General term for rules, including delegated legislation and self-regulation
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For our 200th episode, we had the pleasure and privilege of speaking with Nat Bullard, one of the sharpest minds in the energy world. A leading analyst in climate and energy, Nat is known for his clear insights on clean energy, decarbonization, and the global energy transition. Formerly Chief Content Officer at BloombergNEF, he is now also a co-founder of the AI company Halcyon. Nat is perhaps best known for his annual 200-slide deck, a rich compilation of global data and charts that paints a clear, fact-based picture of where the energy sector is heading. Our conversation spans major shifts shaping the future: the electrification of the Global South, the rise of AI and datacenters, the unravelling of ESG, and the evolving geopolitics of energy through the lens of "Electrostates vs. Petrostates"—and how investment flows are responding. We also explore the dominant narratives in the energy space, many of which, we agree, are self-serving and unhelpful. Ultimately, the energy transition is being held back less by technology and more by entrenched interests and a lack of curiosity. But the world is changing fast—and there is reason for hope. We thank AFRY for supporting the show. Reference for reports quoted during the showThe Electrotech Revolution – Ember and Kingsmill Bond https://ember-energy.org/latest-insights/the-electrotech-revolution/ Afry: Market and regulatory overview of the North Atlantic Transmission One -Link project https://afry.com/en/exploring-nato-l-project-and-transatlantic-power-exchange-decarbonised-future "AFRY provides engineering, design, digital and advisory services to accelerate the transition towards a sustainable society. At AFRY, we are 19,000 devoted experts in industry, energy and infrastructure sectors, creating impact for generations to come. Best example of AFRY expertise is the report they just released on the Regulatory and Revenue Models for the North Atlantic Transmission One – Link."
Broadcast from KSQD, Santa Cruz on 10-16-2025: Dr. Dawn explains the 2025 Nobel Prize in Physiology awarded to Shimon Sakaguchi, Mary Brunkow, and Fred Ramsdell for discovering T regulatory cells. Previously, medical teaching held that the thymus only eliminated self-attacking T cells, but Sakaguchi found that removing the thymus from newborn mice caused autoimmune disease, suggesting protective regulatory cells existed. He identified CD4+CD25+ cells that suppress inflammation and can convert other T cells. Brunkow and Ramsdell discovered the FOXP3 gene that controls these cells, linking mutations to severe autoimmune diseases like IPEX syndrome. Tissue-specific Tregs regulate metabolism in fat, maintain gut microbiome tolerance, promote wound healing in skin, and control muscle regeneration. Therapeutic applications include stopping type 1 diabetes, preventing organ rejection, and treating multiple sclerosis. An emailer asks about a study linking soft drinks to depression through gut bacteria changes. Dr. Dawn critiques the cohort association study for establishing only correlation, not causation, with a weak risk ratio of 1.1 representing just 10% increased association. She explains that bacteria can influence food cravings, making it unclear whether sodas change bacteria levels or bacteria drive soda consumption. Without Koch's postulates—isolating bacteria, growing them, and reproducing disease—the causal direction remains uncertain despite statistical significance. Dr. Dawn reads David Whyte's essay on injury as invitation to transformation, exploring how pain reveals vulnerability, changes identity, requires patience, and teaches compassion. She notes this perspective may come easier to men who reach midlife believing they control their bodies, while menstruation disabuses women of that illusion earlier. As a physician, she emphasizes the ego crisis when people transition from healthy to "person with disease," requiring identity restructuring that can shake foundations but also mature and strengthen individuals. A caller responds enthusiastically to the injury essay, citing quotes from André Gide, James Hillman, and Norman O. Brown about how illness opens doors to reality closed to healthy mindedness, how the soul sees through affliction, and how vulnerability is inherent to being human. Dr. Dawn agrees that many religions embrace wounds as paths to spiritual enlightenment and commits to deeper reflection on suffering's role in the human condition. Dr. Dawn discusses cognitive functional therapy for chronic back pain, describing firefighter Joe Lawrence who believed his spine was irreparably damaged until physical therapist Peter O'Sullivan challenged those beliefs. The therapy addresses psychological aspects by teaching that backs need movement, not protection, and that tensing muscles worsens pain. The three-step approach examines pain origins including emotional context, gradually reintroduces avoided activities while learning relaxation, and establishes healthy sleep and exercise routines. GLP-1 drug prices have dropped dramatically to $499 monthly at Costco due to compounding pharmacy competition. Dr. Dawn urges immunizations, noting studies show shingles vaccination reduces dementia risk by 20% over seven years, possibly by generating T regulatory cells that reduce brain inflammation. Natural experiments in England where vaccine rollout occurred at different times in different regions provided strong evidence. She explains that chickenpox vaccination in childhood prevents both chickenpox and future shingles. Even tetanus shots appear to lower dementia risk, suggesting vaccines activate immune responses that reduce chronic inflammation. She concludes with practical advice to reduce microplastic exposure by avoiding plastic cups and containers, especially with heat. Eight-year-old coffee makers contain twice the microplastics of six-month-old machines due to deterioration. She recommends ceramic cups, glass or metal kettles, removing food from plastic before cooking, and washing polyester clothing on low heat to minimize microplastic generation.
In this episode of This Week in AML, Elliot Berman and John Byrne cover a wide range of pressing topics in the anti-money laundering and financial crime compliance space. They discuss the UK's latest sanctions targeting Russian energy giants, the European Banking Authority's report on crypto asset risks, and the Charity & Security Network's concerns about IRS scrutiny of nonprofits. The hosts also explore a revealing OCCRP investigation into corruption linked to Iraqi Kurdistan's ruling family and break down FinCEN's new FAQs on suspicious activity reporting. Plus, updates on GTO extensions and staffing concerns in EU regulators.
Today we're talking about housing. The ROAD to Housing Act passed the Senate Banking, Housing, and Urban Affairs Committee 24-0 in late July. Last week — despite the shutdown — it cleared the Senate. It's a package of 27 pieces of legislation to boost housing supply, improve affordability, reduce regulatory roadblocks, and reduce homelessness.When you zoom out a bit, what's happened here is pretty surprising. The chair of the committee, Republican Tim Scott, and the Ranking Member, Elizabeth Warren, a Democrat, co-sponsored the bill. The bill is the committee's first bipartisan housing markup in over a decade. Passing through committee unanimously doesn't happen often for serious bills of this sort. I wanted to understand how this bill happened, and came to have a serious shot at passing. And I also wanted to get a better sense of what's actually in the bill, and why it matters for housing. If you're like me, most of the debates you hear about housing policy focus on zoning, which is a local issue — very little federal say. So what are all these pieces of legislation? Do they matter?Joining me is an unorthodox trio:* Will Poff-Webster was legislative counsel for Senator Brian Schatz, a Democrat from Hawaii. He's our inside guy today: he worked on the bill within the Senate. And today, he covers housing policy here at IFP.* Alex Armlovich is Senior Housing Policy Analyst at the Niskanen Center. He has been working on housing issues for a long time, and his fingerprints are on parts of this bill package. He's my advocate from the outside.* Brian Potter is Senior Infrastructure Fellow at IFP and author of Construction Physics, which I very much enjoy editing. If I can make one newsletter recommendation to you besides Statecraft, it's Construction Physics. He has a background in private-sector home building. And has written about several of the proposals in this package.Table of contents:* What's the federal role in housing policy?* What's in the bill?* Regulatory reform* Technical assistance plus incentives* Funding and financing reform* A brief sidebar on manufactured home chassis* Will the bill matter?* How did the bill happen, politically speaking?* The policy wonk success storyThank you to Harry Fletcher-Wood and Katerina Barton for their judicious transcript and audio edits.For the full transcript of this conversation, go to www.statecraft.pub. This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.statecraft.pub
David Seymour is welcoming New Zealand First's changes to his Regulatory Standards Bill as a 'win-win'. Political reporter Russell Palmer reports.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Young Juhn, CEO of Wellysis.Wellysis is the Samsung spinout behind S-Patch, a lightweight wearable that enables long-term ECG monitoring without the discomfort of established cardiac monitoring devices.Young has spent more than two decades bridging hospital and home-based care — from his early career at Johnson & Johnson, to more than a decade at Kaiser Permanente, to leading healthcare innovation at Samsung before spinning out Wellysis in 2019.In this interview, Young shares why patient interviews should shape product design, how regulatory clearance is just the starting point for global commercialization, and why building a medical foundation before branching into consumer markets is critical for lasting adoption.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 Young Juhn.
Deirdre Madden, Professor of Law at UCC, and first Chair of the Assisted Human Reproduction Regulatory Authority, discusses how AHRRA will operate in the coming months.
Computation is killing the wet lab—and reshaping enzyme innovation in the process. Maria Fátima Lucas, CEO of ZYMVOL, shares how AI and physics-based simulation shrink enzyme discovery from 100 million sequence variants to fewer than 300 lab-tested hits—cutting timelines, risk, and cost by orders of magnitude.In this episode, Maria unpacks how ZYMVOL is making biocatalysis not just greener, but cheaper and faster—bringing clean chemistry to sectors previously priced out. From Europe's regulatory drivers to a bold product pivot into bio-based melanin, this is a rare look inside a deeptech company scaling with precision, not hype.Tune in for a fresh look at building ventures that last, not just raise.--- Hey Climate Tech enthusiasts! Searching for new podcasts on sustainability? Check out the Leaders on a Mission podcast, where I interview climate tech leaders who are shaking up the industry and bringing us the next big thing in sustainable solutions. Join me for a deep dive into the future of green innovation exploring the highs, lows, and everything in between of pioneering new technologies.Get an exclusive insight into how these leaders started up their journey, and how their cutting edge products will make a real impact.Tune in on…YouTube: https://www.youtube.com/@leadersonamissionNet0Spotify: https://open.spotify.com/show/7o41ubdkzChAzD9C53xH82Apple Podcasts: https://podcasts.apple.com/us/podcast/leaders-on-a-mission/id1532211726…to listen to the latest episodes!Timestamps:00:00 – Clean chemistry = mission02:41 – From pharma to enzymes05:07 – Bootstrapping for 6 years07:03 – AI + physics workflow10:55 – Why cost always wins11:15 – Regulatory bans as tailwind14:52 – End-to-end solution model19:31 – First hits in 3 months23:47 – Enzyme marketplace vision28:42 – Bio-melanin case study35:24 – Fundraising and futureUseful links: ZYMVOL website: https://zymvol.com/ZYMVOL LinkedIn: https://www.linkedin.com/company/zymvol/Maria Fatima Lucas LinkedIn: https://www.linkedin.com/in/fatimalucas/Leaders on a Mission website: https://cs-partners.net/podcasts/Simon Leich's LinkedIn: https://www.linkedin.com/in/executive-talent-headhunter-agtech-foodtech-agrifoodtech-agritech/
The intersection of innovation and regulatory – specifically when it comes to food is health – is a growing conversation. This week, we are joined by Dave Riggs, Business Cluster Unit President for Eurofins SFA, to talk laboratory science, consulting food brands around the world and health emerging as a trend on their minds. We get into: The work his SFA team leads and who they aim to serve How much food companies have to think about in product development and the risks that come up in a product's life cycle in quality and safety standard aren't met How laboratory scientists approach their work like consultants to overcome challenges and drive big outcomes for food brands around the world Food is Health making its way into the Eurofins labs and unintended consequences that have come alongside the movement Balancing innovation and scientific discovery with an evolving regulatory landscape Challenges and headwinds on the horizon for the food industry and how those create opportunities for creativity across the value chain Dave's advice to young talent considering science careers What's ahead for Eurofins
A new report from Verisk predicts a “new reality” in future natural catastrophes, with unprecedented global losses to exceed $152 billion annually. It's being driven by “frequency perils” − frequent events, such as daily afternoon summer storms and hurricanes, that are driving high-impact losses.Former Florida Deputy Insurance Commissioner Lisa Miller sits down with a Verisk modeler and a Florida property insurance company meteorologist and risk analyst, to discuss how catastrophe modeling works, how insurance companies use it to set homeowners rates, and its importance in understanding and mitigating extreme weather risks now and in the future.Show Notes (For full Show Notes, visit https://lisamillerassociates.com/episode-60-our-growing-catastrophe-risk/) The podcast discusses the increasing frequency and severity of storms and their impact on property insurance rates, particularly in Florida. Dr. Julia Borman is Assistant Vice President of the Regulatory and Rating Client Services Team at Verisk. It's part of the data analytic firm's Extreme Event Solutions division, which assists clients in working with regulators and rating agencies on a variety of projects, including data calls, utilizing catastrophe modeling in rating plans, and stress tests. Natalie Ferrari is a Meteorologist and Catastrophic Risk Analyst for American Integrity Insurance Company, based in Tampa, Florida. She provides data-driven insights into developing storms and their potential impacts by leveraging Verisk's modeling. Together, with host Miller, they explored the evolving landscape of catastrophic risk modeling in rate filings and regulatory processes, the intensifying impact of extreme weather, and the need for resilience and preparedness in the face of natural disasters that modeling can guide.Catastrophe Models: The Backbone of Modern InsuranceVerisk's newest report, Modeling Insured Catastrophe Losses: A Global Perspective for 2025, projects expected future global losses to exceed $152 billion annually. That's up from the $132 billion annual average loss over the past five years. Host Miller quoted Verisk Extreme Event Solutions President Rob Newbold's remarks on the September 2025 report, that “the modeled losses reflect a fundamental shift in the risk landscape. Natural catastrophe losses are no longer statistical anomalies. They are the new normal.” Borman said the report's $152 billion figure is a particularly significant one, given that the actual global losses in 2024 were around $137 billion. “Over half of it was what we call frequency peril loss. You used to hear around the industry, folks were calling things like severe thunderstorms and wildfire ‘secondary perils.' We don't call them that at Verisk anymore. They are frequency perils based on the fact that they happen often, typically within a year and those can really aggregate up into a large proportion of an insurance company's overall loss for the year,” Borman said.The catastrophe models look at a variety of different perils, including hurricanes, earthquakes, flooding, wildfires, and winter storms. “We were writing the report not just to understand the total amount of loss, but also the insurance gap that might exist around the world and where that was most prevalent,” she added. (For full Show Notes, visit https://lisamillerassociates.com/episode-60-our-growing-catastrophe-risk/)
You're invited to go behind the scenes and listen as case managers tell their stories – of long hours, little sleep, and always being ambushed by a bell ringing for help.These unsung heroes of healthcare are receiving their moment in the sun during the next live edition of Monitor Mondays, with a special 60-minute broadcast. The first half of the venerable weekly Internet broadcast will continue to bring you the news and information you've come to rely upon.During the second segment, Patti Velky, American Case Management Association's Board President, will report on the sweeping changes in the newly signed One Big Beautiful Bill Act (OBBBA). The law includes nearly $1 trillion in Medicaid cuts, potentially affecting 12 million people. Changes to state-directed payments and provider taxes could slash hospital funding by $340 billion. With key programs like Disproportionate Share Hospitals (DSHs), telehealth, and Hospital at Home still in limbo, the impact on hospitals, especially in Medicaid expansion and non-expansion states, will be profound. Case management teams will face mounting challenges in discharge planning, amid shrinking resources.Also during the second half of the 60-minute broadcast, Mary Beth Pace, American Case Management Association's Board President-Elect, will report on the one of case management's toughest challenges: difficult discharges. With shrinking resources and limited post-acute options, getting “ready-to-go” patients safely discharged is harder than ever. Mary Beth will share new tactics and practical strategies to help case managers navigate these complex situations.Finally, Adriana Peters, Board President for the Association of Physician Leaders in Care Management (APLCM), will report on how hospitals can turn data into action through the smarter use of metrics, KPIs, and analytics-driven storytelling.The weekly broadcast 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 analyst for Zelis, will report on the news happening at the intersection of healthcare and congressional action.
As a prelude to the Ten Across Convergence in Jacksonville coming up on October 22nd—where insurability planning will be a focal topic—we're sharing a conversation Charlie Sidoti and Stephen Brandt, founders of the nonprofit InnSure. Concerned about the risk protection gap growing with climate change in the U.S., these two have applied their combined decades of insurance industry expertise to form a professional network dedicated to developing insurance products that support—and therefore incentivize—communities' proactive fight against the risks they face. Ten Across participants are well-aware of disaster recovery costs soaring in this part of the country. Between 2020 and 2022, State Farm and Allstate dropped a shocking 2.8 million insurance policies in fire-prone areas of California—yet Florida and Louisiana lead the nation with even higher nonrenewal rates. Regulatory reform is struggling to relieve insurers and the insured, and the private market continues to retreat as losses exceed underwriting metrics. InnSure believes the insurance sector can lead the development of new models that incentivize risk reduction and community-based action—that in fact it must, in order to remain viable as an industry. In this episode, Charlie Sidoti and Stephen Brandt walk us through the challenges and solutions insurers consider in devising effective products to support climate risk mitigation—a preview to the multi-sector problem-solving work that attendees will undertake at the upcoming 10X Convergence. Relevant Articles and Resources Charlie Sidoti: “Running Toward Climate Risk” (InsuranceThoughtLeadership.com, August 2022) “How Shutdown Gridlock Could Impede Disaster Preparedness” (The New York Times, Sept. 2025) “A Trump Administration Playbook: No Data, No Problem” (The New York Times, Sept. 2025) REPORT: “Next to Fall: The Climate-Driven Insurance Crisis is Here—And Getting Worse” (Senate Budget Committee, December 2024) “The risky economics of living without homeowners insurance” (Reuters, March 2024) Relevant Ten Across Conversations Podcasts Carolyn Kousky on Using Insurance Models to Drive Positive Change Checking in with Dave Jones on California's Insurance Outlook Urban Expert Bill Fulton's Perspective of How LA Can Rebuild Following the Fires 2023 Insurance Series on California, Louisiana, and Florida CreditsHost: Duke ReiterProducer and editor: Taylor GriffithMusic by: From Now On and Lennon HuttonResearch and support provided by: Kate Carefoot, Rae Ulrich, and Sabine Butler About our guests: Charlie Sidoti is executive director of InnSure, a network of insurance professionals and consultants developing innovative industry tools that contribute to the battle against climate risk. Charlie is also a founding coalition partner of GreenieRE, a reinsurance company with a mission to de-risk and unlock capital for clean energy projects. He has more than 25 years of experience in the insurance industry. Stephen Brandt is chief development officer and founding board member of InnSure. Stephen previously served as senior vice president of sales for Vitech Systems Group, a group insurance and pension administration software company. He has more than 20 years of experience in the insurance technology field.
In this insightful conversation, Rosa Leal shares her inspiring journey from designing NASCAR alternators to leading commercial product strategy and customer experience at Rheem. With over 20 patents and a passion for innovation, Rosa reflects on how empathy, listening, and collaboration have shaped her leadership approach across engineering and product development. She dives into the complexity of designing for layered customer ecosystems, the importance of staying ahead of regulatory shifts, and how her experience as an immigrant and non-native English speaker sharpened her ability to truly hear customer needs. Rosa also unpacks the role of product management in aligning internal teams, managing risk through stage-gate processes, and fostering a culture where ideas and challenges are welcomed. This episode is a blueprint for leaders who want to drive innovation without sacrificing humility or humanity. Additional Resources: Strategic Leader | Engineer | Patent Holder | Selected as one of the 2023 Top Women in HVAC and Engineered Systems's 2023 20 to Watch: Women in HVAC Attend Unleashing Leaders University! Learn more about Unleashing Leaders Follow Unleashing Leaders on LinkedIn Connect with Lee on LinkedIn Follow Unleashing Leaders on Facebook Follow Unleashing Leaders on Instagram Key Takeaways: Innovation starts with truly listening to customers. Product strategy succeeds when cross-functional teams align early. Empathy, kindness, and clarity drive stronger leadership. Regulatory shifts are opportunities, not obstacles. Building trust enables open, risk-aware innovation.
The October 8 edition of the AgNet News Hour featured another powerful conversation with Shannon Douglass, president of the California Farm Bureau, who returned to the show to sound the alarm about Proposition 50 and its potential consequences for rural California . Douglass explained that Prop 50 would suspend California's Independent Redistricting Commission, a system created to ensure fair representation by keeping communities intact. “This commission takes in tens of thousands of public comments and really listens to communities of interest,” Douglass said. Under Prop 50, however, politicians would regain control of the process and could redraw districts behind closed doors, leaving rural communities with little to no voice. She highlighted one proposed district as an example of the absurdity: Alturas in Modoc County being lumped in with Sausalito in Marin County. With vastly different economies, incomes, and priorities, such pairings would dilute rural representation and shift political power further toward urban centers. “This isn't about Democrats or Republicans — it's about ensuring agriculture and rural voices continue to have a seat at the table,” Douglass stressed. Douglass also reminded listeners that agriculture already faces enormous challenges: Regulatory costs have increased nearly 1,400% in the past 20 years. California has lost 20% of its family farms in the last decade. Farmers are struggling with water shortages, labor issues, and global trade pressures. Losing rural representation, she argued, would only make those problems worse. Without strong farm voices in Sacramento and Washington, issues like the Farm Bill, forest management, and water storage could slip further down the priority list. Douglass urged voters not only to vote “No” on Prop 50 but also to spread the word. “When that ballot arrives in your mailbox, don't let it sit on the pile. Open it, fill it out, and vote no,” she said. She called on farmers and allies to share the message with neighbors and friends, emphasizing that the outcome will likely be close. Hosts Nick Papagni and Josh McGill underscored Douglass's message, reminding listeners that California agriculture is a $60 billion industry that sustains jobs from the farm to the ports. “Food security is national security,” McGill added, noting that farmers cannot afford to lose more ground in representation. Hear Shannon Douglass's full interview on the AgNet News Hour, by clicking the player below or on your favorite podcast app.
In this candid, practice-focused conversation, Joe is joined by Norwegian psychologist and researcher Ivar Goksøyr to explore how therapists' own healing journeys can measurably improve client outcomes—and why MDMA-assisted experiences, used thoughtfully, may be a uniquely powerful catalyst for professional development. Ivar shares lessons from Norway's psychedelic research team (PTSD and the world's first MDMA-for-depression trial), his clinic Psykologvirke in Oslo, and his online course, “The Wounded Healer,” which uses authentic footage from his FDA-approved MAPS volunteer MDMA sessions to illuminate real clinical processes, countertransference, and the “inner healing intelligence” as a working metaphor rather than dogma. The discussion ranges from implementation realities (laws, ethics, and conservative regulatory cultures) to the pragmatic: how an MDMA experience helped Ivar resolve chronic anxiety reactions in the therapy chair, reduced burn-out, increased receptivity, and improved attunement—changes he believes many clinicians can cultivate when personal growth is prioritized alongside methods training. He outlines a developing collaboration with the University of Oslo on Empathogen-Assisted Therapies Development—not to “dose for certification,” but to support therapists' self-awareness and resilience in legally sanctioned research contexts. They also compare compounds: why MDMA may be easier to integrate into mainstream psychiatry than classic tryptamines (fewer projective processes, more biographical focus, smoother affect regulation), while acknowledging the immense promise—and higher demands—of psilocybin and other psychedelics. Throughout, they emphasize humility, guardrails, and the need to keep learning as the field scales (with frank reflections on ketamine's mixed rollout and avoiding idealization/devaluation cycles). Highlights Why therapist factors often outweigh modality—and how personal work translates into better outcomes. Using real session video (with Ivar as participant) to normalize vulnerability, illuminate process, and train pattern recognition. Regulatory and ethical nuances of self-experience in training; building consensus before policy change. Inner healing intelligence as a clinical metaphor aligned with Rogers, Rank, and psychodynamic concepts (unconscious therapeutic alliance). MDMA vs. classic psychedelics for implementation; sequencing with ketamine in public systems. Global classroom: 270+ clinicians from every continent; course structure centered on reflection, discussion, and live analysis.
In this episode of the Pipeliners Podcast, Jim Curry of Babst Calland returns for an in-depth discussion on current and upcoming PHMSA rulemakings. The conversation covers the agency's evolving focus on risk-based, technology-driven regulation — including the growing role of AI and advanced analytical tools — and what these changes mean for operators. Curry also provides insights into regulatory reform, repair criteria modernization, and how industry can engage proactively to shape durable, data-driven rules that improve safety and efficiency. Visit PipelinePodcastNetwork.com for a full episode transcript, as well as detailed show notes with relevant links and insider term definitions.
In this episode, Matthew Allen is joined by Brendan Reilly, Managing Director and Head of US Corporate Affairs at Barclays, to discuss how rapid US policy shifts, tech-driven innovation, and evolving market regulation are shaping global cooperation and opportunities.
In this episode, Duane Mancini sits downs with Leo Eisner, a seasoned expert in medical device safety and compliance, as he shares his extensive experience and knowledge on the IEC 60601 standards. With a career spanning over 40 years, Leo talks about his beginnings at NASA, his role in the development of medical safety standards, and the intricacies of compliance testing. Discover the complexities of the IEC 60601 updates, the importance of staying informed, and practical advice for medical device manufacturers.Leo Eisner LinkedInEisner Safety Consultants WebsiteImpacts on IEC 60601-1 WebinarDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn
Marty talks about a new enterprise study that will use the AVP as a means for collecting EEG waves from people with neurological disorders, allowing them to communicate through the device. “This Startup Wants to Put Its Brain-Computer Interface in the Apple Vision Pro” – Wiredhttps://www.wired.com/story/this-startup-wants-to-put-its-brain-computer-interface-in-the-apple-vision-pro/Key Points1. Who Cognixion is- A California-based startup focused on non-invasive BCIs (EEG-based), avoiding surgical implants.- Its mission is to enable communication for people with ALS, paralysis, and other conditions that limit speech.- Previously built the dedicated Axon-R headset, tested with ALS patients.2. Vision Pro Integration- Cognixion is preparing a clinical trial with ~10 participants using a Vision Pro modified with their custom EEG headband.- The system detects visual fixation and attention patterns so users can select items on-screen by focusing on them.- A neural-computing pack worn at the hip processes the brain-signal data.3. Role of AI- Cognixion uses per-user generative-AI models trained on the user's prior communication to predict words or phrases.- In Axon-R trials, participants reached near-conversational communication speeds during multi-hour weekly sessions.4. Opportunities & ChallengesAdvantages:- Non-invasive → less risk, potentially faster adoption.- Leverages a mainstream headset (Vision Pro) and its spatial-computing ecosystem.- AI support can help overcome the low signal resolution of non-invasive EEG.Challenges:- EEG remains less precise than implanted BCIs, so decoding speed and reliability must improve.- The hardware still involves extra components (headband, hip pack) and must be ergonomic and socially acceptable.- Regulatory hurdles: moving from small clinical trial to FDA-approved assistive-tech product.We'll revisit this topic in an upcoming Vision ProFiles episode with more expert insights and discussion.Remember to follow the live stream at YouTube.com/@VisionProfiles on Monday nights at 9 PM EST, or catch the recording later on YouTube, or subscribe to the audio version on your favorite podcast platform.Email: ThePodTalkNetwork@gmail.comWebsite: ThePodTalk.NetYouTube: YouTube.com/@VisionProFiles
This episode tackles the often-overlooked but critical topic of medical device reimbursement. Host Etienne Nichols speaks with Haley King, co-founder and CEO of Paxos Health, about why this process is just as vital as FDA approval for a device's commercial success. They explore the journey a medical device takes, highlighting the distinction between FDA approval and securing reimbursement from payers.Haley explains the three key pillars of reimbursement: coding, coverage, and payment. She delves into the complexities of CPT codes and the significant difference between a temporary Category 3 code and the gold-standard Category 1. The discussion also covers the immense challenges medical device companies face, including the lengthy timeline—sometimes years—to secure payer coverage, which can be a make-or-break factor for startups. The conversation wraps up with a look at how artificial intelligence is beginning to streamline the cumbersome, manual process of patient access and appeals.Key Timestamps1:45 - The initial challenge of making coverage match medical need.3:30 - The three-part reimbursement pathway: coding, coverage, and payment.5:50 - Navigating CPT codes and the difference between Category 1 and Category 3.10:15 - Common challenges for medical device companies seeking payer coverage.13:20 - The multi-year timeline to achieve Medicare coverage for innovative devices.15:00 - Advice for regulatory and quality professionals on speeding up reimbursement.20:10 - How AI is currently being used in patient access and reimbursement.24:45 - Debating the accuracy of AI and its role in replacing human expertise.Quotes"A lot of times patients are not going to be able to pay out of pocket for expensive medical treatments, and a lot of times providers are not going to be able to write off those treatments on their side. So somebody needs to pay for this. And that's usually the health insurance companies..." — Haley King"I think that for this sort of a use case [AI], you're always going to want some human in the loop... AI has the potential to be super, super powerful in this space, but I think you're always going to want to have human experts involved." — Haley KingTakeawaysIntegrate reimbursement strategy early: Unlike FDA approval, which focuses on safety and efficacy, payers also demand evidence of a device's clinical and economic value. Medical device companies, particularly startups, should integrate reimbursement planning into their pitch decks and product development timelines from the outset.Recognize the two-step process: FDA approval is not a golden ticket to reimbursement. Companies must understand the subsequent and often lengthy process of securing coding, coverage, and payment from payers like CMS and private insurance companies, which can take several years.Enhance clinical trials for payers: Regulatory and quality professionals can speed up the reimbursement process by designing clinical trials that not only meet FDA requirements but also generate robust data to prove a device's clinical and economic value. This may involve including additional endpoints to justify the cost.Harness AI for efficiency, not replacement: AI is a powerful tool for automating the tedious parts of reimbursement, such as sifting through patient records and payer policies. However, it should be viewed as a way to enhance, not replace, the work of human experts who can handle complex edge cases and appeals.Be aware of coding complexities: The distinction...
Diketso Mashigo of South Africa's FSCA joins Compliance Champions to break down their landmark crypto licensing regime: 470+ CASP applications, 279 licenses granted, and a clear regulatory framework under the FAIS Act.
Recently, a federal court vacated the Centers for Medicare & Medicaid Services 2023 Risk Adjustment Data Validation (RADV) Final Rule.This action is reshaping the landscape for Medicare Advantage compliance. The rule had authorized contract-level extrapolation and eliminated the longstanding fee-for-service (FFS) adjuster — two changes that dramatically increased the potential scale of overpayment recoveries.Reporting this developing story during the next live edition of Monitor Monday will be senior healthcare analyst Frank Cohen,The weekly broadcast 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: Adam Brenman, senior legislative affairs analyst for Zelis, will report on the news happening at the intersection of healthcare and congressional action.
In this episode, Uzair talks to Zeeshan Khattak, Commissioner at the Securities & Exchange Commission of Pakistan (SECP) about the deepening of financial markets in Pakistan and the ways in which the SECP is trying to expand access to finance at the individual and corporate level. Mr. Zeeshan Rehman Khattak joined the SECP as Commissioner in November 2024. He has over two decades of local and international experience in Real Estate Investment & Management, Regulatory Affairs, Wealth Management, and Development of Export-led Technology Infrastructure. Mr. Khattak brings rich experience in capital markets, regulatory oversight and assets' management. Mr. Khattak's most recent association was with Pakistan Software Export Board (PSEB) as Chief Commercial Officer and additionally as Chief Executive Officer designate. Chapters: 0:00 Introduction 2:20 SECP's priorities 11:25 Savings via digital gold 14:20 Regulatory sandboxes 25:05 Focus on startups 27:30 Climate finance
Mark Hamilton sits down to discuss some of the latest news stories in F1. Mark also looks towards the Singapore Grand Prix. Looking for unique and authentic F1 merchandise? Check out www.racingexclusives.com! Check out The RaceWknd magazine here! Title music created by J.T. the Human: https://www.jtthehuman.com/ Hit that subscribe button and tune in for the full, unfiltered breakdown! You don't wanna miss this!
On this week's episode of Passive Income Playbook, Pascal Wagner interviews Peter Sack. They dig into why Chicago Atlantic targets underserved private credit niches, especially state-by-state cannabis lending where limited competition can mean first-lien structures at lower leverage with mid-teens to ~20% returns, plus classic lender protections. Peter explains how regulatory moats, disciplined underwriting, and downside focus beat “sexy” equity stories, and how potential legalization would likely trigger refinancings, prepayment fees, and warrant upside rather than harm. They also compare private funds to public options through Chicago Atlantic's BDC and mortgage REIT tickers, LIEN and REFI, and outline what LPs should evaluate in credit managers from lien position to non-accruals and third-party administration. Peter SackCurrent role: Managing Partner, Chicago AtlanticBased in: Miami, FloridaSay hi to them at: https://www.chicagoatlantic.com/ | LinkedIn | investors@chicagoatlantic.com This is a limited time offer, so head over to aspenfunds.us/bestever to download the investor deck—or grab their quick-start guide if you're brand new to oil and gas investing. Get 50% Off Monarch Money, the all-in-one financial tool at www.monarchmoney.com with code BESTEVER Join the Best Ever Community The Best Ever Community is live and growing - and we want serious commercial real estate investors like you inside. It's free to join, but you must apply and meet the criteria. Connect with top operators, LPs, GPs, and more, get real insights, and be part of a curated network built to help you grow. Apply now at www.bestevercommunity.com Podcast production done by Outlier Audio Learn more about your ad choices. Visit megaphone.fm/adchoices
Danielle Kidney is the founder of The Creative Pack, a Los Angeles-based agency specializing in packaging design for CPG and DTC brands. With over two decades of experience in the industry—including work with Tesco and a diverse portfolio of well-known consumer brands—Danielle brings a wealth of expertise in every aspect of packaging, from strategy and brand storytelling to materials and production.In this episode of DTC Pod, Danielle breaks down the behind-the-scenes process of creating packaging that not only looks great but also delivers on function, compliance, and scalability. She covers everything from the earliest stages of design and competitor audits, to the nuances of materials, regulatory requirements, and print production. Danielle shares practical advice on how brands can avoid costly mistakes, streamline their supply chain, and create packaging that stands out both online and on the shelf.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 importance of packaging in brand perception and sales2. Process: From initial idea to production-ready design3. Building a design brief and establishing project scope4. Competitive reviews and designing for hierarchy and function5. Balancing creative innovation with must-have regulatory details6. Collaborating with clients, manufacturers, and printers7. Prototyping, mockups, and unboxing experience8. Print technology, material choices, and cost management9. Regulatory review, legal claims, and compliance essentials10. Lead times, timeline planning, and pitfalls of rushing production11. Early-stage packaging vs. scaling up for retail and DTC12. Lessons learned: common mistakes and strategic tips13. Pricing, form factor, and packaging design as sales leversTimestamps00:00 Introducing Danielle Kidney & The Creative Pack05:42 The Creative Pack's client process: from idea to brief10:50 Balancing branding vs. functionality for sales and conversion18:03 Manufacturing realities: materials, dielines, and cost constraints24:39 Colors, mockups, and bringing digital designs to life26:22 Real-world costs of packaging mistakes and risk mitigation29:27 Regulatory musts: nutrition facts, barcodes, legal pitfalls35:10 Realistic timelines for packaging launches and scale40:33 Strategies for startups vs. brands scaling up43:23 Lessons learned and tips for optimizing packaging decisions50:20 Where to connect with Danielle and The Creative PackShow 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 TikTokDanielle Kidney - Founder of The Creative PackBlaine Bolus - Co-Founder of CastmagicRamon Berrios - Co-Founder of Castmagic
This webinar explores key developments in environmental regulatory compliance requirements affecting businesses operating across international jurisdictions, with a focus on how evolving rules are reshaping sustainability and ESG obligations for businesses.
If you have built your BigLaw career around a thriving regulatory or enforcement practice, you know how difficult it can be for you and your practice when that work suddenly isn't there. One month you are buried in nvestigations motivated by government inquiries or merger reviews, and the next your phone goes quiet because enforcement priorities shifted, agency budgets got cut, or a new administration has redirected resources. It is unsettling, especially when your brand, reputation and and client base are tied to that flow of work. In this episode, I walk through the reality of what it can feel like and what to do when your once-busy enforcement and regulatory practice slows. I share how to distinguish between cyclical downturns and structural changes that reshape a practice like this long term, and share some specific examples across areas such as FCPA, antitrust, and privacy to illustrate how BigLaw attorneys can pivot effectively. I also outline practical steps to stay visible with clients as well as inside your firm so that even when the billable work is not there, your value and future opportunities are. At a Glance: 00:00 Introduction need to navigate BigLaw downturns in regulatory and enforcement work 01:20 When busy practices suddenly dry up: regulatory shifts and enforcement changes 02:14 How external forces such as politics, budgets, and agency leadership reshape your practice overnight 03:03 Early warning signs that your work is slowing down in these areas 03:37 The emotional impact: anxiety, uncertainty, and fear of career derailment 04:08 Diagnosing cyclical vs. structural downturns with concrete indicators 05:16 Why this distinction matters for your long-term career strategy 05:39 Examples of temporary pivots that kept practices alive (FCPA, antitrust, GDPR, privacy) 07:04 How lawyers can broaden their practices to adapt to structural changes 08:08 The importance of proactive client communication, including with “good news” updates 09:37 What to do when billable hours stall: seeking work across departments and staying visible 10:41 Positioning yourself as a thought leader through articles, CLEs, and conferences 11:29 Documenting outreach, cross-practice contributions, and client loyalty for firm leadership 12:21 Demonstrating cross-practice value: aligning with busier groups inside your firm 13:30 How client loyalty and referrals strengthen your standing even in slow periods 13:58 Reframing your practice to be less narrowly defined by one enforcement area 14:27 How one partner survived cuts by documenting value and broadening expertise 15:16 Long-game mindset: showing your firm that you are indispensable beyond billable hours Rate, Review, & Follow on Apple Podcasts & Spotify Do you enjoy listening to Big Law Life? Please consider rating and reviewing the show! This helps support and reach more people like you who want to grow a career in Big Law. For Apple Podcasts, click here, scroll to the bottom, tap to rate with five stars, and select “Write a Review.” Then be sure to let me know what you loved most about the episode! Also, if you haven't done so already, follow the podcast here! For Spotify, tap here on your mobile phone, follow the podcast, listen to the show, then find the rating icon below the description, and tap to rate with five stars. Interested in doing 1-2-1 coaching with Laura Terrell? Or learning more about her work coaching and consulting? Here are ways to reach out to her: www.lauraterrell.com laura@lauraterrell.com LinkedIn: https://www.linkedin.com/in/lauralterrell/ Instagram: https://www.instagram.com/lauraterrellcoaching/ Show notes: https://www.lauraterrell.com/podcast
Medboard Europe TToo much Incomplete Tech File - Let's explain to you how to do it: https://www.team-nb.org/wp-content/uploads/2025/09/Team-NB-PositionPaper-BPG-IVDR-V2-20250903.pdf 2025/1920 on Master UDI-DI - Not only lenses but also Spectacle frames and Ready-to-wear: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202501920 Borderline manual Update - New products included: https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf red blood cell additive solutions containing adenine dual action cream with menthol and capsaicin Lactose tablets for vaginal use microabrasion dental stain removers medical examination table covers Mobile sterile air system EU asks your feedback on EU MDR and IVDR - Enjoy reading some 100 feedbacks: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en Switzerland Swissdamed Technical Documentation - XML upload: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/swissdamed-technical-documents.html Business Rules Swissdamed: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_002e_pu_swissdamed_business_rules.pdf.download.pdf/BW630_40_002e_PU_swissdamed_Business_Rules.pdf UK UK PMS guidance for Report - Template available: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/requirements-of-the-manufacturers-pms-system PMSR Template: https://www.gov.uk/government/publications/medical-devices-standardised-format-for-the-post-market-surveillance-report Magazine Issue 1: Sept/Oct 2025 - Next one will come November 2025: https://easymedicaldevice.com/emd-mag/ Events Medtech Conf events - Be listed on the MAP: https://medtechconf.com/events-map-2/ EasyIFU Free trial for eIFU with EASYIFU - Compliant EU 2025/1234: https://easyifu.com ROW US FDA Computer System Assurance - SOP offered on the show notes: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software-0 Malaysia affiliate member of MDSAP - What does it change?: https://portal.mda.gov.my/index.php/announcement/1636-malaysia-is-now-mdsap-medical-device-single-audit-program-mdsap-member Australia Essential Principles Checklist Update -: Update the templates V1.2: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist Egypt guidance to import your devices - Medical Devices, Accessories, IVD: All type of devices: https://edaegypt.gov.eg/media/lafopofx/1-regulatory-guideline-of-issuance-of-import-approvals-of-all-types-of-medical-devices_gd.pdf Medical Equipment and Accessories: https://edaegypt.gov.eg/media/fltnd1qc/4-regulatory-guideline-of-issuing-import-approvals-for-medical-equipment-and-their-accessories_gd.pdf IVD: https://edaegypt.gov.eg/media/e2rf4qg5/2-regulatory-guideline-of-the-procedures-and-rules-of-obtaining-import-approvals-for-iaboratory-and-diagnostic-equipment-gd.pdf Podcast Episode 353: Cybersecurity in Medical Devices: What QA/RA must do Today: https://podcast.easymedicaldevice.com/353-2/ Episode 354: From Surgeon to CEO: Building Neurogyn AG: https://podcast.easymedicaldevice.com/354-2/ Episode 355: Postmarket Surveillance for SaMD and AI: https://podcast.easymedicaldevice.com/355-2/ Easy Medical Device Service Support for Consulting (QA RA projects) Support for Authorized Representative and Market Access Integration to an eQMS Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice
In this episode, Jesse Gordon-Blake, PhD, delves into the intricacies of medicinal chemistry, particularly focusing on drug discovery for ALS (amyotrophic lateral sclerosis). Jesse explains the process of discovering molecules that modulate biological pathways, the difference between structure-based and phenotype-based drug design, and the role computational methods play in drug development. The conversation also explores the challenges of crossing the blood-brain barrier, the importance of validating target response, and the complexities of progressing from a theoretical compound to preclinical studies. Additionally, Jesse touches on the significance of target product profiles, CNS drug design characteristics, and the iterative nature of medicinal chemistry. He concludes by discussing his current projects at Cortex, including fundraising strategies and timelines for drug development.00:00 Introduction to Medicinal Chemistry00:37 Drug Discovery Approaches02:01 Computational Methods in Medicinal Chemistry03:21 Challenges in ALS Drug Discovery04:23 Blood-Brain Barrier and Drug Design05:29 Key Properties for CNS Drug Design08:58 Day-to-Day in Drug Discovery09:45 Early Stage Drug Development12:28 Validating Drug Targets16:15 From Theory to Animal Testing22:46 Funding and Timeline Considerations25:45 Regulatory and Manufacturing Considerations28:32 Conclusion and Contact InformationDr. Jesse Gordon-Blake is an independent biotechnology and drug discovery consultant with expertise in medicinal chemistry and neurotherapeutics. He has led efforts in small molecule and peptide therapeutic development, AI-enabled drug discovery, and biotech startup formation, and currently serves as the CSO of Cortexa Therapeutics. He earned his PhD in Medicinal Chemistry from the University of Illinois at Chicago, focusing on developing innovative small-molecule enzyme modulators for Alzheimer's disease.https://www.linkedin.com/in/jesse-gordon-blake-phd-52a26274/https://www.cortexatherapeutics.com/Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
The award-winning Compliance into the Weeds is the only weekly podcast that takes a deep dive into a compliance-related topic, literally going into the weeds to explore a subject more fully. Looking for some hard-hitting insights on compliance? Look no further than Compliance into the Weeds! In this episode of Compliance into the Weeds, Tom Fox and Matt Kelly discuss the bot attack on Cracker Barrel during its abortive name change imbroglio. They explore the notion that social media risk is not a new concept, but rather an amplifier of existing risks for companies. It discusses the heightened potential for misinformation about a company's values and how social media platforms have magnified this risk. Regulatory measures and accountability issues are addressed, with a nod to the role of prominent figures like Elon Musk. The episode underscores the inevitable, albeit unfair, reality of managing these amplified risks in today's digital landscape. Key highlights: Introduction to Social Media Risks Amplification of Existing Risks Challenges in Managing Misconceptions The Unavoidable Reality of Social Media Accountability Resources: Matt on Radical Compliance Tom Instagram Facebook YouTube Twitter LinkedIn A multi-award-winning podcast, Compliance into the Weeds was most recently honored as one of the Top 25 Regulatory Compliance Podcasts, a Top 10 Business Law Podcast, and a Top 12 Risk Management Podcast. Compliance into the Weeds has been honored with a Davey, Communicator, and W3 Award for podcast excellence. Learn more about your ad choices. Visit megaphone.fm/adchoices
Regulatory whiplash in California as the state effectively held a funeral for the two largest components of the Advanced Clean Fleet Rules, including mandates for high-priority fleets and drayage trucks. Despite the official withdrawal of these mandates by CARB, zero-emission vehicle sales are surprisingly growing in the state, suggesting market momentum is now driven by factors beyond regulatory pressure. The ongoing pricing standoff in the parcel sector, where UPS and FedEx are imposing significant peak season surcharges despite projections for muted demand growth, has heated up. Analysts warn that demanding these high fees in a soft market is short-sighted, leading to a major diversion of volume to alternative carriers like Amazon, Walmart, and independent services like OnTrac. Our brief concludes with the tectonic plates shifting in corporate freight strategy, starting with the massive $85 billion UP-NS merger that is already forcing competitors like CSX to seek its own merger partner after a CEO change. Meanwhile, ArcBest unveiled an ambitious plan to double its adjusted earnings per share by 2028 by targeting a highly optimized, asset-based operating ratio of 87% to 90% through technology and cost controls. Finally, we address the industry's perennial challenge of safety, noting that Wyoming currently tops the list for deadly truck crashes by death rate while Texas leads the nation in total fatalities by volume. These sobering statistics are fueling calls from victim advocates for mandatory safety technology, specifically demanding that all new commercial trucks be equipped with Automatic Emergency Braking. Learn more about your ad choices. Visit megaphone.fm/adchoices
This episode of the Pipeliners Podcast features a conversation with Osten Olorunsola of Aradel Holdings about the opportunities and challenges of building measurement capability at the national level in Nigeria. The discussion explores the critical role of measurement in oil and gas operations, the regulatory landscape, and the impact of shifting from multinational operators to indigenous companies. Listeners gain insight into how Nigeria is working to standardize practices, close capability gaps, and strengthen its long-term energy infrastructure. Visit PipelinePodcastNetwork.com for a full episode transcript, as well as detailed show notes with relevant links and insider term definitions.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Josh Vose, CEO of Tulavi Therapeutics.Tulavi is advancing hydrogel-based implants like the allay Hydrogel Cap, which is designed to optimize nerve injury recovery and reduce the risk of neuroma formation.Josh is a physician, engineer, and entrepreneur with more than 20 years of experience in medical devices. He has held leadership roles at Medtronic following its acquisition of PEAK Surgical and drove growth at startups including SIA Health, which he led through commercialization and acquisition by Integra LifeSciences.In this interview, Josh shares why defining the clinical problem with absolute clarity is the foundation of medtech success, and how leaning into the harder regulatory path can create lasting moats.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 Josh Vose.
Adam Stettner believes the cannabis industry is primed for growth acceleration but faces critical roadblocks from D.C. Optimism was sparked after President Trump made a social media post that endorsed CBD use for seniors. Adam talks about the state and federal challenges for cannabis as the steps companies need to take ahead of potential legalization.======== Schwab Network ========Empowering every investor and trader, every market day.Options involve risks and are not suitable for all investors. Before trading, read the Options Disclosure Document. http://bit.ly/2v9tH6DSubscribe 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 – https://twitter.com/schwabnetworkFollow us on Facebook – https://www.facebook.com/schwabnetworkFollow us on LinkedIn - https://www.linkedin.com/company/schwab-network/About Schwab Network - https://schwabnetwork.com/about
PM Dickon Mitchell has announced that Grenada will host the headquarters of the new Caribbean CBI regulatory authority.View the full article here.Subscribe to the IMI Daily newsletter here.
On this episode, associates are joined by Professor Jennifer Oliva to discuss the world of regulatory exclusivities and how they interact with patents.
In this episode of Yet Another Value Podcast, host Andrew Walker welcomes back Steve Gorelik from Firebird Management for a deep dive into Molina Healthcare (ticker: MOH). Together, they explore the sharp drop in Molina's stock despite its long-standing compounder reputation. Steve outlines how Molina operates as a low-cost Medicaid-focused managed care organization, making it uniquely resilient amid rising medical costs and regulatory challenges. They discuss Molina's competitive advantages, risks tied to healthcare policy, redetermination effects, and its strategic M&A playbook. Tune in to understand why Steve believes Molina remains undervalued and poised to outperform its peers—even as the broader Medicaid sector stumbles.___________________________________________________________[00:00:00] Intro and sponsor mention[00:02:25] What is Molina Healthcare?[00:05:31] Medicaid model and revenue growth[00:06:25] Molina stock chart and July crash[00:07:13] Industry-wide margin compression[00:11:28] Why Steve sees alpha in Molina[00:13:29] ROE vs. cost structure explained[00:15:04] Admin efficiency as competitive edge[00:17:04] Molina's playbook and cost culture[00:20:16] Medicaid redetermination impact[00:24:07] Market share gains amid member losses[00:26:26] What's driving cost inflation now[00:28:44] Will premiums rise to match costs?[00:30:26] Regulatory risks in Medicaid[00:32:19] Medicaid vs. private cost efficiency[00:33:54] Denials, approvals, and outcomes[00:37:50] Molina's denials as cost control[00:40:42] Tender process and doctor networks[00:41:43] What keeps Steve up at night[00:44:41] Acquisitions: model and pipeline[00:47:18] M&A parallels to John Malone[00:48:19] CEO incentives and share ownership[00:50:48] Share buybacks and capital returns[00:51:19] Could Molina be acquired?[00:52:57] Long-term compounding vs. exit[00:53:28] Scooby-Doo investing explained[00:54:23] Wrapping up the conversationLinks:Yet Another Value Blog - https://www.yetanothervalueblog.com See our legal disclaimer here: https://www.yetanothervalueblog.com/p/legal-and-disclaimer
Joel Hawthorne shares his outlook on the crypto market's surprising comeback, fueled by positive regulatory conversations and increased institutional interest. He believes the recent rally in Coinbase (COIN) is tied to the broader market's bullish momentum.======== 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 – https://twitter.com/schwabnetworkFollow us on Facebook – https://www.facebook.com/schwabnetworkFollow us on LinkedIn - https://www.linkedin.com/company/schwab-network/ About Schwab Network - https://schwabnetwork.com/about
Episode overviewIn this special episode, hosts and Co-Chief Investment Strategists Kevin Headland and Macan Nia welcome Nathan William Thooft, Chief Investment Officer for Multi Assets and Equities at Manulife Investments. Nate shares his global perspective on markets, asset allocation, and the evolving investment landscape, with insights tailored for Canadian investors.---Key topics & insights1. U.S. economic outlook: resilience amid uncertainty· No imminent recession expected—Nate explains that while recent U.S. labor market data has softened, it's not likely a signal for an imminent recession. The U.S. economy's balance between manufacturing and services helps offset sector-specific weaknesses.· Policy uncertainty—Earlier legislative and tariff changes have caused “paralysis” in company decision-making, but clarity is expected to improve economic data in coming months.· New paradigm—The severity of future U.S. recessions may be more muted due to the economy's diversification.2. Inflation & tariffs: what's really happening?· Tariff impact delayed—Studies show tariffs typically take up to a year to affect inflation. Many imports are exempt, and companies are absorbing costs, leading to lower-than-expected inflationary effects.· Substitution effect—Companies are shifting imports to countries with lower tariffs, further dampening inflation pressures. 3. Regional equity markets: Europe & Asia· Europe's outperformance—European equities have surprised with strong returns in 2025. Nate attributes this to a sentiment shift away from the U.S. amid geopolitical uncertainty, but sees it as opportunistic rather than a long-term trend.· Active vs. passive management—Active management is especially valuable in regions like Europe and Asia, where opportunities are less covered.· China's mixed signals—Despite strong equity performance and policy support, China's fundamentals (consumer spending, industrial production) remain weak. Nate is cautiously optimistic, citing potential in technology and AI, and improving sentiment.4. Asset allocation: equities vs. fixed income· Modest equity overweight—Manulife portfolios remain overweight equities, reflecting solid fundamentals despite stretched valuations.· Fixed income caution—Less conviction in long-duration fixed income due to changing yield curve dynamics and rising term premiums.· Diversification beyond 60/40—Nate advocates for broader diversification, including alternative assets, to manage risk.5. Private Assets & Alternatives· Democratization of privates—The trend toward making private assets (infrastructure, private credit, real estate) accessible to retail investors is accelerating, as seen in recent industry partnerships.· Role in portfolios—Private assets offer diversification and potential downside protection, especially when traditional fixed income may be less effective.6. Artificial Intelligence (AI) in asset management· Efficiency & speed—AI is transforming research, data analysis, and commentary writing, but won't replace portfolio managers who bring creativity and intellectual capital.· Research revolution—AI enables analysis of vast data sets, improving productivity and decision-making. 7. Cryptocurrency: a legitimate asset class?· Growing acceptance—Nate views crypto as a legitimate asset class, though volatility and regulatory uncertainty mean exposures should remain modest and client-specific.· Regulatory trends—As demand grows, policy is likely to become more accommodating.8. Career advice for aspiring portfolio managers· Decisiveness—Don't wait for perfect information—make decisions with 60–80% of the data to avoid missing opportunities.· Passion & objectivity—Be passionate about investing, but unemotional in decision-making. The ability to cut losses and remain objective is crucial for success.---Actionable takeaways for Canadian investors· Stay diversified—Consider global opportunities and alternatives beyond traditional stocks and bonds.· Monitor policy impacts—Watch for delayed effects from tariffs and monetary policy.· Embrace active management—Especially in regions with less coverage and more inefficiencies.· Explore private assets—As access expands, these can enhance portfolio resilience.· Leverage technology—AI will increasingly support research and efficiency, but human insight remains essential.---Links & Resources · Listen to the episode: Investments Unplugged Podcast · Learn more about Manulife Investments: Manulife IM Canada---Share & SubscribeIf you enjoyed this episode, please share it with your network and subscribe for future insights on markets, investing, and portfolio strategy.---For informational purposes only. This episode does not constitute investment advice. Please consult a qualified advisor before making investment decisions.---Show notes prepared by Investments Unplugged Podcast Team, September 2025.
North America’s railways are at a crossroads. After decades defined by consolidation and cost-cutting, the sector is pivoting toward growth, but trade volatility, regulatory uncertainty, and merger politics may shape how far it can go. In this conversation with RealAgriculture's founder Shaun Haney, Anthony Hatch, of ABH Consulting, lays out the forces at play in... Read More
A recent case filed by the U.S. Department of Justice (DOJ) reveals how an insider was able to detect fraud in a large managed care organization (MCO).Although the topic of medical loss ratio (MLR) might be arcane to some, when the subject involves millions of dollars of potential fraud, it quickly becomes a large blip on the government's fraud detection radar.More on this topic will be reported during the next live edition of Monitor Mondays. That's when whistleblower attorney Max Voldman returns to the long-running Internet broadcast to report on how a payer, Inland Empire Health Plan, miscalculated its MLR in a scheme to rebate less money to the government than to which it was legally obligated.The weekly broadcast 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, senior legislative affairs analyst for Zelis, will report on the news happening at the intersection of healthcare and congressional action.
Managed service providers (MSPs) are experiencing significant growth driven by interest in artificial intelligence (AI), with 92% reporting an uptick in business. However, a concerning trend has emerged: only about half of these providers feel equipped to assist small and mid-sized businesses in adopting AI tools, a sharp decline from 90% the previous year. This growing readiness gap highlights the challenges MSPs face in meeting customer expectations as AI adoption accelerates. Experts emphasize the need for integrated security solutions to help navigate the complexities of AI.OpenAI's recent benchmarks reveal that a staggering 95% of enterprise AI projects fail, underscoring the difficulties companies encounter in justifying their AI investments. Despite advancements in AI models, their effectiveness remains inconsistent, particularly in handling complex, ongoing projects. The evaluation system introduced by OpenAI aims to bridge the gap between theoretical capabilities and real-world demands, indicating that while AI can perform tasks faster and cheaper than humans, it still struggles with contextual understanding and interaction.In the realm of digital content, Cloudflare has launched a feature allowing website owners to block Google's AI overview search product, addressing concerns from publishers about traffic losses due to AI-generated content. This move comes amid legal challenges faced by Google from publishers who argue that their content is being used without proper attribution. While Cloudflare's feature offers a potential solution, its effectiveness hinges on Google's compliance, raising questions about the future of content ownership in the age of AI.Regulatory pressures are also reshaping the landscape for major tech companies. Microsoft has been compelled to offer free extended security updates for Windows 10 in select European markets, responding to consumer advocacy for better support. Meanwhile, Apple has delayed the release of several features in Europe due to compliance challenges with the EU's Digital Markets Act. These developments highlight the increasing influence of regulation on technology services, prompting MSPs to prepare for client inquiries regarding disparities in service offerings across regions.Four things to know today00:00 92% of MSPs Report AI-Driven Growth, But Only Half Feel Ready to Support SMB Adoption02:50 Fast, Cheap, and Fragile: OpenAI Finds AI Struggles in Real Work While Cloudflare Challenges Google's AI Overviews06:44 EU Pressure Forces Microsoft to Extend Free Windows 10 Updates as Apple Delays Features Under DMA09:39 Innovation vs. Obligation: How Debt, Automation, and AI Metrics Are Rewriting the Managed Services PlaybookThis is the Business of Tech. Supported by: https://mailprotector.com/ Webinar: https://bit.ly/msprmail All our Sponsors: https://businessof.tech/sponsors/ Do you want the show on your podcast app or the written versions of the stories? Subscribe to the Business of Tech: https://www.businessof.tech/subscribe/Looking for a link from the stories? The entire script of the show, with links to articles, are posted in each story on https://www.businessof.tech/ Support the show on Patreon: https://patreon.com/mspradio/ Want to be a guest on Business of Tech: Daily 10-Minute IT Services Insights? Send Dave Sobel a message on PodMatch, here: https://www.podmatch.com/hostdetailpreview/businessoftech Want our stuff? Cool Merch? Wear “Why Do We Care?” - Visit https://mspradio.myspreadshop.com Follow us on:LinkedIn: https://www.linkedin.com/company/28908079/YouTube: https://youtube.com/mspradio/Facebook: https://www.facebook.com/mspradionews/Instagram: https://www.instagram.com/mspradio/TikTok: https://www.tiktok.com/@businessoftechBluesky: https://bsky.app/profile/businessof.tech Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
In this conversation, Stephan Livera and Jesse Myers discuss the current state and future of Bitcoin treasury companies, focusing on Smarter Web Company's strategies and performance. They explore the implications of PIPE deals, the importance of a solid track record in delivering Bitcoin yield, and the regulatory environment's impact on investment strategies. The discussion highlights successful examples like Metaplanet and the potential for Bitcoin treasury companies to accumulate a significant portion of Bitcoin in the coming years. They also address the challenges investors face, including understanding mNAV and justifying premiums in Bitcoin investments. Jesse also introduces the P-Bid ratio as a new metric for evaluating these companies, emphasizing the need for a strong retail investor base and the significance of operational businesses in sustaining value. The discussion concludes with reflections on the future of Bitcoin treasury companies and their role in the broader financial landscape.Takeaways:
CJ King, CTO at Torc Robotics, joins the show to talk about the future of autonomous trucking at scale. Instead of asking “can we build one self-driving truck?” Torc is asking, “how do we safely put 10,000 on the road?” From supply chain transformation to regulatory hurdles, CJ breaks down what it really takes to bring production-ready autonomous semis into the market and why the ripple effects will reach far beyond trucking.Key Takeaways• Scaling autonomous vehicles isn't about prototypes—it's about building production-ready systems from the ground up.• Trucks face unique technical challenges, from 1,000-meter perception needs to fully redundant systems that can't rely on cloud compute.• Removing driver limitations could extend operations from 8 hours a day to 20, unlocking major gains in supply chain efficiency.• Regulatory collaboration is critical—success depends on alignment with federal and state agencies, law enforcement, and logistics partners.• Adoption will come in step-functions: once proven safe and reliable, logistics companies are ready to adopt at scale.Timestamped Highlights00:45 – Torc's focus on hub-to-hub autonomous trucking02:03 – Why scaling to thousands of trucks matters more than building one prototype06:48 – The unique technical problems of trucks vs. passenger cars09:25 – How extended operating hours reshape logistics and supply chains14:17 – Working with regulators and law enforcement to ensure safety and compliance17:42 – AV3.0, synthetic data, and billions of miles of training for safer systems22:31 – Building public trust and societal acceptance of autonomous trucking25:21 – Why large-scale adoption will happen in step functions, not tricklesA Line That Stuck With Us“Our bare minimum is to drive as good as a human—our mission is to be safer than one.” – CJ KingCall to ActionIf you enjoyed this episode, share it with someone who cares about the future of tech and logistics. Make sure to follow the show so you never miss conversations that dig into how technology is reshaping our world.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Ahmed Elmouelhi, CEO of TRiCares. TRiCares is developing Topaz, the first purpose-built transcatheter tricuspid valve replacement system — a technology designed specifically for the right side of the heart, where complex anatomy has made durable solutions elusive.Ahmed is a 20-year medtech veteran with leadership experience across electrophysiology, men's health, neuromodulation, and structural heart. Before joining TRiCares, he helped build multiple businesses at AtriCure and held key roles at Medtronic during the early days of TAVR. He also serves as Chairman of the American Heart Association in Minnesota.In this interview, Ahmed shares why adoption — not added complexity — is the ultimate measure of medtech innovation, how a small group of physician champions can accelerate clinical studies faster than internal resources alone, and why treating your board like collaborators in the “sandbox” leads to stronger partnerships and better outcomes.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 Ahmed Elmouelhi.
The Trump Administration's Regulatory Agenda is the starting point for David, Nita, and Burt's lively discussion of the consequences of the Administration's de-regulatory agenda and its efforts to exert presidential control over all executive agencies. The “nuclear option” for confirming nominees, judicial rulings questioning the constitutionality of administrative enforcement, and the impact of the budget debate make this a timely and informative conversation.Contact Fortney & Scott: Tweet us at @fortneyscott Follow us on LinkedIn Email us at info@fortneyscott.com Thank you for listening! https://www.fortneyscott.com/
Brandon Weichert highlights the immense power demands of AI and AGI data centers, requiring gigawatts of electricity and facing significant regulatory hurdles. He discusses the potential weaponization of AI, noting human nature's tendency to weaponize new technologies. Weichert shares personal experiences with AI tools like Grok, Gemini, and Claude, including instances of AI "diversion" rather than hallucination. He emphasizes the need to master this technology, as the substantial investment ensures its permanence. 1958
Newt talks with Patrick McLaughlin, a research fellow at the Hoover Institution, where he leads the QuantGov analytics project focusing on regulations. McLaughlin discusses the growth of regulatory requirements from 400,000 restrictive terms in 1970 to 1.1 million today, highlighting the economic friction and opportunity costs associated with regulatory accumulation. He estimates that if regulations had been held constant since 1980, the U.S. economy could be 25% larger by 2012, equating to a $4 trillion increase. They also discuss the impact of the Supreme Court's decision to end Chevron deference, which previously allowed agencies to interpret statutes with significant discretion. Their conversation concludes with an examination of Virginia Governor Glenn Youngkin's successful regulatory reforms, which include a 25% reduction in regulatory inventory and the use of AI for cost-benefit analysis, setting a new standard for regulatory management.See omnystudio.com/listener for privacy information.