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In this episode, Kyle S delivers an emergency news update on Netflix's acquisition of Warner Brothers Studios, HBO, and HBO Max for $82.7 billion. This monumental deal reshapes the entertainment landscape, merging Netflix's streaming dominance with Warner Brothers' iconic IPs like DC Comics and Harry Potter. Takeaways Netflix acquires Warner Brothers Studios, HBO, and HBO Max. The deal is valued at $82.7 billion. This acquisition reshapes the entertainment landscape. Netflix merges streaming dominance with iconic IPs. Warner Brothers' iconic IPs include DC Comics and Harry Potter. The merger faces regulatory scrutiny and shareholder approval. Netflix pledges to maintain Warner Brothers' operations until 2029. The deal accelerates Hollywood's shift to digital-first distribution. Potential impacts on creativity and content diversity are discussed. The merger could lead to significant industry changes. Sound bites Netflix acquires Warner Bros for $82.7B. Warner Bros and HBO join Netflix. Streaming landscape reshaped by Netflix's acquisition. Netflix merges with Warner Bros' iconic IPs. Regulatory scrutiny for Netflix's acquisition. Netflix pledges to maintain Warner Bros' operations. Hollywood's shift to digital-first distribution. Impact on creativity and content diversity. Significant industry changes expected. Netflix's strategic acquisition of Warner Bros. Chapters 00:00:00 - Introduction and Emergency News Update 00:01:00 - Details of Netflix's Acquisition 00:02:00 - Impact on the Entertainment Industry
In this episode of This Week in AML, Elliot Berman and John Byrne unpack a pile of developments across the globe. From the EU's decision to add Russia to its AML blacklist and phase out Russian gas imports, to major enforcement action against a crypto mixer, the conversation dives deep into the evolving financial crime landscape. They also cover Canada's updated guidance on politically exposed persons, U.S. alerts on cross-border transfers, OCC's changes for community banks, and a surprising OFAC penalty tied to real estate sanctions. Plus, insights on humanitarian access challenges and upcoming year-in-review discussions. Stay informed on what's shaping compliance and risk management today.
The short-term rental market is entering a new phase — one where stability, not volatility, is driving the biggest changes. In this fireside chat from the Data & Revenue Management Conference, Jamie Lane joins Simon Lehmann and Pedro Borges to break down the real signals behind 2025's “steady state” and what it means for hosts and managers heading into 2026. This isn't a hype-filled projection; it's a data-backed look at supply slowdowns, shifting guest behavior, and how professionalization continues to reshape the competitive landscape.From the K-shaped performance split between luxury and mid-market listings to the growing influence of OTA ranking systems, the conversation highlights why outperforming your market now depends less on macro tailwinds — and more on operational sharpness. Jamie and Pedro dig into pricing challenges, the emerging STR-to-midterm pivot in major cities, and how rising owner expenses like taxes and insurance are reshaping what “profitability” even means. If you want a grounded, unfiltered view of where the industry is actually heading, this episode delivers it.For STR operators planning their next move, this is essential listening. You don't want to miss this episode!Key TakeawaysStability requires strategy: With occupancy flat and supply growth at historic lows, 2025–2026 will be a competition for share, not an automatic lift.Quality gaps matter: Listings with sub-4.7 ratings are shrinking fastest as OTAs elevate top-tier properties and push weaker performers to page two and beyond.Profitability is the real KPI: Rising insurance and property taxes mean managers must understand — and communicate — homeowner-level financial realities.Luxury grows, mid-market squeezes: The K-shaped recovery continues, rewarding high-end supply while challenging budget and mid-tier operators.Midterm strategies surge: Regulatory pressure and seasonality are accelerating the blend of STR and midterm stays, especially in cities like NYC, Denver, and LA.Sign up for AirDNA for FREE
In a time when organizations are navigating generational change, evolving leadership expectations, and shifting workforce dynamics, cooperative boards have a unique opportunity to lead differently, anchored in values, purpose, and shared ownership. This episode of the Forward Thinking Podcast features FCCS SVP of Marketing and Communications Stephanie Barton, Vice President of Organizational Development for FCCS Jay Lux, and Angie Coleman, Organizational Development Consultant with FCCS. Their conversation centers around director strategies for connecting with the spirit of cooperative identity so that every choice made in the boardroom strengthens both the organization and the people it serves. Episode Insights Include: What makes cooperative governance distinct? The cooperative structure is made up of the members, for the members. Decisions made by the board directly impact those whom it serves. Boards include member-owners of the organization. Cooperative governance starts with member benefits, not shareholder return. Decisions are made with and for the people that the board serves. Cooperatives exist to create value with their people. The future of cooperative boards As businesses grow in complexity, cooperative boards offer insights into how to best serve their members. Shifting workforce and generational shifts are aligned with what cooperatives value. Board focus is shifting toward what really matters to employees today. The collaborative nature of how organizations are structured and governed is revealing. Key differentiators between corporate and collaborative structures benefit the patrons of the cooperative, rather than the owners. Cooperatives exist to create value with their people. These principles matter in today's current landscape more than ever before. Three leadership challenges that cooperatives address Employees are distrustful of organizations that value profit over people. The triple bottom line affects consumer and employee decision making. Workforce expectations have shifted toward what the cooperative structure offers. The cooperative model is uniquely positioned toward employee expectations. Performance and purpose are effectively addressed by the cooperative model. Board decision-making principles in the cooperative model All seven cooperative model principles may show up in the boardroom at any given time Cooperative boards are focused on long-term viability of the business, and ultimately, the member-owner. Annual returns are positively impacted by the cooperative model. These principles are the foundation for the structure and purpose of the institution. Employee engagement and good governance Employees today expect transparency, participation, and purpose. Employees want to know the why behind decision making. High-performing teams have clear expectations, visibility, and effective feedback loops. When people understand the why, the don't just buy-in, they believe-in. Board decisions need to reflect employee needs. Respectful dissent in the boardroom is addressing conflict done well. Healthy conflict requires getting curious and asking clarifying questions. Shifting governance expectations in the face of leadership transitions and increased complexity Demographic changes for management transitions with the new generation. Growing organization size creates new complexities. Technology advancements are regular conversations in today's boardroom Businesses are run of people, by people. Regulatory landscape requirements have made business operations increasingly challenging. Individual expertise must be balanced with collective decision making at the board level. Effective board and management collaboration and education Preliminary preparation is essential for effective conversations. Engage in robust debate about ideas, not individuals. The executive session is a powerful tool for meaningful board discussions. When in doubt, bring in a subject matter expert. Directors have a responsibility to build regular learning into the boardroom. Annual board performance reviews are essential. Succession planning should be embedded throughout the boardroom culture. This podcast is powered by FCCS. Resources Connect with Jay Lux — Jay Lux Connect with Angie Coleman — Angie Coleman Get in touch info@fccsconsulting.com "Cooperative governance starts with member benefits, not shareholder return." — Angie Coleman "Cooperative boards are focused on long-term viability of the business, and ultimately, the member-owner, not just the profit of the cooperative institution itself." — Jay Lux "When people understand the why, the don't just buy-in, they believe-in." — Angie Coleman "In the cooperative model, it's not optional to have a voice. It's part of the cooperative principle." — Angie Coleman
Regulations, Water Challenges, and the 2026 Outlook: Roger Isom on the AgNet News Hour In this Thursday edition of the AgNet News Hour, Nick Papagni and Lorrie Boyer sit down with Roger Isom, a leading voice in California agriculture. The conversation covers critical challenges and opportunities for growers, including regulatory pressures, water scarcity, rising energy costs, and strategies for advocacy heading into 2026. Advocacy and Grassroots Engagement Active participation in agriculture advocacy is essential. Growers and farm suppliers are encouraged to engage with legislators and county supervisors. Joining industry organizations strengthens collective influence: Western Tree Nut Association (WTNA): wtna.org California Cotton Ginners and Growers Association (CCGGA): ccgga.org 2026 is an election year—growers need to be heard in policy and voting decisions. Regulatory Challenges Rodenticide restrictions: Proposed DPR rules may limit usage, affecting food safety and crop protection. Sustainable pest management: Phase-out of priority pesticides by 2050 raises concerns about balanced advisory representation. Automation hurdles: Driverless tractors face restrictions under OSHA rules, despite driverless cars operating freely. Increasing paperwork burdens take time away from actual farming. Water, Energy, and Affordability Pressures Groundwater restrictions are enforced ahead of SGMA 2040 benchmarks. Funding gaps prevent critical infrastructure development for water conveyance and storage. Rising PG&E rates threaten farm operations: Proposed 27% electricity hike California agricultural rates up to 3x higher than Texas Solar payback periods under NEM 3.0 now nearly 20 years. The Future of California Agriculture Population loss and migration of growers to states like Texas and Idaho. Regulatory and energy burdens threaten long-term agricultural viability. Advocacy, voter engagement, and unified industry action are critical to protecting California agriculture. Wine Industry Insights Younger generations are drinking less wine due to cost, health, lifestyle, and cannabis alternatives. Wine marketing must emphasize storytelling, tasting experiences, and approachable options. Sampling and education about varietals, winemakers, and history can grow consumer appreciation. In today's episode of the AgNet News Hour, host Nick Papagni (The Ag Meter) and co-host Lorrie Boyer wrapped up a lively discussion on the changing landscape of wine consumption and what the wine industry can do to engage new generations of drinkers. Younger Consumers: Price, Health, and Lifestyle Drive Decisions Lorrie explained that younger adults are drinking less wine for several reasons—cost being a major factor. Many prioritize health, career, or school, while others prefer non-alcoholic beverages now trending in breweries and restaurants. She noted that wineries may need to expand into non-alcoholic options, just as beer companies have. Experience Over Alcohol: What Today's Drinkers Want Nick and Lorrie agreed that modern consumers focus more on experiences than alcohol volume. Craft cocktails, tasting-room visits, and curated beverage moments continue to capture interest. At the same time, the overwhelming number of wine choices can intimidate new drinkers, especially when bottle prices are high. The Value of Tasting and Storytelling Lorrie shared her personal love for wine tasting—trying small pours, exploring Cabernet and Zinfandel, and discovering new favorites based on food, mood, and weather. She emphasized that winery visits are about more than wine: Meeting the winemaker Learning the history Hearing the story behind each bottle Nick added that “every bottle has a story,” underscoring why wine remains a unique and powerful part of agriculture. Wrapping Up Nick and Lorrie closed the episode with excitement for upcoming holiday-themed content and encouraged listeners to return tomorrow for more ag news, insights, and seasonal fun. Listeners can find additional information, connect on social media, and subscribe to podcasts through AgNetWest.com.
At the Fall '25 vCon Conference, Doug Green, Publisher of Technology Reseller News, sat down with Rebekah Johnson, Founder & CEO of Numeracle, for a timely and urgent discussion on the escalating global fraud crisis and the role identity must play in restoring trust to communications. Johnson, a long-time industry leader on identity assurance, shared insights from her panel on “the state of fraud,” which revealed troubling trends despite industry-wide mitigation efforts. Johnson explains that while robocalls may be declining, fraud itself is surging due to increasingly sophisticated tactics and AI-enabled targeting. “Despite all these mitigation efforts, we actually have a declining situation, not an improving situation,” she notes. Bad actors are using fewer touchpoints and more advanced tools, turning communications channels into highly efficient conduits for financial theft, often to fund organized crime, trafficking, and even hostile state activities. Central to Johnson's message is the need to bring Know Your Customer (KYC) principles into communications—just as the banking industry has done for decades. Without verified identity, she argues, consumers remain vulnerable. “If you're going to get access to communications… there should be a verification process to ensure you are who you say you are,” she says, emphasizing that transparency and verifiable identity are essential to helping consumers make safe choices. Regulatory momentum is building: the FCC's proposed rulemakings touch directly on identity delivery and KYC requirements. But Johnson warns that progress will hinge on implementation by carriers, who face technical burdens without clear financial incentives. Still, she sees identity adoption as inevitable—especially with AI now eroding human ability to distinguish real from synthetic interactions. AI itself, she says, will accelerate the need for digital credentials tied to trustworthy identity. As the conversation turns to Numeracle's mission, Johnson highlights the company's role in protecting enterprise communication channels from being mislabeled as fraud or spam, enabling hospitals, universities, financial institutions, and brands to reach customers reliably. Numeracle also supports UCaaS and CPaaS providers seeking to protect customer reputations across the network. Despite the alarming fraud statistics—estimated in the hundreds of billions—Johnson remains optimistic. “It's not doomsday,” she says. “I'm excited about the future and the role our engineers will play in it.” To learn more about Numeracle's identity and reputation protection services, visit https://www.numeracle.com/.
Should we use regulations to treat the symptoms of healthcare market dysfunction or try to cure its causes? David W. Johnson and Julie Murchinson debate on, “Pushing the Right Regulatory Buttons,” the new episode of the 4sight Health Roundup podcast, moderated by David Burda.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Colby Holtshouse, President and CEO of May Health.May Health is developing a minimally invasive ovarian ablation therapy designed to restore ovulation in women with polycystic ovary syndrome (PCOS) and PCOS-related infertility.Before May Health, Colby served as Global Medtech Commercial Lead at Organon, overseeing the worldwide launch of the Jada System following Organon's acquisition of Alydia Health, where she held roles including COO, Interim CEO, and VP of Marketing. She has also held leadership positions at Pelvalon, AccessClosure, Medtronic, and Guidant.In this discussion, Colby shares why early clinical evidence should be built in focused layers rather than oversized, all-at-once trials. She explains how a small, deliberate early launch can reveal the workflow nuances and real-world expectations no study ever captures. And she outlines why founders should define the raise first — and how clarity, preparation, and a deep understanding of strategic partners can dramatically accelerate the fundraising process.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 Colby Holtshouse.
In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Steven O'Rourke, regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways.They discuss:- The hidden costs of regulatory failure and how to avoid them- Why early engagement with regulatory agencies is critical- Global regulatory models, including emerging markets like China and the UAE- A clear explanation of UDI and serialization- How regulatory impacts extend beyond compliance teams- The role of LinkedIn and storytelling in regulatory careers- Steven's experience running for the European Parliament and what it taught him about policyTimestamps00:00 – Introduction and Guest Welcome00:38 – The Hidden Costs of Regulatory Failure03:47 – Engaging with Regulators Early05:26 – Global Regulatory Models and Emerging Markets10:07 – Understanding UDI and Serialization15:16 – The Power of LinkedIn and Personal Stories17:11 – Running for European Parliament and Policy Insights21:18 – Conclusion and Contact InformationConnect with Steven O'RourkeWebsite: https://clarifi.fiLinkedIn: https://linkedin.com/in/sorourkdeSubscribe to Let's Combinate for more conversations exploring combination product development, quality systems, and regulatory strategy.Stephen O'Rourke is a regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. Based in Helsinki, Finland, his work spans UDI, 510(k), EU MDR, combination products, and novel ingredient safety.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.
This week, Hemish is joined by Ashley Preston, SVP of Regulatory, Quality and Medical Writing at Blossom Hill Therapeutics, for a conversation about what it really takes to win hearts and minds early in quality leadership.Ashley took an unconventional path into QA, stepping into his first Quality leadership role after a long career in Regulatory Affairs.Because of that, he's had to lead through something far more important than technical depth: communication, trust, and people.In the episode, Ashley shares:Why he moved from Regulatory into Quality leadershipHow to build trust quickly when you're new to QAHow leaders can empower technical experts and still influence effectivelyPractical ways to build quality systems and culture in a small biotechWhy communication, self-awareness and soft skills matter more than everHow quality can earn a stronger, more strategic voice at the executive tableAshley's perspective is grounded, pragmatic, and incredibly relevant for leaders in emerging and clinical-stage biotech.#QualityLeadership #Biotech #RegulatoryAffairs #QualityCulture #LetsTalkQuality
PREVIEW — Joseph Sternberg — The Failure of the "Brussels Effect." Joseph Sternberg of the Wall Street Journalcritiques the "Brussels Effect," a regulatory theory positing that heavy European Union regulatory standards would enable European companies to achieve competitive advantage through compliance-driven market dynamics. Sternbergcharacterizes this strategic approach as "total nonsense," demonstrating that EU regulatory frameworks have systematically stifled the growth of major technology startups and innovative enterprises compared to the dynamism of Silicon Valley, producing technological and economic underperformance. Sternberg reports that Brussels officials are gradually accepting this uncomfortable reality and reconsidering the regulatory framework's strategic efficacy. 1884 BRUSSELS
Alina Bridges, MD, FAAD interviewed by Ryan Hick, MD, FAAD
Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we'll explore the latest advances and strategic moves shaping the industry, providing you with insights into how these developments might influence drug development and patient care.The pharmaceutical and biotech sectors are currently experiencing a wave of transformative changes. A significant development is the trade agreement between the United States and the United Kingdom, which excludes medicines from import tariffs. This strategic move, orchestrated by the Trump administration, is set to reduce costs and bolster investments in pharma sectors across both nations. By enhancing market accessibility, it aims to stimulate cross-border investment in pharmaceutical research and production.On the clinical front, Eli Lilly is making headlines by joining Novo Nordisk in reducing self-pay prices for its GLP-1 receptor agonist, Zepbound. This reflects a broader industry trend towards patient-centric pricing models aimed at improving affordability. With healthcare costs on the rise, these measures could ease financial burdens for patients requiring long-term medication regimens.Regulatory updates are also making waves, with the FDA planning stricter vaccine regulations under Dr. Vinay Prasad's leadership at the Center for Biologics Evaluation and Research (CBER). These updates come amid concerns over vaccine safety during COVID-19-related incidents, underscoring a commitment to maintaining public trust in vaccines. Regulatory scrutiny continues as Prasad focuses on COVID-19 vaccine safety in children amid reports linking 10 child deaths to vaccines via VAERS—emphasizing challenges interpreting safety data while highlighting the need for robust methodologies ensuring reliable causality conclusions.In corporate restructuring news, Valneva is streamlining its operations by closing a site and eliminating 30 roles. This move highlights an industry focus on optimizing resources to bolster vaccine development pipelines. Meanwhile, Microsize and Schedio's acquisition of Lonza's Swiss micronization plant underscores ongoing investments in advanced manufacturing technologies critical for high-quality pharmaceuticals.In ophthalmology, Belite Bio is advancing with promising Phase 3 results for tinlarebant in treating Stargardt disease—a rare genetic eye disorder. This success positions Belite to file for FDA approval, potentially expanding treatment options for this underserved patient population. Such advancements in targeted therapies emphasize the need for ongoing research in genetic disorders.Regeneron is betting $150 million on Tessera's gene writing technology targeting alpha-1 antitrypsin deficiency (AATD). This collaboration highlights the industry's growing interest in gene therapy as a frontier for treating rare diseases, marking a shift towards precision medicine where tailored genetic interventions offer hope for previously untreatable conditions. Regeneron's strategic move investing $275 million partnering with Tessera exploring gene editing capabilities—focusing on TSRA-196 targeting the SERPINA1 gene linked to AATD showcases potential advancing therapeutic options for genetic disorders through gene editing technologies offering new disease treatment avenues.AI-driven platforms were spotlighted at RSNA 2025 by industry leaders such as GE Healthcare, Philips, and Siemens. These innovations promise to revolutionize radiological workflows by enhancing diagnostic accuracy and operational efficiency through AI integration. As AI continues to permeate healthcare technologies, its potential to transform diagnostic processes marks a significant leap towards personalized medicine.Akebia Therapeutics' acquisition ofSupport the show
2/4. Politics vs. Markets: The Failures of Incentivized Climate Solutions — Terry Anderson (Editor) — Andersondiscusses adaptation barriers, noting that regulatory frameworks systematically impede Alaskan Native Villages'traditional ecological knowledge and adaptive ingenuity. Anderson critiques incentivized climate solutions, particularly carbon taxation schemes, arguing they fail fundamentally due to political polarization driven by the perverse incentive structure ("don't tax me, tax them"). Anderson advocates instead for market-driven responses that empower consumers as decision-makers, catalyzing genuine adaptation outcomes, including strategic crop relocation and agricultural practice modification in response to changing environmental conditions. 1838
The False Claims Act (FCA) suit was initiated by the U.S. government, not a traditional whistleblower. Nonetheless, the recent $45 million settlement with a Florida physician and his wound care group – Vohra Wound Physicians Management LLC – resolved allegations that group knowingly submitted claims to Medicare for medically unnecessary yet lucrative surgical procedures, when routine non-surgical wound management had actually been done. During the next live edition of the long-running Monitor Monday Internet broadcast, famed whistleblower attorney Mary Inman will report the details of the amazing case, as a not-so-subtle reminder that crime doesn't pay.Broadcast segments will also include these instantly recognizable features:· Monday Rounds: Ronald Hirsch, MD, vice president of R1 RCM, will be making his Monday Rounds. · The RAC Report: Healthcare attorney Knicole Emanuel, partner at the law firm of Nelson Mullins, will report the latest news about auditors. · Legislative Update: Matthew Albright, chief government affairs analyst for Zelis, will report on the news happening at the intersection of healthcare and congressional action.· Risky Business: Healthcare attorney David Glaser, shareholder in the law offices of Fredrikson & Byron, will join the broadcast with his trademark segment.
Regulatory Delays: The Silent Killer of Ontario's Housing Construction
Speakers: Leanne Loranger and Sean FitzGerald In this episode, Sean and Leanne dive into how artificial intelligence is popping up in physiotherapy—from chatbots for booking and billing tasks and scribe tools for clinical documentation to robotics - and the regulatory considerations to keep in mind. With the explosion of AI tools, physiotherapists may look at options that help them in their work. Before implementing an AI tool there are a few things to know about doing so in a way that's consistent with the Standards of Practice and regulatory requirements. We unpack the privacy laws you need to know (think the Personal Information Protection Act, Health Information Act and Personal Information Protection and Electronic Documents Act), the current status of proposed AI regulation, and why it's crucial to keep up with changing legislation. Sean reminds us: even if your workplace picks the AI tool, you're responsible for your compliance with the standards and relevant legislation, which means that you need to do your due diligence to be sure you are using an AI tool appropriately. Transparency is key — clients should always know if AI is involved in their care, and that they can say "no thanks" at any time. Watch out for bias in the AI tools you use, keep your clinical skills sharp, and don't let reliance on AI tools lead to a loss of skills. We discuss cybersecurity and even the environmental impact of AI data centers. Bottom line? Stay informed about new developments in AI and always put your clients first. Remember, AI is meant to support your expertise, not replace it. Resources: • Artificial Intelligence Guide for Alberta Physiotherapists Links: Subscribe on Apple Podcasts Subscribe on Spotify
When the U.S. President launches a meme token, how do regulators crack down on others doing the same?Chief Legal Officer of Bitcoin.Com Joseph Collement breaks down how Trump's “pump token” changed the regulatory tone overnight.
The Aerospace Corporation presented ‘Space Governance: Policy and Regulatory Frameworks' at the Caribbean Space Summit, exploring how Puerto Rico can become a leader in the commercial space industry through smart policy. Here is part of their conversation with the UK Space Agency and UK Space Regulator at the Civil Aviation Authority. Remember to leave us a 5-star rating and review in your favorite podcast app. Be sure to follow T-Minus on LinkedIn and Instagram. T-Minus Guest Lori Gordon, Systems Director at The Aerospace Corporation is joined by Matthew Archer, Director of Launch at the UK Space Agency (UKSA) and Colin Macleod, Head of UK Space Regulator at the UK Civil Aviation Authority. Share your feedback. What do you think about T-Minus Space Daily? Please take a few minutes to share your thoughts with us by completing our brief listener survey. Thank you for helping us continue to improve our show. Want to hear your company in the show? You too can reach the most influential leaders and operators in the industry. Here's our media kit. Contact us at space@n2k.com to request more info. Want to join us for an interview? Please send your pitch to space-editor@n2k.com and include your name, affiliation, and topic proposal. T-Minus is a production of N2K Networks, your source for strategic workforce intelligence. © N2K Networks, Inc. Learn more about your ad choices. Visit megaphone.fm/adchoices
Key Takeaways:Data centers, senior housing, self-storage, and student housing are the niche real estate asset classes poised to shape investment trends in 2026, but each comes with unique opportunities and challenges.Office sector recovery is uneven: top-tier buildings in strong markets are performing well, while lower-quality or less-central offices continue to struggle.Economic uncertainty remains high for 2026; interest rates, inflation, and capital availability are top concerns for real estate investors, with overall optimism dropping since last year.Regulatory risk and transparency are major issues—exemplified by the controversial Trump ballroom project, which bypassed normal review processes and raised concerns about public-private project standards.The 50-year mortgage proposal is widely criticized, offering slightly lower monthly payments at the cost of much greater interest paid over time and slow equity accumulation, making it unattractive for most buyers.
Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve deep into a series of transformative events that underscore the dynamic nature of our industry, where scientific innovation meets regulatory evolution and market adaptation.We begin with significant regulatory news from Medicare, which recently announced price reductions for 15 prescription drugs, including Novo Nordisk's semaglutide products, Ozempic and Wegovy. This initiative is part of the Inflation Reduction Act aimed at making essential medications more affordable. By potentially increasing accessibility to these treatments, this move highlights a growing trend towards cost containment in drug pricing within the U.S. healthcare system. It reflects a broader effort to ensure that life-saving treatments remain within reach for more patients, emphasizing the need for balance between innovation and affordability.Turning to approvals, Otsuka has secured FDA clearance for Voyxact, a first-in-class treatment targeting IgA nephropathy (IgAN). This positions Otsuka in an increasingly competitive market space populated by major players like Novartis and Vertex. The entry of Voyxact could pave the way for innovative therapeutics in kidney diseases, offering new hope to patients who have had limited treatment options until now.On the other side of the Atlantic, French authorities have conducted a raid on Sanofi's headquarters as part of a tax fraud investigation. This development sheds light on ongoing scrutiny in the pharmaceutical sector regarding financial practices and regulatory compliance. Such investigations can have far-reaching implications on corporate governance and transparency, reminding us of the importance of ethical practices in maintaining industry trust.Novo Nordisk has strategically used its FDA national priority voucher to expedite the review process for a high-dose formulation of Wegovy. This move underscores the importance of regulatory incentives in accelerating drug development timelines, allowing for quicker patient access to potentially life-changing therapies. It's a testament to how strategic navigation through regulatory pathways can significantly impact drug availability.In clinical trials, Sarepta Therapeutics received FDA clearance to conduct a study combining its gene therapy Elevidys with sirolimus in patients with Duchenne muscular dystrophy. The study aims to address liver safety issues associated with Elevidys, which had led to previous label restrictions. This reflects the industry's commitment to enhancing therapeutic safety profiles while expanding treatment indications.In oncology advancements, AstraZeneca's Imfinzi received FDA approval for use in early-stage stomach cancer, marking its third perioperative indication. This approval underscores the expanding role of immunotherapy across various cancer types and stages, offering new treatment paradigms that could improve surgical outcomes and long-term patient survival.Despite these advances, there is skepticism regarding artificial intelligence's role in regulatory compliance submissions among pharmaceutical professionals. A survey reveals that 65% express distrust towards AI-generated outputs, highlighting challenges that AI technologies face in gaining acceptance within highly regulated environments such as pharmaceuticals. However, federal recommendations to revamp U.S. biotechnology research emphasize incorporating AI into scientific processes to maintain global competitiveness. This call reflects concerns over potential declines in innovation leadership and underscores the need for strategic investment in research infrastructure.In antitrust news, the Federal Trade Commission (FTC) outlined its case agaiSupport the show
AI Regulation: The Danger of Fear and the Need for a National Framework — Kevin Fraaser — Fraser critiques the regulatory rush surrounding AI, faulting the EU's approach to establishing guardrails based on "speculative fears" rather than documented harms. He warns against allowing "robophobia"—unfounded fear of artificial intelligence—to drive policy, advocating instead for regulatory focus on beneficial applications including healthcare diagnostics and educational access. Fraaser advocates for a unified U.S. regulatory framework to prevent a fragmented patchwork of state laws and excessive litigation that stifles technological innovation. 1930
How This Is Building Me, hosted by world-renowned oncologist D. Ross Camidge, MD, PhD, is a podcast focused on the highs and lows, ups and downs of all those involved with cancer, cancer medicine, and cancer science across the full spectrum of life's experiences. In this episode, Dr Camidge sat down with Gideon Blumenthal, MD, vice president of Clinical Development Oncology at Merck in Silver Spring, Maryland. Drs Camidge and Blumenthal discussed Dr Blumenthal's experience serving on both sides of the oncology regulatory divide. Though initially leaning toward humanities during his education, he pursued a career in medicine. During medical school, he shifted his focus from neuroscience to oncology due to the field's high unmet need, fascinating drug development pathways, and the intensity of patient interaction. He chose to complete his hematology and oncology fellowship at the National Cancer Institute to immerse himself in translational oncology and drug development. Before joining industry, Dr Blumenthal also spent several years working for the FDA. He started there as a medical officer, focusing on all facets of drug development, from ethics and manufacturing to trial design and biostatistics. He emphasized that success at the FDA involves both approving effective agents and identifying drugs that do not work, maintaining transparency through venues like the public Oncologic Drug Advisory Committee meetings. He used FDA data to conduct independent meta-research, such as analyzing the correlation between response rates and overall survival in lung cancer. His proudest achievement at the FDA was helping to establish the Oncology Center of Excellence, which unified drug development reviews across different centers within the agency. Dr Blumenthal left the FDA in early 2020, seeking to gain direct experience in developing new therapeutics. Joining Merck, he first worked in regulatory affairs, navigating international regulations in addition to US filing procedures, which are typically prioritized in oncology. He later transitioned into clinical development, and currently focuses on new assets as Merck evolves its pipeline beyond pembrolizumab (Keytruda). Dr Blumenthal concluded that he is excited by the future of oncology, anticipating radical changes driven by new modalities and advanced biomarkers like artificial intelligence–driven digital pathology.
On this episode of The Art of Boring, Global Credit Portfolio Manager Brian Carney unpacks what he believes are some of the most pressing issues in credit markets today. He explores whether recent private market bankruptcies signal deeper systemic concerns, how to position for sovereign bond issuer risk in a sticky inflation world, and the impact of the AI-driven debt wave on credit spreads. He also discusses regulatory rollbacks in the lending markets, credit risk premium mispricings, and concrete portfolio actions for late cycle markets. Key Highlights Recent private market bankruptcies may signal broader, systemic credit market weakness rather than isolated events, with deteriorating lending standards and rising delinquencies warranting caution. Growing sovereign debt and persistent inflation are challenging the traditional "safe haven" status of U.S. Treasuries, prompting a preference for shorter duration and higher-quality credit exposure. The surge in AI-driven capital expenditures is fueling a wave of debt issuance by large tech companies, likely putting upward pressure on credit spreads and shifting market dynamics in favour of lenders over time. Regulatory rollbacks in the U.S. are reducing transparency and increasing risk-taking, especially in unregulated and private markets, raising concerns about financial stability and corporate behaviour. Credit risk premiums remain compressed, with investors often inadequately compensated for lower-quality credit risk; opportunities are limited, and selectivity is critical. Defensive positioning—focusing on capital preservation, short duration, and high-quality issuers—remains key, with readiness to deploy capital quickly when market dislocations create attractive opportunities. Host: Kevin Minas, CFA, Institutional Portfolio Manager Guest: Brian Carney, CFA, Portfolio Manager This episode is available for download anywhere you get your podcasts. Founded in 1974, Mawer Investment Management Ltd. (pronounced "more") is a privately owned independent investment firm managing assets for institutional and individual investors. Mawer employs over 250 people in Canada, U.S., and Singapore. Visit Mawer at https://www.mawer.com. Follow us on social: LinkedIn - https://www.linkedin.com/company/mawer-investment-management/ Instagram - https://www.instagram.com/mawerinvestmentmanagement/
Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a landscape rich with scientific innovation, regulatory scrutiny, and strategic business decisions shaping the future of healthcare.Let's begin with Novartis, which has achieved a significant milestone by securing FDA approval for Itvisma. This is an intrathecal formulation of its gene therapy Zolgensma, designed to treat older patients with spinal muscular atrophy (SMA). Priced at $2.59 million, this approval is a critical advancement in gene therapy for SMA, broadening the treatment horizon for a wider patient demographic. Gene therapies are increasingly crucial in addressing rare genetic disorders, offering transformative potential in patient care. Novartis's SMA market expansion post-FDA approval of Itvisma not only enhances its SMA portfolio but also signifies growing acceptance towards gene therapies as viable treatment options for genetic disorders. Meanwhile, Novartis is strategically restructuring, planning to cut 550 jobs at a Swiss plant by 2027 while expanding its workforce in North Carolina. This move reflects broader industry trends toward optimizing global operations and investing in regions with strategic manufacturing capabilities.In the sphere of regulatory scrutiny, lawmakers are questioning the FDA's National Priority Voucher Program amid concerns about corruption and expedited reviews. This situation highlights ongoing challenges within regulatory frameworks to balance innovation speed with rigorous safety assessments. An investigation into the FDA's new priority review voucher program has been initiated due to concerns over corruption and expedited review processes potentially compromising drug safety. This inquiry could influence future regulatory frameworks and underscores balancing accelerated drug approvals with rigorous safety standards. Richard Pazdur expressed concerns about expedited drug approval programs' safety and legality as he takes on his new role as director of the FDA's Center for Drug Evaluation and Research. These initiatives aim to accelerate drug reviews but spark debate over patient safety implications—underscoring an ongoing tension between innovation speed and regulatory diligence.Turning to Novo Nordisk, their expansion of the Amycretin program demonstrates a commitment to tackling chronic conditions like diabetes. Following promising Phase 2 data showcasing dual agonist capabilities, Novo Nordisk is advancing pivotal trials focused on obesity. This strategic pivot aligns with market needs and scientific discoveries that could significantly enhance diabetes management options. Further emphasizing Novo Nordisk's commitment to diabetes management, their expansion of the amycretin program after promising Phase 2 results demonstrates the efficacy of a dual agonist originally focused on obesity. This underscores a trend toward multifunctional biologics addressing metabolic disorders by targeting multiple pathways—indicative of broader industry shifts towards integrated therapeutic approaches. Novo Nordisk's recent mid-stage clinical trial results for Amycretin—a weight loss treatment—are noteworthy as they demonstrated sustained efficacy over 36 weeks in type 2 diabetes patients without a plateau in weight loss. Analysts highlight its potential as a superior therapeutic option in the burgeoning weight loss market due to its durable solution for weight management.On a contrasting note, SK Life Science encounters regulatory hurdles as the FDA scrutinizes advertising practices related to its antiseizure medication Xcopri. This scenario underscores the complex interplay between marketing strategies and regulatory compliance within the pharmaceuticSupport the show
This is the final episode of TPDi’s 5-part Tech Mirror mini-series, Australia vs Social Media: Inside the world-first online safety experiment. In this episode, we turn our attention to the future, looking at policy priorities for the Government going forward, including privacy law reform, a prohibition on unfair trading practices, competition codes, and the introduction of a digital duty of care. We also call on the Tech Mirror community to get involved and help shape Australian tech policy to make sure that it works well for everyone. Featured experts in this episode include Privacy Commissioner Carly Kind, Lizzie O’Shea from Digital Rights Watch, ACCC Chair Gina Cass-Gottlieb, eSafety Commissioner Julie Inman Grant, and clinical psychologist Dr Danielle Einstein. Links: PM Press Conference at Parliament House (30 July 2025) https://www.youtube.com/watch?v=Zv-ZQ6jyLxw Children’s Online Privacy Code, via the Office of the Australian Information Commissioner https://www.oaic.gov.au/privacy/privacy-registers/privacy-codes/childrens-online-privacy-code Age appropriate design: a code of practice for online services, Information Commissioner’s Office (UK) https://ico.org.uk/for-organisations/uk-gdpr-guidance-and-resources/childrens-information/childrens-code-guidance-and-resources/age-appropriate-design-a-code-of-practice-for-online-services/ Regulatory reform in digital platform markets is needed to improve competition and consumer outcomes, via the ACCC (June 2025) https://www.accc.gov.au/media-release/regulatory-reform-in-digital-platform-markets-is-needed-to-improve-competition-and-consumer-outcomes Minister for Communications announcement of duty of care obligations (November 2024) https://minister.infrastructure.gov.au/rowland/media-release/new-duty-care-obligations-platforms-will-keep-australians-safer-online Statutory Review of the Online Safety Act 2021, led by Delia Rickard, released February 2025 https://minister.infrastructure.gov.au/rowland/media-release/report-online-safety-act-review-released Minister for Communications Press Conference regarding digital duty of care survey (November 2025): https://minister.infrastructure.gov.au/wells/transcript/press-conference-canberra-0 Minister for Communications media release on commitment to digital duty of care (November 2025) https://minister.infrastructure.gov.au/wells/media-release/government-continues-commitment-online-safety Government survey on digital duty of care online (November 2025) https://minister.infrastructure.gov.au/wells/media-release/government-continues-commitment-online-safety Credits Written and narrated by Johanna Weaver, Executive Director, Tech Policy Design Institute. Produced by Olivia O’Flynn & Kate Montague, Audiocraft. Research by Amy Denmeade. Original music by Thalia Skopellos. Created on the lands of the Ngunnawal, Ngambri people and the Gadigal people of the Eora Nation. Special thanks to all the team at the Tech Policy Design Institute, without whom the pod would not be possible, especially Zoe Hawkins, Meredith Hodgman, and Dorina Wittmann. See omnystudio.com/listener for privacy information.
Regulators around the world, from the US to Singapore and Australia, are trying to revive initial public offerings. The London Stock Exchange raised less than $2 billion since the beginning of 2024, its worst drought since 1998, while the number of publicly listed companies in the US has halved from 8,000 in 1996. Regulatory burdens, litigation risks and abundant private capital have pushed companies to remain private. Paul Atkins, chairman of the US Securities and Exchange Commission, has vowed to "make IPOs great again". But what can regulators do to entice companies to list? And why is Hong Kong bucking this trend – the city is on track to raise more than $40 billion this year and has a pipeline of more than 300 mainland Chinese firms seeking listing. Larry Tabb, Bloomberg Intelligence head of market structure research, and Sharnie Wong, BI senior analyst – diversified financials, joins John Lee on the Asia Centric podcast.See omnystudio.com/listener for privacy information.
Michael and Buck broke down how well search and automated regulatory workflows are already helping small, lean production teams move faster. Instead of digging through PDFs, Buck can pull a full well history in seconds, and he sees the next big win as using AI for diagnostics, spotting trends, suggesting likely issues, and helping pumpers focus on what actually matters. They also talked about the huge amount of tribal knowledge stuck in people's heads and how tools like transcripts and voice-to-text can finally capture it so newer hands aren't starting from scratch.Click here to watch a video of this episode.Join the conversation shaping the future of energy.Collide is the community where oil & gas professionals connect, share insights, and solve real-world problems together. No noise. No fluff. Just the discussions that move our industry forward.Apply today at collide.ioClick here to view the episode transcript. https://twitter.com/collide_iohttps://www.tiktok.com/@collide.iohttps://www.facebook.com/collide.iohttps://www.instagram.com/collide.iohttps://www.youtube.com/@collide_iohttps://bsky.app/profile/digitalwildcatters.bsky.socialhttps://www.linkedin.com/company/collide-digital-wildcatters
Todd broke down how we're actually getting real ROI out of AI instead of chasing buzzwords, starting with the simple idea that domain expertise and clear value beats any hype cycle. He walked through the three places AI moves the needle G&A, capital, and risk and safety showing how agents can take over the daily grind like SCADA alert triage, revenue statements, AFEs, regulatory filings, and even capturing tribal knowledge before it walks out the door. He explained how Collide sits above systems like Quorum, WellView, SCADA, and accounting so teams can query everything in one place and see how a single well status change ripples across leases, contracts, and compliance. Regulatory use cases are exploding W-10s, injectors, flaring permits, methane reporting and mapping is becoming a key layer using tools like Mapbox. On the non-op side, the team is already extracting revenue statements and AFEs, pushing data into Aries and accounting, and setting up real ROI analysis for OBO partners. The takeaway start small, prove the value, then expand into a stack of agents that quietly take on the busywork so teams can focus on decisions that matter.Click here to watch a video of this episode.Join the conversation shaping the future of energy.Collide is the community where oil & gas professionals connect, share insights, and solve real-world problems together. No noise. No fluff. Just the discussions that move our industry forward.Apply today at collide.ioClick here to view the episode transcript. https://twitter.com/collide_iohttps://www.tiktok.com/@collide.iohttps://www.facebook.com/collide.iohttps://www.instagram.com/collide.iohttps://www.youtube.com/@collide_iohttps://bsky.app/profile/digitalwildcatters.bsky.socialhttps://www.linkedin.com/company/collide-digital-wildcatters
October 2025 shook the crypto world. Bitcoin crashed harder than any October since 2015, someone accidentally minted $300 trillion in stablecoins, and traditional banks started an all-out war against crypto companies trying to get federal charters. Tedd Huff, founder of Fintech Confidential and CEO of fintech advisory firm Voalyre, sits down with Rob Musiala, partner at Baker Hostetler who co-leads The Blockchain Monitor, to break down what moved Web3 when it mattered most. They walk through why stablecoins just crushed major card networks with $2.6 trillion in annual volume, how Western Union suddenly decided blockchain payments make sense, and what the Genius Act really means for everyone trying to operate in this space. This isn't theory. Banks are fighting to protect their turf while crypto infrastructure gets bought up for billions. The conversation covers enforcement crackdowns, court rulings that actually matter, regulatory battles over OCC charters, and why sitting this one out stopped being an option months ago. KEY TAKEAWAYS 1️⃣ Financial institutions must evaluate make-or-buy decisions on stablecoin infrastructure before competitors capture market share as platforms offering blockchain-based payments already process volumes exceeding major card networks. 2️⃣ Developers building on Ethereum layer-2 solutions can expect 30-60% lower transaction fees after Fusaka activates December 3rd, allowing projects to adjust pricing models or capture improved margins. 3️⃣ Stablecoin issuers, custodians, payment facilitators, and exchanges face different compliance requirements based on their specific business models under the Genius Act framework. 4️⃣ Retail investors and traders experienced 60-80% losses across major meme coins during October, while newcomers like Mini U and MemeCore surged during the same downturn. 5️⃣ Businesses operating cross-border payments between Japan and international markets gain new infrastructure as institutions push toward 10 trillion yen stablecoin circulation targets. LINKS Host:Tedd Huff (LinkedIn) - https://www.linkedin.com/in/teddhuff/Voalyre - https://voalyre.com CI (Confidential Informant):Rob Musiala (LinkedIn) - https://www.linkedin.com/in/robertmusiala/The Blockchain Monitor - https://www.theblockchainmonitor.com Company:Baker Hostetler - https://www.bakerlaw.com Fintech Confidential:YouTube - https://www.youtube.com/@FintechConfidentialWebsite - https://fintechconfidential.comNewsletter - https://fintechconfidential.com/newsletterLinkedIn - https://www.linkedin.com/company/fintech-confidential SUPPORTERS Dfns - Secure wallets built right. API-first, multi-chain MPC wallet infrastructure for payments platforms, custodians, and exchanges. Request demo: fintechconfidential.com/dfns Skyflow - Build fast without breaking privacy. Zero trust data privacy vault delivered as an API for PCI, GDPR, and SOC 2 compliance. Learn more: skyflowsecure.com Hawk AI - Fight fraud and financial crime with real-time payment screening, AML transaction monitoring, and dynamic customer risk rating. Sign up for demo: GetHawkAI.comAbout:GuestConfidential Informant - Robert Musiala - Partner - BakerHostetlerRobert Musiala has been working in the blockchain and digital assets market since 2012 and has led multiple digital asset investigations, including as the court appointed receiver over cryptocurrency investment funds used in a major fraud. Robert also advises on a variety of regulatory compliance issues involving digital assets and has drafted/negotiated agreements for a wide range of transactions...
Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of impactful events and breakthroughs that are shaping patient care and drug development.The U.S. Food and Drug Administration recently granted early approval for a combination therapy using Padcev and Keytruda for the perioperative treatment of bladder cancer, a decision made months ahead of schedule. This approval represents a significant advancement in the therapeutic landscape for this type of cancer, offering new hope to patients who have had limited treatment options. The combination of these two therapies underscores the growing trend of integrating multiple mechanisms of action to tackle complex diseases like cancer more effectively. It also highlights the potential of combination therapies to provide enhanced clinical benefits by leveraging different therapeutic targets.In another notable development, Merck's partner Kelun announced successful Phase 3 trial results for an antibody-drug conjugate combined with Keytruda in treating PD-L1-positive non-small cell lung cancer (NSCLC). The trial results demonstrated statistically significant improvements in progression-free survival compared to Keytruda alone. This finding reinforces the expanding role of antibody-drug conjugates in oncology and emphasizes the importance of biomarker-driven therapies in personalizing cancer treatment. These advancements reflect a broader industry shift towards precision medicine, which aims to improve patient outcomes by tailoring treatments based on individual patient profiles.Meanwhile, Novo Nordisk experienced setbacks as its shares fell nearly 9% following two unsuccessful Phase 3 trials of semaglutide for Alzheimer's disease. Despite these disappointing results, this outcome highlights the persistent challenges and complexities inherent in developing therapies for neurodegenerative diseases—areas where unmet needs remain substantial. The market's reaction reflects investor sensitivity to clinical trial outcomes, particularly in high-stakes areas like Alzheimer's where breakthroughs are eagerly anticipated.Switching gears to AstraZeneca, the company is making a strategic move by expanding its manufacturing capabilities with a $2 billion investment in Maryland. This expansion reflects an ongoing trend among pharmaceutical companies to enhance their production infrastructure, driven by increasing demand for biologics and complex therapeutics. Such investments are crucial for supporting large-scale production needs and ensuring robust supply chains that are essential for meeting global health demands.In regulatory news, a collective letter from biotech CEOs addressed to FDA director Marty Makary has raised concerns about regulatory stability in the U.S., with 82% of biopharma respondents expressing apprehension over the FDA's ability to function predictably. This plea underscores how regulatory volatility can hinder innovation and emphasizes the importance of consistent policies that support long-term research and development efforts.In clinical trial updates, Bayer's oral FXIa inhibitor asundexian has shown promise in reducing stroke risk during Phase 3 trials. These findings revive interest in FXIa inhibitors as potentially blockbuster drugs after previous setbacks in this class. This development illustrates ongoing efforts to identify novel anticoagulant therapies that balance efficacy and safety, offering new hope for improved therapeutic options.Now turning our attention to Johnson & Johnson's recent setback with their anti-tau antibody posdinemab in a phase 2 trial targeting Alzheimer's disease. The trial was unable to demonstrate a significant slowing of clinical decline, leading JSupport the show
In this episode, Duane Mancini interviews Allison Komiyama, a former FDA reviewer turned successful entrepreneur, who shares her journey from her early passion for biology, through her academic achievements in molecular cell biology and neuroscience, to landing a role at the FDA. She recounts the challenges and lessons learned starting her own regulatory consulting business and scaling it to a successful acquisition. The conversation delves into her latest venture, Bluestocking Health, a medtech hype company aimed at educating the public and professionals about medical technology. They discuss the importance of understanding the FDA's role, navigating the complexities of bringing new tech to market, and the significance of promoting and celebrating medtech innovations.Allison Komiyama LinkedInBluestocking Health LinkedInBluestocking Health Website“Your Life Depends on It” Book by Talya Miron-Shatz, PhDDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn
Chris DuPont, a seasoned MedTech engineer, entrepreneur, and co-founder of Galen Data, which was acquired by Matrix One in late 2024. With a background in aerospace software from NASA and a career dedicated to medical device connectivity, Chris shares a rare behind-the-scenes look at starting a cloud platform with just $600, scaling it into an FDA compliant infrastructure solution and navigating both technical and financial risk.In this episode, we dive into the unexpected similarities between outer space and inner space, how “Twiddler Syndrome” inspired a connected care solution and why the future of SaMD relies on proactive, cybersecure, cloud native design. Chris opens up about managing through the SVB collapse, regulatory war stories from his days at Cyberonics, and what he learned about entrepreneurship that no incubator can teach. From minimal viable features to medical-grade quality systems, this episode is packed with real lessons from a founder who's seen it all.Timestamps[00:01:05] From Space Station Freedom to Inner Space: NASA to MedTech[00:02:56] Launching Galen Data with Just $600[00:06:21] Why They Built Their Own Incubator[00:08:36] Fundraising in a Non-VC Town (Houston)[00:11:33] The Silicon Valley Bank Collapse and Business Risk[00:16:25] Twiddler Syndrome and the Birth of a Connected Platform[00:19:35] Cybersecurity and Compliance in the Cloud[00:22:20] FDA Approval Without Reimbursement: A Regulatory War Story[00:24:32] Why Not Every Feature Deserves to Ship[00:29:13] “You Can't Fake Science”: Betting on Yourself in MedTechConnect with Chris - https://www.linkedin.com/in/chris-dupont-38b5ba15/Learn more about MatrixOne - https://matrixone.health/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwalSubscribe to the Podcast
It's raining RACs. And many other third party auditors. It seems like every submission of medical records is being scrutinized for omission and commission. Then enter artificial intelligence (AI). The use of AI in auditing, although relatively new, is here to stay.How is your facility faring compared to your peers? More audits? Less auditing? More denied claims? More money being recouped?Now you can see for yourself how you're doing comparing to others. Thanks to the annual benchmark study performed by MDaudit and shared here on Monitor Monday, you will be able to judge for yourself.During the next live edition of the long-running Internet broadcast, Ritesh Ramesh, CEO for MDaudit, will share the findings of his company's annual 2025 Benchmark study.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.
“They expect us to be perfect.”That's how Dr. Jamie Grifo, Chief Executive Physician of the Inception/Prelude Network, describes the expectations placed on reproductive endocrinologists from patients, payors, and policymakers alike.And while perfection may be impossible, preparation and partnership aren't.He discusses:– Why NYU Langone has three in-house genetic counselors in their REI department– How they counseled over 700 new patients last year– What led to 300 PGT-M cycles out of 5,500 retrievals– The challenges of sharing counselors across a growing network– Regulatory complexities from state and federal oversight– Why some REIs may be missing key opportunities to help patients with mosaic embryos
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In this episode, Brenna T. Loufek, Director of AI Regulatory and Quality at Mayo Clinic, discusses how the organization safely translates AI innovations into clinical practice. She explains governance frameworks, ethical considerations, and strategies for deploying AI tools to support both administrative efficiency and clinical decision-making while maintaining trust and patient safety. - The views expressed are Brenna's personal views, and do not necessarily reflect the policy or position of Mayo Clinic.
Over subsequent Parliaments, ACT has tried to pass a version of the Regulatory Standards Bill — with limited success, until now. Deputy Prime Minister and Regulation Minister David Seymour explains how he thinks the bill will work. Q+A questions him about his selection of principles, whether the Government follows its own ideas of good regulation, and some legal uncertainties created by the bill. . As Associate Education Minister, Seymour is leading work on setting up charter schools. But the demand for state schools to undergo conversion to charter has been lower than expected. Jack Tame asks Seymour why. . Join Jack Tame and the Q+A team and find the answers to the questions that matter. Made with the support of NZ on Air.
Mining Stock Daily welcomes Jon Cherry, CEO of Perpetua Resources, to discuss the strategically important Stibnite Gold Project in Idaho. Stibnite is advancing as a critical mineral supplier while simultaneously committing to the responsible restoration of a long-neglected mining district. The project holds the United States' only SK 1300 published reserve of antimony, a critical mineral the U.S. currently relies on from foreign sources. Antimony is vital for national defense, as the Stibnite project is expected to supply about 35% of the U.S. demand, including crucial antimony trisulfide for military munitions. Cherry details the project's recent milestones, including receiving the federal record of decision and the final 404 wetlands permit, allowing the company to break ground on construction about a month ago. The CEO unpacks the monumental $255 million financing package, featuring investments from Agnico Eagle and JP Morgan Chase, highlighting that Perpetua was the inaugural recipient of the latter's Strategic Resilience Initiative funding. The discussion also covers the current lack of downstream processing capacity in the U.S. for the antimony concentrate and ongoing exploration efforts targeting gold, antimony, and tungsten. This episode of Mining Stock Daily is brought to you by... Revival Gold is one of the largest pure gold mine developer operating in the United States. The Company is advancing the Mercur Gold Project in Utah and mine permitting preparations and ongoing exploration at the Beartrack-Arnett Gold Project located in Idaho. Revival Gold is listed on the TSX Venture Exchange under the ticker symbol “RVG” and trades on the OTCQX Market under the ticker symbol “RVLGF”. Learn more about the company at revival-dash-gold.comVizsla Silver is focused on becoming one of the world's largest single-asset silver producers through the exploration and development of the 100% owned Panuco-Copala silver-gold district in Sinaloa, Mexico. The company consolidated this historic district in 2019 and has now completed over 325,000 meters of drilling. The company has the world's largest, undeveloped high-grade silver resource. Learn more at https://vizslasilvercorp.com/Equinox has recently completed the business combination with Calibre Mining to create an Americas-focused diversified gold producer with a portfolio of mines in five countries, anchored by two high-profile, long-life Canadian gold mines, Greenstone and Valentine. Learn more about the business and its operations at equinoxgold.com Integra Resources is a growing precious metals producer in the Great Basin of the Western United States. Integra is focused on demonstrating profitability and operational excellence at its principal operating asset, the Florida Canyon Mine, located in Nevada. In addition, Integra is committed to advancing its flagship development-stage heap leach projects: the past producing DeLamar Project located in southwestern Idaho, and the Nevada North Project located in western Nevada. Learn more about the business and their high industry standards over at integraresources.com
Rapid advances in drone technology are reshaping construction, from jobsite safety and progress tracking to automation and AI-powered insights. And with the FAA's newly proposed Part 108 rule for Beyond Visual Line of Sight (BVLOS) operations, the industry may soon see its biggest leap yet. In this episode of ConstructorCast, host Max Nelson sits down with: Spencer Phillips, Counsel, Regulatory and Litigation Advocacy AGC of America | https://www.agc.org/ Grant Hagen, Head of Community DroneDeploy | https://www.dronedeploy.com/ Together, they break down what contractors need to know about the proposed rule, including: How BVLOS operations differ from the current Part 107 limitations What “airworthiness acceptance” means and how it could impact the drone market How contractors would certify their drone programs, not just individual pilots The shift toward autonomous and remote piloting The opportunities and risks as drones integrate into the national airspace The timeline for FAA rulemaking and how contractors can engage in the process Whether your firm is already using drones or just considering what's next, this conversation helps demystify the regulatory landscape and paints a clear picture of what the future of drone usage in construction may look like. Resources: 2026 Construction Hiring and Business Outlook Survey: https://www.surveymonkey.com/r/7VFSFT2 AGC's Comments on FAA 108: https://news.agc.org/wp-content/uploads/2025/10/FAA-2025-1908-2836_attachment_1.pdf Article Overview on AGC News: https://news.agc.org/advocacy/faa-moves-to-allow-for-expanded-usage-of-drones/ The 2025 AI Resource Guide for Construction Professionals: https://www.agc.org/system/files?file=Files/TechHub/2025%20AI%20Resource%20Guide%20for%20Construction%20Professionals%20%28Final%29.pdf DroneDeploy's Built Different Podcast: https://podcasts.apple.com/us/podcast/built-different/id1620061125
With the federal government back up and running, NPC CEO Kam Quarles and COO Mike Wenkel called into the Eye on Potatoes podcast this week to discuss the National Potato Council's top priorities for the next two months and provide updates on key labor and environmental regulatory efforts. Join us as we take a deep dive into: Congressional priorities now that the government is reopened; key recommendations of the Specialty Crop Farm Bill Alliance for the new Farm Bill; the outlook and critical deadlines for emergency relief programs for growers; and top legislative and appropriations priorities, including securing funding for research and market development.Mike will also provide updates on the regulatory environment, covering: the potential impacts of the Department of Labor's new two-level wage structure for the H-2A program; and the benefits of the new EPA WOTUS proposal, specifically the clarity on excluding certain ditches.
The coalition is in the throes of internal warfare - with Winston Peters and David Seymour slinging barbs over the Regulatory Standards Bill. In a stunning about-face today, Mr Peters has pledged to revoke that law - ACT's brainchild - next term - despite voting it through last week. It has prompted an extraordinary rebuke from David Seymour - who says Mr Peters looks like he's gearing up to jump ship to a Labour coalition. Acting political editor Craig McCulloch spoke to Lisa Owen.
Winston Peters says the Coalition is doing just fine after his change of position on ACT's Regulatory Standards Bill. The NZ First Leader says next year he will campaign on getting rid of the legislation, despite supporting it just last week. ACT Leader David Seymour finds that worrying. But Peters told Mike Hosking he rejects any claim the Coalition is crumbling. He says their number one responsibility is providing a stable Government, which it is doing. LISTEN ABOVE See omnystudio.com/listener for privacy information.
Today, we're hopping back into the archive and revisiting an episode with Gerard Barron, the co-founder, CEO, and chairman of The Metals Company, who joined us to discuss the company's plans to harvest critical metals off the sea floor. Summary:The Trump administration has made American reindustrialization a top priority, but to do that, the US is going to need access to an abundance of metals like copper, manganese and nickel. The challenge then is to find a way to source these materials that doesn't rely on Chinese supply chains, and won't lead to serious environmental harm.Gerard Barron is the co-founder, CEO and chairman of The Metals Company, which trades on the Nasdaq under the symbol TMC. The Metals Company mission is to harvest and process metal-containing nodules from the sea floor, providing a clean and abundant source of raw materials for an array of critical industries, like steelmaking and EV production. Gerard walks us through the evolution of TMC, their groundbreaking tech, and some recent regulatory breakthroughs that have brought them closer to achieving their goals than ever before.Highlights:The Metals Company Mission (2:07)The history of seabed harvesting (3:43)Land-based supply chains (7:17)TMC's tech (10:44)Regulatory roadblocks (12:28)Defense implications (15:51)EVs (17:37)Korea Zinc deal (19:41)Looking ahead (21:34)PE Involvement (24:22) Links:Gerard's LinkedInThe Metals Company LinkedInThe Metals Company WebsiteICR LinkedInICR TwitterICR Website Feedback:If you have questions about the show, or have a topic in mind you'd like discussed in future episodes, email our producer, Joe@lowerstreet.co.
In this episode of Unlocking Innovation: A National Call to Action, the spotlight turns to one of the most persistent themes raised during the BioEnterprise-hosted national roundtables: Canada’s regulatory system, and the growing concern that its slow, complex processes are holding back agri-food innovation. For this episode of the podcast series, host Shaun Haney is... Read More
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Kaitlin Maier, co-founder and CEO of Reia. Reia has developed a self-managed pessary — a collapsible device that empowers women to treat pelvic organ prolapse comfortably and independently. A mechanical engineering graduate of Dartmouth, Kaitlin previously worked at Sherpa Technology Group, developing patent strategies for leading life science and technology firms. In this conversation, Kaitlin shares how she and her co-founders turned a student project into an FDA-cleared product using resource constraints as a design advantage. She explains how to turn FDA feedback into forward momentum, why running an NIH-funded randomized controlled trial (RCT) strengthened both credibility and confidence, and how non-dilutive funding can buy the time and control founders need to build on their own terms.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 Kaitlin Maier.
Recently, the controversial Regulatory Standards Bill passed its third and final reading. The bill has raised concerns amongst many for a variety of reasons, including its lack of recognition of Te Tiriti o Waitangi, the risks it poses to the environment, and what opponents say is its ‘narrow neoliberal framework'. The bill, during public submissions, received 156,000 submissions, with over 98% voicing their opposition to the proposed legislation. News and Editorial Director Joel spoke to Geoffrey Bertram, a visiting scholar and retired lecturer at the Victoria University of Wellington about the bill, why it is so polarising, and what the passing of this bill means heading forward.
In this episode, our host sits down with Gary Plant, PeerNova's Valuation Risk Leader and Subject Matter Expert (SME), to explore what true regulatory readiness looks like in today's fast-moving valuation risk landscape. Uncover why traditional monthly or quarterly IPV cycles no longer meet regulatory expectations, how fragmented infrastructures slow firms down, and why valuation teams need more transparent, agile, and scalable controls to keep pace.Learn how Cuneiform® for Valuation Risk helps firms modernize IPV, achieve real-time oversight, reduce human middleware, and deliver audit-ready transparency across the valuation lifecycle.Gary answers the following questions:What are the biggest challenges firms face in achieving regulatory readiness for valuation risk? How are regulators pushing firms toward daily (or real-time) valuation oversight?What structural and operational barriers prevent modernization?Why do firms need a single, strategic solution to meet increasing demands and reduce manual processes?How does Cuneiform® for Valuation Risk address these challenges with real-time execution, transparency, and compliance alignment?
The Centers for Medicare & Medicaid Services (CMS) recently released the 2026 Medicare Physician Fee Schedule. And while that's not breaking news, the important news is that you and your team could benefit by understanding its hidden traps – so you can protect your revenue. During the next live edition of Monitor Monday, senior healthcare analyst Frank Cohen will reveal the latest developments in Medicare audit reforms and statistical extrapolation, including the Medicare Program Integrity Manuel (MPIM) standards, plus how artificial intelligence (AI) is changing audit selection for 2025.You and your team will receive expert analysis and practical guidance, as well as gain a better understanding of the true scope of improper payments.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 healthcare legislative affairs analyst for Zelis, will report on the news happening at the intersection of healthcare and congressional action.
In this conversation, Stephan Livera and Carel Van Wyk discuss the evolution of Bitcoin as a medium of exchange, focusing on the role of MoneyBadger in facilitating Bitcoin payments across South Africa. They explore the journey of integrating Bitcoin payments into major retailers, the technological innovations that have made this possible, and the implications for merchants and consumers alike. The discussion also touches on the broader context of Bitcoin's role in the global payment landscape and the ongoing debate about its function as a store of value versus a medium of exchange. They explore the economic challenges faced by South Africans, the regulatory landscape, and the importance of demonstrating Bitcoin as a medium of exchange. The discussion also touches on the implications of capital gains tax, the strategies for promoting Bitcoin adoption, and the potential for Bitcoin to serve as a viable alternative to traditional payment systems. Carel emphasizes the urgency of using Bitcoin as money and the need for a shift in mindset among both consumers and regulators.Takeaways: