Podcasts about regulatory

Bob Zimmerman covers ESA's fast-tracked Apophis asteroid mission, a commercial attempt to rescue a NASAtelescope, and the contrasting regulatory environments of the UK and New Zealand for space launches.

Recent weeks have seen extreme cross‑asset volatility, with sharp unwinds hitting US and China tech stocks, precious metals and cryptocurrencies. In China, renewed concerns about regulatory scrutiny are weighing on sentiment, even as the case for a stronger renminbi continues to build.In this episode of Moving Markets: The View Beyond, Richard Tang, Head of Research Hong Kong at Julius Baer, speaks with Hong Hao, Managing Partner and CIO of Lotus Asset Management Ltd., to discuss what the market dislocations mean for investors, and how these cross-asset dynamics may shape positioning in the weeks ahead.(00:30) - The big precious metals selloff (04:04) - Cryptocurrencies – near and long-term outlook (08:13) - Industrial metals remain supported by rising strategic demand (10:36) - China tech – is it time to buy the dip? (13:55) - Defining “value” in China's rotation (15:32) - Regulatory scrutiny – how worried should investors be? (20:20) - A-shares vs H-shares in the short term? (23:03) - Renminbi strength and outlook

If one man may legally own another, then he should likewise have the right to disown this property. To deny this right by law involves simultaneously affirming the right of one human to own another as his property but not the right to stop owning another human.Original article: https://mises.org/mises-wire/olaudah-equianos-manumission-regulatory-barriers-freedom

Marc Elovitz is Global Head of Investment Management Regulatory at McDermott Will & Schulte – a leading global law firm. Marc advises private fund managers on running their businesses consistent with all relevant laws, regulations and legal requirements. Marc's cutting-edge work also covers the latest trends of interest to private funds, including blockchain technology and digital assets. He advises on the legal and regulatory considerations involving virtual and digital currency business initiatives and the blockchain technology behind them. In this podcast, we discuss: From Litigation to Regulation The Private Market Boom "Project Crypto" and Regulatory Harmonisation Beyond Digital Gold The Yield Obstacle in Stablecoins Future-Proofing Digital Assets The Trust Factor in Private Equity Solving the AI Explainability Crisis The Delaware Governance Battle Perspective through Fiction

If one man may legally own another, then he should likewise have the right to disown this property. To deny this right by law involves simultaneously affirming the right of one human to own another as his property but not the right to stop owning another human.Original article: https://mises.org/mises-wire/olaudah-equianos-manumission-regulatory-barriers-freedom

Interview with Nolan Peterson, CEO of Atlas SaltOur previous interview: https://www.cruxinvestor.com/posts/atlas-salt-tsxvsalt-developer-targets-north-americas-30-40-de-icing-salt-supply-gap-8975Recording date: 5th February 2026North America faces a growing crisis in road salt supply that most investors have overlooked. While the US$26 billion global salt market operates largely beneath public awareness, severe winter weather across the northeastern United States and Canada has exposed a structural deficit that has persisted for decades. Atlas Salt (TSXV:SALT) is developing the Great Atlantic Salt Project in western Newfoundland—the continent's first new salt mine in nearly 30 years—to address this critical infrastructure gap.The North American deicing road salt market imports 8-10 million tons annually to meet demand that domestic production cannot satisfy. Existing mines date predominantly from the mid-20th century, with operations beginning between 1906 and 1982. These aging facilities operate at depths of 500-600 meters, often beneath lakes, requiring high operating costs and substantial capital expenditures. Regulatory challenges and thin historical margins have prevented new mine development despite growing demand from population growth, expanded road networks, and increased vehicle numbers.Atlas Salt's competitive advantage stems from its shallow 200-meter deposit depth, which allows access via horizontal drift rather than expensive vertical shaft construction. Located just three kilometers from an existing port facility, the project gains direct access to Atlantic Ocean shipping lanes and the eastern seaboard market. The simplified production process requires only mechanical crushing of 96% grade salt—no chemical processing, tailings, or refining—enabling two-month environmental assessment approval.At full production capacity of 4 million tons annually, Atlas would need to capture only 30-40% of current import volumes, targeting non-cyclical government customers legally mandated to purchase salt for road safety. The market's inelastic demand was demonstrated in January 2026 when Ontario spot prices surged from $65-75 per ton to over $190 during severe winter conditions. CEO Nolan Peterson emphasizes the dual investment appeal: "We are working with lenders who view this as investing into an airport or power plant—something that has long-term sales baked in because you're selling your product to governments, citizens and people."View Atlas Salt's company profile: https://www.cruxinvestor.com/companies/atlas-saltSign up for Crux Investor: https://cruxinvestor.com

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore a series of significant shifts in the industry, marked by leadership changes, scientific advancements, strategic partnerships, and regulatory challenges.Starting with Sanofi, a notable leadership transition has taken place as Paul Hudson steps down from his role as CEO. Belen Garijo from Merck KGaA has stepped into this pivotal role. Her appointment is part of a broader industry trend toward diversifying leadership, especially with more women leading top-tier pharmaceutical companies. The implications of this shift could be profound for Sanofi, potentially stabilizing its operations and revitalizing its research pipeline. Stakeholders are keenly observing how this new leadership might steer Sanofi through complex market dynamics.In regulatory news, Moderna has encountered a significant hurdle with the FDA declining to review its next-generation mRNA flu vaccine. This decision has sparked an ongoing public dialogue between Moderna and U.S. health regulators, underscoring the complexities involved in navigating regulatory pathways for novel mRNA technologies beyond their initial success with COVID-19 vaccines. The Department of Health and Human Services has supported the FDA's decision, emphasizing the critical importance of meticulous scrutiny when it comes to new vaccine platforms. This development highlights the challenges biotech companies face in ensuring compliance with stringent regulatory standards.Financial updates reveal CSL experiencing a sharp decline in net profits, dropping from $2 billion to $384 million year-over-year. This financial downturn has been linked to strategic missteps or operational inefficiencies within the company, prompting a change in leadership. Such shifts reflect broader challenges faced by companies within the biotech sector as they strive to maintain financial stability amid fluctuating market conditions.In contrast, Alnylam Pharmaceuticals has reported its first profitable year despite underwhelming sales figures for its drug Amvuttra in the ATTR-CM market. This milestone is significant for Alnylam as it demonstrates resilience and the potential to pivot successfully amidst market uncertainties. However, the company will need to remain vigilant about revenue streams and market dynamics moving forward.Turning to advertising strategies, Johnson & Johnson's Tremfya continues to buck industry trends by maintaining a strong presence in television advertising through 2026. This strategy is noteworthy given the general decline in traditional media spending across the industry. J&J's commitment highlights its determination to sustain market share against competitors such as AbbVie's Rinvoq and Skyrizi.On the strategic front, Takeda Pharmaceuticals is consolidating its U.S. operations by reducing its Boston presence. By subleasing over 630,000 square feet of office space, Takeda aims to streamline operations and concentrate resources on key development projects at its new Cambridge hub. This move reflects broader industry trends towards operational efficiency and resource optimization.In clinical advancements, BridgeBio has reached a promising milestone with successful Phase 3 trial results for infigratinib in treating dwarfism. This breakthrough offers new therapeutic options for children affected by this condition and exemplifies ongoing innovations in genetic medicine. The success of this trial positions BridgeBio on a path toward regulatory approval, potentially transforming care for patients with limited treatment options.Agilent has achieved FDA approval for its companion diagnostic test alongside Merck's Keytruda for ovarian cancer treatment. This approval highlights the growing importance of precision medicine in oncology, where tailored treatments based on individual paSupport the show

Part 2 of a 2-part episode on Information Blocking From a December 2025 WEDI virtual spotlight, a panel of health IT leaders break down the current state and the future of regarding information blocking, and how organizations can stay compliant while moving interoperability forward. The panel: Rebekah Fiehn, Strategic Partnership Developer, American Dental Association Andrew Tomlinson, Senior Director, Regulatory & International Affairs, AHIMA Arna Meyer, Technical Product Manager, Stedi Alisa Kuehn, VP, General Counsel & Privacy Officer, Indiana Health Information Exchange Chelsea Arnone, Director, Federal Affairs, CHIME Sasha TerMaat, EHRA's Information Blocking Compliance Task Force The moderator is Jeff Coughlin, Director, Federal Affairs, American Medical Association

Guest: Bob Zimmerman. Musk announces SpaceX will prioritize the Moon before Mars; regulatory approvals for Starship launches are pending, while Voyager Space secures a management contract for ISS operations.1906. WELLS. MARTIAN

In this episode of the Rational Reminder Podcast, we are joined by Theresa Ebden, Vice President of the Investor Office at the Ontario Securities Commission, for a deep dive into how regulators are thinking about modern investor risks—from AI-powered scams to finfluencers and the gamification of investing apps. Theresa explains how the OSC works to protect investors through policy, education, behavioral research, and direct engagement with the public, and why investor education is one of the most powerful tools regulators have. Key Points From This Episode: (0:01:55) Overview of the OSC and why its investor research and education work matters. (5:42) What the Ontario Securities Commission does and its mandate to protect investors and capital markets. (6:25) Inside the OSC Investor Office: policy, education and outreach, and the investor contact centre. (9:28) How the Investor Office identifies priority issues using inquiry data, behavioral insights, and global collaboration. (12:11) The nature of investor inquiries: fraud, crypto confusion, complaints, and recovery room scams. (14:01) How contact-centre data feeds into education, outreach, and policy responses. (16:07) Overview of GetSmarterAboutMoney.ca and its role in investor education. (20:43) Major retail investor risks today: AI-enhanced scams, finfluencers, dark patterns, and gamification. (24:43) What to do if you're impersonated by AI in scam advertisements. (29:28) What a "finfluencer" is and the different categories they fall into. (31:01) Research findings on how strongly finfluencers influence investor decisions. (32:55) Why non-investors are especially vulnerable to finfluencer advice and social-media scams. (36:11) How investors can evaluate online financial advice and check credentials. (38:02) Regulatory challenges in overseeing finfluencers and online financial content. (41:04) How AI magnifies traditional scams and why AI-enhanced fraud is more effective. (43:42) Mitigation strategies: education, just-in-time warnings, and system-level tools. (47:25) Relationship investment scams and why they are especially damaging. (52:53) Research on gamification in investing apps and its effects on investor behavior. (55:25) The Get Smarter About Trading simulator and how it demonstrates gamification effects. (57:19) How gamification can be used positively to improve diversification and outcomes. (58:16) Theresa's perspective on success and her focus on improving the individual investor experience. Links From Today's Episode: Meet with PWL Capital: https://calendly.com/d/3vm-t2j-h3p Rational Reminder on iTunes — https://itunes.apple.com/ca/podcast/the-rational-reminder-podcast/id1426530582. Rational Reminder on Instagram — https://www.instagram.com/rationalreminder/ Rational Reminder on YouTube — https://www.youtube.com/channel/ Benjamin Felix — https://pwlcapital.com/our-team/ Benjamin on X — https://x.com/benjaminwfelix Benjamin on LinkedIn — https://www.linkedin.com/in/benjaminwfelix/ Dan Bortolotti — https://pwlcapital.com/our-team/ Dan Bortolotti on LinkedIn — https://ca.linkedin.com/in/dan-bortolotti-8a482310 Editing and post-production work for this episode was provided by The Podcast Consultant (https://thepodcastconsultant.com)

What do most people regret at the end of their careers? According to legendary venture capitalist Bill Gurley, it's not the failures — it's the risks they never took. In this wide-ranging episode of The Puck, Jim Baer sits down with Gurley — longtime Benchmark partner, early Uber board member, and author of Running Down a Dream — for a candid conversation on boldness, bubbles, AI speculation, venture capital cycles, and America's structural challenges. Gurley reflects on: - Why “boldness regret” weighs heavier than failure - How to turn passion into mastery — and why most people don't - The resume arms race and why young people feel trapped - AI: real revolution or speculative excess? (Hint: both) - Venture capital's evolution — from discipline to burn-at-all-costs - Why five-year AI forecasts may set companies up to stumble - Regulatory capture in healthcare and education - State-by-state competition as America's hidden advantage From Austin's music scene to Silicon Valley's capital cycles, Gurley delivers battle-tested insights from decades at the center of tech's biggest waves. If you care about careers, markets, AI, or the future of the U.S. economy, this episode is essential listening.

What does it take to deploy AI across national health systems? In Part 2, Vidur Mahajan shares lessons from large-scale rollouts at RadNet and Singapore's health network, covering interoperability, regulation, and success metrics.   Timestamps:  00:00 – Introduction  00:55 – Deploying CARPL  05:50 – Real-world stories  10:52 – Regulatory challenges  13:30 – Interoperability  16:17 – Success metrics 

In this crossover episode of The Consumer Finance Podcast and Payments Pros, Taylor Gess, Jason Cover, and Caleb Rosenberg explore the heightened attention from regulators and legislators on small business finance programs and trade credit. They discuss the growth of fintech-driven and embedded business-to-business financing, the shift from simple trade credit to more complex installment and term products, and how these offerings increasingly trigger disclosure, registration, rate cap, and fair lending requirements — sometimes even pulling in federal rules like Reg E and Reg B when consumer accounts are involved. This episode also emphasizes the expanding structure of state commercial financing laws in California, Texas, and other states, with a focus on new disclosure regimes, and novel consumer-type protections. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

When it comes to Data Center development, how much control should the state, county and municipal governments have?

SPONSORMedboard: https://www.medboard.com/EUROPE New Harmonization Standards -  Implementing Decision 2026/193: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600193Neurosurgical implantsEN ISO 14155:2020 on clinical investigationsEN ISO 18562 series on Biocompatibility for Breathing gas pathways Germany: Transition from DMIDS to EUDAMED - March 19, 2026:https://www.bfarm.de/DE/Aktuelles/Veranstaltungen/Termine/2026-03-19-registrierung-mp.html?nn=986770EUDAMED mandatory by May 28th, 2026  High-Level Conference on Medical Devices - March 16th, 2026 - Brussels:https://health.ec.europa.eu/events/high-level-conference-medical-devices-innovation-and-patient-safety-16-march-2026-brussels-belgium-2026-03-16_enThe conference will feature three breakout sessions focusing on:Enhanced predictability for conformity assessments: combining certainty with flexibilityClinical evidence at EU level to support the regulatory framework: the key role of Expert PanelsBreakthrough technologies for better care: turning guidance into realityTeam-NB: Letter on Cybersecurity - MDR and IVDR proposal draft version:https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdfSwitzerlandSwissmedic inspection on Importers -30 importers, 232 product samples, RESULT?:https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/smc-ueberprueft-ch-importeure-2025.pdf.download.pdf/md-schwerpunktaktion-importeure-2025_en.pdf Swissdamed Webinar - May 28th, 2026:https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/swissdamed-webinar.htmlUKUK to exempt Health Institution - Not a priority for nowhttps://www.gov.uk/government/publications/health-institution-exemption-for-general-medical-devicesTrainingTeam-NB: Training on MDR technical Documentation - For manufacturers on April 19th, 2026:https://www.team-nb.org/new-session-mdr-technical-documentation-training-for-manufacturers/EasyIFUCreate eIFU and Labels easily - Compliance to EU MDR/IVDR:Https://easyifu.comRoWNorth AmericaFDA: General Wellness devices - Guidance by the FDA:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devicesFDA: Cybersecurity in Medical Devices - QMS and Pre-market submission:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarketAPACMalaysia: Electronic Certificates issued by MDA - For FSC, Manufacturing Certificates and Export Certificateshttps://portal.mda.gov.my/index.php/announcement/1746-implementation-of-electronic-certificates-for-certificate-of-free-sale-manufacturing-certificate-and-export-certificate-issued-by-medical-device-authority-mda-malaysiaIndia: Import of IVD - Online Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4NDE%3DAfricaEgypt: Database for Product Registration -Online Electronic Service: https://eservicesdata.edaegypt.gov.eg/MedicalDevicesMiddle EastSaudi Arabia: SFDA inspection of QMS requirements - Process that would be followed:https://www.sfda.gov.sa/sites/default/files/2026-01/MDS-REQ10E.pdfPodcastEpisode 372 - How to remediate a Design History File (DHF): https://podcast.easymedicaldevice.com/372-2/Episode 373 - QMSR is coming: Why FDA inspections with change completely in 2026: https://podcast.easymedicaldevice.com/373-2/Episode 374 - Validation & Supplier Management in MedTech: https://podcast.easymedicaldevice.com/374-2/ServicesConsulting support: info@easymedicaldevice.comAuthorized Representative: EO@easymedicaldevice.comSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

In this episode of Valley of Depth, we sit down with David Tearse, co-founder and CEO of Karman Industries, to explore a piece of the AI boom that rarely gets attention: thermal infrastructure.As hyperscale data centers grow into multi-gigawatt “AI factories,” the limiting factor is no longer just chips or capital — it's how efficiently we can move and reject heat. David explains how Karman's Heat Processing Unit (HPU) reimagines cooling from first principles, bringing aerospace-grade turbomachinery and modern power electronics to a decidedly unglamorous but critical layer of the AI stack.The conversation moves from the physics of heat to the politics of data centers, and ultimately to why thermal efficiency may become a quiet national security advantage.We discuss:Why thermal management—not chips—may be the next bottleneck in the AI stackHow Karman's HPU replaces traditional chillers and dry coolers outside the data centerHow much additional compute Karman can unlock from the same power inputWhy CO₂ refrigerant de-risks data center builds from a regulatory standpointHow Karman thinks about reliability, uptime, and “aerospace-style” engineeringWhy data centers are becoming a national security issueWhere Karman could expand beyond data centers—nuclear, geothermal, and beyond…and much more.• Chapters •00:00 – Intro00:51 – Elara Nova ad01:21 – Karman Industries mascot02:28 – How would David describe himself?05:01 – The original insight that became Karman Industries06:31 – What do people underestimate about thermal management?07:26 – The story behind the name08:21 – How David and co-founder CJ Karla ended up working together11:15 – Why is now the right time to be solving thermal management?15:13 – Where does the heat go today?16:31 – Energy usage for compute vs cooling17:32 – Energy Savings with Karman's heat processing units (HPUs)18:05 – Why C02?20:48 – Replacing vs integration21:37 – Regulatory side24:42 – Karman's customer pipeline26:33 – Reliability28:59 – Engineering challenges30:39 – What comes next for Karman31:55 – Is thermal management a national security issue?33:21 – David's thoughts on rerouting heat36:23 – HPUs in space37:58 – The company culture that allows for building relaiable solutions quickly44:35 – Milestones for Karman in the next couple of years47:00 – What does David do for fun? • Show notes •Karman's website —https://www.karmanindustries.com/David's socials — https://x.com/7earseMo's socials — https://x.com/itsmoislamPayload's socials — https://twitter.com/payloadspace / https://www.linkedin.com/company/payloadspaceIgnition's socials — https://twitter.com/ignitionnuclear / https://www.linkedin.com/company/ignition-nuclear/Tectonic's socials  — https://twitter.com/tectonicdefense / https://www.linkedin.com/company/tectonicdefense/Valley of Depth archive — Listen: https://pod.payloadspace.com/ • About us •Valley of Depth is a podcast about the technologies that matter — and the people building them. Brought to you by Arkaea Media, the team behind Payload (space), Ignition (nuclear energy), and Tectonic (defense tech), this show goes beyond headlines and hype. We talk to founders, investors, government officials, and military leaders shaping the future of national security and deep tech. From breakthrough science to strategic policy, we dive into the high-stakes decisions behind the world's hardest technologies.Payload: www.payloadspace.comTectonic: www.tectonicdefense.comIgnition: www.ignition-news.com

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In today's episode, we delve into the dynamic landscape of these industries, exploring ambitious strategic plans, regulatory hurdles, scientific breakthroughs, and emerging trends that are shaping the future of healthcare.Let's begin with AstraZeneca, which has set an ambitious target to achieve $80 billion in revenue by 2030. This goal reflects their intention to bring over 25 blockbuster drugs to market, underscoring a commitment to innovation and expansion in their therapeutic portfolio. The focus on cutting-edge research is not just a strategy for growth but also a sign of the broader industry trend where large pharmaceutical companies pursue high-value targets to strengthen their market positions. AstraZeneca is also making strides in the weight-loss market with its new candidate elecoglipron, undergoing an extensive late-stage program to evaluate its efficacy as a monotherapy and in combination treatments for various indications. This development positions AstraZeneca competitively in the burgeoning sector, offering a novel therapeutic option for obesity management.Meanwhile, CSL Limited is undergoing a leadership transition. CEO Paul McKenzie has stepped down under pressure, and Gordon Naylor has been appointed as interim chief. This change highlights the critical role of strategic leadership in navigating industry challenges and maintaining growth trajectories amidst a rapidly shifting market landscape.In a display of financial success, Novartis reported a record-breaking performance for 2025. This achievement led to a 30% increase in CEO Vas Narasimhan's compensation, reaching $32 million. The company's robust financial health is attributed to advancing innovative treatments targeting unmet medical needs, emphasizing how achieving innovation milestones can significantly enhance corporate valuation and leadership rewards.Incyte is preparing for the patent expiration of its blood cancer drug Jakafi in 2028 by focusing on Opzelura, a topical cream that has witnessed a 33% sales increase from the previous year. With sales reaching $678 million, Opzelura's success highlights Incyte's strategic pivot to diversify its product offerings and mitigate risks associated with patent cliffs. This exemplifies how companies must continuously innovate and adapt to maintain competitive advantages.Moderna has entered into a long-term agreement with Mexico to ensure local mRNA vaccine supply through technology transfer to Laboratorios Liomont. This partnership extends Moderna's global footprint and underscores the critical role of mRNA technology in pandemic preparedness and vaccine accessibility, reinforcing its transformative impact on public health strategies.Regulatory landscapes have also seen notable activity. The FDA issued untitled letters concerning potentially misleading drug advertisements from companies like Novo Nordisk, Argenx, and Sobi. Such actions emphasize regulatory vigilance in marketing practices. Additionally, Lilly's Kinsunla failed to secure approval in Scotland, while Regenxbio faced rejection for its gene therapy for Hunter syndrome. These regulatory hurdles highlight the rigorous oversight pharma companies face and the complex pathways drugs must navigate before market approval.Collaborations within the industry are proving crucial for innovation. Merck's collaboration with Calla Lily Clinical Care aims to enhance delivery systems for vaginal therapeutics. Similarly, Bristol Myers Squibb's partnership with Evinova focuses on integrating AI into clinical development processes. These alliances reflect an industry-wide emphasis on leveraging technology to improve drug delivery efficiency and streamline clinical trial operations.Shifting our focus now to scientific advancements and clinical trial results that aSupport the show

The Financial Conduct Authority's response to Which?'s super-complaint about home and travel insurance, and the regulatory ripple effects now facing the industry, are the focus of the latest episode of the Insurance Post Podcast. Hosted on Acast. See acast.com/privacy for more information.

In this episode of Medsider Radio, we sat down with Justin Zenanko, co-founder & CEO of SynerFuse.SynerFuse is developing the e-TLIF procedure, which combines spinal fusion with neuromodulation by placing leads directly at exposed nerves during surgery.A certified public accountant and serial entrepreneur, Justin previously served as CFO and senior vice president of corporate development at Recombinetics, where he led fundraising efforts totaling $68 million.In this interview, Justin discusses approaching FDA interactions as negotiations, validating procedures with off-the-shelf components before investing in custom devices, and structuring private raises through investment banks to preserve control while delaying institutional venture capital.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Justin Zenanko.

What if the solution to healthcare's coding workforce challenges has been hiding in plain sight?The conversation doesn't end with rethinking who can succeed in medical coding. In Part II of this special Talk Ten Tuesday series, the focus is on how healthcare organizations can get involved.This broadcast will highlight a growing partnership with the American Health Information Management Association (AHIMA), and outlines how organizations can participate in a neurodiversity-focused coding internship model.Learn what it means to host interns, support neurodiverse candidates, and create structured, sustainable pathways into health information management (HIM) careers.For healthcare leaders facing persistent workforce shortages, accuracy concerns, and burnout, this discussion will move from inspiration to implementation – showing how inclusive workforce strategies can strengthen coding operations while expanding opportunities.If you're ready to move beyond awareness and explore practical ways to build a more resilient, forward-thinking coding workforce, this is for you.The popular Internet broadcast will also feature these additional instantly recognizable panelists, who will report more news during their segments:POV: Penny Jefferson, Manager of Coding & Clinical Documentation Integrity Services for the University of Davis Medical Center, will share her point of view during the broadcast.CDI Report: Cheryl Ericson will provide an update on clinical documentation integrity (CDI).The Coding Report: Christine Geiger will report on the latest coding news.News Desk: Timothy Powell, ICD10monitor national correspondent, will anchor the Talk Ten Tuesdays News Desk.

Cybersecurity is no longer just an IT or privacy issue. For FDA regulated companies, it's a patient safety issue, a product quality issue, and increasingly a regulatory enforcement issue. FDA has made it clear that cybersecurity vulnerabilities can affect medical devices, software, manufacturing operations, clinical data, and even the availability of life saving products.Today, we're bringing together two perspectives—the FDA regulatory lens and the cybersecurity lens—to talk about what companies need to understand and where they're getting tripped up.Questions and Comments: wkirton@bakerlaw.com or egyasi@bakerlaw.com

Welcome to the 9Innings Podcast where we Educate, Empower and Engage. ON THIS WEEKS PODCAST: In this episode of the 9innings Podcast," host Kevin Thompson and guest Tyrone Ross Jr. analyze the recent turmoil in Bitcoin and the broader crypto market. They discuss causes of the downturn, institutional involvement, regulatory uncertainty, and the shift toward permissioned blockchains. Tyrone critiques the dilution of crypto's original vision, warns of speculative risks, and calls for a market “washout” to eliminate weak projects. The conversation covers blockchain transparency, misconceptions about Bitcoin ownership, and the future of digital assets, emphasizing the need for education, better infrastructure, and a more sustainable crypto ecosystem. Recent Bitcoin Liquidations and Market Downturn (00:01:28) Institutional Involvement and Co-opting of Crypto (00:03:50) Crypto's Original Sins and Market Narratives (00:06:47) Altcoins, Scams, and Market Washout (00:08:11) Problems with Crypto Trading and Market Structure (00:11:43) Regulatory and Custody Challenges (00:14:53) Venture Capital, Founders, and Retail Burnout (00:17:36) Blockchain Transparency and Traceability (00:22:16) Long-Term Vision for Crypto and Blockchain (00:25:27) High Interest Rates in Crypto and DeFi Risks (00:28:36) NEWSLETTER (WHAT NOW): https://substack.com/@9icapital?r=2eig6s&utm_campaign=profile&utm_medium=profile-page Follow Us: youtube: / @9icap Linkedin: / kevin-thompson-ricp%c2%ae-cfp%c2%ae-74964428 facebook: / mlb2cfp Buy MLB2CFP Here: https://www.amazon.com/MLB-CFP%C2%AE-90-Feet-Counting-ebook/dp/B0BLJPYNS4 Website: http://www.9icapitalgroup.com Hit the subscribe button to get new content notifications. Corrections: Editing by http://SwoleNerdProductions.com Disclosure: https://sites.google.com/view/9idisclosure/disclosure

It's raining RACs.The Recovery Auditor Contractors (RACs), together with an alphabet soup of other private and public auditors, are coming down hard on hospitals and physician practices, looking for omissions and errors in submitted claims.Then there are seemingly contradictory rules from the Centers for Medicare & Medicaid Services (CMS).It's little wonder that providers are treading cautiously as they look to thread the needle of compliance.This coming Monday, the venerable Monitor Mondays broadcast will present a cadre of the sharpest minds in healthcare auditing. You'll hear auditing news you won't find anywhere else – just here.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. ·      Risky Business: Healthcare attorney David Glaser, shareholder in the law offices of Fredrikson & Byron, will join the broadcast with his trademark segment.·      Legislative Update: Cate Brantley, legislative affairs liaison for Zelis, will report on current healthcare legislation.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a fascinating array of stories that highlight the scientific advancements, regulatory updates, and strategic maneuvers shaping our industry.Let's begin with Biogen's efforts to breathe new life into its spinal muscular atrophy treatment, Spinraza. In response to declining sales, Biogen is launching a high-dose version in Japan, aiming to enhance therapeutic efficacy and regain market competitiveness. This move underscores the company's strategy to offset projected revenue declines by 2026. The decision to pursue this high-dose version reflects Biogen's commitment to maintaining its foothold in a challenging market landscape where innovation is key to survival.Shifting gears to regulatory news, the FDA, led by Commissioner Marty Makary, has taken a firm stance against the proliferation of illegal copycat drugs. This announcement comes on the heels of Hims & Hers' controversial introduction of a compounded version of Novo Nordisk's obesity drug, Wegovy. The FDA's commitment to protecting intellectual property and patient safety is crucial in an era where health tech firms increasingly challenge traditional pharmaceutical boundaries. Novo Nordisk's aggressive marketing strategy for Wegovy, including a high-profile Super Bowl advertisement, highlights the competitive pressures in this growing market segment and underscores the legal tensions between established pharma giants and emerging tech-driven companies.In an unexpected turn of events, BridgeBio faced a significant setback as Pfizer withdrew its tafamidis patent in Europe. This led to a notable drop in BridgeBio's stock price and raised concerns about earlier generic entries into the ATTR-CM market. Such developments signal potential shifts in market dynamics and pricing strategies that companies must navigate carefully.On the clinical front, Bayer's phase 3 study of asundexian has demonstrated remarkable results—a 26% reduction in stroke risk. This positions Bayer favorably against competitors Bristol Myers Squibb and Johnson & Johnson, setting a new benchmark in the high-stakes anticoagulant market. Innovation continues to be paramount as companies strive for superior clinical outcomes that can significantly impact patient care.Regulatory landscapes are evolving as well, with Gilead's Yescarta receiving clearance for expanded use. These milestones are crucial for broadening therapeutic indications and enhancing patient access, underscoring ongoing efforts to address unmet medical needs while sustaining growth trajectories.Meanwhile, Pfizer-backed Priovant has reported promising mid-stage results for brepocitinib in treating dermatomyositis and other rare skin conditions. As a TYK2/JAK1 inhibitor, brepocitinib exemplifies precision medicine's expanding role in addressing autoimmune disorders through targeted therapies.The IPO scene remains vibrant with Agomab Therapeutics and Spyglass Pharma making substantial entries into Nasdaq, collectively raising $350 million. This influx indicates continued investor confidence in biopharma innovation despite broader economic uncertainties—a testament to the sector's resilience and potential for groundbreaking advancements.Corporate dynamics are also shifting as seen with Moderna's Chief Medical Officer Jacqueline Miller stepping down after a brief tenure. Leadership changes such as these often signal strategic realignments within companies as they adapt to complex regulatory environments and competitive pressures.Summarizing these developments illustrates a dynamic landscape marked by scientific innovation, regulatory vigilance, and strategic marketing initiatives. As companies strive for competitive advantage through new drug formulations and market expansions, they must also navigate legal challenges and regSupport the show

Steve Gantner, Elias Saltz, and Tina Montone attended the CURT National Conference in Orlando, Florida in early February 2026 and returned with a clear throughline from the conversations taking place across the conference. In this discussion with Dave Stutzman, they reflect on how AI, data centers, power infrastructure, and construction productivity are no longer separate topics, but deeply interconnected forces shaping the future of project delivery.As data centers continue to be built at unprecedented speed, demand for reliable, redundant power is rising just as quickly. At the same time, AI is emerging as a practical tool to improve construction productivity not by pushing crews to work faster, but by reducing rework, improving information flow, enhancing safety, and accelerating knowledge transfer across generations.Despite the momentum, significant challenges remain. Regulatory complexity, labor shortages, and long-term declines in U.S. construction productivity continue to strain the industry. A consistent theme throughout CURT was the need for earlier collaboration and better alignment of data across design, construction, and procurement as a pathway to reducing inefficiencies and building long-term industry resilience.Key TakeawaysIndustry Insight:AI, data centers, power availability, and construction productivity are no longer separate issues, they are part of a single, interdependent system shaping project delivery.Practice Takeaway:Productivity gains will come less from working faster and more from eliminating rework, improving information accuracy, and getting the right data to the right people earlier.Process Lesson:Early alignment of design, construction, and procurement data is essential to reducing RFIs, delays, and downstream inefficiencies.Risk or Opportunity:AI presents a significant opportunity to offset labor and productivity challenges, but only if paired with reliable power infrastructure and disciplined implementation.People & Culture:Technology will not replace experience; the real value lies in using AI to capture, transfer, and amplify human expertise across generations.

In this episode, Harsha Goli from Magnolia Financial discusses the launch of their Bitcoin-enabled banking services across the US, navigating regulatory challenges, and the importance of partnerships with banks. He emphasizes the need for better user experiences in Bitcoin transactions, the role of price oracles, and the implications of the Clarity Act on Bitcoin development. The conversation also touches on the tension between traditional banks and the crypto industry, the future of community banks, and innovations in Bitcoin technology. Harsha shares insights on potential use cases for Magnolia's services and the challenges of bridging the gap in Bitcoin adoption, while also addressing privacy concerns in Bitcoin transactions.Takeaways:

In this Editor's Special Episode of The HemOncPulse, a conversation with Nicholas Richardson, DO, MPH, vice president of clinical development at Precision for Medicine, focuses on the evolving regulatory role of measurable residual disease in multiple myeloma clinical trials. The discussion is designed to contextualize recent FDA draft guidance for a broad clinical and research audience.

Who determines what 'good' Compliance actually looks like?  The obvious answer is regulators (and in some jurisdictions) prosecutors. But what if it were the regulated Firms themselves?  That's the idea behind purpose-driven compliance, which I'm exploring on this episode.Episode Summary To explore this, I'm joined by Veronica Root Martinez, Professor of Law at Duke University School of Law, to explore a deceptively simple but unsettling idea: 100% compliance is impossible. While we often behave as though perfect compliance is the goal — and in some safety-critical domains it must be — most organisational compliance involves humans. And humans make mistakes. Things get missed. Context changes. Stuff goes wrong.So if perfection isn't realistic, the real question becomes: how do organisations decide what really matters? The traditional answer has been to look outward — to regulators, enforcement authorities, and in some jurisdictions (particularly the US), prosecutors. Their priorities, expressed through sentencing guidelines, enforcement actions, and settlements, end up defining what “good” compliance looks like. Veronica challenges that logic. She argues that this gets things the wrong way round. Instead of letting enforcement priorities dictate behaviour, she makes the case for purpose-driven compliance — where organisations set their own priorities based on their purpose, values, and actual risks, rather than chasing shifting regulatory expectations. Along the way, the conversation explores culture, human judgment, psychological safety, technology, experimentation, and why “best practice” can sometimes make things worse rather than better. This episode is for anyone who writes rules, enforces them — or simply has to live under them.Guest BiographyVeronica Root Martinez is a Professor of Law at Duke University School of Law, where she researches corporate compliance, ethics, and organisational culture. Her work on purpose-driven compliance challenges enforcement-led models and explores how organisations can set priorities based on their own purpose, values, and risks.Before entering academia, Veronica practised as an associate at a large law firm in Washington, DC, where she worked on regulatory and white-collar matters — experience that strongly informs the practical orientation of her research.LinksProfessor Veronica Root Martinez – Faculty Profilehttps://law.duke.edu/fac/martinezVeronica on LinkedInhttps://www.linkedin.com/in/veronica-root-martinez/Purpose-Driven Compliance (paper discussed in the episode)https://papers.ssrn.com/sol3/papers.cfm?abstract_id=6078766AI-Generated Timestamped Summary00:00 – 02:00 | “Because they said so”Christian reframes compliance as a universal human experience — not just a professional discipline — and introduces the problem of rules justified solely by regulatory expectation.02:00 – 05:30 | Why 100% compliance is impossibleVeronica explains why modern organisations cannot realistically achieve perfect compliance when humans are involved — and why pretending otherwise creates problems.05:30 – 10:30 | Tolerated misconduct and cultural driftHow allowing “small” rule-breaking can escalate into bigger issues, drawing on behavioural ethics and real-world corporate failures. 10:30 – 14:30 | Risk, prioritisation, and what really mattersA discussion of risk-based thinking, irrecoverable vs recoverable errors, and why organisations — not regulators — are best placed to set priorities. 14:30 – 18:30 | Enforcement swings and resilienceWhy compliance programmes built around enforcement trends are fragile, expensive, and reactive — and how purpose-driven approaches create stability. 18:30 – 23:30 | Innovation, uncertainty, and guardrailsWhy regulators are always behind innovation — and how values-based guardrails help employees make decisions in uncharted territory.23:30 – 30:30 | Technology, AI, and the human in the loopThe limits of automation, the danger of over-reliance on tech, and why human judgment remains essential.30:30 – 36:30 | Rules, loopholes, and malicious complianceHow overly detailed rulebooks create loopholes — and why purpose and principles offer a better basis for accountability.36:30 – 40:30 | The Costco exampleA powerful illustration of simplicity: four ethical principles that employees can actually understand and use.40:30 – 45:30 | Training, regulators, and unintended consequencesWhy blanket training requirements often miss the mark — and how enforcement agreements can accidentally undermine effectiveness.45:30 – 52:30 | Measuring culture and compliance effectivenessMoving beyond counting inputs to assessing outputs, including psychological safety, Speak Up systems, and cultural indicators.52:30 – 57:30 | Experimentation and learningWhy failed interventions aren't failure — they're information — and why compliance should be treated as an evolving experiment.57:30 – End | Reclaiming responsibilityA closing reflection on extrinsic motivation, “because I said so,” and why purpose-driven compliance offers a more human, defensible, and sustainable way forward.

Chris Markowski discusses the realities of Wall Street, the challenges investors face, and the importance of understanding the economic landscape. He emphasizes the need for transparency in financial dealings, critiques regulatory bodies, and explores the impact of technology on the job market. Markowski also addresses the role of the Federal Reserve and the implications of government intervention in the private sector, advocating for free market principles as the best approach to economic growth.

Send us a textBob Hankins brings over 20 years of dedicated experience in the medical-device industry, spanning engineering leadership, product development, process improvement and strategic technical oversight. As Director of Engineering at TE Connectivity, he leads a global team of engineers and scientists focused on designing, developing and delivering innovative customer-centric medical device solutions—particularly complex machined, extruded and laser-cut components. In this role he ensures design for manufacturing and quality within ISO 13485-compliant systems, marrying deep technical understanding with regulatory-driven manufacturing discipline.Before his current role Bob led Research & Product Development Engineering at Nordson Medical and has held key leadership positions at several medical-device companies, including overseeing product development platforms, multi-site engineering operations, manufacturing automation and system launches. Throughout his career he has honed core competencies in manufacturing process improvement, continuous improvement (including Six Sigma/Lean methodologies), design for manufacturing/assembly, regulatory compliance (ISO 13485, ISO 14971, FDA), and product R&D for the health-care market.Bob's academic background includes a Bachelor of Science in Mechanical Engineering from the University of California, Irvine, and an Executive MBA from the Drucker School at Claremont Graduate University. This combination of technical and business education supports his ability to lead engineering organizations in bridging innovation with operational execution, customer development and quality.In this episode we'll dive into how Bob thinks about leading engineering teams in the regulated medical-device space, how he drives design and process improvements globally, how he balances innovation with manufacturing rigor, and what advice he has for engineers growing into leadership roles in healthcare technology. We'll also explore his views on what the next wave of medical-device manufacturing and design looks like—and how engineering leaders can foster a culture of excellence, empowerment and impact. LINKS:Guest LinkedIn: https://www.linkedin.com/in/rthankins/Guest website: https://www.te.com/en/home.html Aaron Moncur, hostThe Wave is  a place for engineers to actively learn, share ideas, and engage with people doing similar work. Learn more at thewave.engineer Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us Watch the show on YouTube: www.youtube.com/@TeamPipelineus

This is a 2-part episode: From a December 2025 WEDI virtual spotlight, a panel of health IT leaders break down the current state and the future of regarding information blocking, and how organizations can stay compliant while moving interoperability forward. The panel: Rebekah Fiehn, Strategic Partnership Developer, American Dental Association Andrew Tomlinson, Senior Director, Regulatory & International Affairs, AHIMA Arna Meyer, Technical Product Manager, Stedi Alisa Kuehn, VP, General Counsel & Privacy Officer, Indiana Health Information Exchange Chelsea Arnone, Director, Federal Affairs, CHIME Sasha TerMaat, EHRA's Information Blocking Compliance Task Force The moderator is Jeff Coughlin, Director, Federal Affairs, American Medical Association

Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon Foeger, Founder of SIFO MEDICAL, shares real-world experience and practical guidance on validation, risk management, and supplier development.Key topics discussed include:Test Method Validation: definition, regulatory expectations, and when it is requiredFDA warning letters and the risks of non-compliant validation approachesCommon pitfalls and best practices for Test Method ValidationProcess Validation and Packaging ValidationThe role of statistics in MedTech, including sample size justificationRisk management linked to validation activitiesSupplier management, from sourcing components to audits and long-term supplier developmentSimon also explains how SIFO MEDICAL supports medical device manufacturers through consulting and online training focused on:Process validation and equipment qualificationTest Method Validation trainingISO 13485 and 21 CFR 820.30 complianceSupply chain development, including injection molding and cleanroom manufacturing environmentsThis episode is essential for quality managers, regulatory professionals, validation engineers, and MedTech manufacturers looking to strengthen compliance, avoid warning letters, and build robust validation strategies.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkSimon Foeger Linkedin: https://www.linkedin.com/in/simonfoeger/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

Payments in emerging markets are often discussed as infrastructure.But the real differentiation happens in how deeply payments are embedded into business operations.In the final episode of this special Qatar Development Bank series of Couchonomics with Arjun, Arjun sits down in Doha with Saad Ishfaq, CEO of TESS Payments, to unpack how a payments company built for Qatar is scaling by solving real operational pain, not just processing transactions.TESS Payments is a QCB-licensed payment service provider designed specifically for the Qatari market. Rather than chasing regional expansion, Saad explains why the company chose to go deep instead of wide, focusing on enterprise-grade flexibility, managed services, and bespoke integrations for large organisations across real estate, government, and critical infrastructure.The conversation explores how payments sit at the centre of SME enablement, why micro and small businesses remain underserved across the GCC, and how fintechs and banks must collaborate rather than compete. Saad also shares how TESS evolved beyond payments into CFO tooling and digital lending, including a new sandboxed lending platform addressing Qatar's blue-collar workforce.From owning core infrastructure to navigating bank partnerships, regulatory sandboxes, and product adjacencies, this episode offers a grounded look at how fintech scale is built inside regulated markets.

Today's podcast hosted by the City Bar's Presidential Task Force on Artificial Intelligence and Digital Technologies explores the ethical and legal dimensions of informed consent in AI healthcare settings. Anne Zimmerman, Chair of the City Bar's Bioethical Issues Committee and Editor-in-Chief of the Voices in Bioethics Journal at Columbia University, Alex John London from Carnegie Mellon University and Susannah Rose from Vanderbilt University Medical Center. The discussion covers the significance of informed consent in healthcare, challenges with AI integration, patient autonomy, regulatory issues, and the balance between disclosure and effective use of AI. It also delves into potential impacts on patient care, operational uses of AI, and the importance of building trust and communication between clinicians and patients. If you are interested in learning more about emerging AI developments and policy, join us for the 2026 Artificial Intelligence Conference on June 18 to hear from industry experts and connect with leading legal professionals across the field. 00:00 Introduction to the Podcast and Guests 01:30 Understanding Informed Consent in Healthcare 02:32 Ethical Considerations of AI in Healthcare 06:05 Challenges and Frameworks for AI Consent 06:47 AI's Impact on Clinical and Operational Settings 07:28 Patient Autonomy and AI Decision-Making 11:19 Regulatory and Safety Concerns with AI 17:12 The Role of AI in Patient Communication 18:37 Equity and Justice in AI Deployment 20:10 Future of AI in Healthcare and Concluding Thoughts 29:43 Closing Remarks and Podcast Information

"Capacity reduction is clearly under way. Regulatory enforcement of qualifications and safety standards was arguably the most welcome development in 2025 for our industry." - Adam Miller, CEO of Knight-Swift Transportation Holdings The trucking industry has been flooded with headlines about enforcement: English language proficiency checks, non-domiciled CDL restrictions, immigration raids, and court stays. On the surface, this might look like a political story or an emotional response to a few high-profile fatal crashes, but it is not primarily about either paperwork or politics. It's about freight market capacity. Who is allowed to operate? Where are they willing to operate? Can they operate profitably while following the rules? And how quickly can excess freight capacity be removed without destabilizing the whole system? In this episode of the Art of Supply podcast, Kelly Barner covers: Why CDL enforcement has become a de facto freight capacity lever What the data says about drivers and smaller freight companies leaving the market How localized disruption is starting to show up before national trends And what we should be watching instead of (or at least in addition to) the headlines Links: Kelly Barner on LinkedIn Art of Supply LinkedIn newsletter  Art of Supply on AOP Subscribe to This Week in Procurement

In this episode, we break down how Uber Freight posted flat Q4 results but finally achieved breakeven profitability through disciplined cost measures. We also discuss the company's pivot toward autonomous trucking as a long-term strategy to drive higher asset utilization. On the asset-based side, we analyze why losses continue at Heartland Express as the carrier navigates costly fleet integrations and a soft market. Despite recording its tenth consecutive net loss, the company's improving operating margins offer a glimmer of hope for a turnaround. Regulatory news takes center stage as the EPA targets truck engine makers to investigate widespread DEF system failures causing "limp mode" incidents. This major shift aims to treat equipment reliability as a manufacturer quality issue rather than a driver compliance problem. Global instability forces the Gemini Alliance to rely on military forces to secure Red Sea voyages, even as other carriers continue to divert around Africa. Back home, the industry faces a bureaucratic paradox where 65,000 new visas are available but remain inaccessible due to a State Department freeze. Finally, we examine the broader economic fallout as weak freight demand triggers facility closures and layoffs across the logistics and manufacturing sectors. With over 3,000 jobs cut since mid-January, the industry is questioning how much leaner operations can get. Follow the FreightWaves NOW Podcast Other FreightWaves Shows Learn more about your ad choices. Visit megaphone.fm/adchoices

What does it take to bring medical devices to the market? It's a question lawyer Randy Prebula thinks about every day. Randy is a partner at a global law firm who specializes in the regulatory world of medical devices and technology. In this episode, he shares how he transitioned from a more than 20-year career as a scientist into the world of law and how that informs his legal work. He breaks down FDA's emergency use authorization, what qualifies as a device versus a drug, how products navigate FDA approval pathways, and why risk-benefit analysis drives every FDA decision. He also reflects on what it was like working in this field during the COVID-19 pandemic, helping to bring one of the first at home COVID-19 tests to market. Randy is a graduate of the Catholic University of America.This episode is hosted by Kyle McEntee.Mentioned in this episode:Colorado Law SchoolLearn more about Colorado LawLoyola Law SchoolLearn more about Loyola Law SchoolAccess LawHub today!

Housing has become one of the most urgent—and complex—challenges facing economic developers today. In this episode of Develop This!, host Dennis Fraise sits down with Michael Mohrfeld, Owner and President of Mohrfeld Electric, Green Oak Development, Mohrfeld Solar, and a housing developer. Speaking candidly from a developer's perspective, Michael shares what it really takes to make housing projects work in small and mid-sized communities—and why so many well-intentioned plans never move from concept to construction. Drawing on his diverse portfolio across construction, real estate, energy, and community-focused development, Michael explains how housing challenges are deeply intertwined with workforce availability, zoning, financing, and local leadership. Dennis and Michael explore: Why housing is now a top economic development constraint The growing difficulty of delivering affordable and workforce housing How labor shortages in construction are impacting timelines and costs Regulatory and zoning hurdles that can stall or stop projects entirely The differences between new construction and renovation-based development Opportunities in both multifamily and single-family housing markets Why small communities must rely on local leadership—because "there's no cavalry coming" Key Takeaways Housing is one of the most critical issues facing economic developers Developers bring practical insight into what makes projects viable Small communities face unique housing and financing challenges Workforce shortages significantly affect construction feasibility Affordable housing is increasingly complex to build Zoning and regulatory processes can impede development New construction and renovation projects require different strategies Strong community leadership is essential for success Both multifamily and single-family housing present opportunities Local champions are key to driving meaningful progress

In this episode of The Association Insights Podcast, host Meghan Henning sits down with Lisa Townsend, Director of Marketing & Communications at the Association of Clinical Research Professionals (ACRP), to unpack what it looks like when an association doesn't just react to industry change—but leads through it.As the global clinical research industry prepared for significant updates to the ICH E6 guidelines, ACRP recognized the moment for what it was: not just a regulatory update, but a critical inflection point for education, trust, and leadership. Lisa shares how her team transformed that complexity into a coordinated, member-driven communications and learning ecosystem—earning an Association Insights CommImpact Award and empowering tens of thousands of professionals worldwide.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of insightful updates that highlight the dynamic and rapidly evolving nature of these sectors, driven by scientific advancements, regulatory shifts, and strategic industry maneuvers.Starting with Merck, which is strategically planning for a post-Keytruda era, projecting over $70 billion in annual opportunities over the next decade. With Keytruda's patent expiration looming in 2028, Merck is actively expanding its portfolio through acquisitions and partnerships, focusing on oncology and immunology. These areas have been significantly impacted by Keytruda's success, and Merck's proactive approach aims to sustain growth and innovation beyond its current flagship product. During their 2025 full-year earnings call, CEO Robert Davis emphasized their expansive pipeline, highlighting recent strategic deals as pivotal to Merck's robust pipeline—the broadest it has been in years—signaling long-term growth through diversified therapeutic areas and innovative drug candidates.The U.S. Food and Drug Administration (FDA) is making waves with its regulatory approach to CAR-T cell therapies for autoimmune diseases. This shift reflects an increasing recognition of the potential these therapies hold for transforming treatment paradigms for conditions like lupus and multiple sclerosis. By offering a more flexible regulatory framework, the FDA is encouraging innovation while maintaining a focus on patient safety.In other regulatory news, AstraZeneca faces a setback with the FDA's rejection of its subcutaneous version of Saphnelo for lupus. The decision underscores the challenges associated with developing more patient-friendly administration methods for biologics. However, AstraZeneca remains optimistic about achieving a quick turnaround in the approval process, which could enhance patient adherence by offering a self-administered alternative to intravenous infusions.Sanofi finds itself in the spotlight after CEO Paul Hudson was sanctioned by the UK's Prescription Medicines Code of Practice Authority for making overly ambitious claims about Pfizer's RSV vaccine. This incident illustrates the competitive nature of vaccine procurement and underscores the importance of accurate communication by pharmaceutical leaders.In Massachusetts, Thermo Fisher Scientific is reducing its workforce with the closure of its Franklin site, impacting around 200 employees. This move is part of broader strategic realignments within the industry aimed at optimizing operations and focusing resources on high-growth areas.Acadia Pharmaceuticals faces potential rejection by the European Union for its drug trofinetide intended for Rett syndrome. This highlights ongoing challenges in gaining approval for treatments targeting rare diseases, despite their significant unmet needs.Meanwhile, GSK plans to lay off up to 350 R&D workers across the U.S. and UK as part of efforts to streamline operations and focus on core therapeutic areas. Such layoffs reflect broader industry trends toward consolidation and efficiency amid rising R&D costs.On a more promising note, Pfizer's GLP-1 receptor agonist has demonstrated significant results in a Phase 2b trial for weight loss, validating their substantial investment in this area. The drug's potential to offer competitive weight loss results with monthly dosing positions it as a strong contender in the obesity treatment market. Additionally, Pfizer continues to accelerate its efforts in obesity treatment with promising mid-stage trial results for PF-3944, showing up to a 12.3% weight loss at 28 weeks. This suggests Pfizer is keen on expanding its presence in obesity management through strategic clinical development as competition within this therapeutic area intensifies.The U.S. Department of Health and HumanSupport the show

In this episode, the hosts dissect a high-revenue, fast-scaling precious metals buyer that might be both a goldmine and a landmine—complete with potential regulatory issues, cash-heavy operations, and lending red flags.Business Listing - https://dashboard.dealforce.com/deals/profiles/Profile69159.pdfWelcome to Acquisitions Anonymous – the #1 podcast for small business M&A. Every week, we break down businesses for sale and talk about buying, operating, and growing them.Looking to build a professional website in minutes? Try Wix: https://wix.pxf.io/c/6898629/3115214/25616?trafcat=templateHubSpot is the backbone for how businesses scale without chaos. Try them out here: https://go.try-hubspot.com/OeG9Vr

A Note from Michael: The Thriving Farmer Podcast is currently on pause as we navigate a busy season on the farm. While we're taking this break, we're excited to share Farm in Focus, a special series of short, focused conversations recorded earlier this year. These bite-sized episodes highlight practical insights from farmers and experts across the industry. We hope they're helpful and encouraging as you continue your farming journey. What does it really take to run a small, year-round local market? In this Farm in Focus episode, Michael sits down with Emma de Long of Kneehigh Farm to talk about the creation and day-to-day operation of Red Dog Market, a year-round local food market in Pennsylvania. Emma shares how Red Dog Market grew out of increased demand during the COVID-19 pandemic and how it has evolved into a community-centered outlet for her farm and other local producers. From staffing and sourcing to signage, POS systems, and regulatory considerations, Emma offers a candid look at the realities behind keeping fresh food accessible all year long. Whether you're considering opening a farm store, expanding into retail, or simply curious about the behind-the-scenes work of local food markets, this episode offers practical, grounded insights from someone doing it every day.   In this episode, you'll hear about: The Origin of Red Dog Market • How COVID-19 accelerated demand for local food access [02:42] • Why Kneehigh Farm serves as the market's anchor vendor [02:42] Market Operations & Staffing • Running a year-round market with a small, focused team [08:32] • The role of a dedicated market manager and daily task division [08:32] • Why maintaining fresh produce is "a puzzle every day" [14:39] Sourcing & Vendor Relationships • How Emma vets vendors—especially for meat and dairy products [12:25] • The importance of building strong relationships with local producers [05:34] • Balancing product variety with quality and consistency [12:25] Systems, Marketing & Logistics • The complexities of using POS systems for a small, hybrid market model [14:39] • Effective signage and in-person marketing strategies [16:51] • Leveraging existing farm share and CSA memberships to build traffic [16:51] Advice for Aspiring Market Owners • Why starting slow and understanding your costs is critical [16:51] • Regulatory considerations every market owner should be aware of • How community engagement shapes long-term success [20:40] Bio: Emma de Long is a farmer, educator, and fiber advocate based in Chester County, Pennsylvania. She founded Kneehigh Farm in 2013 and has since grown a diverse mix of vegetables, dye plants, and fiber crops. Since 2019, Emma has cultivated indigo for natural pigment extraction, and in 2020 she co-founded the Pennsylvania Flax Project, an initiative dedicated to rebuilding regional flax processing infrastructure. Kneehigh Farm operates as a 100% women-run operation, and in 2021 Emma opened Red Dog Market, a year-round outlet for farm goods and local products. Links:

The freight recession may finally be over as January transportation metrics reveal a market in firm expansion territory. With the overall index hitting 59.6, a convergence of tightening capacity and rising rates suggests the cycle has officially turned. Regulatory pressures are squeezing the driver pool just as Werner Enterprises settles an 11-year-old lawsuit regarding driver wages. This $18 million payout underscores the rising floor for labor costs in an increasingly constrained environment. On the demand side, a surge in Japanese machine tool orders points to a manufacturing rebound later this year. North American orders jumped nearly 30%, signaling that industrial production is gearing up for a strong second half of 2026. Macroeconomic policy could also provide a tailwind if Fed Chair nominee Kevin Warsh shifts focus back to Main Street. His criticism of current monetary strategy suggests relief may be on the way for the industrial and small business sectors. Meanwhile, rail infrastructure is booming with Norfolk Southern customers advancing over $7.7 billion in new projects. Adding to the positive momentum, legal distractions are clearing up for major players following the dismissal of charges against NFI's CEO. Follow the FreightWaves NOW Podcast Other FreightWaves Shows Learn more about your ad choices. Visit megaphone.fm/adchoices

The National Retail Federation's annual NRF conference has become a showplace for the latest technology, as well its core retail foundations. Sheryl Kingstone returns to discuss what was on display and how it will impact retail and the larger tech landscape with host Eric Hanselman. While we may be a ways off from having robot dogs retrieving shoes at your local mall store, automation and agentic applications are delivering significant value in customer interactions - $22 billion in the recent 451 Research study. The days of clunky chatbot interfaces seem to be well and truly behind us. One the greater challenges in scaling agentic applications is maintaining consumer trust as applications and use cases grow. Part of that trust will depend on effectively managing fleets of agents. In order to scale, organizations have to develop an AI agent control plane that can manage memory, maintain context and guide agent actions. Regulatory requirements are in their early stages, but enterprises have to focus on controls that will ensure they can maintain customer trust as matter of basic business operations.   More S&P Global Content: Next in Tech podcast: Agentic Customer Experience Next in Tech episode 222:  FinOps Next in Tech | Ep. 205: Agentic AI Impacts AI for security: Agentic AI will be a focus for security operations in 2025   For S&P Global subscribers: NRF 2026 Spotlight: Agentic Experiences Redefine Retail Execution NRF 2026 Big Show signals physical retail's digital backbone Agents in the enterprise: Laying the groundwork for automation The CX AI Agent Index 2025 Agents are already driving workplace impact and agentic AI adoption – Highlights from Vot… Big Picture 2026 AI Outlook: Unleashing agentic potential   Credits: Host/Author: Eric Hanselman  Guest: Sheryl Kingstone Producer/Editor: Feranmi Adeoshun Published With Assistance From: Sophie Carr, Kyra Smith

David Kaplan checks in at the NYSE desk and provides a check-up on healthcare giant Merck (MRK). The company reported a slight beat in its 4Q earnings figures, and Kaplan says its Keytruda product pipeline will be important as it starts to face generic competitors. He notes headwinds in the vaccine business and weakness in China due to regulations impacting its ability to market pharmaceutical products. Kaplan discusses the M&A activity in the biopharma space and how Keytruda combination therapies will be something to monitor. ======== Schwab Network ========Empowering every investor and trader, every market day.Subscribe to the Market Minute newsletter - https://schwabnetwork.com/subscribeDownload the iOS app - https://apps.apple.com/us/app/schwab-network/id1460719185Download the Amazon Fire Tv App - https://www.amazon.com/TD-Ameritrade-Network/dp/B07KRD76C7Watch on Sling - https://watch.sling.com/1/asset/191928615bd8d47686f94682aefaa007/watchWatch on Vizio - https://www.vizio.com/en/watchfreeplus-exploreWatch on DistroTV - https://www.distro.tv/live/schwab-network/Follow us on X – / schwabnetwork Follow us on Facebook – / schwabnetwork Follow us on LinkedIn - / schwab-network About Schwab Network - https://schwabnetwork.com/about

What if the solution to healthcare's coding workforce challenges has been hiding in plain sight?During this special two-part Talk Ten Tuesday series, UC Davis Health shares how an innovative neurodiversity-focused coding internship is redefining how talent is identified, trained, and retained. Join Tami McMasters Gomez, Executive Director, for the Mid-Revenue Cycle, Enterprise-Wide Coding and CDI Operations for the University of California Davis Medical Center, when she reports on how this program is unlocking untapped strengths, improving accuracy, and building a more resilient health information (HIM) workforce.This unique conversation will challenge long-standing assumptions about who succeeds in medical coding.If you were responsible for the coding operations of a complex medical center, would you build tomorrow's workforce the same way you do today? Be sure to listen and learn.This popular Internet broadcast will also feature these additional instantly recognizable panelists, who will report more news during their segments:·      POV: Penny Jefferson, Manager of Coding & Clinical Documentation Integrity Services for the University of Davis Medical Center, will share her point of view (POV) during the broadcast.·      CDI Report: Cheryl Ericson will provide an update on clinical documentation integrity (CDI).·      The Coding Report: Legendary Rose Dunn, COO for First Class Solutions, will handle the coding report for Christine Geiger. Rose will report on the latest False Claims Act (FCA) settlement.·      News Desk: Timothy Powell, ICD10monitor national correspondent, will anchor the Talk Ten Tuesdays News Desk.

In this bonus episode, Host Angie Dickson, President of the Inogen Alliance and EVP of Antea Group USA, speaks with Sasikumar, Chief Marketing Officer with Chola Risk Services in India. Sasikumar shares a real-world case study from a 750 MW solar project that faced significant regulatory, permitting, and community challenges mid-development.The conversation highlights the blocks and bottlenecks they faced, and how they were overcome. Guest Quote“ This solar project is uh, for capacity of seven 50 megawatt, which was in a central part of India, which was taken up by one of large corporate in India. And what had happened over that was they had some issues related to regulations, local agitations from the village, and they came to us.” - SasikumarTime Stamps00:00 Introduction to the Energy Transition Bonus Case Study00:45 Overview of the 750 MW Solar Project in Central India01:55 Regulatory, Forest Zone, and Water Body Constraints03:45 Community Resistance and Public Hearing Challenges04:55 Addressing Livelihood Concerns and Misconceptions About Solar Heat05:45 Education, Safety Communication, and Local Language Engagement06:25 Design Changes: Pathways, Access, and Infrastructure Adjustments07:30 Key Lessons: Compliance, Planning, and Stakeholder Trust08:10 How the Project Shaped Future Solar DevelopmentsSponsor CopyRethinking EHS is brought to you by the Inogen Alliance. Inogen Alliance is a global network of 70+ companies providing environment, health, safety, and sustainability services worldwide. Visit inogenalliance.com to learn more.LinksInogenAlliance.com/resourcesInogenAlliance.com/podcastAngie on LinkedIn  Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Welcome back to the markets after a brutal weekend. Gold just had its worst day since 1983, crashing 9%, while silver fell a staggering 27%—the largest drop ever recorded. Add to that steep declines in copper and oil, and we've got the recipe for a volatile open. Meanwhile, Asian equities got crushed, with the KOSPI down 5%, and China's manufacturing PMI missed badly. In Europe, green shoots: France and the UK posted surprise PMI gains, while Germany's retail sales shocked to the upside. In crypto, BTC fell to $74K before rebounding, with more than $5.5B in liquidations since Thursday. Regulatory talks begin today at the White House, while Ripple secures a full EU license. The week is off to a chaotic start—catch the full breakdown inside.

There was a time when Relative Value Units (RVUs) felt like a stable currency – something you and others could take to the bank. That was then. This is now.Then, productivity could be measured, compensation plans could be managed, and economic models could assume relative stability in physician work measurement.Recently, actions by the Centers for Medicare & Medicaid Services (CMS) – culminating in the 2026 Physician Fee Schedule – signal a philosophical shift in how physician work is valued, adjusted, and used as a policy lever. The takeaway is not that RVUs are broken; it is that they are no longer designed to be static. For more details on this change, the producers of Monitor Mondays have invited senior healthcare analyst Frank Cohen to be the special guest during the next live edition of the venerated Internet broadcast, coming up on Monday, Feb. 2.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. ·      Risky Business: Healthcare attorney David Glaser, shareholder in the law offices of Fredrikson & Byron, will join the broadcast with his trademark segment.·      Legislative Update: Matthew Albright, chief legislative affairs liaison for Zelis, will report on current healthcare legislation.