Podcasts about Breakthrough therapy

Remembering the anniversary of the fall of Baghdad THE INTERVIEW Kyle Hausmann-Stokes won the 2024 South by Southwest Audience Award for his directorial debut of the feature film "My Dead Friend Zoe," which he also co-wrote and produced. The film is a creative take on the post-war experience and a tribute to veterans of all generations. Hausmann-Stokes, who served as a paratrooper with the Army in Iraq, talks about the film, his military experience and how he helped co-found an organization for military veterans in the entertainment industry, Veterans in Media & Television, in the basement of American Legion Post 43 in Hollywood. SCUTTLEBUTT Veterans in Agritherapy - Celebrating Community Gardens week DOD commits $9.8 million to study psychedelics for active-duty troops Special Guest: Kyle Hausmann-Stokes.

The new Year is upon us! How about a fresh start by getting rid of those depression and anxiety-triggering old memories of negative events. If you have enough of feeling you are stuck in the past, and you want to know how to neutralize painful old memories, join us for an insightful conversation with expert guest Janet Bayramyan, LCSW.  In our chat we will delve into the world of EMDR (Eye Movement Desensitization and Reprocessing). In this episode, you'll discover: How EMDR works: Learn about the science behind EMDR and how it helps reprocess distressing memories. The benefits of EMDR: Understand why EMDR is effective for treating PTSD, anxiety, and other trauma-related conditions. The unique advantages of EMDR: Discover how EMDR stands out from traditional talk therapy, offering rapid results and a less retraumatizing approach. A personal transformation story: Hear firsthand how EMDR can positively impact your life and help you heal from trauma. The difference between talk therapy and EMDR. As you tune in you will gain valuable insights into this powerful healing technique and how EMDR can help you reclaim your mental well-being. New year, new you!  Interested in having an EMDR session with Janet? Look no further: https://www.instagram.com/therapy_with_janetb https://www.facebook.com/therapywithjanetb   Any questions or comments? Find Franz here: https://substack.com/@franzsidney   Topics Covered: EMDR, trauma, anxiety, PTSD, therapy, mental health, healing, personal growth, brain science   Did you enjoy this episode and would like to share some love?

There's an alarming shortage of neurologists in the United States. That shortage makes it hard to be seen by a neurologist and, in some regions of the U.S., you may not even find an MS specialist without having to travel hundreds of miles. The good news is now there's an app for that! Joining me to talk about how an app called BeCare is already changing the game when it comes to MS care is the Chief Medical Officer of BeCareLink, Dr. Charisse Litchman. The FDA has designated Tolebrutinib as a Breakthrough Therapy for the treatment of adults with non-relapsing secondary progressive MS. We're sharing the details. We'll tell you where you can participate in a phase 2 clinical trial that's designed to test the efficacy of Foralumab, an investigational disease-modifying therapy formulated as a nasal spray, among adults with non-relapsing secondary progressive MS. We'll share the details of a report that provides some frustrating data about out-of-pocket costs for MS prescription medications. Dr. Alicyn Magruder reviews the risks and benefits of using off-label medications to manage MS. And we'll share the results of a study that focused on how socioeconomic status impacts disease severity among kids and teens living with MS. We have a lot to talk about! Are you ready for RealTalk MS??! This Week: An app that can tell you if your MS is worsening   :22 FDA awards Tolebrutinib Breakthrough Therapy designation  1:04 Phase 2 clinical trial for Foralumab adds 6 additional sites  3:13 Study compares out-of-pocket costs of MS DMTs with meds for other neurologic conditions  5:55 Dr. Alicyn Magruder discusses using off-label medications to manage MS  9:51 Study analyzes the impact of socioeconomic status on disease severity in pediatric-onset MS  15:27 Dr. Charisse Lichtman explains how the BeCare MS app is changing the game and providing an important bridge to better MS care   19:52 Share this episode  30:53 Have you downloaded the free RealTalk MS app?  31:13 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/381 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com RealTalk MS on YouTube https://www.msif.org/webcast-clinical-trials CLINICAL TRIAL: A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients https://clinicaltrials.gov/study/NCT06292923 STUDY: Costs Are Still On the Rise for Commonly Prescribed Branded Neurologic Medications https://neurology.org/doi/10.1212/WNL.0000000000210029 STUDY: Association of Social Determinants of Health with Brain MRI Outcomes in Individuals with Pediatric Onset Multiple Sclerosis https://neurology.org/doi/10.1212/WNL.0000000000210140 Join the RealTalk MS Facebook Group https://facebook.com/groups/realtalkms Download the RealTalk MS App for iOS Devices https://itunes.apple.com/us/app/realtalk-ms/id1436917200 Download the RealTalk MS App for Android Deviceshttps://play.google.com/store/apps/details?id=tv.wizzard.android.realtalk Give RealTalk MS a rating and review http://www.realtalkms.com/review Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 381 Guests: Dr. Alicyn Magruder, Dr. Charisse Litchman Privacy Policy

Welcome back to The Integrated Man Project! I'm your host, Travis Goodman, and today we have a truly transformative episode lined up for you. We're diving deep into personal growth, healing, and the journey to reconnect with our true selves. Joining us is the incredible Sam Powers—a personal development coach, custom home builder, and dedicated father of three.In this heartfelt conversation, Sam opens up about his struggles with shame, feelings of inadequacy, and how these led to alcohol abuse and an emotional breakdown in 2020. We'll hear about the life-changing impact of his six-day intensive therapy workshop at On Site and his journey of rebuilding both his home and his emotional life.Together, we'll explore the pressures of evangelical and purity culture, the challenges of codependency, and the importance of empathy, vulnerability, and intentionality in the process of healing. Sam shares profound insights from his work on "primal questions" and offers practical advice on how men can embrace their emotional healing.HIGHLIGHTS: The Breaking Point and Redemption: Sam opens up about his emotional breakdown in June 2020, driven by shame and feelings of inadequacy, leading him to alcohol abuse. His turning point came through his wife's encouragement and attending a six-day intensive therapy workshop called On-Site. Codependency Unraveled: Reflecting on his past, Sam discusses how he discovered his codependent tendencies and worked diligently to address them. He credits Melody Beattie's book, "Codependent No More," as a critical resource during his recovery, allowing him to break free from unhealthy patterns and find authentic ways to cope. Primal Questions and Personal Growth: Sam introduces the concept of "primal questions" – core emotional needs stemming from childhood – and how asking these questions has transformed his approach to coaching and personal development. What's one question you need to answer about yourself to start your journey toward emotional healing and personal growth? Reflect on this and consider what steps you can take to seek the answers you need.So, sit back, relax, and get ready for a powerful and enlightening conversation that promises to inspire and empower you on your own journey to integration.SUPPORT THE SHOW:CLICK HERE!JOIN THE MAILING LIST & GET INVOLVED!CLICK HERE: MAILING LISTWATCH ON YOUTUBE:WATCH HEREConnect and Support Sam:Instagram: swamipowersWeb: www.sampowerscoaching.comConnect and Support Travis:YouTube: Travis GoodmanInstagram: @integratedmanprojectCheck out the Website: IntegratedManProject.com

Ken Mariash, CEO of Sinaptica Therapeutics, talks with EisnerAmper's TechTalk host Janina Teoxon about the novel approach his startup is taking to develop a non-drug therapy to treat Alzheimer's. In this episode, Ken acknowledges the repeated failures the industry has faced on its quest to find a cure for the disease and explains why his personalized and connectome-targeted neuromodulation approach has gained the FDA breakthrough designation. Learn how Ken and his team are overcoming investor skepticism as their promising treatment emerges.

This episode has themes of: Neuroplasticity, Mind/Body Healing, Psilocybin, Guided Healing, Breakthrough Therapy, Mindset, Intuitive Awareness, Self-Awareness, Deep Healing & Mental Blocks.Join Your New Era Academy today through the link below.Elisaunfilteredcoaching.com/group-coaching Tara is the founder of Arcadia Healing Sanctum, an emotional wellness and whole-body healing centre, that specializes in bridging clinical and traditional modalities to heal in one setting. Tara is a former paramedic of 9 years who broke the mold of her own limiting beliefs, toxic relationships, and trauma bonds with psilocybin, otherwise known as Magic Mushrooms.Learn more: https://www.arcadiahealing.caFollow her on socials: https://www.instagram.com/nudemushroomBuy here book NUDE on Amazon HERE!

Today's guest is Madeline from SIT WITH SELF, who helps grown-up good girls access authenticity, flow, and balance in their lives. Madeline and Amy discuss the journey of Sit With Self, from the very early DIY stages to the place she is today, the pitfalls of people-pleasing, the pressures of starting a business while balancing family, and how Madeline's engagement with Brand Universe Generator has helped her venture into the expertise and authenticity needed to attract her dream clients.BRAND UNIVERSE GENERATORFind Sit With Self Here– This podcast is created & produced on Darkinjung Land. Hosted & Produced by Amy Pearson from SUN MOTHER STUDIO. Original Music by J. Dale Pearson www.sunmotherstudio.com Find Amy on Instagram

Weight loss treatment has approval expanded; Paxlovid with Emergency Use Authorized label must be disposed of; psychedelic gets Breakthrough therapy designation; Advisory Committee announce meeting to discuss Alzheimer treatment; ALS treatment trial results

Over-the-counter birth control pill to be available in the coming weeks; first over-the-counter continuous glucose monitor to be available starting this summer; the 2024-2025 US influenza season vaccine will be trivalent; LSD granted Breakthrough Therapy for treatment of generalized anxiety disorder; interchangeable biosimilars to Prolia and Xgeva approved. 

Marine Corps veteran Juliana Mercer, Veteran Advocacy and Public Policy Director of Healing Breakthrough, discusses her work in advocating for the adoption of MDMA-Assisted Therapy in the U.S. Department of Veteran Affairs. Juliana talks about removing the stigma of psychedelics use, the experience of MDMA-assisted therapy, and the work her organization is doing to fulfill their mission of making this treatment available to veterans in the United States. Special Guest: Juliana Mercer.

Since there's an extra day on the calendar, we're taking the opportunity to introduce the newest members of the Tango Alpha Lima family. Host Stacy Pearsall introduces her new co-hosts, Army veteran Adam Marr and Navy veteran Joe Worley.

Cardiol Therapeutics CEO David Elsley joined Steve Darling from Proactive to share some significant news: the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the company's lead small molecule drug candidate aimed at treating pericarditis, including recurrent pericarditis. This designation is a major validation of CardiolRx's potential in addressing a debilitating heart condition. Elsley explained that recurrent pericarditis is a serious heart disease characterized by symptoms that significantly impact patients' quality of life and physical activity. The FDA's decision to grant ODD underscores the potential of CardiolRx to improve the lives of individuals suffering from this condition. MAvERIC-Pilot is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRx™ administered to patients with recurrent pericarditis. In addition to standard safety assessments, MAvERIC-Pilot is designed to evaluate improvement in objective measures of this rare disease. Orphan Drug Designation is granted by the FDA to drugs or biological products intended to prevent, diagnose, or treat rare diseases or conditions affecting fewer than 200,000 people in the United States. This designation offers several benefits to sponsors, including potential seven-year marketing exclusivity, exemptions from certain FDA fees, and tax credits for qualified clinical trials. Additionally, products with ODD may qualify for accelerated regulatory review through Fast Track, Breakthrough Therapy, or Priority Review designations. This milestone represents a significant advancement for Cardiol Therapeutics and its efforts to develop innovative therapies for cardiovascular diseases. With CardiolRx currently in Phase II clinical trials for recurrent pericarditis and acute myocarditis, the ODD from the FDA further strengthens the company's position in advancing treatments for these conditions #proactiveinvestors #cardioltherapeuticsinc #nasdaq #crdl #tsx #crdl #PericarditisTreatment, #OrphanDrugDesignation, #HeartHealth, #MedicalInnovation, #RareDisease, #HealthcareNews, #ClinicalTrials, #FDAApproval, #Biopharmaceutical, #InflammationTreatment, #MedicalResearch, #HealthTech, #PatientCare, #MedicalAdvancements, #HeartDiseaseAwareness, #PublicHealth, #HealthcareIndustry, #Cardiology, #MedicalBreakthroughs, #DrugDevelopment, #HeartMedicine, #HealthcareUpdates, #MedicalScience, #HealthcareTechnology #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from August 28, 2023 – September 8, 2023.  Please check back every Monday morning so that you can stay up to date. Here is information on the latest US FDA approvals, the week of August 28 –  September 8, 2023. Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast  Here are the highlights: Ilaris for Gout Flares in Adults: FDA approved Ilaris (canakinumab) for adult gout flares when other treatments failed; previously approved for CAPS and other diseases. Generics of ADHD Medication: FDA approved several generic versions of Vyvanse; Takeda's patent expired; medication was in short supply due to manufacturing issues. sNDA for Balversa in mUC: Janssen submitted sNDA for Balversa for urothelial carcinoma patients with specific genetic alterations; previously granted accelerated approval in 2019. INO-3107 for RRP: FDA granted Breakthrough Therapy designation for INO-3107 for recurrent respiratory papillomatosis caused mainly by HPV-6/11; Inovio to initiate a trial in 2024. Crovalimab for PNH: FDA accepted BLA for crovalimab as a treatment for PNH based on positive Phase III study results; potential approval expected late 2023/early 2024. Intro and outro music Garden Of Love by Pk jazz Collective

Top 5 Most Read RNS's on Vox Markets for Wednesday 26th April 2023 1. Supply @ME Capital #SYME - Commitment for first Inventory Monetisation from traditional funding. SYME has secured a binding commitment provided by an institutional investor to invest in the first IM using traditional funding sources, pursuant to the Company's action plan to work with a consortium of European investors to fund IM transactions with monetisable value of up to €5m, as announced on 20 January 2023. The Commitment provided by the Investor will be used by the StockCo to monetise up to €1.2m of warehoused goods of an Italian client company, which is one of the market leaders in the tyre re-treading sector with operations around the world. 2. Polarean Imaging #POLX - First order for XENOVIEW gas blend received Polarean Imaging announces that it has received its first order for a gas blend cylinder for the production of XENOVIEW from Cincinnati Children's Hospital Medical Center. XENOVIEW is the only hyperpolarised contrast agent approved by the U.S. FDA for use with magnetic resonance imaging (MRI) for the evaluation of lung ventilation in adults and paediatric patients aged 12 years and older. 3. hVIVO #HVO - FDA Breakthrough and Fast Track for US biotech hVIVO notes the announcements dated 13 April 2023 and 18 April 2023 from SAB Biotherapeutics (NASDAQ: SABS), reporting that the US FDA has granted Breakthrough Therapy and Fast Track designations for its investigational therapeutic for the treatment of seasonal influenza, SAB-176. hVIVO conducted a Phase 2a human challenge trial to assess the efficacy of SAB-176 using its Influenza Human Challenge Study Model. 4. Atlantic Lithium #ALL - International Lithium Association Membership Atlantic Lithium announce that it has become an Associate Member of the International Lithium Association (ILiA), the global trade association for the lithium industry. ILiA is a not-for-profit association based in London, founded in 2021 by some of the leading global lithium producers, at a time when the market for lithium was rapidly changing. Today more than 85% of the lithium industry is part of ILiA. 5. Alien Metals #UFO - Elizabeth Hill and Hancock Project Updates Alien Metals is pleased to deliver a maiden JORC compliant Mineral Reserve for the Company's flagship Hancock Iron Ore Project, situated in the prolific iron ore producing region of the Pilbara, Western Australia. Ore Reserve: 1.9Mt @ 60.2% Fe Updated JORC Mineral Resource Estimate (using a 58% cut off grade): o Indicated Resource 1.7Mt @ 61.0% Fe o Inferred Resource 7.4Mt @ 60.1% Fe o Global Resource 9.1Mt @ 60.3% Fe Inaugural declaration of Indicated Mineral Resources of 1.7 million tonnes ("Mt") @ 61.0% Fe

Moderna's Melanoma Vaccine has been granted "breakthrough therapy" status by the US Food and Drug Administration (FDA), paving the way for a rapid approval process in just six months. Advertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy

Podcast Description: More than 300 clinical thought leaders, pharma industry executives, and ophthalmology investors gathered recently in San Diego, CA, for OIS XII. In addition to announcing pivotal new data, presenters discussed drug and device innovations, advances in clinical trials, and how to gain or maintain a competitive edge in today's market.For this week's OIS Podcast, surgeon Ehsan Sadri, MD, co-founder of Visionary Ventures; and Sharon Bakalash, MD, PhD, founder and CEO of SB Strategic Development Consultants, sat down with an all-star cast of ophthalmology leaders. Here's a preview of the cast and what they talk about:·         Avellino CEO John Robson, on how he brings decades of experience analyzing data to eye care. He also explains how (and why) Avellino uses artificial intelligence and machine learning to fuel drug discovery—specifically, precision medicine therapies.·         Dompé's global head of medical and clinical affairs Georgea Pasedis, PharmD, gives an update on Dompé's neurotrophic keratitis product. She also talks about how the company uses the fourth-fastest supercomputer in the world.·         Tyler Stowater, partner and vice president of Bluestem, a private equity company based in Sioux Falls, SD, shares how the company mitigates losses in a down market, as well as his predictions for the next few months.·         Iveric Bio president Pravin Dugel, MD, talks about Iveric's Breakthrough Therapy designation for Zimura (avacincaptad pegol), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy.·         Mina Sooch, cofounder and CEO of Ocuphire Pharma, gives the scoop behind Ocuphire's exclusive license agreement with FamyGen Life Sciences and what it means for the eye care sector at large.·         Ranya Habash, MD, cofounder of MetaMed, takes Dr. Bakalash on a tour of the metaverse.The podcast also includes insights from Tarsier Pharma founder and CEO Daphne Haim-Langford, PhD, and Stuart Therapeutics president and CEO Eric Schlumpf.Click “play” to listen.

Guest:  Rebecca “Becca” Stoddard is a pediatric occupational therapist and owner of Breakthrough Therapy based in Phoenix, AZ. Becca is enthusiastic about working with children and their families to help them achieve their gross motor milestones. Becca has completed 2 courses on Dynamic Movement Intervention (DMI). She plans to complete a 3rd course at the beginning of the year. With experience in visor therapy settings, Becca uses both intensive DMI therapy and ongoing weekly DMI therapy at her practice. She also offers a free gross motor skills screening that can be done virtually, in person, and at home.  Interview: What is Dynamic Movement Intervention (DMI)? DMI is a specialized, hands-on technique focusing on head control, trunk control, and achieving gross motor milestones. Some of those milestones are rolling, sitting, balancing, crawling, standing, and walking. DMI exercises look different from the traditional therapy approach. Some exercises use gravity and a lot of sensory input to get automatic responses from the child to help them reach milestones. There is also a unique box set that is used as the child gets older and progresses. One of the main parts of DMI is an emphasis on neuroplasticity. That's a fancy term for creating new connections in the brain. The key factor in achieving this is repetition to create those new pathways.  How do I know if my child would be a good fit for DMI therapy? When a child exhibits gross motor delays, it can be things like the inability to hold their head up, not being able to roll, and the inability to maintain balance while sitting up. In a study, gross motor delays can occur in up to 68% of children with autism. Children with autism are more at risk of delayed gross motor skills.  What are some red flag diagnoses that might be indicated for gross motor delay?  There is a wide range of diagnoses that can include gross motor delay. Some of the main ones are cerebral palsy, spinal cord injuries, traumatic brain injury, gross motor delays, and development delays. Every child is different and can be a possible candidate that can benefit from DMI therapy.  What is an example of what DMI therapy may look like for a child?  One example could be putting a child in an inverted upside-down position to work on core strength. The brain will automatically want to be upright when in an inverted position. Putting a baby in that position will force the body to create the desired response to be upright. Another example would be an exercise focusing on walking and stepping up on a surface. The thigh would be supported as the child tries to step up onto a box. DMI support goes from proximal to distal. As the therapy progresses, the support will go from the hips to the thigh to the ankles.  What can a parent do at home to help their child strengthen and build gross motor skills?  Parents can take their children to the playground and practice going up steps without holding onto the railing. With a baby sitting on the lap, lean him/her backward, and give the baby a chance to try and sit up to build belly muscles that work out core strength. When laying down, aid the baby with holding him/herself up with his/her arms and exercises on the knees. A website Becca refers her clients to is pathways.org as a reference to what to expect maybe their child to be doing at certain ages.  Recap:  - Work on core strength - Encourage play in various positions - Physical play with toddlers and slightly older children    Resources: www.DMItherapy.com Pathways.org | Tools to maximize child development www.breakthrough-therapy.com Instagram: @breakthrough_therapy_dmi Article Reference Research reference: Hedgecock, J. B., Dannemiller, L. A., Shui, A. M., Rapport, M. J., & Katz, T. (2018). Associations of Gross Motor Delay, Behavior, and Quality of Life in Young Children With Autism Spectrum Disorder. Physical therapy, 98(4), 251–259. https://doi.org/10.1093/ptj/pzy006   Subscribe Now & Leave a Review Apple Podcasts, Spotify,  Google Podcast, &  Stitcher Visit our Website www.pureheartstherapy.com Follow Us: Facebook: Pure Hearts Therapy Facebook Group: Autism Family Resource Instagram: Purehearts_Therapy

Current ACOG/SMFM/CDC guidelines for the prevention of Group B Strep neonatal infection are aimed at prevention of early onset GBS neonatal disease. But late onset infections still occur worldwide and are devastating for the newborn. This is why there is a new Group B Strep (GBS6) vaccine in the pipeline! On September 22, 2022 the FDA granted this vaccine “Breakthrough Therapy designation”. In this session, we will review what that designation means, why this vaccine is needed, and where we are in the process.

Next stop...the Underground, in this part of the PsycheCity we will cover the latest stories coming out of the shadowy, often risky realm where people are actually acquiring and utilizing these compounds, while the Renaissance plows ahead with policy victories, Breakthrough Therapy designations, companies mushrooming all over the marketplace. The reality is the drug war continues and people are still going to jail around this stuff. The fact is, most citizens of the psychedelic city are acquiring these compounds they want or need, whether for medicines, sacraments, or just party favors. They're getting them on the darknet markets. Now I've listened to over 1000 hours of psychedelic pods. And I've heard barely a peep about this reality. So I think there's plenty of room for honest research and reportage about these dark net markets. There's plenty of stories that are really quite compelling that go beyond just the occasional drug bust or some fentanyl laced tragedy. There's stories that go to the heart of our technological civilization, because the technologies that empower these marketplaces via encrypted communications, cryptocurrency, the super secure Tor Browser. These tools embody essential practices for our data rich and privacy poor world and can give us insights into how we get off the grid of surveillance capitalism.

David Bronner is the CEO, or Cosmic Engagement Officer, for Dr. Bronner's. Family-owned and run, Dr. Bronner's makes socially & environmentally responsible products of the highest quality—all while dedicating their profits to help make a better world. David and the rest of the Bronner family are leaders that set an example of being human, and supporting humanity, at the core of everything they do. You can learn more and keep up with what Dr. Bronner's is doing by visiting their website. In this episode we discuss How Dr. Bronner's instigated a fight with the DEA over hemp, and won Why organic certification doesn't go far enough The most effective tool we have for fighting climate change The cultural norm we'll look back on as “cruel and unusual punishment” What Patagonia's founder believes is required reading for those who are serious about transforming business to help save our home planet Key Takeaways: I'm reminded by the Margaret Mead quote “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it's the only thing that ever has.” It's incredible to see the impact this one company, Dr. Bronner's, has made by committing to drive social and environmental change. Just imagine what the world would look like, if we all behaved as trusted stewards of the planet and humankind. As consumers, we can start demanding more than just organic. We can go further in our expectations of the food and products we bring into our homes. The ROA created the Regenerative Organic Certification by combining the best standards across soil health, animal welfare, and social fairness into a single certificate. With the objective to heal a broken system, repair a damaged planet, and empower farmers and eaters to create a better future through regenerative organic farming. Look out for the Regenerative Organic Certification on products you buy. The immense healing power in psychedelic therapy for PTSD, depression, anxiety and addiction. I'm very grateful for the support Dr. Bronner's has put behind advocating for this cause.  I'm also immensely grateful for the healing power psychedelic therapy had on me. Never forget the power of your own voice, to share your own story as a way to help shift the cultural conversation around psychedelic therapy or any other taboo topic. Also, never forget the power of your vote, to support causes you care about and create change. References Bronner's Six Cosmic Principles This case study examines codifying “steward-ownership” in Germany All-One or All-None: A Conversation with David Bronner and Gero Leson. Article in Los Angeles Review of Books by Ayize Jama-Everett. June 21, 2021 Regeneration International's page on Regenerative Agriculture Regenerative Organic Certification Rodale Institute Patagonia Demeter biodynamic certification Compassion in World Farming animal welfare organization Fair World Project fair-trade organization A Greener World page on Animal Welfare Approved certification Global Animal Partnership animal welfare certification Honor Thy Label: Dr. Bronner's Unconventional Journey to a Clean, Green, and Ethical Supply Chain by Gero Leson Multidisciplinary Association for Psychedelic Studies The Compassionate Use Act (California Proposition 215) The Emperor Wears No Clothes by Jack Herer FDA page on Breakthrough Therapy designation Psilocybin Program Initiative (Oregon Measure 109) Campaign to Decriminalize Nature DC Drug Addiction Treatment and Recovery Act (Oregon Measure 110) Bronner's Magic All-One Chocolate Theo Chocolate Maestrani Connect & Share: If you enjoy the podcast, would you please consider leaving a short review on Apple Podcasts/iTunes? It takes less than 60 seconds, and it really makes a difference in helping to convince hard-to-get guests. I also love reading them! If this episode resonated with you, I ask you to send it to a friend. Help bring even more visibility to these leaders that are using business as a force for good! Subscribe to the podcast to make sure you don't miss future episodes. This podcast is for you, the listener. I'd love to hear what resonated with you, or if you have a suggestion on who would be a great guest for this show. Please send me a note at info@KathyVarol.com. If you want to work with me to embed purpose into your business, go to www.KathyVarol.com

This week on A Tale of Two Hygienists TIPisode we are joined by Dr. Joy D. Void-Holmes, RDH, BSDH, MHSc, AADH to discuss Silver Diamine Fluoride and why you should think outside the box and incorporate a new product into your operatory. Dr. Joy is the founder of Dr. Joy, RDH and the creator of the Dental Hygiene Student Planner.   Episode Highlights Silver Diamine Fluoride  Think outside of the box Timeline of SDF Safety Benefits for Patients Off label uses Who is this for Quotes “Why would someone want to purposely blacken teeth?”    “In 2016 SDF received the Breakthrough Therapy designation by the Food and Drug Administration because of its ability to arrest decay.”    “This is the first oral health therapy to receive this designation.”    “That is 2x more fluoride than is found in fluoride varnish.”    “It's worth the extra step in my opinion for the patient to maintain a cosmetically pleasing smile.”    “⅓ patients suffer from dentinal hypersensitivity.”   “Approximately 50% of older adults suffer from root caries.”   “Early Childhood Caries is still the number one childhood disease in the world.”   “My math may not be exact but chances are ½ of the patients you see on a daily basis could benefit from Silver Diamine Fluoride.”    “My patients are worth it, and your patients should be too.”    Links  Follow Dr. Joy on Instagram  Follow Dr. Joy on Facebook Visit Dr. Joy's website More TIPisodes

This week on A Tale of Two Hygienists TIPisode we are joined by Dr. Joy D. Void-Holmes, RDH, BSDH, MHSc, AADH to discuss Silver Diamine Fluoride and why you should think outside the box and incorporate a new product into your operatory. Dr. Joy is the founder of Dr. Joy, RDH and the creator of the Dental Hygiene Student Planner.   Episode Highlights Silver Diamine Fluoride  Think outside of the box Timeline of SDF Safety Benefits for Patients Off label uses Who is this for Quotes “Why would someone want to purposely blacken teeth?”    “In 2016 SDF received the Breakthrough Therapy designation by the Food and Drug Administration because of its ability to arrest decay.”    “This is the first oral health therapy to receive this designation.”    “That is 2x more fluoride than is found in fluoride varnish.”    “It's worth the extra step in my opinion for the patient to maintain a cosmetically pleasing smile.”    “⅓ patients suffer from dentinal hypersensitivity.”   “Approximately 50% of older adults suffer from root caries.”   “Early Childhood Caries is still the number one childhood disease in the world.”   “My math may not be exact but chances are ½ of the patients you see on a daily basis could benefit from Silver Diamine Fluoride.”    “My patients are worth it, and your patients should be too.”    Links  Follow Dr. Joy on Instagram  Follow Dr. Joy on Facebook Visit Dr. Joy's website More TIPisodes

In July 2012, Congress created what is known as Breakthrough Therapy designation, a distinction that affords biotechnology and pharmaceutical companies an expedited review process for experimental drugs that may have treatment advantages over existing therapies for hard-to-treat diseases. In November 2013, Gazyva, a drug used in combination with chlorambucil for patients with chronic lymphocytic leukemia, made history as the first breakthrough therapy to receive FDA marketing approval. Since then, hundreds of drugs have earned the designation, and several have reached commercialization. An area that remains underrepresented on the FDA breakthrough therapy list that could make waves in the coming years is that of the emerging market of psychedelics, where companies such as Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (Profile) is striving to provide relief for patients with chronic pain by developing evidence-based innovation in areas where today's approved drugs and therapies are lacking. Tryp is part of a select group of companies that are advancing or have already advanced psychedelic treatments into Phase 2 of the FDA clinical trial process, a small collection of impressive companies that includes COMPASS Pathways Plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ), ATAI Life Sciences N.V. (NASDAQ: ATAI) and Cybin Inc. (NEO: CYBN) (OTCQB: CLXPF).

In July 2012, Congress created what is known as Breakthrough Therapy designation, a distinction that affords biotechnology and pharmaceutical companies an expedited review process for experimental drugs that may have treatment advantages over existing therapies for hard-to-treat diseases. In November 2013, Gazyva, a drug used in combination with chlorambucil for patients with chronic lymphocytic leukemia, made history as the first breakthrough therapy to receive FDA marketing approval. Since then, hundreds of drugs have earned the designation, and several have reached commercialization. An area that remains underrepresented on the FDA breakthrough therapy list that could make waves in the coming years is that of the emerging market of psychedelics, where companies such as Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (Profile) is striving to provide relief for patients with chronic pain by developing evidence-based innovation in areas where today's approved drugs and therapies are lacking. Tryp is part of a select group of companies that are advancing or have already advanced psychedelic treatments into Phase 2 of the FDA clinical trial process, a small collection of impressive companies that includes COMPASS Pathways Plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ), ATAI Life Sciences N.V. (NASDAQ: ATAI) and Cybin Inc. (NEO: CYBN) (OTCQB: CLXPF).

Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.

致幻药（psychedelic-drug）为何又受到资本热捧？ 就在不久前的 6 月 17 日，专注于研发治疗精神疾病致幻药的 ATAI 生物科技公司上市，估值 22 亿美元，其创立�至今才两年时间。而在 2020 年，同类公司 MindMed 和 Compass Pathways 早已相继上市。 听起来让人惊悚三分的致幻药，本质上是传统化工药，历史能够追溯到上古时期，被应用于现代医学治疗也已有几十年历史，但要真正用于治疗精神疾病，还有很长的路要走。本期节目，我们分别找来糊糊和Josh Wu深入探讨这个话题。 在节目前半部分，糊糊和我们一起梳理了致幻药的发展历史，学界/媒体对于致幻药的态度；下半部分，Josh 从更业内的角度为致幻药祛魅，并且介绍了几种经典的致幻药及原理，以及相关科研背景与商业化逻辑。 欢迎收听！ 加入我们 另外，声动活泼正在招聘「节目制作人」、「内容研究员 」、「内容营销负责人」、「业务拓展和合作管理总监/经理」以及「声音设计师」，查看详细讯息请在公号「声动活泼」回复暗号：入场券 。简历接收邮箱

A new portable radiation delivery platform system is available for some cancer patients with difficult to treat tumors. IU Health Physicians doctors Michael House, MD, and Ryan Rhome, MD, discuss a collaborative approach to Intraoperative Radiation Therapy in the OR.

The Coronavirus pandemic has put a spotlight on drug supply and the approval process for new medications. In this episode, we will define the different expedited drug approval processes, and take a closer look at how successful these programs are in identifying drug efficacy.   Guest speaker: Steven Lucio, PharmD, BCPS Senior Principal, Pharmacy Solutions Vizient   Moderator: Gretchen Brummel, PharmD, BCPS Pharmacy Executive Director Vizient Center for Pharmacy Practice Excellence   Show Notes: [01:25] Four mechanisms used by FDA to expedite approval of medications: Fast Track, Breakthrough, Accelerated Approval and Priority Review [01:54] Fast track and breakthrough help drug developers increase communications with the FDA to make approval process flow smoothly [02:14] The “Fast Track” designation [2:42] A “Breakthrough” designation – FDA will talk to you more, give advice   [3:18] Example of an Accelerated Approval [4:00] Accelerated Approval looks at a surrogate indicator of a disease state's ultimate outcome [4:33] “Priority Review” – FDA reviews drug within six months [5:19] Three reasons why pharmacists need to be aware of the approval programs [6:07] Expedited approvals are used for serious diseases [6:15] Analysis: In 2018, 81% of new molecular entities took advantage of at least one expedited program [6:38] Drugs that use expedited programs have fewer clinical studies and a smaller profile of how they work [7:20] Survey: 3/4th physicians didn't know what Breakthrough Therapy meant [7:57] Analysis of “Accelerated Approval” between 1992 - 2017 [8:44] Why you should know about the expedited drug approval processes   Links | Resources: JAMA Network: FDA Approval and Regulation of Pharmaceuticals, 1983 – 2018, Click Here JAMA Network: Physicians' Knowledge About FDA Approval Standards and Perceptions of the “Breakthrough Therapy” Designation, Click Here JAMA Network: Assessment of the Clinical Benefit of Cancer Drug Receiving Accelerated Approval, Click Here   Subscribe Today! Apple Podcasts Google Podcasts Spotify Stitcher Android RSS Feed  

Dr. Steve Kanes, Chief Medical Officer, Sage Therapeutics takes the view that mental disorders and brain health disorders need to be treated like any other medicine. Driving this paradigm shift is the development of breakthrough zuranalone, an oral limited-time treatment to replace taking medicine chronically for those suffering from major depressive disorder. Clinical trials are showing when people do experience recurrences of MDD and episodes are treated when they occur, there are long and prolonged benefits. @SageBiotech #depression #MajorDepressiveDisorder #MDD #postpartum  SageRx.com Listen to the podcast here.

Dr. Steve Kanes, Chief Medical Officer, Sage Therapeutics takes the view that mental disorders and brain health disorders need to be treated like any other medicine. Driving this paradigm shift is the development of breakthrough zuranalone, an oral limited-time treatment to replace taking medicine chronically for those suffering from major depressive disorder. Clinical trials are showing when people do experience recurrences of MDD and episodes are treated when they occur, there are long and prolonged benefits. @SageBiotech #postpartum #depression #MajorDepressiveDisorder #MDD SageRx.com Download the transcript here.

FDA approval to treat Post Traumatic Stress Disorder with MDMA is imminent, explained Betty Aldworth, Director of Communications and Events for the Multidisciplinary Association for Psychedelic Studies (MAPS).“We are on the precipice of filing that application to the FDA for approval of MDMA-assisted psychotherapy for PTSD,” Aldworth said.Indeed, several years ago the Food and Drug Administration designated MDMA-assisted therapy for PTSD a “Breakthrough Therapy,” which ensures that the FDA will work closely with MAPS to complete the Phase 3 trials currently underway. This would also fulfill MAPS’ aims to develop MDMA into an FDA-approved prescription treatment, a move Aldworth said would bring a great deal of relief to those suffering from PTSD as well as other mental health conditions. “What we are seeing right now is an acknowledgment that psychedelics might fundamentally change the way we think about mental health conditions,” Aldworth explained. “It may offer us a window into treating these conditions by giving people the tools to work with to get to the core of the issues that are causing them, whether it’s PTSD, depression, or anxiety since many of these things are very much connected.” MAPS is also are studying whether MDMA-assisted psychotherapy can help heal the psychological and emotional damage caused by sexual assault, war, violent crime, and other traumas including anxiety related to life-threatening illnesses.“We are looking at psychedelics as a catalyst to provide people with a new way of looking at themselves and the elements of their lives that are causing them stress and anxiety, with the hope that we might be able to fundamentally shift how we’re treating mental health within the western paradigm,” Aldworth said. 

The psychedelic medicine revolution was born when the FDA gave Psilocybin the coveted ‘Breakthrough Therapy' label as a mental wellness treatment. David Nikzad of E.i. Ventures discusses the scientific research and development of psychedelic based treatments for mental health disorders, and the financial aspects behind the next possible green rush. David is the co-founder of Emotional Intelliengence Ventures, a life and plant sciences company focused on bringing botanical psychedelic therapies. like medicinal mushroom products to the market. 

This week, the top managed care news included FDA advising against changes to vaccine dose schedules; drop in mammography screenings during the first months of the pandemic; first anti-TIGIT therapy granted Breakthrough Therapy designation by the FDA.

CSE's Barrington Miller chats with Michael Frank, CEO of Revive Therapeutics Ltd. (CSE:RVV) about his company's ambitions to enter Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19.Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injuryfrom organ transplantation. Related linkshttps://revivethera.com/https://thecse.com/en/listings/life-sciences/revive-therapeutics-ltd

Это аудио-версия моей статьи, текстовую версию которой можно прочитать здесь: http://bit.ly/2BaGi0a ССЫЛКИ - Сеть кофеен "Coffee-in-Action" - Арнольд Людвиг, американский психиатр - Карл Юнг, швейцарский психиатр, основоположник аналитической психологии. - "Аяуаска - для пережитого нет кнопки "Undo", статья - "Everything You Want to Know About Microdosing", статья - "How MDMA Went From Club Drug to ‘Breakthrough Therapy", статья - "Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer", научная статья - "Taking Psychedelics Seriously", научная статья - "The trip treatment", статья The Newyorker - "Can Mushrooms Treat Depression?", статья the New York Times КОНТАКТЫ Александр Лядов: Facebook | Twitter | Linkedin | Telegram | Medium Остальные эпизоды подкаста: http://alyadov.com/podcast/ Все текстовые статьи: https://medium.com/@AlexanderLyadov О ПОДКАСТЕ Подкаст является частью “In-between” — проекта об искусстве жить между Хаосом и Порядком. Для этого я исследую жизнь с разных точек зрения — бизнес, семья, здоровье, спорт, психология, общество. Своими догадками и находками я делюсь через статьи, аудио-подкаст и видео-блог.  ОБ АВТОРЕ Как бизнес-терапевт, я помогаю предпринимателям быстрее ориентироваться в нестандартных ситуациях. Подробнее о моем опыте и бизнес-терапии можно прочитать здесь. Если вы в бизнесе столкнулись с новой, нестандартной ситуацией, то возможно вам пригодится мой “Чек-лист предпринимателя." ПОДПИСАТЬСЯ Чтобы не пропустить новые эпизоды, вы можете оформить подписку на мой подкаст. На компьютере это можно сделать через  каталог подкастов в iTunes Store. В айфоне для этого нужно скачать эппловское приложение "Подкасты" (Podcasts). В Андроиде нужно установить бесплатное приложение Google Podcasts, Stitcher, SoundCloud или их аналог. Затем в разделе «поиск» в приложении нужно найти подкаст "In-between with Alexander Lyadov» и нажать кнопку «Subscribe», то есть «Подписаться". Тогда каждый новый эпизод автоматически закачается на ваш телефон в момент публикации и вы сможете его слушать в дороге, в пробке или во время прогулок.

My guest today is, Dr. Jessi Sigander, creator of Brain Breakthrough Therapy and ACT Parenting. We discuss how trauma affects the brain and how learning disabilities, anxiety, and other common problems can also be caused by trauma. She explains how Brain Breakthrough Therapy helps to rewire the brain, and she gives us some practical tips for dealing with anxiety and parenting children with anxiety. You won't want to miss it. @ACT Parenting Community   Coupon Code for Parenting in an Anxious World Course- Awaken20 Contact Dr. Jessi Sigander nfo@thebrainbreakthrough.com https://l.facebook.com/l.php?u=https%3A%2F%2Fwww.instagram.com%2Fbrainbreakthroughtherapy%2F%3Ffbclid%3DIwAR1rsS-KvzUQu3uwr7MHCaArV-JO-kojju7uPn5ceFk0Q113c45bvF7Dr_A&h=AT20MwzGuDhohTJGYwPTH38Hu8-QhdqbIoidbDmmL9BxCEQyA9MdkofiNPkRxcR9IP48KVr514pK-XgKOKP8CL8q6LLoRRaSRVKxdqrMpZknwXvvaEfrR4aSvdOGSX-bheymvg5I2EzdTRKlrDs   https://l.facebook.com/l.php?u=https%3A%2F%2Fwww.instagram.com%2Fbrainbreakthroughtherapy%2F%3Ffbclid%3DIwAR1rsS-KvzUQu3uwr7MHCaArV-JO-kojju7uPn5ceFk0Q113c45bvF7Dr_A&h=AT20MwzGuDhohTJGYwPTH38Hu8-QhdqbIoidbDmmL9BxCEQyA9MdkofiNPkRxcR9IP48KVr514pK-XgKOKP8CL8q6LLoRRaSRVKxdqrMpZknwXvvaEfrR4aSvdOGSX-bheymvg5I2EzdTRKlrDs https://www.facebook.com/groups/ACTParentingCommunity/ Contact me: https://melissaoatman.com melissaoatman77@gmail 636-748-4943   Purchase my new book: https://www.barnesandnoble.com/w/beautifully-broken-melissa-oatman/1136174371?ean=9781989579060 https://www.amazon.com/Beautifully-Broken-Spiritual-Thriving-Surviving/dp/198957906X https://www.goodreads.com/book/show/50977070-beautifully-broken   Follow me on social media: https://www.facebook.com/reikiwithlissa/ http://www.instagram.com/melissaoatman222   https://www.youtube.com/channel/UCQPtU9hPeEWjbHr62LxuEXA   Donations are not necessary, however, if you feel inclined to donate to my channel through Venmo or PayPal, your energetic gifts are very much appreciated! Venmo @Melissa-Ann-161 PayPal: melissaoatman77@gmail.com

Humans have consumed psychedelics for at least the last 10,000 years. The outlawing of psychedelics in most of the world in the 20th century didn’t stop that, but it did put an end to promising research into their psychotherapeutic applications to treat depression, addiction, PTSD, anxiety, and trauma. Today, we’re in the midst of a psychedelic renaissance, with some psychedelics fast on their way to becoming legal medicines. One of the key players behind this movement is Rick Doblin, Ph.D.. In 01986, he founded the Multidisciplinary Association of Psychedelic Studies (MAPS), a non-profit research and educational organization that has developed the medical and legal framework for the use of psychedelics to treat mental health conditions. MAPS has distributed over $20 million to fund psychedelic research and education, and in 02017 won fast-tracked “Breakthrough Therapy” designation from the FDA for using MDMA-assisted psychotherapy to treat Post-traumatic stress disorder (PTSD). With legalization now in sight, what is the future of psychedelic medicine? Rick Doblin, Ph.D., is the founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS). He received his doctorate in Public Policy from Harvard’s Kennedy School of Government. His life’s work is to develop legal contexts for the beneficial uses of psychedelics.

Can a medicated Everett make it through one episode with a transfeminine co-host without getting cancelled?In this episode of Mythic Politics we talk about the president of Brazil's bizarre Leonardo Dicaprio conspiracy, the Trump administration's immigrant entrapping fake colleges, we call BS on Beck claiming he was never a Scientologist, and cheer the FDA declaring Psilocybin a breakthrough therapy for major depression.We make up some new words, and we talk about what would happen if the Zodiac Killer Ted Cruz fought Nikola Tesla in a conspiracy deathmatch. Finally, we settle for once and all if Trump should be impeached.Links Mentioned:Brazil’s president claims DiCaprio paid for Amazon fires ICE arrested 250 foreign students enrolled in the government’s fake university Beck Claims He Was Never a Scientologist. Leah Remini and Others Are Calling BS. Psilocybin for major depression granted Breakthrough Therapy by FDA Look sharp and support the show by getting our new Hinagon tee! Follow Mythic Politics:Subscribe to our clip channel! Get email updates Support us on Patreon Follow us on FacebookFind us on TwitterPeep us on InstagramSubscribe on YouTubeVibe with us on Soundcloud Stream us on Spotify...Stich us on SticherSupport the show (https://patreon.com/mythicpolitics)

The fifth installment of Ropes & Gray's podcast series, Non-binding Guidance, is the first part of a two-episode discussion of FDA expedited review programs. In this episode, Ropes & Gray lawyer Greg Levine interviews his partner Kellie Combs, who provides an overview of the four expedited review programs for drugs and biologics: the Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval programs. These programs, which are broadly intended to address unmet needs in the treatment of serious or life-threatening conditions for which existing therapies are insufficient, are associated with significant benefits for manufacturers, such as earlier and more frequent FDA interactions, streamlined clinical development requirements, and a shorter FDA review clock—all of which may accelerate time to market and improve the bottom line. In this episode, Kellie discusses the eligibility criteria and benefits associated with each program, and describes timing and other practical issues for product manufacturers to consider. Tune in to this discussion to learn more about the expedited review programs and how to secure the benefits. Next week, we'll release the second episode of this two-part series, which will focus on the Breakthrough Devices Program. Please stay tuned.

Liana Sananda Gillooly is a lifetime activist for social justice, drug policy reform, ending war, and the environment. She is the Development Officer at Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is the largest non-profit investigating the therapeutic uses of psychedelics. Currently, we are in Phase III FDA trials utilizing MDMA Therapy to treat PTSD. Results have been so promising, it earned the designation of Breakthrough Therapy from the FDA. In addition to her role at MAPS, Liana is engaged in transformational technology movement, with an interest in VR/AR therapy and emergent blockchain technologies. To highlight the connection between the psychedelic and cryptocurrency community, she instigated the formation of CryptoPsychedelic, an event series that kicked off last February in Tulum and gathers together these communities all over the globe. Before joining MAPS, Liana worked as Outreach Manager for a prominent cannabis investment and market research firm, The Arcview Group, where she helped grow the accredited investor network, advocated for legalization, and supported the work of Marijuana Policy Project. She has worked in event, festival, and film production, as well as artist representation, art curation, and art creation. She owned a visionary art gallery in Venice Beach, California, called Sananda Gallery. She has produced fundraisers, parties, and art happenings for special events and festivals, including High Times Cannabis Cups, MAPS conferences, Envision Festival, Serenity Festival, and Fractal Planet at Burning Man. She has been a featured speaker at numerous events, lobbied Congress, lectured MBA students, and given a TedX talk. She is an experienced meditator and trained death midwife. LianaSananda on Instagram MAPS.org

Dr. Robert A. Beardsley or "Al" is a Co-Founder and the Chief Operating Officer at Galera Therapeutics, a clinical-stage biotech company discovering and developing innovative cancer treatments. Al is interested in developing new drugs that target how oxygen is metabolized in cells. In particular, Al and the team at Galera Therapeutics are working to develop therapeutics to use with radiation therapy that will block the processes that cause damage to normal tissue while also increasing damage to the tumor. While Al is passionate about science and drug development, he also enjoys watching soccer, coaching soccer, being outdoors, and hiking in the mountains in his free time. Al received his BS in Chemical Engineering from the University of Iowa, an MBA in finance from the University of Chicago, and subsequently his PhD in Biochemical Engineering from the University of Iowa. Prior to co-founding Galera Therapeutics, Al served as CEO at Metabolic Solutions Development Corporation, CEO of Kereos, acting CEO at Metaphore Pharmaceuticals, and he has held various roles at Confluence Life Sciences, SImile Investors, bioStrategies Group, and Vector Securities International. Galera Therapeutics’ new drug Abasopasem Manganese has been designated as a “Breakthrough Therapy” by the FDA for reduction in the duration, incidence, and severity of oral mucositis induced by radiation therapy in cancer patients. Recently, Al and the team at Galera Therapeutics raised $150 million in investment for their company, which represents the largest single capital round ever raised by a life-sciences company founded in St. Louis. In this podcast interview, Al spoke with us about his experiences in life and science.

Dr. Dennis Riley is Co-Founder and Chief Scientific Officer at Galera Therapeutics, a clinical-stage biotech company discovering and developing innovative cancer treatments. He is also an Adjunct Professor of Chemistry at Washington University in St. Louis. Dennis and his colleagues have been developing synthetic enzymes that target undesired or toxic metabolic byproducts. One compound Dennis has developed protects healthy tissue from radiation damage during cancer treatment. When he’s not doing work, Dennis enjoys mountain biking, golfing, and amateur astronomy. He earned his Bachelor’s degree in chemistry and mathematics from Heidelberg College and his PhD in inorganic chemistry from The Ohio State University. Afterwards, Dennis conducted postdoctoral research at the University of Chicago. Dennis began his career working in research and development with Proctor and Gamble, and he spent much of his career working at Monsanto where he held the positions of Senior Science Fellow and Manager of Metal-Mediated Chemistry. He subsequently served as Vice President of Research at Metaphore Pharmaceuticals and Senior Vice-President at the start-up company Kereos before co-Founding Galera Therapeutics. Dennis is an elected Fellow of the American Association for the Advancement of Science and he has received the American Chemical Society St. Louis Section’s Chemist of the Year Award. In addition, Galera Therapeutics’ new drug GC4419 has been designated as a “Breakthrough Therapy” by the FDA for reduction in the duration, incidence, and severity of oral mucositis induced by radiation therapy in cancer patients. In this podcast interview, Dennis spoke with us about his experiences in life and science.

Help support the show! - http://www.patreon.com/dailyinternet   Merchandise! - https://teespring.com/stores/the-ireadit-emporium   #10 - Psychedelic psilocybin therapy for depression granted Breakthrough Therapy status by FDA   #9 - Active shooter reported at Pittsburgh synagogue   #8 - Obama: 'There's a pattern' of Republicans running the economy 'into the ground' and Democrats having to 'come back and clean things up'   #7 - School boy takes MICROWAVE to school to carry books after school bans bags   #6 - Man arrested for groping woman on flight says 'President says it's OK to grab women's private parts'   #5 - Surveillance footage shows Saudi operative in Khashoggi's clothes after he was killed, Turkish source says Turkish drone Footage shows Saudis burning documents at consulate 1 day after Khashoggi's disappearance Killed journalist Jamal Khashoggi's children are reportedly barred from leaving Saudi Arabia, some are dual US citizens The son of murdered journalist Jamal Khashoggi has left Saudi Arabia after the travel ban was lifted   #4 - Mom with 'gut feeling' stops school shooter before planned attack   #3 - U.S. spy agencies have determined that Russia and China are eavesdropping on President Trump's personal phone calls in order to gain information that they can use to influence American policy Obama: If Republicans really cared about Clinton's emails they would be 'up in arms' over Trump's iPhone   #2 - Explosive Devices Found in Mail Sent to Hillary Clinton and Obama   #1 - Teen Climate Activist to Crowd of Thousands: 'We Can't Save the World by Playing by the Rules Because the Rules Have to Change'   Connect with us:   Patreon: http://www.patreon.com/dailyinternet   Website: http://mjolnir.media/ireadit Subreddit: http://www.reddit.com/r/ireaditcast   Facebook: http://www.facebook.com/ireadit YouTube: https://www.youtube.com/channel/UCZXcQHg5RGMinTm5_yLOGVg   Instagram: https://instagram.com/ireaditcast Twitter: http://twitter.com/ireaditcast   E-mail: feedback.ireadit@gmail.com Voicemail: (508)-738-2278   Michael Schwahn: @schwahnmichael Nathan Wood: @bimmenstein

This month on The BloodStream Podcast, Nabila Husseni from Gujarat, India shares her story of living with Factor V deficiency and championing women’s equality, Natalie presents a recent NBC story on the rise of depression, we discuss Takeda’s acquisition of Shire, and Hope For Hemophilia founder Jonathan James joins us for the Interview Segment. All that and more on Episode 24 of The BloodStream Podcast! Exclusive Sponsor: Shire Latest Ask The Expert Podcast: Episode 14 - Physical Therapy  Latest Powering Through Podcast: Episode 16 - HANY's Family Education Conference Like Segment: Major depression on the rise among everyone, new data shows // Depression Symptoms   Share Segment: Nabila Husseni- Strength Comment Segment: Japan's Takeda clinches $62 billion Shire Deal Interview Segment: Hope for Hemophilia   Community News in 60 Seconds: Hemlibra Named a Breakthrough Therapy for Hemophilia A Without Inhibitors On World Hemophilia Day, Bioverativ Shares Success Stories from the Developing World CRISPR “One Shot" Cell Therapy for Hemophilia Developed Gene-Editing Study in Monkeys Sets Stage for Further HIV Cure Research Gene Therapy Injected Into Dog Muscle Fares Well in Hemophilia B Study Hemophilia therapy could be first drug with $1M price tag: 3 things to know Seattle Plans to Build an AIDS Memorial Called The AMP   BloodFeed: https://www.bloodfeed.com Connect with BloodStream: Email mailbag@bloodstreammedia.com Find all of our bleeding disorders podcasts on BloodStreamMedia.com BloodStream Facebook Page BloodStream Twitter Account Subscribe to BloodStream: iTunes: http://bit.ly/bloodstreamitunes Stitcher: http://bit.ly/bloodstreamstitcher LibSyn: http://bit.ly/bloodstreamlibsyn SoundCloud: http://bit.ly/bloodstreamSC TuneIn: http://bit.ly/bloodstreamtunein Google Play: http://bit.ly/bloodstreamPlay Spotify: http://spoti.fi/2nNPhui

The FDA keeps approving drugs that have been tested on groups of patients that are not really diverse and this is a problem. Listen in and find out why.    Show note links: Drug Trials Snapshots page from the FDA's website where you can learn about what these snapshots are about, how to use them, snapshot limitations and sort the table of snapshots to find the newest drugs that made the list in 2018 (so far) 2017 Drug Trials Snapshots Summary Report  2018 new drug FDA approvals mentioned in this episode: Akynzeo Crysvita Tavalisse Ilumya Trogarzo Erleada Symdeko Biktarvy Lutathera   *****BONUS links: USA Today article on the Tuskegee Syphilis Study 45 Years Later The FDA's press announcement (released March 2018) on the new drug approval for Trogarzo which was approved based on clinical data results of 40 patients via Fast Track, Priority Review, Breakthrough Therapy designation and Orphan Drug status Join our private Facebook group - Consumers Unite!

It's a new year and we have a lot to talk about! There's good news about new clinical trials...the FDA has given a "Breakthrough Therapy" designation for the first MS treatment approved for children and teens living with MS...UCLA researchers have identified why estrogen seems to have real potential as a treatment for MS...prices for some MS drugs are going up...pharmaceutical companies are suing the state of California over prescription price transparency...and host Jon Strum will tell you why the pace of scientific discovery is going to increase in 2018. Are you ready for some RealTalk MS?

Katee Verhoef and Corbin Weaver, from the new show The Vagibonds Podcast are in the studio to talk about their work discussing feminism through the OB/GYN student lens, as well as how they never introduce their co-host who just happens to be familiar to the SCP audience. Plus, we explore the taste of medications. Right out of the research lab, they usually taste gross. This is why pharmaceutical companies go to a lot of effort sweetening them up, otherwise you'd throw up instead of being soothed. But Dave suspects that Big Pharma hasn't fully considered the possibilities for how medicine should taste, so he devises one of his 'experiments' to test whether medicine should taste like ham and gravy baby food instead. Katee, Corbin, Elizabeth Shirazi and Hillary O'Brien help Dave test this medical marketing breakthrough (psst, GSK, call us!). And listeners Evelyn and "Maynard" wrote in with feedback and questions for The Short Coats. And Ryan Gray, MD of the Specialty Stories Podcast wrote in offering a clarification of our answer to Terel's recent question. Perhaps a bigger breakthrough, however, is the news that the FDA is willing to consider evidence that MDMA (or ecstasy) could be a "Breakthrough Therapy" for the treatment of post-traumatic stress disorder. And what about the new genetically engineered T-cells designed to seek out and destroy childhood leukemia, which the FDA has actually approved? What experiments should Dave inflict on his co-hosts next? Do you want to call us out on some bogus thing we said? Call us at 347-SHORTCT anytime, visit our Facebook group, or email theshortcoats@gmail.com. Do all three!

Download In this episode, Joe and Kyle discuss the difference contexts of psychedelic use: Therapeutic Recreational Psychospiritual & Self-Discovery Ceremonial & Shamanic While these categories can be flexible and sometimes merge into one another, we thought that it would be important to give context to the variety of experiences. As MAPS has just received "Breakthrough Therapy" status on the MDMA-assisted psychotherapy research, this is an exciting time for research and therapeutic use of a powerful medicine. However, there may be some confusion about how the therapeutic approach is different from some of these other contexts and ways of using psychedelics. While we believe that all contexts are valid or legitimate and each carry their own risk/benefit, we thought that it would be helpful and fun to talk about our views about this subject. Become a Patron!https://c6.patreon.com/becomePatronButton.bundle.js If you want to learn more about navigating the psychedelic experience or learn more about safety guidelines for these different contexts, check out our new online course, "Navigating Psychedelics: Lessons on Self-Care & Integration." Useful Texts & Resources Coyote Medicine: Lessons from Native American Healing Coyote Wisdom: The Power of Story in Healing LSD Psychotherapy LSD: Doorway to the Numinous The Road to Eleusis: Unveiling the Secret of the Mysteries Psychedelic Explorers Guide Ayahuasca in My Blood: 25 Years of Medicine Dreaming  Show Notes/Links Opium Wars Safe Injection Sites - Denver Greek / Eleusinian Mysteries

Office of Pharmaceutical Quality Director Michael Kopcha discusses the allure of coming to FDA from the private sector and working with CDER Director Janet Woodcock, OPQ’s role in the “Breakthrough Therapy” designation process, the competitive advantages of continuous manufacturing, and priorities for OPQ moving forward.

Induced After-Death Communication IADC is a new therapy for grief and trauma that has helped thousands of ordinary people come to terms with their grief by allowing them the experience of private communication with their departed loved ones. It has been called one of a few major breakthroughs in psychology in the last 100 years. IADC offers hope, comfort and a new kind of peace of mind. Since his 1995 discovery of IADC while using Eye-Movement Desensitization and Reprocessing therapy EMDR for counseling a Vietnam vet, Allan Botkin, a clinical psychologist, has honed his treatment and taught the procedure to therapists around the country. While IADC does not directly address all post traumatic stress disorders, it can address the most deeply painful feelings of sadness and disconnect from the deceased and resolve interpersonal problems and unfinished business with forgiveness. IADC can heal the deep sadness, and sense of grief even for lost pets.

Teragram Therapy was created by Dr Margaret Rogers Van Coops. It was the first of her Breakthrough Therapy treatments that became widely acclaimed as a healing tool integrating the energy of crystal stones and the energy of the Five Bodies of the Human entity. In this show, she describes the beauty and simplicity of this awesome therapy and shows how … Read more about this episode...