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En una muy interesante entrevista hablamos con Marco Ferraz, Presidente de CLIA, Cruise Lines International Association, por sus siglas en inglés, entidad que nuclea el quehacer de la industria de cruceros en todo el mundo. Con el hablamos de la actualidad de la industria a nivel global y los desafíos para la región donde cada vez más usuarios utilizan este tipo de barcos para vacacionar en distintos destinos. En la nota, habló del crecimiento de la industria en la región e hizo hincapié en el potencial que tiene en la Argentina.Turismocero radio es el programa radial del site ww.turismocero.com, que desde 2011 informa sobre la actualidad del turismo en toda Latinoamérica, emitiéndose semanalmente en radios de distintas localidades de Argentina, Uruguay Perú.
Call to OrderRoll CallApproval of Minutes: April 17, 2025 May 28, 2025 – Special Assembly: Board of Equalization Approval of AgendaReports of Officials and Committees: Mayor's Report Assembly Committee Reports Treasurer's Report Manager's Report Communications to the Assembly: Correspondence Hear Citizens PresentOrdinances, Resolutions, & Proclamations: Public Hearing, Second Reading, and Adoption of Ordinance No 25-08: Amending the FY25 Budget to Appropriate Funds for a Seasonal Firefighting Position to Support Emergency Services in Dyea (Public Hearing was opened and closed on May 15, 2025; Active Motion for Adoption) Public Hearing and Adoption of Resolution No. 25-16R: Updating the Fifteen-Acre Site Plan Near the Klondike Highway and Directing the Creation of a Public Dog Park Unfinished BusinessNew Business: Consideration of Mayoral Resignation and Declaration of Vacancy Approval of Pedestrian Crowding and Vehicle Traffic Congestion on Broadway Proposal: Phase 1 Award of Garden City RV Park Utilities Design Contract Approval of Rock Slope Summer Monitoring Proposal Award of Ore Peninsula Redevelopment Pile Anodes ContractApproval of Ore Basin Dredging Support Services Proposal Approval of Ore Dock Electrical Construction Support Services Proposal Approval of Broadway Dock Fuel Header Relocation Study Proposal Approval of Station Request to Close Fourth Avenue for Fourth of July Festivities Consideration of Response to Announcement Regarding the Cascade Point Ferry Terminal Consideration of Rescheduling the June 20, 2025 Assembly MeetingMayor and Assembly Discussion ItemsExecutive session: Matters, the immediate knowledge of which would clearly have an adverse effect upon the finances of the public entity, and matters which by law, municipal charter, or ordinance are required to be confidential: Discussion of CLIA v. Municipality of Skagway, Case No. 1JU-25-00628CI AdjournmentPacket
The 2025 NovaUCD Student Enterprise Competition, an intensive 4-week accelerator programme for student entrepreneurs, which is now in its 11th year, has commenced today at University College Dublin (UCD) with 11 early-stage ventures and 22 participating students. The participating ventures are focused on a wide range of business ideas including; sustainable agriculture, robotics, edtech, smart sensing systems for healthcare, sustainable fashion and music. A €3k NovaUCD One to Watch Prize, sponsored by Terra Solar, is available for the overall winning venture at the end of this year's competition. The accelerator programme is run by NovaUCD, the innovation and start-up hub, as a framework to support UCD undergraduate and postgraduate students who want to work together to develop and grow start-up companies. The aim of the accelerator is to assist the students in refining their start-up ideas through a series of structured workshops, including taught content from industry experts, interactive workshops, regular mentoring and pitching sessions. Caroline Gill, Innovation Pathway Manager at NovaUCD who manages the competition said, "Over the next month we will be supporting the participating student entrepreneurs as they begin the process of accelerating their business ideas into early-stage start-ups. A key objective of this annual competition is to provide the students with the skills, the confidence, and the opportunity to further develop their ideas and hopefully in time launch their start-ups in Ireland and even internationally." The 4-week accelerator, which uses the Lean Startup and Business Model Canvas approach, includes a series of structured and interactive workshops delivered by Raomal Perera, Lean Disruptor. Topics such as, customer development; value proposition; working in teams; design thinking; prototyping, environment mapping; financial planning and effective fundraising and pitching, will be covered. At a final workshop, to be held in late-June, the participating ventures will pitch to a judging panel. Based on the evaluation of the presentations an overall winner will be selected and will receive the €3k NovaUCD One to Watch Prize sponsored by Terra Solar. At the end of the 2024 competition physiotherapists Rory Lambe and Ben O'Grady, both then masters students in the UCD School of Public Health, Physiotherapy and Sports Science, were announced as winners of the Tech Sustainability Prize. Clia, their early-stage venture, aims to make a meaningful difference to the lives of people with cardiovascular disease by combining clinical data with wearable technology to improve its management. Rory is now a PhD student and earlier this year to further develop Clia he was one of several UCD students selected to participate in Conception X, a nine-month venture programme in London, focused on supporting PhD students from the UK and across Europe, to turn their research into deep tech start-ups. Fourteen (14) postgraduate and 8 undergraduate students are participating on this year's accelerator programme. Over 80 early-stage ventures and some 200 students have completed NovaUCD Student Enterprise Competitions to date. More about Irish Tech News Irish Tech News are Ireland's No. 1 Online Tech Publication and often Ireland's No.1 Tech Podcast too. You can find hundreds of fantastic previous episodes and subscribe using whatever platform you like via our Anchor.fm page here: https://anchor.fm/irish-tech-news If you'd like to be featured in an upcoming Podcast email us at Simon@IrishTechNews.ie now to discuss. Irish Tech News have a range of services available to help promote your business. Why not drop us a line at Info@IrishTechNews.ie now to find out more about how we can help you reach our audience. You can also find and follow us on Twitter, LinkedIn, Facebook, Instagram, TikTok and Snapchat.
What does it take to stand up for people navigating the complex journey of immigration? Mary Choate knows firsthand as Executive Director of the Center for Legal Immigration Assistance (CLIA) in Lincoln, Nebraska.Founded in 2001, CLIA provides comprehensive legal services to help immigrants and refugees thrive throughout Nebraska. Mary explains why this work matters deeply: "Your neighbors probably have an immigration story they could tell." These are people living in our communities, paying taxes, and contributing to local economies—yet they face significant challenges navigating legal systems, especially amid widespread misinformation.Want to learn more or support CLIA's vital work? Visit www.cliane.org to discover how you can help Nebraska's immigrant communities thrive.Welcome to the Agency for Change podcast.
Everyone loves a good tech strategy session—but how do we make sure those plans don't just sit on a shelf? We're diving into the realities of making strategy happen. Join us for the second installment of Tech Strategy in Action, a series where we dive into exactly that. Today we will be discussing how CLIA has implemented their newly imagined website based on an enormous amount of user research, led by our guest Jill Straniero, SVP of Digital Solutions and Managing Director of Global Technology. We will discuss how deep user interviews and audience analysis revealed the need to shift from a department-focused approach to an audience-focused digital strategy. The findings helped streamline twelve websites into two distinct ones. The conversation highlights how user research is not just for usability—it's a strategic tool for long-term organizational alignment and smarter tech investments Hosted by Norma Castrejon, Vice President, Information Technology at the American Osteopathic Association and Rhoni Rakos, Lead Consultant, Digital Strategy at Ellipsis Partners. Make sure to follow TPAC on LinkedIn: https://www.linkedin.com/company/asae-tpac/
J.C. Sheppard, is the Founder of The Fentanyl Test, the world's first FDA-CLEARED, CLIA-waived dip-card test for over-the-counter use, and the world's only Harm Reduction test strip to reach the cutoff level of 1ng/mL which is also the world's only test to not require dilution of any tested substance. China says fentanyl issue is responsibility of the United States
Louise Craddock Oceania Cruises (Director of Sales UK & Ireland) shares her journey into her current role as well as an overview of the Oceania brand. Having been with Oceania Cruises for over 14 years her passion remains as she tells us more about what sets Oceania apart and how they have elevated what they offer their guests onboard and ashore. For those lucky to be joining us at CLIA conference they will get their first chance to catch a glimpse of their latest ship Oceania Vista which will also give agents a taste of what's to come in their upcoming ship Allura. She also has some exciting updates about shorter sailings which can be a great entry point for first time customers looking to experience Oceania. Join the Join the Trader Inside Oceania Cruises UK Facebook group at https://www.facebook.com/share/g/1EXD1z6ZTg/?mibextid=wwXIfr
As you’ll hear in this discussion, it’s Earth Month, and we couldn’t not have an episode about sustainability efforts within travel. Here, host Rebecca Tobin speaks with Paula Vlammings, the chief impact officer of nonprofit Tourism Cares, and Travel Weekly hospitality editor Christina Jekski about some of the hot topics of 2025. Topics we cover: Solutions to overtourism; why travelers don’t want to pay more for green travel initiatives; and whether recent shifts in U.S. policy will have an impact on sustainability efforts. This episode was recorded April 24 and was edited for length and clarity. Episode sponsor: This episode is sponsored by The TTC Tour Brands https://agents.ttc.com/login Related links: Sustainability-minded hotels are staying the course https://www.travelweekly.com/Travel-News/Hotel-News/Sustainability-minded-hotels-staying-the-course Arnie Weissmann’s From the Window Seat column: CLIA: “Regulate us. please!” https://www.travelweekly.com/Arnie-Weissmann/CLIA-Regulate-us-Please From 2024: A focus on overtourism overlooks destinations’ problems: https://www.travelweekly.com/Travel-News/Tour-Operators/Overtourism-focus-misses-destination-problems From 2024: Overtourism solutions: putting residents first https://www.travelweekly.com/Travel-News/Travel-Agent-Issues/Tourism-related-issues-need-right-approach-experts-say Tourism Cares: https://www.tourismcares.org/ Note: This episode is ahead of the news: A column by Christina Jelski on Trina White and the Parkside Hotel & Spa will be published later this week.See omnystudio.com/listener for privacy information.
Feeling exhausted, dealing with brain fog, or noticing unexplained weight gain—even though you're doing all the right things? This episode dives into the surprising root cause behind symptoms often blamed on hormone imbalance or stress. It's something most women overlook, and it could be sabotaging your energy, focus, and sleep. Tune in to uncover what might really be going on beneath the surface—and why your environment could be playing a bigger role than you think.
10:05A – 10:22A (17mins) Weekly: Susie Moore, Deputy Managing Editor, Redstate.com @SmoosieQThe FBI Is Quietly-Behind The Scenes Making America Safe Again 10:41 – 10:56 (15mins) J.C. Sheppard, Founder of The Fentanyl Test Republican AGs urge Trump to crack down on obscure 'loophole' cartels use to flood US with fentanyl Fentanyl is the #1 killer of Americans aged 18-49 and the fastest growing killer of children under the age of 14… J.C. Sheppard, is the Founder of The Fentanyl Test, the world's first FDA-CLEARED, CLIA-waived dip-card test for over-the-counter use, and the world's only Harm Reduction test strip to reach the cutoff level of 1ng/mL which is also the world's only test to not require dilution of any tested substance.See omnystudio.com/listener for privacy information.
10:05A – 10:22A (17mins) Weekly: Susie Moore, Deputy Managing Editor, Redstate.com @SmoosieQThe FBI Is Quietly-Behind The Scenes Making America Safe Again 10:41 – 10:56 (15mins) J.C. Sheppard, Founder of The Fentanyl Test Republican AGs urge Trump to crack down on obscure 'loophole' cartels use to flood US with fentanyl Fentanyl is the #1 killer of Americans aged 18-49 and the fastest growing killer of children under the age of 14… J.C. Sheppard, is the Founder of The Fentanyl Test, the world's first FDA-CLEARED, CLIA-waived dip-card test for over-the-counter use, and the world's only Harm Reduction test strip to reach the cutoff level of 1ng/mL which is also the world's only test to not require dilution of any tested substance.See omnystudio.com/listener for privacy information.
Et s'il manquait un maillon à la chaîne judiciaire ? L'audition de l'enfant ! L'audition préventive ou conventionnelle permet à l'enfant d'être entendu et ce, par des personnes formées.
Episode 130 - Andy Talks with Jos Dewing from explorearth.com by CLIA
10:05 – 10:15 (10 mins) J.C. Sheppard J.C. Sheppard - MAKE AMERICA HEALTHY AGAINFounder of The Fentanyl Test, the world's first FDA-CLEARED, CLIA-waived dip-card test for over-the-counter use, and the world's only Harm Reduction test strip to reach the cutoff level of 1ng/mL which is also the world's only test to not require dilution of any tested substance.Starts by Eliminating the New Face of the Drug Epidemic in the U.S.Canada PM Trudeau Bends the Knee to Trump, Appoints ‘Fentanyl Czar’Fentanyl is the #1 killer of Americans aged 18-49 and the fastest growing killer of children under the age of 14…Fentanyl Has Killed More Americans Than All Previous Wars Combined 10:41 – 10:56 (15mins) Weekly: Drew Thomas Allen @DrewThomasAllen Author, America's Last Stand: Will You Vote to Save or Destroy America in 2024Host of ‘The Drew Allen Show’ podcast VP of client development at Publius PR & Editor of the Publius National Post.columnistSee omnystudio.com/listener for privacy information.
10:05 – 10:15 (10 mins) J.C. Sheppard J.C. Sheppard - MAKE AMERICA HEALTHY AGAINFounder of The Fentanyl Test, the world's first FDA-CLEARED, CLIA-waived dip-card test for over-the-counter use, and the world's only Harm Reduction test strip to reach the cutoff level of 1ng/mL which is also the world's only test to not require dilution of any tested substance.Starts by Eliminating the New Face of the Drug Epidemic in the U.S.Canada PM Trudeau Bends the Knee to Trump, Appoints ‘Fentanyl Czar’Fentanyl is the #1 killer of Americans aged 18-49 and the fastest growing killer of children under the age of 14…Fentanyl Has Killed More Americans Than All Previous Wars Combined 10:41 – 10:56 (15mins) Weekly: Drew Thomas Allen @DrewThomasAllen Author, America's Last Stand: Will You Vote to Save or Destroy America in 2024Host of ‘The Drew Allen Show’ podcast VP of client development at Publius PR & Editor of the Publius National Post.columnistSee omnystudio.com/listener for privacy information.
We are well into 2025 so saying Happy New Year is not appropriate anymore. I think now people are asking others how they are doing with their resolutions. I have just one goal this year and that is to learn something new. I'll let you know how I do. Send me your resolutions in the comment section. I am excited for you to listen to my conversation with Dr. Brian Fiske, Chief Scientist for the MJFF. I like to kick off the new year/new season with a medication update. This year we are going to get an update on the research landscape and what it means compared to previous years. There are therapies in various stages of clinical testing using several different therapeutic approaches. It is exciting to learn about what to expect in the future and how we all can contribute to move things forward faster. Let's learn from Dr. Fiske what we now know about the biology of Parkinson's, genetics and the environment's contribution, the advances in testing for a Parkinson's diagnosis, and where we stand in slowing the progression of the disease. This podcast is sponsored by CND Life Sciences, home of the Syn-One Test ® - the first commercially available skin-based test to help clinicians diagnose Parkinson's and related disorders. CND Life Sciences supports the care of patients facing the potential diagnosis of a neurodegenerative disease. CND's Syn-One Test® helps clinicians to diagnose suspected synucleinopathies using skin biopsies to detect, visualize, and quantify phosphorylated alpha-synuclein located in nerves in the skin. The Syn-One Test is performed in CND's CLIA-certified and CAP-accredited laboratory located in Scottsdale, AZ. https://www.michaeljfox.org/state-field https://www.michaeljfox.org/ppmi https://www.michaeljfox.org/trial-finder https://cndlifesciences.com/ https://cndlifesciences.com/syn-one-test/
Peter Mingils hosts Harshman Travel Agency Building Fortunes Radio show on Cruises and Discounts. Building Fortunes Radio and The Youmongus Ad Network host a weekly radio show. Pam Harshman and Ron Harshman review Harshman Travel Agency on Vax and Mask Mandates and Cruises with Peter Mingils. Save money on your cruises. https://www.harshmantravel.com Harshman travel Radio show is on https://www.buildingfortunesradio.com/harshman-travel/ Here's an example of a previous show: https://www.buildingfortunesradio.com/harshman-travel/weekly-updates-on-cruises-on-the-building-fortunes-harshman-travel-radio-show-with-peter-mingils-4066 https://harshmantravel.com is the site to book and look for your vacation and travel plans. You can find this and much more on The Youmongus Ads https://www.youmongusads.com Contact Peter Mingils 386 445-3585 Our Affiliate program is https://buildingfortunes.com For generic travel news, go to https://travelagency.news
Harshman Travel Agency new cruise line expansion with Peter Mingils in 2025 on Building Fortunes Radio with Pam Harshman and Ron Harshman. Building Fortunes Radio and The Youmongus Ad Network host a weekly radio show. Pam Harshman and Ron Harshman review Harshman Travel Agency on Vax and Mask Mandates and Cruises with Peter Mingils. Save money on your cruises. https://www.harshmantravel.com Harshman travel Radio show is on https://www.buildingfortunesradio.com/harshman-travel/ Here's an example of a previous show: https://www.buildingfortunesradio.com/harshman-travel/weekly-updates-on-cruises-on-the-building-fortunes-harshman-travel-radio-show-with-peter-mingils-4066 https://harshmantravel.com is the site to book and look for your vacation and travel plans. You can find this and much more on The Youmongus Ads https://www.youmongusads.com Contact Peter Mingils 386 445-3585 Our Affiliate program is https://buildingfortunes.com For generic travel news, go to https://travelagency.news
Women who believe their implants are making them sick report a wide range of symptoms including extreme fatigue, muscle and joint pain, headache, brain fog, hair loss, rashes, dry mouth and eyes, depression, anxiety, and insomnia. These conditions appear within a few months to several years following surgery and seem to follow a secondary surgery like revision or exchange. However, the exact cause is difficult to pin down because other conditions, like Lyme disease and toxic mold exposure, can cause similar symptoms. Using PCR testing (instead of traditional CLIA-based lab testing), Dr. Rob discovered that over 60% of the breast implants he removed all had one thing in common. Dr. Robert Whitfield describes his methodology for identifying this complicated, misunderstood condition and shares his treatment strategies utilizing nutrition and genetic testing to put his patients on the path to healing. For more healing resources created by Dr. Rob, visit our store - Dr. Rob's Solutions at https://drrobssolutions.myshopify.com (https://drrobssolutions.myshopify.com). Show Highlights: Causes of BII (00:03:56) Biofilm and its significant contribution to breast implant illness cases What is Biofilm? (00:04:56) Explanation of biofilm as a bacterial or fungal contaminant affecting health and inflammation Environmental Factors (00:05:26) Environmental exposures, like mold and Lyme disease, and their role in BII symptoms Gut Health and Immune Response (00:07:43) Gut health's impact on immune function and overall wellness in BII patients Identifying Symptoms and Providers (00:10:12) How to identify symptoms and seek appropriate medical guidance for BII Explant Surgery Options (00:10:12) Overview of surgical options available for patients considering explant surgery Symptom Abatement Timeline (00:11:20) Discussion on the expected timeline for symptom improvement after explant surgery Pathology and Testing (00:12:36) Importance of laboratory analysis in evaluating post-surgery health and contamination Nutritional Support and Genetic Testing (00:13:50) The role of nutrition and genetic predisposition testing in managing BII Cautions on Online Medical Advice (00:15:13) Warnings against seeking medical advice from unqualified sources online Links and Resources Let's Connect... Podcast: https://podcasts.apple.com/gb/podcast/breast-implant-illness/id1678143554 Spotify: https://open.spotify.com/show/1SPDripbluZKYsC0rwrBdb?si=23ea2cd9f6734667 TikTok: https://www.tiktok.com/@drrobertwhitfield?t=8oQyjO25X5i&r=1 IG: https://www.instagram.com/breastimplantillnessexpert/ FB: https://www.facebook.com/DrRobertWhitfield Linkedin: https://www.linkedin.com/in/dr-robert-whitfield-md-50775b10/ X: https://x.com/rob_whitfieldmd Read this article - https://www.breastcancer.org/treatment/surgery/breast-reconstruction/types/implant-reconstruction/illness/breast-implant-illness Shop: https://drrobssolutions.com SHARP: https://www.harp.health NVISN Labs - https://nvisnlabs.com/ Get access to Dr. Rob's Favorite Products below: Danger Coffee - Use our link for mold free coffee - https://dangercoffee.com/pages/mold-free-coffee?ref=ztvhyjg JASPR Air Purifier - Use code DRROB for the Jaspr Air Purifier - https://jaspr.co/ Echo Water - Get high quality water with our code DRROB10 - https://echowater.com/ BallancerPro - Use code DRROBVIP for the world's leader in lymphatic drainage technology - https://ballancerpro.com Ultrahuman - Use code WHITFIELD10 for the most accurate wearable - https://www.ultrahuman.com/ring/buy/us/?affiliateCode=drwhitfield
Ron Harshman and Pam Harshman own Harshman Travel Agency and discuss Holiday Cruise Industry News with Peter Mingils for 2025. Building Fortunes Radio and The Youmongus Ad Network host a weekly radio show. Pam Harshman and Ron Harshman review Harshman Travel Agency on Vax and Mask Mandates and Cruises with Peter Mingils. Save money on your cruises. https://www.harshmantravel.com Harshman travel Radio show is on https://www.buildingfortunesradio.com/harshman-travel/ Here's an example of a previous show: https://www.buildingfortunesradio.com/harshman-travel/weekly-updates-on-cruises-on-the-building-fortunes-harshman-travel-radio-show-with-peter-mingils-4066 https://harshmantravel.com is the site to book and look for your vacation and travel plans. You can find this and much more on The Youmongus Ads https://www.youmongusads.com Contact Peter Mingils 386 445-3585 Our Affiliate program is https://buildingfortunes.com For generic travel news, go to https://travelagency.news
Dr. Sara Naseri joins me on this episode to talk about the exciting, at home, affordable, easy to use, hemoglobin A1C testing her company QVin had developed that utilizes menstrual blood. Throughout this episode I just kept saying: why weren't we always doing this??!! But the wait is over as QVin can send an FDA approved, CLIA certified and easy to collect test right to your door. H1C is a test we all need and may get pushback from our providers or our insurance about routinely checking it so it's win, win, win, win and has some exciting prospects for future testing on other hormones and possibly even screening for conditions like endometriosis. Episodes referenced in this show: Dr Brooke Show #398 Making Sense of Blood Sugar Testing: Hemoglobin A1C, Glycomark, CGMs and More Stuff I Know You Will Love If you are looking for an expert prescriber for HRT during your perimenopause or menopause journey but are at odds with your local provider being a bit behind current best practices or you simply can't find anyone near you to help, Join MIDI! I've worked with a number of telehealth services in my search for providers that are up to date on modern menopause medicine, have great customer service and who are licensed in all 50 states and I'm so thrilled to have found my provider with MIDI. If you too need help with getting HRT please use this link to check out MIDI! No membership fees and insurance billing available. Did you know that 95% of women taking a prenatal are still nutrient deficient? The founders of Needed saw this as a big problem and I couldn't agree more! But Needed quickly became a bigger solution to a bigger problem by providing more options for moms and moms to be. Women need so much support during the time from thinking about getting pregnant all the way to having little ones and so often they are left with options that don't address their needs (prenatals that have nutrients in the wrong forms or that they can't take due to nausea) or they are left with low energy, anxiety or even colds/flus while they are pregnant or nursing because there aren't natural products that are considered safe during these times. Needed solved all of these problems as well as created a community of no-guilt, education and support for new moms and moms to be. Learn more about Needed visit thisisneeded.com and save 20% off your first order with code BETTEREVERYDAY at checkout. Don't miss Organifi Gold Pumpkin Spice! Limited edition of their cozy cup of relaxing deliciousness with turmeric, passionflower, lemon balm and Reishi. Perfect end of a fall evening! Get it before it's gone! Link www.organifi.com/bettereveryday saves you 20%. Be sure you connect with me in my FREE PRIVATE Facebook group: Hormones & Happiness with Dr Brooke where other amazing, like minded women like YOU are already hanging out! Join us! Follow Dr Brooke on Instagram and get signed up for my awesome emails here. Seriously, I write really great emails, or so 1000s of women tell me and I'd like to send you one too. To work with Dr Brooke click here and if you loved this episode please leave a review!
Research Requires Flexibility: Protease-Free Permeabilization Expands FISH Tissue Applications.-Andrelie Branicky, Shared Laboratory Resources, Lerner Research Institute, Cleveland Clinic, Cleveland, OH Fluorescence in situ hybridization (FISH) visualizes the presence of a specific DNA or RNA sequence in a tissue sample or cell. This method, particularly the mRNA version, detects gene expression when protein might not be present or IHC is impossible. FISH combined with immunohistochemistry enables spatial transcriptomics, which provides significantly more information about the tissue microenvironment. Formalin-fixed paraffin-embedded (FFPE) tissues are the standard for tissue preservation in the clinical world. Most commercial mRNA probe and amplification systems are built around the model of FFPE tissue that can withstand harsh protease permeabilization. In the research world, tissues are fixed in different fixatives for varying times; all at the discretion of the investigator instead of an organization like the CLIA. Given the wide range of tissue preparations, the HCR automated FISH-ISH protease-free program provides the flexibility to combine FISH and fluorescent immunohistochemistry on tissue fixed in a variety of ways such as: 10% NBF, Histochoice (a glyoxal-based fixative), and methanol/acetic acid, with only minor changes to the basic protocol. Additionally, the lack of harsh protease pre-treatment maintains tissue integrity and morphology for staining and imaging.
Priyanka Jain is the co-founder & CEO of Evvy, a precision women's health startup discovering unnoticed biomarkers, starting with the vaginal microbiome. The episode explores the challenges women face in diagnosing and treating conditions like PCOS and the significance of the vaginal microbiome in women's health. Priyanka Jain shares her journey from working in nonprofits to founding Evvy, a company dedicated to improving women's health through better data and diagnostics. Evvy's at-home vaginal microbiome test is the first and only CLIA-certified, mNGS vaginal health test, providing you with the most reliable, comprehensive answers from a single swab. The discussion covers the impact of hormonal imbalances, the role of the vaginal microbiome in preventing infections, and the importance of personalized healthcare. Sponsors: Find SmartMouth at CVS, Walgreens, and Walmart or visit https://smartmouth.com/shemd to snag a special discount on your next SmartMouth purchase. Your mouth will thank you!You can try Freed for free right now by going to https://getfreed.ai. Listeners can use the SHEMD code for $50 off their first month.Timeline is offering 10% off your first order of Mitopure. Go to https://timeline.com/SHEMD.Get 10% off your first order sitewide with code SHEMD at https://OSEAMalibu.com.Nutrafol is offering our listeners ten dollars off your first month's subscription and free shipping when you go to https://Nutrafol.com and enter promo code SHEMD.In This Episode:[2:55] Priyanka Jain's background and journey[5:50] The importance of destigmatizing women's health issues[8:20] Understanding the vaginal microbiome[20:03] Evvy's approach to vaginal health testing[31:02] Insights from Evvy's data on women's health[46:45] Tips for maintaining a healthy vaginal microbiomeKey Takeaways:Consult Before Self-Diagnosing: Always seek professional medical advice or testing before assuming you know the cause of any vaginal symptoms. This helps avoid unnecessary treatments and ensures accurate diagnosis.Be Your Own Advocate: Pay close attention to your body and symptoms. Gather data and information about your health to effectively communicate with healthcare providers, ensuring you receive the best care possible.Understand the Impact of Sexual Activity: Recognize that sexual activity can influence vaginal health. Be mindful of changes in symptoms following sexual encounters and consider discussing these with a healthcare provider if issues arise.Consider Proactive Testing: If you experience recurrent symptoms or are in a specific life stage (e.g., trying to conceive, menopause), consider using at-home testing services like Evvy to monitor your vaginal health and seek guidance when necessary.Avoid Overuse of Antibiotics: Be cautious with antibiotic use, as it can disrupt the natural balance of bacteria. Discuss alternative treatments with your healthcare provider, such as probiotics or lifestyle changes, to maintain a healthy microbiome.About the Guest:Priyanka is the co-founder & CEO of Evvy, a precision women's health startup discovering overlooked biomarkers, starting with the vaginal microbiome. Before founding Evvy, Priyanka was the Head of Product at pymetrics, a startup using behavioral science and AI to make talent matching more effective and fair. She graduated from Stanford University and serves on advisory boards for the XPRIZE Foundation and the United Nations Foundation's Girl Up campaign.Priyanka received her B.S. from Stanford University, where she was a Mayfield Fellow and President of Stanford Women in Business. She has been recognized as Forbes 30 under 30 and Inc's Top Female Founders.EvvyEvvy's at-home vaginal microbiome test is the first and only CLIA-certified, mNGS vaginal health test — providing you with the most reliable, comprehensive answers from a single swab. All results come with a custom plan of clear next steps, along with science-backed education, community, and 1:1 coaching. For eligible tests, they also offer integrative, prescription treatment programs. The results from the Evvy testing kit are analyzed to give users a detailed report on their vaginal health. This report can include information on the balance of different microorganisms, potential health issues, and personalized recommendations for maintaining a healthy microbiome. In addition to its products, Evvy provides educational resources to help women understand their vaginal health better. This includes information on how the vaginal microbiome works, how to interpret test results, and ways to support overall vaginal health. Resource Links:Priyanka's LinkedInInstagram @evvy Company URL www.evvy.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
Healthcare industry: medical transportation, medical billing, homecare business
Deepen your medical billing expertise with Part 2 of our series! Learn essential terms including the QW modifier for CLIA-waived tests, understand what upcoding means and why it's prohibited, and master the difference between Local and National Coverage Determinations (LCD/NCD). Schedule a demo with our experts to improve your medical billing operations. With BillPro you can easily beat your competition!
In this insightful episode of the Click&Go Travel Podcast, Paul & Gill are joined by CLIA's Andy Harmer, a leading cruise expert to explore the booming world of cruises, with a special focus on trends shaping the Irish market. From recent industry growth to exciting innovations onboard, we cover everything a curious cruiser might want to know before setting sail.
Join me as I dive into the fascinating world of epigenetics and biological age with TruDiagnostic™ Co-Founder Hannah Went. With a deep-rooted passion for longevity and wellness, Hannah shares insights into how we can measure and influence our biological age. Discover the power of methylation testing, TruDiagnostic's revolutionary health assessments, and actionable strategies to improve health and potentially reverse aging.Hannah Went is the Co-Founder of TruDiagnostic, a pioneering health data company and CLIA-certified laboratory specializing in epigenetic testing and research. As the creator and host of the Everything Epigenetics Podcast, she connects audiences with the world's leading physicians and researchers.A molecular biologist by profession and a content creator by passion, Hannah is dedicated to empowering individuals to take charge of their health and discover innovative strategies to enhance wellness and performance.Website: https://everythingepigenetics.com/X: https://x.com/EverythingEpiFacebook: https://www.facebook.com/EverythingEpigenetics/Instagram: https://www.instagram.com/everythingepigenetics/LinkedIn: https://www.linkedin.com/in/thehannahwent/TruDiagnostic™Website: www.trudiagnostic.comFacebook: https://www.facebook.com/TruDiagnosticInstagram: https://www.instagram.com/trudiagnosticofficial/?hl=enLinkedIn: https://www.linkedin.com/company/trudiagnostic/PODCAST Thank you for listening please subscribe and share! - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Shop supplements: https://healthybydrjen.shop/ CHECK OUT a list of my Favorite products here: https://www.healthybydrjen.com/drjenfavorites WATCH THIS:https://www.youtube.com/watch?v=2lSyAFy5U4U&list=PLaDiqj0yz1eeCOATXPoUDt8HEJxz1_lfW - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - FOLLOW ME: Instagram :: https://www.instagram.com/integrativedrmom/ Facebook :: https://www.facebook.com/pflegmed Tik Tok :: https://www.tiktok.com/@integrativedrjen YouTube :: https://www.youtube.com/@integrativedrmom - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - FTC: Some links included in this description might be affiliate links. If you purchase a product through one of them, I will receive a commission (at no additional cost to you). I truly appreciate your support of my channel. Thank you for watching! Video is not spons...
Send us a textWhat does the FDA jurisdiction for LDTs mean for the labs? Do they need to worry? How do they need to change the way they operate?In this episode, I talk with Dr. Thomas Nifong, a clinical pathologist and VP of CDX operations at Acrovan Therapeutics, about the recent FDA ruling on laboratory-developed tests (LDTs) issued on May 6th, 2024. We discuss the implications of considering LDTs as medical devices, requiring regulation, and explore the authority of FDA versus CLIA. The conversation also covers historical contexts, practical implications of regulatory changes, and the roles of organizations like CAP, ACLA, and AMP in legal challenges against the FDA. We dive into the differences in requirements between CLIA and FDA, New York's alternative approval route, and potential impacts on lab operations and compliance. Join us for an insightful conversation filled with essential information for those in the field of molecular pathology.00:00 Introduction and Special Guest Announcement00:24 FDA's New Rule on Laboratory Developed Tests (LDTs)01:58 Recording the Podcast: A Casual Lunch Conversation03:47 Understanding FDA's Authority Over Medical Devices08:07 Disputes and Legal Challenges12:03 Practical Implications and Industry Reactions12:47 Understanding FDA's Focus: Safety and Efficacy14:11 The Role of CMS and Medical Necessity14:48 Congressional Involvement and Legal Authority16:06 Impact on Labs and Future LDTs18:33 Quality Systems and Compliance20:16 Modifications and Software Updates21:16 Conclusion and Next StepsSupport the showBecome a Digital Pathology Trailblazer get the "Digital Pathology 101" FREE E-book and join us!
Jason Sheppard, is the Founder of The Fentanyl Test, the world's first FDA-CLEARED, CLIA-waived dip-card test for over- the-counter use. PA Dems say 50 Cents is Worth More Than Their Constituents' Lives
On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma environments and startups, shedding light on the significant time and resource investments required for successful IVD development. ---------------------------------- Chapters: Exploring In Vitro Diagnostics with Devin Campbell In this episode of the Combinate Podcast, host Subhi Siddek welcomes back Devin Campbell, founder and managing director of Product Know You, to discuss in vitro diagnostics (IVDs). They delve into various aspects of IVD development, including the clinical implications, risk management, and distinctions between companion diagnostics and precision medicine. They also cover regulatory pathways, lab-developed tests, and the rigorous validation processes involved. The conversation aims to demystify the complexities of IVDs for professionals in pharma and medical devices. -------------------------------------- 00:00 Introduction 01:58 Understanding In Vitro Diagnostics (IVDs) 05:26 Companion Diagnostics and Precision Medicine 08:49 Lab Developed Tests (LDTs) 12:39 IVD Development Process 15:27 Risk Management in IVDs 20:17 Clinical Testing and Validation 29:12 Challenges and Considerations in IVDs 37:04 Conclusion and Contact Information Devon Campbell is the Founder, Prodct LLC and Chief Product Officer(CPO), myBiometry. He's launched and exited several MedTech ventures and has worked in large Pharma and large IVD companies in executive roles focusing on engineering and product development. https://www.devonccampbell.com/
Send us a textCurious about how genetic testing can transform your health journey? Join us for a compelling conversation with Dahlia Attia-King, founder and CEO of Panacea, as we uncover the power of predictive genetic testing. Discover how advancements in genetic research, such as the BRCA1 and BRCA2 genes, are not only revolutionizing our understanding of risks for diseases like cancer and heart disease but also empowering individuals to make informed health decisions. We promise you'll walk away with a deeper insight into the role genetics plays in healthcare and the actionable steps you can take to harness this knowledge.Dahlia shares her inspiring journey from aspiring medical student to trailblazing healthcare innovator, revealing the personal motivations behind Panacea's mission to make genetic testing accessible and actionable. We'll explore the technical differences between direct-to-consumer and clinical genetic testing, with a spotlight on technologies like microarray and next-generation sequencing (NGS). Learn about the significant barriers to access, such as insurance coverage and physician hesitancy, and how Panacea is breaking down these obstacles to bring advanced genetic testing directly to the public.Our discussion is enriched with insights from expert genetic counselors, emphasizing the importance of comprehensive clinical guidance alongside genetic testing. We'll also delve into the critical aspects of data privacy, certifications like CLIA and CAP, and the importance of understanding genetic test results. This episode is a must-listen for anyone interested in the future of preventive healthcare, providing a holistic view of how genetic testing can be a powerful tool in managing and mitigating health risks.Panacea's Website: www.seekpanacea.comDiscount Code: DRNOSEWORTHY20You can listen to the Inflammation Nation podcast on Apple Spotify and all other major podcast platform You can also watch on YouTube. Check out my online store for self-learning/DIY programs for thyroid, gut health and detox. You can use this form to reach out and request an Initial ConsultationVisit my LabShop store to self-order the same tests I use with my one-on-one coaching clients. https://labs.rupahealth.com/store/storefront_3GMxe4pSOCIAL LINKSInstagramFacebookTikTok
My guest today is Kelly Craighead, President & CEO of CLIA - one of the travel industry's most important associations representing all things cruises! Before running CLIA, Kelly was the senior government representative for all travel and tourism matters at the Department of Commerce. So if you're interested in travel trends and what's new in the cruise industry, you're in for a treat! Kelly and I chat about everything from how millennials are the fastest growing generation for cruise travel, to sustainability on the oceans, to fabulous new destinations you can reach by ship. Learn more at www.luxtravelinsider.com Connect with me on Social: Instagram LinkedIn
Two-time Emmy and three-time NAACP Image Award-winning, television Executive Producer Rushion McDonald, interviewed Sheila Michelle Foye. Her career began with the Gas Company here in Atlanta just before natural gas was deregulated. She began as an Office Assistant and moved lattice style into mission-critical senior leadership roles within organizations and across industries such as SunTrust Banks (Truist), CapGemini, Accenture, Cox, and healthcare giants such as Morehouse School of Medicine, Piedmont, and Grady. Foye leveraged her corporate knowledge gained over the years to become an award winning, respected successful Entrepreneur in Drug Testing and CLIA-waived Laboratory Testing. Drug Testing was chosen due to her oldest son's murder (age 24), which was drug/ gang violence related and her family history of substance/alcohol abuse that made for a rocky road in life. Nearly two years into the business, Michelle was able to innovate and pivot Precis Screening by establishing a consulting arm that has now assisted more than 3,000 Entrepreneurs and counting. #BEST #AMI #STRAW #SHMSSee omnystudio.com/listener for privacy information.
Two-time Emmy and three-time NAACP Image Award-winning, television Executive Producer Rushion McDonald, interviewed Sheila Michelle Foye. Her career began with the Gas Company here in Atlanta just before natural gas was deregulated. She began as an Office Assistant and moved lattice style into mission-critical senior leadership roles within organizations and across industries such as SunTrust Banks (Truist), CapGemini, Accenture, Cox, and healthcare giants such as Morehouse School of Medicine, Piedmont, and Grady. Foye leveraged her corporate knowledge gained over the years to become an award winning, respected successful Entrepreneur in Drug Testing and CLIA-waived Laboratory Testing. Drug Testing was chosen due to her oldest son's murder (age 24), which was drug/ gang violence related and her family history of substance/alcohol abuse that made for a rocky road in life. Nearly two years into the business, Michelle was able to innovate and pivot Precis Screening by establishing a consulting arm that has now assisted more than 3,000 Entrepreneurs and counting. #BEST #AMI #STRAW #SHMSSee omnystudio.com/listener for privacy information.
Her career began with the Gas Company here in Atlanta just before natural gas was deregulated. She began as an Office Assistant and moved lattice style into mission-critical senior leadership roles within organizations and across industries such as SunTrust Banks (Truist), CapGemini, Accenture, Cox, and healthcare giants such as Morehouse School of Medicine, Piedmont, and Grady. Foye leveraged her corporate knowledge gained over the years to become an award winning, respected successful Entrepreneur in Drug Testing and CLIA-waived Laboratory Testing. Drug Testing was chosen due to her oldest son's murder (age 24), which was drug/ gang violence related and her family history of substance/alcohol abuse that made for a rocky road in life. Nearly two years into the business, Michelle was able to innovate and pivot Precis Screening by establishing a consulting arm that has now assisted more than 3,000 Entrepreneurs and counting. #STRAW #SHMSSupport the show: https://www.steveharveyfm.com/See omnystudio.com/listener for privacy information.
Her career began with the Gas Company here in Atlanta just before natural gas was deregulated. She began as an Office Assistant and moved lattice style into mission-critical senior leadership roles within organizations and across industries such as SunTrust Banks (Truist), CapGemini, Accenture, Cox, and healthcare giants such as Morehouse School of Medicine, Piedmont, and Grady. Foye leveraged her corporate knowledge gained over the years to become an award winning, respected successful Entrepreneur in Drug Testing and CLIA-waived Laboratory Testing. Drug Testing was chosen due to her oldest son's murder (age 24), which was drug/ gang violence related and her family history of substance/alcohol abuse that made for a rocky road in life. Nearly two years into the business, Michelle was able to innovate and pivot Precis Screening by establishing a consulting arm that has now assisted more than 3,000 Entrepreneurs and counting. #STRAW #SHMSSee omnystudio.com/listener for privacy information.
Diana Azzam, PhD joined us on OsteoBites to discuss her lab's work on functional precision medicine for the treatment of pediatric and adult cancers. This presentation describes the foundational principles of functional precision medicine as applied to pediatric cancers and how major technological improvements as well as an explosive broadening of the cancer pharmacopeia has enabled the bridging of genomics with functional drug testing as clinical decision support tools to impact patient care.Diana Azzam, PhD, is an Assistant Professor and Research Director of the Center for Advancing Personalized Cancer Treatments at Florida International University. She has a Masters in Biochemistry from the American University of Beirut, Lebanon and a PhD in Biochemistry & Molecular Biology from the University of Miami, Florida. Her lab focuses on implementing functional precision medicine (FPM) approaches in adult and pediatric cancer patients that have run out of treatment options. Working with local hospitals including Nicklaus Children's Hospital and Cleveland Clinic Florida, her lab delivers individualized treatment plans based on a patient's cancer genomic profile and ex vivo drug response. She is currently engaged in two clinical studies to assess feasibility and clinical utility of FPM in relapsed/refractory patients with childhood cancer (ClinicalTrials.gov registration: NCT05857969) and adult cancer (ClinicalTrials.gov registration: NCT06024603). Dr. Azzam is working on setting up the first CLIA-certified lab in the State of Florida dedicated for functional cancer drug testing. Her goal is to launch large-scale prospective multi-center randomized clinical trials to better assess efficacy of FPM approaches in the treatment of refractory/relapsed cancers. In parallel, she is working on utilizing FPM as a tool to reduce health disparities in childhood cancer patients from minority populations. She is also integrating a novel machine learning approach to identify specific biomarkers among minority populations that can be targeted using FDA-approved drugs. Her lab also investigates cancer stem cells and how they may result from chronic environmental exposures to toxic metals such as arsenic.After a short presentation on this research, she will take questions from attendees. Share your questions in advance with us at Christina@MIBAgents.org.
Two emerging start-ups, Clia and Orgo, have today been announced as winners of the 2024 NovaUCD Student Enterprise Competition, an intensive 4-week accelerator programme for student entrepreneurs, at University College Dublin (UCD). Following pitches to a judging panel at the culmination of the competition, Clia, an emerging medtech start-up, was named winner of the €3k Tech Sustainability Prize sponsored by Terra Solar and Orgo, an emerging edtech start-up, was named winner of the €3k One to Watch Prize sponsored by NovaUCD. Clia is developing software-as-a-service, which plugs into existing cardiac rehabilitation services to improve support and treatment for people at risk of cardiac disease. Using wearable health data Clia aims to track and provide insights in heart health, offering links to structured exercise services and give check-ups with cardiac specialist physiotherapists. The founders of Clia are physiotherapists, Rory Lambe and Ben O'Grady, who are currently research masters students, investigating wearable technology, in the UCD School of Public Health, Physiotherapy and Sports Science under the supervision of Dr Cailbhe Doherty. Rory Lambe said, "We are delighted to have been named the winner of the Tech Sustainability Prize at the conclusion of the 2024 NovaUCD Student Enterprise Competition, especially as the quality of the participating ventures was very high." Ben O'Grady added, "Wearable health data is a rapidly expanding industry. At Clia, we are building a team of exercise specialists in wearable data accuracy who have worked in the Irish healthcare and cardiac rehab systems to monitor heart health and to ultimately improve cardiac health and reduce cardiac disease in line with the UN SDG 3, Good Health and Well-Being." He concluded, "We are passionate about health, technology and innovation, and our vision at Clia is central to this. We aim to validate and progress our concept to bring our research knowledge in wearable health to market with the goal of improving heart health and wellness." Orgo is developing a mobile e-learning platform focused on Organic Chemistry to enable students across the academic spectrum to become comfortable with the subject. The mobile app will help students with bite-size lessons and revision questions to ensure success throughout their college careers. The founder of Orgo is Zackary Musumeci, currently a Biochemistry and Molecular Biology undergraduate student in the UCD College of Science. Zackary Musumeci said, "It is a great honour to have been named the winner of the One to Watch Prize at the end of the 2024 NovaUCD Student Enterprise Competition, given the many fantastic early-stage student start-ups which took part in this year's competition." He added, "A key reason for high attrition rates among students of health sciences or medicine is the difficulty of preparatory course content, particularly Organic Chemistry. This subject is fundamental to these students, but it can be unintuitive and requires extensive practice, which requires a significant time investment. With Orgo studying for Organic Chemistry is easier than ever. Our solution consists of a mobile app that includes a gamified learning experience with bite-sized lectures and revision content. This allows students to get practice in at any time of the day. With long term learning, consistency is key even if students are only using the app for a few minutes a day." He concluded, "My future plan with Orgo is to try and build out a full prototype by the end of the summer. With consumer facing apps, especially ones that prioritise education, having the best possible user experience is a must. I am looking for talent to assist me to this end and wish to take this idea as far as I can." The annual NovaUCD Student Enterprise Competition is delivered by NovaUCD as a framework to mentor and support undergraduate and postgraduate students who want to work together to develop and grow start-up companies. Thirteen (13)...
Andy Harmer talks to industry veteran Bernie Carter about expedition cruising and the real buzz it's experiencing as well as sharing what took him to his role at Atlas Voyages. Bernie shares a huge excitement at being involved in creating a unique experience for guests and how the importance of being able to educate travel partners via events from CLIA as well as a plethora of resources and contacts for agents to utilise.
Shaun broadcasts LIVE from Cigar Night! PLUS, The Biden Administration has done nothing about the fentanyl flowing over our border and killing our citizens. Jason Sheppard, founder of WimKim Social Media, tells Shaun about his latest project to help save some of the many lives lost to fentanyl - he came up with the first (and only) FDA-approved, CLIA-waived, over the counter fentanyl dip tests. Buy yours today at www.thefentanyltest.com and use promo-code LIBERTY for 10% off your order. And Shaun talks to Jim Bovard, author of Last Rights: The Death of American Liberty, about the mistake of putting our politicians on a pedastal and the dangers of our new drugged up society.See omnystudio.com/listener for privacy information.
The Biden Administration has done nothing about the fentanyl flowing over our border and killing our citizens. Jason Sheppard, founder of WimKim Social Media, tells Shaun about his latest project to help save some of the many lives lost to fentanyl - he came up with the first (and only) FDA-approved, CLIA-waived, over the counter fentanyl dip tests. Buy yours today at www.thefentanyltest.com and use promo-code LIBERTY for 10% off your order.See omnystudio.com/listener for privacy information.
JCO PO author Dr. Jun Gong shares insights into his JCO PO articles, “Phase II Study of Erdafitinib in Patients with Tumors with FGFR Amplifications: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Sub-protocol K1" and “Phase II Study of Erdafitinib in Patients with Tumors with FGFR Mutations or Fusions: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Sub-protocol K2”. Host Dr. Rafeh Naqash and Dr. Gong discuss the limited activity of FGFR inhibition in solid tumors with FGFR amplifications and mutations or fusions in this NCI-MATCH phase II trial. TRANSCRIPT Dr. Rafeh Naqash: Hello and welcome to JCO Precision Oncology Conversations, where we bring you engaging conversations of clinically relevant and highly significant JCO PO articles. I'm your host, Dr. Rafeh Naqash, Social Media Editor for JCO Precision Oncology and Assistant Professor at the Stevenson Cancer Center at the University of Oklahoma. Today, we are excited to be joined by Dr. Jun Gong, Associate Professor in the Division of Medical Oncology at Cedars-Sinai Medical Center and lead author of the JCO Precision Oncology article entitled "Phase II Study of Erdafitinib in Patients with Tumors Harboring FGFR Amplifications: Results from the NCI-MATCH ECOG-ACRIN Trial EAY131 Subprotocol K1" and "Phase II Study of Erdafitinib in Patients with Tumors with FGFR Mutations or Fusions: Results from the NCI-MATCH ECOG-ACRIN Trial EAY131 Subprotocol K2." Our guest's disclosures will be linked in the transcript. Dr. Gong, welcome to our podcast and thank you for joining us. Dr. Jun Gong: Thank you, Dr. Naqash and JCO Precision Oncology for having me. Dr. Rafeh Naqash: We are excited to be discussing some interesting aspects that you have led and published on from the NCI-MATCH trial. We were trying to understand from a background perspective, since this master protocol has been going on for quite some time, could you give us a little bit of background for the sake of our listeners on what the NCI-MATCH is and what were the specific objectives for these two subprotocols? Dr. Jun Gong: Yes, of course, Dr. Naqash. So, as you may all know, the importance of targeted therapies in the current era of precision oncology. And on that backdrop, the NCI-MATCH was a national multicenter study designed essentially to look for signals of efficacy across various solid tumor and hematologic malignancy types, with a focus on specific mutations. The master protocol is unique in that there are several arms to the trial, each targeting a specific potential targetable alteration using available agents in cancer today. Dr. Rafeh Naqash: Excellent. Thank you for that background. I know this master protocol has been going on for quite some time with different subprotocols. I believe some of them are immunotherapy-based. Also, you've led two important subprotocols, which are the FGFR amplification and the FGFR mutation or fusion. There are some differences, from what I gather, in responses for the fusions versus the amplifications or mutations versus the amplifications. Could you first delve into the first paper of the fusions, and describe what were the tumor types? As you mentioned in the paper, some tumors were excluded. What was the reason for the exclusion of some of those tumor types? Why did you want to study the fusions and mutations versus the amplifications separately? What was the background for that? Could you highlight some of those points for us? Dr. Jun Gong: Firstly, as a kind of a more background, FGFR has been a recognizable target for a couple of tumor types. And if you look at the broad landscape of FGFR alterations, they occur in about 5%-10% of cancers, with the majority being FGFR amplifications actually, and mutations and rearrangements following second and third respectively in most commonly identified alterations. With that being said, FGFR mutations and rearrangements have already been established in a couple of tumor types. Actually, the first FDA approval for an oral FGFR inhibitor was erdafitinib, which was the agent used in both of these back-to-back trials. However, erdafitinib was first approved in urothelial carcinoma, and since then, there has been an explosion in oral FGFR inhibitors targeting fusions and mutations in other cancer types, such as cholangiocarcinoma. More recently, there was even an FDA approval in a myeloid malignancy as well. So, we used erdafitinib, being that it was the first FDA-approved, orally available agent to target this alteration. We conducted the two back-to-back studies in recognition that although rearrangements and mutations have already been established in certain tumor types, we were more interested in looking at the more common FGFR alteration, that being amplifications. However, the efficacy in that was a little unknown, and so these two separate subprotocols were developed: K2, which was to look at FGFR mutations and fusions in tumor types, excluding urothelial carcinoma, to look if there was a signal of efficacy beyond currently FDA-approved indications, and amplification as a separate cohort. Dr. Rafeh Naqash: That's a very good explanation of why you concentrated on the tumor types in these protocols. Now, going back to subprotocol K1, could you tell us what were some of the tumor types that you did include, and what was the sample size, and what was the hypothesis for the sample size as a meaningful level of activity that you wanted to see and would have potentially led to a bigger, broader trial? Dr. Jun Gong: So, subprotocol K1 was the arm investigating erdafitinib in those with FGFR amplifications, and these were predefined on the NCI-MATCH protocol, looking at FGFR 1, 2, 3, and 4 amplifications essentially. These were allowed to have local testing through a local CLIA-certified assay, but then they needed to be confirmed on a central assay, which is the NCI-MATCH Oncomine assay. These statistics are uniform for the NCI-MATCH trials, and the goal was at least 31 patients, with the hypothesis that if the response rate was 16% or more, this was considered a signal of activity. However, there was an additional protocol specific requirement in that if the sample size was fewer than 31 patients, then the primary efficacy population would be assessed against a null hypothesis overall response rate of 5%. Meaning that if there were less than 31 subjects, an overall response rate of greater than 5% would be defined as positive. Again, the NCI-MATCH was uniform. Secondary objectives included progression-free survival, overall survival, and safety and toxicity. With that being said, K1 originally began accrual. The NCI-MATCH actually launched in 2015, but in the subprotocol K1, 35 patients were initially enrolled in the study. If you go down the eligibility criteria, however, a lot of these patients dropped out due to a lack of central tumor confirmation and various reasons. Ultimately, 18 patients were included in the pre-specified primary efficacy cohort. Dr. Rafeh Naqash: Thank you. I did see for subprotocol K1, you mostly had stable disease in a couple of patients, no responses, and I think one individual with breast cancer had a prolonged stable disease. Now, from an FGFR amplification standpoint, did you or were you able to correlate - again, this is not objective responses, it's not a partial response or a complete response - was there any correlation from the level of amplification to the duration of stable disease? Dr. Jun Gong: That's actually the core of our discussion about why K1, despite a variety basket of solid tumor types, somewhere, preclinical data had suggested FGFR amplifications could be targeted, that K1 was ultimately a negative trial with a 0% response rate. We dive in that although we included as an eligibility criteria a copy number variation of seven as the threshold for amplification, we realized that if you look at some of the literature out there, that even in the FGFR 1 and 2 amplification cohorts, where these are the more common cohorts of amplified tumor types that have been targeted, you really needed a high level of amplification, more than 99% of tumor cells being amplified in the previous studies, to actually generate a response. The thought was that we assumed that FGFR amplification would lead to protein expression and dependence on FGFR signaling, providing sensitivity to FGFR inhibition. However, we realized that there is a certain degree where a high level of amplification needs to happen, and it may not be for all FGFR amplifications. We looked into the literature that FGFR 1 and 2 were the more commonly studied FGFR amplifications. FGFR 1, if you actually look at the amplicon structure, it tends to amplify a lot of other genes because it's such a huge amplicon structure. But FGFR 2 is shorter and centered on just FGFR 2 with a few other genes co-amplified. So, actually in the literature, they've already been seeing that maybe FGFR 2 amplification tumors are more readily targetable based on the robustness of evidence, rather than FGFR 1. But across all of these, the higher the level of amplification, seems the more targetable. Dr. Rafeh Naqash: Those are interesting discussions around protein expression on the tumor that could imply therapeutic vulnerability. So I've always thought about it, whether trials like NCI-MATCH trials or ASCO TAPUR, for example, would be perhaps more informative if, on a secondary analysis standpoint, proteomics is something that could be done on the tumor tissue, because similar to NCI-MATCH, ASCO TAPUR has other sub protocols where some of these mutations or amplifications don't necessarily result in antitumor responses. But I think from a biology standpoint, as you mentioned, a certain amplification might correspond to RNA expression and that might correspond to protein expression, which is downstream. So looking at that would be something interesting. Have you planned for something like that on these tumor specimens? If you have biobanked any of those specimens. Dr. Jun Gong: I think that's a great future direction. And I know you, Dr. Naqash, being involved in so many cooperative trials, I think it is possible, but it really depends on good trial planning from the onset. When designing such massive trials like this, I think the more important thing is if your trials are negative, but they are informative for the field to go back and have these postdoc available biobanks that you said. And I think having it integrated firstly, is way more efficient than to have kind of an amendment kind of going through halfway or when the trial is started. That could be a little bit more logistically difficult. Dr. Rafeh Naqash: I completely agree. And you mentioned corporate groups, I think we've been discussing, and I'm pretty sure you have also, there's a lot to be learned from clinical trials that are negative. We often, in the academic or non-academic setting, end up not publishing some of those negative results, pharma or corporate group based studies. And I think the resources, the specimens, and the negative results could correlate to some other novel findings if some of those exploratory analyses are done in the appropriate manner. Now, going to the drug itself or the erdafitinib here, it's a pan-FGFR inhibitor. Is that something that you think is a limitation in the drug development space? I do early phase trials, and I'm pretty sure you do a lot of these basket early phase trials. Is that something that you feel is a limitation when you have a drug that targets different mutations or different protein changes of the same gene or different amplifications? Could that be a reason why something like this doesn't necessarily work because it doesn't have as much specificity against the isoform as one might need to inhibit the downstream kinase activation? Dr. Jun Gong: That is also a great point. The NCI-MATCH sub protocol K1 and K2 used erdafitinib, which was the first FDA-approved FGFR inhibitor. But as many of the listeners and yourself may know, there have been newer iterations in next-generation development of the FGFR inhibitors. And it's very fascinating, the tyrosine kinase inhibitors, with each iteration, you seem to have a little more potency and the ability to bypass some of the resistance mutations, almost paralleling the lung cancer space, where we kind of follow that, and they've been kind of the pioneers in that space. And to your point, yes, we consider– the NCI-MATCH was developed nearly a decade ago, and the available agents at that time, would it have changed the findings if we used a kind of a newer generation or more potent FGFR inhibitor? It's possible, I think, especially in the K1 cohort with the amplifications. We even suggested in the discussion of the paper future directions, is that one way to kind of bypass the amplification issue is to use more potent and specific FGFR inhibitors. And so I think it's very possible that you highlight this point. Dr. Rafeh Naqash: And for the sake of our listeners, Jun, especially trainees, could you highlight what are currently some of the FDA-approved FGFR inhibitors, and what tumor types are they currently approved in? Dr. Jun Gong: The first one, as we have hinted, was in treatment of refractory, essentially urothelial carcinoma with FGFR mutations and rearrangements, mainly 2 and 3. And this is where oral erdafitinib was approved. And it's interesting, I kind of teach my fellows and our health staff that erdafitinib is interesting in that its FDA label insert requires a starting dose of about 8 milligrams daily, and it's a 28-day cycle. But during the first 14 days, we're really looking at the serum phosphate levels. If they are within a certain level, if they are within 5.5 to 7, for example, you continue the current dose. But if they are less than 5.5, the FDA label actually mandates that you increase it to 9 milligrams oral daily, continuously. This is biologically logical to me. FGFR is located to the renal tubules, and so this is a major phosphate kind of metabolism pathway here. And so you're using that as a surrogate, essentially, if the right dosing is achieved. And so that's unique. And then the subsequent kind of FGFR inhibitors that came about, you had a couple in cholangiocarcinoma, where, unlike urothelial carcinoma, where it's about 30% of the time, you'll find the FGFR alterations of target. It's about half of that 15% in cholangiocarcinoma, and it's mainly intrahepatic cholangiocarcinoma in that sense. And here you have pemigatinib, which is one of the FGFR inhibitors approved for cholangiocarcinoma. And then you also had infragatinib, which is approved. But however, infigratinib eventually had their FDA label culled. It was withdrawn by the company, I think it was in 2022. And then more recently, you had even a more potent FGFR inhibitor in cholangio approved and futibatinib. It's interesting that with these more later generations of FGFR inhibitors, they do show a correlation with phosphate levels, but they don't have that specific kind of dosing early on in the first cycle, like erdafitinib. And so it's interesting to see that with the later generations, you're seeing more potency as well. Dr. Rafeh Naqash: Thank you for that overview, which I'm sure most of the trainees appreciate since this is an up and coming field in the space of precision medicine, especially FGFR. From a side-effect profile standpoint, you mentioned phosphate issues. Do you think that is a drug class effect here, or is that an FGFR receptor subtype effect, depending on which FGFR receptor, 1 or 2 or 3, that is being targeted? Dr. Jun Gong: I do think this is a class effect that you'll see across a lot of the trials where phosphorus elevations or decreases are going to be probably your most common treatment-related adverse event. And I actually emphasize this is probably one of the most trickier side effects of this class, where we're almost having to have to monitor the phosphorus levels pretty routinely, pretty closely. And you also have other class effects on the nails. There's some rare retinal ocular toxicities that's unique to the FGFR class as well. And so it's a very exciting class of compounds, but it does require some close monitoring of some unique class effects as you've hinted. Dr. Rafeh Naqash: Based on the results from your K1 sub protocol, are FGFR inhibitors still the approach within, let's say, within cholangio or urothelial with FGFR amplifications? Is that still something that has been established and seen from a clinical response standpoint? Dr. Jun Gong: The FDA approvals are really for mutations and fusions. So this K1 sub protocol, essentially, I think provides one answer that we've been all wondering about for the longest time, “Hey, could amplifications be targeted as well?” Unfortunately, we didn't include urothelial carcinomas in this study because of the FDA approval. But from a kind of a basket solid tumor perspective, I think this really dampens the enthusiasm. As of right now, it really is fusions and mutations that are targetable. Amplifications need further investigation before becoming established in solid tumors. Dr. Rafeh Naqash: Going to the discussion with the second K2 protocol, which is mutations and fusions, can you highlight again which tumor types there where you saw some clinical outcomes that you saw and any unique insights on certain mutations or protein changes that were a little more relevant than some others? Dr. Jun Gong: Sure. So this is the parallel study to K1, in that now we are looking at fusions and mutations of FGFR1, 2, 3, and 4. And essentially, we, again, excluded those with urothelial carcinoma, given the FDA approval for erdafitinib in this trial. The trial actually opened then the FDA approvals for the FGFR inhibitors for cholangiocarcinoma happened. So this trial didn't really exclude those with FGFR mutated or rearranged cholangiocarcinoma as well. If you look at the breakdown of the cohort in K2, you saw a good mix of breast cancers or a couple of gynecologic malignancies. There were a couple of head and neck cancers. There were several brain tumors as well. There was one lung cancer. There were four noted intrahepatic cholangiocarcinomas. Again, we could not exclude those due to the fact that the trial had opened and was accruing when the FGFR inhibitors approved for cholangiocarcinoma happened. Similar design, with a phase II, single-arm, open-label of erdafitinib, and again, the same statistical design was implemented in that if it's higher than 31 patients, 16% overall response rate was a primary endpoint goal. If it was less than that, it was against the 5% overall response rate. And here in K2, 35 patients were enrolled and 25 patients were ultimately included in the primary efficacy analysis. So because it was fewer than 31 in the primary efficacy cohort, it followed the NCI-MATCH to be specified with a primary endpoint goal of 5% or higher. And here, in a heavily pre-treated cohort of more than 50% of subjects who have received prior than 3 or higher lines of therapy, overall response rate essentially confirmed was 16% with the p value of 0.034, which met the positivity cutoff of 5%. However, an additional seven patients experienced stable disease as best confirmed response. And it's important to note that four of these were grade IV glioblastomas with prolonged progression-free survival. So ultimately, this trial was positive in reading the endpoint that outside of urothelial carcinoma, could FGFR inhibition be pursued in other tumor types that had FGFR rearrangements or fusions? Dr. Rafeh Naqash: You mentioned glioblastoma, which is an area of huge unmet need. Do you think a trial like this as an upfront approach in glioblastoma, perhaps maybe after Temodar, could be a more meaningful way using the strongest, more precise therapy earlier on when there are certain mechanisms that inhibition of which would result in anti-tumor responses? Do you think doing this earlier on rather than second, third, fourth line would be more intriguing in some ways? Dr. Jun Gong: I think you've hit upon several key points there. Firstly, just a high unmet need in glioblastomas, in general. And then to us, although it was a stable disease it was quite noticeable that four of these occurred in IDH1 and 2 wild-type brain tumors. We kind of discussed that in the discussion as well. And of these, we actually realized that in the pre-clinical and other published literatures space that for some reason, IDH1 and wild-type tended to have more FGFR alterations, while 0% were found in IDH1 and 2 mutant high grade gliomas. So I think there is something hypothesis generating coming out of this study as well even though there were stable disease. And that you may be selecting for– We may be able to have future studies to select for a specific niche of glioblastomas. And as to your point, Dr. Naqash, I think if we can have a design trial looking for these specific molecular subsets, I think it's wide open for trials of this nature in the first line, second line, or refractory space. Even piggybacking into cholangiocarcinoma, you see, they're now looking at these in the neoadjuvant and adjuvant space as well. So I think we can identify the subset - it's wide open out there. Dr. Rafeh Naqash: I completely agree. I remember my program director a few years back when immunotherapy was in the metastatic setting, it was very exciting. He gave a talk in which he said "Early, earlier, earliest," and the more early, the better it seems. So I'm guessing that it's probably something similar for precision medicine-based approaches like targeting FGFR perhaps earlier. So what is next for some of these two studies, or these ideas that have come out of these two studies? Are you trying to develop something subsequently, or is NCI-MATCH looking at it from a certain perspective? Or what would you want to do as a next step, ideally if you had the funding and the pharma support? Dr. Jun Gong: That's the million dollar question. So just from the broad strokes, I think what these two back to back papers and studies comment is that amplifications may not be the more targetable of FGFR subset, but there is avenue for improvement there and further investigation. FGFR fusions and mutations however seem to go along with what we know in some of the FDA approved types now. Now the next step is in the area of precision oncology is could we expand the label indications now to other subtypes with FGFR fusions and mutations. And this is I think following precedent. You and the audience may know that there are a lot of different tumor agnostic approvals now for both immunotherapy and other targeted therapy types. So I think the goal of this study was to provide momentum for, perhaps, advancements into a tumor agnostic indication for FGFR inhibitors. And we do cite in the K2 manuscript the results of a phase II study that was also published around the time we were writing the study up. It was the phase II RAGNAR study. And that enrolled patients, again, with FGFR fusions and mutations. And that trial was positive, too. That one was a larger study of 217 subjects. We highlight some differences in study populations as to why maybe the difference in responders were detected. Both were positive studies. It was reassuring that the overall survival impulse studies were about the same. And again, I think they don't compete. I rather think they complement each other in providing this body of evidence that may meet- at one point, the FDA should be approached with this evidence for a tumor agnostic mutation so that more patients with this subset could be benefitting. Dr. Rafeh Naqash: Excellent. Thank you so much, Jun. Now, could you tell us briefly what your background is, where you've trained, and your interests, and how you balance clinical research with some of your personal interests? Dr. Jun Gong: Sure. Thank you for that interest. I did my training in medical school in New York. I went to New York Medical College. And then I did my residency at Cedars-Sinai for medicine. And I went to City of Hope for fellowship where I was trained in GU by Dr. Monty Powell who maybe you folks are familiar with. And my GI training was with Dr. Fakih at City of Hope. And since then I returned back to Cedars-Sinai where I serve as a dual GI/GU focused medical oncologist. I do clinical trials in both and translational science, really focused on targeting tumor metabolism in both as well. My advice to the listeners and trainees and I tell my own fellows this, I think it's very rare now unless you're in phase I to do a dual focus. So I actually emphasized to my trainees that the more focused you can be, the better. Unless you are going into phase I, for example. With that, you can hone in, develop your craft. But then again, I have known several mentors who do multiple tumor types. But I think the more traditional mechanism is to focus as much as you can is my advice for the listeners. Dr. Rafeh Naqash: Thank you again, Jun, for all those interesting scientific and personal insights. We appreciate you and working with JCO Precision Oncology for both of your manuscripts. This is the first time we have ever invited a lead author for two manuscripts at the same time. It's always good to be the first in something, and I learned a lot and hopefully, our audience would have learned a lot. Dr. Jun Gong: Thank you, Dr. Naqash, for having me. It was a pleasure speaking with you and the crew. Dr. Rafeh Naqash: Thank you. Thank you for listening to JCO Precision Oncology Conversations. Don't forget to give us a rating or review, and be sure to subscribe so you never miss an episode. You can find all ASCO shows at asco.org/podcasts. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experiences, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
If there's one person you'd want to talk to about immunology, the immune system and Covid, holes in our knowledge base about the complex immune system, and where the field is headed, it would be Professor Iwasaki. And add to that the topic of Women in Science. Here's our wide-ranging conversation.A snippet of the video, Full length Ground Truths videos are posted here and you can subscribe. Ground Truths is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.Transcript with many external link and links to the audio, recorded 30 April 2024 Eric Topol (00:06):Hello, it's Eric Topol and I'm really thrilled to have my friend Akiko Iwasaki from Yale, and before I start talking with Akiko, I just want to mention there aren't too many silver linings of the pandemic, but one for me was getting to know Professor Iwasaki. She is my go-to immunologist. I've learned so much from her over the last four years and she's amazing. She just, as you may know, she was just recently named one of the most influential people in the world by TIME100. [and also recognized this week in TIME 100 Health]. And besides that, she's been elected to the National Academy of Medicine, National Academy of Sciences. She's the president of the American Association of Immunologists and she's a Howard Hughes principal investigator. So Akiko, it's wonderful to have you to join into an extended discussion of things that we have of mutual interest.Akiko Iwasaki (01:04):Thank you so much, Eric, for having me. I equally appreciate all of what you do, and I follow your blog and tweets and everything. So thank you Eric.Eric Topol (01:14):Well, you are a phenom. I mean just, that's all I can say because I think it was so appropriate that TIME recognize your contributions, not just over the pandemic, but of course throughout your career, a brilliant career in immunology. I thought we'd start out with our topic of great interest on Long Covid. You've done seminal work here and this is an evolving topic obviously. I wonder what your latest thoughts are on the pathogenesis and where things are headed.Long CovidAkiko Iwasaki (01:55):Yeah, so as I have been saying throughout the pandemic, I think that Long Covid is not one disease. It's a collection of multiple diseases and that are sort of ending up in similar sets of symptoms. Obviously, there are over 200 symptoms and not everyone has the same set of symptoms, but what we are going for is trying to understand the disease drivers, so persistent viral infection is one of them. There are overwhelming evidence for that theory now, all the way from autopsy and biopsy studies to looking at peripheral blood RNA signatures as well as circulating spike protein and nucleocapsid proteins that are detected in people with Long Covid. Now whether that persistent virus or remnants of virus is driving the disease itself is unclear still. And that's why trials like the one that we are engaging with Harlan Krumholz on Paxlovid should tell us what percentage of the people are suffering from that type of driver and whether antivirals like Paxlovid might be able to mitigate those. If I may, I'd like to talk about three other hypotheses.Eric Topol (03:15):Yeah, I'd love for you to do that.Akiko Iwasaki (03:18):Okay, great. So the second hypothesis that we've been working on is autoimmune disease. And so, this is clearly happening in a subset of people, again, it's a heterogeneous disease, but we can actually not only look at reactogenicity of antibodies from people with Long Covid where we can transfer IgG from patients with Long Covid into an animal, a healthy animal, and really measure outcomes of a pathogenesis. So that's a functional evidence that antibodies in some people with Long Covid is really actually causing some of the damages that are occurring in vivo. And the third hypothesis is the reactivation of herpes viruses. So many of us adults have multiple latent herpes virus family members that are just dormant and are not really causing any pathologies. But in people with Long Covid, we're seeing elevated reactivation of viruses like Epstein-Barr virus (EBV) or Varicella-zoster virus (VZV) and that may again be just a signature of Long Covid, but it may also be driving some of the symptoms that people are suffering from.(04:32):So that's again, we see the signature over and over, not just our group, but multiple other groups, Michael Peluso's group, Jim Heath, and many others. So that's also an emerging evidence from multiple groups showing that. And finally, we think that inflammation that occurs during the acute phase can sort of chronically change some tissue tone. For instance, in the brain with Michelle Monje's team, we developed a sort of localized mild Covid model of infection and showed that changes in microglia can be seen seven weeks post infection even though the virus is completely gone. So that means that inflammation that's established as a result of this initial infection can have prolonged sequence and sequela within the person and that may also be driving disease. And Eric, the reason we need to understand these diseases separately is because not only for diagnostic purposes, but for therapeutic purposes because to target a persistent virus is very different approach from targeting autoantibodies, for example.Eric Topol (05:49):Well, that's great. There's a lot to unpack there as you laid out four distinct paths that could result in the clinical syndrome and sequelae. I think you know I had the chance to have a really fun conversation with Michelle about their joint work that you've done, and she reminded me how she made a cold call to you to start as a collaboration, which I thought was fantastic. Look what that yielded. But yeah, this is fascinating because as I think you're getting at is that it may not be the same pathogenesis in any given individual so that all these, and even others might be operative. I guess maybe I first delve into the antibody story as you're well aware, we see after people get Covid a higher rate of autoimmune diseases crop up, which is really interesting because it seems to rev up self-directed immune response. And this I think many people haven't really noted yet, although obviously you're well aware of this, it's across all the different autoimmune diseases, connective tissue disease, not just one in particular. And it's, as you say, the idea that you could take the blood from a person suffering from Long Covid and give it to an experimental animal model and be able to recapitulate some of the abnormalities, it's really pretty striking. So the question I guess is if you were to do plasmapheresis and try to basically expunge these autoantibodies, wouldn't you expect people to have some symptomatic benefit pretty rapidly or is it just that the process is already far from the initiating step?Akiko Iwasaki (07:54):That's a great question. Plasmapheresis may be able to transiently improve the person if they're suffering from these autoantibody mediated diseases. People have reported, for example, IVIG treatment has dramatically improved their symptoms, but not in everybody. So it's really critical to understand who's suffering from this particular driver and appropriately treat those people. And there are many other very effective therapies in autoimmune disease field that can be repurposed for treating these patients as well.Eric Topol (08:34):The only clinical trial that has clicked so far, interestingly, came out of Hong Kong with different types of ways to manipulate the gut microbiome, which again, you know better than me is a major modulator of our immune system response. What are your thoughts about taking advantage of that way to somehow modulate this untoward immune response in people with this condition?Akiko Iwasaki (09:07):Yeah, so that is an exciting sort of development, and I don't mean to discount the importance of microbiome at all. It's just the drivers that are mentioning are something that can be directly linked to disease, but certainly dysbiosis and translocation of metabolites and microbiome itself could trigger Long Covid as well. So it's something that we're definitely keeping our eyes on. And as you say, Eric, the immune system is in intimate contact with the gut microbiome and also the gut is intimate contact with the brain. So there's a lot of connections that we really need to be paying attention to. So yeah, absolutely. This is a very exciting development.Eric Topol (09:57):And it is intriguing of course, the reactivation of viruses. I mean, we've learned in recent years how important EBV is in multiple sclerosis (MS). The question I have for you on that pathway, is this just an epiphenomena or do you actually think that could be a driving force in some people?Akiko Iwasaki (10:19):Yeah, so that's really hard to untangle in people. I mean, David Putrino and my team we're planning a clinical trial using Truvada. Truvada obviously is an HIV drug, but it has reported antiviral activity to Epstein-Barr virus (EBV) and others. So potentially we can try to interrogate that in people, but we're also developing mouse models that can sort of recapitulate EBV like viral reactivation and to see whether there's any sort of causal link between the reactivation and disease process.Eric Topol (10:57):Right now, recently there's been a bunch of anecdotes of people who get the glucagon-like peptide one (GLP-1) drugs which have a potent anti-inflammatory, both systemic and in the brain. I'd love to test these drugs, but of course these companies that make them or have other interests outside of Long Covid, do you think there's potential for a drug like that?Akiko Iwasaki (11:23):Yeah, so those drugs seem to have a lot of miraculous effects on every disease. So obviously it has to be used carefully because many people with Long Covid have issues with liver functions and other existing conditions that may or may not be conducive to taking those types of GLP-1 agonists. But in subset of people, maybe this can be tried, especially due to the anti-inflammatory properties, it may benefit again, a subset of people. I don't expect a single drug to cure everyone. That would be pretty amazing, but unlikely.Eric Topol (12:09):Absolutely. And it's unfortunate we are not further along in this whole story of clinical trials, testing treatments and applauding your efforts with my friend Harlan there to get into the testing which we had hoped RECOVER was going to do with their more than billion dollars or allocation, which didn't get us too far in that. Now before we leave Long Covid, which we could speak about for hours, I mean it's so darn important because so many people are really out there disabled or suffering on a daily basis or periodically they get better and then get worse again. There's been this whole idea that, oh, it's going away and that reinfections don't pose a threat. Maybe you could straighten that story out because I think there seems to be some miscues about the risk of Long Covid even as we go along with the continued circulating virus.Akiko Iwasaki (13:11):Right, so when you look at the epidemiological evidence of Long Covid, clearly in the beginning when we had no vaccines, no antivirals, no real good measure against Covid, the incident of developing Long Covid per infection was higher than a current date where we do have vaccines and Omicron may have changed its property significantly. So if you compare, let's say the Delta period versus Omicron period, there seems to be a reduced risk per infection of Long Covid. However, Omicron is super infectious. It's infected millions of people, and if you look at the total number of people suffering from Long Covid, we're not seeing a huge decline there at all because of the transmissibility of Omicron. So I think it's too early for us to say, okay, the rates are declining, we don't need to worry about it. Not at all, I think we still have to be vigilant.(14:14):We need to be up to date on vaccines and boosters because those seem to reduce the risk for Long Covid and whether Paxlovid can reduce the rate of Long Covid at the acute phase for the high risk individual, it seems to be yes, but for people who are not at high risk may or may not be very effective. So again, we just need to be very cautious. It's difficult obviously, to be completely avoiding virus at this time point, but I think masking and anything you can do, vaccination boosters is going to be helpful. And a reinfection does carry risk for developing Long Covid. So that prior infection is not going to prevent Long Covid altogether, even though the risk may be slightly reduced in the first infection. So when you think about these risks, again we need to be cognizant that reinfection and some people have multiple infections and then eventually get Long Covid, so we're just not safe from Long Covid yet.Nasal Vaccines and Mucosal ImmunityEric Topol (15:24):Right. No, I think that's the problem is that people have not acknowledged that there's an ongoing risk and that we should continue to keep our guard up. I want to applaud you and your colleagues. You recently put out [Yale School of Public Health] this multi-panel about Covid, which we'll post with this podcast that gave a lot of the facts straight and simple diagrams, and I think this is what you need is this is kind of like all your threads on Twitter. . They're always such great educational ways to get across important information. So now let's go onto a second topic of great mutual interest where you've also been a leader and that's in the mucosal nasal vaccine story. I had the privilege of writing with you a nice article in Science Immunology back in 2022 about Operation Nasal Vaccine, and unfortunately we don't have a nasal vaccine. We need a nasal vaccine against Covid. Where do we stand with this now?Akiko Iwasaki (16:31):Yeah, so you're right. I mean nasal vaccines, I don't really know what the barrier is because I think the preclinical models all support the effectiveness against transmission and infection and obviously disease. And there is a White House initiative to support rapid development of next generation vaccine, which includes mucosal vaccine, so perhaps that's sort of pushing some of these vaccine candidates forward. You're probably more familiar than me about those kinds of events that are happening. But yeah, it's unfortunate that we don't have an approved mucosal booster vaccine yet, and our research has shown that as simple as a spray of recombinant spike protein without any adjuvants are able to restimulate immune response and then establish mucosal immunity in the nasal cavity, which goes a long way in preventing infection as well as transmission. So yeah, I mean I'm equally frustrated that things like that don't exist yet.The Neomycin and Neosporin SurpriseEric Topol (17:52):Well, I mean the work that you and many other groups around the world have published on this is so compelling and this is the main thing that we don't have now, which is a way to prevent infection. And I think most of us would be very happy to have a spray that every three or four months and gave us much higher levels of protection than we're ever going to get from shots. And your whole concept of prime and spike, I mean this is something that we could have had years ago if there was a priority, and unfortunately there never has been. Now, the other day you came with a surprise in a paper on Neomycin as an alternate or Neosporin ointment. Can you tell us about that? Because that one wasn't expected. This was to use an antibiotic in a way to reduce Covid and other respiratory virus.Akiko Iwasaki (18:50):Right. So yeah, that's a little known fact. I mean, of course widespread use of antibiotics has caused some significant issues with resistance and so on. However, when you look at the literature of different types of antibiotics, we have reported in 2018 that certain types of antibiotics known as aminoglycoside, which includes Neosporin or neomycin, has this sort of unintended antiviral property by triggering Toll-like receptor 3 in specialized cell types known as conventional dendritic cell type 1. And we published that for a genital herpes model that we were working on at the time. But because it's acting on the host, the Toll-like receptor 3 on the host cell to induce interferon and interferon stimulated genes to prevent the replication of the virus, we knew that it could be pan-viral. It doesn't really matter what the virus is. So we basically leverage that discovery that was made by a postdoc Smita Gopinath when she was in the lab to see if we can use that in the nasal cavity.(20:07):And that's what Tianyang Mao, a former graduate student did, in fact. And yeah, little spray of neomycin in the nose of the mice reduce this infection as well as disease and can even be used to treat shortly after the infection disease progress and using hamster models we also showed that hamsters that are pretreated with neomycin when they were caged with infected hamsters, the transmission rate was much reduced. And we also did with Dr. Charles Dela Cruz, a small clinical trial, randomized though into placebo and Neosporin arms of healthy volunteers. We asked them to put in a pea size amount of Neosporin on a cotton swab into the nose, and they were doing that twice a day for seven days. We measured the RNA from the nose of these people and indeed see that more than half the participants in the Neosporin group had elevated interferon stimulated genes, whereas the control group, which were given Vaseline had no response. So this sort of shows the promise of using something as generic and cheap as Neosporin to trigger antiviral state in the nose. Now it does require a much larger trial making sure that the safety profiles there and effectiveness against viral infection, but it's just a beginning of a story that could develop into something useful.New Frontiers in Immunology and Tx CellsEric Topol (21:51):Yeah, I thought it was fascinating, and it does bring up, which I think has also been underdeveloped, is our approaches for interferon a frontline defense where augmenting that, just getting that exploiting the nasal mucosa, the entry site, whether it be through that means or of course through even more potent a nasal vaccine, it's like a missing, it's a hole in our whole defense of against this virus that's led to millions of people not just dying, but of course also sick and also with Long Covid around the world. So I hope that we'll see some progress, but I thought that was a really fascinating hint of something to come that could be very helpful in the meantime while we're waiting for specific nasal vaccines. Now added to all these things recently, like last week you published a paper in Cell with your husband who's in the same department, I think at Yale. Is that right? Can you tell us about that and this paper about the whole new perspectives in immunology?Akiko Iwasaki (23:05):Yeah, so my husband Ruslan Medzhitov is a very famous immunologist who's in the same department, and we've written four or five review and opinion pieces together over the years. This new one is in Cell and it's really exploring new perspectives in immunology. We were asked by the editors to celebrate the 50th anniversary of the Cell journal with a perspective on the immune system. And the immune response is just a beautiful system that is triggered in response to specific pathogens and can really provide long-term or even sometimes lifelong immunity and resistance against pathogens and it really saves our lives. Much has been learned throughout the last 20, 30 years about the innate and adaptive immune system and how they're linked. In this new perspective, we are trying to raise some issues that the current paradigm cannot explain properly, some of the mysteries that are still remaining in the immune system.(24:22):And we try to come up with new concepts about even the role of the immune system in general. For instance, is the immune system only good for fighting pathogens or can it be repurposed for conducting normal physiology in the host? And we came up with a new subset of T-cells known as, or we call it Tx cells, which basically is an interoceptive type of T-cells that monitor homeostasis in different tissues and are helping with the normal process of biology as opposed to fighting viruses or bacteria or fungi. But these cells, when they are not appropriately regulated, they are also the source of autoimmune diseases because they are by design reactive against auto antigens. And so, this is a whole new framework to think about, a different arm of the immune function, which is really looking inside of our body and not really fighting against pathogens, but we believe these cells exist, and we know that the counterpart of Tx cells, which is the T regulatory cells, are indeed well known for its physiological functions. So we're hoping that this new perspective will trigger a new set of approaches in the field to try to understand this interceptive property of T-cells.Eric Topol (25:59):Yeah, well, I thought it was fascinating, of course, and I wanted to get into that more because I think what we're learning is this immune system not only obviously is for cancer whole. We're only starting to get warmed up with immunotherapy where checkpoint inhibitors were just the beginning and now obviously with vaccines and all these different ways that we can take the CAR-T cells, engineered T-cells, take the immune system to fight cancer and potentially to even use it as a way to prevent cancer. If you have these, whether it's Tx or Tregs or whatever T-cells can do this. But even bigger than that is the idea that it's tied in with the aging process. So as you know, again, much more than I do, our senescent immune cells are not good for us. And the whole idea is that we could build immune resilience if we could somehow figure out these mysteries that you're getting at, whereby we get vulnerable just as we were with Covid. And as we get older, we get vulnerable to not just infections, but everything going wrong, whether it's the walls of our arteries or whether it's the cancer or the immunity that's going on in our brain for Alzheimer's and neurodegenerative diseases. How can we fix the immune system so that we age more healthilyThe Immune System and Healthy Aging Akiko Iwasaki (27:37):Oh yeah. A lot of billionaires are also interested in that question and are pouring money into this question. It's interesting, but when you think about the sort of evolutionary perspective, we humans are only living so long. In the very recent decades, our life expectancy used to be much shorter and all we had to survive was to reproduce and generate the next progeny. But nowadays, because of this amazing wealth and health interventions and food and everything else, we're just living so much longer than even our grandparents. The immune system didn't evolve to deal with such one to begin with. So we were doing fine living up to 30 years of age or whatever. But now that we're living up to a hundred years, the immune system isn't really designed to keep up with this kind of stressors. But I think you're getting at a very important kind of more engineering questions of how do we manipulate the immune system or rejuvenate it so that we can remain healthy into the later decades? And it is well known that the immune system itself ages and that our ability to produce new lymphocytes, for example, decline over time and thymus that is important for T-cell development shrinks over time. And so anatomically it's impossible to help stop that process. However, is there a way of, for example, transferring some factors or engineering the immune cells to remain healthy and even like hematopoiesis itself can be manipulated to perhaps rejuvenate the whole immune system in their recent papers showing that. So this is a new frontier.Eric Topol (29:50):Do you think that some point in the future, we'll ex vivo inject Yamanaka factors into these cell lines and instead of this idea that you know get young plasma to old folks, and I mean since we don't know what's in there and it doesn't specifically have an effect on immune cells, who knows how it's working, but do you foresee that that might be a potential avenue going forward or even an in vivo delivery of this?Akiko Iwasaki (30:22):Yeah, it's not impossible, right? There are really rapidly evolving technologies and gene therapies that are becoming online. So it's not impossible to think about engineering in situ as you're suggesting, but we also have to be certain that we are living longer, but also healthy. So we do have to not only just deal with the aging immune system, but preventing neurodegenerative diseases and so on. And the immune system may have a role to play there as well. So there's a lot of, I mean, I can't think of a non-genetically mediated disease that doesn't involve the immune system.Eric Topol (31:03):Sure. No, I mean, it's just, when I think about this, people keep talking about the digital era of digital biology, but I actually think of it more as digital immunobiology, which is driving this because it's center stage and in more and more over time. And the idea that I'm concerned about is that we could rejuvenate the relevant immune cells or the whole immune response, but then it's such a delicate balance that we could actually wind up with untoward, whether it's autoimmune or overly stimulated immune system. It's not such a simple matter, as I'm sure you would agree. Now, this gets me to a broader thing which you've done, which is a profound contribution in life science and medicine, which is being an advocate for women in science. And I wonder if you could speak to that because you have been such a phenomenal force propelling the importance of women in science and not just doing that passively, but also standing up for women, which is being an activist is how you get things to change. So can you tell us about your thoughts there?An Activist for Women in ScienceAkiko Iwasaki (32:22):Yeah, so I grew up in Japan, and part of the reason I left Japan at the age of 16 was that I felt very stifled because of the societal norm and expectation of what a woman should be. And I felt like I didn't have the opportunity to develop my skills as a scientist remaining in Japan. And maybe things have changed over the years, but at the time when I was growing up, that's how I felt. And so, I was very cognizant of biases in society. And so, in the US and in Canada where I also trained, there's a lot less barrier to success, and we are able to do pretty much anything we want, which is wonderful, and that's why I think I'm here. But at the same time, the inequity still exists, even in pay gaps and things like that that are easy to fix but are still kind of insidious and it's there.(33:32):And Yale School of Medicine has done a great job partly because of the efforts of women who spoke up and who actually started to collect evidence for pay gap. And now there's very little pay gap because there's active sort of involvement of the dean and everyone else to ensure equity in the medical school. But it's just a small segment of the society. We really need to expand this to other schools and making sure that women are getting paid equally as men in the same ranks. And also, I see still some sexual harassment or more just toxic environment for people in general in academia. Some PIs get away with a lot of behavior that's not conducive to a healthy environment, so I have written about that as well and how we can have antidotes for such toxic environments. And it really does require the whole village to act on it. It's not just one person speaking up. And there should be measures placed to make sure that those people who does have this tendency of abusive behavior that they can get training and just being aware of these situations and corrective behavior. So I think there's still a lot of work left in academia, but things have obviously improved dramatically over the last few decades, and we are in a very, very good place, but we just have to keep working to achieve true equity.Why Don't We Have Immunome Check-Ups?Eric Topol (35:25):Well applauding your efforts for that, and I'm still in touch with that. We got a ways to go, and I hope that we'll see steady and even more accelerated and improvement to get to parity, which is what it should be. And I really think you've been a model for doing this. It isn't like you aren't busy with everything else, so to fit that in is wonderful. In closing up, one of the things that I wonder about is our ability to assess back to the immune system for a moment isn't what it should be. That is we do a CBC and we have how many lymphocytes, how many this, why don't we have an immunome, why doesn't everybody serially have an immune system checkup? Because that would tell us if we're starting to go haywire and then maybe hunt for reactivated viruses or what's going on. Do you foresee that we could ever get to a practical immunome as we go forward? Because it seems like it's a big missing link right now.Akiko Iwasaki (36:33):Yeah, I think that's a great idea. I mean, I'll be the first one to sign up for the immunome.Eric Topol (36:40):But I'm depending on you to make it happen.Akiko Iwasaki (36:44):Well, interestingly, Eric, there are lots of amazing technologies that are developed even during the pandemic, which is monitoring everything from antibody reactivity to reactivated viruses to the cytokines to every cell marker you can imagine. So the technologies out there, it's just I think a matter of having the right set of panels that are relatively affordable because some of these things are thousands of dollars per sample to analyze, and then of course clinical validation, something that's CLIA approved, and then we can start to, I guess the insurance company needs to also cover this, right? So we need to demonstrate the benefit to health in the long run to be able to afford this kind of immunome analysis. But I think that very wealthy people can already get this done.Eric Topol (37:43):Yeah, well, we want to make it so it's a health equity story, not of course, only for the crazy ones that are out there that are taking 112 supplements a day and whatnot. But it's intriguing because I think we might be able to get ahead of things if we had such an easy means. And as you said during the pandemic, for example, my friends here in La Jolla at La Jolla Immunology did all kinds of T-cell studies that were really insightful and of course done with you and others around the country and elsewhere to give us insights that you didn't get just from neutralizing antibodies. But it isn't something that you can get done easily. Now, I think this immunome hopefully will get us to another level in the future. One of the most striking things I've seen in our space clinically before wrapping up is to take the CD19 CAR T therapies to deplete the B cells of people with lupus, systemic sclerosis and other conditions, and completely stop their autoimmune condition. And when the B cells come back, they're not fighting themselves. They're not self-directed anymore. Would you have predicted this? This seems really striking and it may be a clue to the kind of mastering approaches to autoimmune diseases in the future.Akiko Iwasaki (39:19):Yeah, absolutely. So for multiple sclerosis, for example, where B cells weren't thought to be a key player by doing anti-CD20 depletion, there's this remarkable clinical effects. So I think we can only find the answer experimentally in people when they do these clinical trials and show this remarkable effects. That's when we say, aha, we don't really understand immunology. You know what I mean? That's when we have to be humble about what we think we understand. We really don't know until we try it. So that's a really good lesson learned. And these may be also applicable to people with autoimmune phenotype in Long Covid, right? We may be able to benefit from similar kinds of depletion therapy. So I think we have a lot to learn still.Eric Topol (40:14):Yeah, that's why, again, going back to the paper you just had in Cell about the mysteries and about some new ideas and challenging the dogma is so important. I still consider the immune system most complex one in the body by far, and I'm depending on you Akiko to unravel it, not to put any weight on your shoulders. Anyway, this has been so much fun. You are such a gem and always learning from you, and I can't thank you enough for all the work. And the fact is that you've got decades ahead of you to keep building on this. You've already done enough for many people, many scientists in your career, and I know you'll keep going. So we're all going to be following you with great interest in learning from you on a frequent basis. And I hope we'll build on some of the things we've talked about like a Long Covid treatment, treatments that are effective nasal vaccines, maybe even some dab of Neosporin, and keep on the momentum we've had with the understanding of the immune system, and finally, someday achieving the true parity of gender and science. And so, thank you for all that you do.Akiko Iwasaki (41:35):Thank you so much, Eric.************************CreditsHeadshot photo credits by Robert Lisak, Yale School of MedicineMy producer for Ground Truths is Jessica Nguyen, Scripps Research and our technical support for audio/video is by SInjun Balabanoff at Scripps Research.I hope you found the spot informative. Please share itThe Ground Truths newsletters and podcasts are all free, open-access, without ads.Voluntary paid subscriptions all go to support Scripps Research. Many thanks for that—they greatly helped fund our summer internship programs for 2023 and 2024.Note: you can select preferences to receive emails about newsletters, podcasts, or all I don't want to bother you with an email for content that you're not interested in.Comments are welcome from all subscribers. Get full access to Ground Truths at erictopol.substack.com/subscribe
Ted Karkus CEO & Chairman Of The Board Of ProPhase Labs $PRPH Ticker: PRPH Website: https://www.prophaselabs.com/ Bio: Ted Karkus Chairman & CEO of ProPhase Labs Ted Karkus, CEO and Chairman of ProPhase Labs, drives the company's diverse and synergistic businesses with his successful track record in biomedical and health companies. He transformed ID Biomedical's strategy and valuation from $25 million to $1.4 billion sale to GlaxoSmithKline. As CEO of ProPhase Labs, he restructured the go-to-market strategy for the flagship product Cold-EEZE, turned around and significantly grew revenues, ultimately selling it for $50 million to Mylan. ProPhase Labs is a fast-growing biotech, genomics and diagnostics company due to its commitment to growth, innovation, and execution excellence outlined in Ted's high growth roadmap. He pivoted into industry leading CLIA labs, and then further diversified by acquiring genomics leader Nebula Genomics. Constantly innovating, Ted then created ProPhase BioPharma to deliver antivirals, cancer tests and therapeutic cancer compounds. The new acquisitions and legacy businesses work to drive synergistic growth with multi-billion-dollar potential. He holds a BS in Psychology from Tufts University with Magna Cum Laude Honors and an MBA in Finance from Columbia University School of Business with Beta Gamma Sigma Honors. --- Support this podcast: https://podcasters.spotify.com/pod/show/smartmoneycircle/support
About Fred Turner:Fred Turner is the Chief Executive Officer and co-founder of Curative. Turner was named one of the top 100 practicing scientists in the UK by the Science Council in 2013. He was also included in Forbes' ‘30 Under 30' list and ranked first in the European Union Contest for Young Scientists. Recently, Fred was awarded Comparably's Best CEO Award and Modern Healthcare's Top 25 Emerging Leaders in 2021.Under Turner's leadership, Curative launched a first-of-its-kind health insurance plan that offers unmatched transparency into healthcare costs. Inspired by his vision to create a healthcare system that works for and supports patients' whole health through every step of their personal health journey, Turner and the Curative team developed a path-breaking health plan with no copays, no deductibles, and no cost-sharing for its members.Previously, Turner led Curative as it became the national leader in bringing COVID-19 testing and vaccine administration resources to people in response to the pandemic, providing more than 36 million tests and two million vaccines across thousands of locations in more than 40 states. Before creating both of Curative's highly innovative business models, Fred founded and led a 16z and YC-backed diagnostics (Dx) startup that built a CLIA lab for validating and launching an STD testing product in Menlo Park, California.Things You'll Learn:High Deductible Health Plans (HDHP) are leaving insured individuals functionally uninsured, unable to afford out-of-pocket costs for care.Curative's unique model offers 120 days of no out-of-pocket cost for in-network care, promoting preventative care and simplifying health benefits.Employers experiencing rising insurance costs can benefit from exploring new options like those offered by Curative to better support their employees' health and well-being.The importance of making healthcare access and benefits clear and straightforward. Curative's approach yields an impressive 98% member engagement rate, demonstrating the effectiveness of its model in promoting proactive health management.Resources:Connect with and follow Fred Turner on LinkedIn.Follow Curative on LinkedIn and visit their website.
Do you know that prostate cancer is the second most prevalent cancer in American men, following skin cancer? A new diagnosis of prostate cancer occurs every two minutes. We are delighted to partner with Oxford Biodynamics for today's episode with Dr. Robert Heaton, who joins us to discuss a ground-breaking new prostate cancer screening test that predicts the risk of prostate cancer with 94% accuracy, using a simple blood test. Dr. Heaton is a board-certified pathologist. He completed his medical training at Georgetown University and then spent the next twenty years in the US Navy. After finishing his residency training in pathology, Dr. Heaton became the Director of Laboratory and Clinical Support Services for the National Naval Medical Center before joining various hospital pathology labs and life sciences companies. He is currently the Laboratory Medical Director for Oxford Biodynamics at their CLIA-certified clinical lab in Maryland, where he oversees the clinical operations of their liquid biopsy blood tests. In today's episode, we dive into the details of the innovative EpiSwitch Prostate Screening test, known as the PSE, designed to confirm the presence of prostate cancer, whether symptoms are present or not. This technological advancement is a game-changer! It empowers urologists by providing a precise tool to assess whether a patient should undergo a biopsy or opt for continued monitoring. Stay tuned to learn how this simple yet powerful tool streamlines the screening process for men struggling with prostate cancer. Disclaimer: The Prostate Health Podcast is for informational purposes only. Nothing in this podcast should be construed as medical advice. By listening to the podcast, no physician-patient relationship has been formed. For more information and counseling, you must contact your personal physician or urologist with questions about your unique situation. Show Highlights: At what age should men start getting checked for prostate cancer? What the screening for prostate cancer typically entails The importance of establishing a baseline to monitor how PSA changes over time Dr. Heaton dives into the details of the EpiSwitch PSA test How men can access the EpiSwitch PSA test Dr. Heaton discusses the accuracy of the EpiSwitch PSA test What is the expected turnaround time for the EpiSwitch PSC test results? Dr. Heaton explains the role of the Epi Switch PSA test in different scenarios The revolutionary EpiSwitch Prostate Screening test has remarkable accuracy in predicting prostate cancer risk through a simple blood test. It holds immense promise for men battling prostate cancer by providing urologists with a precise diagnostic tool and offering a streamlined approach for patients facing the complexities of prostate cancer. Links: Follow Dr. Pohlman on Twitter and Instagram - @gpohlmanmd Get your free What To Expect Guide (or find the link on our podcast website) Join our Facebook group Follow Dr. Pohlman on Twitter and Instagram Go to the Prostate Health Academy to sign up. You can access Dr. Pohlman's free mini webinar, where he discusses his top three tips to promote men's prostate health, longevity, and quality of life here. Oxford BioDynamics: Website LinkedIn Facebook Twitter: @oxbiodynamics and #OBD Instagram: @oxbiodynamics YouTube: @oxfordbiodynamics PSE: Website LinkedIn Facebook Twitter: (@94percent_com) Instagram: (@get_the_pse)
Unlock the mysteries of your skin's health and aging process in our enlightening conversation with Dr. Barbara Paldus PhD, founder of Codex Labs. Ever wondered how our DNA holds the keys to our body's functions, and how small genetic variants can have substantial impacts on our health? Dr. Paldus takes us on a captivating journey of understanding the world of genetics, exploring how single nucleotide polymorphisms can serve as markers for medical conditions.Get invaluable insights about Codex Labs' innovative DNA kits, 'Decode my Skin DNA' and 'Vitamins DNA,' that offer a comprehensive analysis of genes linked to skin conditions and vitamin deficiencies. Learn about the rigorous process of genetic testing, the evolution of sequencing, and the importance of CLIA certification for quality lab practices. Moreover, we delve into the vital role of medical professionals in prescribing tests and interpreting their clinical utility.We also tackle the fascinating relationship between genes and skin aging, highlighting the essential role vitamins play in skin health. Dr. Paldus shares compelling insights into the impact of specific genes on skin's health, the influence of environmental factors, and the importance of understanding our genetic predispositions. We also weigh the advantages and challenges of genetic testing, emphasizing the value of professional guidance in interpreting results. Pull up a chair and feed your curiosity about the intersection of genetics, skin health, and aging in this engrossing conversation with Dr. Barbara Paldus, PhD.Get 50% off for first 50 customers using the code TRYDNATEST50 when you visit www.codexlabs.comSupport the showFollow The Show On All Socials Using The Tag @skincareanarchy
EPISODE 154 - The Healing Power of Sex & Play Parties with Kelsey DarraghPersonal development, anxiety, mental health, breakups, and the healing power of sex and play parties. In this episode we talk about the healing power of Sex Parties and how they've impacted our lives for the better. We talk about how the least interesting thing at the play parties we go to is the sex! What? Yeah, and we'll tell you why. We also talk about breakups, dealing with anxiety, mental health, and some fun and juicy stories of how we met. Another topic we bring up is after care.. What's after care? What's your after care? Let's dive in. Kelsey Darragh is a comedian, writer and actress that has worked as a development executive at Buzzfeed, helping write, direct, produce and star in some of their most successful unscripted and scripted series. I am also a creator, author, and filmmaker focused on impact with taboo subjects like mental health, sex, and sobriety.Check her out: Website: kelseydarragh.comBook titled: Don't Fucking Panic! instagram.com/kelseydarraghNext retreat is March 2024 - www.dontpanicretreat.comDon't forget to get tested regularly Imaware: FULL STI TEST - With this test, you can take control of your sexual health and screen for ten key STI/STD biomarkers from the privacy of your home.Available Now - FREE SHIPPINGAll of our tests are performed by CLIA-certified, CAP-accredited labs, the gold standard in lab testing quality regulation Get $25 Off!!! Referral link: https://glnk.io/kowpr/sexybizbabe Discount code: SEXYBIZBABEConnect with me on IG - @sexybizbabe 5 Steps to Mind Blowing SEX ➡️➡️FREE Workshop & WAITLIST for my Signature Sexy Goddess Course - https://bit.ly/sexygoddesschallenge
Travel Agent Chatter | Starting and Growing Your Travel Agency
Welcome to Friday 15! In episode 131 Steph chats with April Swales, Director of Marketing & Sales from Uniglobe Travel Center about what a FIT is and how to specialize in it, getting an IATA & CLIA number as a new independent agent, and helping clients get a US Passports. Here's a list of helpful resources for today's episode: https://hostagencyreviews.com/friday15 (Submit questions, sign up for reminders for the F15, along with that week's questions we'll be covering!) https://hostagencyreviews.com/hostweek (Register for HAR's Host Week event!) https://hostagencyreviews.com/friday15 (Submit questions, sign up for reminders for the F15, along with that week's questions we'll be covering!) https://hostagencyreviews.com/blog/the-independent-travel-advisor-report-2023 (Indie report is out!) https://hostagencyreviews.com/survey (Sign up for survey reminders for 2024) https://hostagencyreviews.com/blog/travel-industry-terms (Get the free download for HAR's abbreviated travel industry glossary) https://hostagencyreviews.com/7DS-accelerator (Get the full travel industry glossary by signing on for our 7 Day Setup Accelerator course) https://hostagencyreviews.com/travelagentchatter/travel-agent-chatter-vol-8-madeline-jhawar-italy-beyond-the-obvious (Travel Agent Chatter podcast episode with advisor who does FIT vacations) https://hostagencyreviews.com/travelagentchatter/andres-zuleta-boutique-japan (Travel Agent Chatter podcast episode with advisor who does FIT vacations) https://hostagencyreviews.com/blog/travel-agent-commissions (Learn more about travel agent commissions) https://hostagencyreviews.com/page/travel-advisor-research-reports/ (HAR's research reports with data on income by niche, year, and lots of other good stuff!) https://hostagencyreviews.com/blog/travel-agency-accreditation (Learn more about accreditation option https://cibtvisas.com/ (CIBT Visas) https://travel.state.gov/content/travel/en/passports/how-apply/where-to-apply.html (Where you can apply for passports) https://hostagencyreviews.com/blog/travel-industry-lawyer-list (List of travel industry specific attorneys to help with your Terms and Conditions) https://hostagencyreviews.com/hosts/uniglobe-travel-center (Uniglobe's profile on HAR) https://www.uniglobetravelcenter.com/contact (Schedule a time to chat) Nov 10 (Levarte Travel), Nov 17 (TPI), Off for Black Friday https://hostagencyreviews.com/hostweek (Register for Host Week! It's free. It's fun. It's full of info to grow your agency!) We do this every week! If you have travel industry questions, HAR likely has an answer :) Submit your burning question here Har.News/Friday15 and join us this Friday (and every Friday!) at 12CT for travel agent tips!
Travel Agent Chatter | Starting and Growing Your Travel Agency
Welcome to Friday 15! In episode 129 Steph chats with Jenn Lee, VP Industry Engagement and Support for Travel Planners International about travel certification, hosting outside of the US, and developing your brand. A list of helpful resources for today's episode: https://hostagencyreviews.com/friday15 (Submit questions, sign up for reminders for the F15, along with that week's questions we'll be covering!) https://hostagencyreviews.com/hostweek (Register for HAR's Host Week event!) https://hostagencyreviews.com/blog/travel-agent-certification (Travel agent certification options, including Travel Institute, ASTA, CLIA) https://travellermade.com/ (Traveller Made, a European based consortium, changed its name to the much harder to remember and pronounce: Serandipians!) https://hostagencyreviews.com/hosts/departure-lounge (Departure Lounge takes advisors that are not US citizens that live in the following countries: USA, Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Holy See, Hungary, India, Ireland, Italy, Luxembourg, Monaco, Montenegro, Netherlands, Norway, Poland, Portugal, Puerto Rico, Spain, Sweden, Switzerland, Türkiye, United Kingdom of Great Britain and Northern Ireland, Virgin Islands (U.S.)) https://hostagencyreviews.com/hosts/1000-mile-travel-group (1000 Mile Travel Group takes advisors worldwide.) https://hostagencyreviews.com/blog/travel-agency-websites (A list of the different travel agency specific website programs, including Voyageur that Jenn mentioned, as well as some non-TA-specific ones) https://www.google.com/business/ (Sign up for Google My Business) https://girlbossdesigner.com/ (Offers web design and branding services + marketing courses to travel agencies) https://www.tiquehq.com/services (Copywriting and branding services for agencies) https://travelmarketingandmedia.com/website-in-a-weekend/ (Travel Marketing and Media has a website in a week program to help with copywriting and fully building out your website) https://hostagencyreviews.com/hosts/travel-planners-international (TPI's profile on HAR) https://www.facebook.com/groups/fiercelyforwardtraveladvisors/ (Fiercely Forward FB group for all advisors. Doesn't need to be a part of TPI) jennl@tpionline.com (Jenn's email) October 27th, (Outside Agents) Nov 3rd (uniglobe), Nov 10 (Levarte Travel) https://hostagencyreviews.com/hostweek (Register for Host Week! It's free. It's fun. It's full of info to grow your agency!) Submit your burning question here Har.News/Friday15 and join us this Friday (and every Friday!) at 12CT for travel agent tips! Join 30,000+ agents and subscribe to our newsletter: http://www.hostagencyreviews.com/newsletter
Aaron Godfrey of My Heritage joins us as we explore DNA, your history, and your heritage. We're also going to hear all about pickle ball evangelism from Christy Largent! Make sure you catch this unusual but exciting broadcast! Today's Sponsor Amaze Yourself with My Heritage. Uncover your ethnic origins and find new relatives with our simple DNA test. Go to lancewallnau.com/myheritage to save 55% today! "At MyHeritage, your privacy and the security of your data is as important to us as it is to you. We have made significant investments to ensure that your account and personal details are secured and protected by multiple layers of encryption. All testing is done in our world-leading CLIA-certified, CAP-accredited laboratory in the United States."
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