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On episode 109 of Astonishing Healthcare, host Justin Venneri explores pharmacogenomics (PGx) with a trio of experts: Caitlin Munro, PharmD (Clinical Partnerships Lead, Judi Health); Haleh Campbell, PharmD (Clinical Programs Administration Manager, Judi Health); and Houda Hachad, PharmD (Vice President of Clinical Operations, Aranscia). Together, they break down what PGx is, why now is the right moment for broader adoption, and how genetics can shape the way each of us processes and responds to medications.The conversation moves from the basics to the practical: where the evidence is strongest, which patients stand to benefit most, and what it takes to apply PGx in a way that's clinically responsible and genuinely useful for patients and providers. They also dig into findings from a study the Judi Health team recently presented at the Pharmacy Quality Alliance (PQA) annual meeting and explain why pharmacist support and clinical decision support, not just a lab report, make all the difference.Key TakeawaysPGx adds a piece to the puzzle; it's not a silver bullet. Pharmacogenomics looks at how inherited genetic differences affect the way a person processes or responds to medications. It narrows uncertainty and supports clinical judgment, but it doesn't replace it.Several forces are converging to make this the right moment. Testing costs have dropped, evidence-based guidelines from expert consortia are now widely adopted, and hundreds of FDA labels include pharmacogenomic information.The strongest use cases involve complexity and risk. Patients on multiple medications, those starting new therapies, and people who've had treatment failures or unexpected side effects often benefit most, especially across common drug classes like antidepressants, cardiovascular medications, and pain therapies.Human support drives engagement and trust. Rx Helix data showed that testing adoption was significantly higher among members who received clinician-led, pre-test telephone outreach.The future is proactive. With unified claims processing that combines pharmacy and medical data, leaders see a path toward PGx-enabled medication management, identifying patients before therapy begins to optimize treatment earlier in their journey.Related ContentHealth Benefits 101: The Importance of Clinical ProgramsAH073 - How Low Cost Alternative Programs Can & Should Work, with Jackie Lolos, PharmD, and Haleh Campbell, PharmDReplay – The Bridge to Better Healthcare: Uniting Medical and Pharmacy Services on One Platform to Achieve Value-Based CareAH060 - A New Approach to Colorectal Cancer (CRC) Screening, with GeneoscopyFor more information about this episode and its transcript, please visit Judi Health Insights.
I sit down with Dr. Jennifer Huffman, a board-certified pediatric neuropsychologist, PDA woman with lived experience, and creator of the Neurodynamic Navigator System and the Neurodynamic Quotient. After twenty-five years working with children whose profiles were called often called ODD (Oppositional Defiant Disorder), she developed a framework to make the dynamic, fluctuating nature of the PDA brain visible and usable for parents, teachers, and clinicians.We talk about her childhood as an undiagnosed PDA autistic person, why ODD as a diagnosis isn't helpful, how she assesses children who cannot come into an office, and the app she is building to help families. After all that great insight, just her closing message for parents of PDA kids in burnout makes this episode worth a listen.Key TakeawaysGrowing Up as an Undiagnosed PDA Autistic Neuropsychologist | 00:02:48 Dr. Huffman describes a childhood marked by academic failure in math from third grade, severe bullying that led her parents to drive her thirty minutes each way to attend school in a different town, and the recurring experience of being told she was not living up to her potential. She names the specific mechanism she now recognizes in herself: she cannot process on demand. If someone tells her to do something, or if it feels redundant, her brain shuts off. This is not willfulness. It is the same mechanism she has spent twenty-five years helping children and families understand. She describes finding neuropsychology in her third year of undergraduate study as a light bulb moment, not because she wanted a career but because she was trying to figure out her own brain.The ODD Buster: Why Oppositional Defiant Disorder Is So Often the Wrong Label | 00:12:39 Dr. Huffman describes spending twenty-five years working with the complex cases other clinicians could not crack, children who had been given ODD diagnoses and whom nobody wanted to work with. She calls herself the ODD buster and states directly that in her clinical experience, she has rarely seen a child who actually had ODD. What she consistently found underneath that label was high empathy, anxiety, sensory differences, social communication differences, and learning differences, often in combination. She names ODD as an example of a DSM category built by non-neurodivergent clinicians describing externalized behavior without curiosity about what is underneath it.How She Assesses Children Who Cannot Come Into an Office | 00:17:38 Dr. Huffman explains that when a child is in burnout and cannot access evaluation, the work does not begin with the child. It begins with the parent: helping them advocate with the school, coordinating with medical providers who may not understand why the child cannot leave the house, and slowly building a relationship with the child themselves. She describes spending six months to a year playing Minecraft with a child before any formal assessment data is collected, and names this as genuinely valuable clinical time. She also holds PSYPACT certification, which allows her to work with families across most of the United States without the family ever entering her office.The Neurodynamic Quotient: Making the Dynamic Nature of the PDA Brain Visible | 00:36:57 Dr. Huffman introduces the Neurodynamic Quotient, her framework for understanding why PDA children can do something one day and appear to lose the skill the next. The formula combines dynamic safety, which includes felt safety, connection, information, and autonomy, with dynamic capacity, which includes the battery, sensory load, and executive functioning scaffolding, plus motivation. She explains why autonomy functions as a multiplier: if it reaches zero, the entire product is zero regardless of how much skill or capability is present. She also names motivation as the variable parents and teachers most often misuse, pushing past natural capacity because the child demonstrated what they were capable of once.Do Not Get in Front of Your Child | 00:55:03 Dr. Huffman closes with a message for parents whose children are in burnout. She names never assuming the child is not capable as the most important thing a parent can hold onto, and shares her own story as evidence: her parents could not have predicted she would become a neuropsychologist. She uses the phrase "do not get in front of your child" to mean: if they have something they want to do, let them fly. The child who is in their room with the lights off on Minecraft is telling you what they need. Meeting that need and staying regulated yourself is what moves them through burnout faster than fighting against it.Relevant ResourcesUnderstanding PDA — Free class with context on the nervous system disability framework and the dynamic, cumulative nature of activation Dr. Huffman builds on throughout this conversationBurnout — Free class with context for the red zone experience Dr. Huffman describes and the burnout recovery process for both children and parentsParadigm Shift Program — Our signature program where parenting for autonomy, safety, and connection is taught in fullUnlocking the PDA Brain by Dr. Jennifer Huffman — Dr. Huffman's book introducing the Neurodynamic Navigator System, written as a manual for understanding and supporting the PDA brainThe Able Center — Dr. Huffman's private neuropsychology practice in IllinoisThe Baby Fold — The Illinois nonprofit where Dr. Huffman serves as Vice President of Clinical Operations, specializing in trauma and higher support needs neurodivergent childrenBeyond Behaviors by Mona Delahooke — Mentioned by Dr. Huffman for understanding what is happening beneath the behavior in neurodivergent childrenDr. Huffman is also a board member of PDA North America.
In this episode of the Site Realities series, Tammy D'Lugin-Monroe continues her conversation with Przemyslaw Wziatek, Country Head for Poland and Ukraine within Clinical Operations at Syneos Health, exploring how sites navigate the complexity of working within large CRO organizations. Together, they discuss the importance of clear communication pathways, operational ownership and timely escalation processes in building strong site partnerships. From reducing communication noise to improving site launch meetings and helping sites quickly connect with the right support teams, the conversation highlights practical ways CROs can create a more seamless and supportive site experience.Listen in as they share perspectives on how thoughtful communication, clarity and collaboration can strengthen trust and improve study execution at scale.The views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you'll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub. Like what you're hearing? Be sure to rate and review us! We want to hear from you! If there's a topic you'd like us to cover on a future episode, contact us at podcast@syneoshealth.com.
Heads up — this is Part 2 of Jamie's conversation with Jaclyn Taylor If you haven't heard Part 1 yet, go back and start there. It sets up everything we unpack today. Most healthcare teams are working hard. They're just not working together. And the patient is the one absorbing the cost. In this second half of the conversation, Jamie and Jaclyn move from the why into the how. What does it actually look like when a provider stops responding to today's schedule and starts managing an entire patient panel? How do you turn a community health worker, a pharmacist, a PT, and a social worker into one coordinated team instead of four parallel ones? And what's the difference between data that produces reports and data that produces decisions? You'll hear: Why "frequent touches" only work when they're connected — and how fragmented touches still land patients back in the hospital The quarterback model — what it actually means for a provider to own a patient's trajectory, not just their visit The shift from seeing patients to managing a population — and why most providers were never taught how Why we don't have a resource problem in healthcare — we have an orchestration opportunity How to use technology and data without drowning in either What "showing up" really means inside a system that isn't perfect yet This is the episode for anyone trying to lead change from inside a system that's still catching up. Press play. www.YourHealth.Org
In this episode of the Site Realities series, Tammy D'Lugin-Monroe sits down with Przemeslaw Wziatek, Country Head for Poland and Ukraine within Clinical Operations at Syneos Health, to explore how relationships between Clinical Research Associates (CRAs) and Clinical Sites are evolving in today's increasingly complex research environment. As competition for high-performing sites intensifies, strong partnerships have become more important than ever. Tammy and Przemeslaw discuss what sites truly expect from CRO partners, why the CRA role has evolved beyond monitoring into that of an ambassador and problem solver, and how trust is built through responsive, thoughtful communication. Together, they examine the realities sites face every day, from balancing patient care alongside multiple studies to navigating increasing operational complexity and technology demands. The conversation also explores how CROs can better align with site priorities, reduce communication friction and create stronger long-term partnerships that ultimately support study success and improve the patient experience.The views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you'll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub. Like what you're hearing? Be sure to rate and review us! We want to hear from you! If there's a topic you'd like us to cover on a future episode, contact us at podcast@syneoshealth.com.
Why do life science companies still scramble when an inspection is coming, even when their quality systems are solid on paper? Yeime Martich, a 25-year quality veteran, makes the case that readiness is a logistics and culture problem, not a documentation problem, and that the procedures you wrote may be creating more audit risk than you realize.Yeime discusses why "minimally compliant" is a discipline rather than a shortcut, how leadership shapes quality culture through what they ask about, fund, and tolerate, and why the strongest signal of a healthy quality system is when people come to quality voluntarily to report problems.A few of Yeime's key takeaways:Inspection readiness is the natural output of a healthy quality system, not something you build in the weeks before an audit"Minimally compliant" means meeting the regulatory intent without overcommitting in your procedures to things your team can't actually followQuality should come to the table with options, not just a no — release to warehouse on risk while the investigation closes, for exampleLeadership shapes culture through what they ask about, what they fund, and what they tolerateThe strongest quality culture signal: people voluntarily surfacing problems without fear of blameAI is useful for data analysis and review, but accountability for quality decisions sits with people — "AI didn't tell us" showed up in a recent FDA warning letterDesign your QMS around flexibility — rigid procedures that block product release unnecessarily are self-imposed constraints the regulation never requiredAbout Yeime MartichYeime Martich is Vice President of Quality Assurance at TerSera Therapeutics with 25 years of experience in pharmaceutical and medical device quality systems. Before TerSera, she spent over 11 years at Hospira in global compliance roles overseeing internal audit programs across international manufacturing sites, and held quality systems leadership positions at Melinta Therapeutics and Abbott.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
What if every "non-compliant" patient was actually a signal that the system isn't working for them? In this episode, Jamie sits down with Jaclyn Taylor, Clinical Strategy Director at Your Health and a nurse practitioner who started her career as a home-based provider in 2020 — thrown straight into the fire of COVID, isolated patients, and a healthcare world rewriting itself in real time. What she saw inside patients' homes — medications scattered on tables, food insecurity, missing transportation — changed how she thinks about every chart she's ever read. You'll hear: Why a nurse-first pathway gives nurse practitioners a fundamentally different lens than a medical school pathway — and why patients feel it What working across home care, telehealth, trauma, and wellness teaches you about treating the whole human, not just the diagnosis Why trauma surgery turned Jacqueline into a believer in proactive, longitudinal care — and what gets missed when we only meet patients after something has already gone wrong The two words she uses to describe what's most broken in traditional healthcare: fragmentation and misalignment How empathy stops being a poster and starts being operational — built into the design of care itself If you've ever felt invisible inside the healthcare system, or if you're the one trying to fix it, this conversation reframes the whole game. Press play. www.YourHealth.Org
Tonight on The Mark White Show, I'll be talking with Karen Belcher, Co-Founder and Director of Clinical Operations for The Adoption and Foster Care Clinic in Birmingham. Karen is a registered nurse and TBRI practitioner who has spent more than two decades working with children and families navigating adoption, foster care, and kinship care. What started at UAB Children's Hospital has grown into a standalone nonprofit focused on meeting the real, often unseen needs of these families through medical care, mental health support, and guidance for caregivers. We're going to take a closer look at what these children and families are truly facing, the misconceptions that often surround their journeys, and why understanding and support from the community matters more than most people realize. Join me for a conversation that brings insight, compassion, and a better understanding of how we can all be part of the support system. Real stories. Real people. Real impact. News That Unites!™️
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/
April 28, 2026 - Dr. Bernard Lim of Memorial Specialty Care Cardiology and Director of Clinical Operations at DMH, Dr. Kelly Hill, joined Byers & Co to talk about how technology advancements and artificial intelligence have made significant advancements in reducing length and success rates in atrial fibrillation ablation procedures. Listen to the podcast now!See omnystudio.com/listener for privacy information.
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/
What will AI and clinical trials look like in the year 2030? Mike Sullivan, head of IT globally for development operations at Bristol Myers Squibb, joins The Scope of Things to discuss how creating value with AI depends on redesigning how clinical operations teams work. He covers the four pillars of what AI and clinical operations can look like in the next few years, as well as how AI will affect the job market. Plus, host Deborah Borfitz gives you the latest rundown on building the capacity to collaborate with patients, a new playbook for pediatric clinical trial reporting, lithium treatment for verbal memory decline, sex-specific effects of dementia, open-source database for scaling cancer trials, and a proposed 10-year trial of anti-obesity drugs for preventing obesity-related cancers. Show Notes News Roundup Power dynamics in researcher-patient relationships Study published in Health Expectations Playbook forpediatricclinical trial reporting Statement on reporting protocols published in The BMJ Statement on reprintng completed trials published in The BMJ Low-dose lithium for slowing verbal memory decline Study in JAMA Neurology News on the University of Pittsburgh Medical Center website Parkinson's-related protein linked to faster Alzheimer's progression in women Study in JAMA Network Open Press release on the Mayo Clinic website AstroID database for studying cancer Study in Journal for Immunotherapy of Cancer News release on the Johns Hopkins website Anti-obesity drugs for preventing cancer News release from the European Congress on Obesity Guest Mike Sullivan, head of IT globally for development operations at Bristol Myers Squibb The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider's look at clinical research today.
Pharmakovigilanz sorgt oft für rauchende Köpfe, ist aber das Herzstück jeder Studie. Gemeinsam mit Claudia Kolar (Roche, Clinical Operations) blickt Denise hinter die Kulissen der Arzneimittelsicherheit. Warum ist die Dokumentation von Nebenwirkungen so entscheidend? Wie behaltet ihr bei SAEs, SUSARs & Co. den Durchblick? Erfahrt, warum Pharmakovigilanz kein trockenes Regelwerk ist, sondern echte Detektivarbeit zum Schutz eurer Patient:innen. Durch eure Arbeit tragt ihr direkt dazu bei, dass Medikamente für Patient:innen in ganz Deutschland sicherer werden! Holt euch wertvolle Tipps für euren Studienalltag und erfahrt, wie ihr Prozesse in eurem Team optimieren könnt. Gibt es Themen, die dich besonders interessieren und zu denen du dir eine zukünftige Episode wünschst? Teile uns deine Ideen und dein Feedback gerne mit.
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/
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/
On February 16, 2026, Nursing Economic$ Editorial Board member Therese Fitzpatrick, PhD, MS, RN, FAAN, talked with Ms. Cedrial Moore, the Senior Vice President of Kaufman Hall & Associates, LLC. They discussed the three distinct functions of the revenue cycle, key steps in revenue cycle management, the responsibility of executive leaders and chief nurse officers in revenue cycle management, and the concept of a write-off and its implications for hospital operations.Therese Fitzpatrick, PhD, MS, RN, FAAN, is the Managing Director at Kaufman Hall & Associates, LLC, in Chicago, Illinois, and a member of the Nursing Economic$ Editorial Board Cedrial Moore, BS, is Senior Vice President at Kaufman Hall & Associates, LLC , in Chicago, Illinois.© Jannetti Publications, Inc.All rights reserved. No portion of this podcast may be used without written permission.To learn more about Nursing Economic$, visit http://www.nursingeconomics.net Visit our new JPI journal platform at www.jannettipublications.comMusical selections by Scott Holmes.http://www.scottholmesmusic.com
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 Your Health University episode, Jamie sits down with Nurse Practitioner, Brooke Howard, President of Clinical Operations, to talk about Biote, wellness, and bioidentical hormone optimization—and why it has been life-changing for both of them. Brooke shares how a trusted colleague pushed her to look deeper when she was exhausted, gaining weight, and “holding it together by a thread.” Jamie opens up about anxiety, ADD medication, and how feeling hormonally balanced gave him the confidence to step into a new chapter. This conversation is for anyone who feels “off,” has been told their labs are “normal,” and wants to explore a more complete picture of wellness. www.YourHealth.Org
This podcast is brought to you by Outcomes Rocket, your exclusive healthcare marketing agency. Learn how to accelerate your growth by going to outcomesrocket.com Effective value-based care depends on tight care coordination, clinician trust, and financial alignment that prevents avoidable hospitalizations. In this episode, three healthcare leaders discuss why proactive kidney care depends on early identification and ongoing patient education, long before dialysis decisions become urgent. Colette Boroch, Director of Clinical Services at PRINE Health, explains how early screening, repeated education, and removing barriers like transportation help prevent patients from “crashing” into the hospital. Kathryn Anderton, Vice President of Clinical Operations at ThoroughCare, shares how care management platforms reduce documentation burden, standardize workflows, and free clinicians to focus on patients, while Jonathan Goldstein, Chief Financial Officer at PRINE Health, outlines how care coordination lowers avoidable utilization, improves quality metrics, and supports shared savings. Together, they explore provider buy-in, fragmented data, AI-enabled scalability, and why value-based care must be treated as a strategic asset. Tune in and learn how clinical care, technology, and finance must work together to successfully scale value-based care. Resources Connect with and follow Colette Boroch on LinkedIn. Follow PRINE Health on LinkedIn and discover their website! Follow and connect with Kathryn Anderton on LinkedIn. Learn more about ThoroughCare on LinkedIn and explore their website. Listen to Kathryn's previous interview on the podcast here. Email Kathryn directly here.
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/
In this episode of the Behavioral Observations Podcast, I'm joined by Kim Dean, founder of Apollo Behavior, and Kristen Vaughn, Vice President of Clinical Operations, to talk about what it really takes to build and sustain clinical excellence in autism services. We discuss Apollo's decision to launch in Georgia, their highly selective hiring process, and how values alignment plays a central role in building their culture. Kim and Kristen share how Apollo approaches training differently — including a four-week RBT onboarding program that exceeds certification requirements and a structured mentorship model for BCBAs. The results are notable, with 99% of Apollo's RBTs passing their exams on the first attempt! Even more impressive is that 84% of Apollo-trained BCBAs pass their exam on the first attempt too. Compared to the current average pass rate that hovers around 52-54%, that's simply amazing! We also dig into how Apollo defines and measures clinical excellence, including the use of norm-referenced assessments, family feedback, progress toward less restrictive environments, and ongoing data analysis to improve training and service delivery. This conversation is especially relevant for BCBAs, clinical leaders, and practice owners who are thinking seriously about how to scale services without sacrificing quality — and how to design systems that support clinicians, families, and long-term outcomes. If this sounds like a great work environment to you, and you'd like to learn more, click here. Related BOP Episodes: From Clinician to Leader: Apollo CSS 8 with Kristen Vaughn All previous Apollo Series BOP episodes This podcast is brought to you by: The School Behavioral Solutions for Special Educators & Behavior Analysts. The Behavior Toolbox Conference is a one-day, high-impact professional convening that brings together experienced practitioners and leaders from across education and behavior science to share what actually works in schools. Rather than relying on theory divorced from practice, this conference features presenters who actively operate within classrooms, districts, research settings, and state-level systems. Behavior analysts, educators, researchers, and system leaders come together to examine behavior change from multiple levels of impact — adult behavior, decision-making, values, and the systems that shape outcomes. It's taking place virtually through BehaviorLive on March 5th, 2026, and will be available on-demand for those who can't make it on the day of the event. Office Puzzle: A thriving ABA practice depends on systems that actually support your team, not slow them down. If you've struggled with software that's buggy, hard to navigate, or offers little support when you need it most, you're not alone. That's why so many practices are switching to Office Puzzle. Go to officepuzzle.com/bop to learn more! The 2026 Verbal Behavior Conference! Taking place March 26–27, 2026, in Austin, Texas, or livestream and on-demand on BehaviorLive. Presenters will include Drs. Mark Sundberg, Patrick McGreevy, Caio Miguel, Alice Shillingsburg, Sarah Frampton, Andresa De Souza, and Danielle LaFrance will share how Skinner's analysis of verbal behavior can guide the assessment and treatment of generative learning challenges in children with autism and other developmental disabilities. And don't miss the special pre-conference workshop on Wednesday, March 25. CEUs from Behavioral Observations. Learn from your favorite podcast guests while you're commuting, walking the dog, or whatever else you do while listening to podcasts. New events are being added all the time, so check them out here.
On a cold January day in South Carolina, Jamie and Matt Staub unpack why focus is one of the most underrated leadership skills—especially in healthcare, where everything can feel urgent. They break down how leaders decide what deserves attention, how to “push pause” on non-emergencies, and why coaching people through problems is often more effective than absorbing them. The conversation also explores decision fatigue, the difference between being busy and being focused, the role of habits (including insights from Atomic Habits), and how boundaries protect the work that actually moves the mission forward. Along the way, they normalize attention struggles, reframe “failure” as part of growth, and offer practical ways to stay aligned to goals without losing empathy or accessibility.
Scaling a product from preclinical development to commercial manufacturing is one of the most complex transitions life science teams face—and one of the easiest places to lose time and momentum.In this episode of The Life Science Rundown, host Nick Capman speaks with Jackie Klecker, Executive Vice President of Quality and Development Services at Lifecore Biomedical, about how sponsors and CDMOs can build robust, phase-appropriate quality systems without over-engineering early or under-preparing later.Drawing on decades of experience across pharmaceutical drug products, medical devices, APIs, and biologics, Jackie shares practical guidance on knowledge transfer, risk management, QMS maturity, and regulatory expectations across the U.S. and EU. The conversation focuses on what actually prevents costly delays—and how disciplined communication and documentation make scaling achievable.A few key takeaways:Early quality work should be right-sized, not commercialized prematurelyDesign space, material variability, and sensitivities must be understood and documented earlyFMEA works best when it evolves with the product—not when it's treated as a one-time exerciseFDA and EU requirements can diverge in ways that materially affect submission timingClear documentation and regular, direct communication prevent avoidable delaysJackie Klecker is Executive Vice President of Quality and Development Services at Lifecore Biomedical, a fully integrated CDMO with decades of experience supporting pharmaceutical drug products, medical devices, biologics, and APIs. She has led quality systems and development programs across multiple global manufacturing sites and brings deep expertise in FDA 21 CFR 210, 211, and 820, ISO 13485, EU GMP, and ICH Q7 environments. Her background spans chemical engineering, process development, validation, risk management, and cross-functional leadership.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/
What does it take to run a truly effective Functional Service Provider (FSP) model in today's biopharma landscape? From harmonizing global teams to embedding innovation into daily delivery, FSP engagement is more than a resourcing solution — it's about strategic collaboration and approaches that accelerate delivery. The Syneos Health Podcast: Functionally Speaking series explores the nuances that make these models work. In this episode of the Functionally Speaking series, host Lynn Hamilton sits down with Wayne Wise, Vice President of Clinical Operations at Syneos Health, to explore the real-world shifts happening in large pharma partnerships. With nearly two decades at the company and deep cross-functional experience, Wayne shares how agility, strategic governance and trust-based team leadership are reshaping FSP delivery models. From evolving CRA roles and co-created governance to the increasing use of AI, Wayne offers a firsthand look at how functional teams are adapting in real time to operational and strategic shifts across the industry. You will walk away with insights on:Moving beyond transactional models to strategic, insight-driven partnershipsBuilding agile teams that thrive amid complexityTransforming governance to focus on action, not just KPIsHow the CRA role is evolving with tech-enabled site engagementWhat sponsors can do to unlock value through co-creationThe views expressed in this podcast belong solely to the speakers and do not represent those of their organization. If you want access to more future-focused, actionable insights to help biopharmaceutical companies better execute and succeed in a constantly evolving environment, visit the Syneos Health Insights Hub. The perspectives you'll find there are driven by dynamic research and crafted by subject matter experts focused on real answers to help guide decision-making and investment. You can find it all at https://www.syneoshealth.com/insights-hub. Like what you're hearing? Be sure to rate and review us! We want to hear from you! If there's a topic you'd like us to cover on a future episode, contact us at podcast@syneoshealth.com.
The FDA Group's Nick Capman sits down with Mike Martin, President and CEO of ISPE, for a conversation on how the pharmaceutical industry must rethink workforce development amid rapid technological and cultural change.Drawing on nearly four decades of global experience in pharmaceutical engineering, operations, and manufacturing leadership, Mike shares his perspective on why the industry is entering a new industrial era — often referred to as Pharma 4.0 — and what that means for engineers, operators, and leaders at every level.The discussion explores how automation, robotics, and AI are reshaping day-to-day work, why deep technical expertise remains critical in an AI-driven environment, and how organizations must move beyond reactive reskilling toward more intentional “pre-skilling” of future talent. Mike also reflects on the enduring importance of character, integrity, curiosity, and trust, arguing that these traits matter as much as technical competence in a highly regulated industry.Nick and Mike examine the evolving role of professional organizations like ISPE in building global communities of practice, sharing knowledge across borders, and supporting lifelong learning. The conversation also addresses how learning itself is changing — from long-form training to bite-sized, modular education — and what leaders must do to engage a new generation of professionals with different expectations around purpose, speed, and technology.Throughout the episode, Mike emphasizes a unifying theme: innovation and compliance are not opposing forces. When approached correctly, innovation strengthens quality, improves compliance, and ultimately enhances patient safety.This episode is a must-listen for anyone responsible for building teams, modernizing operations, or preparing their organization for the future of pharmaceutical manufacturing and engineering.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, Michael S. Smith, MD, MBA, Associate System Chief of Gastroenterology for Clinical Operations and Strategic Planning at The Mount Sinai Health System and Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, discusses key trends in GI care, late cancellations, telehealth, AI adoption, and how strong leadership and culture can support both providers and patients.
The FDA Group's Nick Capman sits down with Chris Masterson, Senior Vice President of Quality and Chief Quality Officer at Tolmar, for a wide-ranging conversation about how to create and sustain a quality-centric culture that drives compliance, operational excellence, and long-term resilience in the biopharmaceutical industry. A microbiologist by training with more than 35 years of BioPharma leadership experience, Chris has led global quality organizations at Ipsen, Cubist (Merck), and now Tolmar, as well as his own consultancy. Across the U.S., Europe, and Asia, he has managed large CMO networks, established inspection-readiness programs, and led cultural change within complex, matrixed organizations.Nick and Chris explore what truly defines a quality-centric culture, how leadership and accountability shape it, and the practical, long-term steps required to sustain it.In this conversation, Chris shares insights on:What “quality culture” really means—and how to make it visible at every level of an organization.The leadership behaviors that create alignment and consistency across global teams.How to embed compliance and continuous improvement into daily operations.Managing uncertainty, pressure, and change without losing focus on the patient.Practical methods for measuring and improving quality culture over time.Why humility and transparency are non-negotiable for sustainable performance.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 Behind the Knife, the minimally invasive surgery (MIS) team dives deep into the evolving field of common bile duct exploration (CBDE). From the historical context of laparoscopic approaches to the latest advances including robotic-assisted techniques, Drs. Shaina Eckhouse, James Jung, Zachary Weitzner, and Joey Lew discuss key evidence shaping modern practice. Listeners will learn about indications and anatomy guiding trans-cystic versus trans-choledochal approaches, practical tips for safe stone clearance, and critical considerations around learning curves and team coordination for robotic procedures. The episode also highlights important studies comparing single-stage laparoscopic CBDE with staged ERCP and cholecystectomy, emphasizing outcomes such as stone clearance, pancreatitis rates, and hospital length of stay. This comprehensive overview is a must-listen for MIS and acute care surgeons interested in optimizing the management of choledocholithiasis and streamlining patient care with minimally invasive techniques. Hosts: - Shaina Eckhouse, MD, Bariatric Surgery Medical Director and Vice Chair of Clinical Operations, Department of Surgery, Duke University - James Jung, MD, PhD, Assistant Professor of Surgery, Duke University - Zachary Weitzner, MD, Minimally Invasive and Bariatric Surgery Fellow, Duke University, @ZachWeitznerMD - Joey Lew, MD, MFA, Surgical resident PGY-3, Duke University, @lew__actually Learning Goals: By the end of this episode, listeners will be able to: - Describe the historical approaches to managing choledocholithiasis, including staged interventions and the evolution toward single-stage laparoscopic common bile duct exploration (CBDE). - Summarize key clinical evidence comparing CBDE and ERCP, including landmark studies and meta-analyses evaluating outcomes, complications, and trends over time. - Distinguish between transcystic and transcholedochal approaches to CBDE, explaining indications, contraindications, and technical nuances for each technique. - Identify appropriate candidates for transcystic exploration based on cystic duct anatomy and stone characteristics. - Recognize the impact of newer surgical technologies—such as digital choledochoscopy, Spyglass, and robotic platforms—on CBDE practice, efficiency, and safety. - Discuss the importance of multidisciplinary teamwork, preparation, and perioperative planning for successful CBDE, particularly in complex or altered anatomy cases. - Appraise the learning curve and quality of evidence for new CBDE procedures, outlining the need for mentorship, ongoing training, and knowing when to collaborate with GI or hepatopancreaticobiliary (HPB) surgery. - Outline approaches and bailout strategies for challenging cases, including patients with surgically altered anatomy and use of adjuncts such as intraoperative cholangiography (IOC), feeding tube placement, and Fanelli stents. - Evaluate safety outcomes and limitations associated with robotic-assisted CBDE and single-stage management, incorporating recent data from population-based studies. - Reflect on strategies for tailoring CBDE techniques to individual patient anatomy, surgeon experience, and available resources, advocating for evidence-based practice and continuous learning. References: - Giurgiu DI, Margulies DR, Carroll BJ, et al. Laparoscopic Common Bile Duct Exploration: Long-term Outcome. Arch Surg. 1999;134(8):839-844. doi:10.1001/archsurg.134.8.839 https://pubmed.ncbi.nlm.nih.gov/10443806/ - Lyu Y, Cheng Y, Li T, Cheng B, Jin X. Laparoscopic common bile duct exploration plus cholecystectomy versus endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy for cholecystocholedocholithiasis: a meta-analysis. Surg Endosc. 2019;33(10):3275-3286. doi:10.1007/s00464-018-06613-w https://pubmed.ncbi.nlm.nih.gov/30511313/ - Bekheit M, Smith R, Ramsay G, Soggiu F, Ghazanfar M, Ahmed I. Meta‐analysis of laparoscopic transcystic versus transcholedochal common bile duct exploration for choledocholithiasis. BJS Open. 2019;3(3):242-251. doi:10.1002/bjs5.50132 https://pubmed.ncbi.nlm.nih.gov/31183439/ - Cironi K, Martin MJ. Reclaim the duct! Laparoscopic common bile duct exploration for the acute care surgeon. Trauma Surg Acute Care Open. 2025;10(Suppl 1). doi:10.1136/tsaco-2025-001821 https://pubmed.ncbi.nlm.nih.gov/40255986/ - Zhang C, Cheung DC, Johnson E, et al. Robotic Common Bile Duct Exploration for Choledocholithiasis. JSLS J Soc Laparosc Robot Surg. 2025;29(1):e2024.00075. doi:10.4293/JSLS.2024.00075 https://pubmed.ncbi.nlm.nih.gov/40144383/ - Kalata S, Thumma JR, Norton EC, Dimick JB, Sheetz KH. Comparative Safety of Robotic-Assisted vs Laparoscopic Cholecystectomy. JAMA Surg. 2023;158(12):1303-1310. doi:10.1001/jamasurg.2023.4389 https://pubmed.ncbi.nlm.nih.gov/37728932/ Ad Disclosure: Visit goremedical.com/btkpod to learn more about GORE® SYNECOR Biomaterial, including supporting references and disclaimers for the presented content. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. Rx only Please visit https://behindtheknife.org to access other high-yield surgical education podcasts, videos and more. 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The FDA Group's Nick Capman sits down with Carlos Carrillo, PhD, MSc, Senior Vice President of Regulatory Affairs & Quality Assurance at SAB Biotherapeutics. With nearly 30 years of experience across Operations, R&D, Regulatory Affairs, Quality Assurance, and Project Management, Carlos has led global regulatory strategy for small- and large-molecule programs from Phase 1 through launch. He has prepared IND/IMPD/CTA/CTR/BLA/MAA submissions across multiple regions, secured expedited designations, managed FDA and ex-US health authority meetings, and built RA/QA systems for growing biotech organizations.Carlos shares practical, experience-tested guidance on how small and mid-size biotech companies can build regulatory resilience: strengthening governance, preparing for FDA interactions, improving documentation discipline, and integrating external partners without losing control. He also breaks down how to evaluate vendors, structure joint governance, embed QA into outsourced workflows, and design audit-ready data flows that prevent institutional knowledge loss.Topics discussed include:Why early regulatory infrastructure prevents costly reworkLeadership behaviors that shape regulatory cultureHow to prepare for high-stakes FDA and ex-US health authority meetingsThe risks of “tribal knowledge” in fast-moving organizationsA structured model for evaluating and managing external partnersHow small companies can stay inspection-ready with lean teamsOne takeaway: External partners can be force multipliers or liabilities—the sponsor's structure and oversight determine which.About The FDA Group:The 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 specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations.https://www.thefdagroup.com/
In a collaborative podcast with the American Psychosocial Oncology Society hosted by Daniel C. McFarland, DO, guests Louis P. Voigt, MD, and Yesne Alici, MD, discussed the ethical and clinical complexities of assessing decision-making capacity (DMC) in oncology, emphasizing its role as the ethical core of person-centered care. The discussion began by dissecting modern medicine's need for formal DMC assessment. Voigt framed DMC as a fundamental issue of patient rights and respect, asserting that every human being has absolute rights and that the integrity of a person requires honoring their self-determination. He advocated for clinicians to act as professionals, earn trust, customize their approach based on individual needs through precision medicine, and demonstrate humility by re-explaining information when a patient cannot summarize their understanding. Alici provided a detailed clinical framework for DMC, defining it as a person's ability to decide on the specific issue at hand while appreciating the foreseeable consequences. She outlined the 4 key elements, or pillars, of the assessment: the patient's ability to understand the information, to appreciate the risks and benefits, to provide a rationalization for the decision to ensure no delusional thinking interferes, and to communicate a consistent choice. She clarified that DMC is decision-specific and time-dependent, emphasizing that conditions like dementia, schizophrenia, major depression, or even a central nervous system malignancy do not automatically mean a patient lacks capacity; it must be assessed for each situation and may be restored if cases like delirium are reversible. She cautioned that clinicians must be mindful of potential mislabeling when patients with aphasia interact, as simple gestures may not fully represent informed consent. Finally, the experts addressed the crucial implications that follow an assessment of incapacity. Voigt highlighted that a lack of DMC is not a "stop sign"; decisions must still be made, requiring the health care team to look to a designated proxy or the patient's next-of-kin. He stressed the need for hospitals to establish system-wide processes and workflows to prepare all stakeholders for these contingencies and help patients become familiar with advanced directives, thereby reducing the immense emotional burden placed on surrogates who must perform substituted judgment. McFarland concluded that being aware of DMC elevates the quality of care, reinforces an ethical climate, and enhances the entire organization. McFarland is the director of the Psycho-Oncology Program at Wilmot Cancer Center and a medical oncologist who specializes in head, neck, and lung cancer, in addition to being a psycho-oncology editorial advisory board member for the journal ONCOLOGY. Voigt is an intensivist and chair of the Ethics Committee at Memorial Sloan Kettering Cancer Center (MSKCC). Alici is vice chair of Clinical Operations in the Department of Psychiatry and Behavioral Sciences, clinical director, associate attending psychiatrist, and medical director of the Biobehavioral Health Clinic at MSKCC.
The FDA Group's Nick Capman sits down with Maria Vassileva, PhD—Chief Science & Regulatory Officer at the Drug Information Association (DIA)—for a grounded, forward-looking discussion on how regulators are actually using AI today, where the technology is going, and what life science organizations should be preparing for now.Maria draws on two decades of leadership across nonprofit, government-funded clinical research, and biomedical science programs—spanning patient registries, clinical trials, multi-stakeholder consortia, DEI initiatives, and regulatory strategy. As the head of DIA's global science and regulatory portfolio, she works closely with regulators, industry sponsors, academia, and technology developers to advance responsible, evidence-driven innovation.In this conversation, Maria breaks down the reality behind AI in the regulatory ecosystem: what's currently in use, how agencies are evaluating and validating tools, why risk-based tiers matter, and how the field is moving toward lifecycle oversight rather than one-time checks. She also highlights the ethical and equity considerations that must be embedded from the start and shares insights from global regulatory trends and DIA's convening role.Key topics discussed include:How regulatory agencies are already using AI internally for document-heavy workflows, safety surveillance, and information retrievalWhy validation must focus on end-to-end workflow integrity, not just the modelThe emerging role of risk-based tiers for AI-enabled toolsThe importance of lifecycle control frameworks such as TPLC and PCCPsGlobal convergence themes around transparency, bias mitigation, and human accountabilityHow agencies are preparing for increasing AI adoption—and what industry teams should be doing nowDIA's role as a neutral convener helping harmonize expectations and accelerate responsible innovationAbout 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: https://www.thefdagroup.com/
Coruna Medical's Vice President of Quality, Jeff Hines, joins host Nick Capman to share a leadership-driven playbook for navigating FDA remediation—without overwhelming teams or losing focus on long-term improvement.Drawing from nearly four decades in pharmaceutical quality, including more than 30 years at Eli Lilly, Jeff offers practical guidance for building calm, effective inspection environments and keeping people confident under pressure. He outlines the four-room model for inspection management, strategies for responding to observations, and proven methods for closing data-integrity gaps while daily operations continue.Jeff and Nick also explore the leadership mindset that sustains progress beyond the initial response—fostering transparency, prioritization, and a culture of accountability that prevents repeat findings.Topics discussed include:The leadership posture that steadies teams during inspections and remediationHow to stand up the four-room inspection model (Front, Back, Doc-QC, SME-Prep)Responding to 483s: when to push, when to accept, and how to align internallyData-integrity vulnerabilities and effective interim controlsBalancing remediation with production demandsBuilding transparency and accountability into quality cultureKeeping systems current to avoid backsliding into repeat observationsAbout 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: https://www.thefdagroup.com/
In this episode of What's Best For The Patient Is Best For Business, Jerry sits down with Lissa Taitano, Director of Clinical Operations for Livara Health. Livara is a purpose-built musculoskeletal (MSK) management solution that combines care planning, delivery, and navigation to create a more connected healthcare system.Lissa, a physical therapist by training with over 15 years of experience in value-based care, pulls back the curtain on how a truly patient-centric model delivers superior outcomes for both people and businesses. She details Livara's journey from a local clinic to a national leader, explaining how integrating a holistic, biopsychosocial approach—including physical therapy, pain reprocessing therapy, nutrition, and health coaching—led to patients getting "100% better, faster" while simultaneously reducing costs and surgical utilization.This conversation is a masterclass in the future of MSK care. Jerry and Lissa tackle the tough questions every practice owner needs to ask, challenging the unsustainable fee-for-service status quo and outlining the essential mindset shift required to thrive.Key Takeaways:• Why the traditional, fragmented model is failing MSK patients and how a "quarterback" approach creates central accountability and a seamless patient journey.• The power of a holistic, biopsychosocial model: Discover how addressing contextual drivers like stress, nutrition, and mental health is the key to unlocking better outcomes and preventing chronic pain cycles.• How to build a powerful patient engagement strategy that extends beyond episodic clinic visits, using technology and personalized communication to meet patients where they are.• The business case for value-based care: Learn how proactive, high-engagement models lead to dramatically lower costs (35-45%), reduced surgical utilization (40-53%), and higher patient satisfaction.• The two things clinic owners must do today to prepare for the future: Collect and leverage your clinical outcome data, and be open-minded about changing your business model to prioritize value over volume.Tune in for an inspiring and practical look at how getting upstream, owning the patient's entire MSK journey, and focusing on what's truly best for the patient is, unequivocally, the best path forward for business. If you'd like to learn more about Strata EMR & RCM and achieving a 99.99% reimbursement rate for your PT, OT, or SLP Clinic head over to stratapt.com and book a demo with their team!
The FDA Group's Nick Capman speaks with Marwan Fathallah, President and CEO of DIA Global, for a wide-ranging discussion on what it takes to lead effectively across the life science product development cycle—from concept to commercialization.With nearly 30 years of leadership experience spanning pharmaceuticals, medical devices, and diagnostics, Marwan has held senior roles in R&D, regulatory, clinical, scientific affairs, and operations. He brings a rare, holistic view of how leadership, culture, and systems thinking come together to drive successful outcomes in complex, regulated environments.Their conversation explores how to balance innovation and compliance, structure cross-functional teams for consistent execution, and foster cultures that prioritize transparency, collaboration, and patient focus.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: https://www.thefdagroup.com/
Many healthcare organizations know they need an outpatient CDI program, but are tripped up by the most fundamental question: What is the expected return on investment after a considerable upfront investment of time, human capital, training, and technology? Discover the tangible impact of outpatient CDI on revenue, risk capture, provider alignment, and compliance in this special session of Off the Record. Jason Jobes, Senior Vice President, Solutions, Norwood, and Carol Ann Hudson, AVP of Quality and Clinical Operations and Population Health for Lifepoint Health first presented this popular session at the ACDIS 2026 national conference and later for a select virtual audience, and I'm pleased to bring it to my listeners. You'll walk away with a big picture understanding of OP CDI and concrete, operational strategies for transforming your program. If you haven't started yet, consider this your blueprint. Note that “ROI” doesn't only equate to revenue. Return on investment can also come in the form of denials resistant documentation, coding compliance, and improved patient care and value based care alignment through a greater emphasis on patient scheduling. All of which Lifepoint Health experienced. Note: Jason and Carol Ann refer to slides at points of this session; the audio can stand alone but if you prefer you can also download them on the Norwood website (free with registration): https://www.norwood.com/resource/the-roi-of-outpatient-cdi-slide-deck/
The FDA Group's Nick Capman speaks with Regina Atim, PharmD, pharmacist, maternal and perinatal health advocate, and founder of Clinicians Touch Healthcare Solutions. Regina brings deep expertise at the intersection of clinical practice, regulatory strategy, and maternal health innovation—including work on technologies to detect pregnancy-acquired cardiovascular disease.Their conversation explores FDA/ICH's new E21 draft guidance, Inclusion of Pregnant and Breastfeeding Women in Clinical Trials. Regina explains why pregnant and breastfeeding women have historically been excluded from research, how that has left clinicians and patients with insufficient evidence, and why E21 represents a cultural and scientific shift toward safe, risk-based inclusion.Read the draft guidance here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e21-inclusion-pregnant-and-breastfeeding-women-clinical-trialsRegina shares practical insights on:How physiologic changes in pregnancy alter drug absorption, distribution, metabolism, and elimination.The dangers of underdosing, overdosing, or avoiding treatment altogether in the absence of trial data.Why clinicians should avoid inappropriate substitutions (e.g., some NSAIDs) and instead rely on evidence-based dosing.How E21 encourages continued monitoring of participants who become pregnant during a trial rather than automatic withdrawal.The stepwise approach to lactation studies—starting with breast milk concentration, then estimating infant dose, and eventually assessing infant exposure and safety.The role of PK/PD modeling, nonclinical data, and real-world evidence in bridging evidence gaps.How sponsors can engage FDA early to align on inclusion triggers and maternal–fetal expertise.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: https://www.thefdagroup.com/
The FDA Group's Nick Capman speaks with Jeff Brenneman, Vice President of Global Operations Quality at Alora Pharmaceuticals. With more than 25 years of pharmaceutical manufacturing experience spanning branded, generic, and OTC products, Jeff brings a deep perspective on sustaining inspection readiness across multiple sites while leading global quality teams.Jeff shares why inspections feel less predictable today—with more variability in inspector experience and a higher likelihood that minor issues become formal observations—and how leaders can respond without overreacting. He explains how to prepare documentation so that it's understandable to any inspector, what makes a quality system truly “robust” in practice, and why culture, accountability, and simplicity matter as much as compliance.Nick and Jeff also explore practical steps for keeping data integrity controls sharp, building efficient systems that don't overburden teams, and fostering engagement so quality is seen as a partner, not just a policing function.About The FDA Group: The 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: https://www.thefdagroup.com/
The FDA Group's Nick Capman speaks with Catherine Lunardi, Founder and CEO of GenAIz. With nearly a decade leading GenAIz and prior leadership roles at GSK, CGI, and Héma-Québec, Catherine brings a seasoned perspective on how life science organizations can practically and compliantly deploy AI to build the next generation of labs.Catherine explains the biggest challenges labs face today—like fragmented data, manual processes, and costly compliance reviews—and how AI can help orchestrate data, surface anomalies, and accelerate insights without replacing the people at the center of science. She outlines a step-by-step approach to identifying the right challenges, aligning AI projects with company strategy, piloting solutions with clear ROI, and managing change so teams embrace and sustain new tools.Nick and Catherine also discuss the balance between innovation and regulation, how to keep humans in the loop, and why strong governance and explainability are essential to ensuring AI adds real value in GLP environments.About The FDA Group: The 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: https://www.thefdagroup.com/
In this interview, we sit down with John Tobin, Vice President of Clinical Operations at Splice Bio, to explore groundbreaking gene therapy research for Stargardt's disease and its potential impact on the blind and visually impaired community. John shares insights into Splice Bio's mission, how their innovative work could transform options for people living with vision loss, and what families, professionals, and supporters should know about emerging treatments. Stay tuned until the end for information on how to get involved in Splice Bio's clinical trials. Learn more here: www.splice.bio/clinical Or send an email to: Clinicaltrials@splice.bio #SpliceBio #genetherapy #clinicaltrials
The FDA Group's Nick Capman speaks with Marcus Gesner, Vice President of Global Quality at embecta. With more than two decades of leadership experience at companies including Boston Scientific, Olympus, Covidien, JUUL Labs, and others, Marcus brings a unique perspective to what makes a quality organization truly high-performing.Marcus shares why compliance is only the baseline “entry fee” for quality—and how high-functioning teams go further by protecting a company's right to compete, preventing manufacturing and supply disruptions, enabling speed to market, and building trust across the business.He discusses the metrics that matter most (like defect rates, back orders, holds, complaints, and R&D delays), how to structure incentives that drive the right behaviors, and practical strategies for recruiting, onboarding, and retaining people with the drive, courage, and creativity to lead meaningful change.Nick and Marcus also explore how leaders can create the right balance of accountability and innovation, foster collaboration across functions, and ensure quality is seen as a value-driving partner rather than a cost center or policing function.About The FDA Group:The 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: https://www.thefdagroup.com/
Nobody knows ALS better than people living with the disease. Therefore, it’s crucial for scientists to utilize the perspectives of people with lived experience in their research. Earlier this year, ALS TDI joined with Her ALS Story—a group of women diagnosed with ALS before the age of 35—to put on a series of Town Hall webinars that highlighted the importance of this connection. The three-part series featured discussions about ALS risk factors, lesser-known symptoms, and stories of diagnosis. In each session, researchers from ALS TDI’s ALS Research Collaborative, or ARC Study, presented information about our current scientific understanding of each topic, while Her ALS Story members shared their own personal experiences. Today, on Endpoints, we’ll hear some highlights from each episode of the series. We’ll also be joined by Dr. Danielle Boyce, ALS TDI’s Principal Investigator, Real World Evidence, and Alan Premasiri, our Director of Clinical Operations, to discuss what they learned from the discussions and how conversations like these can help shape the way they approach their research. If you'd like to learn more about ALS TDI's research and how we are incorporating lived experience to advance research, consider attending the ALS TDI Summit on October 17th, 2025 in Boston, MA or online. Register here: https://fundraise.als.net/alssummit/Support the show: https://www.als.net/donate/See omnystudio.com/listener for privacy information.
(00:00:00) Intro (00:00:32) Welcome Katie Martin, PA-C (00:02:22) How I treat patients and manage operations (00:04:34) How to measure an employee's success (00:05:59) How we decide what treatments to add to our practice (00:08:02) Growth beyond the empire (00:09:48) How training translates into consistency between practices (00:11:50) The value of having good processes in place (00:14:16) Why safety always comes first (00:14:55) Key takeaways about working in aesthetics (00:15:38) Links and outro As the VP of Clinical Operations at Holden Timeless Beauty, Katie Martin, PA-C wears a lot of hats. While seeing patients, she leads the day-to-day operations of a thriving, multi-location medical spa which requires consistency across locations and experienced staff.For Katie, safety and compliance always come first, even in a beauty-forward environment. Her mantra is safety first, beauty second. When it comes to performance management, Katie's team keeps a close eye on metrics like total revenue, revenue per hour, and revenue per visit to gauge each provider's impact.As the business grew to four locations, she learned the challenges of scaling and standardizing clinical care while making sure they never lost the personal touch. About Katie Martin, PA-CKatie Martin, PA-C is a Physician Associate specializing in medical aesthetics since 2015. Her passion is in education — clients, injectors and industry professionals. Katie is the Vice President of Clinical Operations and an advanced injector at HTB Aesthetics in Southern California. As a GAIN trainer for Galderma, she travels the country to train other injectors in safe techniques with natural results. Connect with Katie on LinkedInFollow Katie on Instagram @katie.the.injectorLearn more about Holden Timeless BeautyGuestKatie Martin, PA-C, Vice President of Clinical OperationsHolden Timeless BeautyHostRobin Ntoh, VP of AestheticsNextechPresented by Nextech, Aesthetically Speaking delves into the world of aesthetic practices, where art meets science, and innovation transforms beauty.With our team of experts we bring you unparalleled insights gained from years of collaborating with thousands of practices ranging from plastic surgery and dermatology to medical spas. Whether you're a seasoned professional or a budding entrepreneur, this podcast is tailored for you.Each episode is a deep dive into the trends, challenges, and triumphs that shape the aesthetic landscape. We'll explore the latest advancements in technology, share success stories, and provide invaluable perspectives that empower you to make informed decisions.Expect candid conversations with industry leaders, trailblazers and visionaries who are redefining the standards of excellence. From innovative treatments to business strategies, we cover it all.Our mission is to be your go-to resource for staying ahead in this ever-evolving field. So if you're passionate about aesthetics, eager to stay ahead of the curve and determined to elevate your practice, subscribe to the Aesthetically Speaking podcast.Let's embark on this transformative journey together where beauty meets business.About NextechIndustry-leading software for dermatology, medical spas, ophthalmology, orthopedics, and plastic surgery at https://www.nextech.com/ Follow Nextech on Instagram @nextechglowAesthetically Speaking is a production of The Axis: theaxis.io Theme music: I've Had Enough, Snake City
Send us a textIn this episode of the Life Science Success Podcast my guest is Lauri Befus, Vice President of Clinical Operations at M3 Wake Research, a leading integrated site network in the United States. With over 13 years of experience in clinical research and healthcare operations, Lauri brings a unique perspective to clinical trials, focusing on patient-centric strategies and operational excellence.00:00 Introduction to Life Science Success Podcast00:37 Meet Lauri Befus: Vice President of Clinical Operations at M3 Wake Research00:59 Lauri's Journey into Clinical Research01:53 Educational Background and Early Career02:36 Career Progression and Key Milestones04:25 Challenges in the Life Sciences Industry05:18 Diversity and Inclusion in Clinical Trials06:16 Overview of M3 Wake Research07:37 Lauri's Role and Responsibilities13:59 Innovative Projects and Initiatives16:28 Future Goals and Industry Innovations17:31 Leadership Insights and Advice24:19 Conclusion and Final Thoughts
Navigating the complexities of running a therapy practice today means balancing clinical care with growing administrative demands and emerging technology.Ted Faneuff, a practicing therapist and Head of Clinical Operations at Upheal, joins Michael Fulwiler to explore how AI is reshaping mental health care and helping therapists reclaim time and reduce burnout.Ted shares his personal journey, including his late ADHD diagnosis, and explains how AI-powered tools can support therapists in staying fully present with clients while easing documentation burdens.Listen to this conversation to understand what therapists need to know about AI, data privacy, and ethical adoption (plus why therapist involvement is critical in shaping the future of mental health technology).In the conversation, they discuss:How AI assistants can transform therapy workflows and save hours each weekThe importance of clear consent and privacy standards for AI use in therapyAddressing fears about AI replacing therapists and the role of human validationConnect with the guest:Ted on LinkedIn: https://www.linkedin.com/in/ted-faneuff-lisw-s-lmsw-lcsw-mba-b3030350/ Visit the Upheal website: https://www.upheal.io/ Connect with Michael and Heard:Michael's LinkedIn: https://www.linkedin.com/in/michaelfulwiler/ Newsletter: https://www.joinheard.com/newsletter Book a free consult: joinheard.com/consult Jump into the conversation:(00:00) Welcome to Heard Business School(00:34) Meet Ted Faneuff (01:20) Exploring How AI Can Support Therapy and Mental Health Care(02:19) Breaking Down What Artificial Intelligence Really Means(04:15) A Simple Explanation of Generative AI(06:58) How Large Language Models Power Today's AI Tools(10:07) Addressing the Privacy Concerns That Come with AI(11:02) What Therapists Need to Know About HIPAA and SOC 2 Security(13:06) Why Getting Clear Consent Matters When Using AI(14:45) The Debate on Whether AI Could Ever Replace Therapists(17:21) Looking at AI's Ability to Show Empathy and Build Trust(19:38) How AI Can Lend a Hand and Ease Therapist Workloads(27:47) Why It's Important for Therapists to Help Guide AI Development(35:54) What to Look for When Choosing AI Tools for Your Practice(44:23) How AI Might Expand Access and Help Therapists Stay in the FieldThis episode is to be used for informational purposes only and does not constitute legal, business, or tax advice. Each person should consult their own attorney, business advisor, or tax advisor with respect to matters referenced in this episode.
This episode features Dr. Benjamin J. Pieters, Pediatric Anesthesiologist and Vice Chair of Clinical Operations at Children's Mercy Kansas City, discussing major trends in anesthesiology, including workforce shortages, private equity involvement, and evolving employment models. He shares how his team is leveraging data, evidence-based care, and leadership development to shape the future of pediatric anesthesia and healthcare delivery.
Join Dr. Stephanie on Converge Autism Radio with special guest Courtney Lasky, M.Ed., BCBA, LBA and PhD candidate, as they unpack the real-world impact of Applied Behavior Analysis (ABA) in autism. Courtney shares insights from her 10+ years leading compassionate, trauma-informed clinical teams at ABS Kids, explores common myths, highlights crucial components of effective ABA care, and reveals how leadership strategies can foster psychological safety in therapy settings. Whether you're a caregiver, clinician, or advocate, this episode offers fresh perspectives and practical guidance to support autistic individuals and their families with dignity and expertise.About the speaker: Courtney Lasky, M.Ed., BCBA, LBA Courtney Lasky is a Board Certified Behavior Analyst (BCBA) amd PhD candidate with over a decade of experience in Applied Behavior Analysis (ABA). As the Director of Clinical Operations for ABS Kids, she leads clinical teams in providing high-quality, compassionate care to children and families.Recognized as a subject matter expert, Courtney has been featured on Crime Stories with Nancy Grace and the Dr. Drew Podcast, where she shares her insights on behavior analysis and its broader applications. She is passionate about leadership, staff training, and fostering psychological safety within clinical teams.Beyond her professional work, Courtney is a dedicated wife and mother of six, living in Irmo, South Carolina. Balancing a thriving career with a full and adventurous family life, she brings both expertise and heart to everything she does.
This episode recorded live at the Becker's 22nd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference features Michael Bottros, Clinical Operations Chief and Medical Director for Pain Services, Department of Anesthesiology, Keck School of Medicine of USC. He shares key trends in non-opioid pain management, the shift toward curative procedures, and how innovation, workforce investment, and care path efficiency are shaping the future of outpatient spine and orthopedic care.
This episode recorded live at the Becker's 22nd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference features Michael Bottros, Clinical Operations Chief and Medical Director for Pain Services, Department of Anesthesiology, Keck School of Medicine of USC. He shares key trends in non-opioid pain management, the shift toward curative procedures, and how innovation, workforce investment, and care path efficiency are shaping the future of outpatient spine and orthopedic care.
This episode recorded live at the Becker's 22nd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference features Michael Bottros, Clinical Operations Chief and Medical Director for Pain Services, Department of Anesthesiology, Keck School of Medicine of USC. He shares key trends in non-opioid pain management, the shift toward curative procedures, and how innovation, workforce investment, and care path efficiency are shaping the future of outpatient spine and orthopedic care.
In this episode of Positive Philter, Philip reconnects with high school friend Dr. Haley Parker, the Director of Clinical Operations and Professor at Virginia University of Integrative Medicine. Haley shares her inspiring journey from studying Anthropology and Religious Studies to embracing Eastern Medicine and Acupuncture. Together, they explore the importance of a holistic approach to healing—one that nurtures the mind, body, and spirit—and how it complements Western healthcare practices. Haley also reflects on her commitment to cultural humility, discussing how her broader worldview shapes her work as a healer and advocate for integrative medicine. Shout Outs and Plugs Website for VUIM: https://www.vuimclinic.com/ VUIM's Instagram Page: https://www.instagram.com/vuimclinic/ VUIM's LinkedIn Page: https://www.linkedin.com/company/vuimedu/ Dr. Haley's Instagram: https://www.instagram.com/dr.haley.vuim/ Dr. Haley's LinkedIn Page: https://www.linkedin.com/in/haley-parker-vuim/ If you have a question for the podcast call 571-336-6560 or leave a question via this Google Form. Five Minute Journal by Intelligent Change Affiliate Code: https://www.intelligentchange.com/?rfsn=4621464.017186 Tappy Card “Electronic Business Card” Affiliate Code: https://tappycard.com?ref:philip-wilkerson Please leave a rating/review of the Podcast https://lovethepodcast.com/positivephilter Intro music provided by DJ BIGyoks. Check out his Instagram and Soundcloud channel here: https://www.instagram.com/beats.byyoks/ https://soundcloud.com/dj-bigyoks Outro music provided by Ryan Rosemond. Check out his Soundcloud channel here: https://soundcloud.com/brothersrosemond/albums Purchase "Forty Years of Advice" by Philip Wilkerson: https://a.co/d/2qYMlqu Leave Your Feedback by filling out this audience survey: https://forms.gle/ncoNvWxMq2A6Zw2q8 Sign up for Positive Philter Weekly Newsletter: http://eepurl.com/g-LOqL Please follow Positive Philter: Positive Philter Facebook Page Positive Philter Twitter Positive Philter Instagram If you would like to support the podcast, please consider donating to the Positive Philter Patreon page: https://www.patreon.com/positivephilter Positive Philter was selected by FeedSpot as Top 20 Positive Thinking Podcasts on the web. https://blog.feedspot.com/positive_thinking_podcasts/ Jeff's Anti-Hunger Fund The Positive Philter Podcast is dedicated to Jeff Kirsch. A long-time supporter of the show and a major influence on this show's growth. Please support the careers of future advocates by donating to the Jeff Kirsch Fund for Anti-Hunger Advocacy. This fund was named after Jeff Kirsch for his decades of service in fighting hunger and inequality. Link to fund: https://frac.org/kirschfund Pats for Patriots If you are a member of the #MasonNation, please consider sending a Pats for Patriots. Pats for Patriots are a free and easy way to thank, recognize, show appreciation for a Mason colleague or student who has taken the time to do something kind, generous or thoughtful towards others. For more information, visit: https://forms.office.com/r/HRZGvhdJEA We have received more than 2,000 nominations from the Mason community so far. Keep those nominations coming in!
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