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Today on Australia's ONLY Christmas Podcast we have a Podcast a day, every day from now till Christmas. We uncover the best Christmas Sandwich Combination of all time. We look at all the best flavors and fillings that come out at this time of year and see what matches best for the ultimate Sarni. Our Tinsel is in a Tangle with a new Holiday Travel Trend that can make your next trip super uncomfortable and may even get you a little hot under the festive colour Plus Are you an annual Ornament Collector. The cute tradition of collecting the same type of decoration year upon year and why it ads to the joy of the season With your Aussie Hosts Liam and Ness talking all things Christmas every day with a daily podcast from now till Christmas Day Tune In to Christmas Talk Radio. Our 24/7 Christmas Radio Station talking All Things Christmas, Non-Stop every day of the week. Find us on the I Heart Radio Ap or Click on the link to listen below https://tunein.com/radio/Christmas-Talk-Radio-s345979/
Combination regimens improve survival in advanced EGFR-mutated NSCLC, but they also increase toxicity. Jorge Nieva, MD, shares how he talks with patients about potential adverse events. He describes the options available for prophylaxis and how he treats the toxicities that do arise.
The Gazette sports writer K.J. Pilcher and Iowa wrestling legend Dick Briggs how the Iowa Hawkeyes, Iowa State Cyclones, UNI Panthers and the small college wrestling teams fared and their upcoming meets/duals.
Colin Russell, PhD / John Watkins, MBBCh, BSc - A Shot in the Arm: Leveraging Combination Vaccines for Global Health Impact
Colin Russell, PhD / John Watkins, MBBCh, BSc - A Shot in the Arm: Leveraging Combination Vaccines for Global Health Impact
Colin Russell, PhD / John Watkins, MBBCh, BSc - A Shot in the Arm: Leveraging Combination Vaccines for Global Health Impact
Colin Russell, PhD / John Watkins, MBBCh, BSc - A Shot in the Arm: Leveraging Combination Vaccines for Global Health Impact
Colin Russell, PhD / John Watkins, MBBCh, BSc - A Shot in the Arm: Leveraging Combination Vaccines for Global Health Impact
Colin Russell, PhD / John Watkins, MBBCh, BSc - A Shot in the Arm: Leveraging Combination Vaccines for Global Health Impact
Josh Pauls was born without a tibia in both legs and had them both amputated at 10 months old. At age eight, he would be introduced to the game of sled hockey. Within eight years of first trying out the sport, he was called up to his first world championship team. Pauls made his Paralympic debut at the Paralympic Winter Games Vancouver 2010, where he was the youngest player on the team at 17. He would later serve as captain for the U.S. sled hockey team at the 2018 and 2022 Paralympic Games. Pauls is the only sled hockey player to win four Paralympic gold medals. He is the author of “Lessons Learned: My Journey to the Podium” and hopes to be a professional hockey coach when his sled hockey career is finished.
Why is Rosh Chodesh considered more Mekudash than Shabbos, and the depth of Chanukah.Source Sheet: https://drive.google.com/file/d/1S0n6hH70eK0I_wOos9bNxCY_fa21T5Sy/view?usp=share_link
In this episode of Leadership Bites, I interview Guido Palazzo, Professor of Business Ethics, University of Lausanne, who explores the dark side of corporate behaviour and the systemic issues that lead to ethical failures. We discuss Guido's background, the concept of his brilliant book 'The Dark Pattern: The Hidden Dynamics of Corporate Scandals' in corporate scandals, and the importance of understanding the systems and cultures that allow unethical behaviour to thrive. The conversation delves into the psychological aspects of corporate culture, the slippery slope of ethical compromise, and the need for organisations to create environments that promote ethical decision-making. Ultimately, we highlight the importance of awareness and proactive measures to prevent ethical failures in business.TakeawaysGuido focuses on the absence of ethics in business.Corporate scandals often involve good people making bad decisions.Systems, not just individuals, drive unethical behaviour.Leadership plays a crucial role in shaping organisational culture.Group dynamics can lead to conformity and ethical blindness.The slippery slope of compromise can lead to significant ethical failures.Survival instincts can overshadow ethical considerations in the workplace.Creating a 'bright pattern' can help organisations avoid ethical pitfalls.Awareness and proactive measures are essential for ethical business practices.The importance of having a court jester to provide honest feedback in organisations.Key Moments & Chapters00:00 Introduction to Ethics and Corporate Responsibility03:03 Guido's Background and Academic Journey05:37 Understanding Ethics in Business08:49 The Role of Systems in Ethical Failures11:45 Exploring Corporate Scandals and Dark Patterns14:35 The Impact of Leadership on Organizational Culture17:41 Group Dynamics and Ethical Decision Making20:30 The Combination of Dark Patterns in Corporations23:28 Survival and Ethical Compromise in Business26:12 Conclusion: The Human Element in Corporate Ethics26:42 The Dark Patterns of Corporate Culture29:39 The Slippery Slope of Compromise33:16 The Illusion of the Messiah in Leadership40:13 The Disconnect Between Leadership and Reality44:11 Finding the Bright Pattern in Dark TimesTo find out more about Guy Bloom and his award winning work in Team Coaching, Leadership Development and Executive Coaching click below.The link to everything CLICK HEREUK: 07827 953814Email: guybloom@livingbrave.com Web: www.livingbrave.com
Results of a phase II trial of olaparib in combination with ceralasertib in patients with recurrent and unresectable osteosarcomaOsteosarcoma Webinar Series: Katie Janeway, MD and Suzanne Forrest, MD join us on OsteoBites to discuss results of a phase II trial of olaparib in combination with ceralasertib in patients with recurrent and unresectable osteosarcoma.Dr. Janeway received her MD and MMSc from Harvard Medical School. She completed her pediatrics residency and her Pediatric Hematology-Oncology fellowship at Boston Children's Hospital and Dana-Farber Cancer Institute. She is an Associate Professor of Pediatrics, a Senior Physician who cares for young people with sarcoma, and Director of Clinical Genomics. Dr. Janeway's research is focused on precision oncology and bone sarcomas. She leads clinical trials both as an independent investigator and as the Chair of the Children's Oncology Group (COG) Bone Tumor Committee. The Janeway Laboratory leads several studies, which have enrolled and sequenced more than 2,500 patients with childhood cancers. They are using this data to deepen the understanding of clinical and genomic factors explaining prognosis and treatment response, and resistance, with a focus on sarcomas. In collaboration with Count Me In, the group is innovating patient partnerships in sarcoma research.Dr. Forrest completed her medical school training at Yale University, followed by pediatrics training in the Boston Combined Residency Program. She then pursued a pediatric oncology fellowship at Dana-Farber Cancer Institute / Boston Children's Hospital. Currently, she serves as an Assistant Professor of Pediatrics at Harvard Medical School and an Attending Physician in the Department of Hematology/Oncology at Dana-Farber / Boston Children's Cancer and Blood Disorders Center. Her research focuses on developing novel clinical trials that utilize cancer genomics to guide treatment strategies for pediatric solid tumors.After a short presentation on this research, they will take questions from attendees. Share your questions in advance with us at Christina@MIBAgents.org.
Episode Timeline & Main Topics 00:00 — Opening & Community Update • First week doing the podcast fully live thanks to the On The Pen community • Overview of why this week's news is a major turning point in obesity medicine 02:30 — Introducing the “One-and-Done” Obesity Drug (Wave Life Sciences) • WVE-007 early data drops • Why this therapy is unlike GLP-1s or any nutrient-stimulated hormone • Fat loss results and lean-mass increase 06:30 — How Wave-007 Works: INHBE Gene Silencing • Mechanism behind visceral fat reduction • Why this shifts the field toward “quality of weight loss” 09:15 — Why Lean-Mass Preservation Matters • Current GLP-1 medications and muscle loss • Why women dominate trial enrollment and the larger implications • Medicare patients and the coming wave of GLP-1 coverage 13:45 — The Future of Maintenance Therapies • Fractyl Health Revita results • Lilly's orforglipron maintenance design • Why “holding the line” after GLP-1 therapy is the next major category 17:30 — Amylin Agonists: Cagrelintide vs. Eloralintide • Novo's delays and the strategy behind them • Lilly's surprising phase 2 results (up to 20% weight loss) • Combination therapies with tirzepatide or retatrutide 22:30 — FDA Pipeline Acceleration • Potential removal of traditional phase 3 trials • How this speeds up the arrival of next-generation therapies 24:15 — Oral GLP-1 Small Molecules (Structure Therapeutics) • Alaniglipron data and the stock surge • Comparisons to orforglipron and past failures like denuglipron • Why Dave remains skeptical 28:40 — Sponsor Break: Shed & Shapa • Access, coaching, and patient support • Using a numberless scale to build a healthier relationship with weight tracking 31:10 — Counterfeit Ozempic Warning • New fake lot discovered in U.S. pharmacies • How to identify counterfeit pens • Why this should be a national headline • The broader question of drug supply-chain vulnerability 36:00 — Closing Thoughts on the Future of Obesity Medicine • Moving from “more weight loss” to “better weight loss” • Why the field is closer than ever to reshaping obesity as a disease • Gratitude for the community making full-time coverage possible Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
Dick Vermeil joins the 94 WIP Morning Show sharing that he believes that there is a combination of things that are the issue. However, he believes the Eagles will beat the Chargers.
Heavy Metal! “Tuba Christmas” comes to the Cedar Rapids Public Library Dec. 13. It's an ad hoc ensemble that will feature nearly 100 instruments. Rehearsal takes place immediately prior to the show, and all players are welcome, regardless of age or experience level. Admission and participation are free, but audience members are encouraged to bring … Continue reading
Got a show or guest idea? Send us a text!For the full report, visit: https://mcculloughfnd.org/pages/autism-research-reportFor updated research, follow @nichulscher on XFor decades, the causes behind the relentless rise in autism have been hotly debated. Some claim it's due to better diagnosis or changing definitions; others point to environmental stressors and genetics. Yet until now, no comprehensive analysis has ever examined all potential factors—genetic, environmental, immunologic, and iatrogenic—together within a single scientific framework.The McCullough Foundation's landmark report, Determinants of Autism Spectrum Disorder, represents the most exhaustive synthesis ever conducted on the causes of autism. Drawing from over 300 peer-reviewed studies across epidemiology, clinical medicine, toxicology, immunology, and molecular biology, this analysis provides an authoritative, data-driven evaluation of how vaccination and other determinants contribute to autism risk.By comparing the strength, direction, and biological plausibility of every major proposed risk factor, this landmark report delivers unprecedented clarity: autism is a multifactorial neurodevelopmental disorder—but one major, modifiable factor stands out above all others.Combination and early-timed routine childhood vaccination emerges as the single most significant driver of autism risk, supported by convergent mechanistic, clinical, and epidemiologic evidence.Support the show
This week, we are thrilled to welcome Brennan McGrath and Kapono Chung to the show! They are Partners at Combo, a strategic creative agency that uses strategy and design to unlock what's next. Their work spans from deep research and thorough strategy to design and beyond. They've worked with brands like Away, Target, Nike, Aldo, GAP, Instagram, Bed Bath & Beyond, Street Easy, and more! We talk about all things Combo: how they came to be, and how they chose the name when their two companies merged, their aspirations, and the state of design present and future. We had a great time talking with them, they're two very thoughtful dudes! Enjoy!
Blunt Business speaks with Joel Latham, CEO of Incannex Healthcare (NASDAQ: IXHL), a clinical-stage biopharmaceutical company pioneering the use of proprietary combination medicines. Latham breaks down their strategy of fusing synthetic cannabinoids and well-characterized active drug components to target chronic conditions with significant unmet needs, emphasizing a robust intellectual property position and synergistic drug action.Advertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy
This is a combination of two teachings by Apologist Sandy Simpson. Sandy discusses in back-to-back teachings, New Heresies and the New Indigenous Christian Religion.
BDA: HOCKEY AND SCOTTISH BOOBIES OPEN PHONES: MARSHALL TELLS US A FUNNY STORY ABOUT A TRANS COUPLE OPEN PHONES: I SMOKED WEED ON EASTER AND IT CHANGED MY LIFE ALL ADVICE SHOW: MY SON IS TAKING TWO BIG GIRLS TO PROM
In this episode of More Than A Pretty Face, Dr. Azi speaks with Dr. Tomi Wall about modern rosacea management, including pulsed-dye lasers, V-Beam, combination treatments, and intradermal Botox for flushing. She then sits down with Dr. Monica Boen to discuss the resurgence of CO₂ and Erbium resurfacing lasers, evolving technology, and the cautious excitement around regenerative treatments like exosomes and PDRN. Both dermatologists share practical skincare advice, treatment philosophy, and their go-to in-office approaches for natural, effective results. Timeline of what was discussed: 00:00 – Podcast intro & welcome 00:07 – Introducing Dr. Tomi Wall 00:55 – Why rosacea emotionally affects patients 01:40 – Types of rosacea explained 02:35 – Top at-home treatments (azelaic acid, ivermectin, sulfur) 03:40 – In-office vascular treatments with PDL 04:40 – How vascular lasers improve rosacea 05:25 – V-Beam for scarring 06:15 – Best timing to start scar laser treatment 07:15 – Treating bruising immediately after filler 08:10 – V-Beam settings for bruising 09:00 – Botox for flushing & neurovascular mechanisms 10:00 – Dilution, dosing, safety precautions 11:05 – Topicals for temporary redness & rebound effects 12:00 – Rapid-fire questions 13:25 – Close of interview 1 15:25 – Introducing Dr. Boen & her practice 15:55 – Why CO₂ & Erbium ablative lasers are returning 16:35 – What ablative lasers do & why patients accept downtime 17:25 – UltraPulse CO₂ & Erbium for deep resurfacing 18:10 – UltraClear: lighter resurfacing with minimal downtime 19:10 – Choosing mild vs aggressive resurfacing settings 19:55 – Combination treatments (Pico, PDL, Fraxel, Clear & Brilliant) 20:40 – PDRN ("salmon DNA"): buzz vs data 21:40 – Exosomes: potential & regulatory concerns 22:50 – Real complications seen from unregulated injectables 23:35 – Dr. Boen's personal favorite treatments 24:10 – Daily skincare must-haves (SPF, retinoids, antioxidants) 25:00 – LED masks: when they help and when they don't 25:55 – Final message: patient education matters 26:40 – Podcast closing & where to submit questions ______________________________________________________________ Follow Tomi Wall on Instagram: @dr.tomileewall Dr. Tomi Wall is a laser fellowship–trained, board-certified dermatologist based in Northern California. With advanced training from Harvard Medical School and extensive experience teaching residents at Stanford, she specializes in vascular and laser-based treatments for rosacea, scarring, and inflammatory skin conditions. Dr. Wall is known for her research-informed approach, dedication to patient-centered care, and expertise in combination therapy to achieve natural, evidence-based outcomes. Follow Monica Boen on Instagram: @drmonicaboen Dr. Monica Boen is a board-certified dermatologist practicing in San Diego with advanced specialization in aesthetic and procedural dermatology. Trained in ablative and regenerative laser surgery, she is recognized for bringing modern innovation to legacy resurfacing technologies such as CO₂ and Erbium lasers. Dr. Boen is known for her comprehensive treatment planning, commitment to clinical safety, and ability to blend multiple modalities for powerful yet natural skin rejuvenation results. ______________________________________________________________ Submit your questions for the podcast to Dr. Azi on Instagram @morethanaprettyfacepodcast, @skinbydrazi, on YouTube, and TikTok @skinbydrazi. Email morethanaprettyfacepodcast@gmail.com. Shop skincare at https://azimdskincare.com and learn more about the practice at https://www.lajollalaserderm.com/ The content of this podcast is for entertainment, educational, and informational purposes and does not constitute formal medical advice. © Azadeh Shirazi, MD FAAD.
Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, "NEALS 2025: Takeaways That Matter for ALS Care," ALS experts Jinsy Andrews, MD, MSc, and James Berry, MD, MPH, reflect on key themes from the 2025 NEALS Annual Meeting, now reintroduced as the Network of Excellence for ALS. They discuss format changes that elevated lightning science, the expanding gene therapy pipeline, and a growing slate of NEALS-affiliated trials. The conversation highlights updates from the HEALEY Platform Trial, the MY-MATCH biomarker-guided precision trial, SOD1 program data, and new antisense and viral vector therapies aimed at sporadic ALS. They also explore the impact of Act for ALS on trial access, the ALL ALS biospecimen repository, and NIH-supported expanded access cohorts. The discussion closes with insights on combination therapy strategies, genetic subtypes, presymptomatic enrollment, and how new collaborations, digital endpoints, and infrastructure advances are shaping momentum heading into 2026. Looking for more Neuromuscular discussion? Check out the NeurologyLive® Neuromuscular clinical focus page. Episode Breakdown: 1:05 – Reflections on meeting highlights and NEALS rebranding into a global network 5:00 – Notable NEALS-affiliated trials and promising new mechanisms in ALS care 12:45 – Combination therapy strategies and future approaches in ALS research 15:20 – Neurology News Minute 18:00 – Expanding clinical trial access for rare and genetic ALS subtypes 22:10 – Building momentum and expectations for the 2026 NEALS Annual Meeting The stories featured in this week's Neurology News Minute, which will give you quick updates on the following developments in neurology, are further detailed here: FDA Approves Doxecitine and Doxribtimine Combination Therapy as First Treatment for Thymidine Kinase 2 Deficiency Supplemental New Drug Application Submitted for AXS-05 as Treatment for Alzheimer Disease Agitation BTK Inhibitor Fenebrutinib Meets Primary End Points in Phase 3 Trials for Both Relapsing and Primary Progressive MS Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.
In today's episode, filmed live at the 43rd Annual Chemotherapy Foundation Symposium, lung cancer expert Benjamin P. Levy, MD, hosted a cross-specialty discussion with genitourinary (GU) cancer expert Scott T. Tagawa, MD, MS, FACP, FASCO, about the rapidly evolving treatment paradigms for prostate and kidney cancer. Dr Levy is the clinical director of medical oncology at the Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital and an associate professor of oncology at the Johns Hopkins University School of Medicine in Washington, DC. Dr Tagawa is a professor of medicine and urology at Weill Cornell Medicine, as well as an attending physician at NewYork-Presbyterian – Weill Cornell Medical Center in New York, New York. Their conversation began with a focus on prostate-specific membrane antigen (PSMA)–positive prostate cancer. Dr Tagawa explained that PSMA is a cell surface protein, and that PSMA imaging agents are commonly used to assess biochemical recurrence and perform initial disease staging. He noted that therapy-related adverse effects are often site-specific, including dry mouth/change in taste, and myelosuppression from the radiation payload. For monitoring long-term safety, Dr Tagawa emphasized that renal function must be tracked. Beyond PSMA, other prostate cancer targets include TROP-2, B7-H3, and markers specific to aggressive or neuroendocrine variants, such as DLL3, he reported. In advanced GU cancers, circulating tumor DNA (ctDNA) testing is increasingly important, Dr Tagawa highlighted. In prostate cancer, ctDNA testing is used to assess homologous recombination deficiency (HRD) status and BRCA expression, he said, explaining that evidence for the use of ctDNA testing in GU cancers stems from findings with this type of assay to evaluate minimal residual disease levels in urothelial cancer. He noted that studies show that if patients with urothelial cancer become ctDNA positive within the first year of receiving neoadjuvant chemotherapy, they benefit from treatment with atezolizumab (Tecentriq). Similarly, he stated that patients with previously untreated HRD-positive metastatic prostate cancer also see a progression-free survival benefit when a PARP inhibitor is added to an androgen deprivation therapy/androgen receptor pathway inhibitor backbone. Shifting the conversation to the management of frontline advanced clear cell renal cell carcinoma (RCC), the experts reviewed standard approaches, which involve an immune-oncology (IO) agent plus either a CTLA-4 inhibitor or a VEGF TKI. Tagawa noted that IO/VEGF TKI combinations may be preferred for symptomatic patients needing a rapid response, whereas IO/IO combinations may offer greater potential for treatment cessation. He brought up a key distinction in RCC, which is that re-instituting PD-1/PD-L1 inhibition upon progression in the metastatic setting has generally shown no benefit. Dr Levy brought a broad scope to the GU cancer discussion through his lung cancer expertise, introducing parallels between the treatment paradigms. The interview provided an opportunity to show the importance of creating connections across oncology specialties to bring nuanced perspectives to future advances in clinical research and patient care.
Lots has happened recently. Today I decided once and for all to set some non-negotiables 1. No Phone in My Room - 2. I Move 10,000 Steps Every Day - 3. I Run a Timed Mile Every Thursday - 4. I Listen to a General Conference Talk Every Day - 5. I Study the Scriptures Every Day - 6. I Write for Two Hours a Day -7. I Invest Two Hours Every Monday into a Combination of Cleaning, Planning, and Overall Life Maintenance - Resources Mentioned:"One Percent Better" Talk: https://www.churchofjesuschrist.org/study/general-conference/2021/10/54dunn?lang=eng"Good, Better, Best" Talk: https://www.churchofjesuschrist.org/study/general-conference/2007/10/good-better-best?lang=eng"Where Will This Lead?" Talk: https://www.churchofjesuschrist.org/study/general-conference/2019/04/35oaks?lang=eng"The Power of Spiritual Momentum" Talk: https://www.churchofjesuschrist.org/study/general-conference/2022/04/47nelson?lang=engMore From Me:Subscribe to YIELD Deeply - https://dallincandland.substack.com/Check out my second book, "Patience in These Pages" - https://a.co/d/4kfFqW8Watch the Dallin Candland YouTube channel (for more on the podcast, behind the scenes videos, and more!): https://www.youtube.com/@dallincandlandTime Stamps:Quotes:8:12 - "The battle is against sin, NOT each other."Support the show
In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Leonel Venegas, a seasoned quality and regulatory professional who has worked with global leaders including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.Leonel shares how integrating Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP) is essential to successful combination-product development. He discusses his journey from chemist to regulatory-affairs expert, uncovering common disconnects between pharma and device cultures, and the critical role of design controls, risk management, and timelines.The conversation also explores GMP and process validation, IDE vs. IND pathways, the challenges of rare-disease programs, and how understanding the cost of quality can reshape testing strategies. Leonel closes by reflecting on becoming a Lean Six Sigma Black Belt and what continuous improvement really looks like in combination-product development.⏱ Timestamps00:00 – Welcome & Introduction00:52 – Integrating GLP, GCP & GMP02:22 – Challenges in Developing Combination Products04:02 – Device-Led Combination Products07:35 – Working with Rare Diseases09:58 – GMP & Process Validation15:08 – Clinical Trials: Drug vs Device19:22 – Cost of Quality & Six Sigma25:12 – Conclusion & Contact InformationLeonel Venegas is the Founder of Precision Regulatory Consulting LLC and an expert in quality and regulatory affairs with over two decades of experience across six global pharma and medtech leaders, including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.He is certified by ASQ as a CMQ/OE, CQE, CBA, and CSSBB, and holds an M.S. in Regulatory Affairs. Leonel specializes in combination products, medical devices, and IVDs, integrating GLP, GCP, GMP, and GVP principles into complex global development programs.
The Fracture of Reagan's First Marriage, Hollywood's Red Scare, and the Appearance of Nancy Davis. Max Boot discusses the marriage between Ronald Reagan and Jane Wyman, which was considered an "odd combination." Wyman was drawn to Reagan because he was a "nice guy" and a "white knight," though Reagan was "very hard to get to commit." By the eve of World War II, Reagan was professionally ascending, but the war derailed his commercial film career as he spent the entire conflict in Hollywood making training and propaganda films. When the war ended, there was diminished demand for his services, while Jane Wyman's career soared after the war. Reagan became increasingly active in the Screen Actors Guild (SAG) and Hollywood politics, still an "idealistic liberal" and New Dealer, while Wyman became uninterested in politics, leading them to drift apart. The political climate was dominated by Congress's search for communists in Hollywood. Reagan served as the unpaid president of SAG and navigated the "treacherous politics" of the McCarthy era skillfully, appearing liberal when testifying before HUAC while quietly acting as an FBI informant. Jane Wyman initiated the divorce in 1948, shocking Reagan and leaving him adrift. Nancy Davis then entered his life, leading to a marriage that made sense, as Nancy wanted to be a wife and mother and threw herself into the role of the "perfect wife." Reagan needed a strong woman, and Nancy became absolutely integral to his career advancement, acting as a shrewd political figure who often handled hiring and firing.
In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh welcomes Mark Kramer, the founding director of FDA's Office of Combination Products (OCP). Mark takes us on a deep dive into the history of how combination products have been regulated in the U.S., starting with the Safe Medical Devices Act of 1990 and how the process evolved into the formation of OCP in 2002.We explore questions such as: What challenges did industry and the FDA face in the early days of combination products? How did the “Request for Designation” process come about, and how is regulatory identity determined? What is the “Primary Mode of Action” (PMOA) rule and why does it matter? How do user fees, cross-center coordination, and post-market regulations shape how combination products get to market and are monitored? Mark also highlights current regulatory gapssuch as cross-labeling and site registration issues that continue to impact developers.Whether you're working in med-tech, pharma, or regulatory affairs, this episode offers historical perspective, technical insights, and strategic take-aways for navigating the combination-product space. Tune in for a candid conversation with one of the leading figures in this field.Timestamps:00:00 Introduction & Guest Welcome00:35 Historical Background of Combination Products03:05 Creation of Office of Combination Products (OCP)04:29 Early Challenges and Developments04:54 MDUFA, PDUFA, User Fee Programs & Legislative Impact14:24 Defining Primary Mode of Action (PMOA)18:35 OCP's Role & Responsibilities26:49 Industry Adoption & Challenges38:48 Regulatory Gaps & Future Directions46:00 Conclusion & Contact InformationContact & Resources:Connect with Mark Kramer on LinkedIn or via email at Mark.Kramer@greenleafhealth.comMark Kramer is Principal of the Medical Devices & Combination Products regulatory practice at Eliquent Life Sciences (formerly Greenleaf Health). He has more than 35 years experience at FDA and in regulated industry. At FDA, he established and directed the Office of Combination Products and was a scientific reviewer and later supervisor of the premarket review of devices in a variety of medical discipline areas. Following his FDA career, he served as Regulatory Affairs Executive and Chief Regulatory Strategist at GE Healthcare and then as an independent regulatory consultant for over 10 years before joining Greenleaf. Mark served as a board member of the Regulatory Affairs Professionals Society (RAPS) and in 2021, he was awarded the RAPS Founders Award, the profession's highest honor, recognizing exemplary regulatory professionals who have shaped regulatory policy and practice and have made a positive impact on the profession.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
Join Jim and Greg for the Wednesday 3 Martini Lunch as they dig into the Democrats' hilariously bad messaging on the government shutdown, China's chilling fusion of AI and genetic engineering, and Jon Stewart's absurd comparison of Zohran Mamdani to Jackie Robinson.First, they marvel at how Democrats proudly admit to causing real pain for Americans in an attempt to gain political leverage in the shutdown fight. It's a cold, heartless message but Democrats are more than welcome to keep using it.Next, Jim shares insights from Bill Drexel of the Hudson Institute, who joined Jim on the recent trip to India. Drexel reports that China is combining artificial intelligence with genetic engineering in pursuit of future generations with no flaws and who will be superior soldiers. Jim also explains how the ethical nightmare surrounding this plan won't even matter to Xi Xinping and the Chinese Communist Party.Finally, they roll their eyes as Jon Stewart of The Daily Show fawns over Democrat New York City mayoral nominee Zohran Mamdani and compares him to legendary baseball player Jackie Robinson. Jim and Greg document how the Democrats have shifted from running away from Mamdani to a full embrace once they sensed he could win.Please visit our great sponsors:Cancel unwanted subscriptions and reach your financial goals faster with Rocket Money at https://RocketMoney.com/MARTINI Build your fall sanctuary of comfort with Boll and Branch. Save 20% plus free shipping on your first set of sheets at https://BollAndBranch.com/THREEMARTINI —offer ends soon, exclusions apply.
Join Jim and Greg for the Wednesday 3 Martini Lunch as they dig into the Democrats' hilariously bad messaging on the government shutdown, China's chilling fusion of AI and genetic engineering, and Jon Stewart's absurd comparison of Zohran Mamdani to Jackie Robinson. First, they marvel at how Democrats proudly admit to causing real pain for […]
Watch every episode ad-free & uncensored on Patreon: https://patreon.com/dannyjones Thomas Seager, PhD is CEO of Morozko Forge ice bath company. He is also Associate Professor in the School of Sustainable Engineering & the Built Environment at Arizona State University. He's authored two books - "Uncommon Cold: The Science & Experience of Cold Plunge Therapy" & "Uncommon Testosterone: Cold Plunge Therapy for Optimizing Sexual Health." SPONSORS https://whiterabbitenergy.com/?ref=DJP - Use code DJP for 20% off EPISODE LINKS https://www.morozkoforge.com Uncommon Testosterone Book: https://a.co/d/6eUuE9j Uncommon Cold Book: https://bit.ly/3L7O4MU https://www.instagram.com/seagertp https://x.com/seagertp FOLLOW DANNY JONES https://www.instagram.com/dannyjones https://twitter.com/jonesdanny OUTLINE 00:00 - Pre-cooling vs. post-cooling with ice baths 15:11 - Ice baths are replacing TRT 25:24 - Best length of a cold plunge 30:10 - When ice baths went mainstream 40:04 - Mitochondrial health, brown fat & cold exposure 46:04 - How the mitochondria emit visible light 55:59 - UVA vs. UVB light 01:02:32 - How often you should cold plunge 01:08:57 - Combination of sauna & cold plunge 01:17:44 - How the body survives a fast 01:25:21 - Best cure for headaches & migraines 01:37:30 - Seed oils, food dyes & sugar 01:50:27 - Why RFK is perfect for HHS 01:57:52 - How to fix nutrition in poor populations 02:05:29 - What REALLY causes autism in kids 02:14:28 - Insurance incentives for hospitals 02:22:13 - New pharmaceutical ad requirements 02:32:01 - Hot tubs make you sick Learn more about your ad choices. Visit podcastchoices.com/adchoices
Nancy Harhut, Founder of HBT Marketing, joins AMA's CEO and podcast host, Bennie F. Johnson, for a conversation about the misconceptions of B2B marketing, what happens when you employ behavioral science in marketing campaigns, and why it's always necessary to employ the brain.
The FiltrateJoel Topf @kidneyboy.bsky.socialSwapnil Hiremath @hswapnil.medsky.socialNayan Arora captainchloride.bsky.socialSopia Ambruso @sophia-kidney.bsky.socialSpecial Guests Brendon Neuen @brendonneuen.bsky.social Associate Professor and Program Lead, Renal and Metabolic at The George Institute for Global Health. Nephrologist and Director of Kidney Trials at Royal North Shore Hospital.Neuen has had three prior appearances on Freely Filtered: EMPA Kidney, DUPLEX and Sparsentan in FSGS, FLOW and SemaglutideMuthiah Vaduganathan @mvaduganathan on X. Cardiologist at Brigham and Women's Hospital and Harvard Medical School. Assistant Professor of Medicine.Editing byJoel TopfThe Kidney Connection written and performed by Tim YauShow NotesDONATE to NephJC! Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes NEJM | NephJC SummaryFIDELIO Bakris et al, NEJM 2020 | NephJC Summary; subgroup throws doubt on efficacy of finerenone in patients on flozinsFIGARO Pitt et al, NEJM 2021; subgroups clearly shows finerenone works, flozins or notNEJM editorial (wrongly) saying do not use Flozins unless on RASi Don't use dual RAS blockade ONTARGET Yusuf et al, NEJM 2008; VA NEPHRON-D Fried et al NEJM 2013Why we cannot study finerenone in HFrEF (RALES Pitt et al NEJM 1999) Muthu is jealous of GFR slope and albuminuria surrogate endpoints and wants to borrow them for HFpEF (Inker et al EHJ 2025)Combination therapy and CV outcomes in hypertension (Wang et al JAMA Card 2024 on low dose combinations and BP; Egan et al Blood Pressure 2022 review of topic) CONFIRMATION HF trial registry entry (Finerenone and Empagliflozin in hospitalized patients with HF)23:20: Nayan and Swap miss a chance to say ‘de-flozination' to discuss stopping a flozin which would allow a patient to be included in the trial Finerenone is a CYP3A4 substrate (Heinig et al Clin Pharmacokinetics 2023); Useful list of CYP3A4 inducers and inhibitors Everyone should get an ABPM (Bugeja et al CMAJ 2022)EASiKIDNEY study design Albuminuria mediates CKD benefits with Finerenone (Agarwal et al Ann Intern Med 2023)GFR slope and Albuminuria and the FDA (Taylor et al eClin Med 2025) Dapagliflozin and Eplerenone combination crossover trial (Provenzano et al JASN 2022)Joel gets promoted! (PBFluids reflection) Bluesky NephJC Chat discussion on ‘renal remission' Withdrawal of Finerenone and worse outcomes from FINEARTS (Vaduganathan et al JACC 2025)Combination therapies Analysis from Brendan and Muthu (Neuen et al Circulation 2024)Do not use KFRE when GFR > 60 (KDIGO Practice Point 2.2.4: Note that risk prediction equations developed for use in people with CKD G3–G5, may not be valid for use in those with CKD G1–G2) Finerenone vs Spironolactone trial in Primary Aldosteronism (Hu et al Circulation 2025)FIND CKD trial design (Heerspink et al NDT 2025) FINE-ONE trial design (Heerspink et al Diab Res Practice 2023) Tubular SecretionsNayan keeping his chin up as Yankees lose and Mariners follow (MLB Playoffs)Sophia's adventures with Beekeeping (Royal Jelly?) Brendon loves listening to ‘Susan' by Raye Muthu is back into Taekwondo Swap is still reading Martha Wells (Witch King on GoodReads)Joel will be hiking the Laugavegur trail in Iceland
Featuring an interview with Dr Aaron Lisberg, including the following topics: Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) for Patients with Previously Treated EGFR-Mutated Advanced Non-Small Cell Lung Cancer (NSCLC): A Pooled Analysis of the TROPION-Lung01 and TROPION-Lung05 Trials (0:00) Ahn M-J et al. Efficacy and safety of datopotamab deruxtecan (Dato-DXd) in patients (pts) with previously-treated EGFR-mutated advanced non-small cell lung cancer (NSCLC): A pooled analysis of TROPION-Lung01 and TROPION-Lung05. ESMO Asia 2024;Abstract LBA7 Ahn M-J et al. A pooled analysis of datopotamab deruxtecan in patients with EGFR-mutated NSCLC. J Thorac Oncol 2025;[Online ahead of print]. Abstract Sacituzumab Tirumotecan for Previously Treated Advanced EGFR-Mutated NSCLC: Results from the Randomized OptiTROP-Lung03 Study (7:08) Fang W et al. Sacituzumab tirumotecan versus docetaxel for previously treated EGFR-mutated advanced non-small cell lung cancer: Multicentre, open label, randomised controlled trial. BMJ 2025;389:e085680. Abstract Zhang L et al. Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study. ASCO 2025;Abstract 8507. Combination of Dato-DXd and Immunotherapy as First-Line Therapy for Patients with Advanced NSCLC (13:12) Cuppens K et al. First-line (1L) datopotamab deruxtecan (Dato-DXd) + durvalumab ± carboplatin in advanced or metastatic non-small cell lung cancer (a/mNSCLC): Results from TROPION-Lung04 (cohorts 2 and 4). ESMO Targeted Anticancer Therapies Congress 2025;Abstract 8O. Okamoto I et al. TROPION-Lung07: Phase III study of Dato-DXd + pembrolizumab ± platinum-based chemotherapy as 1L therapy for advanced non-small-cell lung cancer. Future Oncol 2024;20(37):2927-36. Abstract Levy BP et al. TROPION-Lung08: Phase III study of datopotamab deruxtecan plus pembrolizumab as first-line therapy for advanced NSCLC. Future Oncol 2023;19(21):1461-72. Abstract Aggarwal C et al. AVANZAR: Phase III study of datopotamab deruxtecan (Dato-DXd) + durvalumab + carboplatin as 1L treatment of advanced/mNSCLC. World Conference on Lung Cancer (WCLC) 2023;Abstract P2.04-02. TROP2-Targeting Antibody-Drug Conjugates as Neoadjuvant and/or Adjuvant Therapy for Patients with Resectable NSCLC (19:08) A phase III, randomised, open-label, global study of adjuvant datopotamab deruxtecan (Dato-DXd) in combination with rilvegostomig or rilvegostomig monotherapy versus standard of care, following complete tumour resection, in participants with Stage I adenocarcinoma non-small cell lung cancer who are ctDNA-positive or have high-risk pathological features (TROPION-Lung12). NCT06564844 Cascone T et al. Perioperative durvalumab plus chemotherapy plus new agents for resectable non-small-cell lung cancer: The platform phase 2 NeoCOAST-2 trial. Nat Med 2025;31(8):2788-96. Abstract CME information and select publications
Daily Radio Program with Charles Stanley - In Touch Ministries
Keep your focus on God and pray with faith, knowing He will answer your petitions.See omnystudio.com/listener for privacy information.
Daily Radio Program with Charles Stanley - In Touch Ministries
Keep your focus on God and pray with faith, knowing He will answer your petitions.
Keep your focus on God and pray with faith, knowing He will answer your petitions.See omnystudio.com/listener for privacy information.
Keep your focus on God and pray with faith, knowing He will answer your petitions.
Keep your focus on God and pray with faith, knowing He will answer your petitions.See omnystudio.com/listener for privacy information.
Keep your focus on God and pray with faith, knowing He will answer your petitions.
Daily Radio Program with Charles Stanley - In Touch Ministries
Write down your prayer requests to better focus your mind and pray in detail.See omnystudio.com/listener for privacy information.
Daily Radio Program with Charles Stanley - In Touch Ministries
Write down your prayer requests to better focus your mind and pray in detail.
Write down your prayer requests to better focus your mind and pray in detail.See omnystudio.com/listener for privacy information.
Write down your prayer requests to better focus your mind and pray in detail.
Write down your prayer requests to better focus your mind and pray in detail.See omnystudio.com/listener for privacy information.
Write down your prayer requests to better focus your mind and pray in detail.
Flight is an incredibly complex process that involves a combination of unique traits in birds all working together.
Visit our website:https://www.thewealthwarehousepodcast.com/Fresh off the annual South Dakota pheasant trip, Dave and Paul unpack how time in the field mirrors smart money habits. From planning that survives “first contact,” to keeping dry powder ready so you can seize opportunities, to teaching kids stewardship and building legacy, this episode ties hunting camp lessons directly to the Infinite Banking Concept (IBC). Expect talk on independence, autonomy, privacy, patience & timing, and why liquidity you control beats balances that just “look good on paper.”Becoming Your Own Banker by Nelson Nash:https://infinitebanking.org/product/becoming-your-own-banker/ref/46/Episode Highlights:0:00 - Teaser & open2:17 - The crew: annual trip, fellowship, and why like-minded matters3:38 - How the hunt parallels IBC4:52 - Healthy disagreements (Bitcoin, moon landing) + shared values6:22 - The common thread7:00 - Independence, autonomy, privacy & healthy skepticism8:39 - Legacy and making memories with your kids9:31 - Planning meets reality12:00 - Translating hiccups to IBC13:16 - Patience & timing14:23 - Loaded shotgun vs. locked-up 401(k) liquidity15:53 - Fancy gear vs. dry powder16:34 - Getting better each year = older policies perform better17:24 - Stewardship and teaching the next generation18:02 - Accessing capital without interrupting growth22:02 - Save 30% rule: habits that build wealth22:32 - Seeking independence from commercial banking23:50 - Why IBC contributors may fuel less inflation24:57 - Hunters' autonomy as a money mindset28:27 - Episode wrap-upABOUT YOUR HOSTS:David Befort and Paul Fugere are the hosts of the Wealth Warehouse Podcast. David is the Founder/CEO of Max Performance Financial. He founded the company with the mission of educating people on the truths about money.David's mission is to show you how you can control your own money, earn guarantees, grow it tax-free, and maintain penalty-free access to it to leverage for opportunities that will provide passive income for the rest of your life.Paul, on the other hand, is an Active Duty U.S. Army officer who graduated from Norwich University in 2002 with a B.A. in History and again in 2012 with a M.A. in Diplomacy and International Terrorism. Paul met his wife Tammy at Norwich.As a family, they enjoy boating, traveling, sports, hunting, automobiles, and are self-proclaimed food people.Visit our website:https://www.thewealthwarehousepodcast.com/Catch up with David and Paul, visit the links below!Website: https://infinitebanking.org/agents/Fugere494 https://infinitebanking.org/agents/Befort399LinkedIn: https://www.linkedin.com/in/david-a-befort-jr-09663972/ https://www.linkedin.com/in/paul-fugere-762021b0/Email:davidandpaul@theibcguys.com