Podcasts about Regulatory affairs

Surge Copper has spent the past several months building out its executive bench to advance the Berg copper project in British Columbia. A pre-feasibility study released this summer put Berg's base-case after-tax NPV8% at C$4.6 billion, with a 24% IRR and a 2.9-year payback. If built, the project would rank among Canada's top three copper mines and become the country's largest molybdenum producer. As governments roll out their own critical minerals strategies, companies looking to build large copper mines are increasingly aligning themselves with those national priorities. Jennifer Anthony joined Surge Copper as VP, Environment and Regulatory Affairs early this year, after more than 20 years in British Columbia's public sector — most recently as Assistant Deputy Minister, Permitting Transformation, where she led the province's negotiations on the Blackwater mine and other resource projects.

Frozen food gets a bad reputation it hasn't earned. If you've ever felt a flicker of guilt tossing a bag of frozen peas into dinner, or wondered whether a frozen entree is really as nutritious as something made from scratch, this episode is for you. I'm joined by Jennie Norka, MPH, Senior Director of Scientific and Regulatory Affairs at the American Frozen Food Institute, to walk through what's actually happening behind your freezer door. We take on five common myths, one at a time: that frozen food is less nutritious than fresh, that it's loaded with preservatives, that frozen meals are automatically unhealthy, and that reaching for frozen makes you a lazy parent. Jennie explains how flash freezing locks in nutrients at the moment of harvest, often preserving more nutrition than produce that's been sitting in your fridge for a week. We also get into label reading, a side-by-side comparison of frozen entrees versus homemade recipes, and one food safety detail every parent of a baby or toddler needs to hear about frozen vegetables. Whether you're feeding a family on a tight schedule, a tight budget, or both, you'll walk away with practical ways to build balanced meals using what's already sitting in your freezer aisle. In this episode: •    Why the "fresh is always more nutritious" belief doesn't hold up •    How individual quick freezing (IQF) actually protects nutrients and texture •    What's really in a frozen meal, and how to read the label with confidence •    A side-by-side comparison: frozen entrees vs. homemade recipes •    The one food safety step every parent should know before serving frozen vegetables to a baby or toddler •    Simple ways to build a balanced meal using frozen fruit, vegetables, and proteins •    How frozen food can help stretch a grocery budget and cut down on food waste Resources mentioned: •    The American Frozen Food Institute: frozenadvantage.org •    Sign up for the Munch newsletter and more parent resources at thenourishedchild.com

As banks explore the potential of permissionless blockchains, questions around risk, compliance and accountability remain. Project Pigeon, a new APAC industry working group, aims to develop a common framework to help financial institutions navigate these challenges. On Viewpoint, Lynlee Foo speaks to June Lau, APAC Head of Policy and Regulatory Affairs at Elliptic, about what’s holding banks back, whether these risks can be managed, and what wider adoption of permissionless blockchains could mean for the future of financial services.See omnystudio.com/listener for privacy information.

Most companies bring in regulatory expertise when they're ready to file. Leland Keyt, VP of Regulatory Affairs and Quality Assurance at Apreo Health, makes the case that by then you've already absorbed costs you didn't need to, and explains what early regulatory partnership actually looks like in practice.Leland and Nick get into why risk tolerance is the thing that catches scaling companies, the hidden costs of rework beyond timeline, how regulatory input changes product decisions across geographies, and what regulators are scrutinizing more closely now.A few of Leland's key takeaways:Early means concept phase, not pre-submission. Even your IP narrative can matter years later in a submissionCompanies often run more testing than they need. Efficiency means answering the right questions with the least dataRisk tolerance is what gets companies in trouble. What's acceptable in development isn't acceptable at PMAPost-market obligations happen underneath the water, and they're a resourcing problem more than a regulatory oneRework isn't just timeline, it's product cost and a supply chain issueBiocompatibility interpretation varies by geography and can change what you develop and whenAI, usability, and management review are all getting closer regulatory attentionBuild a scalable QMS. It's the bedrock, and it isn't an afterthoughtAbout Leland KeytLeland Keyt is VP of Regulatory Affairs and Quality Assurance at Apreo Health, which is running a US pivotal study for an implantable airway scaffold for severe emphysema. She has over 20 years in medical devices across startups, mid-size companies, and multinationals, previously serving as Chief Product Officer at Biorithm and Senior Director of RA/QA at Pulmonx, where she navigated FDA's Breakthrough Device Program to a 178-day PMA approval.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

Quality and regulatory compliance are fundamental to bringing safe and effective medical devices to market. As regulations continue to evolve and technologies become more complex, manufacturers must adopt a proactive approach to quality throughout the entire product lifecycle.This podcast collection explores key topics shaping today's medical device industry, including the FDA's transition to the Quality Management System Regulation (QMSR), effective validation and supplier management strategies, and structured approaches to managing software defects in Software as a Medical Device (SaMD).Together, these discussions highlight how strong quality systems extend beyond documentation. They emphasize the importance of risk-based thinking, supplier oversight, software quality, and continuous improvement to ensure compliance while protecting patients.Whether you're working in Quality Assurance, Regulatory Affairs, Engineering, or Product Development, these conversations offer practical insights to help strengthen your Quality Management System and prepare for the evolving regulatory landscape.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Why do quality and R&D fall into adversarial roles even when both are working toward patient safety? Shawn Fuller, who spent 24 years at Surmodics and rose from regulatory manager to VP of Quality, Regulatory and Clinical Affairs, is candid about how both sides create the problem and what it takes to break the pattern.Shawn and Nick get into the learned behavior behind the roadblock stereotype, why quality's timeline never gets extended, the memo-to-file versus special 510(k) trade-off, and the difference between a compliance gatekeeper and a strategic risk advisor.A few of Shawn's key takeaways:The quality roadblock and the R&D cowboy are learned behaviors, and each one justifies the otherA regulatory conclusion delivered without the risk logic or alternatives behind it guarantees a defensive responseIf quality is afraid of FDA, R&D takes the cue. Don't ask the agency what to do, but you can share what you plan to doQuality gets the last timeline and it rarely gets extended, which builds the speed-versus-quality conflict into the scheduleQuality plans are prescriptive, which cuts both ways. Consider folding quality into the project plan insteadTrust is built outside the meeting, over time, and you can't assume it when you walk in the doorDon't blindly defend your own team. A leader who lets their group go down the wrong road to protect the quality seat loses trust fastestAbout Shawn FullerShawn Fuller spent more than 24 years at Surmodics, joining as a regulatory manager and rising to Vice President of Quality, Regulatory and Clinical Affairs. She built the quality and regulatory infrastructure supporting Class I, II, and III devices and served as program director for a Class III device from concept through commercialization. She previously held regulatory roles at Protein Design Labs and conducted transplant research at the University of Minnesota. She is now semi-retired.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

Join us for a timely discussion on two developments shaping the future of digital assets in the United States. We will examine the CLARITY Act and its effort to establish clear rules for whether digital assets fall under SEC or CFTC oversight, as well as the ongoing dispute over Federal Reserve master accounts for crypto-focused banking institutions.Together, these issues highlight a central question: will digital asset firms gain both regulatory clarity and meaningful access to the nation’s financial infrastructure? The webinar will explore how the interaction between market-structure legislation and banking access could influence stablecoins, institutional adoption, and the broader integration of crypto into traditional finance.Opening Remarks:Hon. Cynthia Lummis, U.S. Senate, WyomingFeaturing:Paige Paridon, Executive Vice President and Co-Head of Regulatory Affairs, Bank Policy InstituteAlex Pollock, Senior Fellow, Mises InstituteCorey Then, Deputy General Counsel of Regulatory Strategy and Global Policy, CircleProf. David Zaring, Elizabeth F. Putzel Professor and Professor of Legal Studies & Business Ethics, The Wharton School, The University of Pennsylvania(Moderator) J.C. Boggs, Partner, King & Spalding

Can regulators promote growth and competitiveness while preserving financial stability? In this episode of Current Account, Clay is joined by IIF's Kyle Grieser, Director, Regulatory Affairs, and Miguel Lobo, Policy Advisor, to examine two major developments shaping the future of banking regulation: the ongoing implementation of Basel III and the European Commission's new banking competitiveness agenda. They discuss how post-crisis reforms have strengthened the banking sector, why policymakers are increasingly focused on regulatory simplification and modernization, and what the latest proposals could mean for banks in the United States, Europe, and the United Kingdom. The conversation also explores whether global regulators are finally approaching the end of the Basel III process and what comes next for cross-border regulatory alignment and growth. Programming note — Current Account will return in September after a summer break. This IIF Podcast was hosted by Clay Lowery, Executive Vice President, Research and Policy, with production and research contributions from Christian Klein, Digital Graphics and Production Associate and Miranda Silverman, Senior Program Assistant.

Apotheke und sonst nichts? Dabei ist das nur eine von vielen Möglichkeiten.

What would happen if your Risk Management File disappeared tomorrow?Would your medical device suddenly become less safe?For many organizations, the answer is probably no—because the file was created to document decisions after they were made, rather than guiding those decisions in the first place.In this episode of the Medical Device Made Easy Podcast, we challenge the traditional view of risk management and explore why ISO 14971 should be treated as a continuous decision-making framework—not simply a regulatory requirement.What You'll LearnIs Your Risk Management File Driving Design?Risk management should begin at the earliest stages of product development.Instead of documenting completed work, it should actively influence design choices, identify hazards, evaluate risks, and verify that risk control measures are effective throughout development.Common Signs Your Risk File Is Becoming FictionMany organizations unintentionally weaken their risk management process by:Reusing generic hazard lists from previous projectsCompleting risk documentation just before certificationFailing to connect hazards with design decisionsTreating the Risk Management File as a static document instead of a living processRisk Management Is a Cross-Functional ResponsibilityEffective risk management isn't owned solely by Quality or Regulatory Affairs.Engineering, Clinical Affairs, Manufacturing, Service, Post-Market Surveillance, and Customer Support all generate valuable information that should continuously improve the organization's understanding of product risk.Why Traceability MattersStrong traceability allows organizations to answer critical questions:Why was this hazard identified?Which design decision addressed it?How was the risk control verified?Does new PMS or complaint data change our understanding of the risk?Would we make the same decision today?When these connections are visible, risk management becomes a practical engineering tool rather than a compliance exercise.Keeping Your Risk Management File AliveCertification is not the end of risk management.Complaints, vigilance reports, supplier changes, software updates, PMCF findings, literature reviews, and post-market surveillance all provide new information that should feed back into your risk assessment.Organizations that continuously update their Risk Management File are better equipped to identify emerging risks, improve product safety, and support long-term regulatory compliance.Key TakeawayA Risk Management File should never exist simply to satisfy auditors or Notified Bodies.Its real purpose is to demonstrate how risk-based thinking influences every important design decision throughout the product lifecycle.The strongest organizations don't maintain a perfect document.They maintain a living risk management process—one that evolves as new knowledge is gained and continuously helps make medical devices safer for patients.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

What is the ASLP Interstate Compact and what does it mean for SLPs?Guest: Susan Adams, Esq., CAE, Director of State Legislative & Regulatory Affairs at ASHAEarn 0.10 ASHA CEUs for this episode with Speech Therapy PDWatch on YoutubeIn this episode of First Bite, Michelle Dawson, MS, CCC-SLP, CLC, BCS-S, FNAP, welcomes Susan Adams, Esq., CAE, for a timely discussion about the Audiology & Speech-Language Pathology Interstate Compact (ASLP-IC) and what it means for speech-language pathologists. Together, they break down how the ASLP Compact works, who is eligible to participate, what privileges it provides, and where implementation currently stands across the United States. If you've been wondering how the compact could affect your clinical practice, this episode will help you understand the opportunities, limitations, and what to watch for next.About the Guest: Susan Adams is the Director for State Legislative and Regulatory Affairs at ASHA. She is responsible for advancing the public policy objectives of ASHA by serving as team lead and policy expert on state legislation and regulations affecting audiologists and speech-language pathologists, related to state licensure including the Audiology & Speech-Language Pathology Interstate Compact, and diversity, equity and inclusion issues that affect the ability to practice.Show Notes:Contact Susan on LinkedInASLP-IC WebsiteLove Money: Support ACLU

The deadliest nicotine products in America remain the easiest to buy, while lower-risk alternatives face the toughest fight for regulatory approval and political acceptance. It's a striking contrast. Despite recent progress at the FDA, nicotine pouches remain caught in vaping's regulatory and political wake. They are inheriting the regulatory paralysis, legislative backlash, and moral panic created by the battle over vaping. In Part 1 of this three-part RegWatch special series, Laura Leigh Oyler, Vice President of Regulatory Affairs for Haypp Group, draws on 17 years in tobacco harm reduction to explain the stakes for adult consumers, responsible retailers, and public health. Oyler breaks down the FDA's years-long PMTA delays, its failure to provide pouch-specific guidance, the growth of illicit and counterfeit products, and the landmark modified-risk authorization permitting the claim that using ZYN instead of cigarettes reduces the risk of serious disease. She also warns that tobacco control is already branding nicotine pouches as “the next Juul,” driving fear and misinformation into state legislation. With more than 1,200 combustible tobacco products authorized since 2020 and millions of Americans still smoking, why do the lowest-risk alternatives continue to face the greatest resistance? Find out. Only on RegWatch by RegulatorWatch.com. Only on RegWatch by RegulatorWatch.com. Released: July 25, 2026 Produced by: Brent Stafford https://youtu.be/3M-05qpX70w CELEBRATE WITH US | RegWatch 10th Anniversary Fundraising Campaign GoFundMe: https://www.gofundme.com/f/regwatch-10th-anniversary-fundraiser #RegWatch #VapeNews

Dr. ⁠Basant Bajpai⁠ CEO of ⁠Compliance MedQRA⁠, a UAE-based consulting company specializing in Quality Assurance, Regulatory Affairs, AI governance and compliance for medical devices, SaMD, AI/ML health technologies and digital health solutions. He holds a PhD in Neuroscience focused on brain monitoring and neurotechnology and has more than 12 years of international experience supporting MedTech and digital health companies across Europe, the Middle East and the United States.He explains why regulatory and quality is still one of the most misunderstood functions in MedTech and why so many innovators treat it as a documentation exercise until it becomes an expensive problem at the worst possible moment. We get into the question every founder asks, how long will this take and what will it cost and why there is genuinely no straight answer without first building a proper regulatory strategy.We also tackle the growing trend of companies choosing the US over EU MDR simply because it looks faster. Basant makes the case that regulatory approval alone does not guarantee commercial entry, why reimbursement codes should shape your market choice more than approval timelines and why he now finds EU MDR more convenient than many people expect. He also shares a contrarian view on device classification and why staying in the lowest risk class is not always the smart play.Finally, we explore the GCC regulatory landscape, which Basant argues is not less regulated but differently regulated, with data compliance requirements he found tougher than GDPR or HIPAA. He closes with a clear message on AI in healthcare and why he does not believe regulators will ever allow a clinician to be replaced.Timestamps[00:01:23] From Biomedical Engineering to a First Audit That Changed Everything[00:03:33] Why Everyone Thinks Regulatory Is Just a Documentation Department[00:06:07] How Long Will It Take and What Will It Cost: The Impossible Question[00:09:35] EU MDR vs FDA: Why Reimbursement Should Drive the Decision[00:12:19] Regulatory Approval Does Not Guarantee Commercial Success[00:14:36] Why Staying in the Lowest Risk Class Can Backfire[00:16:00] The GCC: Not Less Regulated, Just Differently Regulated[00:18:24] Why Data Compliance in the Gulf Is Tougher Than GDPR[00:23:30] Who Should Not Pursue a Career in Quality and Regulatory[00:29:17] Final Advice: AI Will Transform Healthcare but Not Replace CliniciansConnect with Basant - https://www.linkedin.com/in/basant-bajpai-phd-63565961Learn more about Complaince MedQRA - https://www.compliancemedqra.net/Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/

In this 100% carbon-neutral episode of Trust and Trade, we talk about greenwashing, the practice of making claims about a product that make it sound more environmentally friendly than it actually is. Taken too far, such claims are illegal and can result in serious penalties for companies that cross that line. In this sustainably sourced episode, host Anant Raut talks to Nestle Health Science US's Greg Fortsch, consumer protection expert Christie Thompson, Kaelah Smith from the Office of the Connecticut Attorney General, and Lemuel Srolovic from the Office of the New York State Attorney General about recent cases brought by their offices and legal standards for environmental claims. Listen now to our most eco-conscious episode ever! With special guests: Greg Fortsch, Assistant General Counsel for Regulatory Affairs, Nestle Health Science U.S. Christie Thompson, Partner, Kelley Drye & Warren LLP Kaelah Smith, Assistant Attorney General, Environment Section, Connecticut Office of the Attorney General Lemuel Srolovic, Chief, Environmental Protection Bureau, Office of the New York State Attorney General Hosted by: Anant Raut

In this Almond Byte, the Almond Board of California's Global Technical and Regulatory Affairs team provides updates on key international trade and regulatory issues affecting California almonds. The episode covers ABC's participation at SNACKEX in Lisbon, recent tariff and trade developments, the new U.S.-EU trade deal that could support almond competitiveness in Europe, and evolving maximum residue limit policies in Vietnam and Thailand. Together, these updates show how ABC works to protect market access, strengthen global relationships and keep almond growers informed about issues that can affect demand and movement of California almonds around the world.

A special one for us: we sat down with Sid Bhatnagar, CEO of ASQ, the American Society for Quality. Sid is an engineer and longtime technology executive who now leads the global body at the center of the quality profession, and he brought a sharp, practical view of how AI is reshaping what leadership requires.Sid and Nick get into why AI pressure now comes from boards and investors rather than the ground up, how to keep human judgment on both ends of the process, what executives owe their people through the change, and how to think about ROI when the technology won't sit still.A few of the takeaways:AI made the executive a steward of adoption and culture, not just a decision-maker, and the pressure is coming top downKeep humans on both ends: ideation from people, work from the tool, validation back to peopleLean toward critical decision-making, not tasks. Pilots and anesthesiologists get paid for what they know when things go wrongHire for innovation, change management, and system thinking. Lead by pulling people along, not pushingExecutives owe their teams upskilling; employees owe the effort. When there's no seat left, be transparent and generousYou can't retrofit ethics, and data isn't power, good data isThink about return on time, not just return on investment. Operations and customer service pay off fastest; talent is the long playAbout Sid BhatnagarSid Bhatnagar is CEO of ASQ, the American Society for Quality, a global organization with members in more than 130 countries. An engineer by training and a longtime technology executive and CIO across manufacturing and financial services, he joined ASQ in 2020 as CIO, became COO and Chief of Staff, and has led as CEO since 2023.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

In this episode, host Kelsey Hipkin chats with AMTA's Andy Barnes, Senior Advisor, Government Relations and Compliance, to discuss the value of AMTA's involvement with key industry organizations and how these relationships help strengthen our advocacy efforts, improve industry engagement, and ensure that the voice of our members is heard where it matters most.Learn more about AMTA's Government Relations and Compliance (GRC) work (formerly known as Compliance and Regulatory Affairs) on our website: https://amta.ca/government-relations.AMTA's Q3 GRC Committee meeting will be held in Calgary on September 15: https://amta.ca/portal/events/16, and the Q4 meeting will be held virtually on December 15: https://www.amta.ca/portal/events/27. These meetings are open to Full Carrier, Subsidiary Carrie, and Elite Members. Register now!Learn more about AMTA Memberships on our website: https://amta.ca/become-a-member, and contact membership@amta.ca with any questions.Learn more about Canadian Council of Motor Transport Administrators (CCMTA): https://www.ccmta.ca/en/Learn more about Private Motor Truck Council of Canada (PMTC): https://www.pmtc.ca/Learn more about the Commercial Vehicle Safety Alliance (CVSA): https://cvsa.org/Learn more about Driver Inc. by watching AMTA's three-part video series: https://www.youtube.com/playlist?list=PLmicsdS-lHRq-4QW_m2sfu1rhylz87mbg.Learn more about Alberta Transportation and Economic Corridors: https://www.alberta.ca/transportation-and-economic-corridorsIf you have any questions or concerns about topics related to what was discussed in this episode, or commercial transportation and driver safety, please do not hesitate to contact our Member Services team at memberservices@amta.ca.Mark your calendars! AMTA's Drawdown Dinner is returning this year to the River Cree Resort and Casino on October 15. More details to come.Save the date for AMTA's 89th Annual Conference, also taking place at the River Cree Resort and Casino on April 7-8, 2027. More details coming soon.AMTA's Whitecourt Safety Summit is on October 1. Join us for a full day of content including a keynote presentation, and sessions with WCB, Trucking HR Canada and more. Network with like-minded transportation professionals and explore our event tradeshow. Register now: https://www.amta.ca/portal/events/17AMTA's Driver Appreciation Days return this September! Dates and volunteer opportunities will come in the near future. In the meantime, do you have swag that you want to donate? This is the official callout! Email events@amta.ca to learn how you can get involved.Are you interested in getting involved with the AMTA? Please contact membership@amta.ca for Membership opportunities and learn the value that AMTA can bring to you and your organization.AMTA seeks to represent our Members in all facets of the industry, but that only works if we hear from you on the issues affecting your day-to-day. We encourage everyone to reach out and share their thoughts and ideas. Please don't hesitate to contact us at memberservices@amta.ca. Do you have any questions or an idea for a future Steering Change series? Message us at marcom@amta.ca. 

What happens when cutting-edge artificial intelligence meets one of our most essential industries? In the latest episode of the Georgia Tech Research Podcast, host Stephanie Richter explores this fascinating intersection with two leading voices in the field. Walker Byrnes, Branch Head for AI, Machine Learning, and Data Analytics at the Georgia Tech Research Institute is joined by Ashley Peterson, Senior Vice President of Scientific and Regulatory Affairs of the National Chicken Council, for an in-depth conversation about how AI is quietly reshaping food safety in poultry processing.   Walker has become a go-to expert on AI-driven foreign material detection, smarter monitoring systems that help prevent recalls, and secure language tools that help plants navigate complex regulations. But this isn't about treating AI like a magic black box; this is about careful, intentional innovation that strengthens the fundamentals of food safety. Throughout the episode, Walker shares his journey into AI, what his team is currently working on, and practical advice for both plant leaders and regulators on integrating these tools effectively. From discussing data security and ownership challenges to explaining how AI systems handle the real-world chaos of variable poultry processing, this conversation offers valuable insights for anyone interested in the future of food safety and agricultural technology. Listen now to discover how GTRI is helping shape the AI world - carefully and intentionally - to improve the safety of the food we eat every day. Brought to you by the State of Georgia's Agricultural Technology Research Program.

As planting and growing season continues across the country, stewardship remains one of the most important responsibilities for growers and applicators. In this episode of North American Ag Spotlight, host Chrissy Wozniak sits down with Mike Aerts, Vice President of Science and Regulatory Affairs at the Florida Fruit and Vegetable Association, to discuss the 2026 BeSure! Campaign and the role stewardship plays in protecting pollinators, wildlife, water quality, and agricultural productivity.Mike explains how the BeSure! Campaign serves as a decision-support resource that encourages growers and applicators to follow best management practices while emphasizing a simple but critical message: read and follow the label. He discusses the extensive scientific research behind pesticide labels and why the phrase "the label is the law" remains one of the most important principles in crop protection.The conversation explores the essential role pollinators play in agriculture, including their contribution to approximately one-third of the food we consume and more than 75% of the world's flowering plants. Mike also addresses common misconceptions surrounding pollinator health and explains how factors such as pests, diseases, habitat loss, weather events, and invasive species often have a greater impact on bee populations than many people realize.Listeners will learn about stewardship practices for treated seed and foliar applications, the importance of proper equipment calibration, spray drift management, and the growing use of technology to improve application accuracy. Mike also shares insights into Florida's Managed Pollinator Protection Plan (MP3), a voluntary program that helps growers and beekeepers communicate effectively to protect pollinators while maintaining crop production.The discussion also highlights a new concern for beekeepers across the United States—the invasive yellow-legged hornet—which has recently been detected in the Southeast and poses a significant threat to honey bee populations.Throughout the episode, Mike emphasizes that food security depends on responsible crop protection practices and collaboration among growers, applicators, beekeepers, registrants, and regulators. The result is a practical conversation about how agriculture continues to improve stewardship while producing the food, fiber, and specialty crops consumers depend on every day.To learn more about the BeSure! Campaign and access stewardship resources, visit GrowingMatters.org/BeSure.Send us Fan MailSchedule a demo today at ecorobotix.com Introducing FarmNewsDaily.com - your source for agriculture news!Subscribe to North American Ag at https://northamericanag.com

Event contracts and digital asset derivatives are emerging under CFTC oversight, while listed options and ETFs remain SEC-regulated. Meanwhile, some platforms are offering both. This panel will examine: •    The SEC and CFTC frameworks and their implications for innovation. •    Whether event contracts should be viewed as gaming, financial hedging, or a hybrid. •    How crypto-linked options and ETFs fit into the regulatory patchwork. •    What market participants need to prepare for as regulatory convergence (or conflict) plays out. Moderator: The Honorable Dawn D. Stump, Principal, Stump Strategic Panelists: JJ Kinahan, Senior Vice President, Head of Retail Expansion and Alternative Investment Products, Cboe Global Markets Ryan Jachym, Global Head of Markets Policy in the Office of Government and Regulatory Affairs, Goldman Sachs Summer Mersinger, Chief Executive Officer, Blockchain Association Thomas Plummer, Prediction Markets, Jump Trading This panel is proudly sponsored by State Street Investment Management

Melissa Soliz, Partner, Coppersmith Brockelman PLC, speaks with Brendan Keeler, Interoperability Practice Lead, HTD Health, and Amy Bagge-Smith, General Counsel and Head of Regulatory Affairs, Arcadia, about the cases that are currently shaping interoperability law and how the health care industry is responding. They discuss which legal theories are gaining traction and which ones are appearing more fragile, impacts on national frameworks and CMS' Aligned Networks initiative, and how tech innovators and health care providers can navigate this complex environment. Melissa, Brendan, and Amy spoke about this topic on a recent AHLA webinar. From AHLA's Health Information and Technology Practice Group.Watch this episode: https://www.youtube.com/watch?v=WtCQbMudXmULearn more about the AHLA webinar that Melissa, Brendan, and Amy spoke on: https://educate.americanhealthlaw.org/local/catalog/view/product.php?productid=1772 Learn more about AHLA's Health Information and Technology Practice Group: https://www.americanhealthlaw.org/practice-groups/practice-groups/health-information-and-technology Essential Legal Updates, Now in AudioAHLA's popular Health Law Daily email newsletter is now a daily podcast, exclusively for AHLA Comprehensive members. Get all your health law news from the major media outlets on this podcast! To subscribe and add this private podcast feed to your podcast app, go to americanhealthlaw.org/dailypodcast.Stay At the Forefront of Health Legal EducationLearn more about AHLA and the educational resources available to the health law community at https://www.americanhealthlaw.org/. 

In this second special collaboration with Sumsub's What the Fraud? podcast, we close out our Money20/20 Europe series with our 8th episode from the show - a deep exploration of how AI, digital identity and agentic commerce are reshaping trust across global financial services. From neobanks rethinking what “trust by design” really means, to product leaders tackling fragmentation, to regulators navigating cross‑border complexity, this episode brings together five voices defining the next era of intelligent, secure and human‑centred finance. Tom Taraniuk, Head of Partnerships at Sumsub took on hosting duties and was joined by: 1/ Mette Gade, CPO, Lunar 2/ Breno Oliveira, Chief Product Officer, payabl. 3/ Bankole Falade, Chief Legal, Regulatory Affairs & Public Policy Officer, Flutterwave 4/ Conny Ploth, Vice President, Global AI Transformation, Santander 5/ Antoine Dauchy, Product Leader, FLOA

In our sixth episode from Money20/20 Europe and the third produced in partnership with LSEG Risk Intelligence, we sit down with six leaders working at the intersection of digital identity, fraud prevention, regulatory transformation and global payments infrastructure. Graham Barrett was was joined by: 1/ Theo Bowden, Senior Product Manager, LSEG Risk Intelligence 2/ Marjan Delatinne, Managing Director Sales and Business Development, Europe, Eastnets 3/ Bankole Falade, Chief Legal, Regulatory Affairs & Public Policy Officer, Flutterwave 4/ Todd Clyde, CEO, Token.io 5/ Kevin Burke, Head of Strategic Partnership, Mangopay 6/ Gordon Stuart, SVP, Fintech & Embedded Services, Sage Across digital ID wallets, verifiable credentials, African cross‑border interoperability, open finance, marketplace onboarding and embedded fintech, this episode explores how identity is rapidly shifting from a compliance checkbox to the foundational trust layer of global commerce.

Why do so many CAPA systems pass their metrics while the same problems keep coming back? Dan Eagles, a medical device quality VP and longtime CAPA mentor, breaks down where these systems quietly fail and how to rebuild them into tools that actually drive improvement.Dan discusses why the problem statement is where most CAPAs go wrong, how teams back-engineer root cause analysis to match a fix they've already chosen, and why "retrain the operator" is usually the wrong answer.A few of Dan's key takeaways:A closed CAPA that fails again for the same reason was never successful, repeat offenders are the clearest sign of a broken-but-compliant systemMost CAPA trouble starts with a poorly worded problem statement, train your owners to write good ones and you get value across NCRs tooHumans back-engineer root cause analysis to justify the fix they already wanted, the J&J forklift story shows how that goes wrongTrade retrospective "wait three months and see" verification for process validation that proves capability with objective evidenceKnow the difference between a correction (fixes the immediate problem) and a corrective action (prevents recurrence)Without leadership buy-in across functional groups, CAPA becomes a hot potato, but a recall costs far more time and moneyTrack whether your VOEs are effective, not just whether CAPAs closed on timeAbout Dan EaglesDan Eagles is Vice President of Quality Assurance at NeuraSignal, a company developing robotic transcranial Doppler ultrasound technology for stroke detection. He has over 20 years in the medical device and pharmaceutical industries, with 23 years in quality assurance and prior roles at NuVasive, Dendreon, Endologix, and Edwards Lifesciences. He is a CAPA and NCR mentor and is listed on 21 ophthalmic device patents.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

In this episode, Andrea Braun-Scherhag, SVP and Global Head of Regulatory Affairs & Safety at Autolus, breaks down what it really takes to bring breakthrough therapies to market, especially when there's no established playbook. From securing rapid global approvals to navigating entirely new pathways in cell and gene therapy, she shares why regulatory sits at the centre of Biotech success. Andrea challenges the common perception of regulatory as operational, revealing it instead as one of the most impactful, forward-looking functions in any biotech. She also highlights the importance of engaging regulators early, aligning teams behind a clear strategy, and putting patients at the heart of development, particularly in rare diseases.

Interview Transcript Kate - Welcome to the Leading Voices in Food podcast. I'm Kate Stanley, a researcher at the World Food Policy Center at Duke University. I'm joined today by my co-host, Katariina Koivusaari, a researcher at North Carolina State University. Together, we collaborate on policy research for the Bezos Center for Sustainable Proteins at NC State. Katariina - Great to have you. Greg, you have been involved in food and agriculture policy in Washington, D.C. for several decades and have worked with both Democratic and Republican administrations. Are food policy politics caught up in party differences depending on which political party is running the executive branch? A very relevant question right now. I guess it would be wrong to say that the political party in office doesn't make a big difference in the policies being carried out by the executive branch. However, in the food and agricultural space, and especially in the areas that I focus on, which is really around these new technologies in food and Ag and how do those get into the marketplace and adopted, that difference hasn't been so big. Let me give you an example or two. I'll take you back first to about 2000, and we had the Clinton administration. We have the regulation at FDA of biotech crops, and they had a voluntary consultation process and there were a number of stakeholders and others who felt that that wasn't sufficient. The Clinton administration interpreted the Food, Drug, and Cosmetic Act to try to turn that into what they called a mandatory consultation, and they proposed a pre-market notification rule. It didn't get finished in, before the end of the administration in January of 2001. Then we had the Bush administration come in, so we went from a Democrat to a Republican. And the Bush administration looked at the same law and looked at that same proposed regulation and said, "We don't have the legal authority to do that." And they withdrew that proposal, and so we still have to this day this voluntary consultation. And I give you that example for two reasons. One, I think what we've seen when it comes to food and policy regulation by different administrations is how they interpret the law. And I can say this in very general, the Democrats have tended to be a little more expansive in how they interpreted the law to try to find more legal authority to do things that they might want to do. And the Republicans have tended to look at that language much more restrictively or look at just exactly what that language said and not try to interpret anything into it. And so, you see that difference here between what happened in the Clinton administration versus what happened in the Bush administration. I mention this example because as many of your listeners may know, right now in this administration, we have the question about voluntary GRAS and whether that's going to become mandatory or not. And some of us who have followed that know that the current FDA has submitted to OMB, to the White House, a proposed rule to make GRAS mandatory. Well, that is-- the regulatory process for those biotech crops is also a GRAS process. It's interesting now that we have a Republican administration who's finding the authority to do that, and we'll see what actually comes out and what the courts do with it. But I think this shows that sort of difference in policies between Democrats and Republicans. But overall, we haven't seen a lot of difference. In this new administration, I think one of the questions people had was what would happen with a technology like cell-cultivated meat? Where would the regulation of it go forward? There's many in the MAHA movement, I think, that felt that that wasn't consistent with what they wanted. But we've seen that those approvals continue to happen. Similarly, pesticides have been an issue in many administrations. Sometimes Democrats have argued to be much more restrictive in the use of pesticides and to make the regulations much harder. And Republicans have oftentimes said to make those easier for the agencies. But what we see is pesticides have moved forward under both administrations. People understand the need for pesticides to produce agriculture. We have some differences in policy, but on the whole, in this area, I think, whether it's Democratic or Republican, they have generally supported following the law. Kate - Greg, you shared some interesting examples of across administrations how we've seen different actions be taken. And I'm curious. Under this administration, for some of these areas you work in, like these novel technologies, what do you see as driving the new federal legislative actions in food policy? The legislative area has generally always been more partisan than the executive branch to some extent. I mean, the executive branch is interpreting laws from Congress; the Congress is setting those. But I think again, in the area of food policy, we've seen many good laws come out that have been bipartisan. And when I look at how did those laws come to be, I sort of see a couple different scenarios. One, and I don't think this is unique to food policy or ag policy, we tend to see legislation when some crisis has occurred. The example I would give in the food space was the establishment of the Food Safety Modernization Act more than a dozen years ago. And to a large extent, that was reaction to a number of outbreaks: spinach outbreaks, peanut butter outbreaks, egg outbreaks. And people getting sick, and some people even dying from those outbreaks. And so that brought a bipartisan coalition together to say, "We need to give more authority to FDA to address our food supply and ensure it's as safe as it could be." So that's one way we've seen that. A second way we see policy change is when a policy is old or that is no longer in favor. And the example I give there is most recently, in this Congress passed the whole Milk for Healthy Kids Act, and that is a definite change in policy from the Hunger-Free Kids Act of 2010. This changes what milks, whether they're flavored, and how much fat they can have and be in the school programs. And I think in both cases, those bills were relatively partisan at the time, and yet they do opposite things. So that would be another reason that we see changes in laws. But the third way, and I wanted to focus a little more on this, is one way the federal government gets involved and Congress gets involved is when states start regulating an area, and we start getting different standards. And then there's a push at the national level to have some sort of uniformity, some sort of have national standard for markets to work properly, for efficiency's sake and so forth. And I can give several different examples. We can go all the way back to the National Organic Law that was passed back in 1990. You had a number of states who had defined organic; they had different organic labels. Congress came together and said, "Hey, let's set up a national organic standard." We had the same thing happen with the National Bioengineered Disclosure Law, that I think happened around 2017 or 2016. In which case you had a number of states proposing legislation. You had Vermont that had passed legislation requiring mandatory labeling of genetically engineered ingredients. And in fact, the law that was passed by Congress was passed, I think, within a week or two of when the Vermont law was about to go into effect. And people felt it was better to come together and have a national standard than have different states doing different things. Because the reality is, consumers and manufacturers don't just purchase things in one state or produce things for one state. They produce it for the nation. We're a nationwide market. And then we see even those kinds of things happening today, and I go back to the pesticide area as another example. We've had different states having pesticide laws or regulations that have been different than the federal situation. We have a Supreme Court case now that the Supreme Court is going to hear in April of this year about whether that's those state regulations are preempted by the federal law. But Congress and the Farm Bill has also put in language that would ensure that the federal standard is the standard that is applied, not having multiple different state standards. So that's been a way that we've seen a lot of things happen in this food and Ag space. Kate - We've seen a lot of food policy action at the state level in the past few years. Katariina and I were on this podcast not long ago talking about state legislation aiming to restrict how cell-cultivated meat products are labeled or even banning those products altogether. We've seen action in a variety of other areas as well. Are there issues that states have started regulating where you think we could see federal action in the near future? I do. I think that the MAHA movement in particular has really set up a situation where we see states taking the lead on a number of issues, and we'll see whether the federal government decides to come in, and particularly Congress, to address those at a national level. For example, in the area of synthetic dyes and food additives, I think there's some 30 states that have introduced bills. And a number of which have passed, either restricting those use at all in any foods, restricting their use in school lunches, having different labeling associated with many of those ingredients. And we've seen some of those laws pass, and we've already seen some court cases. A court case in West Virginia which said that those laws are preempted by federal law. One could envision either something at FDA or in Congress that would set some uniform standard for how this moves forward federally. You mentioned cell-cultivated meat and the three of us were involved in a paper that looked at the state regulation in that area, especially around labeling. And again, if we don't have a lot of those products on the market yet, but as those products get closer and get on the market, I could definitely see a push again to have some uniform labeling. Either again from the federal executive branch or from the legislative branch. And also, in areas like ultra-processed foods is another one. California has passed a law defining how they're going to define ultra-processed foods. We've heard that FDA may issue a definition about ultra-processed foods, but I could also see Congress getting involved eventually and setting a standard. Katariina - I'm sure that in working with US regulatory agencies for so long, you've seen trends develop and persist over time. What would you highlight right now for our listeners? Well, as I said, I've worked very much in this space where we talk about new science, new technology, new kinds of products coming into the marketplace and how do we regulate that? What are the policies and regulations to ensure that that's safe for humans and safe for the environment, and that there's information and access that's necessary for those safe products to, to thrive in the marketplace. And when you look at that, I think I have some observations, I guess, about the US regulatory agencies and what they've done in this area. The first one is that the science tends to move faster in the private sector and in the research community, like you're both in, than it does in the federal government. And so generally, the people in the federal government, who I have the utmost respect for, the career people, tend to always be playing catch up on the science. That the science is moving faster and they're not there. An example I would give is cloned animals. When the industry went to FDA and said, "Hey, can we put these cloned animals into the m- into the marketplace?" FDA sort of said, "Well, wait. We need to look and see whether we need to do a risk assessment to see if there's any risks out there." And they spent a couple years doing that, and they asked for a voluntary moratorium while they were figuring that out. In the end, they figured out that for many cloned animals, there was no risk and there didn't need to be regulation, but they had to catch up. They had to catch up on the science. And I think that's the first thing. It's important for industry and public sector scientists like yourselves to make as much information about new technologies and new products available in the public realm so that those experts in the federal government can stay as close as possible to what is happening. Second is, anytime you have a first-of-a-kind product. You talked about cell-cultured meat, Kate, a little while ago. We can talk about biotech crops. We can talk about a number of genetically engineered salmon. We can talk about a number of different new products of methane-reducing feed additives. The first-of-its-kind is always going to take a little longer to figure out what is that regulatory pathway. It's great to be the first into the marketplace. You get a lot of advantages, but I guess one of the disadvantages is that you probably have a little slower regulatory timeframe. That again bodes for that transparency for that additional information. The third thing I'd mention, and you would think, oh, this is something that is sort of a given and expected, and that is the level of transparency that we have in our federal government. But that's not true. I've traveled around the world, and many governments don't have that. But interestingly, most of our regulations are, you know, they're all publicly available. There's lots of guidance documents out there. We can go online today and see GRAS applications and decisions made at FDA. We can see what information was submitted for cell-cultivated meat crop, meat, meat products, and what decision the agency made on those. We can do that for genetically engineered animals and for genetically engineered plants. And so, we do have a fair amount of transparency, and I impress upon people to use that to their advantage. I think that builds trust for consumers, but also for people in the industry. It helps them learn so they can be as efficient as possible when they go through the regulatory process. And the final thing I might mention is it may look like from the outside the government moves slow all the time. But I think having been inside the government and in the role, I played as the Chief Regulatory Officer at USDA, that slowness, in part, is to make sure that the government speaks as a single voice. We've been talking a lot about FDA, and we talk about USDA, but there are actually some 18 or 20 different agencies that actually regulate different parts of the food supply, for example. A decision made in one agency may have some indirect impact on a decision or a regulatory process in another agency. And so, it's important before major decisions are made or major regulations are promulgated, that we have an interagency review of those things to make sure that the government is speaking consistently with one voice about how they interpret laws; about how they apply risk assessments; about how they look at safety and so forth within the context of their laws. And that sometimes takes some time. It is a big bureaucracy, a big government, and again, that could be looked at upon negatively. But at the same time you can look at upon that positively as an opportunity to make sure that the decisions that are made in one place are consistent with other decisions and other statutes in another place. Katariina - Thank you for sharing that. It's really helpful to get more insight into the policy process. Let me ask you one final question. For organizations seeking to navigate through state and federal regulations in order to bring a food product to market, what are the key, what are key takeaways you would highlight? Well, there are a number of them. First, I would tell companies or public researchers, whoever is bringing a product to market, to be as transparent as possible. Put as much information about your product and your technology in the public record, especially if it's in peer-reviewed journals that are accessible to everybody. That is only going to come to your benefit. That's going to help the regulators. They know that information is out there. They know that other people have that information. They can utilize that to help make decisions about whether there is a food safety or a risk to the environment, and then how maybe to address those risks. So that would be my first response. The second one is, and I think, again, this is something that I thought was going to be universal when it came to interactions between the regulated community and the regulators, but it's not around the world, and that is to consult. All the agencies that I've worked for have open door policies where they say, if you have a question, as you're thinking of bringing a product to market, come in and consult with us. Come in and talk to us. Let us help you figure out what the regulatory pathway is going to be, what the data you are going to need is, why we need that data, and go through all of that. And, in my consulting business, that's one of the things I do. I help facilitate those conversations between one of the agencies and a client. And I think that just the earlier you do that and the more often you do that, the more efficient you will be, the less money you will spend, the quicker your review process will be. And while I have clients who don't always agree with the decisions by the agencies of what information they might need or what regulatory process they have, it's still better to know that upfront and earlier in the process than later in the process. The third thing I'd mention is to be a little creative. The regulators, you know, they're trying to ensure they're representing the public, and they're trying to make sure that a product is safe for human consumption, for animal consumption, for the environment. They don't always have all the answers, and sometimes they are fitting square pegs into round holes because new technologies come along that aren't exactly a perfect fit. But be creative. Try to help them. I think, you know, sometimes working with people like me or others to help think about what a good regulatory pathway would be, what are the potential risks that really need to be addressed here that can be really helpful. The fourth thing is, you know, that the devil is always in the details. The details and the science matter, and that is something that is very important. And so, we want to look for analogies of your product or your technology to other ones that have happened in the past, and that's always good. But also understand the differences. And so, really, I think, sometimes people think, "Oh, they don't need to engage with the regulators as much about exactly what I'm doing," or "They don't need to know all those details." Those details actually do matter, and I do think those are important. And then I would finally say that, you know, it does take time, especially when we're talking about new technologies and new products, to figure out what that regulatory process will be. And we don't have neat situations. Our laws are written a long time ago. We don't want to write a new law for every new kind of product or every new kind of technology. I'm not sure that's the most efficient way to do it. But by not doing that, we're sometimes, as I mentioned earlier, fitting square pegs into round holes. We have a law, for example, the Food, Drug, and Cosmetic Act, dealt with food, but it never envisioned genetically engineered crops. It doesn't talk about biotechnology. We have a meat law that regulates meat at USDA. Didn't think about cell-cultivated meat. And we have to think about how those fit together. And sometimes we can do that without the new laws, and sometimes you need new laws. When I was at USDA, we worked on methane-reducing feed additives. FDA regulates them, but they really don't fit very well. They're not a drug, but they're also not a feed because they don't have a nutritional benefit. And so how do we fit those into the regulatory system? FDA's come up with a temporary regulatory pathway, but there's also a bill in Congress to set up a more definitive regulatory pathway. And we see that for some of these new technologies that we might see some legislation. And then the final point I would just make is to temper everybody's view that a compromise is essential in this area. No one company or no one stakeholder gets everything they want. Governing and the government's job is to, you know, figure out what's the appropriate balance. They want to ensure safety, but they also want to make sure that safe products can get to market and that consumers can get to take advantage of those products, and we can get the benefits from those products. And so all of this is always a balancing. There will always have to be some sort of compromise. And I'm not saying that's a bad thing, just pointing it out as something that people should be conscious of. BIO   Gregory Jaffe is President of Jaffe Policy Consulting, which provides strategic advice on national and international policies involving agriculture and food, with specific expertise in sustainability, climate, bioeconomy, biotechnology, PFAS, pesticides, food safety, and food loss and waste. He recently worked as the Senior Advisor for Regulatory Affairs in USDA's Office of the Secretary and the USDA's Chief Regulatory Officer. He managed a broad portfolio of policy issues, including bioeconomy, biotechnology, biofuels, pesticides, PFAS, food safety, sustainability, and scientific research and development. Before joining USDA, Greg worked for at the Center for Science in Public Interest (CSPI), a non-profit consumer organization working on food and nutrition issues. While at CSPI worked extensively in Sub-Saharan Africa and Southeast Asia on projects funded by USAID and the Gates Foundation. He worked with government officials and stakeholders helping them develop laws, policies and regulations that allow for the adoption of agricultural technologies, including biotechnology. He advised on agricultural policy, sustainability, and trade issues, conducted capacity building, and worked on international treaty implementation.

What happens between scientific discovery and clinical trials? For too many drug candidates, the answer is “failure”—not because the idea lacked merit, but because the critical handoff between discovery and IND-enabling studies gets overlooked, rushed, or under-resourced.This episode features Milan Tomic, whose journey stretches from nucleic acid chemistry to leading GMP manufacturing and biodefense initiatives with hundreds of millions in US government support. Milan's focus lies in streamlining drug development, from rapid molecule design to building manufacturing infrastructure, all grounded in holistic, systems-level thinking.Topics discussed:Why so many promising programs fail between discovery and the clinic, and how to close this gap through early, iterative design and testing (02:52)The practical advantages and considerations of cell-free protein synthesis for rapid prototyping and testing during development (07:30)How to decide when to deploy cell-free production versus traditional CHO systems (08:29)Recommendations for resource-constrained startups: what to focus on first and why stability and documentation matter most (10:55)Consistent success factors across Milan's experiences, from government contract projects to launching his own company (13:54)Candid stories of setbacks and lessons—such as the critical importance of safety in development and the impact of overlooked technical details like facility lighting (15:30)The importance of linking drug design decisions to target patient needs and regulatory considerations, thinking holistically, and using target product profiles to guide development (20:22)Smart insight: Perhaps the most powerful takeaway isn't technical, but personal. Staying curious, open-minded, and deriving enjoyment from the process is vital for sustaining the drive necessary for biotech's long and often unpredictable journey. The best way to bridge the valley of death in biotech is through rigorous iterative design, early testing of critical attributes, holistic planning, and a relentless commitment to learning.If you enjoyed this episode you might also like listening to:Episodes 189 - 190 : Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)Episodes 123 - 124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan SharfsteinEpisodes 213 - 214: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe LicariEpisodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri KornmannConnect with Milan Tomic:LinkedIn: www.linkedin.com/in/milan-tomic-phdAlbrem Biopharma: www.albrem.comNext Step:If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.Support the show

With regulators increasingly urging consumer communities and dealers to "turn in your neighbor," your dealership cannot rely on local complacency to escape compliance penalties. We caught up with Lauren Bailey, Vice President of State and Regulatory Affairs at ComplyAuto, for an exclusive sneak peek at the advertising, privacy, and safety compliance strategies she is bringing to the VADA '26 Convention stage at the Marriott Virginia Beach Oceanfront. Register for VADA '26: https://vada.com/convention/ In this bonus "Convention Sneak Peek" episode, Lauren challenges dealers to shift their mindsets away from viewing legal compliance as a dry line-item cost. Instead, she outlines how robust compliance gives dealerships a massive edge in customer experience and employee retention. Lauren breaks down the shifting rules of AI-generated advertising, emerging state privacy laws, and why your physical service drive setup might be making you a target for unexpected OSHA inspections. In this episode: The "Turn In Your Neighbor" Era — Regulatory agencies are actively hunting for deceptive automotive retail ads. Relying on the excuse that "the guy down the street is doing it" is no longer a safe harbor. The Deceptive Reality of AI Ads — Dealerships are leveraging AI for customer testimonials, virtual chatbots, and credit decisions. Lauren highlights the legal risks of automated deception and the mandatory disclosures required by attorneys general. The Looming Privacy Patchwork — State privacy regulations have expanded across 21 states. Assuming your business is fully exempt under the Gramm-Leach-Bliley Act (GLBA) is an operational trap. OSHA's Heat Enforcement Trap — Franchise dealerships are usually excluded from OSHA's national emphasis program on heat injury. However, depending on your NAICS code classification and whether your service center is a non-contiguous location, your shop could be hit with steep penalties under the General Duty Clause. Once Every 100 Years — Statistically, a standard dealership is only inspected by OSHA once a century. But disgruntled employees or unsatisfied consumers change those odds instantly. Lauren details how to handle complaints proactively. Watch, then register: https://vada.com/convention/

The gap between a “drug” and a true “product” is where many therapies fail.Milan Tomic, biotech veteran, GMP manufacturing expert, and founder of Albrem, has spent 30 years turning promising science into scalable, executable products that can actually reach patients. His experience spans everything from antibody development to building large-scale GMP facilities. Today, he helps biotech teams align scientific innovation with the operational and regulatory realities needed for successful commercialization.Topics discussed:Milan's path from curiosity-driven research in molecular biology to biotech industry leadership (05:24)The importance of integrating work-life factors into career decisions, and balancing scientific depth with operational and business responsibilities (08:22)The unexpected role that salesmanship plays for scientists moving into entrepreneurship (10:40)Lessons from transitioning between scientific disciplines, including dealing with setbacks like unpublished graduate work (12:57)How curiosity led Milan to oversee the redesign of a 2,000-liter GMP manufacturing facility (16:16)Key advice for scientists on process design and scaling up, especially for those involved in CMC (20:18)Smart insight: A promising molecule isn't enough—successful drug development requires designing early for scalability, GMP compliance, and real patient need. Companies that align science with manufacturability and market fit are far better positioned to advance, attract investors, and secure partners.If you enjoyed this episode you might also like listening to:Episodes 189 - 190 : Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)Episodes 123 - 124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan SharfsteinEpisodes 213 - 214: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe LicariEpisodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri KornmannConnect with Milan Tomic:LinkedIn: www.linkedin.com/in/milan-tomic-phdAlbrem Biopharma: www.albrem.comNext Step:If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.Support the show

Everyone wants more housing, more clean energy, more transit, more care infrastructure, and more of the things people need to live good lives. But too much of the “abundance” debate treats workers, unions, environmental review, and community voice as obstacles to building — instead of asking who has power, who benefits, and who gets left out. This week, Goldy and Paul talk with Columbia professors Kate Andrias and Alexander Hertel-Fernandez about their Roosevelt Institute report, Democratic Abundance: An Abundance That Works for Workers. They argue that the problem isn't too much democracy — it's too little. If we want to build at the scale this moment demands, we need an abundance agenda that puts workers, communities, and democratic power at the center from the start. Kate Andrias is the Patricia D. and R. Paul Yetter Professor of Law at Columbia Law School, and serves as co-director of both the Columbia Law School Center for Constitutional Governance and the Columbia Labor Lab. Previously, she served as associate counsel and special assistant to President Barack Obama and as chief of staff in the White House Counsel's Office. Alexander Hertel-Fernandez is an associate professor and vice dean at Columbia University's School of International and Public Affairs, and serves as co-director of the Columbia Labor Lab. From 2021 to 2023, he served as a deputy assistant secretary in the Department of Labor and a senior fellow in the White House Office of Information and Regulatory Affairs. Further reading:  Report: Democratic Abundance: An Abundance That Works for Workers The American Political Economy: Politics, Markets, and Power State Capture: How Conservative Activists, Big Businesses, and Wealthy Donors Reshaped the American States and the Nation Website: http://pitchforkeconomics.com Facebook: Pitchfork Economics Podcast Bluesky: @pitchforkeconomics.bsky.social Instagram: @pitchforkeconomics Threads: pitchforkeconomics TikTok: @pitchfork_econ YouTube: @pitchforkeconomics LinkedIn: Pitchfork Economics Twitter: @PitchforkEcon, @NickHanauer Substack: ⁠The Pitch⁠

To get a taste of the discussions that were happening at the 2026 Food Safety Summit, we spoke face-to-face with Jeremy Zenlea, M.B.A., Vice President and Head of Health and Safety for EG America and Laurie Farmer, Director of the U.S. Food and Drug Administration's (FDA's) Office of Retail Food Protection; David Clifford, M.B.A., Director of Food Safety at Nestlé USA and Sara Mortimore, M.Sc., Founder of Sara Mortimore LLC and formerly Vice President for Food Safety at Walmart; Frank Curto, Ph.D., Vice President of Operations at Ecowize North America; and Drew McDonald, Senior Vice President of Quality, Food Safety, and Regulatory Affairs for Taylor Fresh Foods and Conrad Choiniere, Ph.D., Director of FDA's Office of Microbiological Food Safety. In this episode of Food Safety Matters, we speak with: Mr. Zenlea and Ms. Farmer about issues related to retail/foodservice food safety, including the intersection of sanitation and culture, FDA's Comprehensive Employee Health Toolkit, and utilizing employee health policies to reduce norovirus risk [3:06] Mr. Clifford and Ms. Mortimore about the process and benefits of digitalizing Hazards Analysis and Critical Control Points (HACCP) programs [21:46] Dr. Curto about building an "audit-ready everyday" food safety culture [42:31] Mr. McDonald and Dr. Choiniere about data sharing within organizations and across sectors. [1:00:04] Sponsored by: Ecowize  We Want to Hear from You! Please send us your questions and suggestions to podcast@food-safety.com

Why do life science companies still scramble when an inspection is coming, even when their quality systems are solid on paper? Yeime Martich, a 25-year quality veteran, makes the case that readiness is a logistics and culture problem, not a documentation problem, and that the procedures you wrote may be creating more audit risk than you realize.Yeime discusses why "minimally compliant" is a discipline rather than a shortcut, how leadership shapes quality culture through what they ask about, fund, and tolerate, and why the strongest signal of a healthy quality system is when people come to quality voluntarily to report problems.A few of Yeime's key takeaways:Inspection readiness is the natural output of a healthy quality system, not something you build in the weeks before an audit"Minimally compliant" means meeting the regulatory intent without overcommitting in your procedures to things your team can't actually followQuality should come to the table with options, not just a no — release to warehouse on risk while the investigation closes, for exampleLeadership shapes culture through what they ask about, what they fund, and what they tolerateThe strongest quality culture signal: people voluntarily surfacing problems without fear of blameAI is useful for data analysis and review, but accountability for quality decisions sits with people — "AI didn't tell us" showed up in a recent FDA warning letterDesign your QMS around flexibility — rigid procedures that block product release unnecessarily are self-imposed constraints the regulation never requiredAbout Yeime MartichYeime Martich is Vice President of Quality Assurance at TerSera Therapeutics with 25 years of experience in pharmaceutical and medical device quality systems. Before TerSera, she spent over 11 years at Hospira in global compliance roles overseeing internal audit programs across international manufacturing sites, and held quality systems leadership positions at Melinta Therapeutics and Abbott.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

In this episode of the Export Stories Podcast, host Betsy Olim sits down with Cindy Allen, a global trade expert and former Vice President of Regulatory Affairs and Compliance at FedEx Logistics, to unpack the growing complexity of international trade. With over four decades of experience, Cindy shares her journey from an entry-level customs clerk to leading compliance strategy at some of the world's largest logistics organizations. She offers a behind-the-scenes look at how global trade systems have evolved—and why compliance is now a critical business function, not an afterthought. The conversation dives deep into today's most pressing issues, including: The rise of AI in government trade enforcement and risk analysis How tariffs, trade regulations, and policy shifts are impacting importers and exporters Why companies must understand their compliance “risk profile” The increasing role of compliance leaders at the executive level Real-world strategies for navigating audits, disputes, and regulatory challenges Cindy also explains how government agencies are leveraging decades of trade data with advanced AI tools to identify anomalies—making proactive compliance more important than ever. Whether you're an experienced exporter, importer, or business leader navigating global markets, this episode delivers practical insights to help you stay compliant, reduce risk, and make smarter strategic decisions in an increasingly complex trade environment.

A new episode of the Center for Immigration Studies' podcast, Parsing Immigration Policy, examines the issuing of employment authorization documents (EADs), the use of executive discretion in granting work permits, and a proposed regulation affecting asylum applicants. The episode features CIS Director of Regulatory Affairs and Policy Elizabeth Jacobs and Senior Legal Fellow George Fishman […]

A new episode of the Center for Immigration Studies' podcast, Parsing Immigration Policy, examines the issuing of employment authorization documents (EADs), the use of executive discretion in granting work permits, and a proposed regulation affecting asylum applicants.The episode features CIS Director of Regulatory Affairs and Policy Elizabeth Jacobs and Senior Legal Fellow George Fishman discussing how millions of immigrants, including illegal aliens, parole recipients, TPS beneficiaries, DACA recipients, asylum applicants, and temporary visa holders, have received work permits without Congress's authorization.According to CIS estimates, roughly 15 million individuals currently possess work authorization and 4.3 million illegal aliens may be eligible for work permits. As a result, USCIS reports that it faces more than 1.7 million pending EAD applications.The discussion also focuses on a recent DHS regulation that would tighten eligibility for asylum-based work permits by increasing the waiting period from 180 to 365 days and barring applicants who are prima facie ineligible for asylum from receiving employment authorization and requiring the agency to pause acceptance of asylum-based EAD applications when affirmative asylum processing times exceed 180 days. Currently, processing times average over 1,200 days, while a new affirmative asylum applicant could expect to wait decades, according to DHS, before receiving a final decision on their claim.The episode explains that lengthy asylum processing times have created strong incentives for individuals to file asylum claims primarily to obtain work authorization and remain in the United States for extended periods while cases are pending. USCIS currently faces massive asylum and EAD backlogs, contributing to longer processing times across the immigration system.The conversation also examines broader legal questions surrounding executive authority to issue work permits under the Immigration and Nationality Act and whether decades of expanding administrative interpretation have effectively allowed the executive branch to operate an immigration system outside the numerical and statutory limits established by Congress.In his closing commentary, Mark Krikorian, the Center's executive director and podcast host highlights Acting ICE Director Todd Lyons' recent announcement that ICE identified more than 10,000 foreign students in the Optional Practical Training (OPT) program who claimed employment with “highly suspect employers” and that this represents “only the tip of the iceberg.” OPT, which allows foreign graduates to work in the United States for up to 12 months, or up to 36 months for STEM graduates, was created through executive action rather than congressional authorization. The Center has called for the elimination of the program many times in the past.HostMark Krikorian is the Executive Director of the Center for Immigration Studies.GuestsElizabeth Jacobs is the Director of Director of Regulatory Affairs and Policy at the Center for Immigration Studies. George Fishman is a Senior Legal Fellow at the Center for Immigration Studies.LinksDHS Proposes to Amend Asylum Work-Permit Rules to Reduce Fraud and AbuseDOJ: Asylum Applicants Are Skipping Immigration Court at Record Levels; Their goal all along was work permits, not protectionDHS Issues New Regulation to Automatically Extend the Validity Period of Many Work PermitsWork Authorization Expansion Attracts and Embeds Illegal ImmigrantsGovernment Data Reveal Millions of New Work Permits Issued in 2009OPT Needs to EndIntro MontageVoices in the opening montage:Sen. Barack Obama at a 2005 press conference.Sen. John McCain in a 2010 election ad.President Lyndon Johnson, upon signing the 1965 Immigration Act.Booker T. Washington, reading in 1908 from his 1895 Atlanta Exposition speech.Laraine Newman as a "Conehead" on SNL in 1977.Hillary Clinton in a 2003 radio interview.Cesar Chavez in a 1974 interview.House Speaker Nancy Pelosi speaking to reporters in 2019.Prof. George Borjas in a 2016 C-SPAN appearance.Sen. Jeff Sessions in 2008 comments on the Senate floor.Candidate Trump in 2015 campaign speech.Charlton Heston in "Planet of the Apes".

Access to high-speed internet is pivotal to enabling local communities access to the value that the internet can provide in the digital age. We sit down with Caitlin Ganley, Senior Director of Government and Regulatory Affairs at Comcast, and Jennifer Bilotta, VP, Communications at Comcast, to explore how one of the region's largest employers approaches connectivity, community partnerships, and customer experience across Chester County and beyond. Caitlin and Jenn walk us through the challenges of expanding broadband infrastructure into underserved areas, Comcast's efforts to provide low-cost internet access to those in need, and the company's role in supporting local nonprofits. We also discuss AI, innovation, and and some exciting offerings from Comcast. OUR PARTNERSouthern Chester County Chamber of CommerceLINKSComcastWebsite: xfinity.comXfinity Internet EssentialsProject UpJob opportunities with Comcast: jobs.comcast.comCaitlin Ganley and Jennifer BilottaCaitlin Ganley on LinkedInJennifer Bilotta on LinkedInLocal NonprofitsLCH Health & Community ServicesWomen's Resource Center (WCS)Chester County Food BankUnited Way of Greater Philadelphia and Southern New JerseyChester County Chamber of Business & IndustryCharles A. Melton Arts & Education CenterOscar Lasko YMCA and Childcare CenterAdditional LinksPennsylvania Broadband Development AuthorityDigital Alliance of Chester CountyOpa TavernaCarlino'sRelated EpisodesAddressing Health Needs of Underserved Communities with Ronan GannonTranscriptThe full episode transcript will be posted on our website as soon as it is available.

Why do audits still trigger panic even at companies with strong quality systems? Sneha Saggurthi — a quality compliance manager and lead auditor in cell therapy — breaks down the gap between being compliant and being audit ready, and shares the psychology, patterns, and logistics that actually determine inspection outcomes.Sneha discusses how auditors think and prioritize, why logistics matter more than most companies realize, and the specific psychological techniques auditors are trained to use — including how to handle them.A few of Sneha's key takeaways:Being compliant and being audit ready are not the same thing — compliance is your documentation; readiness is your logistics, your plan, and your ability to defend your approachAuditors think in terms of SISPQ (safety, identity, strength, purity, quality) — everything rolls up to whether the product has those attributesLogistics are the make or break — fast document retrieval, defined roles, and coordinated teams create more auditor confidence than perfect systems with slow accessBatch records are the most common rabbit hole — have a storyboard ready for anything you put in front of an auditorTrain your floor staff to be comfortable with auditors, not to hide from them — use internal audits as practiceAuditors use strategic silence, open-ended questions, and deliberate friendliness to get people talking — train your team to give concise answers and redirect to documentationThe daily question that changes everything: "If someone reads this two years from now, will they know what happened?"About Sneha SaggurthiSneha Saggurthi is Quality Compliance Manager at Cartesian Therapeutics, a cell therapy company, where she manages inspection readiness, supplier quality, and the audit program. She holds an ASQ Certified Quality Auditor (CQA) credential and a Lean Six Sigma Green Belt, with prior quality and training roles at Catalent, Precision For Medicine, and Charles River Laboratories. She is an adjunct instructor at Frederick Community College and serves as Vice Chair of Young Women In Bio.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

In this episode of Revamping Retirement, Pete Ruffel and Jennifer Doss sit down with Kelsey Mayo, Chief of Retirement Policy and Regulatory Affairs at the American Retirement Association, to unpack the Department of Labor's newly proposed rule on fiduciary duties and the selection of designated investment alternatives (DIAs). Mayo explains why the rule is asset-class neutral, how it aims to recalibrate litigation standards, and what the DOL is signaling to both fiduciaries and the courts. With the 60-day comment period underway, this episode offers timely insight into what plan sponsors and fiduciaries should be thinking about now and what may come next.

Why are there over 400 phase three oncology programs but only one in dialysis? John Butler, who has spent over 30 years in the kidney disease space, breaks down the regulatory and reimbursement dynamics that have created a surge of innovation in rare kidney diseases while leaving dialysis patients behind, and what it would take to change that.John discusses how FDA clarity on endpoints transformed the rare kidney disease investment landscape, why the dialysis bundle makes innovation functionally impossible for providers, and how the Kidney Care Access Protection Act could be the first meaningful step toward a sustainable path for new dialysis therapies.A few of John's key takeaways:Regulatory clarity is the single biggest driver of rare kidney disease investment — FDA's work with industry to define approvable endpoints changed the entire landscapeThe dialysis bundle is structurally hostile to innovation — at $280 per session for all services, supplies, and drugs, there's no room for new therapiesThe Corsuva story is a cautionary tale — a good product at a reasonable price failed because the payment mechanism didn't workK-CAPA could change the calculus by extending the TDAPA window to three years and shifting to pay-per-use reimbursementInvestors are willing to take clinical risk, but they need a clear path to both approval and paymentFDA and CMS are generally better when they don't try to coordinate — FDA should focus on science and benefit-risk, not system costThe science is moving upstream — SGLT-2s, GLP-1s, porcine kidney transplants, and wearable kidneys all point toward a future with fewer patients on dialysisAbout John ButlerJohn Butler is President and CEO of Akebia Therapeutics, where he has led the company for over 12 years. He has worked in kidney disease since 1991, with roles at Amgen and 13 years at Genzyme leading the renal and rare disease businesses. John chaired the American Kidney Fund and Kidney Care Partners, and recently testified before the House Ways & Means health subcommittee on dialysis innovation and reimbursement reform. He holds an MBA from Baruch College's Zicklin School of Business and a BA in Chemistry from Manhattan University.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

The US public policy landscape continues to evolve and impact US and global businesses. We cover key developments in Washington, D.C., including tariffs, AI, and other areas as well as at the SEC and PCAOB, along with what it all means for financial reporting and strategic decision-making.In this episode, we discuss:1:04 – Overview of the 2026 public policy environment and business implications 4:17 – Affordability challenges and limits of policy solutions9:35 – Tariff strategy shifts and ongoing uncertainty for businesses13:43 – SEC and PCAOB priorities and leadership changes 27:51 – INVEST Act and the outlook for capital formation 31:06 – AI governance and the fragmented state and federal approach 36:48 – Key takeaways and what businesses should monitor in 2026For more on tariffs, listen to our recent episode, Tariff uncertainty: Business and financial reporting impacts. Be sure to follow this podcast on your favorite podcast app and subscribe to our weekly newsletter to stay in the loop. About our guestsRoz Brooks is PwC's US Public Policy Leader. Roz is responsible for ensuring PwC has a voice in important debates at the nexus of business and government and helping the firm successfully execute its business strategy. Roz leads PwC's engagement with Congress, the White House, regulatory agencies, state and local governments, and organizations including trade associations, think tanks, and NGOs.Michael O'Brien is a PwC Director in the Office of Government, Regulatory Affairs & Public Policy. Michael represents the firm and its interests before Congress, the Executive Branch and federal regulatory agencies. He has advocated on the firm's behalf on matters including the implementation of Sarbanes-Oxley and Dodd-Frank, state and federal taxation matters, IFRS, litigation reform, and the competitiveness of the U.S. capital markets. Besides assisting in general lobbying activities, Michael has researched and developed periodic political analyses and strategies for firm distribution.About our guest hostKyle Moffatt is PwC's Professional Practice leader, leading a team responsible for working with standard setters and regulators as well as delivering brand-defining thought leadership and educational materials. He also consults with engagement teams and audit clients on SEC reporting matters. Before PwC, Kyle spent almost 20 years with the SEC, most recently as Chief Accountant and Disclosure Program Director in the Division of Corporation Finance.Transcripts available upon request for individuals who may need a disability-related accommodation. Please send requests to us_podcast@pwc.com.Did you enjoy this episode? Text us your thoughts and be sure to include the episode name.

Discusses the regulation of cell therapy products and the importance of training on this topic.  Our guests today are Kathy Loper and Jared Schuster.  Kathy serves as the Director of Regulatory Affairs for NMDP, a nonprofit providing life-saving cellular therapies to patients. Kathy has extensive experience in biological product manufacturing and works closely with regulatory agencies, professionals, and other organizations to move the industry forward. Jared also has extensive experience in biotech, specializing in cell therapy CMC, regulatory strategy, and analytical development. He has held scientific, quality, and regulatory roles throughout his career, and is clinically certified as a Histotechnologist and Advanced BioTherapies Professional. At NMDP, he oversees regulatory CMC and strategy functions for cell and gene therapy programs, focusing on procurement of cellular starting materials.  Additional resources: NMDP: https://www.nmdp.org/ Regulation of Cell Therapy course: https://about.citiprogram.org/course/regulation-of-cell-therapy-products/ CITI Program's course catalog: https://about.citiprogram.org/course-catalog 

The first panel discussion from the Gray Center's Fall 2025 conference featuring: James Burnham, King Street Legal, and formerly of the U.S. Department of Government Efficiency Susan Dudley, former Administrator, White House Office of Information and Regulatory Affairs; Founder & Senior Scholar, GW Regulatory Studies Center; Distinguished Professor of Practice, Trachtenberg School of Public Policy […]

The first panel discussion from the Gray Center's Fall 2025 conference featuring: James Burnham, King Street Legal, and formerly of the U.S. Department of Government EfficiencySusan Dudley, former Administrator, White House Office of Information and Regulatory Affairs; Founder & Senior Scholar, GW Regulatory Studies Center; Distinguished Professor of Practice, Trachtenberg School of Public Policy & Public AdministrationLisa Heinzerling, Georgetown University Law CenterModerator: Mene Ukueberuwa, Wall Street Journal

What does it actually take to navigate global regulatory filings across the FDA, EMA, and PMDA, and why do so many programs stumble despite technically harmonized dossiers? AJ Acker draws on about 30 years of rare disease regulatory experience to break down the real differences between regions and the strategies that drive successful multi-regional approvals.AJ discusses why ICH compliance doesn't equal regulatory alignment, how Japan's evolving regulatory landscape creates both opportunity and complexity, and why the preparation that starts early in development (not at submission) is what determines whether a program achieves tight global approval timelines.A few of AJ's key takeaways:FDA, EMA, and PMDA share the same goal but ask fundamentally different questions — sponsors need to understand each lens, not just the shared scienceICH harmonization provides a common foundation, but technical alignment is not regulatory alignment — region-specific engagement is essentialStart planning for all three regions early, especially Japan — PMDA will ask why they weren't included in early developmentExpect different regulators to want different endpoints from the same data — early conversations prevent study design misalignmentLocal regulatory experts and ex-regulators are most valuable as strategic advisors and early warning systems, not just document producersSimultaneous filings are becoming the norm, but resource planning for parallel review cycles is criticalAI is emerging as a tool for sharpening submission strategy — not replacing expertise, but catching gaps human reviewers might missAbout AJ AckerAJ Acker is Senior Vice President of Regulatory, Quality & Clinical Safety at Annexon Biosciences. He has about 30 years of pharmaceutical industry experience with a focus on rare diseases and global regulatory approvals across the FDA, EMA, and PMDA. Prior to Annexon, AJ led global regulatory affairs at Zogenix (including serving as President of Zogenix Japan K.K.) and held regulatory leadership roles at Bioskin, Santen, and BioMarin. He is an Oregon State University alumnus.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

In this episode, host Etienne Nichols speaks directly to professionals in industries like automotive, aerospace, and manufacturing who are looking to transition into MedTech. Drawing from his own experience moving from aerospace to medical devices, Etienne demystifies the industry's high barriers to entry and explains why your existing skills are more valuable than you might think.The conversation centers on the "three doors" of entry: Quality, Regulatory Affairs, and Product Development. While each path has unique requirements, Etienne emphasizes that foundational skills like project management, root cause analysis, and technical writing are the true drivers of success. He also clarifies the shift in mindset required to work in a highly regulated environment where "move fast and break things" is replaced by rigorous documentation and risk-management protocols.Finally, Etienne provides a five-step roadmap for career switchers, ranging from learning the regulatory language to networking with intention. He concludes with a powerful reminder that technical competence is only the entry fee; long-term career growth in MedTech requires mastering the "layer above"—communication, visibility, and storytelling.Key Timestamps00:00 – The "career switcher" mindset: Why MedTech is a stable and fulfilling choice.03:15 – The Regulatory Universe: Comparing IATF 16949 and AS9100 to ISO 13485 and 21 CFR Part 820.06:42 – Door #1: Quality. Roles in quality systems, auditing, and why "document control is document control."10:15 – Door #2: Regulatory Affairs. How to break into the most specialized sector of MedTech.13:50 – Door #3: Product Development. Designing with guardrails and the importance of design controls.17:30 – Transferable Skills: Project management (PMP), root cause analysis, and process validation (IQ/OQ/PQ).22:10 – What doesn't transfer: The reality of MedTech speed and the death of "good enough" thinking.26:45 – 5 Steps to making the jump: Language, credentials, networking, targeting, and honesty.32:15 – The Layer Above Competence: Navigating workplace politics and the "Workplace Poker" philosophy.Quotes"In automotive, a quality failure means a recall. In MedTech, a quality failure could mean that somebody gets hurt. It changes the math." - Etienne Nichols"If we didn't document it, it didn't happen. Getting used to that level of rigor is one of the biggest adjustments career switchers face." - Etienne NicholsTakeawaysFocus on the QMS Foundations: If you are coming from a quality background, prioritize learning ISO 13485 and ISO 14971 (Risk Management). These are the global languages of MedTech quality.Document Everything: Successful MedTech professionals must transition from "casual" documentation (emails/memos) to formal Design Controls, where every input has a verified output.Leverage Cross-Industry Skills: Lean on your experience in Six Sigma, Root Cause Analysis (RCA), and Process Validation; the statistics are the same, even if the regulatory "overlay" is different.Target Mid-Sized Companies: While big names like J&J are attractive, medium-sized companies or Contract Manufacturers (CMOs) often provide better mentorship and a faster learning curve for newcomers.Master "The Layer Above": Technical skills get you hired, but visibility and the ability to communicate technical risks to non-technical stakeholders are what lead to promotions.MedTech 101 SectionIQ/OQ/PQ (Process Validation) Think of this like baking a signature cake for a high-stakes competition.IQ (Installation Qualification): Did you plug the oven in correctly and is it the right model? (Is the equipment installed right?)OQ (Operational Qualification): Does the oven actually hit 350°F when you turn the dial, and does it stay there? (Does it work at its limits?)PQ (Performance Qualification): Can you bake ten perfect cakes in a row using your actual ingredients and staff? (Does the process consistently produce a good product?)ReferencesISO 13485:2016: The international standard for medical device quality management systems.21 CFR Part 820 / QMSR: The FDA's requirements for medical device manufacturers.RAPS (Regulatory Affairs Professionals Society): Recommended for Regulatory Affairs Certification (RAC).Workplace Poker by Dan Rust: A recommended read for navigating office politics and career growth.Etienne Nichols' LinkedIn: Connect with Etienne hereSponsorsThis episode is brought to you by Greenlight Guru. If you are transitioning into MedTech, you'll quickly realize that documentation is everything. Greenlight Guru offers the only dedicated Quality Management System (QMS) and Electronic Data Capture (EDC) solutions designed specifically for the medical device industry. Whether you are navigating your first clinical trial or scaling a quality system from scratch, Greenlight Guru helps you move faster while staying compliant.Feedback Call-to-ActionWe want to hear your story! Are you trying to make the jump into MedTech, or have you recently made the switch? Send your questions, topic suggestions, or feedback to podcast@greenlight.guru. Etienne reads every email and provides personalized responses to help you on your journey. We'd also love for you to leave a review on your favorite podcast platform!

On this episode of the IPhO Podcast, we are joined by Raj Shah, Associate Principal Scientist and Regulatory Affairs Liaison in Neuroscience at Merck, and Timothy Haji, Associate Director in U.S. Regulatory Affairs at Merck and former Rutgers RPIF Regulatory Affairs Fellow. Raj and Tim share how their careers in the pharmaceutical industry began, one through direct entry and the other through a regulatory affairs fellowship, and discuss the opportunities, challenges, and mentorship that helped shape their paths. They explore key topics for students and early-career professionals, including the differences between fellowship and direct entry roles, how to build credibility early in your career, and the importance of networking, communication, and presentation skills in industry. They also touch on the growing role of artificial intelligence in regulatory work, along with practical advice on mentorship, professional development, and making the most of opportunities throughout pharmacy school and beyond. Listen in now!

Are you using the right contract for your building projects in Texas?In this episode of the Your Project Shepherd Podcast, Curtis Lawson sits down with three industry leaders to unpack the value, structure, and legal protection behind TAB Contracts:Frances Blake – General Counsel & VP of Regulatory Affairs, Texas Association of BuildersAdam Aschmann – Senior Vice President & General Counsel, Tilson HomesDonald Shelton – Attorney/Shareholder, Bush Rudnicki Shelton, PCTAB (Texas Association of Builders) contracts are specifically written for residential construction in Texas — and they're designed to protect builders operating under Texas law.In this conversation, we cover:Why TAB contracts exist and how they differ from generic templatesCommon contract mistakes that expose builders to unnecessary legal riskHow properly structured agreements protect both builders and homeownersThe role contracts play in dispute prevention and risk managementWhy professional builders should treat contracts as a strategic tool — not just paperworkIf you're a custom home builder, remodeler, or residential contractor in Texas, this episode will help you better understand how to protect your business and operate more professionally.Contracts aren't just legal documents — they set expectations, define relationships, and can determine whether a project ends in success or in court.Listen in and learn why TAB contracts may be one of the most important investments you make in your business.

Today, I'm joined again by Laura Leigh Oyler, VP of Regulatory Affairs at HAYPP to talk about the latest going-ons in the world of tobacco and nicotine regulation in the US!For all the breaking snus news, newest reviews, and extensive information - http://www.Snubie.comSnubie Podcast - http://www.PouchCast.comSocial Media:Facebook - http://www.Facebook.com/SnubieInstagram - http://www.Instagram.com/SnubieDotComTwitter/X - http://www.X.com/SnubieDotComReddit - http://www.reddit.com/r/SnubieDotCom

From global trade shows to major tariff and trade developments, ABC's Global Technical and Regulatory Affairs team breaks down what matters most in highlights from their February Global Update. Tune in to this Almond Byte episode for key takeaways on international market access, evolving trade agreements, and why global engagement remains critical for U.S. almonds.

Please enjoy this encore of Career Notes. Lauren Van Wazer, Vice President, Global Public Policy and Regulatory Affairs for Akamai Technologies, shares her story as she followed her own North Star and landed where she is today. She describes her career path, highlighting how she went from working at AT&T to being able to work in the White House. She shares how she is a coach and a leader to the team she works with now, saying "my view is I've got their back, if they make a mistake, it's my mistake, and if they do well, they've done well." Lauren hopes she's made an impact in the world by making it a little bit better than before, and discusses how she doesn't let anyone stop her from her goals. Lauren shares her outlook on her experiences, calling attention to different roles in her life that made her journey all the better. We thank Lauren for sharing. Learn more about your ad choices. Visit megaphone.fm/adchoices