Podcasts about Regulatory compliance

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Let's dive into the latest happenings shaping the landscape of this dynamic industry. The pharmaceutical and biotech sectors are navigating a complex landscape replete with scientific advancements and regulatory challenges. A significant legal development comes from Takeda, which faces an $885 million verdict in a landmark pay-for-delay antitrust case. This ruling highlights the intense scrutiny of pharmaceutical companies over antitrust regulations, with potential implications for drug pricing strategies and industry practices. The possibility of tripling damages under these laws could set a precedent affecting future business operations, as Takeda plans to appeal, underscoring the high stakes involved in such litigation. Meanwhile, on the regulatory front, the White House's decision to include 600 generic medications in the TrumpRx purchasing portal marks a strategic effort to improve drug affordability. While its overall impact remains uncertain, this initiative aims to bridge gaps in medication accessibility for cost-sensitive populations. Similarly, Roche's licensing agreement with the Medicines Patent Pool to allow generic versions of Xofluza in 129 developing countries is a noteworthy step towards enhancing global access to essential medicines. These efforts underscore ongoing attempts to address affordability and accessibility concerns on a global scale. In clinical developments, UCB's Bimzelx has shown promising results against AbbVie's Skyrizi in treating psoriatic arthritis, demonstrating a statistically significant reduction in disease activity compared to Skyrizi in a Phase 3b trial. With nearly half of the patients showing improved outcomes at week 16, Bimzelx is poised to become a competitive therapeutic option, potentially redefining treatment protocols for psoriatic arthritis. Novartis's termination of its contract with Chinese CDMO Porton Pharma Solutions due to regulatory issues underscores the challenges inherent in cross-border pharmaceutical partnerships. The $64 million legal claims looming over this decision highlight the financial and operational risks associated with international collaborations. Meanwhile, biopharmaceutical buyers are increasingly turning to artificial intelligence and local expertise to navigate rising licensing costs in China. Sanofi and Wave Life Sciences are making progress in addressing α1-antitrypsin deficiency (AATD), a genetic disorder that has witnessed limited therapeutic innovation for decades. Their efforts were highlighted at the American Thoracic Society meeting, showcasing ongoing attempts to bridge treatment gaps for rare diseases through next-generation approaches. Strategic investments continue to shape the industry, as evidenced by Lauxera Capital Partners' successful EUR520 million fundraising aimed at advancing healthcare technologies. Additionally, Merck's agreement to supply Keytruda for Exelixis' colorectal cancer trial exemplifies collaborative efforts crucial for advancing cancer research. These developments reflect an industry balancing innovation with regulatory compliance and market dynamics. Scientific progress is also evident in Relay Therapeutics' advancement with its PI3K inhibitor, which has shown promising Phase 2 data in treating blood vessel disorders. This underscores the potential of PI3K inhibitors to address unmet medical needs by targeting pathways significant in cancer and other diseases. The integration of artificial intelligence into drug discovery processes is another critical trend. Incyte's collaboration with Edison Scientific aims to enhance decision-making and streamline drug discovery, showcasing AI's potential to revolutionize R&D efficiency. However, persistent challenges remain as AI scales up but doesn't yet resolve clinical trial protocol issues fully. On the business front, Bristol Myers Squibb considers investing $1 billion in a Houston manufacturing plant, emphasizing strategic infrastructure investments crucial for meeting growing pharmaceutical demands. In drug approvals, AstraZeneca's Baxfendy has received FDA approval for treating uncontrolled hypertension by targeting aldosterone synthesis—offering a novel approach as a combination therapy. Moreover, Merck & Co.'s sacituzumab tirumotecan has achieved Phase 3 success in endometrial cancer trials, demonstrating superior survival outcomes compared to chemotherapy. This highlights the growing impact of targeted therapies in oncology and the ongoing shift towards precision medicine. Despite these positive developments, challenges persist. BioMarin Pharmaceutical's BMN 401 faced setbacks after missing key Phase 3 endpoints for skeletal healing in ENPP1 deficiency patients—highlighting complexities in rare disease drug development. In conclusion, these diverse developments reflect an industry steadfastly committed to advancing healthcare through scientific innovation while navigating regulatory hurdles and operational challenges. As these sectors evolve further, maintaining a balance between rapid innovation and rigorous oversight remains essential to ensuring impactful treatments reach patients worldwide promptly. Thank you for tuning in to Pharma Daily—stay informed and stay ahead of industry trends with us tomorrow!Support the show

Earn 1.0 CPD here: https://quiz.ensombl.com/CPDC-26052000-02030001 0.25 Professionalism and Ethics 0.25 Client Care & Practice 0.25 Technical Competence 0.25 Regulatory Compliance and Consumer Protection In this episode, Ben is joined by Niall McConville, Managing Director at Bombora Advice. They unpack how regulation, product design, mental health claims, and pricing pressures are reshaping the Australian and New Zealand life insurance markets, and how advisers, licensees, group cover, and AI can work together to protect more clients sustainably. Niall McConville LinkedIn: https://www.linkedin.com/in/niall-mcconville/ Bombora Website: https://bomboraadvice.com.au/ PFAN Website: https://www.probonoadvice.com.au/ Visit The Adviser Portal and partner with Zurich and OnePath today: https://ensombl.com/go/20260521-2/ General Disclaimer – https://www.ensombl.com/disclaimer/

Earn 1.0 CPD here: https://quiz.ensombl.com/CPDC-26051801-36300001 0.25 Technical Competence 0.25 Client Care and Practice 0.25 Regulatory Compliance & Consumer Protection 0.25 Professionalism and Ethics In this episode, Rocksy speaks with Craig Kouimanis, Head of Paragem. They unpack how Count helps advice firms grow through licensing support, M&A and equity partnerships, technology and client engagement frameworks, succession planning, and practice management disciplines - all while balancing governance, profitability, and high‑quality client service. Craig Kouimanis LinkedIn: https://www.linkedin.com/in/craig-kouimanis-a6815531/ Count Website: https://www.count.au/ Paragem Website: https://paragem.com.au/ UncommonCents Podcast: https://podcasts.apple.com/au/podcast/uncommoncents/id1823576529 Explore the road less travelled at https://ensombl.com/go/20260519-2/ General Disclaimer – https://www.ensombl.com/disclaimer/

Earn 1.0 CPD here: https://quiz.ensombl.com/CPDC-26051100-30200001 0.25 Client Care & Practice 0.25 Technical Competence 0.25 Regulatory Compliance and Consumer Protection 0.25 Professionalism and Ethics In this episode, Rocksy is joined by Stuart Jones, Managing Director, Senior Financial Planner and Mortgage Broker at Michael Roach Financial Solutions. They discuss his journey from accounting to advice, how the firm evolved from low-cost super and insurance consolidation into a growing, tech-enabled financial planning and mortgage broking business, and the practical realities of pricing, team structure (including offshore support), client relationships, and preparing the practice for sustainable future growth. Stuart Jones LinkedIn: https://www.linkedin.com/in/stuart-jones-872ba334/ Michael Roach Financial Solutions Website: https://michaelroach.com.au/ General Disclaimer – https://www.ensombl.com/disclaimer/

The Institute of Internal Auditors Presents: All Things Internal Audit In this episode, Pam Strobel Powers and Mark Maraccini discuss The IIA's recently updated Global Practice Guide Auditing Procurement in the Public Sector. They walk through the three pillars that make public sector procurement unique, explain how to distinguish a vendor from a subrecipient, and share why fraud risk in procurement deserves its own lane in your audit approach. *Members Save in May* Members can save 20% on CIA, CRMA, and IAP application and exam fees throughout May. Becker, the official CIA exam review partner of The IIA, is also offering up to 20% off CIA exam prep and $50 off IAP prep. Use the code May20% and access the offer here. HOST: Pamela Stroebel Powers, CIA, CGAP, CRMA, CPADirector of Professional Guidance, Public Sector, The IIA GUEST: Mark Maraccini, CIA, CPA Partner, Crowe LLP Member, International Internal Audit Standards Board     KEY POINTS: Introduction [00:00:02 - 00:00:30] What Makes Public Sector Procurement Unique [00:01:07 - 00:04:16] Transparency in Procurement [00:01:37 - 00:02:42] Fairness and Equity in Procurement [00:02:42 - 00:03:31] Legal and Regulatory Compliance [00:03:31 - 00:04:16] Vendor vs. Subrecipient: Key Differences [00:05:24 - 00:08:44] Applying the Procurement Lifecycle [00:09:34 - 00:10:54] Using Risk and Control Matrices [00:11:23 - 00:12:54] Manual vs. Technology-Driven Risk Assessment [00:11:48 - 00:12:33] Fraud Risk in Procurement [00:13:24 - 00:15:31] Equity and Supplier Diversity Programs [00:17:49 - 00:20:11] Auditing Program Effectiveness vs. Compliance [00:20:47 - 00:21:28] Final Thoughts [00:21:28 - 00:21:50] IIA RELATED CONTENT:  Interested in this topic? Visit the links below for more resources: Global Practice Guide: Auditing Procurement in the Public Sector, 2nd Edition Audit Tool: Procurement Risks and Controls for the Public Sector Examples Third-Party Topical Requirement Global Internal Audit Standards Knowledge Centers: Public Sector Certifications May Sale Visit The IIA's website or YouTube channel for related topics and more. Follow All Things Internal Audit: Apple Podcasts Spotify Libsyn Deezer

Earn 1.0 CPD here: https://quiz.ensombl.com/CPDC-26050401-06290001 0.25 Client Care & Practice 0.25 Technical Competence 0.25 Regulatory Compliance and Consumer Protection 0.25 Professionalism and Ethics In this episode, Rocksy is joined by Kara Treeby and Sarah Leslie from Story Wealth. They share how they built and evolved Story Wealth and Ageing with Grace into a specialist, intergenerational and aged‑care focused advice business, while navigating the GFC, raising families, structuring their partnership, and using process, tech, and deep empathy to support clients and their advisers through complex later‑life decisions. Kara Treeby LinkedIn: https://www.linkedin.com/in/kara-treeby/ Sarah Leslie LinkedIn: https://www.linkedin.com/in/sarah-leslie/ Story Wealth Website: https://storywealth.com.au/ Ageing with Grace Website: https://ageingwithgraceadvisory.com.au/ General Disclaimer – https://www.ensombl.com/disclaimer/

In this episode of Disruption/Interruption, host KJ sits down with Ome Ogbru, PharmD, CEO and founder of AINGENS, to tackle a decades-old problem hiding in plain sight: life sciences runs on groundbreaking science, but is buried in broken processes. After 20+ years as a clinician, professor, and pharmaceutical executive, Ome reached a breaking point, and instead of finding a new job, he built a new company. He shares how generative AI, used responsibly and strategically, can finally give researchers their time back, cut through misinformation, and help the right information reach the right people faster. Four Key Takeaways: The scientific content workflow is fundamentally broken [4:15] -- Research teams are so resource-strapped that PhDs spend their time managing IT systems instead of doing science. Procuring a software solution could take one to two years and often didn't even solve the right problem. Generative AI isn't the magic wand, it's how you use it [20:01] -- When Ome first tested ChatGPT on biotech content and got poor results, he had a revelation: the tool wasn't the problem. The problem was not knowing how to use it. Pairing AI with deep domain expertise and proper workflows is where the real power lies. The human expert must remain in the driver's seat [32:30] -- AINGENS' platform (MACG) is built so the professional is in control. The AI handles the time-consuming, mundane tasks like literature search, drafting, and formatting, while the expert applies regulatory knowledge, judgment, and guardrails. Misinformation in life sciences is a public health problem [35:49] -- Misinformation travels faster than accurate data. Ome's vision is for generative AI to help industry proactively get accurate, personalized scientific information to the people who need it, patients, clinicians, and researchers alike, before the noise wins. Quote of the Show (35:41):"Misinformation flies faster than correct information." -- Ome Ogbru Join our Anti-PR newsletter where we’re keeping a watchful and clever eye on PR trends, PR fails, and interesting news in tech so you don't have to. You're welcome. Want PR that actually matters? Get 30 minutes of expert advice in a fast-paced, zero-nonsense session from Karla Jo Helms, a veteran Crisis PR and Anti-PR Strategist who knows how to tell your story in the best possible light and get the exposure you need to disrupt your industry. Click here to book your call: https://info.jotopr.com/free-anti-pr-eval Ways to connect with Ome Ogbru:LinkedIn: https://www.linkedin.com/in/ome-ogbru-pharmd/Company Website: http://www.aingens.com How to get more Disruption/Interruption: Amazon Music - https://music.amazon.com/podcasts/eccda84d-4d5b-4c52-ba54-7fd8af3cbe87/disruption-interruption Apple Podcast - https://podcasts.apple.com/us/podcast/disruption-interruption/id1581985755 Spotify - https://open.spotify.com/show/6yGSwcSp8J354awJkCmJlDSee omnystudio.com/listener for privacy information.

How will artificial intelligence transform the most human parts of wealth management? In this episode, we explore where technology meets empathy, and what the future looks like for financial professionals and their clients as AI adoption accelerates across the industry. Our guest, Carrie Nelson, is the founder of Atlas Point and a veteran leader with experience at Ernst & Young, Experian, and Edward Jones. Carrie shares her journey from big-firm consulting to building a platform that empowers advisors to navigate a rapidly changing landscape, with a focus on the coming great wealth transfer and the next generation of clients. Together, we discuss why human connection is still essential—even as AI creates new efficiencies—and how Atlas Point blends behavioral science and smart tools to bridge the gap. For anyone interested in the future of finance, entrepreneurship, or the emotional side of money, this is a must-listen episode filled with real-world stories and actionable insights.   To get the latest from Carrie Nelson, you can follow her below! https://www.linkedin.com/in/carrie-nelson-5377864/ https://www.theatlaspoint.com/   Sign up for Marcia's newsletter to receive tips and the latest on Angel Investing! Website: www.marciadawood.com Do Good While Doing Well Learn more about the documentary Show Her the Money: www.showherthemoneymovie.com And don't forget to follow us wherever you are! Apple Podcasts: https://pod.link/1586445642.apple Spotify: https://pod.link/1586445642.spotify LinkedIn: https://www.linkedin.com/company/angel-next-door-podcast/ Instagram: https://www.instagram.com/theangelnextdoorpodcast/ Pinterest: https://www.pinterest.com/theangelnextdoorpodcast/ TikTok: https://www.tiktok.com/@marciadawood

Earn 0.75 CPD here: https://quiz.ensombl.com/CPDC-26042323-55000001 0.25 Client Care & Practice 0.25 Technical Competence 0.25 Regulatory Compliance and Consumer Protection In this episode, Ben is joined by Jack Standing, Group Head of Advice at WT Financial Group. They discuss WT's growth from a single practice to a large advice network, and how it leverages scale, education, technology, and evolving adviser training and remuneration models to improve the quality, efficiency, and commercial viability of life insurance advice and claims support. Jack Standing LinkedIn: https://www.linkedin.com/in/jack-standing-35b52373/ WT Financial Group Website: https://www.wtfglimited.com/ Visit The Adviser Portal and partner with Zurich and OnePath today: https://ensombl.com/go/20260427-2/ General Disclaimer – https://www.ensombl.com/disclaimer/

Earn 0.75 CPD here: https://quiz.ensombl.com/CPDC-26041623-54090001 0.25 Regulatory Compliance and Consumer Protection 0.25 Client Care & Practice 0.25 Technical Competence As longevity increases and retirement decisions grow more complex, host Amie Baker is joined by Ben Hillier (AMP North) and Liz Haile (Haile Financial) to explore new approaches to structuring income in retirement. They unpack the IRIS framework as a flexible alternative to traditional pensions and annuities - designed to improve spending confidence, optimise Centrelink outcomes, and support lifetime income without sacrificing investment flexibility. With practical strategies spanning accumulation through to retirement, this episode highlights how advisers can better balance adequacy, longevity, and client outcomes in a changing retirement landscape. Liz Haile LinkedIn: https://www.linkedin.com/in/liz-haile-490a6941/ Haile Financial Website: https://www.hailefinancial.com.au/ Ben Hillier LinkedIn: https://www.linkedin.com/in/ben-hillier-au/ Amie Baker LinkedIn: https://www.linkedin.com/in/amie-baker-10975828/ Grow with North. https://ensombl.com/go/20260420-2/ General Disclaimer – https://www.ensombl.com/disclaimer/

In this episode of The Bookkeepers Podcast, sponsored by Xero, we discuss whether starting a new bookkeeper practice is a sound decision given the current industry trends. We also explore the impact of artificial intelligence on the profession and share our thoughts on the future of work in bookkeeping. This conversation is essential for anyone considering a small business in this evolving field. ----------------------------------------------- About us We're Jo and Zoe and we help bookkeepers find clients, make more money and build profitable businesses they love. Find out about working with us in The Bookkeepers' Collective, at: 6figurebookkeeper.com/collective ----------------------------------------------- About our Sponsor This episode of The Bookkeepers' Podcast is sponsored by Xero. Get 90% off your first 6 months by visiting: https://xero5440.partnerlinks.io/6figurebookkeeper ----------------------------------------------- Promotion This video contains paid promotion. ----------------------------------------------- Disclaimer The information contained in The Bookkeepers' Podcast is provided for information purposes only. The contents of The Bookkeepers' Podcast is not intended to amount to advice and you should not rely on any of the contents of the Bookkeepers' Podcast. Professional advice should be obtained before taking or refraining from taking any action as a result of the contents of the Bookkeepers' Podcast. The 6 Figure Bookkeeper Ltd disclaims all liability and responsibility arising from any reliance placed on any of the contents of the Bookkeepers' Podcast. Chapters: 00:00:00 - Introduction 00:00:15 - Challenges and Opportunities in Starting a Bookkeeping Practice 00:00:22 - The Impact of AI on the Industry 00:00:47 - The Importance of Mindset and Curiosity 00:01:30 - The Changing Nature of the Industry 00:02:50 - The Importance of Continuous Learning 00:03:39 - The Future of Bookkeeping: Helping Clients Make Money 00:03:50 - Redefining the Role of Bookkeepers 00:04:19 - The Importance of Value in Pricing 00:06:32 - Challenges in Adapting to New Pricing Models 00:11:28 - The Need for a Growth Mindset 00:11:47 - Building a Bookkeeping Business Today 00:15:05 - The Role of AI in Enhancing Client Interaction 00:15:35 - The Importance of Understanding Client Needs 00:16:20 - The Potential of AI in Streamlining Workflow 00:17:31 - The Value of a Unique Business Model 00:19:09 - The Importance of Regulatory Compliance in Starting a Practice 00:19:27 - The Bookkeepers Collective and its Benefits 00:21:56 - The Impact of AI on Business Strategy 00:24:48 - The Evolution of Information Sharing and the Role of AI 00:28:07 - The Excitement of Building a Practice with AI #bookkeeper

Donal Bourke, Managing Director at Eleco Asset Management, a company that is focused on software to help organizations manage physical assets and maintenance operations joins … Read more The post Regulatory Compliance Is Not a Technical Issue. It's a Leadership One. appeared first on Top Entrepreneurs Podcast | Enterprise Podcast Network.

Earn 0.75 CPD here: https://quiz.ensombl.com/CPDC-26041601-47180001 0.25 Technical Competence 0.25 Regulatory Compliance and Consumer Protection 0.25 Client Care and Practice This week, Pat speaks with Colin Jowell, Founder at BillWill. They discuss how BillWill, founded from Colin's personal experience with his father's estate, helps advisers bridge the gap between wills and clients' real lives by providing a white‑label, tech-enabled estate planning and legacy service that leverages open banking, strong security, and emerging AI tools to better support families before and after death. Colin Jowell LinkedIn: https://www.linkedin.com/in/colinjowell/ BillWill Website: https://billwill.com.au/ Discover a world of client engagement: https://ensombl.com/go/20260417-2/ General Disclaimer – https://www.ensombl.com/disclaimer/

Earn 0.75 CPD here: https://quiz.ensombl.com/CPDC-26041001-14430001 0.25 Client Care & Practice 0.25 Technical Competence 0.25 Regulatory Compliance and Consumer Protection In this episode, Sacha is joined by Sacha Burchgart, Founder and Managing Director at Burcheart, and Vincent Holland, Co-Founder at Plutosoft. They discuss how advice firms should move beyond the “all-in-one vs tech stack” debate by using a single core advice/CRM platform as the engine of the business, supported by targeted integrations, strong data integrity, and thoughtful change management driven by the team. Sacha Burchgart LinkedIn: https://www.linkedin.com/in/sacha-burchgart-42587939/ Burcheart Website: https://www.burcheart.com.au/ Vincent Holland LinkedIn: https://www.linkedin.com/in/vincent-holland-6b50ab62/ To see how Plutosoft can transform your practice, book a demo: https://ensombl.com/go/20260415-2/ General Disclaimer – https://www.ensombl.com/disclaimer/

Earn 0.75 CPD here: https://quiz.ensombl.com/CPDC-26040923-30460001 0.25 Regulatory Compliance and Consumer Protection 0.25 Client Care & Practice 0.25 Technical Competence As portfolios become increasingly concentrated beneath the surface, host James Whelan is joined by Eric Marais (Orbis Investments) to challenge what genuine diversification really means. They unpack how passive indices and many active funds are heavily exposed to US mega-cap, tech-driven growth themes, creating hidden risks if leadership shifts. Drawing on history and current valuation extremes, the discussion highlights opportunities beyond the obvious—including mid-caps, healthcare, and international markets—while stressing diversification across style, geography, and currency. With a focus on preparation over prediction, this episode helps advisers build portfolios resilient to a wider range of outcomes. Eric Marais LinkedIn: https://www.linkedin.com/in/eric-marais/ Rethinking Genuine Diversification Whitepaper: https://lnkd.in/emQtYVhe Orbis Investments Disclaimer: https://ensombl.com/orbisdisclaimer/ James Whelan LinkedIn: https://www.linkedin.com/in/james-whelan-68146036/ Prepare your clients for a new investing dawn. Discover more: https://ensombl.com/go/20260413-2/ General Disclaimer – https://www.ensombl.com/disclaimer/

Earn 0.75 CPD here: https://quiz.ensombl.com/CPDC-26040901-32320001 0.25 Technical Competence 0.25 Regulatory Compliance and Consumer Protection 0.25 Client Care and Practice In this episode, Patrick speaks with Daniel Donovan, Founder at Alpine Advisory. They discuss how practices can more effectively scale and improve client experience by first fixing and mapping their processes, then applying automation and emerging AI tools (like Claude, Copilot, and Cowork) in targeted, deterministic ways rather than simply hiring more staff or chasing new software. Daniel Donovan LinkedIn: https://www.linkedin.com/in/danieldonovan09/ Alpine Advisory Website: https://www.alpineadvisory.ai/ Discover a world of client engagement: https://ensombl.com/go/20260410-2/ General Disclaimer – https://www.ensombl.com/disclaimer/

Earn 0.75 CPD here: https://quiz.ensombl.com/ENSO-26033103-18270001 0.25 Client Care & Practice 0.25 Technical Competence 0.25 Regulatory Compliance and Consumer Protection In this instalment, Tanya speaks with Harry Flaskas, Practice Principal at Atlas Wealth Advisory, and Ashton Jones, Director of Customer Innovation at MLC. They discuss how advisers can use retirement income philosophies, income layering, and innovative retirement income solutions (IRIS) alongside traditional products to manage longevity and sequencing risks, optimise Centrelink outcomes, and give clients greater confidence to spend sustainably in retirement. Harry Flaskas LinkedIn: https://www.linkedin.com/in/harry-flaskas-7123a076/ Atlas Wealth Website: https://atlaswealthadvisory.com.au/ Ashton Jones LinkedIn: https://www.linkedin.com/in/ashjones/ MLC Expand. For more information visit https://ensombl.com/go/20260401-2/ General Disclaimer – https://www.ensombl.com/disclaimer/

Earn 0.75 CPD here: https://quiz.ensombl.com/ENSO-26032704-24130001 0.25 Client Care & Practice 0.25 Technical Competence 0.25 Regulatory Compliance and Consumer Protection In this first episode, Tanya is joined by Terry Dillon, Chief Executive Officer for Shadforth, and Ashton Jones, Director of Customer Innovation at MLC. They discuss how Innovative Retirement Income Solutions (IRIS) and related strategies - such as income layering, managing longevity and sequencing risk, and leveraging age pension concessions - can help advisers design more confident, sustainable retirement income plans for Australian clients. Terry Dillon LinkedIn: https://www.linkedin.com/in/terry-dillon-697116165/ Shadforth Website: https://www.sfg.com.au/ Ashton Jones LinkedIn: https://www.linkedin.com/in/ashjones/ MLC Expand. For more information visit https://ensombl.com/go/20260401-2/ General Disclaimer – https://www.ensombl.com/disclaimer/

Earn 1.0 CPD here: https://quiz.ensombl.com/ENSO-26032923-13100001 0.25 Client Care & Practice 0.25 Technical Competence 0.25 Professionalism and Ethics 0.25 Regulatory Compliance and Consumer Protection In this episode, Rocksy speaks with Justin O'Donoghue, Head of Advice Operations and Excellence at Ironbark. They discuss regional advice, outsourcing and offshore teams, technology and AI enablement, values-based client advice, and how to scale high-quality financial planning to tens of thousands of Australian families. Justin O'Donoghue LinkedIn: https://www.linkedin.com/in/justin-o%C2%B4donoghue-25bab637/ Ironbark Website: https://www.ironbarkfg.com.au/ Otter.ai Website: https://otter.ai/ Claras Website: https://claras.ai/ General Disclaimer – https://www.ensombl.com/disclaimer/

Earn 0.75 CPD here: https://quiz.ensombl.com/ENSO-26032700-17180001 0.25 Client Care & Practice 0.25 Technical Competence 0.25 Regulatory Compliance and Consumer Protection In this episode, Ben speaks with Paul Milbourne, Business Protection and Life Insurance Specialist at Milbourne Insurance Solutions. They discuss how and why he left a large firm to build a profitable, referral-driven, risk-only advice business from scratch - covering his costs through upfront commissions, growing rapidly via ideal-client referrals and LinkedIn presence, leveraging strong systems, estate planning and claims advocacy, and emphasising mentorship, deep client relationships, and MDRT-style professional community as the foundation for sustainable growth. Paul Milbourne LinkedIn: https://www.linkedin.com/in/paulmilbourne1/ Milbourne Insurance Solutions Website: https://www.milbourne.com.au/ MDRT: https://globalconference.mdrt.org/ Marc Fabris: https://point1.com.au/ Visit The Adviser Portal and partner with Zurich and OnePath today: https://ensombl.com/go/20260330-2/ General Disclaimer – https://www.ensombl.com/disclaimer/

Earn 0.75 CPD here: https://quiz.ensombl.com/ENSO-26032602-23060001 0.25 Technical Competence 0.25 Regulatory Compliance and Consumer Protection 0.25 Client Care and Practice This week, Pat is joined by Mark Zaglas, CEO and Director at Encore Advisory Group. They explore how leadership, operating models, and AI-driven technology are reshaping advice firms through the “Big Six” trends for 2026, covering the rise of the COTO role, rebuilding sales engines, adviser mobility, evolving value propositions, emerging conflicts of interest, and the execution gap between knowing and doing. Mark Zaglas LinkedIn: https://www.linkedin.com/in/mark-zaglas/ Encore Advisory Website: https://www.encoreadvisorygroup.com.au/ Between Meetings with Matt Heine – Discover a podcast for wealth professionals: https://ensombl.com/go/20260327-2/ General Disclaimer – https://www.ensombl.com/disclaimer/

Earn 1.0 CPD here: https://quiz.ensombl.com/ENSO-26032223-39010001 0.25 Technical Competence 0.25 Client Care and Practice 0.25 Regulatory Compliance & Consumer Protection 0.25 Professionalism and Ethics In this episode, Rocksy is joined by Matt Lawler, CEO of Akumin. They discuss his journey from growing up around advice to leading Akumin's spin-out from AMP, industry reforms, growth and efficiency (including AI), adviser capacity and talent shortages, licensee myths, and Akumin's shift toward adviser-owned, nationally scaled, “freedom within a framework” advice businesses. Matt Lawler LinkedIn: https://www.linkedin.com/in/matt-lawler/ Akumin Website: https://akumin.com.au/ Explore the road less travelled at https://ensombl.com/go/20260324 General Disclaimer – https://www.ensombl.com/disclaimer/

Earn 0.75 CPD here: https://quiz.ensombl.com/ENSO-26032000-04430001 0.25 Client Care & Practice 0.25 Technical Competence 0.25 Regulatory Compliance and Consumer Protection This week, Ben is joined by Mitch Ramsbotham, Head of Growth and Strategy at Coastal Advisory Australia. They discuss how Coastal Advisory Australia has built a fast‑growing, multi‑disciplinary financial advice business with a dedicated, methodical life insurance (risk) capability at its core, using specialisation, internal referral systems, technology and acquisitions to drive scalable growth and intergenerational client relationships. Mitch Ramsbotham LinkedIn: https://www.linkedin.com/in/mitchell-ramsbotham-04122812/ Coastal Advisory Australia Website: https://coastaladvisory.com.au/ Visit The Adviser Portal and partner with Zurich and OnePath today: https://ensombl.com/go/20260323 General Disclaimer – https://www.ensombl.com/disclaimer/

In this episode of Cloud Wars Live, Bob Evans speaks with Bonnie Tinder, founder and CEO of Raven Intelligence, about the surge of hype, confusion, and opportunity surrounding AI in enterprise technology. As headlines claim AI could replace traditional software and “vibe coding” threatens SaaS vendors, Tinder brings a grounded perspective from years of advising organizations on enterprise systems like Salesforce, Workday, and SAP. Their conversation explores what AI can realistically do today, why enterprise software remains critical, and how companies can move forward without falling for hype. Episode 58: AI Hype vs. Reality The Big Themes: Why “Vibe Coding” Won't Replace ERP: The idea that AI-powered “vibe coding” could replace enterprise applications is a popular narrative, but both Evans and Tinder challenge its practicality. Even companies developing cutting-edge AI models are still relying on traditional enterprise systems. For example, Tinder notes that AI companies themselves are hiring administrators for established software platforms rather than replacing them. Leadership Must Guide AI Adoption: The discussion also emphasizes that AI adoption cannot be left solely to technology teams. According to Evans, the entire executive leadership team, especially the CEO, needs to be actively involved in defining how AI will shape the organization. AI initiatives affect workflows, job roles, data governance, and competitive strategy. Without clear leadership alignment, different departments may pursue conflicting approaches, slowing progress or introducing risk. Fear and FUD Are Slowing Progress: Ironically, the greatest threat from AI hype may be paralysis. Tinder argues that fear, uncertainty, and doubt in the market are causing many companies to delay decisions altogether. Organizations worry about choosing the wrong tools, implementing technology too early, or missing the next wave of innovation. This hesitation can prevent companies from making meaningful progress. Instead of waiting for perfect clarity, organizations should take practical steps. The Big Quote: “You can vibe code your way around [a] notion or a content system, that's way different though, than having an in-house solution for an enterprise software." More from Bonnie Tinder: Connect with Bonnie on LinkedIn. Visit Cloud Wars for more.

Key Takeaways Herain Oberoi, Microsoft's general manager for data security, privacy, and compliance, recently held a session where he outlined top security challeneges within the AI era. Specifically, Oberoi outlined three concerns enterprises must address to build secure, scalable AI operations. He stressed strict access controls and disciplined data hygiene to prevent oversharing and sensitive data leakage. Second, regulatory compliance now requires continuous auditability of AI agent operations, with Microsoft Purview Compliance Manager enabling on-demand proof of control. Finally, fragmented solutions increase cost and complexity, while expanded Purview unifies data security, governance, and compliance in a single pane of glass. Enterprises that quickly adapt to rising security expectations will be best positioned to scale AE operations and realize the full value of the AE era. Visit Cloud Wars for more.

Compliance and regulatory reporting used to mean endless spreadsheets, fragmented data sources, and teams drowning in manual work. Today, AI is transforming how the world's largest companies manage financial reporting, sustainability disclosures, and audit workflows—not by replacing humans, but by giving them time back to do strategic work. In this episode of IT Visionaries, host Chris Brandt sits down with Kim Huffman, CIO of Workiva, the platform used by 85% of the Fortune 100 for critical financial and compliance reporting. Kim shares her unique perspective as both a former Workiva customer and now the CIO steering the company into an AI-powered future. They explore how the office of the CFO is evolving under pressure from new sustainability regulations, how AI governance actually works in practice, and why collaboration between IT, finance, sustainability, and risk teams has become essential. Kim also discusses the changing role of the CIO, the coming wave of autonomous agents in the workplace, and why having more data doesn't always mean making better decisions.   Key Moments: 00:58 – The State of Compliance Today 02:18 – Why Standards and Regulations Matter 05:48 – The Complexity of Global Compliance 07:36 – Data Collection Across Teams 08:36 – Single Source of Truth 10:20 – The Sustainability Data Challenge 13:36 – The Endless Spreadsheet Problem 16:12 – What's Driving the CFO Office 19:46 – AI's Strategic Role at Workiva 23:02 – Beyond Repetitive Tasks 25:20 – Transforming How Teams Work 27:03 – Will AI Replace Jobs or Create Capacity? 30:00 – Measuring AI's Business Impact 33:06 – Speed vs. Data Overload 36:25 – The Evolving Role of the CIO 40:00 – Technology Leadership in Transition 43:09 – The Next Five Years for CIOs 46:14 – Managing the Coming Wave of AI Agents 50:02 – AI Will Create Its Own Security Industry 52:26 – The Sustainability Reporting Reality 55:31 – Resource Constraints and AI Consumption 57:34 – Why ESG Data Is Now Critical Business Intelligence 59:23 – Keeping NPS High While Innovating   -- This episode of IT Visionaries is brought to you by Meter - the company building better networks. Businesses today are frustrated with outdated providers, rigid pricing, and fragmented tools. Meter changes that with a single integrated solution that covers everything wired, wireless, and even cellular networking. They design the hardware, write the firmware, build the software, and manage it all so your team doesn't have to.That means you get fast, secure, and scalable connectivity without the complexity of juggling multiple providers. Thanks to meter for sponsoring. Go to meter.com/itv to book a demo.---IT Visionaries is made by the team at Mission.org. Learn more about our media studio and network of podcasts at mission.org. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

In this second part of our conversation on hostile acquisitions and digital governance, we shift the focus toward regulatory compliance and its growing impact on multinational enterprises (MNEs). With Juan Camilo Bolívar Sánchez, we examine how evolving regulatory frameworks such as the GDPR in Europe and the CCPA in the United States are reshaping the operational strategies of global technology firms.Drawing from his experience at TikTok in France and Belgium, Bolívar explains the practical challenges of navigating regulatory fragmentation across jurisdictions and the commercial implications of managing data protection, contract negotiations, and compliance risks in different legal environments. We explore how regulatory divergence affects business models, operational costs, and competitive positioning, and what this means for the future of cross-border digital operations.Join us as we analyze how compliance is no longer just a legal requirement, but a strategic dimension of international business in the digital era.

Hosts Fran Chismar and Tom Knezick connect with Mike McGraw (Senior Project Manager. Regulatory Compliance and Wildlife Surveys; Senior Wildlife Biologist) of Princeton Hydro, and Santino Lauricella (Education Manager) of Bowman's Hill Wildflower Preserve, to discuss the Roots So Deep Documentary. Topics include how Mike became involved with the project, generational shifts in family owned agricultural businesses, and the live Q&A with Mike, Santino, and Fran from the Newtown Theater in PA on January, 21st, 2026. Music by Egocentric Plastic Men, Outro music by Dave Bennett. Rent the Roots So Deep Documentary Here. Follow Princeton Hydro Here. Follow Bowman's Hill Wildflower Preserve Here. Have a question or a comment?  Call (215) 346-6189. Follow Native Plants Healthy Planet – Website / Instagram / Facebook / YouTube Follow Fran Chismar Here. Buy a T-shirt, spread the message, and do some good. Visit our store Here! Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Stories we're covering this week:• Michele Gooch Announces Candidacy for MISD School Board• Mansfield Teen Sentenced in Florida School Swatting Case• We'll Talk About Movin' Downtown Dirt in A Moment With the Mayor• Mansfield Mission Center Breaks Ground on New Facility• State Historical Marker Approved for Mansfield Community Leader• Public Input Welcome at Upcoming Desegregation Meeting• Goodwill to Open Larger Mansfield Store in April• Visit Mansfield Lists the Best Places to Locally Propose Marriage• In Sports, North Texas SC Signs MLS SuperDraft PickIn the Features Section:• Angel Biasatti talks about the role protein plays in your daily diet in Methodist Mansfield News to Know• We will talk with the city's Director of Regulatory Compliance on this week's 40 Under 40• Brian Certain serves up a drink that he describes as committed, deep and layered in this week's Cocktail of the WeekIn the talk segment, Steve talks with retired prosecuting attorney Denise Wilkerson. We are Mansfield's only source for news, talk and information. This is About Mansfield.

South Africa’s budget airline FlySafair is set to be acquired by local private equity firm Harith General Partners, a move that could reshape the domestic aviation landscape and help the airline comply with local ownership laws. Aviation expert Guy Leitch speaks to John Maytham about what the change in ownership could mean for FlySafair, its passengers, and the broader South African aviation industry, offering insight into whether this deal is a positive or concerning development for the sector. Presenter John Maytham is an actor and author-turned-talk radio veteran and seasoned journalist. His show serves a round-up of local and international news coupled with the latest in business, sport, traffic and weather. The host’s eclectic interests mean the program often surprises the audience with intriguing book reviews and inspiring interviews profiling artists. A daily highlight is Rapid Fire, just after 5:30pm. CapeTalk fans call in, to stump the presenter with their general knowledge questions. Another firm favourite is the humorous Thursday crossing with award-winning journalist Rebecca Davis, called “Plan B”. Thank you for listening to a podcast from Afternoon Drive with John Maytham Listen live on Primedia+ weekdays from 15:00 and 18:00 (SA Time) to Afternoon Drive with John Maytham broadcast on CapeTalk https://buff.ly/NnFM3Nk For more from the show go to https://buff.ly/BSFy4Cn or find all the catch-up podcasts here https://buff.ly/n8nWt4x Subscribe to the CapeTalk Daily and Weekly Newsletters https://buff.ly/sbvVZD5 Follow us on social media: CapeTalk on Facebook: https://www.facebook.com/CapeTalk CapeTalk on TikTok: https://www.tiktok.com/@capetalk CapeTalk on Instagram: https://www.instagram.com/ CapeTalk on X: https://x.com/CapeTalk CapeTalk on YouTube: https://www.youtube.com/@CapeTalk567 See omnystudio.com/listener for privacy information.

Dr. Jeni Hayes, Senior Clinical Manager, Strategic Clinical Intelligence, and Dr. Heather Pace, Senior Clinical Manager, Ambulatory Care, join host Carolyn Liptak to discuss the Vizient Winter 2026 Spend Management Outlook, with a focus on pharmacy projections and key changes from prior outlooks. The episode also covers ambulatory care and self-administered drugs, biosimilar therapeutic insights, and dynamic pharmacy market forces.   Guest speaker:     Jeni Hayes, PharmD, BCPS   Senior Clinical Manager, Strategic Clinical Intelligence Vizient Spend Management Solutions   Heather Pace, PharmD   Senior Clinical Manager, Ambulatory Care Vizient Center for Pharmacy Practice Excellence     Host:   Carolyn Liptak, MBA, BS Pharm Pharmacy Executive Director, Regulatory Compliance & Revenue Integrity Center for Pharmacy Practice Excellence (CPPE) Vizient   00:05 — Introduction Announcer welcomes listeners to Verified Rx, produced by the Vizient Center for Pharmacy Practice Excellence.   00:14 — Episode Overview Host Carolyn Liptak, Pharmacy Executive Director at Vizient, introduces the Winter 2026 Spend Management Outlook (SMO). Focus areas: Pharmacy inflation projections Acute vs ambulatory care trends Provider-administered vs self-administered drugs Biosimilar therapeutic insights Dynamic pharmacy market forces shaping 2026–2030 Guests: Jeni Hayes, Senior Clinical Manager, Strategic Clinical Intelligence Heather Pace, Senior Clinical Manager, Ambulatory Care   01:09 — What Is the Spend Management Outlook (SMO)? Biannual Vizient publication projecting price trends across healthcare spend categories. Pharmacy headline: Inflation slightly lower than last edition Total spend still rising, driven by utilization growth and new technologies   01:49 — Top-Line Pharmacy Inflation Projection 2.84% projected drug inflation for purchases between July 2026 – June 2027. Down from 3.35% in the prior edition. Based on October 2024 – September 2025 wholesaler data. Heavily weighted toward highest-spend drugs. Contracted products show lower inflation; non-contract drugs still ~70% of spend.   02:45 — Inflation by Site of Care Acute Care 3.03% projected inflation Driven by: Sugammadex Kcentra Clotting factors Ambulatory Care 2.85% overall, but with key divergence: Provider-administered drugs: 3.35% Self-administered drugs: 2.43%   04:02 — Provider-Administered Drugs: What's Driving Growth Oncology infusions are the main drivers. Key agents: Keytruda Darzalex Faspro Continued growth due to: Expanded indications Increased outpatient infusion utilization Oncology split by site of care: Inpatient: High-cost CAR T (e.g., Yescarta) Outpatient: Infusions, bispecifics, emerging cellular therapies Emphasizes importance of site of care strategy.   05:14 — Self-Administered Drugs: Utilization Over Inflation Five key drivers: Autoimmune / inflammatory: Skyrizi, Dupixent, Rinvoq Diabetes / metabolic / weight loss: Ozempic, Wegovy, Mounjaro, Zepbound Spend growth fueled by: Media exposure Expanded indications Increased patient demand Opportunity for: Retail & specialty pharmacy optimization Margin capture Patient support (adherence, counseling, benefits investigation)   06:45 — New Section: Dynamic Pharmacy Market Forces (2026–2030) Seven strategic forces influencing pharmacy practice: Growth in specialty and cell & gene therapies Expansion of value- and outcomes-based contracting Siteofcare shifts toward ambulatory and home Digital transformation & automation Supply assurance and resilience Expanded pharmacist clinical scope & workforce models Regulatory and policy efforts to lower drug prices 340B changes IRA Medicare Part D negotiations   09:37 — Practical Takeaways for Pharmacy Leaders Use 2.84% inflation as a baseline — then customize using Vizient Pharmacy Analytics. Leverage segmented views to prioritize: Acute vs ambulatory strategies Provider-administered vs self-administered drugs Identify top spend movers and align them with long-term market forces. Consider: Specialty pharmacy expansion Site of care optimization   10:48 — Biosimilar Therapeutic Insights: 2025 Recap Heather Pace highlights: Shift from biosimilar approval to active adoption management. Ustekinumab (Stelara) as defining example: Multiple biosimilars Uptake driven by payer and PBM strategy Utilization varies widely based on: Formulary design Benefit alignment Biosimilars now actively steered, not passively adopted.   11:50 — Why Stelara Was a Turning Point PBM-developed, private-label biosimilars drove adoption. Net cost and copay design outweighed: Interchangeability status Manufacturer differentiation Sets expectations for future biologic launches.   12:25 — Operational Impact for Health Systems Expect payer-specific product preferences. Frequent switching will become routine. Key considerations: Siteofcare mandates Product presentation Supply chain logistics Billing & reimbursement complexity Clinical barriers are decreasing; workflow flexibility is critical.   13:09 — What to Expect From Biosimilars in 2026 Faster adoption timelines Earlier payer-driven switching Fewer preferred products Less reliance on reference product trial periods   13:45 — Biosimilars With Major 2026 Impact Eylea — multiple launches expected post-litigation Xolair — expansion into asthma/allergy and retail specialty Perjeta — oncology pathway disruption expected late 2026 / early 2027   15:01 — 2025 Biosimilars Impacting 2026 Ustekinumab (Stelara): broader formulary shifts Denosumab (Prolia, Xgeva): full year of impact; all interchangeable Eculizumab (Soliris): first rare-disease biosimilar entry   15:58 — FDA Biosimilar Guidance to Watch Late-2025 FDA guidance: Reduced reliance on clinical efficacy trials Greater emphasis on analytical similarity Aims to: Reduce development cost Accelerate market entry   16:26 — Interchangeability: Where Things Are Headed Moving toward expectation that all biosimilars are interchangeable. Shifts responsibility to: Payers Health systems Pharmacists managing transitions and education   17:17 — Biggest Shift in the Biosimilar Landscape Faster launches Larger scale adoption Payer strategy more influential than timing of approval Success depends on: Formulary fit Channel alignment Operational simplicity   17:41 — Final Biosimilar Insight Biosimilar strategies must be molecule-specific. One-size-fits-all approaches are no longer effective.   18:13 — Final Thoughts on the SMO Inflation projections are a starting point. Leaders should: Focus on top spend drugs Understand siteofcare and specialty drivers Translate projections into actionable budgets   18:40 — Resources Winter 2026 Spend Management Outlook available on Vizient's SMO Hub. Includes current and prior editions and related insights.   18:58 — Closing Carolyn thanks Jeni and Heather. Reminder to subscribe, like, and share feedback. Verified Rx is produced by the Vizient Center for Pharmacy Practice Excellence.   Links | Resources:  Vizient Spend Management Outlook webpage Vizient Winter 2026 Spend Management Outlook Vizient Biosimilars Therapeutic Insights   Subscribe Today! Apple Podcasts Spotify YouTube RSS Feed    

Stewart Alsop interviews Tomas Yu, CEO and founder of Turn-On Financial Technologies, on this episode of the Crazy Wisdom Podcast. They explore how Yu's company is revolutionizing the closed-loop payment ecosystem by creating a universal float system that allows gift card credits to be used across multiple merchants rather than being locked to a single business like Starbucks. The conversation covers the complexities of fintech regulation, the differences between open and closed loop payment systems, and Yu's unique background that combines Korean martial arts discipline with Mexican polo culture. They also dive into Yu's passion for polo, discussing the intimate relationship between rider and horse, the sport's elitist tendencies in different regions, and his efforts to build polo communities from El Paso to New Mexico. Find Tomas on LinkedIn under Tommy (TJ) Alvarez.Timestamps00:00 Introduction to TurnOn Technologies02:45 Understanding Float and Its Implications05:45 Decentralized Gift Card System08:39 Navigating the FinTech Landscape11:19 The Role of Merchants and Consumers14:15 Challenges in the Gift Card Market17:26 The Future of Payment Systems23:12 Understanding Payment Systems: Stripe and POS26:47 Regulatory Landscape: KYC and AML in Payments27:55 The Impact of Economic Conditions on Financial Systems36:39 Transitioning from Industrial to Information Age Finance38:18 Curiosity and Resourcefulness in the Information Age45:09 Social Media and the Dynamics of Attention46:26 From Restaurant to Polo: A Journey of Mentorship49:50 The Thrill of Polo: Learning and Obsession54:53 Building a Team: Breaking Elitism in Polo01:00:29 The Unique Bond: Understanding the Horse-Rider Relationship01:05:21 Polo Horses: Choosing the Right Breed for the GameKey Insights1. Turn-On Technologies is revolutionizing payment systems through behavioral finance by creating a decentralized "float" system. Unlike traditional gift cards that lock customers into single merchants like Starbucks, Turn-On allows universal credit that works across their entire merchant ecosystem. This addresses the massive gift card market where companies like Starbucks hold billions in customer funds that can only be used at their locations.2. The financial industry operates on an exclusionary "closed loop" versus "open loop" system that creates significant friction and fees. Closed loop systems keep money within specific ecosystems without conversion to cash, while open loop systems allow cash withdrawal but trigger heavy regulation. Every transaction through traditional payment processors like Stripe can cost merchants 3-8% in fees, representing a massive burden on businesses.3. Point-of-sale systems function as the financial bloodstream and credit scoring mechanism for businesses. These systems track all card transactions and serve as the primary data source for merchant lending decisions. The gap between POS records and bank deposits reveals cash transactions that businesses may not be reporting, making POS data crucial for assessing business creditworthiness and loan risk.4. Traditional FinTech professionals often miss obvious opportunities due to ego and institutional thinking. Yu encountered resistance from established FinTech experts who initially dismissed his gift card-focused approach, despite the trillion-dollar market size. The financial industry's complexity is sometimes artificially maintained to exclude outsiders rather than serve genuine regulatory purposes.5. The information age is creating a fundamental divide between curious, resourceful individuals and those stuck in credentialist systems. With AI and LLMs amplifying human capability, people who ask the right questions and maintain curiosity will become exponentially more effective. Meanwhile, those relying on traditional credentials without underlying curiosity will fall further behind, creating unprecedented economic and social divergence.6. Polo serves as a powerful business metaphor and relationship-building tool that mirrors modern entrepreneurial challenges. Like mixed martial arts evolved from testing individual disciplines, business success now requires being competent across multiple areas rather than excelling in just one specialty. The sport also creates unique networking opportunities and teaches valuable lessons about partnership between human and animal.7. International financial systems reveal how governments use complexity and capital controls to maintain power over citizens. Yu's observations about Argentina's financial restrictions and the prevalence of cash economies in Latin America illustrate how regulatory complexity often serves political rather than protective purposes, creating opportunities for alternative financial systems that provide genuine value to users.

APS is seeking a rate increase of 14% this year. Anne Carlton, manager of regulatory compliance with APS joined the show to talk about why they are requesting this rate increase. 

SummaryIn this episode of The Compliance Guy, Sean Weiss interviews Joe Rivet, a healthcare attorney with extensive experience in federal matters, including prior authorization processes and the No Surprises Act. They discuss the potential changes in legislation regarding prior authorizations, the challenges faced by physicians in getting necessary treatments approved, and the implications of recent Supreme Court rulings on healthcare legislation. Joe shares insights on navigating appeals, the importance of advocating for patients, and the complexities of the IDR process.TakeawaysPrior authorization processes are being scrutinized for their impact on patient care.The proposed 'Doctors Know Best' bill aims to empower physicians.Advocating for patients is crucial, especially in off-label drug use cases.The No Surprises Act has significant implications for healthcare providers and patients.There is a lack of private right of action under the No Surprises Act.The IDR process is complicated and often exploited by private companies.Medical necessity determinations can be challenged, even after prior authorization approval.Physicians should not accept denials without exhausting all options.Recent Supreme Court rulings have clarified the limitations of private actions in healthcare disputes.Transparency in enforcement actions is needed for better accountability in healthcare.

Prashant Mehrotra, Chief AI Officer at US Bank, discusses how the bank evaluates AI initiatives and scales projects from pilot to production. He explains how to build customer trust through responsible AI design and prepare for the future of autonomous banking in CXOTalk episode 906. This conversation covers key aspects of AI in business and AI implementation within a large banking institution.=======Please support our sponsor Emeritus: Explore executive education programs from Emeritus, in collaboration with top universities: https://cxotalk.partner.emeritus.org/=======Key topics discussed:→ Why AI should transform processes, not simply make them more efficient→ How U.S. Bank cut governance approval times in half by engaging risk partners early→ The critical role of baselines in determining whether AI pilots scale or fail→ Why "AI without data is a hallucination" and how the bank organizes Digital, Data, and AI under one leader→ Building AI literacy across the entire workforce, from executives to frontline associates→ The shift from building models to leveraging external foundation models at scale→ Balancing personalization with privacy in customer interactionsMehrotra emphasizes that the client remains the "North Star" for every AI initiative. He offers practical guidance on metrics, funding pilots through to production, and creating repeatable governance processes that accelerate rather than slow down AI deployment.

In this episode of Disruption/Interruption, marketing veteran Ed Locher pulls back the curtain on B2B marketing's biggest lie: that the MQL machine actually drives growth. As CMO of PureFacts Financial Solutions and author of "Digital Transformation: People, Process and Technology," Ed reveals why 15 years of marketing automation created a sugar rush that's now crashing, and how AI can help fix it without repeating the same mistakes. This is a no-holds-barred conversation about emotional connection, the 95% of buyers marketers ignore, and why marketing tenure averages just 18 months. Four Key Takeaways: The MQL Mirage Is Built on a Lie 8:56Marketing automation promised accountability through MQLs, but overdelivering on MQL targets quarter after quarter never translated to actual revenue growth. The entire system targets only the 5% of the market ready to buy right now—ignoring the 95% who need demand creation, not demand capture. B2B Buying Committees Have Tripled in Size 16:30The buying committee for enterprise B2B purchases has exploded from 5 people to 16. You can't build credibility and trust with 16 stakeholders through email sequences—you need emotional connection and personalized storytelling that speaks to each person's specific drivers (CFO cares about ROI, compliance cares about regulations, operations cares about not making headlines). AI Raises the Floor, Not the Ceiling 29:59AI protects terrible marketers from themselves by raising the quality floor, but it hasn't raised the bar for great marketing. The real opportunity lies 3-4 standard deviations above the mean—where human empathy, emotional triggers, and genuine understanding of customer pain create outsized impact that AI can't replicate. Marketing Attribution Is a Myth 44:13There will never be a "cast iron steel rod of attribution" connecting marketing activities directly to purchases. Marketers who work for leadership that doesn't understand this are doomed to 18-month tenures, chasing MQL targets that deliver short-term sugar rushes followed by revenue crashes. The rare CEO or investor who recognizes this broken motion is the problem—not the marketer—creates space for real growth. Quote of the Show (44:13):"There will never be a cast iron steel rod of attribution that says marketing did X, which led to this person buying something. It just doesn't work that way.” — Ed Locher Join our Anti-PR newsletter where we’re keeping a watchful and clever eye on PR trends, PR fails, and interesting news in tech so you don't have to. You're welcome. Want PR that actually matters? Get 30 minutes of expert advice in a fast-paced, zero-nonsense session from Karla Jo Helms, a veteran Crisis PR and Anti-PR Strategist who knows how to tell your story in the best possible light and get the exposure you need to disrupt your industry. Click here to book your call: https://info.jotopr.com/free-anti-pr-eval Ways to connect with Ed Locher: LinkedIn: https://www.linkedin.com/in/edlocher/ Company Website: https://purefacts.com How to get more Disruption/Interruption: Amazon Music - https://music.amazon.com/podcasts/eccda84d-4d5b-4c52-ba54-7fd8af3cbe87/disruption-interruption Apple Podcast - https://podcasts.apple.com/us/podcast/disruption-interruption/id1581985755 Spotify - https://open.spotify.com/show/6yGSwcSp8J354awJkCmJlDSee omnystudio.com/listener for privacy information.

Green Isn't Easy|The Truth Behind ‘Sustainable' Transportation w/Kenneth ChesterToday's guest is Ken Chester, a nationally syndicated automotive journalist, tech communicator, and CEO of TechMobility Productions. With a media career spanning over three decades, Ken has been a leading voice at the intersection of mobility, technology, AI, personal privacy, and climate impact. From founding one of the first consumer-focused auto services in 1989 to producing nationally syndicated radio and podcast content, Ken brings unmatched insight into the evolving transportation landscape. He's also a founding member of the Black Automotive Media Group, championing diversity and representation in the industry. Get ready for a dynamic conversation that connects innovation with real-world impact.Links:https://thetechmobilitypodcast.buzzsprout.com/https://www.instagram.com/thetechmobilityshowTags:Adaptive Technology,,Artificial Intelligence (AI)Automation,Automotive,,Climate & SustainabilityElectric Vehicles,Mobility,Regulatory Compliance,Renewable Energy,Robotics,Live Video Podcast Interview,Podcast,Phantom Electric Ghost PodcastSupport PEG by checking out our Sponsors:Download and use Newsly for free now from www.newsly.me or from the link in the description, and use promo code “GHOST” and receive a 1-month free premium subscription.The best tool for getting podcast guests:https://podmatch.com/signup/phantomelectricghostSubscribe to our Instagram for exclusive content:https://www.instagram.com/expansive_sound_experiments/Subscribe to our YouTube https://youtube.com/@phantomelectricghost?si=rEyT56WQvDsAoRprRSShttps://anchor.fm/s/3b31908/podcast/rssSubstackhttps://substack.com/@phantomelectricghost?utm_source=edit-profile-page

Interested in a career at the Metropolitan Washington Airports Authority? See what we have available here: https://www.mwaa.com/careersHave questions for us? We'd love to hear from you! Send us an email at info@thecapitalrunway.comFor more information, please visit our website at https://thecapitalrunway.com.Staff:Tanisha Lewis, VP of Regulatory Compliance and Community EngagementJaimini Erskine, VP of Marketing & ConcessionsCharles Wilson, Co-host/Co-producerAmanda Ohbayashi, Co-host/Co-producer/Social media producerBong Lee, GraphicsBrian McCoy, Digital Strategy/Co-producerSagia Depty, Marketing Lead/Co-producer

Interested in a career at the Metropolitan Washington Airports Authority? See what we have available here: https://www.mwaa.com/careersHave questions for us? We'd love to hear from you! Send us an email at info@thecapitalrunway.comFor more information, please visit our website at https://thecapitalrunway.com.Staff:Tanisha Lewis, VP of Regulatory Compliance and Community EngagementJaimini Erskine, VP of Marketing & ConcessionsCharles Wilson, Co-host/Co-producerAmanda Ohbayashi, Co-host/Co-producer/Social media producerBong Lee, GraphicsBrian McCoy, Digital Strategy/Co-producerSagia Depty, Marketing Lead/Co-producer

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant updates that are shaping the future of healthcare, patient care, and drug development.The U.S. Food and Drug Administration has been particularly active recently, granting Johnson & Johnson a National Priority Review Voucher for its multiple myeloma drug combination. This move highlights the importance of J&J's treatment in addressing unmet needs within oncology, a field continuously striving for innovative solutions. These vouchers expedite the review process, reflecting a broader commitment to accelerating the availability of critical therapies for patients who need them most.Continuing with regulatory advancements, AstraZeneca and Daiichi Sankyo's Enhertu, in combination with Roche's Perjeta, has gained FDA approval as a first-line treatment for unresectable or metastatic HER2-positive breast cancer. This breakthrough is supported by late-stage study results demonstrating a 44% reduction in disease progression or death compared to standard care. The approval signifies not only progress in breast cancer therapeutics but also underscores the potential benefits of strategic collaborations in drug development. Such partnerships are increasingly vital as they aim to optimize therapeutic efficacy through shared expertise and resources.In contrast to these advancements, Pfizer is facing financial recalibrations with projected revenues for 2026 estimated to decline due to diminishing COVID-19 vaccine sales and patent expirations. This situation reflects broader industry challenges as companies navigate post-pandemic market dynamics and patent cliffs, forcing reevaluations of long-term strategies.On another front, Gilead Sciences continues to push boundaries in HIV treatment with a promising single-tablet regimen combining bictegravir and lenacapavir. This innovation targets underserved segments within the HIV market, offering streamlined treatment options that could enhance patient adherence and outcomes significantly.Shifting focus to obesity management, Novo Nordisk's oral semaglutide is emerging as a highly anticipated medication among primary care providers. This trend highlights a growing preference for oral GLP-1 therapies as convenient alternatives to injectable formulations, marking a shift in how obesity—a major public health concern—is managed.The importance of regulatory compliance remains evident as Novo Nordisk received an FDA warning letter concerning manufacturing issues at an Indiana site previously owned by Catalent. This incident underscores the necessity for rigorous quality control in pharmaceutical manufacturing, which can have far-reaching implications on operational dynamics and supply chains.The FDA is also pioneering efforts to incorporate real-world evidence into medical device submissions by opening pathways for extensive deidentified datasets from sources like national cancer registries and electronic health records. This policy shift aims to integrate diverse data sources into the evidentiary foundation for medical device evaluations, potentially fostering innovation within this sector.In line with collaborative efforts, Genentech has partnered with Caris Life Sciences in a multi-year agreement valued at up to $1.1 billion, emphasizing the strategic importance of integrating diagnostic advancements with therapeutic developments to achieve precision medicine goals.Meanwhile, Yarrow Bioscience has acquired an autoimmune thyroid disease drug from China's Gensci, exemplifying a growing trend of cross-border collaborations aimed at leveraging global innovation ecosystems to address diverse therapeutic areas. This acquisition is part of a $1.37 billion deal, reinforcing the globalization of biotech partnerships as companies seek access to novel therapeutics andSupport the show

In "Trimble's Perspective: The Future of Freight is Connected", Joe Lynch and Rob Painter, Trimble's President and Chief Executive Officer, discuss how Trimble connects the freight ecosystem—people, data, and workflows—to navigate the difficult truckload market and drive customer efficiency using AI and integrated commercial solutions. About Rob Painter Rob Painter became Trimble's president and chief executive officer in January 2020. From 2016 through 2019, he served as the Company's chief financial officer. Joining the Company in 2006, Painter held a variety of leadership positions, including corporate development, corporate strategy, general manager of Construction Services, general manager of the Intelligent Construction Tools international joint venture, and vice president of Trimble Buildings construction software. In August 2023, he was appointed to serve on the Synopsys Board of Directors. Painter holds a bachelor's degree in finance from West Virginia University and an MBA from Harvard University. About Trimble Transportation Trimble Transportation provides fleets with solutions to create a fully integrated supply chain. With an intelligent ecosystem of products and services, Trimble Transportation enables customers to embrace the rapid technological evolution of the industry and connect all aspects of transportation and logistics — trucks, drivers, back office, freight and assets. Trimble Transportation delivers an open, scalable platform to help customers make more informed decisions and maximize performance, visibility and safety. Key Takeaways: Trimble's Perspective: The Future of Freight is Connected In "Trimble's Perspective: The Future of Freight is Connected", Joe Lynch and Rob Painter, Trimble's President and Chief Executive Officer, discuss how Trimble connects the freight ecosystem—people, data, and workflows—to navigate the difficult truckload market and drive customer efficiency using AI and integrated commercial solutions. Holistic Solution for a Difficult Truckload Market: Trimble's T&L segment directly addresses the pressures of the current truckload market by providing core operational platforms (TMW.Suite, TruckMate) to help carriers, shippers, and brokers manage operations, accounting, and dispatch, ensuring maximum efficiency and cost control when margins are tight. Driving Strategy with the Connect & Scale Message: The entire product portfolio—spanning TMS, maintenance, visibility, and procurement—is structured to embody Trimble's "Connect & Scale" message, which focuses on integrating people, data, and workflows into a unified ecosystem to drive growth and efficiency. AI-Powered Autonomous Freight Procurement: Trimble is leveraging AI within its Freight Procurement solutions (Transporeon, Freight Marketplace) to move toward autonomous procurement. This helps shippers and brokers efficiently source capacity and optimize freight spend in real-time, which is critical in a volatile capacity environment. Commercial Mapping for Efficiency and Safety: Essential tools like Trimble MAPS (CoPilot, Appian) go beyond basic navigation. They provide commercial-grade routing that accounts for truck-specific constraints and HOS, acting as a crucial element in optimizing routes and protecting drivers (part of the people and workflow components of Connect & Scale). TMS as the Core Workflow Integrator: Comprehensive Transportation Management Systems (TMS) platforms like TMW.Suite act as the central brain for workflows, integrating data across the business from operations to financial accounting, which is foundational to the "Scale" component of Trimble's strategy. Proactive Maintenance and Data Connectivity: Solutions for Asset & Fleet Maintenance focus on maximizing uptime—a key lever in today's market. By using data from connected trucks (fault codes, location) for preventative and predictive maintenance, they ensure assets remain productive and reduce unexpected downtime. Regulatory Compliance and Risk Mitigation (People & Data): The Safety & Compliance offerings help fleets mitigate risk and adhere to federal regulations, ensuring the safety and legal operation of their people (drivers) and assets, proving that technology is essential for responsible management and effective use of operational data. Learn More About Trimble's Perspective: The Future of Freight is Connected Rob Painter | Linkedin Trimble Transportation | Linkedin Trimble Transportation Revolutionizing the Road: Trimble's Tech Solutions with Kelly Williams | The Logistics of Logistics Trimble & Platform Science: The Future of Telematics with Rob Painter and Jack Kennedy The Logistics of Logistics Podcast If you enjoy the podcast, please leave a positive review, subscribe, and share it with your friends and colleagues. The Logistics of Logistics Podcast: Google, Apple, Castbox, Spotify, Stitcher, PlayerFM, Tunein, Podbean, Owltail, Libsyn, Overcast Check out The Logistics of Logistics on Youtube

Security used to be a headache. Now it is a growth engine.In this episode of IT Visionaries, host Chris Brandt sits down with Taylor Hersom, Founder and CEO of Eden Data and former CISO, to break down how fast growing companies can turn cybersecurity and compliance into a true competitive advantage. Taylor explains why frameworks like SOC 2, ISO 27001, and emerging AI standards such as ISO 42001 are becoming essential for winning enterprise business. He also shares how to future proof controls, connect compliance work to real business goals, and avoid the costly pitfalls that stall companies during scale.Taylor also highlights the biggest blind spots in AI security, including model training risks, improper data handling, and the challenges created by relying on free AI tools. If you are building a SaaS product or selling into large companies, this conversation shows how trust, transparency, and strong security practices directly drive revenue. Key Moments:  00:00 — The Hidden Risks of Scattered Company Data04:11 — Why Early-Stage Teams Lose Control of Security08:22 — Compliance Becomes a Competitive Advantage12:33 — SOC 2 vs ISO 27001: What Founders Need to Know16:44 — Framework Overload and How to Navigate It20:55 — Mapping Security Controls to Business Objectives25:06 — The Gap Between Compliance Audits and Real Threats29:17 — Startup Security Blind Spots That Lead to Breaches33:28 — Rising AI Risks Leaders Aren't Preparing For37:39 — Building Customer Trust Through Transparency41:50 — Protecting AI Models and Sensitive Customer Data46:01 — Why Free AI Tools Create Hidden Data Exposure50:12 — Automating Security Controls for Scale54:23 — Continuous Compliance Beats Annual Audits58:34 — Final Takeaways on Security, Trust, and Growth -- This episode of IT Visionaries is brought to you by Meter - the company building better networks. Businesses today are frustrated with outdated providers, rigid pricing, and fragmented tools. Meter changes that with a single integrated solution that covers everything wired, wireless, and even cellular networking. They design the hardware, write the firmware, build the software, and manage it all so your team doesn't have to.That means you get fast, secure, and scalable connectivity without the complexity of juggling multiple providers. Thanks to meter for sponsoring. Go to meter.com/itv to book a demo.---IT Visionaries is made by the team at Mission.org. Learn more about our media studio and network of podcasts at mission.org. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Anne Marie Engel is a third-generation attorney and a fierce advocate for restoring integrity to the legal profession. With deep expertise in employment law, contracts, and regulatory compliance, she helps medium to large businesses, in healthcare, corporate, and government sectors navigate today's complex legal landscape without compromising their values. Anne Marie is the creator of the “Accountability Architecture” framework, which empowers organizations to ensure their legal teams act with true fiduciary loyalty and operational impact. A bold voice against the complacency of Big Law and politicized legal trends, she challenges the status quo by centering constitutional principles, ethical leadership, and legal clarity. She currently practices at Crown Legal and her project, Flourish Professional Development which focuses on women lawyers and leadership Whether she's leading executive workshops or advising ethics-driven CEOs, Anne Marie brings a rare blend of legal rigor and moral courage to every conversation. For more information, visit www.linkedin.com/in/anengel.

Christine Lowthian, Head of Regulatory Compliance at HSBC, on her career journey, the importance of seizing opportunities and building a supportive network. She highlights her experience leading global teams, particularly in commercial banking and the U.S., and the challenges of managing multicultural teams. Lowthian stresses the role of technology, particularly AI, in enhancing compliance efficiency but noted the need for clean data. She advises aspiring leaders to embrace opportunities, maintain open communication with boards and regulators, and focus on strategic thinking and continuous improvement. SHOW NOTES 02:12 Career Journey 05:46 Leading Global Teams 08:50 Managing Multicultural Teams 16:27 Skills for the Compliance Officer of the Future 17:57 Engaging with Boards and Regulators 26:29 Handling Challenging Personalities 29:05 Advice for Women Starting Out Transcript and more GRC content: https://www.riskywomen.org/2025/11/podcast-s813-leading-global-teams-managing-with-impact-christine-lowthian/

Interested in a career at the Metropolitan Washington Airports Authority? See what we have available here: https://www.mwaa.com/careersHave questions for us? We'd love to hear from you! Send us an email at info@thecapitalrunway.comFor more information, please visit our website at https://thecapitalrunway.com.Staff:Tanisha Lewis, VP of Regulatory Compliance and Community EngagementJaimini Erskine, VP of Marketing & ConcessionsCharles Wilson, Co-host/Co-producerAmanda Ohbayashi, Co-host/Co-producer/Social media producerBong Lee, GraphicsBrian McCoy, Digital Strategy/Co-producerSagia Depty, Marketing Lead/Co-producer

Want a legal career blending Intellectual Property (IP), Biotechnology, and Business? We sit down with Jenna Matheny (Vice-President & Managing Director at APIOiX) to break down the path to a high-impact career in medical innovation. This episode is essential listening for law students and those interested in patent law who also have a passion for science, revealing a world of opportunities beyond traditional law firm life.In this episode, we discuss:The Innovation Lifecycle: How lawyers are involved from invention disclosure and patent strategy to regulatory approval (FDA) and commercialization.The Business of IP: The critical, often-overlooked importance of contracting and compliance in developing and licensing medical technology.Finding Your Niche: Jenna's unique career path through university Tech Transfer offices, incubators, and accelerators—and how law students can get their foot in the door.Beyond Science: The growing field of social innovation and how non-science majors can find rewarding IP careers focused on copyright and trademark.Practical Law School Advice: Which broad-based courses (like securities and international tax) set you up for success, and the value of clinics and residencies.(00:00) - Introduction: Blending Law, Science, and Business in an IP Career (01:43) - Meet Jenna Matheny: Expert in Medical Technology IP and Tech Consulting (04:28) - Defining Biotech vs. MedTech: Law's Role in FDA Approval (05:42) - The Core Practice Areas: Patents, Contracting, and Regulatory Compliance (10:09) - Career Pivot: From Medicine Interest to Patent Attorney Path (11:32) - Tech Transfer Offices (TTOs): How Law Students Can Gain Experience (14:28) - Incubators & Accelerators: Consulting and Internship Roles for Attorneys (20:39) - Practical Advice: Essential Law School Courses (Securities, Tax) and Clinics (24:26) - Serendipity & Networking: How Connections Change the Course of a Legal Career (25:59) - Social Innovation: IP Opportunities without a Science Background (Copyright & Trademark) Click here to view the episode transcript.

In this episode, the hosts delve into a shocking insider trading scandal involving the NBA, where organized crime intersects with professional basketball. They discuss the details of the schemes, the players involved, and the motivations behind such risky behavior. The conversation highlights the implications of integrity in sports and the legal challenges faced by those implicated in the fraud. In this conversation, Mark and Matthew delve into the intricate world of insider trading, gambling schemes, and the implications of cheating in professional sports. They explore the mechanics of poker cheating, the role of the mafia in enforcing debts, and the challenges of preventing fraud in gambling. The discussion also touches on regulatory measures and the integrity of professional sports, particularly in the context of the NBA and its investigations.Find us on all streaming platforms! Check out our sponsor 1Trooper on LinkedIn @1Trooper And don't forget to subscribe!

nterested in a career at the Metropolitan Washington Airports Authority? See what we have available here: https://www.mwaa.com/careersHave questions for us? We'd love to hear from you! Send us an email at info@thecapitalrunway.comFor more information, please visit our website at https://thecapitalrunway.com.Staff:Tanisha Lewis, VP of Regulatory Compliance and Community EngagementJaimini Erskine, VP of Marketing & ConcessionsCharles Wilson, Co-host/Co-producerAmanda Ohbayashi, Co-host/Co-producer/Social media producerRyan Burdick, Editor/Co-producerBong Lee, GraphicsBrian McCoy, Digital Strategy/Co-producerSagia Depty, Marketing Lead/Co-producer

US Government Shutdown – What the FDA Can Still Be Doing? When the U.S. government experiences a shutdown, the consequences ripple across every industry — but for medical device manufacturers, the uncertainty can be alarming. In this article, Regulatory Expert Rob Packard explores what happens to the U.S. Food and Drug Administration (FDA) during a shutdown, and how it affects global manufacturers. You'll learn: Which FDA activities continue, and which are suspended How submissions like 510(k), PMA, and De Novo are impacted What happens to clinical trials, recalls, and ongoing investigations Whether this situation has happened before and how long it could last How companies can prepare and what contingency actions to take

What if AI ran your bank?