials (Dow), and Specialty Products (DuPont).

Business of Drinks
97: The 2025 Drinks Industry Year-End Review - Business of Drinks

Business of Drinks

Play Episode Listen Later Dec 31, 2025 38:19


This was a year of contradictions in drinks. Structural headwinds collided with real momentum — and the brands that grew weren't following old rules. They were aligning with how people actually drink, shop, and spend today.In this special year-end episode, Erica Duecy, Scott Rosenbaum, and Caroline Lamb break down the biggest forces reshaping the drinks industry — across alcohol, non-alc, functional, and THC — and what they signal for growth heading into 2026.

Pharma and BioTech Daily
CRISPR Advances and Regulatory Shifts Drive Biotech Innovation

Pharma and BioTech Daily

Play Episode Listen Later Dec 31, 2025 4:31


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of fascinating stories that underscore the dynamic nature of our industry, where scientific innovation meets real-world application.Starting with a significant advancement in gene therapy, researchers have made remarkable progress in a novel approach to treating rare genetic disorders. This new methodology involves the use of CRISPR technology to edit genes directly within the human body, paving the way for potential cures once thought impossible. By targeting specific DNA sequences, scientists can now correct genetic mutations at their source. This breakthrough not only promises to transform the treatment landscape for rare diseases but also enhances our understanding of genetic disorders at a molecular level. The implications here extend beyond rare conditions, potentially offering new avenues for tackling more common genetic diseases in the future.Moving forward, let's discuss recent regulatory developments that have caught the industry's attention. The FDA has granted accelerated approval to a new oncology drug that shows promise in treating advanced forms of breast cancer. This decision was based on compelling clinical trial results demonstrating significant improvements in patient survival rates compared to existing therapies. The drug targets specific proteins involved in tumor growth, offering a more precise treatment option with potentially fewer side effects. This approval exemplifies how regulatory bodies are adapting to expedite access to life-saving treatments while ensuring rigorous safety and efficacy standards.In another noteworthy development, a Phase III clinical trial has yielded positive results for a novel Alzheimer's drug. The trial demonstrated that this drug significantly slows cognitive decline in patients with early-stage Alzheimer's disease. By targeting amyloid plaques in the brain, which are believed to contribute to neurodegeneration, this therapeutic approach represents a potential shift in how we treat this debilitating condition. These findings provide hope for millions affected by Alzheimer's and underscore the importance of continued investment in neuroscience research.Turning our attention to infectious diseases, there's exciting news from a biotech company focusing on vaccine development. They've announced encouraging preliminary data from trials of their new mRNA-based vaccine for respiratory syncytial virus (RSV). RSV is known for causing severe respiratory illness, particularly in infants and the elderly. The vaccine demonstrated robust immune responses and a favorable safety profile, suggesting it could become an important tool in preventing RSV infections globally. This development highlights the versatility of mRNA technology, which has already revolutionized COVID-19 vaccine design and holds promise for addressing various infectious diseases.In terms of industry trends, one cannot overlook the growing emphasis on personalized medicine. Recent advancements in biomarker research are enabling more tailored therapeutic approaches across multiple disease areas. By identifying specific genetic or molecular markers associated with diseases, healthcare providers can better predict patient responses to certain treatments. This shift towards precision medicine not only improves patient outcomes but also enhances healthcare efficiency by reducing trial-and-error prescribing.Lastly, we delve into an intriguing area of metabolic disorders where innovative therapeutic strategies are emerging. A biotech firm has developed a first-in-class oral medication for treating non-alcoholic steatohepatitis (NASH), a serious liver condition linked to obesity and metabolic syndrome. The drug works by modulating key metabolic pathways involved in liver inflammation and fibrSupport the show

DC EKG
Healthcare AI Gets Real: Naomi Lopez on ACCESS, TEMPO, and the Future of Care

DC EKG

Play Episode Listen Later Dec 30, 2025 47:54


Podcast TitleDC EKG with Joe Grogan: A Healthcare Policy Podcast Ep. 122 Healthcare AI Gets Real: Naomi Lopez on ACCESS, TEMPO, and the Future of Care Episode Description-In this episode of DC EKG with Joe Grogan: A Healthcare Policy Podcast, Joe recaps the first Healthcare AI Policy Summit, held on December 10th in Washington, DC, with his co-host for the event, Naomi Lopez, founder of Nexus Policy Consulting. They walk through the big themes shaping healthcare AI right now: how HHS is approaching AI adoption, what real regulatory clarity could look like, and how new federal initiatives like ACCESS and TEMPO may reshape chronic disease management for Medicare patients. Joe and Naomi unpack HHS Deputy Secretary Jim O'Neill's view of AI in government, from using large models to improve physician productivity, payment integrity, and care coordination to managing privacy and re-identification risk when working with federal health data. They dig into the ACCESS Medicare payment model and the FDA TEMPO initiative, explaining how these pilots test AI and machine learning tools in real-world chronic disease management (hypertension, diabetes, musculoskeletal pain, and depression), and what that means for Medicare payment models, FDA oversight, and healthcare innovation. The conversation then widens to physician burnout, interoperability, rural care, and the role of states and federal preemption in setting the rules for healthcare AI. If you care about the real-world impact of healthcare AI on policy, payment, and patients, this episode offers a clear, practical summary of what the summit revealed and what to watch next. Today Joe and Naomi cover: Jim O'Neill's vision for AI at HHS, including internal AI adoption and keeping a direct line open for small innovators. ACCESS and TEMPO as new federal test beds for AI in chronic disease management and Medicare payment. How wearables, remote monitoring, and “virtual ICU” models can support aging in place and reduce pressure on state budgets. Ways AI can reduce documentation burden, support care coordination, and act as a first-line triage tool without replacing clinicians. The emerging idea of personal AI agents that help patients navigate the system and share the right data with clinicians. How AI-enabled diagnostics and tools can expand access in rural and underserved communities. Why interoperability, ONC's API rules, and the balance between state AI regulation and federal preemption will shape how quickly these tools scale. The potential for tech companies to become Medicare Part B providers under ACCESS, and what that means for reimbursement and competition. Key Takeaways: Healthcare AI is being built into policy through programs like ACCESS and TEMPO, tying AI tools to Medicare payment and FDA pathways in chronic disease management. Regulatory clarity and predictable routes from FDA clearance to Medicare reimbursement are essential for sustained AI adoption. AI is currently most valuable as a force multiplier for physician productivity, taking on administrative and analytic work so clinicians can focus on patients. Personal AI agents may become a primary interface between patients and the health system, coordinating data, benefits, and care. Rural and underserved communities could benefit significantly if payment and regulatory rules support AI-enabled diagnostics and remote care. Interoperability, state AI laws, and federal preemption will determine whether healthcare AI stays in pilots or reaches patients nationwide. Naomi Lopez is the founder of Nexus Policy Consulting and a leading voice in healthcare policy, healthcare AI, and state health reform. She co-founded a healthcare AI working group with Joe Grogan and co-hosted the inaugural Healthcare AI Policy Summit on December 10th in Washington, DC.

Global Medical Device Podcast powered by Greenlight Guru
#439: MedTech AI Trends 2025: Scaling Regulatory Intelligence with Michelle Wu

Global Medical Device Podcast powered by Greenlight Guru

Play Episode Listen Later Dec 29, 2025 42:41


In this episode, Etienne Nichols sits down with Michelle Wu, Founder and CEO of Nyquist AI and one of the top 100 women in AI, to discuss the transformative state of artificial intelligence within the MedTech regulatory and quality space. Reflecting on her recent personal experience as a surgical patient, Michelle shares a unique perspective on the critical importance of the devices and quality systems that keep the industry running.The conversation dives deep into the "Great Rewiring" of the medical device industry. Michelle outlines how we have moved past the initial phase of AI skepticism and "AI fatigue" into a period of hyper-acceleration. With the introduction of the FDA's ELSA and the implementation of the EU AI Act, the industry has reached a point where AI is no longer a side project but a fundamental requirement for operational longevity.Finally, the episode provides a roadmap for both organizations and individual contributors. Michelle introduces her "Holy Trinity" framework for AI implementation—Data, Workflow, and Agents—and explains why the next two years will be defined by the "Invisible Colleague" or AI copilot. For junior professionals, the message is clear: knowledge is now a commodity, and the real value lies in the ability to ask high-quality, strategic questions.Key Timestamps00:00 – Introduction and Michelle Wu's background in MedTech and AI.03:45 – A founder's perspective: Michelle's personal experience in the OR seeing her clients' devices.08:12 – The 2025 Inflection Point: FDA ELSA, EU AI Act, and global AI expectations.11:50 – From billable hours to value-based output: How AI is disrupting the consulting business model.15:35 – Micro-timestamp: 2026 Predictions. The shift toward universal AI Copilots and Agents for every MedTech role.18:22 – The Holy Trinity of AI: Breaking down Data Layers, Workflow Automation, and AI Agents.22:10 – Case Study: How a top-tier MedTech company automated 17,000 quality and regulatory tasks.27:45 – The 56.8% Salary Premium: Why AI literacy is the most important skill for young RAQA professionals.31:15 – Shifting from memorization to "Clarity of Mind" and high-quality inquiry.Quotes"Knowledge is a commodity now. Previously, regulatory consultants or professionals stood out by their knowledge. Now, with AI leveling the field, the capability lies in those who can ask high-quality questions." - Michelle Wu, Nyquist AITakeawaysAI Literacy is a Financial Multiplier: LinkedIn data shows that non-engineering knowledge workers with AI literacy can command a salary premium of up to 56.8%.The 80/20 Rule of Automation: Approximately 80% of current RAQA tasks are tedious, manual, or administrative. Successful teams are using AI to automate that 80%, allowing humans to focus on the 20% that is strategic and high-value.The Three-Layer AI Strategy: To effectively implement AI, companies should look at the Data Layer (intelligence), the Workflow Layer (automation of specific tasks), and the Agent Layer (autonomous "employees").Value-Based Billing: As AI reduces the time required for regulatory submissions and gap analyses, the industry is moving away from the "billable hour" toward pricing based on the value and quality of the output.ReferencesNyquist AI: Michelle Wu's platform specializing in global regulatory intelligence and AI-driven workflow automation for MedTech.FDA ELSA: The...

Law of Code
#168 - December crypto regulatory developments in review with Jonathan Schmalfeld

Law of Code

Play Episode Listen Later Dec 29, 2025 43:47


In this episode, Jacob Robinson and Jonathan Schmalfeld break down the biggest U.S. crypto law and policy developments of the month, from the SEC's moves toward bringing public markets on-chain to major CFTC moves on derivatives, prediction markets, and collateral. The conversation also covers crypto tax proposals, DeFi governance disputes, banking access, privacy, quantum risk, and why regulators increasingly view crypto not as an exception, but as core financial infrastructure.Jonathan Schmalfeld is the Policy Director at The Digital Chamber and the author of the Off the Blockchain+ newsletter, where he analyzes crypto regulation, market structure, and emerging policy trends.Timestamps:➡️ 1:03 — SEC market structure reforms and DTC no-action relief➡️ 7:54 — CFTC allows crypto and tokenized treasuries as collateral➡️ 8:45 — Prediction markets and state gambling laws➡️ 13:23 — Crypto tax proposals: wash sales, staking, and airdrops➡️ 16:03 — Aave, DAO governance, and token vs. equity conflicts➡️ 21:48 — GENIUS Act implementation and stablecoin interest debates➡️ 27:33 — The end of Operation Choke Point 2.0 and legislative fixes➡️ 31:02 — DeFi liquidations, market manipulation, and public debate➡️ 34:20 — Quantum computing risk and Bitcoin's long-term resilience➡️ 38:46 — Michael Selig confirmed as CFTC ChairSponsor: This episode is brought to you by the Decentralization Research Center (DRC), a nonprofit think tank advocating for decentralization in emerging technologies. Learn more at thedrcenter.org.Resources: 

Dean's Chat - All Things Podiatric Medicine
Ep. 286 - Dyane Tower, DPM, MPH, MS, CAE - Medical Director, American Podiatric Medical Association

Dean's Chat - All Things Podiatric Medicine

Play Episode Listen Later Dec 26, 2025 48:46


Dean's Chat hosts, Drs. Jensen and Richey, welcome Dr. Dyane Tower to Dean's Chat. This episode is sponsored by the American Podiatric Medical Association (APMA)! Dyane Tower, DPM, MPH, MS, CAE is a nationally recognized leader in podiatric medicine and healthcare administration, currently serving as Medical Director and Vice President of Clinical Affairs for the American Podiatric Medical Association (APMA). With a unique blend of clinical training and executive leadership, Dr. Tower plays a pivotal role in shaping national clinical policy, professional standards, and advocacy efforts for the podiatric profession. She holds the degrees of Doctor of Podiatric Medicine degree from the Scholl College of Podiatric Medicine, and completed her 3 year residency at the North Coloroado Podiatric Medicine Surgery program. Her background highlights advanced expertise in organizational governance, strategy, and healthcare leadership. Her interdisciplinary background allows her to bridge clinical practice, public health, and national-level professional advocacy. At APMA, Dr. Tower oversees: • Clinical policy and professional practice standards • Clinical education and evidence-based guidelines • Regulatory affairs and federal advocacy • Public health integration and interdisciplinary collaboration Dr. Tower is widely respected for her strategic vision, clarity of communication, and deep commitment to advancing podiatric medicine at a national level. As a featured guest on Dean's Chat, she provides expert insight into healthcare policy, clinical governance, professional advocacy, and the future direction of the podiatric profession. Beyond her executive leadership, Dr. Tower is known for her mentorship, national speaking engagements, and ongoing efforts to elevate the voice and visibility of podiatric physicians within the broader healthcare ecosystem. Enjoy!

The John Batchelor Show
S8 Ep235: REGULATING ARTIFICIAL INTELLIGENCE Colleague Kevin Frazier. Kevin Frazier continues, warning against a "waterfall of regulation" by states and advocating for "regulatory sandboxes" to allow experimentation. NUMBER 8

The John Batchelor Show

Play Episode Listen Later Dec 24, 2025 8:50


REGULATING ARTIFICIAL INTELLIGENCE Colleague Kevin Frazier. Kevin Frazier continues, warning against a "waterfall of regulation" by states and advocating for "regulatory sandboxes" to allow experimentation. NUMBER 8 NOVEMBER 1955

The John Batchelor Show
S8 Ep235: EU REGULATION VS. US GROWTH Colleague Michael Toth. Michael Toth critiques the European Union's "regulatory imperialism" and contrasts it with the economic growth of the US. NUMBER 4

The John Batchelor Show

Play Episode Listen Later Dec 24, 2025 10:10


EU REGULATION VS. US GROWTH Colleague Michael Toth. Michael Toth critiques the European Union's"regulatory imperialism" and contrasts it with the economic growth of the US. NUMBER 4 1935 BRUSSELS

DTC POD: A Podcast for eCommerce and DTC Brands
#367 - The Insider's Guide to Supplements: What Every Founder Needs to Know About Compliance, Claims, and Scale

DTC POD: A Podcast for eCommerce and DTC Brands

Play Episode Listen Later Dec 24, 2025 53:37


Graham Rigby is the President and CEO of the American Herbal Products Association (AHPA), the leading trade association for the herbal products industry. With 20 years of experience across startups and industry leadership—including serving as Chief Innovation Officer at Care/of—Graham has helped shape how modern supplement brands navigate regulation, formulation, and go-to-market strategy.In this episode of DTC Pod, Graham shares what it actually takes to launch and scale a supplement brand without getting burned by regulators. He breaks down exactly where the line is between claims that sell and claims that get you in trouble, why so many founders get blindsided by FDA and FTC enforcement, and how to work with contract manufacturers when you're just starting out. Graham also gets into the real opportunity in supplements right now—why clinical trials cost 90% less than they did two decades ago, how AI is changing the formulation game, and why a $70 billion market growing at 6.5% still has plenty of room for new entrants. Plus, his take on the brands that are doing it right, from AG1 to Ritual, and what founders can learn from their playbooks.Episode brought to you by StordInteract with other DTC experts and access our monthly fireside chats with industry leaders on DTC Pod Slack.On this episode of DTC Pod, we cover:1. The evolution and growth of the herbal supplement industry2. Key regulatory milestones: DSHEA, GMPs, and FDA compliance for supplements3. What founders must do to stay compliant when launching a supplement brand4. The distinction between pharmaceuticals, dietary supplements, and nutraceuticals5. Marketing, claims, and the importance of substantiation6. Emerging opportunities with clinical trials and claim innovation7. DTC, Amazon, TikTok, and brick-and-mortar distribution channels for wellness brands8. The practicalities and risks of supplement retail (and when to scale beyond DTC)9. Practitioner and non-traditional channels for supplement sales10. How Ingredient AI, Infinite Garden, and other platforms are applying AI to supplements11. Content creators, credentialed doctors, and the new face of trusted health advice12. The role of diagnostics, wearables, and personalization in driving supplement trends13. Growth outlook: Why the supplement market is just getting startedTimestamps00:00 Intro to DTC POD and Graham Rigby02:25 20 years of supplements: Startup vs. regulatory side03:00 The exponential growth of the herbal products market04:44 Regulatory basics: DSHEA, FDA oversight, and GMPs explained07:14 How AHPA helps brands navigate compliance and education08:03 Launching a supplement brand: Key compliance steps and best practices10:00 FDA's post-market regulatory process and founder responsibilities13:04 Supplements vs. pharmaceuticals: Safety, claims, and approvals17:32 Telling stories and using clinical research for marketing claims20:00 What marketers can and cannot say: Health vs. disease claims22:04 Substantiating claims and the importance of compliance for growth24:31 Label vs. online claims: How rules apply to different channels27:02 DTC vs. Amazon, TikTok, and expanding to retail and practitioner channels30:19 The risks and rewards of brick-and-mortar expansion35:14 AI and technology's role in supplement industry efficiency and safety40:47 The rise of content creators and doctors shaping supplement education46:34 Diagnostics, wearables, and the future of personalized wellness51:13 Supplement industry outlook and advice for emerging brands52:25 How to connect with Graham and AHPA, and upcoming founder programsShow notes powered by CastmagicPast guests & brands on DTC Pod include Gilt, PopSugar, Glossier, MadeIN, Prose, Bala, P.volve, Ritual, Bite, Oura, Levels, General Mills, Mid Day Squares, Prose, Arrae, Olipop, Ghia, Rosaluna, Form, Uncle Studios & many more.  Additional episodes you might like:• #175 Ariel Vaisbort - How OLIPOP Runs Influencer, Community, & Affiliate Growth• #184 Jake Karls, Midday Squares - Turning Your Brand Into The Influencer With Content• #205 Kasey Stewart: Suckerz- - Powering Your Launch With 300 Million Organic Views• #219 JT Barnett: The TikTok Masterclass For Brands• #223 Lauren Kleinman: The PR & Affiliate Marketing Playbook• ​​​​#243 Kian Golzari - Source & Develop Products Like The World's Best Brands-----Have any questions about the show or topics you'd like us to explore further?Shoot us a DM; we'd love to hear from you.Want the weekly TL;DR of tips delivered to your mailbox?Check out our newsletter here.Projects the DTC Pod team is working on:DTCetc - all our favorite brands on the internetOlivea - the extra virgin olive oil & hydroxytyrosol supplementCastmagic - AI Workspace for ContentFollow us for content, clips, giveaways, & updates!DTCPod InstagramDTCPod TwitterDTCPod TikTokGraham Rigby - President & CEO of American Herbal Products Association (AHPA)Blaine Bolus - Co-Founder of CastmagicRamon Berrios - Co-Founder of Castmagic

Pharma and BioTech Daily
2025's Breakthroughs: Oral Wegovy, J&J Verdict, and AI in Drug Discovery

Pharma and BioTech Daily

Play Episode Listen Later Dec 24, 2025 6:29


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the significant events of 2025, a year marked by pivotal scientific breakthroughs, regulatory changes, and industry trends that have reshaped drug development and patient care.One of the standout advancements was Novo Nordisk gaining FDA approval for an oral version of Wegovy, a glucagon-like peptide-1 (GLP-1) receptor agonist for obesity management. This marks a notable shift in treatment accessibility, as it provides an easier alternative to injectables for those managing weight and cardiovascular risks. This development could significantly enhance patient adherence and broaden access to this critical therapy.However, not all news was positive. Pfizer faced a challenging situation when a patient death occurred in the extension of their Hympavzi hemophilia study. Such incidents highlight the intrinsic risks of clinical trials, especially within gene therapy realms where safety monitoring is paramount. These events remind us of the delicate balance between innovation and patient safety in advanced biologic therapies.In legal news, Johnson & Johnson was ordered by a Baltimore jury to pay $1.56 billion in a talc-related cancer case. This ruling underscores heightened scrutiny on product safety and consumer protection within the pharmaceutical industry, potentially influencing future litigation and regulatory measures.Clinical trial outcomes also presented mixed results. Neurocrine Biosciences' Ingrezza did not meet efficacy endpoints in its phase 3 trial for cerebral palsy-related dyskinesia. Although it is approved for other movement disorders, this setback reflects the complexities involved in expanding drug indications. Such challenges highlight ongoing hurdles in translating preclinical successes into clinical realities.Despite geopolitical tensions, particularly between China and the U.S., Chinese biotech firms thrived, maintaining robust deal activity. China's continued growth as an innovation hub is driven by strategic investments and collaborations that bolster global drug development efforts, underscoring its increasing influence in life sciences.Regulatory landscapes also shifted with proposals from the Center for Medicare & Medicaid Innovation to align U.S. drug prices with international rates under Medicare Parts B and D. These proposed models could significantly impact pricing strategies and market dynamics within the U.S., requiring pharmaceutical companies to adapt while ensuring equitable access to medications.Ethical challenges surfaced as six individuals were charged with insider trading involving biotech stocks. Such incidents highlight the necessity for stringent ethical standards and regulatory oversight to maintain investor confidence and market integrity.Meanwhile, AstraZeneca's extended partnership with Niowave for actinium-225 supply reflects an interest in radiopharmaceuticals as targeted cancer therapies. This collaboration highlights the potential of radiopharmaceuticals in oncology, opening promising avenues for precision medicine approaches.As 2025 closes, it's clear that this year has been one of both triumphs and trials for the pharmaceutical and biotech industries. Scientific innovations like Novo Nordisk's oral GLP-1 receptor agonist offer new hope for patients, yet challenges such as clinical trial setbacks and legal battles indicate ongoing hurdles in drug development and commercialization. These developments will likely influence industry strategies and regulatory policies as we advance into 2026.The sustained momentum of China's biotech industry amid global trade tensions remains notable. This trend reflects China's strategic investments in biotech capabilities and its growing role in global markets despite geopolitical frictions.In clinical research, Hope BioscienceSupport the show

John Solomon Reports
Uncovering Accountability: The Battle Against Regulatory Abuse

John Solomon Reports

Play Episode Listen Later Dec 23, 2025 50:03


In this episode, we delve into the latest political happenings with Congressman Scott Perry from Pennsylvania, who discusses his experiences in Congress and the challenges faced by Republicans. He shares insights on Governor Shapiro's stance on police data access and the implications of a weaponized government. Joining us later is Dr. Peter McCullough, who provides an update on the flu outbreak and innovative ways to protect yourself from illness. Finally, Scott Rasmussen shares intriguing polling data that could shape the 2026 election landscape.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Consumer Finance Monitor
The CFPB's Most Ambitious Regulatory Agenda Ever – Part 2

Consumer Finance Monitor

Play Episode Listen Later Dec 23, 2025 46:45


Today's episode features Part 2 of our November 4 webinar, "The CFPB's Most Ambitious Regulatory Agenda Ever."  (Part 1 of this series was released on December 18. We encourage you to listen to that episode as well). In Part 2, we continue to unpack the far-reaching implications of the Consumer Financial Protection Bureau's (CFPB) regulatory ambitions. The CFPB has published a sweeping agenda that promises to reshape the landscape for consumer financial services, and our panel of seasoned attorneys offers vital context and actionable insights for industry professionals, regulators, and informed consumers alike.   Key Topics Discussed:  ·        CFPB's Pre-Rule and Long-Term Actions - What's on the regulatory horizon, including advance notices and rulemaking targets that could reshape consumer finance. ·        Clarifying "Unfair, Deceptive, and Abusive" Practices - Will the CFPB issue new rules or guidance to define these critical terms? The panel reviews statutory definitions and industry implications. ·        Identity Theft and Coerced Debt Regulation - Proposed amendments to Regulation V including new protections for survivors of identity theft and economic abuse. ·        Redefining Large Market Participants - Examination of thresholds for CFPB supervision in areas like auto financing, debt collection, consumer reporting, and international money transfers, aiming to target the largest market players. ·        Qualified Mortgage Rules & Loan Originator Compensation - What changes might be coming to mortgage rules and compensation methods, especially for small-dollar loans? The industry's wishlist and regulatory challenges are explored. ·        The Equal Credit Opportunity Act (ECOA) & Disparate Impact - Is the CFPB shifting its stance on disparate impact liability in lending? Hear the latest on the Trump administration's influence and evolving regulatory language. ·        CFPB's Withdrawal of Guidance Documents- A look at the Bureau's move away from guidance towards formal rulemaking and the impact on regulated entities. ·        Industry Feedback and Uncertainty - Lively discussion about compliance burdens, regulatory rescissions, and the ongoing uncertainty surrounding the CFPB's future funding and priorities. Meet Your Speakers from Ballard Spahr:   ·        Alan Kaplinsky (Host & Moderator): Senior Counsel and Founder and former leader of Ballard Spahr's Consumer Financial Services Group  ·        Rich Andreano, Jr.: Partner and head of the firm's Mortgage Banking Group  ·        John Culhane, Jr.: Partner in the Consumer Financial Services Group  ·        Kristen Larson: Of Counsel, Consumer Financial Services Group   ·        Daniel Wilkinson: Associate, Consumer Financial Services Group   ·        Rob Lieber: Associate, Consumer Financial Services Group   ·        Aja Finger: Associate, Consumer Financial Services Group   Tune in as our expert panel breaks down the complexities, anticipated impacts, and the road ahead under the CFPB's ambitious agenda. Consumer Finance Monitor is hosted by Alan Kaplinsky, Senior Counsel at Ballard Spahr, and the founder and former chair of the firm's Consumer Financial Services Group. We encourage listeners to subscribe to the podcast on their preferred platform for weekly insights into developments in the consumer finance industry.

The Deal
Activist Investing Today: V&E's Solorzano on Executive Order, Regulatory Shifts

The Deal

Play Episode Listen Later Dec 22, 2025 23:59


Jon Solorzano, a partner at Vinson & Elkins, discusses how a sweeping White House executive order could drive changes to proxy advisers and shareholder proposals.

Pharma and BioTech Daily
Biotech Breakthroughs: M&A Moves and Regulatory Shifts

Pharma and BioTech Daily

Play Episode Listen Later Dec 22, 2025 6:11


Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In the ever-evolving landscape of pharmaceuticals and biotechnology, a series of strategic transactions and scientific advancements are reshaping the industry.BioMarin's acquisition of Amicus Therapeutics for $4.8 billion is a significant highlight, marking the company's largest transaction to date. This move signifies a strategic pivot towards enhancing its capabilities in the rare disease sector, leveraging Amicus's expertise and robust pipeline to potentially improve patient outcomes in this highly specialized area. This acquisition is expected to enrich BioMarin's portfolio significantly with promising assets from Amicus, reflecting a strategic shift under new leadership towards rare disease treatments.Regulatory affairs have seen considerable activity as well, with the FDA raising concerns over manufacturing practices at Catalent's gene therapy facility. These issues, documented in a Form 483 following inspections, particularly pertain to the production of Elevidys. Such regulatory scrutiny emphasizes the critical importance of maintaining compliance with manufacturing standards in gene therapy—a burgeoning field within biotech that holds immense promise for treating genetically-driven conditions.The FDA's oversight extends beyond manufacturing practices to advertising, as evidenced by an untitled letter issued to Bristol Myers Squibb regarding their Cobenfy TV ad. This action is part of the FDA's broader initiative to ensure that direct-to-consumer marketing materials accurately portray drug benefits and risks, thereby protecting public health.In another strategic move, Alvotech and Teva are gearing up for the 2026 U.S. launch of an Eylea biosimilar following a settlement with Regeneron. This development highlights the competitive dynamics within the biosimilar market—a segment poised for growth as patents on major biologics expire, offering more cost-effective alternatives and expanding treatment access.Meanwhile, Clovis Oncology has achieved a milestone with Rubraca, which transitioned from accelerated approval to full FDA endorsement for prostate cancer treatment after five years. This progression underscores Rubraca's demonstrated efficacy and safety profile in addressing advanced prostate cancer—a notable achievement amid an increasingly competitive oncology market.Policy changes proposed by Health and Human Services Secretary Robert F. Kennedy Jr. could have profound implications by disrupting funding streams for hospitals providing gender-affirming care to minors. The potential impact on healthcare providers and patients who rely on these services is significant.Turning to clinical trials, Daiichi Sankyo has seen success with Enhertu receiving FDA approval for first-line HER2-positive breast cancer treatment. Nonetheless, challenges persist as a separate phase 3 trial for another antibody-drug conjugate was paused due to unexpected patient deaths. Meanwhile, Takeda plans to seek FDA approval for its TYK2 inhibitor following successful phase 3 trials in psoriasis—indicating promising potential in autoimmune disease therapies.Strategic shifts are evident across organizations as well, highlighted by Kathy Fernando's departure from Pfizer to join Replicate Bioscience as Chief Business Officer. Her new role focuses on advancing Replicate's self-replicating RNA technology platform—an area gaining traction due to its implications for vaccine development and therapeutic applications.On the clinical trials front, Altimmune reported encouraging results from a 48-week study on metabolic dysfunction-associated steatohepatitis (MASH). Their GLP-1/glucagon dual receptor agonist demonstrated sustained weight loss and improvements in non-invasive liver fibrosis measures—offering new hope for MASH patients who face limited treSupport the show

Legal Leaders Exchange
Episode 32: Collaboration, Data, and AI: 2025 Trends and 2026 Predictions

Legal Leaders Exchange

Play Episode Listen Later Dec 22, 2025 33:07


In this episode of Legal Leaders Exchange, host Jennifer McIver sits down with Carlos Gámez of Wolters Kluwer Legal & Regulatory and Sinéad Kenny from Brightflag, to unpack the major themes that shaped the legal industry in 2025.The conversation begins with a lighthearted look at personal passions, such as BBQ rib rubs and the "Motley Accruals" band, before diving into critical industry shifts. They discuss the growing appetite for peer collaboration, the move toward data transparency between clients and law firms, and the practical realities of AI adoption.Looking ahead, they discuss predictions for 2026, debating the potential of agentic AI, the necessity of "cleaning house" regarding data infrastructure, and whether the billable hour is actually going anywhere.

BioTalk Unzipped
Long-acting Cell-Based Gene Therapy, Fabry Disease and Beyond with Glafabra CEO, Dr. Chris Hopkins

BioTalk Unzipped

Play Episode Listen Later Dec 22, 2025 49:00


In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe sit down with Glafabra CEO: Dr. Chris Hopkins, geneticist, biochemist, and biotech entrepreneur, to explore the science and strategy behind next generation cell-based gene therapies for rare diseases.With more than 25 years of experience spanning gene augmentation, rare disease biology, CRISPR licensing, and biotech formation, Dr. Hopkins shares how autologous, ex vivo engineered cell therapies may overcome key limitations of current enzyme replacement and viral gene therapies, particularly for Fabry disease.The conversation dives deep into: • How lentiviral gene augmentation in patient derived cells enables sustained enzyme production • Why redosing matters and where one time AAV therapies fall short • The scientific rationale for early intervention, including potential newborn treatment • Differences between autologous and emerging allogeneic approaches • Regulatory pathways for rare disease therapies and recent FDA developments • The role of non animal models in translational research • Montana's early access therapy law and its broader implications • Building biotech platforms amid a challenging funding environmentTopics include cell based gene therapy, Fabry disease, lentiviral vectors, stem cell engineering, rare disease drug development, regulatory science, and translational medicine. Subscribe to BioTalk Unzipped for in depth conversations with the scientists and leaders shaping the future of biomedical innovation.00:00 - Intro00:53 – Welcome to BioTalk Unzipped, Guest intro: Dr. Chris Hopkins02:10 – Guest charity: Environmental Defense Fund03:12 – His journey into rare-disease therapeutics and Glafabra05:58 – Discovering a new enzyme-deficiency therapy 06:39 – Current standard of care 07:42 – How the new autologous cell therapy works09:40 – Treating patients earlier (even newborns)10:33 – Emerging therapies - AAV gene therapy vs. cell-based therapy12:16 – Long-term results & repeat dosing14:30 – Future plans: T-cells & allogeneic approaches18:08 – New News: FDA resubmission for rare disease20:00 – Navigating FDA pathways22:06 – Non-animal testing & alternative models25:50 – Montana's early-access therapy law & medical tourism29:03 – Could other states follow?31:31 – Biotech's current funding challenges33:46 – New News: Gene therapy trial saves 4-year-old37:09 – Long-term vision for expanding therapies39:53 – Personal segment: outdoor life & skiing44:43 – Guest question on international trade Dr. Christopher Hopkinshttps://www.linkedin.com/in/christopherehopkins/ Glafabra - https://www.glafabra.com/ Environmental Defense Fund - https://www.edf.org/ Dr. Chad Briscoe

Grow Everything Biotech Podcast
160. Sequins Without Sin: Santa Puts Cellsense's Aradhita Parasrampuria on the Nice List

Grow Everything Biotech Podcast

Play Episode Listen Later Dec 19, 2025 49:08


In this episode, Karl and Erum speak with Aradhita Parasrampuria, founder of CellSense, about revolutionizing the fashion embellishment industry through biology. Aradhita shares her journey from witnessing toxic dye masters in Gujarat textile factories to creating biodegradable sequins, beads, and buttons using algae and bacterial cellulose. She explains how her materials can be produced at room temperature, glow in the dark through bioluminescence, and are manufactured through an automated system that eliminates exploitative manual labor. With one in five garments containing embellishments, CellSense addresses a massive market while tackling microplastic pollution, worker health issues, and the 2027 EU ban on microbeads and lead. Aradhita discusses successful pilots with fashion brands and skincare companies, the challenges of achieving vivid colors and iridescence with biomaterials, and her vision for a circular system where anyone can upload a design and receive custom bioplastic solutions. The conversation explores the intersection of design, biotechnology, and sustainability, demonstrating how biology can create materials that don't just replace plastics—they surpass them.Grow Everything brings the bioeconomy to life. Hosts Karl Schmieder and Erum Azeez Khan share stories and interview the leaders and influencers changing the world by growing everything. Biology is the oldest technology. And it can be engineered. What are we growing?Learn more at ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠www.messaginglab.com/groweverything⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Chapters:(00:00:00) - Introduction: Fungi as environmental game-changers(00:26:18) - Podcast updates and Michael Levin episode highlights(02:10:35) - Ashley Beckwith and Foray Biosciences: mining fungal biodiversity(04:57:22) - The untapped power of mycelium in biotechnology(08:04:15) - Launching the Future is Fungi Award(08:58:40) - Susanne Gløersen: Why fungi deserve to be core technology(00:12:09) - Fungi's role in solving climate, pollution, and soil degradation(00:27:06) - Quickfire questions with Susanne Gløersen(00:29:14) - Ricky Casini of Michroma: replacing synthetic food dyes with fungi(00:38:10) - Scaling fermentation capacity in South Korea(00:38:45) - Pitching fungal colorants to food manufacturers(00:40:22) - Regulatory wins and transparency in natural colors(00:41:19) - The future of fungal bio-factories in food production(00:43:05) - Scaling up production and strategic partnerships(00:44:09) - Why color matters in consumer packaged goods(00:45:46) - Winning the Future is Fungi Startup Award(00:46:59) - Quickfire questions with Ricky Cassini(00:49:02) - Dr. Britta Winterberg introduces Mycolever's clean beauty mission(00:50:00) - Fungal bio-compounds replacing petrochemicals in cosmetics(00:52:10) - Technical challenges and breakthroughs in fungal biotech(00:59:52) - Quickfire questions with Dr. Britta Winterberg(01:02:54) - Final reflections on the fungal innovation revolutionLinks and Resources:CellsenseCellsense Partnership with the United NationsBioculture Event hosted by Biofabricate x Juniper VCArahita - LinkedinMountain and The Sea - Ray Nayler 138. Living Textures, Wild Pigments: Suzanne Lee on Nature's New Aesthetic Toolbox154. No Trees Were Harmed: Symmetry Wood's Gabe Tavas on Growing Wood from WasteGrow Everything SubstackGrow Everything PatreonTopics Covered: biomaterials, fashion, embellishments, sequins, bacterial cellulose, fermentationHave a question or comment? Message us here:Text or Call (804) 505-5553 

Tech Talks by Mayer Brown
Artificial Intelligence Provisions in Technology Contracting: Keeping Up With the Evolving Regulatory Landscape

Tech Talks by Mayer Brown

Play Episode Listen Later Dec 19, 2025 34:15


In this Tech Talks episode, Mayer Brown partners Ana Bruder, Julian Dibbell, Gabriela Kennedy, Arsen Kourinian, and Oliver Yaros put four AI regimes head to head: the European Union's risk based Act, the United Kingdom's light touch approach, Asia's mixed models, and the United States' state by state patchwork. Their contracting playbook: lock down roles and risk, and go beyond "comply with law" to require risk management, human oversight, transparency, and data use limits. Our hosts close out by looking ahead to 2026 to see how these regimes diverge further. Show Notes:  00:04 Introductions to Artificial Intelligence Provisions in Technology Contracting 02:52 EU AI Act: Roles, Risk Tiers, and Contract Implications 04:05 UK's Pro Innovation, Light Touch Framework 07:50 Asia Snapshot: China's GenAI Rules vs. Soft Touch Regimes 10:58 U.S. Patchwork: State Laws, High Risk Use Cases, and Contracts 14:41 Negotiating AI Contracts Amid a Shifting Global Regulatory Landscape 18:44 Practical Best Practices for AI Contracting 24:50 Beyond "comply with law": Standards, Data Use, and Future Proofing 27:25 2026 Looking Ahead: Global Regulatory Trajectories

FYI - For Your Innovation
Modernizing Legal Financial Systems With Carlos Domingo

FYI - For Your Innovation

Play Episode Listen Later Dec 18, 2025 49:29


In this episode, Brett Winton and Lorenzo sit down with Carlos Domingo, CEO and co-founder of Securitize, to explore how blockchain infrastructure is transforming capital markets. As a pioneer in the tokenization space, Carlos unpacks what it means to issue native securities—like stocks, bonds, and credit funds—on chain and why the modernization of legacy financial systems is long overdue. Carlos details Securitize's role as a registered transfer agent and broker-dealer, their regulatory journey with the Securities and Exchange Commission (SEC), and why native tokenization (not synthetic derivatives) is essential for future growth. They discuss the promise of 24/7 trading, peer-to-peer transfers, composability with decentralized finance (DeFi) protocols, and the global democratization of financial access—especially in markets underserved by traditional systems. The episode also dives into the tension between blockchain-native systems and financial incumbents, the logic behind Securitize's decision to go public via a special purpose acquisition company (SPAC), and the asset classes best suited for tokenization—from treasuries to public equities and beyond.Key Points From This Episode:(00:00:00) Why capital markets need a blockchain-based ledger upgrade(00:05:46) How tokenization improves global accessibility and financial user experience(00:07:35) Real-world examples: Tokenized treasury and credit funds(00:10:29) Understanding how ownership works: DTCC, transfer agents, and blockchain(00:17:08) Global appetite for tokenized stocks, following stablecoin adoption(00:18:24) Tokenizing private equity and venture capital for broader access(00:25:34) How Securitize tokenizes assets the right way—with issuer involvement(00:28:55) Regulatory clarity accelerates tokenization adoption(00:30:08) Open blockchain infrastructure unlocks composability and innovation(00:35:50) Where Securitize fits in the capital markets stack(00:37:13) Projecting tokenized assets: From $4.6B to $200B assets under management (AUM)(00:39:46) Why Securitize stays blockchain-agnostic despite protocol growth

Consumer Finance Monitor
The CFPB's Most Ambitious Regulatory Agenda Ever – Part 1

Consumer Finance Monitor

Play Episode Listen Later Dec 18, 2025 45:15


Today's episode features Part 1 of our November 4 webinar, "The CFPB's Most Ambitious Regulatory Agenda Ever." In this packed episode, our expert panel breaks down the Consumer Financial Protection Bureau's largest and boldest regulatory agenda to date. Discussing an unprecedented lineup of 24 rulemaking items that could reshape the consumer financial services industry. What's Included: Unprecedented Regulatory Activity: We unpack why this semi-annual agenda stands out, the record number of proposed rules, and what this means for financial institutions, FinTechs, and consumers alike. Hot Topics Covered: From sweeping changes in mortgage servicing to open banking (1033 of Dodd-Frank/personal financial data rights), small business lending rules (1071 of Dodd-Frank), and the rollout of the Financial Data Transparency Act, we cover all the major initiatives and legal battles on the horizon. Industry Insight: Hear why certain rules are stirring up controversy, what compliance challenges lie ahead, and how litigation and funding woes at the CFPB might impact the pace of change. Practical Impact: Learn about technical corrections in remittance transfer rules, new standards for data sharing, and what these changes mean for day-to-day business operations. Meet Your Speakers from Ballard Spahr: Alan Kaplinsky (Host & Moderator): Senior Counsel, founder and former leader of Ballard Spahr's Consumer Financial Services Group  Rich Andreano, Jr.: Partner and head of the firm's Mortgage Banking Group  John Culhane, Jr.: Partner in the Consumer Financial Services Group  Greg Szewczyk: Chair of the firm's Privacy and Data Security Group  Mudasar Pham-Khan: Associate, Consumer Financial Services Group  Kristen Larson: Of Counsel, Consumer Financial Services Group  Daniel Wilkerson: Associate, Consumer Financial Services Group  Rob Lieber: Associate, Consumer Financial Services Group  Aja Finger: Associate, Consumer Financial Services Group  Tune in for strategic insights and practical tips to help you prepare for the CFPB's evolving rulebook. Whether you're a compliance leader, financial executive, or simply interested in how Washington's boldest moves will impact your world, this episode is your essential guide to what's next in consumer financial services. Don't miss Part 2, coming next week with even more updates and expert perspectives! Consumer Finance Monitor is hosted by Alan Kaplinsky, Senior Counsel at Ballard Spahr, and the founder and former chair of the firm's Consumer Financial Services Group. We encourage listeners to subscribe to the podcast on their preferred platform for weekly insights into developments in the consumer finance industry.

Voice of California Agriculture
Episode 87: 12/18/2025 - Research into Non-Lethal Methods to Protect Livestock From Mountain Lions, Clean Water Regulatory Proposal, Persimmons, and Figs

Voice of California Agriculture

Play Episode Listen Later Dec 18, 2025 25:56


Researchers are trying to protect livestock from mountain lions. The American Farm Bureau is pleased with proposed changes in clean water regulations and will check in with a farmer of persimmons and figs to learn a little about the crop and their health benefits.   

AgCulture Podcast
Gregg Doud: Inside Global Trade | Ep. 104

AgCulture Podcast

Play Episode Listen Later Dec 18, 2025 52:08


In this episode of the AgCulture Podcast, Gregg Doud, President and Chief Executive Officer of the National Milk Producers Federation, explains how global agricultural trade negotiations actually work behind closed doors. Drawing on his experience as Chief Agricultural Negotiator at the Office of the United States Trade Representative, Gregg breaks down trade leverage, non tariff barriers, and why communication matters more than tariffs alone. He also shares why agriculture and dairy exports are central to US economic and food security. Listen now on all major platforms to hear this insider perspective on global trade!Meet the guest: Gregg Doud is President and Chief Executive Officer of the National Milk Producers Federation, where he leads efforts to strengthen US dairy competitiveness and global trade. He previously served as Chief Agricultural Negotiator at the Office of the United States Trade Representative and held senior roles in Congress and agricultural economics.What you will learn: (00:00) Introduction(06:13) Trade scale explained(13:18) China negotiations(16:01) Trade preparation(20:32) Regulatory barriers(29:13) Trade misconceptions(45:22) Closing thoughtsDiscover the world of agriculture with the "Ag Culture Podcast". This podcast will be a gateway for those passionate about agriculture to explore its global perspectives and innovative practices.Join Paul as he shares his experiences in the agricultural industry, his travels and encounters with important figures around the world.Available on YouTube, Spotify and Apple Podcasts.Subscribe at http://www.agculturepodcast.com and keep an eye out for future episodes, bringing insights and stories from the vibrant world of agriculture.

MedBoard Matters
Position statements: A licensee's secret weapon for avoiding regulatory problems

MedBoard Matters

Play Episode Listen Later Dec 18, 2025 23:26 Transcription Available


The North Carolina Medical Board is committed to providing our licensees with tools that will help them be successful in their practice. In this episode, we talk with Todd Brosius, one of the Board's Deputy General Counsel about the Board's position statements, how they are developed, and how our licensees can use them as guidance for avoiding Board discipline. Learn more here. Host: Jean Fisher Brinkley, Communications Director, North Carolina Medical BoardGuest: Todd Brosius, Deputy General Counsel, North Carolina Medical BoardProducer: Sylvia French-Hodges, Communications Specialist, North Carolina Medical BoardFollow the North Carolina Medical Board on Facebook, Instagram, LinkedIn, and X.Email your questions to: podcast@ncmedboard.org.

The Tim Ferriss Show
#840: Bill Gurley — Investing in The AI Era, 10 Days in China, and Important Life Lessons from Bob Dylan, Jerry Seinfeld, MrBeast, and More

The Tim Ferriss Show

Play Episode Listen Later Dec 17, 2025 130:09


Bill Gurley (@bgurley) is a general partner at Benchmark, a leading venture capital firm in Silicon Valley. His new book is Runnin' Down a Dream: How to Thrive in a Career You Actually Love.This episode is brought to you by:Momentous high-quality creatine for cognitive and muscular supportOur Place's Titanium Always Pan® Pro using nonstick technology that's coating-free and made without PFAS, otherwise known as “Forever Chemicals”Shopify global commerce platform, providing tools to start, grow, market, and manage a retail businessCoyote the card game​, which I co-created with Exploding Kittens*Timestamps:[00:00:00] Start.[00:01:43] The book that gave Jerry Seinfeld permission to pursue comedy and inspired Runnin' Down a Dream.[00:03:59] AI bubble or not?[00:06:33] Circular deals and SPV chaos.[00:12:01] Angel investing in the AI era.[00:14:32] Why you should be the most AI-enabled version of yourself, regardless of field.[00:20:47] China deep dive: Ten days, six cities, high-speed trains, and a Xiaomi SU7 factory tour.[00:22:43] Communism misconceptions.[00:25:40] Lei Jun: The Steve Jobs of China.[00:29:17] Jack Ma, ByteDance's invisible CEO, and the risks of prominence in China.[00:32:11] America vs. China (Lawyers vs. engineers).[00:41:01] Keys for US competitiveness.[00:43:47] Bill is bullish on these countries.[00:47:30] Matthew McConaughey's “Don't half ass it” moment.[00:49:45] Runnin' Down a Dream thesis: Helping people pursue X instead of A, B, or C.[00:51:03] The 80,000-hour question.[00:52:47] The self-learning test.[00:56:58] Bob Dylan as music expeditionary.[01:00:27] Go to the epicenter where the action is.[01:10:56] Danny Meyer's pivot.[01:13:30] Working for free.[01:19:37] Never too late: Tito Beveridge started Tito's Vodka at 40.[01:21:51] AI sanity checks.[01:25:59] AI-proof bets.[01:29:13] Sam Hinkie's Moneyball moment.[01:32:37] Competitive strategy, avoiding false failures, and regret minimalization.[01:43:46] Purpose, Progress, and Prosperity — the P3 Policy Institute.[01:47:18] Regulatory capture explained.[01:51:55] Why the IPO market is broken.[02:01:52] Stablecoins putting Visa and Mastercard on notice.[02:03:40] Hopes for Runnin' Down a Dream and parting thoughts.*For show notes and past guests on The Tim Ferriss Show, please visit tim.blog/podcast.For deals from sponsors of The Tim Ferriss Show, please visit tim.blog/podcast-sponsorsSign up for Tim's email newsletter (5-Bullet Friday) at tim.blog/friday.For transcripts of episodes, go to tim.blog/transcripts.Discover Tim's books: tim.blog/books.Follow Tim:Twitter: twitter.com/tferriss Instagram: instagram.com/timferrissYouTube: youtube.com/timferrissFacebook: facebook.com/timferriss LinkedIn: linkedin.com/in/timferrissSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Travillian
The Long Game of Bank M&A: Janney and D.A. Davidson on Diligence, Culture, and What Comes Next

Travillian

Play Episode Listen Later Dec 17, 2025 41:11


Bank M&A isn't about speed anymore. It's about preparation.In this episode of the Travillian Next podcast, investment bankers from Janney Montgomery Scott and D.A. Davidson break down how bank M&A has become a long game shaped by diligence, culture, regulation, and timing.Travillian's Brian Love and Andrew Liesch sit down with Dan Flaherty (Janney) and Gene Katz (D.A. Davidson) to discuss how M&A conversations now happen years before a deal is signed, why diligence has become confirmatory rather than exploratory, and how cultural fit, succession planning, and regulatory strategy increasingly determine whether deals succeed or fail.The conversation also explores the role of credit unions as bank buyers, how fintech and private investors fit into today's M&A landscape, and why boards are thinking beyond short-term stock reactions when evaluating acquisitions. For bank executives, directors, and investors trying to understand where consolidation is headed, this discussion offers a realistic, on-the-ground view of what's actually driving deals today.Topics covered include:• The evolution of bank M&A diligence• Why culture is now a core deal risk• Regulatory tone and approval timelines• Succession planning and talent-driven transactions• Credit unions, fintech buyers, and market dynamics• What investment bankers expect for bank M&A in 2026

Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
The Hidden Drivers of Clinical Trial Success: Interview with Rivermark CEO Dr. Adam Kadlec

Medsider Radio: Learn from Medical Device and Medtech Thought Leaders

Play Episode Listen Later Dec 16, 2025 57:34


In this episode of Medsider Radio, we sat down Dr. Adam Kadlec, practicing urologist and co-founder of Rivermark Medical.Rivermark is a clinical-stage company developing FloStent, a first-line, reversible device therapy for benign prostatic hyperplasia (BPH).Before launching Rivermark, Adam built a thriving urological practice in Milwaukee and consulted for several device companies — experiences that ultimately revealed how early true device development begins and why physicians rarely get the chance to influence innovation upstream. Partnering with medtech operator Andy Doraiswamy, Adam transitioned from clinician to CEO and is now leading Rivermark through its pivotal trial.In this interview, Adam shares why workflow integration is one of the most overlooked drivers of adoption, how physician-innovators can build the right decision-making infrastructure, and why understanding who actually enrolls patients at clinical sites can make or break a trial. He also touches on the mindset required to stay resilient through the ups and downs of building a medtech startup.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Adam Kadlec.

Talk Ten Tuesdays
Apple, Chair, Ocean, Book, Clock

Talk Ten Tuesdays

Play Episode Listen Later Dec 16, 2025 29:45


Are you wondering what connects the nouns in the headline together?It's a Medicare cognitive screening devise. Look at these words and commit them to memory. Try to repeat back this list of words twice a day, from memory: Apple, Chair, Ocean, Book, and Clock.  During the next live edition of the popular Talk Ten Tuesday live Internet broadcast, Gloryanne Bryant will report on what some medical experts say about an inability to recall these five words.Could it be signs of cognitive changes or impairment within the brain? Or could it mean that the individual has memory and recall issues? Register now to learn more.The broadcast will also feature these instantly recognizable panelists, who will report more news during their segments:News Desk: Timothy Powell, ICD10monitor national correspondent, will anchor the Talk Ten Tuesdays News DeskThe Coding Report: Jodi Worthington, with First Class Solutions, will substitute for Christine Geiger to report on the latest coding news POV: Penny Jefferson, Manager of Coding & Clinical Documentation Integrity Services for the University of Davis Medical Center, and guest cohost of Talk Ten Tuesday, will share her point of view (POV) during the broadcast.

Dollars & Sense with Joel Garris, CFP
Navigating the Corporate Transparency Act & IRA Rule Changes

Dollars & Sense with Joel Garris, CFP

Play Episode Listen Later Dec 15, 2025 39:27


In this week's episode of Dollars & Sense with Joel Garris, Joel dives into two urgent questions facing American investors and retirees: How will the Corporate Transparency Act (CTA) affect your business, and are you prepared for the costly pitfalls of inherited IRA rules? First, Joel unpacks the latest developments in the Corporate Transparency Act, including an interview with Simon Conway. Listeners learn why recent rule changes and enforcement suspensions mean most U.S. companies are temporarily off the hook for beneficial ownership reporting—but why foreign entities and ongoing litigation could shift the landscape again soon. Joel and Simon highlight the burden on small businesses and the complex path to reversing these requirements. Next, Joel explores the growing crisis of Americans sacrificing retirement savings to support family members. He shares surprising statistics: While most are willing to cut back on their own lifestyles or work longer, only a small fraction are willing to reconsider family support. Joel offers practical strategies for setting boundaries, planning tax-efficient gifts, and balancing the needs of the “sandwich generation.” The episode's third segment tackles the new inherited IRA rules that could cost unwary beneficiaries thousands in penalties. Joel explains how missing required withdrawals can trigger a 25% penalty and push you into a higher tax bracket, plus the common mistakes people make and the tax-smart moves to avoid them. Key Takeaways: Stay updated on CTA regulations and know if your business is affected. Protect your retirement by setting clear boundaries on family financial support. Understand and plan for inherited IRA rules to avoid hefty penalties. Don't miss this engaging episode—click to listen and get expert insights on protecting your wealth, planning smarter, and avoiding costly mistakes! 

Monitor Mondays
The Whistleblower Update

Monitor Mondays

Play Episode Listen Later Dec 15, 2025 30:37


Whistleblower attorney Max Volman will return to the next Monitor Monday broadcast to report the latest news about whistleblowers. As we have learned, often “whistleblowers” are not insiders reporting wrongdoing; they tend to be outside the offending organization.Register now to listen to Max Voldman's exclusive report.Broadcast segments will also include these instantly recognizable features:●       Monday Rounds: Ronald Hirsch, MD, vice president of R1 RCM, will be making his Monday Rounds. ●       The RAC Report: Healthcare attorney Knicole Emanuel, partner at the law firm of Nelson Mullins, will report the latest news about auditors. ●       Legislative Update: Adam Brenman, legislative affairs analyst for Zelis, will report on the news happening at the intersection of healthcare and congressional action.●       Risky Business: Healthcare attorney David Glaser, shareholder in the law offices of Fredrikson & Byron, will join the broadcast with his trademark segment.

The John Batchelor Show
S8 Ep180: REVIEW — Bob Zimmerman — European Union Space Act: Regulatory Overreach Against Private Enterprise. Zimmerman discusses a proposed European Union Space Act, characterizing this legislation as "egregious" regulatory overreach that w

The John Batchelor Show

Play Episode Listen Later Dec 13, 2025 2:16


REVIEW — Bob Zimmerman — European Union Space Act: Regulatory Overreach Against Private Enterprise. Zimmerman discusses a proposed European Union Space Act, characterizing this legislation as "egregious" regulatory overreach that would systematically harm private enterprise innovation and commercial space development. Zimmermanprovides a 50-word summary: Zimmerman critiques the law because the EU is attempting to impose its regulatory sovereignty on non-European companies, specifically dictating satellite construction and launch methodologies for American firms having no European operational presence or connection. Despite unprecedented opposition from the U.S. State Department, the European Space Agency, private American space companies, and the Progressive Policy Institute (a leftist policy organization), Zimmerman warns that the EU characteristically ignores substantive objections and pursues its own regulatory agenda unilaterally, functioning analogously to a Homeowners Association attempting to enforce paint color requirements on properties located in completely different cities outside their jurisdictional authority.

The John Batchelor Show
S8 Ep179: PREVIEW — Jeff Bliss — California Gas Prices and Regulatory Constraints. Bliss reports that while national average gasoline prices are declining due to demand weakness and ample supply, California gasoline prices remain persistently elevated

The John Batchelor Show

Play Episode Listen Later Dec 12, 2025 1:50


PREVIEW — Jeff Bliss — California Gas Prices and Regulatory Constraints. Bliss reports that while national average gasoline prices are declining due to demand weakness and ample supply, California gasoline prices remain persistently elevated, frequently exceeding $5.00 per gallon due to state-specific regulatory frameworks and the systematic closure of petroleum refineries reducing processing capacity. Bliss warns that energy market experts project California gasoline prices could catastrophically escalate to approximately $12.00 per gallon, a devastating potential price increase for a state economy structurally dependent upon private automobile transportation and individual vehicle ownership for employment, commerce, and daily economic activity.

Marketplace Tech
The little-known regulatory bodies that can make or break AI data centers

Marketplace Tech

Play Episode Listen Later Dec 11, 2025 7:02


The AI boom is propelling a once-obscure group of state regulators into key decision-making roles for the economy. AI needs data centers, data centers need power and power is generally regulated in some way — depending on the state — by public utilities commissions.That's the topic of a new report from the Center on Technology Policy at NYU. Scott Brennen, CTP director and author of the report, said these commissions often make decisions on planning and permitting for new infrastructure and decide the rates utilities charge consumers.

Marketplace All-in-One
The little-known regulatory bodies that can make or break AI data centers

Marketplace All-in-One

Play Episode Listen Later Dec 11, 2025 7:02


The AI boom is propelling a once-obscure group of state regulators into key decision-making roles for the economy. AI needs data centers, data centers need power and power is generally regulated in some way — depending on the state — by public utilities commissions.That's the topic of a new report from the Center on Technology Policy at NYU. Scott Brennen, CTP director and author of the report, said these commissions often make decisions on planning and permitting for new infrastructure and decide the rates utilities charge consumers.

The Investing Podcast
Takeaways From Yesterday's Fed Meeting & Oracle Results | December 11, 2025 – Morning Market Briefing

The Investing Podcast

Play Episode Listen Later Dec 11, 2025 25:59


Andrew, Ben, and Tom discuss their takeaways from yesterday's Fed meeting and break down Oracle's earnings.Song: I Will Possess Your Heart - Death Cab for CutieFor information on how to join the Zoom calls live each morning at 8:30 EST, visit:https://www.narwhal.com/blog/daily-market-briefingsPlease see disclosures:https://www.narwhal.com/disclosure

Trader Merlin
Metals Mania!- 12/09/25

Trader Merlin

Play Episode Listen Later Dec 9, 2025 52:16


Today's markets lit up the precious-metals world, and we're breaking it all down. In this episode, we dive into the big surge in silver, gold, platinum, and more, and what's really driving the sudden momentum across the metals complex. But that's not all—JPMorgan just moved its entire metals-trading desk to Singapore. Why would one of the world's biggest market players shift operations halfway around the world? Regulatory pressure? Market opportunity? Strategic positioning? We'll dig into the institutional logic and what it may signal for global metals trading going forward. If you trade commodities—or just watch how capital flows shape markets—you'll want to hear this one. Listen now:

Remarkable Marketing
The Restoration of a French Farmhouse: B2B Marketing Lessons on Balancing the Old and the New with Chief Marketing and Chief Partner Officer at Contentsquare, Jean-Christophe Pitié

Remarkable Marketing

Play Episode Listen Later Dec 9, 2025 47:39


Restoring a 250-year-old farmhouse isn't just a renovation project. It's a blueprint for modern marketing.That's the lesson from Jean-Christophe Pitié, Chief Marketing and Chief Partner Officer at Contentsquare, who's spent the last five years bringing new life to a centuries-old home outside Paris. In this episode, we break down the marketing lessons hidden in his restoration journey.Together, we explore what B2B marketers can learn from blending heritage with innovation, finding creativity in constraints, and designing connected experiences where every touchpoint matters.About our guest, Jean-Christophe PitiéWith 20+ years of experience in international marketing and partner engagement, Jean-Christophe is committed to supporting companies of all sizes in their digital transformation. Passionate about technology and retail, he spent two decades at Microsoft, where he had the opportunity to contribute to the cloud transformation and to launch Microsoft 365 as well as leading Microsoft Stores. Today, as Chief Marketing and Partnerships Officer at Contentsquare, Jean-Christophe's main mission is to drive customer demand in markets around the world, continue to grow our rich partner ecosystem, and bring holistic customer experience insights to more teams worldwide.What B2B Companies Can Learn From the restoration of a French farmhouse:Honor your legacy while modernizing for today. Great brands, like great houses, balance tradition and innovation. Jean-Christophe explains, “I had architects who came initially, and they wanted to put glass everywhere, tear down some big stone walls, and I'm like, guys, this house has had oak beams for 250 years. I'm not gonna tear them down. I'm gonna keep them.” In B2B, the same logic applies. Your legacy, your history, and your customer trust are part of your brand's foundation. Don't tear them down for the sake of what's trendy. Blend your legacy with fresh, modern layers such as new tech, new storytelling, and new energy, without losing what made your brand distinct. That balance between the old and the new is what gives it lasting beauty and credibility.Constraints fuel creativity. Jean-Christophe says, “Sometimes the best projects come when… you have a constraint… either a location constraint or timing or budget, you get very creative to work around the constraints.” His farmhouse's three-foot-thick stone walls forced him to rethink how to add modern features, and that challenge sparked originality. In B2B, the same holds true. Limited budget? Shrinking timelines? Regulatory hurdles? These are the sparks for inventive ideas. Don't let your constraints kill creativity; let them focus it.Every touchpoint shapes the experience. When restoring a house, you have to look at the whole picture; every room, material, and detail needs to connect. Jean-Christophe shared, “It's a bit like your marketing strategy. You need to connect across channels… every touchpoint matters.” Just like a home's design must flow seamlessly from one room to the next, so should your brand experience, across your website, content, product, and sales. Inconsistent moments break trust. When every touchpoint feels connected and intentional, you turn friction into flow, and customers into believers.Quote“History is part of who we are, human beings… It's beautiful… It's like a brand. When you think about brand, you want something that's unique, differentiated, [and] people can relate to, which is so beautiful.”Time Stamps[00:55] Meet Jean-Christophe Pitié, Chief Marketing and Chief Partner Officer at Contentsquare[01:04] Jean-Christophe's French Farmhouse Restoration Project[04:38] Balancing Tradition and Innovation in Restoration Projects[13:56] Creative Solutions and Constraints in Restoration[21:30] Importance of Legacy[26:51] B2B Marketing Lessons from Restoring a French Farmhouse[38:30] Innovations at Content Square[43:33] Advice for CMOs on Investing in Brand[45:45] Final Thoughts and TakeawaysLinksConnect with Jean-Christophe on LinkedInLearn more about ContentsquareAbout Remarkable!Remarkable! is created by the team at Caspian Studios, the premier B2B Podcast-as-a-Service company. Caspian creates both nonfiction and fiction series for B2B companies. If you want a fiction series check out our new offering - The Business Thriller - Hollywood style storytelling for B2B. Learn more at CaspianStudios.com. In today's episode, you heard from Ian Faison (CEO of Caspian Studios) and Meredith Gooderham (Head of Production). Remarkable was produced this week by Jess Avellino, mixed by Scott Goodrich, and our theme song is “Solomon” by FALAK. Create something remarkable. Rise above the noise. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Analytic Dreamz: Notorious Mass Effect
"NETFLIX TO BUY WARNER BROS. IN $83 BILLION DEAL"

Analytic Dreamz: Notorious Mass Effect

Play Episode Listen Later Dec 8, 2025 22:32


Linktree: ⁠https://linktr.ee/Analytic⁠Join The Normandy For Additional Bonus Audio And Visual Content For All Things Nme+! Join Here: ⁠https://ow.ly/msoH50WCu0K⁠Dive into the seismic Netflix-Warner Bros. Discovery deal reshaping streaming in this Analytic Dreamz segment on Notorious Mass Effect. The $72 billion acquisition merges Netflix's 300M subscribers with HBO Max's 130M, targeting 430M global users—possibly $83B including debt. Set for Q3 2026 close, it requires spinning off CNN, Discovery Channel, TBS, and TNT.Netflix scores powerhouse IPs: Batman, Superman, Wonder Woman, Harry Potter, Game of Thrones, The Sopranos, and classics like Casablanca, Citizen Kane. Columbia Business School's Kathryn Harrigan praises the unmatched library. HBO Max stays separate—no subscriber shifts yet—but co-CEO Gregory Peters signals post-close bundles, tiering, and integration amid overlap.Price hikes expected in 12-18 months. Regulatory hurdles mount: Sen. Elizabeth Warren calls it an 'anti-monopoly nightmare'; Trump administration skeptical per CNBC. Paramount-Skydance ($8.4B bid) and Comcast challenge, citing dominance risks. SAG-AFTRA warns of creative workforce threats. CEO Ted Sarandos defends: pro-consumer, pro-innovation, pro-worker, expanding choice.Warner films keep theatrical runs. Netflix also seals $1B Fort Monmouth acquisition for 12 soundstages, 500K sq ft production by 2028. Sarandos-Trump meetings add intrigue. $5.8B breakup fee if failed. Bids beat $28/share. This rivals Disney-Fox, building history's largest streaming empire. Analytic Dreamz delivers the essential analysis.Support this podcast at — https://redcircle.com/analytic-dreamz-notorious-mass-effect/donationsPrivacy & Opt-Out: https://redcircle.com/privacy

Chase & Josh: Fact or Fantasy
Netflix's $82.7 Billion Power Move: Warner Bros Acquisition

Chase & Josh: Fact or Fantasy

Play Episode Listen Later Dec 5, 2025 22:53


In this episode, Kyle S delivers an emergency news update on Netflix's acquisition of Warner Brothers Studios, HBO, and HBO Max for $82.7 billion. This monumental deal reshapes the entertainment landscape, merging Netflix's streaming dominance with Warner Brothers' iconic IPs like DC Comics and Harry Potter. Takeaways Netflix acquires Warner Brothers Studios, HBO, and HBO Max. The deal is valued at $82.7 billion. This acquisition reshapes the entertainment landscape. Netflix merges streaming dominance with iconic IPs. Warner Brothers' iconic IPs include DC Comics and Harry Potter. The merger faces regulatory scrutiny and shareholder approval. Netflix pledges to maintain Warner Brothers' operations until 2029. The deal accelerates Hollywood's shift to digital-first distribution. Potential impacts on creativity and content diversity are discussed. The merger could lead to significant industry changes. Sound bites Netflix acquires Warner Bros for $82.7B. Warner Bros and HBO join Netflix. Streaming landscape reshaped by Netflix's acquisition. Netflix merges with Warner Bros' iconic IPs. Regulatory scrutiny for Netflix's acquisition. Netflix pledges to maintain Warner Bros' operations. Hollywood's shift to digital-first distribution. Impact on creativity and content diversity. Significant industry changes expected. Netflix's strategic acquisition of Warner Bros. Chapters 00:00:00 - Introduction and Emergency News Update 00:01:00 - Details of Netflix's Acquisition   00:02:00 - Impact on the Entertainment Industry  

The John Batchelor Show
S8 Ep156: PREVIEW — Joseph Sternberg — The Failure of the "Brussels Effect." Joseph Sternberg of the Wall Street Journal critiques the "Brussels Effect," a regulatory theory positing that heavy European Union regulatory standards w

The John Batchelor Show

Play Episode Listen Later Dec 2, 2025 1:47


PREVIEW — Joseph Sternberg — The Failure of the "Brussels Effect." Joseph Sternberg of the Wall Street Journalcritiques the "Brussels Effect," a regulatory theory positing that heavy European Union regulatory standards would enable European companies to achieve competitive advantage through compliance-driven market dynamics. Sternbergcharacterizes this strategic approach as "total nonsense," demonstrating that EU regulatory frameworks have systematically stifled the growth of major technology startups and innovative enterprises compared to the dynamism of Silicon Valley, producing technological and economic underperformance. Sternberg reports that Brussels officials are gradually accepting this uncomfortable reality and reconsidering the regulatory framework's strategic efficacy. 1884 BRUSSELS

The John Batchelor Show
S8 Ep150: 2/4. Politics vs. Markets: The Failures of Incentivized Climate Solutions — Terry Anderson (Editor) — Anderson discusses adaptation barriers, noting that regulatory frameworks systematically impede Alaskan Native Villages' traditional ecolo

The John Batchelor Show

Play Episode Listen Later Dec 1, 2025 9:05


2/4. Politics vs. Markets: The Failures of Incentivized Climate Solutions — Terry Anderson (Editor) — Andersondiscusses adaptation barriers, noting that regulatory frameworks systematically impede Alaskan Native Villages'traditional ecological knowledge and adaptive ingenuity. Anderson critiques incentivized climate solutions, particularly carbon taxation schemes, arguing they fail fundamentally due to political polarization driven by the perverse incentive structure ("don't tax me, tax them"). Anderson advocates instead for market-driven responses that empower consumers as decision-makers, catalyzing genuine adaptation outcomes, including strategic crop relocation and agricultural practice modification in response to changing environmental conditions. 1838