Podcasts about Regulatory affairs

When a regulator asks what the downside is of adding one more testing requirement, what is the downside? Just a little more safe. Just in case. Especially when adding one more item to an already exhaustive testing panel. That logic is how licensed cannabis markets end up buried under compliance layers copied from other states, calibrated to someone else's problems. It is also exactly how two adjacent markets with nearly identical consumer bases, Ohio and Michigan, ended up with completely different market structures.  What they do not share is regulatory philosophy. When one state watches another add a rule and asks itself whether it should do the same, the answer it lands on shapes the entire cost structure of every licensed operator inside its borders. Ohio learned to ask the follow-up question. Most states never do. Ohio closed the intoxicating hemp loophole on March 20th, ahead of the federal government, and those shops are starting to close. The next unlock may already be here: THC beverages reaching the customers who will never walk into a dispensary, sold at the restaurant down the street. This week we sit down with Caroline Henry, VP of Government and Regulatory Affairs at Buckeye Relief. The regulator FOMO problem Ohio vs. Michigan: two markets, one lesson THC beverages as the dispensary gateway     Chapters 00:00 The Disconnect in Cannabis Perception 03:12 Navigating Stigma and Misconceptions 05:48 Regulatory Challenges and Industry Standards 08:55 Building Relationships with Regulators 11:54 Small Wins in Regulatory Negotiations 15:02 The Impact of Over-Regulation 17:48 Child-Resistant Packaging and Its Irony 25:38 Navigating Regulatory Challenges in the Cannabis Industry 26:00 The Role of Beverages in Reducing Stigma 30:37 Learning from Michigan: Ohio's Cannabis Strategy 39:31 Focusing on Ohio: The Case for Local Expertise 44:00 The Realities of Working in the Cannabis Industry   Guest Links www.buckeyerelief.com www.amplifydispensary.com Our Links: Bryan Fields on Twitter The Dime on Twitter Extraction Teams: Want to cut costs and get more out of every run? Unlock hidden revenue by extracting more from the same input—with Newton Insights. At Eighth Revolution (8th Rev), we provide services from capital to cannabinoid and everything in between in the cannabinoid industry. The Dime is a top 5% most shared  global podcast The Dime is a top 10 Cannabis Podcast  The Dime has a New Website. Shhhh its not finished.

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.

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

Chuck Spencer, Government Relations Executive Director, and Kennedy Ebner, Government and Regulatory Affairs, both from Growmark, join the program to discuss legislative efforts.Doug Cropp, Premiere Co-Op, takes a look at market movements, including beans up double figures.

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

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.

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/

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!

What actually changes for regulatory leaders when they move between large pharma and small biotech, and what stays the same? Tammy Sarnelli draws on over 35 years of experience across organizations of every size to break down the real differences in workload, risk tolerance, resource access, and culture.Tammy discusses how organizational silos create friction in large companies, why limited resources at small companies can actually accelerate decision-making, and how risk tolerance shapes not just strategy but the speed at which products move forward, especially in rare disease.A few of Tammy's key takeaways:Regulatory expectations are the same regardless of company size — it's the day-to-day experience and workload distribution that differSilos in large organizations restrict collaboration and can fragment how a company approaches health authority interactionsSmall companies benefit from "all-in thinking" — fewer programs mean faster alignment, but leaders must fill multiple roles simultaneouslyRisk tolerance is cultural, not organizational — when people aren't punished for good-faith decisions, they move fasterRegulatory "failure" can mean not taking a chance when you had one, especially in rare disease where patients can't waitAI is shifting medical writing from structured formatting toward strategy and interpretation — but adoption speed depends on resourcesAbout Tammy SarnelliTammy Sarnelli is Senior Vice President and Global Head of Regulatory Affairs and Clinical Quality at Amylyx Pharmaceuticals. She has over 35 years of regulatory experience spanning Biogen (27 years), Bioverativ, EMD Serono (Merck KGaA), and Amylyx, working across therapeutic areas and organization sizes with a sustained focus on rare disease. She holds a Master's degree in Public Administration from Suffolk University and a Bachelor's degree in Biology from Saint Anselm College.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/

Food suggestions are all well and good and mostly harmless, but when they shift into health-related claims, real risks can appear. As the internet is able of producing one opinion and its opposite, Gail Caroll Director of Regulatory Affairs and Compliance Building at the Food Safety Authority Ireland warns that some words may be too good to be true.

How should life science companies govern their data to meet increasingly structured regulatory submission requirements and actually get value from AI? Cary Smithson shares lessons from decades of helping organizations modernize their regulatory, quality, and R&D operations.Cary discusses why data governance has become urgent across three fronts — structured submissions, cross-functional interoperability, and AI reliability — and walks through the foundational steps companies should take, the organizational challenges they'll hit, and what measurable results look like when governance is done right.A few of Cary's key takeaways:Regulatory submissions are no longer just documents — they're structured data that demands consistent master data, controlled vocabularies, and traceable lineageStart with scope and pain points, not a boil-the-ocean exercise — pilot governance in one or two high-value use cases, then scaleData ownership belongs in the business, not IT — IT facilitates, but stewards and business owners should be accountable for their dataTools support governance but don't replace it — get the people and process foundation right before selecting platformsAI reliability depends on governed data — without standardized inputs and clear provenance, models produce unreliable or unexplainable outputsTie governance to business outcomes people are already measured on — submission cycle time, audit readiness, right-first-time metrics — or compliance won't stickAbout Cary SmithsonCary Smithson is Managing Partner and Owner of LeapAhead Solutions, Inc., where she leads a consulting practice focused on IT strategy, data governance, and business process consulting for life sciences. She leads the DIA RIM Working Group and the DIA RIM Intelligent Automation Team and co-authored the DIA RIM eBook. With experience spanning large consulting firms (Grant Thornton, PharmaLex), enterprise technology organizations (OpenText), and her own practice, Cary has served clients including Regeneron, Bristol-Myers Squibb, Johnson & Johnson, Daiichi Sankyo, Bayer, and BeiGene. She is a recognized thought leader who regularly presents at industry conferences on regulatory information management, intelligent automation, and AI adoption in life sciences.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 Current Account, Clay is joined by Doug Elliott, Partner at Oliver Wyman, and Andrés Portilla, Managing Director of Regulatory Affairs at the IIF, to take a closer look at the growing global debate over regulatory modernization. Fifteen years after the Global Financial Crisis led policymakers to introduce an expansive set of rules designed to reinforce financial stability, many jurisdictions are now questioning whether the existing framework has become overly complex, duplicative, or limiting to growth. Together, Clay, Doug, and Andrés unpack what modernization really means today, whether it is simplification, de‑layering, right‑sizing, or true deregulation, and why the conversation is gaining urgency across markets. Doug lays out the philosophical and practical forces behind modernization efforts globally, while Andrés discusses the findings of the recent IIF Report, "Modernization and Simplification — Revamping the Global Banking Regulatory Framework" - underscoring how overlapping constraints and diverging national interpretations create unnecessary friction for banks operating across borders. The discussion also turns to the ongoing debate over central bank independence, an issue increasingly intertwined with the regulatory modernization agenda. They examine how these debates differ across jurisdictions, how they may influence regulatory decision‑making, and why a credible, independent regulatory framework remains essential for market confidence. In addition, the conversation assesses the role of global standard setters, including the Financial Stability Board and the Basel Committee, in helping ensure consistency as countries revise their approaches at different paces. Clay and his guests discuss why maintaining coherence across borders is critical, even as national politics, growth priorities, and competitive pressures pull policymakers in different directions. 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.

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.

Send a textIn this episode of Beyond the Numbers, Kevin sits down with Julie Molendorp Floyd—Vice President of Regulatory Affairs and Dean of Students at RSDS Appraisal—for a candid conversation about risk, regulation, mentorship, and the future of the appraisal profession.They also explore innovative pathways into the profession, including RSDS's Appraisal U practicum model, and discuss why curiosity—not fear—is the right response to shifts like UAD 3.6. Whether you're just entering the field or decades into your career, this episode offers perspective, encouragement, and a forward-looking view of where appraisal is headed.

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.

How do you build an organization that can absorb change, learn from failure, and keep patients at the center—even when the science is uncertain? Nelly Viseux shares lessons from over 20 years in biotech and a decade leading cell and gene therapy development.Nelly discusses how she structured a 100-person CMC organization at Regeneron to balance innovation with operational execution, why documenting your assumptions is critical to managing risk, and what it really takes to maintain resilience when you're literally holding patient lives in your hands.A few of Nelly's key takeaways:Resilience is adaptability—build organizations that absorb and anticipate change rather than resist itSeparate innovation from execution with intentional gates for when new approaches are ready to implementDocument your assumptions so you can revisit decisions effectively when circumstances changeFailure is a process problem, not a personal one—root cause analysis should improve systems, not assign blameData is the common language that aligns scientists, regulators, and stakeholdersEveryone is a leader in cell therapy—manufacturing and QC teams hold patient lives in their handsAbout Nelly ViseuxNelly Viseux is Vice President of Cell Therapies Development, Manufacturing, Supply & Quality at Regeneron, leading a 100-person organization supporting autologous cell therapy programs. She has over 20 years of biotechnology experience spanning large pharma (Shire, Biogen, Baxter) and startups, working across cell and gene therapies, biologics, and nanoparticles. Her accomplishments include building a Phase 1 cell therapy manufacturing facility that achieved 100% cGMP success and first IND submission within two years. She holds a Ph.D. in Biochemistry and Molecular Biology from University of Lille and is a member of the Society for Immunotherapy of Cancer and the American Society of Gene & Cell Therapy.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/

Based on AHLA's annual Health Law Connections article, this special ten-part series brings together thought leaders from across the health law field to discuss the top ten issues of 2026. In the second episode, Zi Peng, Managing Director, StoneTurn, speaks with Alya Sulaiman, Chief Compliance and Privacy Officer & SVP of Regulatory Affairs, Datavant, about some of the primary issues around artificial intelligence (AI) in health care as organizations plan for 2026. They discuss the use of AI in prior authorization and utilization management, tensions between the federal government and the states over AI regulation, and actionable steps health care organizations should take to mitigate risk and ensure responsible AI deployment. Sponsored by StoneTurn.Watch this episode: https://www.youtube.com/watch?v=LCJ5w4CN-QoRead AHLA's Top Ten 2026 article: https://www.americanhealthlaw.org/content-library/connections-magazine/article/a879dda5-35f9-46fb-ad45-1b0799343d74/Health-Law-Forecast-2026Access all episodes in AHLA's Top Ten 2026 podcast series: https://www.americanhealthlaw.org/education-events/speaking-of-health-law-podcasts/top-ten-issues-in-health-law-podcast-seriesLearn more about StoneTurn: https://stoneturn.com/ Essential Legal Updates, Now in Audio AHLA'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 Education Learn more about AHLA and the educational resources available to the health law community at https://www.americanhealthlaw.org/.

The past few years have been a critical time in the development of data privacy laws and the regulation of AI in the United States. As we look toward 2026, the complexities are only increasing. In this episode, the Antitrust Law Section's Privacy and Information Security (PRIS) Committee joins forces with OCA to focus on the highlights of 2025 and predictions for 2026. Hosts Alicia Downey and Anora Wang talk to PRIS Committee vice chairs Jessica Cohen of Verizon Communications and Alex Brown of Alston & Bird about why the next 12 months could redefine how AI and data privacy are regulated at the federal and state levels. In addition, listeners will hear from Jessica about being a mother of five, and get an update on Walter, a beauty pageant-winning dog, who was just a puppy when Alex was a featured guest on OCA Episode #89 back in 2020. With special guests: Jessica Cohen, Senior Counsel, Regulatory Affairs, AI, Cybersecurity & Privacy, Verizon Communications and Alexander G. Brown, Partner, Alston & Bird LLP Related Links: Kathleen Benway, Alexander G. Brown, Maki DePalo, Jennifer C. Everett, Graham Gardner & Hyun Jai Oh, "Flurry of FTC Activity Shows Enforcement Emphasis on Youth Protection," 12 PRATT'S PRIVACY &CYBERSECURITY LAW REPORT 8 (LexisNexis A.S. Pratt 2026) Alexander G. Brown & Katherine Doty Hanniford, "First 100 Days – Federal Privacy and Cybersecurity Regulation and Enforcement Under the Second Trump Administration," Alston & Bird Advisory (May 8, 2025) Our Curious Amalgam, Episode #89 What's the Deal with Data Portability? Understanding the Competition and Privacy Aspects Surrounding the Movement of Data, November 30, 2020, featuring Alex Brown Hosted by: Alicia Downey, Downey Law and Anora Wang, Arnold & Porter

In this episode of Product & Packaging Powerhouse, Megan Young Gamble talks with regulatory specialist Mo Lovelace , co-CEO of Steinberg & Associates, about the evolving landscape of cosmetic product regulations. They discuss the impact of the Modernization of Cosmetics Regulation Act (MOCRA), which now mandates FDA registration for both products and manufacturing facilities, no matter the brand size. Mo Lovelace breaks down responsibilities brands have for reporting adverse events, labeling compliance, and the significance of ingredient bans at both federal and state levels (especially California's new requirements). The conversation emphasizes the importance of regulatory specialists in product development, best practices around documentation, and how brands, big or small, should prioritize compliance to prevent costly mistakes. Plus, there's practical advice on substantiating marketing claims and tips for surviving regulatory changes in 2026. The episode wraps with a fun rapid-fire round exploring Mo Lovelace's passion for tennis and family life.Affiliate & Other Links:[Megan Young Gamble Links][AFFILIATE] Ready to crank out your content in as little as 5 minutes? Use Castmagic, AI powered tool to take your content creation from overwhelmed to overjoyed by saving hours of developing content. Save 20 hours by Signing up today! https://get.castmagic.io/Megan [FREEBIE] Learn about “day in the life” of a Packaging Project Manager → Get our “Starter Packaging PM Freebie” [link] https://glc.ck.page/thestarterpackagingprojectmanager [FREEBIE] Access commonly referenced organizations and tools in ONE PLACE with our handy guide HERE [link] https://bit.ly/OSTPlay Subscribe & Access our Video Vault YouTube Channel [ link] https://bit.ly/GLConYouTubeJoin our Email List [link] https://glc.ck.page/55128ae04b Follow and Connect with Megan on LinkedIn [link] https://linkedin.com/in/megangambleLearn about GLC, Packaging & Project execution firm for CPG brands http://www.getlevelconsulting.comWork with Me @ GLC, Schedule Discovery Call https://calendly.com/getlevelconsulting/15-minute-insight-sessionGot a topic you'd love us to cover? Share your ideas here [link] https://bit.ly/ppptopicform[Powerhouse Guest Mo's LINKS]LinkedIn: https://www.linkedin.com/in/moyin-lovelace-2743a792/Company Website : https://www.steinbergandassociates.comEmail Address:  mo@steinbergandassociates.comAdditional Resource links: Sustainable Packaging Coalition: https://sustainablepackaging.org/Circular Action Alliance: https://circularactionalliance.org/Independent Beauty Association (IBA): https://independentbeauty.org/ Quotes:An ounce of prevention will save you a whole lot of money at the other end.From the FDA and FTC standpoint, your claims should always be truthful and not misleading.I don't want my brands to launch products out here and they're not compliant.Clean does not mean safeYou should be starting now, because as your brand grows, you already understand what compliance looks like.Conquer the US first, build your business here, and then look into going elsewhere.The stronger your claims are, the stronger your data to support that claim should be.

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

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

Allegations of politically motivated “debanking” have intensified debate over how federal regulation, supervisory practices, and concerns about “reputation risk” influence banks’ decisions about which customers to serve. In recent months, the President issued an Executive Order directing agencies to reexamine supervisory and risk-management frameworks, while the banking regulators themselves have taken steps related to supervision, anti-money-laundering obligations, and the treatment of reputation risk—often implicating questions surrounding confidential supervisory information. At the same time, Congress and stakeholders across the financial sector continue to grapple with the scope and meaning of federal “fair access” standards and what they might require of banks going forward.With these developments unfolding in parallel, important questions remain unresolved. What role should the government play in shaping banks’ customer relationships? How should supervisory expectations be calibrated, and what legal clarity—whether legislative or regulatory—might be needed to strike the proper balance?Please join the Federalist Society on Wednesday, January 7, at 12 PM ET for a virtual discussion exploring these issues and examining where regulators and lawmakers may go from here. Featuring: John Berlau, Senior fellow and Director of Finance Policy, Competitive Enterprise InstituteTabitha Edgens, Executive Vice President & Co-Head of Regulatory Affairs, Bank Policy InstituteBrian Knight, Senior Counsel, Corporate Engagement Team, Alliance Defending Freedom(Moderator) John Heltman, Washington Bureau Chief, American Banker

In this episode, Diana O'Lare sits down with Phil Crone, Vice President of State and Regulatory Affairs at Leading Builders of America, for an in-depth conversation on the U.S. housing affordability crisis—and what political and regulatory hurdles exist. Together, they unpack the real-world challenges driving up costs and limiting supply, including permitting delays and the need for reform, the growing burden of regulatory and compliance costs, and how factors like institutional buyers and workforce shortages are reshaping the housing market. They also explore the evolving role of energy efficiency requirements, as well as the design, infrastructure, and construction innovations that could help accelerate production and expand access to more attainable homes. Tune in for a thoughtful discussion on the policies and solutions that can help make housing more affordable for more Americans.

In this episode, James talks with Craig Gordon, Head of Global Policy, Regulatory Affairs, and Business Development at Mainspring Energy. Craig brings deep experience in clean energy—from scaling Invenergy's wind and solar projects to shaping U.S. energy policy with the American Clean Power Association. Today, he's helping Mainspring redefine dispatchable generation for a rapidly electrifying world.They discuss how Mainspring's linear generator technology offers a modular, dispatchable solution ideal for the growing energy demands of hyperscale data centers. Craig shares insights on the importance of fuel flexibility, how the Inflation Reduction Act has reshaped deployment dynamics, and the policy shifts enabling faster, cleaner energy integration behind the meter.How Mainspring's linear generator bridges the gap between renewables and dispatchable generationThe role of fuel-flexibility (natural gas, hydrogen, ammonia) in enabling resilient sitingWhy data center load growth is stressing legacy regulatory frameworksHow recent FERC policy shifts are opening new doors for behind-the-meter innovationA must-listen for developers navigating grid constraints, data center energy needs, and next-gen dispatchable tech.Paces helps developers find and evaluate the sites most suitable for renewable development. Interested in a call with James, CEO @ Paces?

Welcome to Season 3 of ANCOR Links!There's a lot of talk about Medicaid these days, so we decided to resurrect the premise of a quirky show, and bust some Medicaid myths!Donna Martin, VP of State Partnerships & Innovation, and Tom Rice, Director of Policy & Regulatory Affairs, sat down with Tricia DePalatis, Membership Coordinator, to discuss ten myths about the Medicaid program. Join us as we dive deep into one of the federal government's most misunderstood programs.=================This podcast is produced by ANCOR, the leading voice in Washington, DC, for providers of services for people with disabilities. Views expressed during the podcast do not necessarily reflect the position of ANCOR.To learn more, visit ⁠⁠⁠⁠⁠⁠ancor.org⁠⁠⁠⁠⁠⁠.=================Intro and outro music provided by YouTube Audio Library Intro Music ⓒ V for Victory - Audionautix Outro Music ⓒ Dirt Rhodes - Kevin MacLeod

The Centers for Medicare and Medicaid Services has finalized the 2026 Outpatient Perspective Payment System (OPPS) rule, with most policies taking effect on January 1, 2026. Jenna Stern, Vice President of Regulatory Affairs and Public Policy at Vizient, joins host Carolyn Liptak, Pharmacy Executive Director in Vizient's Center for Pharmacy Practice Excellence, to discuss key updates to payment policies, payment rates, and quality provisions affecting Medicare beneficiaries receiving care in hospital outpatient departments and ambulatory surgical centers.   Guest speaker:    Jenna Stern Vice President of Regulatory Affairs and Public Policy Vizient Host:   Carolyn Liptak, MBA, RPh  Pharmacy Executive Director Vizient  Verified Rx Host   Show Notes: 00:05 — Introduction Announcer welcomes listeners to VerifiedRx. Host Carolyn Liptak, Pharmacy Executive Director at Vizient, introduces the episode focus: the 2026 CMS Outpatient Prospective Payment System (OPPS) Final Rule. Guest: Jenna Stern, VP of Regulatory Affairs and Public Policy at Vizient.   01:12 — Overview of the OPPS Final Rule OPPS sets Medicare payment for most hospital outpatient services. Published annually (typically November), effective January 1. Covers payment rates, policies, quality programs, and compliance requirements. Note: CMS delayed enforcement of hospital price transparency requirements until April 1, 2026.   01:34 — Key Takeaways From the 2026 Final Rule Jenna's high-level insights: Hospitals will continue facing financial pressure in 2026. Modest payment rate increase combined with reimbursement-reducing policies. Expansion of site-neutral payment policies will be particularly impactful. Rule reflects emerging administration priorities shaping future policy.   02:21 — OPPS Payment Rate Update for 2026 CMS finalized a 2.6% OPPS schedule increase factor for hospitals meeting quality reporting requirements.   02:40 — What the 2.6% Increase means Based on: 3% market basket update –0.7% productivity adjustment Results in a modest net increase. Slightly better than the proposed 2.4% increase, though still viewed as inadequate. CMS estimates $8 billion increase in total OPPS payments compared to 2025.   03:37 — 340B Remedy Offset: Background From 2018–2022, CMS paid for 340B drugs at ASP –22.5%. Prior Supreme Court decision from 2022 found that CMS lacked authority to vary rates as finalized in prior rulemaking (e.g., without using drug acquisition cost surveys to inform policy).   04:13 — 340B Remedy Offset in the 2026 Final Rule CMS considered increasing the remedy offset from 0.5% to 2%. Stakeholders strongly opposed the increase due to hospital financial strain.   05:10 — Final Outcome CMS retained the 0.5% offset for 2026. CMS signaled that larger offsets may be proposed for 2027. This marks the first year the remedy offset takes effect,   06:00 — Site-Neutral Payment Policy: What It Is Concept: same service = same payment, regardless of site of care. Hospital concern: policy reduces hospital reimbursement without accounting for site of care differences, patient acuity, overhead, or service complexity.   06:15 — Site-Neutral Expansion in the 2026 Rule CMS expanded site-neutral payment to include drug administration services at excepted off-campus provider-based departments.   07:08 — Financial Impact Reimbursement aligns with Physician Fee Schedule rates. CMS estimates $290 million reduction in outpatient spending for 2026. $220 million of savings accrue directly to Medicare. Not implemented in a budget-neutral manner.   08:14 — Non-Opioid Pain Management Payments Temporary additional payments began January 1, 2025. Authorized under the NO PAIN Act (Consolidated Appropriations Act of 2023).   08:28 — What's New for 2026 CMS finalized the renewal of: 5 drugs 13 medical devices eligible for separate payment in HOPD and ASC settings. Per statue, payments available through December 31, 2027.   09:32 — Process Improvements CMS will allow more frequent consideration of new qualifying products (not limited to annual updates). Quality criteria unchanged; timing flexibility added. CMS released guidance on how stakeholders can engage for inclusion.   10:58 — OPPS Drug Acquisition Cost Survey CMS finalized plans to survey hospitals on acquisition costs for separately payable OPPS drugs.   11:21 — Why CMS Is Advancing the Survey Addresses Supreme Court requirements from prior 340B litigation. Aligns with White House Executive Order on lowering drug prices. Positions CMS to use survey data for 2027 rulemaking.   12:47 — OPPS Packaging Thresholds for 2026 Drugs and biologics: Threshold remains at $140. Diagnostic radiopharmaceuticals: Increased to $655 (from $630). Products below thresholds retain Status Indicator “N” (packaged payment).   13:26 — Why Billing Packaged Drugs Still Matters Even though not separately payable, hospitals must bill for packaged drugs. Billing data feeds cost reports used to calculate future bundled payments. Failure to bill can result in inaccurately low reimbursement.   14:14 — Elimination of the Inpatient-Only (IPO) List CMS finalized a three-year transition to eliminate the IPO list by January 1, 2029.   14:32 — Why This Change Is Significant IPO list historically ensured certain services were provided inpatient only. CMS emphasizes provider judgment in determining site of care. Raises concerns about: Patient safety Payer coverage changes Pressure to move services outpatient   16:28 — ASC Covered Procedure List Expansion CMS expanded the ASC Covered Procedure List. Enables more Medicare covered services to be performed in the ASC settings.   16:48 — Price Transparency: Still a Priority No major overhaul, but continued refinement. CMS exploring new uses of price transparency data beyond patient comparison.   17:46 — Most Critical Policies to Watch Jenna highlights: Modest OPPS payment increase Site-neutral payment expansion 340B remedy offset Drug acquisition cost survey Broader regulatory activity beyond OPPS   18:43 — Available Vizient Resources OPPS Final Rule Summary Government Relations & Public Policy Summaries  Advocacy   19:20 — Closing Carolyn thanks Jenna for her insights. Reminder to subscribe, like, and share feedback. VerifiedRx is produced by the Vizient Center for Pharmacy Practice Excellence.   Links | Resources:  Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots: Click Here CMS fact sheet on the Final Rule: Click Here Outpatient Prospective Payment System (OPPS) Drug Acquisition Cost Survey: Click Here Vizient Office of Public Policy and Government Relations final rule summary:  Click Here Final List of Qualifying Products for Separate Payment for non-opioid pain medications: (Table 136, pgs. 1138-1140)   VerifiedRx Listener Feedback Survey: We would love to hear from you - Please click here   Subscribe Today! Apple Podcasts Spotify YouTube RSS Feed    

Verification & Validation (V&V) plays a central role in ensuring that medical devices are safe, effective, and compliant — yet it remains one of the most challenging phases for many teams.In this podcast episode, we sit down with Aaron Joseph, medical device development expert and author of the well-known article “Top 10 V&V Fails”, to explore why V&V so often becomes a source of stress — and how teams can do better.Throughout the discussion, we cover:A clear, simple explanation of Verification vs. ValidationWhy V&V must span the entire development lifecycleHow poor requirements create downstream V&V failuresThe risks of starting V&V planning too lateHow to simplify test methods without losing rigorPractical strategies for handling failed testsHow to think about traceability without fearThe future of V&V as software and AI become more prevalentThis episode is designed to educate, demystify, and inspire QA/RA professionals, engineers, and MedTech leaders looking to build stronger, more resilient development processes.Who is Monir El Azzouzi?Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.Social Media to follow Aaron Joseph Linkedin: https://www.linkedin.com/in/ajosephprofile/Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldevice

As the year closes, this special podcast episode offers a comprehensive overview of what happened at Easy Medical Device in 2025 and the key priorities shaping 2026.The episode reflects on a full year of continuous content creation, including:Weekly podcast episodes covering global medical device regulationsIncreased focus on artificial intelligence and its impact on QA/RA rolesEducational initiatives such as EMD Mag, designed to make complex regulatory topics more accessibleDevelopment of digital tools like EasyIFU, labeling automation, and eQMS solutionsExpansion of consulting, back-office services, and international presenceThe discussion also addresses upcoming challenges:Increasing pressure on Notified BodiesRisks for late MDR/IVDR transitionsThe importance of anticipation and regulatory strategy for new and existing manufacturersMore than a recap, this episode is a strategic pause — an opportunity to reflect, learn, and prepare for the years ahead in a rapidly evolving medtech regulatory environment.Who is Monir El Azzouzi?Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.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/easymedicaldevice

The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximately €170 billion. However, since the implementation of MDR and IVDR, manufacturers—especially SMEs—have faced increasing regulatory complexity, long certification timelines, and reduced market predictability.In this podcast episode, we explore the 2025 EU proposal designed to address these challenges by simplifying regulatory processes while preserving patient safety.The discussion covers:Key shortcomings of the current MDR/IVDR frameworkThe impact on innovation, availability of devices, and SMEsThe eight reform pillars, including proportionality, digitalisation, international cooperation, and improved coordination with EMA and Notified BodiesHow upcoming EU legislation (AI Act, Cybersecurity Act, Biotech Act) will interact with medical device regulationsThis episode provides practical insights for manufacturers, regulatory professionals, and policymakers seeking to anticipate regulatory changes and adapt their strategies accordingly.Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.Links  Adam Linkedin: https://www.linkedin.com/in/adam-isaacs-rae/Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter:https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice 

Ever worry about finding yourself in a civil or criminal case as a result of your actions as a nurse?  Join the co-hosts as they welcome Attorney Rachel Giles to help us demystify nursing legal liability, including must-dos, don't-dos, and real-world pitfalls so you can protect your license, your patients, and your peace of mind. (AMSN Members Earn 0.5 CE Hours*) * This episode is eligible for 0.5 contact hours for AMSN members who listen to the episode and submit a completed evaluation through the online library. None of the individuals with the ability to control the content of this episode have any relevant financial relationships with ineligible companies to disclose. The Academy of Medical Surgical Nurses is an accredited provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation.   SPECIAL GUEST Rachel Giles, JD, MBA/MHA is a United States Army Veteran, brings over a decade of experience in health law, compliance, federal regulations, and risk management. She is dedicated to delivering innovative conflict resolution, consulting, education, and knowledge, leveraging her unique expertise to help clients and healthcare organizations navigate complex challenges in both legal and operational environments. Rachel is passionate about fostering effective communication and equitable solutions to ensure that every person feels safe and empowered to move forward confidently. Rachel's professional experience includes serving as CEO of Giles Mediation, LLC., where she assist low socioeconomic status clients mediate cases in an attempt to stay out of a long costly court battle. She was the Vice President of Compliance & Administration for AshtonBridge Capital, where she implemented risk management frameworks and compliance protocols across diverse industries such as investment, real estate, and commodity trading. Additionally, her tenure in senior roles at multiple Healthcare Organizations within the Texas Medical Center in Houston highlights her skill in mitigating risks, conducting audits, and driving quality and patient safety improvement initiatives. She is adept at contract negotiation, policy development, and litigation support, making her a trusted advisor to organizations. Academically, Rachel holds a Doctorate in Law with a specialization in Compliance, Regulatory Affairs, and Risk Management, alongside dual master's degrees in Business and Health Administration. Her credentials are complemented by certifications in Lean Six Sigma, Project Management, and Mediation. She was recognized for academic excellence, including achieving top marks in cybersecurity coursework, where she developed actionable strategies for addressing HIPAA data breaches. Her ability to merge research with practical application has been a hallmark of her professional and academic career.   MEET OUR CO-HOSTS Samantha Bayne, MSN, RN, CMSRN, NPD-BC is a nursing professional development practitioner in the inland northwest specializing in medical-surgical nursing. The first four years of her practice were spent bedside on a busy ortho/neuro unit where she found her passion for newly graduated RNs, interdisciplinary collaboration, and professional governance. Sam is an unwavering advocate for medical-surgical nursing as a specialty and enjoys helping nurses prepare for specialty certification.    Kellye' McRae, MSN-Ed, RN is a dedicated Med-Surg Staff Nurse and Unit Based Educator based in South Georgia, with 12 years of invaluable nursing experience. She is passionate about mentoring new nurses, sharing her clinical wisdom to empower the next generation of nurses. Kellye' excels in bedside teaching, blending hands-on training with compassionate patient care to ensure both nurses and patients thrive. Her commitment to education and excellence makes her a cornerstone of her healthcare team.   Marcela Salcedo, RN, BSN is a Floatpool nightshift nurse in the Chicagoland area, specializing in step-down and medical-surgical care. A member of AMSN and the Hektoen Nurses, she combines her passion for nursing with the healing power of the arts and humanities. As a mother of four, Marcela is reigniting her passion for nursing by embracing the chaos of caregiving, fostering personal growth, and building meaningful connections that inspire her work.   Eric Torres, ADN, RN, CMSRN is a California native that has always dreamed of seeing the World, and when that didn't work out, he set his sights on nursing.  Eric is beyond excited to be joining the AMSN podcast and having a chance to share his stories and experiences of being a bedside medical-surgical nurse.   Maritess M. Quinto, DNP, RN, NPD-BC, CMSRN is a clinical educator currently leading a team of educators who is passionately helping healthcare colleagues, especially newly graduate nurses. She was born and raised in the Philippines and immigrated to the United States with her family in Florida. Her family of seven (three girls and two boys with her husband who is also a Registered Nurse) loves to travel, especially to Disney World. She loves to share her experiences about parenting, travelling, and, of course, nursing!   Sydney Wall, RN, BSN, CMSRN has been a med surg nurse for 5 years. After graduating from the University of Rhode Island in 2019, Sydney commissioned into the Navy and began her nursing career working on a cardiac/telemetry unit in Bethesda, Maryland.  Currently she is stationed overseas, providing care for service members and their families.  During her free time, she enjoys martial arts and traveling. 

In this episode, Stephanie Batliner, VP of Regulatory Affairs and R&D North America for Bimeda, joined us to discuss the FDA approval process for pioneer and generic animal drugs. She also discussed veterinary devices, pharmacy compounding, counterfeit drugs, and more. This episode of Disease Du Jour is brought to you by Bimeda.GUESTS AND LINKS - EPISODE 171Host: Carly Sisson (Digital Content Manager) of EquiManagement | Email Carly (CSisson@equinenetwork.com)Guest: Stephanie Batliner, VP of Regulatory Affairs and R&D North America for BimedaPodcast Website: Disease Du JourThis episode of Disease Du Jour podcast is brought to you by Bimeda.Connect with the Host: Carly Sisson (Digital Content Manager) of EquiManagement | Email Carly (CSisson@equinenetwork.com)

In this special episode of Aerospace Unplugged, our host Adam Kress reports on location from the inaugural American Aviation Leadership Summit hosted by Honeywell Aerospace in Washington, D.C.The event gathered hundreds of aviation professionals, including regulators and lawmakers, for a series of panels that cover what's needed to ensure America remains the global leader in aviation.Throughout the day, discussions focused on major industry topics such as safety, smarter airspace management, innovation, and more—all of which are spotlighted in this episode.  Episode Highlights:Modernization as the Cornerstone of American Aviation: Explore how lawmakers and industry leaders emphasized the urgent need to modernize aviation infrastructure and airspace, highlighting government and industry collaboration as essential for progress.Integrating New Technologies for Safety and Efficiency: Understand the critical role of airspace integration and air traffic control modernization, as discussed by expert panels, in ensuring safety and operational efficiency as advanced technologies enter the market.Advancing Public Acceptance and State-Level Innovation: Learn how state initiatives, such as those in Florida, are driving modernization in advanced air mobility, drones, and ATC systems, with a focus on public acceptance and regulatory adaptation.Regulatory Pathways and the Future of Aviation Autonomy: Dive into the evolving landscape of aviation certification, autonomy, and artificial intelligence, including insights from industry CEOs and policymakers on the regulatory needs and future trends shaping national airspace and safety.Here insights from: James Currier, President and CEO, Honeywell Aerospace; Sean Duffy, U.S. Secretary of Transportation; Chairman Troy Nehls (R-TX), U.S. House Transportation Committee, Aviation Subcommittee; Rep. Sharice Davids (D-KS), U.S. House Transportation Committee, Aviation Subcommittee; Sharon Pinkerton, Senior Vice President, Legislative & Regulatory Policy, Airlines 4 America (A4A); Brandon Lint, Regulatory Affairs and Certification Specialist, Skygrid; David Murphy, Chief Architect and Product Manager, ANRA Technologies; Kevin Cox, CEO, Atlantic Vertiports; Justin Barkowski, Legislative and Regulatory Counsel, American Association of Airport Executives (AAAE); Clint Harper, Advanced Air Mobility Community Advocate; Jared Perdue, Secretary of Transportation, Florida Department of Transportation; Todd Sigler, Senior Director, Global Safety & Regulatory Affairs, Boeing; Eric Holmberg, Chief Developmental Test Pilot, Gulfstream; Captain Steve Jangelis, Air Safety Chair, Air Line Pilots Association (ALPA); Bryan Bedford, Administrator, Federal Aviation Administration (FAA); Cindy Comer, Vice President, SMS, Certification & Quality, Wisk; Scott O'Brien, Vice President, Legislative Affairs, Reliable Robotics; Dómhnal Slattery, Chairman of the Board, Vertical Aerospace; Eloa Guillotin, Co-Founder & CEO, Beyond Aero; Marc Allen, CEO, Electra; Rep. Jay Obernolte (R-CA), Co-Chair, Artificial Intelligence Task Force, U.S. House of Representatives.

We're counting down to the annual Turkey Burn, but why is there so much confusion this year?Peloton's earnings call happened. We recap the key takeaways for your fitness investment.Peloton's new event hub seems to be missing some key events.Peloton & HYROX are partnering for a special fitness event in Dallas.A weird mileage glitch is plaguing some Peloton Tread runs.Finding a Peloton showroom is now easier thanks to the new store locator on the website.mPaceline announced a major change that affects how you track your fitness data.Peloton is hiring a Head of Compliance, Policy, & Regulatory Affairs.Instructor Jon Hosking is making his way to PSNY.Hannah Corbin is featured in Oprah Daily.Get the tea! Tea Time with Cody Rigsby is officially back.Christine D'Ercole opens up about testosterone and menopause.Selena Samuela has shared her baby's due date.The latest Peloton Artist Series features the music of Anastacia.There's even more new music from Armada Music hitting the platform.SoulCycle is making a move into the strength fitness space.We share the TCO Top Five, a weekly recap of the community's favorite Peloton classes.Find out what's happening "This Week at Peloton."Our TCO Radar highlights the upcoming classes we're most excited about.New Peloton Run Club dates have been announced.The "Move As One" classes are now available.Erik Jager has a brand new 90-minute Power Zone Ride for endurance lovers.Charlotte Weidenbach has launched a new fitness program.Peloton has organized classes into several new and helpful Collections.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

In this masterclass episode of Skin Anarchy, Dr. Ekta Yadav sits down with Dr. Julie Faitg, Senior Manager of Applied Research and Regulatory Affairs at Timeline, to uncover how mitochondrial science is transforming the future of skin longevity.Dr. Feitge challenges the familiar “powerhouse” analogy, instead calling mitochondria the “CEO of the cell.” Far from passive energy producers, these organelles orchestrate communication, repair, and renewal—directly influencing collagen production, elasticity, and cellular resilience. “If your mitochondria aren't healthy,” she explains, “the entire cascade of cellular function begins to falter.”Through vivid analogies, Dr. Feitge describes how mitochondria behave differently across tissues—fueling endurance in muscles, focus in the brain, and regeneration in the skin. This adaptability, she notes, is what makes them the foundation of both vitality and longevity.The conversation dives into mitochondrial resilience, the skin's ability to repair and recover from stress. Aging begins when this resilience declines, leading to diminished energy, slower renewal, and visible signs of fatigue.Dr. Faitgd highlights Timeline's breakthrough ingredient, Mitopure® (Urolithin A)—a clinically validated compound that triggers mitophagy, the process of recycling damaged mitochondria. In trials, topical Mitopure® improved collagen expression, hydration, and firmness while reducing inflammation and UV-induced stress.Developed in Switzerland under rigorous safety and precision standards, Timeline's skincare line redefines beauty as m—a shift from treating the surface to revitalizing the source.