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Send us a textKetamine has been in the news a lot lately and there are a lot of misconceptions about how this medicine is used for the treatment of mental health conditions. Is it safe and effective? Is it addictive? Is it a psychedelic? What's the difference between ketamine and the FDA approved depression medicine, Spravato? In today's episode of the Psychedelic Therapy Frontiers podcast, we discuss the history and clinical applications of these two medicines as we attempt to answer these important questions.For those of you who are new to the show, welcome! Psychedelic Therapy Frontiers is brought to you by Numinus Network and is hosted by Dr. Steve Thayer and Dr. Reid Robison.Learn more about our podcast at https://numinusnetwork.com/learn/podcast/Learn more about psychedelic therapy training opportunities at https://numinusnetwork.com/training/Learn more about our clinical trials at https://www.numinusnetwork.com/researchLearn more about Numinus at https://numinusnetwork.com/Email us at ptfpodcast@numinus.com Follow us on Instagram: https://www.instagram.com/drstevethayer/https://www.instagram.com/innerspacedoctor/https://www.instagram.com/numinushealth/
Novi lijek protiv depresije pokazuje dobre rezultate. Lijek se zove Spravato, hemijski je srodan ketaminu i donosi nadu mnogima koji žive s hroničnim mentalnim bolestima, i ono što je još važnije, lijek će biti uvršten na listu farmaceutskih beneficija, pa njegova visoka cijena neće više biti prepreka u dostupnosti.
Thuốc đặc trị trầm cảm Spravato được đưa vào PBS – Chương trình Trợ giá Dược phẩm, giá khoảng $800 một liều duy nhất, giảm còn $31,60 hoặc $7,70 cho người về hưu và người có thẻ giảm giá.
In this episode of The Psychedelic Podcast, Paul F. Austin welcomes Sam Mandel, co-founder and CEO of Ketamine Clinics Los Angeles (KCLA). Find full show notes and links here: https://thethirdwave.co/podcast/episode-301-sam-mandel/?ref=278 Sam shares his journey co-founding KCLA with his father in 2014, pioneering ketamine infusion therapy when few were exploring its potential for mental health. From humble beginnings in a storage closet to becoming a leading mental health center with over 30,000 infusions administered, Sam discusses the challenges and triumphs of building a patient-centric practice. He explains the science behind ketamine's effectiveness compared to alternatives like Spravato, highlights the importance of individualized treatment, and offers a passionate critique of the current mental healthcare system while envisioning what meaningful reform could look like. Co-founder & CEO of Ketamine Clinics Los Angeles (KCLA), Sam Mandel has channeled his lifelong passion for healthcare advocacy into transforming mental health care. From volunteering at a teen-to-teen suicide prevention hotline at twelve to pioneering one of the foremost Ketamine Infusion Therapy clinics in 2014 alongside his father, Dr. Steven L. Mandel, Sam has been featured in Entrepreneur's Top 10 Inspiring Healthcare Entrepreneurs (2023) and earned two 2024 Stevie Awards. Under his leadership, KCLA has provided over 30,000 infusions to more than 6,000 patients with an 83% success rate, establishing gold-standard treatment protocols while expanding services to include General Psychiatry and TMS therapy. Highlights: The founding story of KCLA and early skepticism from the medical community Why IV ketamine outperforms nasal Spravato in efficacy and cost-efficiency Creating individualized ketamine protocols for optimal patient outcomes How insurance companies create barriers to effective mental healthcare KCLA's 83% success rate compared to 50-70% in controlled research settings Expanding from ketamine to TMS and general psychiatry Preparing for future psychedelic medicines like MDMA and psilocybin The critical flaws in America's mental healthcare system Episode Links: Ketamine Clinics Los Angeles (KCLA) The difference between Ketamine and Spravato (esketamine) Third Wave's Ultimate Guide to Ketamine Episode Sponsor: Psychedelic Coacing Isntitute's Intensive for Psychedelic Professionals in Costa Rica - a transformative retreat for personal and professional growth.
Solvonis Therapeutics PLC CEO Anthony Tennyson talked with Proactive's Stephen Gunnion about the company's transformation and its strategy moving into 2025. Tennyson explained that the company, formerly known as Graft Polymer, exited its industrial plastics business in 2024 to focus entirely on biotechnology, particularly mental health and addiction treatments. "These are segments which have large addressable markets, poor current standards of care and therefore significant unmet medical needs," he said. He outlined how the company raised £1.8 million in mid-2024 to support its new growth strategy, which includes partnerships, joint ventures, and acquisitions. A central part of this strategy is the pending acquisition of Awakn Life Sciences, a clinical-stage biotech company focused on alcohol use disorder (AUD) and PTSD. Solvonis is acquiring Awakn in an all-paper deal valued between £3 million and £5 million. Tennyson said this represented significant value, highlighting that similar assets could command substantially higher valuations. Awakn's AWKN-001, targeting severe AUD, is in phase 3 trials in the UK and EU. AWKN-002, for the US market, has received FDA support for a faster 505(b)(2) development pathway, allowing the use of Johnson & Johnson's SPRAVATO® data to accelerate progress. Tennyson said the top priority for 2025 is closing and integrating the acquisition and executing on the clinical programs. He emphasised plans to file for FDA approval of a phase 2B trial and to continue to work with Awakn's existing UK partners. Visit Proactive's YouTube channel for more updates like this. Don't forget to like the video, subscribe to the channel, and enable notifications for future content. #Solvonis #BiotechNews #MentalHealthTreatment #AddictionRecovery #PTSDResearch #AlcoholUseDisorder #PharmaInvesting #AwaknAcquisition #ClinicalTrials #HealthcareInnovation
In today's episode, we explore ketamine's therapeutic potential with Dr. Joshua Rosenblat, a leading expert and faculty member at the University of Toronto's Department of Psychiatry (learn more). https://x.com/jd_rosenblat?lang=enhttps://pubmed.ncbi.nlm.nih.gov/35688035/https://pubmed.ncbi.nlm.nih.gov/39608193/
After it was approved in 2019, Spravato, a depression treatment derived from the club drug ketamine, was looking like a dud. But recently it has taken off, and it surpassed $1 billion in annual sales last year for its maker, Johnson and Johnson. Further Listening: -A Lawyer Says He Doesn't Need Help for Psychosis. His Family Disagrees. -America's Maternal Mental Health Crisis Further Reading: -J&J's Ketamine-Derived Drug Is Taking Off -Big Pharma Walked Away From Mental Health. Why Some Are Coming Back. Learn more about your ad choices. Visit megaphone.fm/adchoices
Spravato is a groundbreaking treatment for depression in the form of a nasal spray. Patients have been raving about the anti-depressant and here in Tulsa, Parkside Psychiatric Hospital & Clinic has been having good results with the medication. Brad McDaris with Parkside fills us in on the benefits of Spravato and we share our own experiences fighting depression.
Pursuing social anxiety disorder with MDMA. Jason Najum talks to Srinivas Rao, CEO of Atai Life Sciences, a biotech company focused on mental health and psychedelic compounds (1:30). Standing on the shoulders of Johnson & Johnson's Spravato (4:00). Upcoming milestones and clinical trials (13:15). Psychedelic industry sentiment; RFK Jr influence (30:40).Show Notes:Psychedelic Stocks: Focus On Their CashDeep Dive: Atai Life SciencesFDA's MDMA Decision A Setback, But Long-Term Outlook For Psychedelic Stocks UnchangedRead our episode transcriptsFor full access to analyst ratings, stock quant scores and dividend grades, subscribe to Seeking Alpha Premium at seekingalpha.com/subscriptions
This week, I'm diving into a personal experience that's a little different from my usual fitness content. I've been open about my struggles with mental health—OCD, anxiety, depression—but 2024 pushed me to my limits.After losing $24K to a business coach who wrecked my confidence and left me questioning everything, I found myself in a deep hole.I've tried therapy, TMS, antidepressants… and nothing really got me where I needed to be.So I decided to give Esketamine (Spravato) a shot. In this episode, I break down exactly what it was like, how it made me feel, what went wrong, and if it's actually helping.If you've ever been curious about ketamine therapy, are struggling with your own mental health, or just want to hear an unfiltered take on what it's like, this one's for you.
Ozempic gains expanded approval; MS treatment gets Boxed Warning added to label; Monotherapy approval granted for treatment resistant depression Tx Spravato; Leqembi gains maintenance regimen; Enhertu gains new Breast CA indication.
Unlock new, well-reimbursed services: Spravato, a needle-mover for pain practices. Discover how Spravato, an FDA-approved esketamine treatment for depression, can drive significant financial reimbursement for your practice while improving patient outcomes. Join me as I meet with Yakov Kagan, CEO and co-founder of Big Leap Health, as he highlights the clinical efficacy of Spravato, its comparison to ketamine, and its financial impact. Learn key considerations for launching—whether independently or via an MSO—and actionable steps to get started, from staff training to billing essentials. Yakov will also share insights into future developments like monotherapy developments, helping your practice stay ahead in this rapidly evolving field. For more information and to integrate Spravato into your Pain Practice go to https://www.bigleaphealth.com Host David Rosenblum, MD Long island based anesthesiologist, David Rosenblum, MD, is one of the first interventional pain physicians in the country to integrate ultrasound guidance into his pain practice. Since 2007, he has been an international leader in the treatment of chronic pain. He has helped countless of patients suffering from back, neck, knee, shoulder, hip joint pain and has been at the forefront of regenerative pain medicine, minimally invasive pain therapies and medical education. Patients can schedule a consultation by going to www.AABPpain.com or calling: Brooklyn Office 718 436 7246 Garden City Office 516 482 7246 NRAP Academy also offers: Board Review Anesthesiology Pain Management Physical Medicine and Rehabilitation Regenerative Medicine Training Live Workshops Online Training The Virtual Pain Fellowship (online training program with discount to live workshops) Regional Anesthesia & Pain Ultrasound Course Private Training Available Email Info@NRAPpain.org **Disclaimer:** The information presented in this podcast is for educational purposes only and should not be considered medical advice. Always consult a healthcare professional for medical concerns.
Unlock new, well-reimbursed services: Spravato, a needle-mover for pain practices. Discover how Spravato, an FDA-approved esketamine treatment for depression, can drive significant financial reimbursement for your practice while improving patient outcomes. Join me as I meet with Yakov Kagan, CEO and co-founder of Big Leap Health, as he highlights the clinical efficacy of Spravato, its comparison to ketamine, and its financial impact. Learn key considerations for launching—whether independently or via an MSO—and actionable steps to get started, from staff training to billing essentials. Yakov will also share insights into future developments like monotherapy developments, helping your practice stay ahead in this rapidly evolving field. For more information and to integrate Spravato into your Pain Practice go to https://www.bigleaphealth.com Host David Rosenblum, MD Long island based anesthesiologist, David Rosenblum, MD, is one of the first interventional pain physicians in the country to integrate ultrasound guidance into his pain practice. Since 2007, he has been an international leader in the treatment of chronic pain. He has helped countless of patients suffering from back, neck, knee, shoulder, hip joint pain and has been at the forefront of regenerative pain medicine, minimally invasive pain therapies and medical education. Patients can schedule a consultation by going to www.AABPpain.com or calling: Brooklyn Office 718 436 7246 Garden City Office 516 482 7246 NRAP Academy also offers: Board Review Anesthesiology Pain Management Physical Medicine and Rehabilitation Regenerative Medicine Training Live Workshops Online Training The Virtual Pain Fellowship (online training program with discount to live workshops) Regional Anesthesia & Pain Ultrasound Course Private Training Available Email Info@NRAPpain.org **Disclaimer:** The information presented in this podcast is for educational purposes only and should not be considered medical advice. Always consult a healthcare professional for medical concerns.
Unlock new, well-reimbursed services: Spravato, a needle-mover for pain practices. Discover how Spravato, an FDA-approved esketamine treatment for depression, can drive significant financial reimbursement for your practice while improving patient outcomes. Join me as I meet with Yakov Kagan, CEO and co-founder of Big Leap Health, as he highlights the clinical efficacy of Spravato, its comparison to ketamine, and its financial impact. Learn key considerations for launching—whether independently or via an MSO—and actionable steps to get started, from staff training to billing essentials. Yakov will also share insights into future developments like monotherapy developments, helping your practice stay ahead in this rapidly evolving field. For more information and to integrate Spravato into your Pain Practice go to https://www.bigleaphealth.com Host David Rosenblum, MD Long island based anesthesiologist, David Rosenblum, MD, is one of the first interventional pain physicians in the country to integrate ultrasound guidance into his pain practice. Since 2007, he has been an international leader in the treatment of chronic pain. He has helped countless of patients suffering from back, neck, knee, shoulder, hip joint pain and has been at the forefront of regenerative pain medicine, minimally invasive pain therapies and medical education. Patients can schedule a consultation by going to www.AABPpain.com or calling: Brooklyn Office 718 436 7246 Garden City Office 516 482 7246 NRAP Academy also offers: Board Review Anesthesiology Pain Management Physical Medicine and Rehabilitation Regenerative Medicine Training Live Workshops Online Training The Virtual Pain Fellowship (online training program with discount to live workshops) Regional Anesthesia & Pain Ultrasound Course Private Training Available Email Info@NRAPpain.org **Disclaimer:** The information presented in this podcast is for educational purposes only and should not be considered medical advice. Always consult a healthcare professional for medical concerns.
Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. During the latest Johnson & Johnson's Q4 earnings call, the company disclosed a total of $88.8 billion in sales for the full year. They also mentioned a shift in their acquisition strategy, moving towards smaller deals after the massive $14.6 billion purchase of Intra-Cellular. This change will see J&J focusing on single-digit billion buyouts in the future. Arrivent has joined the trend of Chinese licensing deals by potentially entering into a $1.2+ billion agreement with Lepu to advance an antibody-drug conjugate for gastrointestinal cancers. Meanwhile, Gilead is starting fresh after nearly five years into their $5 billion partnership with Galapagos, as they explore new opportunities with a spinoff company. President Trump's recent executive orders have sparked some concerns within the biopharma industry, despite most executives expressing a neutral stance towards his administration at the J.P. Morgan conference. The newsletter also covers topics such as FDA pausing Atara's programs, Chinese biotech Ascentage aiming for a $134 million IPO, and Johnson & Johnson's Spravato making advancements in the challenging depression space with monotherapy approval.Biopharma executives at J.P. Morgan maintained a neutral outlook towards the incoming Trump administration, but worries arose when Trump issued executive orders impacting the industry. Gilead's partnership with Galapagos is evolving after five years, leading to the creation of a new spinoff company. The rise of China's biopharma innovation may face obstacles due to Trump's trade policies. Other highlights from the newsletter include personal anecdotes from J.P. Morgan, Chinese biotech Ascentage gearing up for an IPO, SAGE taking legal action against Biogen, and investment trends for 2025 focusing on immunology and obesity. Notch Therapeutics announced layoffs, while companies like Akron Biotech, Visterra Inc., and Insmed Incorporated are currently hiring for various positions in the biopharma industry.
Solvonis Therapeutics PLC (LSE:SVNS) CEO Anthony Tennyson talked with Proactive's Stephen Gunnion about the company's exciting developments regarding AWKN-002, a drug candidate targeting moderate to severe alcohol use disorder. Tennyson highlighted the significant unmet medical need in the US, where 29 million people suffer from alcohol use disorder and 75% relapse within a year after treatment. In December, Awakn Life Sciences, which Solvonis plans to acquire, received positive feedback from the FDA during a pre-IND meeting. The FDA approved the company's proposal to skip Phase 2a trials and proceed directly to Phase 2b. Furthermore, it supported Awakn's expedited regulatory pathway through the 505(b)(2) process, allowing reference to J&J's Spravato data. Tennyson explained that AWKN-002 is a repurposed version of esketamine delivered through an oral thin film for sublingual administration. He added, “This clarity from the FDA reduces time and provides a clear direction for the R&D program.” The next step involves establishing a scientific bridge to SPRAVATO before seeking Phase 2b approval. Watch the video for more updates, and don't forget to like, subscribe to Proactive's channel, and enable notifications for future videos! #SolvonisTherapeutics #AWKN002 #AlcoholUseDisorder #FDAApproval #PharmaceuticalInnovation #SKetamine #AddictionTreatment #BiotechUpdates #MedicalResearch #ProactiveInvestors
Episode Title: Ketamine for Cancer and Pain Management - Journal Club Host: David Rosenblum, MD Upcoming Free Webinars: 1. Exploring Innovative Mental Health Treatments which are well reimbursed Discussing Spravato, Transmagnetic Stimulation, and Ketamine Infusion, sponsored by Big Leap Health. Register! 2. Understanding Scrambler Therapy Learn about this revolutionary approach to pain management. Register! 3. Cervical Ultrasound: Anatomy and Interventional Pain Targets Sponsored by Clarius, this session will explore advanced imaging techniques. Register! Sign up for the webinars and check out our full calendar of events. Join us for this insightful episode as we explore the potential of ketamine in transforming pain management practices! Summary In today's episode, we delve into the emerging role of ketamine in managing cancer and chronic pain. Our discussion is anchored around a comprehensive review article titled "Ketamine Use for Cancer and Chronic Pain Management," published in Frontiers in Pharmacology on February 1, 2021. This review, authored by Clayton Culp, Hee Kee Kim, and Salahadin Abdi, explores ketamine's potential as an analgesic in chronic pain conditions, particularly cancer-related neuropathic pain. Key Points from the Review Article: - Mechanism of Action: Ketamine functions as an N-methyl-D-aspartate receptor antagonist, providing analgesic effects at sub-anesthetic doses. Its ability to counteract central nervous system sensitization makes it effective in opioid-induced hyperalgesia. - Clinical Efficacy: Recent studies highlight ketamine's potential to reduce pain scores and opioid consumption, offering a promising alternative for patients with refractory pain. - Safety Profile: At lower doses used for analgesia, ketamine's safety and adverse event profile are significantly improved compared to its use as an anesthetic. - Pharmacogenomics and Interactions: The article discusses how genetic variations can affect ketamine metabolism and highlights potential drug interactions that clinicians should be aware of. Reference Culp, Clayton, Hee Kee Kim, and Salahadin Abdi. "Ketamine use for cancer and chronic pain management." Frontiers in Pharmacology 11 (2021): 599721.
In this episode, Erica Zelfand, ND joins to discuss the important topic of pill shaming in psychedelic communities and how psychedelic medicine and traditional pharmaceuticals can both support healing. Dr. Erica Zelfand specializes in integrative mental health, bridging the gaps between conventional and alternative medicine. In addition to seeing patients in private practice, she also teaches facilitation internationally and leads retreats through Right to Heal. In this conversation, Dr. Zelfand tackles the issue of pill shaming in psychedelic communities, showing why this rhetoric falls short and ultimately harms patients. She discusses complementary roles for psychedelic and traditional pharmaceutical medicines, suggesting that a medicine like ketamine may be particularly effective in contexts of acute intervention, whereas an SSRI antidepressant may be most effective for maintenance. Dr. Zelfand notes, however, that drug-drug interactions can be a significant concern and stresses the need for medical expertise and supervision in the context of concomitant usage of pharmaceuticals and psychedelics. In closing, she emphasizes that what is ultimately important is that patients are able to progress in healing, and any tools that are able to safely and effectively support this goal have an important role to play and should not be denigrated. In this episode you'll hear: The pill shaming rhetoric in psychedelic and cannabis communities Pharmaceutical contraindications to psychedelic therapy and the necessity of medical supervision for tapering off such medications Why comparing traditional antidepressant pharmaceuticals to psychedelic medicines is often an apples to oranges comparison The issues with “no pain, no gain” rhetoric in healing Psychiatric support for processing repressed memories uncovered during psychedelic journeys Quotes: “When I went into medicine, I actually specifically went into integrative medicine, functional medicine, because I didn't like that patients were being in this position of having to choose: the conventional route or the alternative medicine route. Both routes have their merits and both routes have their shortcomings and I felt like we all deserve to be able to access both and have it be an integrated model.” [3:06] “The only form of ketamine that is FDA approved for depression—which is Spravato—is only approved in the context in which the person is also taking an oral antidepressant.” [20:48] “We have data showing that if you feel really really freaked out and anxious during your [psychedelic] trip, your outcomes aren't necessarily as good. And the biggest predictor of having a positive experience is actually feeling awe. You don't have to do the ego death thing, but if you can feel awe, if you can feel inspiration during a trip, your outcomes are better. And there's even data showing that individuals who are on an SSRI and then trip—they may actually have better outcomes than people who don't take medication.” [24:12] “I think part of this trepidation is we don't want to harm anybody through a dangerous, or potentially lethal, drug-drug interaction. That's one thing. It's another thing to be like ‘yeah but if you're using these [pharmaceutical] drugs you're doing it wrong and you're not healing right.' And I think the one often is used as a camouflage for the other—and they're two separate things.” [38:59] Links: Dr. Zelfan's website Dr. Zelfand on Instagram Dr. Zelfand on Twitter Dr. Zelfan on LinkedIn Right to Heal website Psychedelic pill-shaming article by Jules Evans and Shayam Suseelan Previous episode: Integrating Challenging Psychedelic Experiences with Keith Kurlander, MA Previous episode: Warning Signs When Selecting a Psychedelic Facilitator with Juliana Mulligan Previous episode: How to Choose a Psychedelic Facilitator or Retreat Center with Joël Brierre Psychedelic Medicine Association Porangui
For some people, depression can be treatment resistant. There's another option for patients in the form of a nasal inhaler to help those patients. A local woman shares how Spravato has changed her outlook on life.
Today, The Frontier Psychatrists welcomes back my friend Ben Spielberg. He's been a reader for a long time and has contributed to the newsletter in the past. It was on Clinical Trial design, a perennial favorite around these parts.With only light edits, what follows is his work, narrated by me, for the Audio Version.I would invite you to the live class today on working as an out-of-network provider, but it sold out last night, so you'll have to wait for the next one. My prior article on Spravato is available here.The year is 2024. OpenAI has just launched its latest update to ChatGPT, promising more natural and less artificial-sounding language. Donald Trump has won the nomination for President of the United States. Another chain of ketamine clinics has engaged in a corporate reorganization. There is conflict in the Middle East. Are we sure that we're not living Groundhog's Day?I am the founder of Bespoke Treatment, an integrative mental health facility with multiple locations that has at times been referred to as a "ketamine clinic." I have also seen countless so-called "ketamine clinics" sell for pennies on the dollar and go bankrupt seemingly overnight. In this case, Numinus, a company that was publicly traded in Canada and owned a number of psychiatric clinics specializing in ketamine in the US and Canada, has sold its clinics to Stella (a company that has stealthily become one of the larger mental health providers in the country and is the first to bring the awesome SGB treatment to scale). It's not the first time this has happened. It's not the second, nor the third, nor even the fourth time this has happened. But yet, the common consensus is that ketamine clinics are a cheap, easy business with recurring revenue. So, what gives?Figure 1. A reddit user asking anesthesiologists if they should start a ketamine or Botox clinic for easy cash on the side. Does this make you feel gross? Should it?The Ketamine Clinic Model 101The most basic outline for a ketamine clinic is as follows: a provider rents an office space with, on average, five or so exam rooms. They buy equipment for infusions like a pump, catheter, needles, and syringes. They buy some comfortable recliner chairs. They hire a receptionist to answer phones, field patient questions, charge credit cards, and handle medical record requests. They hire a nurse to insert the IV, monitor vital signs, check blood pressure, juggle multiple patients at once, and make sure the ketamine is flowing into patients' veins unencumbered. Two SKUs are typically offered: ketamine infusions for mood, which last approximately 40 minutes, and ketamine infusions for pain, which last for up to 4 hours. Zofran is offered for nausea, and some clinics have fun add-ons like magnesium or NAD. An average mood infusion costs around $400-$500 in a medium cost-of-living area, while mood-infusions can run up to $700 in a higher cost-of-living area. Some clinics offer package discounts if patients buy six or more upfront, which helps with cash flow for the clinic (cash now is better than cash later, of course).A Note on Scope of PracticeThe first wave of ketamine clinics was started mainly by providers who were not mental health specialists. Instead, they were owned by anesthesiologists, ER physicians, and sometimes CRNAs. These providers were especially experienced with ketamine in hospital settings, as well as setting up infusions. Psychiatrists, on the other hand, do not usually order infusions in outpatient settings, and very few had actual hands-on experience with ketamine in practice. That being said, there are a number of variations to the model above: psychiatrist-owned ketamine clinics would often prefer to use intramuscular injections in lieu of infusions, but 2-3 injections would have to be given during a single session for mood and pain sessions were out of the question. Other ways to save costs might include having an EMT do the actual injections (this is highly state-dependent), asking nurses or MAs to work the front desk, or working a full-time regular doctor job. In contrast, your nurses run the actual ketamine services via standing orders, a written document that details routine and emergent instructions for the clinic.Some clinics offer full evaluations prior to rendering treatment, but many offer a simple brief screening on the phone to check for contraindications before scheduling a patient for their first session. The clinics owned by psychiatrists have historically been a bit more thorough in terms of the initial psychiatric evaluations, given that they can actually perform initial psychiatric evaluations within their respective scope of practice. Sometimes clinics may have therapists on-site who can render ketamine assisted therapy (meaning, therapy occurring concurrently) for an additional $100-$300. Otherwise, there is not much decision-making that goes on— other than deciding on medication dosages. Most infusions start off at .5mg/kg of body weight, which is by far the most evidence-based dosage. In practice, most clinics increase dosage every session because even though ketamine is considered to be a weight-based medicine for anesthesia, there is thought to be a “sweet spot” of dosage for everyone, if one can imagine an inverted U shape curved, where the ideal dosage for each patient is at the tippity-top of the inversion. Dosage increases are highly variable depending on the clinic: some have a maximum dosage, some will only increase a certain percentage, and some may even use standardized increments (e.g., only offering dosages in increments of 50mg). A typical series of infusions is 6-8 over 3-4 weeks, followed by boosters as needed.Fool's GoldAt first glance, the business model seems fantastic. As a cash business, there are no AR issues, no third party billing companies to deal with, and no prior authorizations to fight over. Sure, the cost is high, but it's not that high compared to many other healthcare services. Since the benefits fade over time, a ketamine clinic has built-in recurring revenue from patients every week, month, quarter, or year – it's like a subscription business! Ketamine is trendy and sexy; TV shows like White Lotus mention it, and ravers from the 90's recall it with great fondness. Unlike SSRIs and psychotherapy, ketamine works for depression fast. It's amongst the fastest treatments for depression that we have today, and there are a lot of depressed people. It can help someone out of debilitating depression in 40 minutes. It has none of the un-sexy side effects of SSRIs like sexual dysfunction, gastrointestinal discomfort, or uncontrollable sweating. Instead, it has sexy side effects: euphoria, hallucinations, and feelings of unity with the universe. Also, unlike SSRIs, it helps most people who try it. It really is an amazing treatment, and I often feel grateful that my clinic is able to offer it to patients in needFigure 2. Most business-savvy reddit user.Supply and Demand… or SomethingMood disorders disproportionately affect individuals who are of lower socioeconomic status compared to individuals with a lot of disposable income. Of course, wealthier individuals are no more immune to mental health disorders than anyone else, but the main target market that benefits most from ketamine just do not have the means to afford it. They don't have $3,000 to burn on yet another treatment that may or may not work. Often, the patients who could really use a series of ketamine infusions cannot scrounge enough money for a single infusion, let alone a whole series and prn boosters. However, there should be enough depressed people with cash to throw around out there… right?Wait, Isn't That A Horse Tranquilizer?Of course, ketamine clinics can find more patients via marketing and advertising. However, I've found that many medical doctors who see this population, like primary care providers, are not up to date with the research. When I first launched my company, I used to go door-to-door to medical buildings in Santa Monica with cookies to speak with them about advancements in interventional psychiatry. I cannot count the number of times that I was laughed out of each office; referring providers are risk-averse, and the perception of ketamine has traditionally been poor. Medical doctors would exclaim, “Of course people feel better; you're getting them high,” and lament that I was administering a drug thought to be highly addictive. Psychotherapists, who would also be fantastic referral partners, generally refer to psychiatry, but it's less common for them to refer to specific treatments. Nowadays, psychotherapists who are particularly invested in ketamine can sign up with venture-backed companies like Journey Clinical and render their own ketamine-assisted psychotherapy with some prescriber supervision. The issue is that despite the media attention, people with depression don't read innovative health newsletters, nor do they review papers in scientific journals. They rely on information from their psychiatrists, medication management providers, and psychotherapists. If they are not told that this is an option for them, they won't hear about it without ad spend. Oh yeah, and there is a major issue with ad spend: the word ketamine itself is a restricted drug term, and legitimate clinics routinely get banned from Google and Meta for mentioning it, which makes digital advertising more difficult than it would be for any other legitimate service.The Matthew Perry EffectKetamine is very desirable for some patients (unfortunately, sometimes the patients who want it most are frankly the worst candidates for it), but I'd wager that the majority of patients who need it are kind of scared of it. They want to feel good, they want relief from depression and trauma, but it's a weird thing to do a drug that is a horse tranquilizer and also an anesthetic in a reclining chair in a medical office that tricks your brain into feeling like you're dead for a little bit. It's kind of far off from acupuncture and more traditional alternative medicine. There is certainly a non-zero addictive potential that needs to be carefully weighed, it's not a particularly comfortable experience for many patients—especially those with a history of trauma—even if it helps after the experience is over. Additionally, the famous actor from the most famous show in the world, who was deemed to have a cause of death relating to ketamine, isn't exactly helping mass adoption. Overall, this just makes marketing and advertising even more expensive, because a) the majority of referring providers are skeptical, b) patients can't pay for it and c) patients who can pay for it are cautious.Disruptive Business ModelsIn the model I've described above, there are 3 sets of cost centers: rent, staff, and marketing. In some areas of the country, rent may be negligible, and in others, it is quite high. Like an owner-operated restaurant, if a clinic is owned by a company that is not a clinician, they have to find one and pay for one. Venture-backed companies like Mindbloom, Better U, and Joyous have also created entire businesses on the back of the COVID-era controlled substance waivers, whereby they send patients ketamine tablets and/or lozenges directly through the mail. Unlike the clinic model, they don't have rent to pay, and since national marketing campaigns are often cheaper than hyper-local brick and mortar campaigns, they are able to find new patients at lower acquisition costs compared to their clinic counterparts. Some patients do extensive research before treatment and only want to find IV clinics that offer specific dosages, but many are fine with the cheapest ketamine possible, and would prefer to pay as low as $150 for an entire month compared to $3,000.Figure 3. Did you sign up for a discounted ketamine subscription on Black Friday after purchasing a new flat-screen TV?Spravato: Coming In HotJohnson & Johnson's branded esketamine (note the prefix es) is on track to reach coveted “blockbuster status.” While it was FDA approved for Major Depressive Disorder in 2019, it took some time to catch on for a number of reasons including skepticism that the added es only added to pharma pockets and didn't actually work, health insurance companies taking time to decide on what their medical necessity criteria should be, and social isolation due to COVID-19 being a thing. My clinic has become one of the larger Spravato providers in the Los Angeles area, and while we still offer ketamine infusions, our infusion census has decreased by over 70%. The scenario is this: a patient with severe depression comes in to see us, they've heard about ketamine, but they find out that Spravato is covered by insurance for a $20 copay. Maybe ketamine has slightly better efficacy (which, in my opinion, is really just a function of being able to adjust dosage). Still, patients would prefer paying a lot less money to receive almost-the-same benefits.Death By A Thousand SticksThere are a number of other issues with the model that become problematic, especially at scale. Large medical distributors like McKesson and Henry Shein have instituted CYA policies, limiting ketamine sales to licensed anesthesiologists. Medical malpractice carriers alike have followed suit, requesting detailed addendums from providers regarding their ketamine training or flat-out refusing coverage for anyone who isn't an anesthesiologist. Since controlled substance manufacturing is directed by the DEA based on their own predictions, it's not uncommon for ketamine to go on shortage for weeks to months at a time. There are a myriad of problems with the model of point solutions which have been detailed here already, but in short, the old adage rings true: if all you have is a hammer, everything looks like a nail, and if all you have is ketamine, everything looks like a juicy vein. But while ketamine is a highly efficacious treatment, it's not the best treatment for everyone, and patients can become downright dysregulated after ketamine, which a clinic in this model just can't handle adequately at scale. And ultimately, methods to do everything cheaper don't work out that well. For example, putting multiple patients in one room may seem like a good idea, but it is ultimately not conducive to the actual ketamine experience. Any sort of vertical integration also adds an insurmountable amount of complexity, like starting to offer Spravato or TMS, because now they have to start accepting insurance, become in-network, manage billing and AR, and so on. Depending on location and the clinic set-up, they also require specialized providers onsite.Figure 4. Supply chain issues abound.Insurance IssuesSome patients try to be well-informed. They, rightly or otherwise, don't believe everything they hear from their providers, so they call up their health insurance companies and ask. They just call the phone number on the back of the card and ask the representative if ketamine infusions are covered. Undoubtedly, the representative says yes—even though many insurance companies have published guidelines that explicitly deny any coverage for ketamine for a mental health disorder. These patients come in frustrated, distrustful of their providers and reaffirms their belief that ketamine clinics are just cash grabs. Even if one manages to obtain a coveted insurance contract for ketamine, like Ketamine Wellness Centers had with the VA, it kickstarts cashflow and complexity issues that scale should sort out, but ultimately doesn't because of the aforementioned issues above.Overall, it is possible to have a successful ketamine clinic in 2024. Still, it isn't easy due to market conditions, the population served, and the ever-changing landscape of mental health treatment. While many successful clinics exist today, the wheels tend to start to fall off when scaling, where all of a sudden, a clinic's reach has surpassed its captive population. Otherwise, it becomes a series of continual cost-cutting until there is nothing left to cut… save for the business itself.Ben Spielberg is the Founder and Chief Executive Officer of Bespoke Treatment, a comprehensive mental health facility with offices in Los Angeles, CA, and Las Vegas, NV. He is also a PhD Candidate in Cognitive Neuroscience at Maastricht University.For more on psychiatric medications, buy my book Inessential Pharmacology. (amazon link).For pieces by other TFP contributors, follow:Alex Mendelsohn, Michelle Bernabe, RN, @Psych Fox, Carlene MacMillan, MD, David Carreon, M.D., Benjamin Lippmann, DO, Awais Aftab, Courtny Hopen BSN, HNB-BC, CRRN, Leon Macfayden and many others! The Frontier Psychiatrists is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit thefrontierpsychiatrists.substack.com/subscribe
Do you have a story you'd like to share on TWTDNH or are you a subject matter expert who would like to shed light on any of the topics I cover? Shoot me a message! This podcast episode is a heartfelt and intense reflection on the challenges and dangers that holidays can bring, especially for those in abusive relationships. Tressa shares personal experiences of abuse during holidays, highlighting how increased stress, alcohol consumption, and financial strain can exacerbate domestic violence. The episode also discusses how events like football games and other sporting events can trigger abusive behavior.Tressa shares a poignant story about Keith Lewis, a soldier who sustained a traumatic brain injury during his military service. Despite his injuries, he continued to serve and later married Sarah Stewart Whitaker, a former military service member and paramedic. Tressa explores the potential connection between the domestic violence and Keith's military service, examining if his trauma and experiences in the military contributed to his abusive behavior. The story highlights the severe impact of untreated mental health issues and the importance of support for those affected.The episode underscores the importance of safety and support for victims of domestic violence, especially during the holiday season. It also calls into question the military's handling of soldiers with PTSD and brain injuries, highlighting the need for better support and intervention.Tressa's message is clear: while holidays can bring joy and togetherness, they can also be a time of increased danger and stress for some. It's crucial to prioritize safety and seek help if needed.What You'll Learn: 1. **Domestic Violence During Holidays**: The episode emphasizes that holidays can be especially difficult for those in abusive relationships. Increased stress, alcohol consumption, and financial strain can exacerbate domestic violence, and sporting events can be significant triggers for abusers.2. **The Impact of Untreated PTSD and Brain Injuries**: The story of Keith Lewis highlights the severe consequences of untreated PTSD and traumatic brain injuries. It underscores the need for better mental health support and intervention for soldiers returning from combat.3. **The Role of the Military in Supporting Veterans**: The episode criticizes the military's handling of mental health issues and brain injuries among soldiers. It calls for greater responsibility and better care for those who have served.4. **The Importance of Safety and Support**: The episode highlights the critical need for safety and support for victims of domestic violence, especially during the holiday season. It also encourages awareness and vigilance in recognizing and addressing signs of abuse.Overall, the episode is a poignant reminder of the complexities of human experiences during the holidays and the importance of empathy, support, and mental health care.Resources:Family says Army ignored unseen wounds of a former Sarasota manArmy combat medic and pregnant wife die in apparent murder-suicideUgly side of the beautiful game: the football world cup and domestic violence | The BMJFind Domestic Violence and Abuse Help, Information and StatsSGB, Spravato, TMS & Ketamine Infusion | Treatment by Stella
Happy Halloween!
Resetting the Nervous SystemIn this episode of the Dr. Gabrielle Lyon Show, we dive deep into groundbreaking approaches for treating PTSD, anxiety, and depression with Dr. John How, an emergency physician turned mental health advocate. Dr. How introduces us to the Stellate Ganglion Block, a powerful and non-invasive procedure that's transforming how we manage trauma and mental health without relying solely on medications.We explore:What the Stellate Ganglion Block is and how it worksIts effectiveness in treating PTSD, depression, and anxietyThe connection between the autonomic nervous system and mental healthHow Dr. How's personal journey with burnout and trauma led him to discover this life-changing procedureThe future of mental health treatments, including ketamine and regenerative medicineIf you or someone you love struggles with mental health challenges, this episode offers insight into innovative treatments that can provide long-term relief.Who is Dr. John How?Dr. John How is an accomplished board certified emergency medicine physician with a passion for healing trauma and aging in both the mind and the body. He is the founder, and medical director of The How Clinic in Encinitas, CA where the focus is on treating the root cause of his patient's problems. He and his team at The How Clinic use traditional and functional medicine combined with cutting edge treatments for pain and injury to combat the symptoms and causes of trauma and aging. These treatments include nerve hydrodissection, regenerative medicine therapies, hormone and nutritional optimization, as well as therapies to address sexual dysfunction. He is a Medical Director at Stella Center, an interventional psychiatry practice. He and the team at Stella specialize in providing a world class combination of evidence-based treatments targeted at treating depression, PTSD, and chronic anxiety. These treatments include Spravato, ketamine infusion therapy, transcranial magnetic stimulation (TMS), an advanced stellate ganglion block (SGB) called the dual sympathetic reset (DSR), and integration therapy. Apply to become a patient - https://drgabriellelyon.com/new-patient-inquiry/ Join my weekly newsletter - https://institute-for-muscle-centric-medicine.ck.page/2ed23e2860 Get my book - https://drgabriellelyon.com/forever-strong/This episode is brought to you by :Manukora - Code DRLYON for $25OFF Starter Kit! - https://manukora.com/DRLYONZocDoc - Book your FREE Appointment Now! - https://zocdoc.com/DRLYONARMRA - Code DRLYON for 15% OFF! - http://armra.com/DRLYONAG1 - Code DRLYON for FREE Welcome Kit and Starter Packs! - https://drinkAG1.com/DRLYONPuori - Code DRLYON for 20% OFF - https://puori.com/DRLYONFind Dr. John How at:Youtube: https://www.youtube.com/@StellaTraumaCareWebsite: https://thehowclinic.comTikTok: http://www.tiktok.com/@thehowclinicFind me at:Instagram: @drgabriellelyonTik Tok: @drgabriellelyonFacebook:...
In this episode host Von discusses the therapeutic use of ketamine with licensed clinical worker Candace Curzon and medical provider Austin Francom. They explore the benefits of ketamine therapy and delve into the administration methods, safety protocols, and the importance of mindset. The discussion highlights the role of music in therapy sessions and emphasizes the need for continued work post-therapy to integrate the experiences gained during treatment.Chapters:(00:00) Introduction to Ketamine Therapy(03:30) Understanding Ketamine: Properties and Uses(06:26) The Therapeutic Process of Ketamine Administration(09:23) The Role of Music in Ketamine Therapy(12:35) Navigating Addiction and Ketamine Therapy(15:19) The Integration of Ketamine Therapy with Traditional Therapy(18:37) The Experience of a Ketamine Therapy Session(21:31) The Importance of Setting and Support in Therapy(24:23) Long-term Management and Self-Care After Therapy(29:54) Exploring Ketamine and Ayahuasca: A Comparative Insight (37:24) Considerations and Precautions for Ketamine Therapy(40:43) Finding the Right Clinic for Ketamine TreatmentKetamine Therapy SLC linktreeFollow Me on Social Media: https://www.instagram.com/thevoncastshow/ https://www.instagram.com/shibavon/ https://www.tiktok.com/@wowshibavonhttps://www.iamvon.net/
Cybin CEO Doug Drysdale talks to Jason Najum about transforming treatment of mental health disorders with psychedelics (0:45). CYB003, Phase 2 results for depression, moving into Phase 3 (3:00). How deuterated psilocin differentiates Cybin from competiton (10:00). IP and patents - critical to ROI (12:45). Esketamine and is JNJ's Spravato blazing a trail for psychedelics? (14:15) FDA challenges and Lykos lessons (21:20). Strong balance sheet will get it through Phase 3 data (25:50) Stock consolidation and attracting new buyers (30:35).Episode transcriptsShow Notes:Imran Khan On Psychedelics - More We Don't Know Than We DoPsychedelic Stocks: Focus On Their CashFDA's MDMA Decision A Setback, But Long-Term Outlook For Psychedelic Stocks UnchangedDe-Risking Psychedelics: Compass Pathways, Cybin And AtaiFor full access to analyst ratings, stock quant scores and dividend grades, subscribe to Seeking Alpha Premium at seekingalpha.com/subscriptions
This week we will discuss the use of Ketamine for treating Depression. Our guest for this week's show is Karen DeCocker, DNP, PMHNP, CNM Karen DeCocker is the Director of Advanced Practice Providers at Stella overseeing the assessment team. She helps to identify which innovative biological medical treatments & virtual therapies can help relieve symptoms of anxiety, depression, PTSD & traumatic brain injury. After completing a virtual assessment of each patient, Dr. DeCocker and her team analyze the medical, biological, psychological & social factors to provide personalized treatment recommendations across Stella's advanced protocols such as Dual Sympathetic Reset (advanced stellate ganglion block), Ketamine Infusion Therapy, Transcranial Magnetic Stimulation (TMS), Spravato, integration therapy, and more. Dr. DeCocker's priority is the patient's outcome. She became a nurse practitioner in 2007 after 10 years of hospital nursing experience. As rates of depression and anxiety have increased dramatically, people have sought therapies outside the standard regimen of oral antidepressants and talk therapy. Beginning in the mid-2010s, more and more doctors started offering ketamine as a treatment for depression. In 2019, the Food and Drug Administration (FDA) approved esketamine as a treatment for forms of depression that haven't improved with standard antidepressants (like citalopram/Celexa or bupropion/Wellbutrin). (Source: Psychology Today)
Welcome to a special episode of The Trip Report Podcast, a production of Beckley Waves, a Psychedelic Venture Studio.Today, we're dissecting the FDA's rejection of Lykos Therapeutics MDMA Assisted Therapy with Dr. Carlene MacMillan MD, a Harvard-trained psychiatrist and Chief Medical Officer at Osmind.In her role at Osmind, Dr. MacMillan has the unique experience of helping practices across the country adopt new treatment modalities like Ketamine, Spravato, and Transcranial Magnetic Stimulation. And through her work with professional societies like the American Psychiatric Association and the Clinical TMS Society, she has been involved in developing policies, treatment codes, and access to new interventional psychiatric treatments. This background and experience made her a great person to speak with about the FDA decision, the most pivotal development this nascent field has seen.In this special dispatch, we dive deep into the potential rationale and aftermath of the FDA's decision, as well as the implications for the future of psychedelic therapies, research, and commercialization. In this conversation, we discuss:* The allegations of research misconduct* The difficulty the FDA and Advisory Committee had with the therapeutic component of the trial* The complexities of psychiatric trial designs and the importance of reliable data.* The role of real-world evidence and post-marketing data in evaluating new treatments.* The challenges of integrating new therapies into mainstream healthcare.* The future of psychiatric treatments, including neuromodulation and other emerging therapies.* And much more.And now, I bring you my conversation with Dr. Carlene MacMillan.Listen to the episode on Substack, Spotify, Google or Apple.Credits:* Hosted by Zach Haigney * Produced by Zach Haigney, Erin Greenhouse, and Katelin Jabbari* Find us at thetripreport.com* Follow us on Instagram, Twitter, LinkedIn and YouTube* Theme music by MANCHO Sounds, Mixed and Mastered by Rollin Weary This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.thetripreport.com
Use AI to Speed up Your Work Flow Ethically and Securely. There are lots of courses on AI out there, but this one is specific only to medical writing and editing. Access the AIMWE course waitlist. https://www.learnamastyle.com/waitlist/ Leqselvi for Alopecia Areata: The FDA has approved deuruxolitinib (Leqselvi) as a first-line treatment for adults with moderate to severe alopecia areata (AA). Developed by Sun Pharma, this oral selective inhibitor of Janus kinases JAK1 and JAK2 is typically dosed at 8 mg twice daily. The approval, based on the THRIVE-AA1 and THRIVE-AA2 trials, marks an important addition to limited treatment options for AA, which has significant psychological impacts. Femlyv Dissolvable Birth Control: The FDA has approved norethindrone acetate and ethinyl estradiol (Femlyv) as an oral dissolvable birth control pill, expanding access for those who have difficulty swallowing. This form of hormonal birth control, in use since 1968 as a swallowable tablet, also helps manage conditions like endometriosis and PMDD. The approval, based on a study of 743 women, offers a new option with common side effects like headache and nausea. Brineura for Batten Disease: The FDA has expanded the indication for cerliponase alfa (Brineura) to treat neuronal ceroid lipofuscinosis type 2 (CLN2 disease) in children under 3 years of age. Developed by BioMarin Pharmaceutical, this enzyme replacement therapy, initially approved in 2017, is administered by infusion into the brain. The expanded approval was based on a phase 2 trial showing reduced motor function decline and delayed disease onset. Erzofri for Schizophrenia: The FDA has approved paliperidone palmitate (Erzofri) extended-release injectable suspension for treating schizophrenia and schizoaffective disorder in adults. This long-acting injectable (LAI) antipsychotic, administered once a month, improves patient adherence by reducing dosing frequency. Developed by Luye Pharma Group, it was granted a U.S. patent in 2023 and approved under the 505(b)(2) pathway. Eque-cel for MS: The FDA has approved the IND application for equecabtagene autoleucel (Eque-cel) for treating multiple sclerosis (MS). Developed by IASO Biotechnology, this chimeric antigen receptor autologous T cell injection showed promising efficacy in six autoimmune diseases in a Chinese trial. MS, affecting 3.07 million people worldwide, is characterized by CNS demyelination and neuronal injury, with Eque-cel offering a new treatment option. Spravato for TRD: Johnson & Johnson has submitted an sNDA for esketamine (Spravato) as a monotherapy for adults with treatment-resistant depression (TRD). Already approved in combination with an oral antidepressant, esketamine is an NMDA receptor antagonist that rapidly alleviates depressive symptoms. The submission is based on Phase 4 TRD4005 study results, showing rapid improvement in depression scores with a consistent safety profile. ZW191 Anti-Tumor Agent: The FDA has cleared the IND application for ZW191, a novel antibody-drug conjugate (ADC) targeting folate receptor alpha (FR⍺) in cancers like gynecologic and NSCLC. Developed by Zymeworks, this TOPO1i ADC uses a novel payload, ZD06519, showing robust antitumor activity and a tolerable safety profile in preclinical models. Clinical development of ZW191 is planned to begin in the second half of 2024.
Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Florida has awarded additional Medicaid contracts to CVS, UnitedHealth, and Molina, after they were excluded from the first round of contracts in April. Meanwhile, Steward Health failed to attract qualified bidders during the first round of hospital sales. In other news, CMS has tightened rules for ACA brokers to prevent unauthorized plan switching. Commure is set to acquire AI scribe Augmedix in a $139 million deal to expand its documentation products. The healthcare industry is increasingly using AI to transform unstructured data and improve patient care. Additionally, online tools are being utilized to address gaps in mental healthcare services. AI and machine learning are also playing a crucial role in improving clinical trials by retaining participants, enhancing key performance indicators, and boosting query quality.The text discusses various updates in the medical technology industry on July 22, 2024. The FDA sent warning letters to Chinese syringe manufacturers, Embecta, a diabetes device firm, is considering a sale, Truvian raised $74 million for a blood test instrument, and a CrowdStrike outage affected US hospitals. Medtronic executive Stacey Churchwell spoke about the use of artificial intelligence in reducing false positives in cardiac monitors. Intuitive's Da Vinci 5 robot launch exceeded Wall Street expectations. The text also includes information on real-time vital signs data, Biden's healthcare legacy, and suggestions for further reading.Private biotech M&A activity has increased significantly, with acquisitions of private biotechs outpacing public offerings. Ionis is moving forward with plans for an Angelman drug that Biogen passed on, with a late-stage study set to begin next year. Meanwhile, J&J is seeking expanded approval for its antidepressant Spravato. The advanced therapeutic medicinal product (ATMP) sector is at the forefront of personalized medicine, with over 1,000 trials in development and potential disruption through manufacturing automation. In the oncology research space, there is fierce competition in the GLP-1 drug race as companies vie for a share of the obesity treatment market expected to surpass $100 billion by the end of the decade.Innovent's Phase III trial for their diabetes drug in China has been successful, bringing them closer to potential approval in the country. The drug, Mazdutide, is also being developed for weight management. Meanwhile, Lilly has received approval in China for their drug Tirzepatide for obesity, following Novo's approval for Semaglutide. Samsung Bioepis has received FDA approval for a biosimilar to AstraZeneca's Soliris. Novo and Lilly are looking to expand their GLP-1 pipelines beyond treating diabetes and obesity. Other news in the biopharma industry includes startups competing in the obesity space, GSK plotting Blenrep's return to market, and a procurement deal between IGA and the US government.Researchers in China conducted a small study using an "off the shelf" CAR-T cell therapy to treat patients with autoimmune diseases. The therapy, made with engineered cells from a healthy donor, resulted in deep remission of immune diseases and a reversal of inflammation and fibrosis in three patients after six months. This study marks a potential breakthrough in allogeneic CAR-T cell therapy for autoimmune diseases, offering a potentially cheaper and easier-to-manufacture alternative to approved autologous therapies. However, despite this progress, payment barriers need to be addressed to make these therapies accessible to patients. The study highlights the need for outside support to overcome barriers in the development and commercialization of cell and gene therapies. Additionally, the research landscape for cancer treatments continues to grow, with oncology being a significant area of growth for pharma drug development. The stud
Audio roundup of selected biopharma industry content from Scrip over the business week ended 19 July 2024. In this episode: J&J's Spravato on track for blockbuster status; US uptake of Rezzdifra held up by payers; CNS drugs are surprisingly valuable; obesity rules large cap stocks; and Legend buyout rumors validate China biotech. https://scrip.citeline.com/SC150621/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
Hello, my beautiful people. I am delighted and honored to have Brittany Remington as my guest today. Brittany and I met at the Women in Leadership Series event, and we instantly connected. With May being Mental Health Awareness Month, Brittany offered to share her knowledge and experiences to help raise awareness. Brittany Remington works for New Directions Mental Health as the Interventional Psychiatry Resource Manager. She explains the various treatments available for those with treatment-resistant depression, including Transcranial Magnetic Stimulation (TMS) and Spravato, an S-ketamine nasal spray. These treatments stimulate the brain to alleviate depressive symptoms and are best used alongside therapy. We discuss the importance of finding what works for you in managing mental health, whether it's therapy, medication, support groups, or lifestyle changes. Brittany emphasizes the need for consistency in treatment and the role of a supportive community. She shares her own journey, highlighting the significance of surrounding yourself with positive, growth-minded individuals. Brittany shares her passion for helping others and her side venture, The Wow Booth Co., a photo booth business that brings joy and connection to people at events. For anyone struggling with mental health, Brittany recommends reaching out to the 988 crisis hotline for immediate support. She also encourages people to explore local resources and support groups available in their communities. This episode is filled with valuable insights and practical advice for anyone looking to improve their mental health and well-being. Join us for an inspiring conversation with Brittany Remington and learn how to take control of your mental health journey. Video version available on my YouTube page. Audio version available on all the major Platforms, Apple, Spotify iHeart Radio etc. https://newdirectionspgh.com/ https://www.wowboothco.com/ https://www.spillwithme.com/ Special Shoutout to my Spotlight Supporters for Mental Health Awareness Month. Ed Meyer CEO/Owner of Tri-State Office Supply https://tristateofficefurniture.com/tri-state-office-furniture-locations/pittsburgh/ Megan Wollerton Owner of Life Force Wellness https://www.lifeforcewellness.com/ Chandra Chappell Owner of Mindful Adaptations https://mindfuladaptations.com/
Hello, my beautiful people. I am delighted and honored to have Brittany Remington as my guest today. Brittany and I met at the Women in Leadership Series event, and we instantly connected. With May being Mental Health Awareness Month, Brittany offered to share her knowledge and experiences to help raise awareness. Brittany Remington works for New Directions Mental Health as the Interventional Psychiatry Resource Manager. She explains the various treatments available for those with treatment-resistant depression, including Transcranial Magnetic Stimulation (TMS) and Spravato, an S-ketamine nasal spray. These treatments stimulate the brain to alleviate depressive symptoms and are best used alongside therapy. We discuss the importance of finding what works for you in managing mental health, whether it's therapy, medication, support groups, or lifestyle changes. Brittany emphasizes the need for consistency in treatment and the role of a supportive community. She shares her own journey, highlighting the significance of surrounding yourself with positive, growth-minded individuals. Brittany shares her passion for helping others and her side venture, The Wow Booth Co., a photo booth business that brings joy and connection to people at events. For anyone struggling with mental health, Brittany recommends reaching out to the 988 crisis hotline for immediate support. She also encourages people to explore local resources and support groups available in their communities. This episode is filled with valuable insights and practical advice for anyone looking to improve their mental health and well-being. Join us for an inspiring conversation with Brittany Remington and learn how to take control of your mental health journey. Video version available on my YouTube page. Audio version available on all the major Platforms, Apple, Spotify iHeart Radio etc. https://newdirectionspgh.com/ https://www.wowboothco.com/ https://www.spillwithme.com/ Special Shoutout to my Spotlight Supporters for Mental Health Awareness Month. Ed Meyer CEO/Owner of Tri-State Office Supply https://tristateofficefurniture.com/tri-state-office-furniture-locations/pittsburgh/ Megan Wollerton Owner of Life Force Wellness https://www.lifeforcewellness.com/ Chandra Chappell Owner of Mindful Adaptations https://mindfuladaptations.com/
In this episode, Joe interviews Joey Lichter, Ph.D.: professor in the Chemistry & Biochemistry department at Miami's Florida International University, and one of the few professors in the U.S. teaching a course about psychedelics at the collegiate level. He talks about his path towards the course, the challenge of creating a curriculum that covers everything in a few months, and the importance of teaching young minds about psychedelics the right away; shifting drug education from the “Just say no!” D.A.R.E. model to a more balanced, honest, and evidence-based approach. He aims for his students to think critically, ignore the hype, and see all possible angles with a fairly simple approach: Present the full story. He discusses: The importance of teaching history, from Stan Grof to MKUltra The work of David Nichols, David Nutt's drug harm scale, and the greatest lesson William Leonard Pickard took from LSD The representation of Spravato as a new drug, and his concerns with the over-medicalization of psychedelics Teaching about the complexities of Timothy Leary: Was he a positive or negative force? Decriminalization, legalization, and how he gets students to think about drug policy and more! For links and more, head to the show notes page.
Synopsis: In this episode of the Biotech2050 podcast, Dr. Mathai Mammen, CEO of FogPharma, shares valuable insights into the future trends of the biotech industry and the development of peptide-based therapeutics. Dr. Mammen's extensive career trajectory, from academia to leading pharmaceutical organizations, provides a comprehensive understanding of the industry's evolution and the pivotal roles he played at Theravance, Merck, and J&J. The episode delves into the significance of intracellular protein interactions and FogPharma's focus on developing helicon peptides to address this unmet need. Dr. Mammen's emphasis on a moonshot culture at FogPharma, coupled with his strategic approach to commercial success in biotech, makes this episode essential listening for executives in the biotech industry who are looking to stay ahead of future trends and gain insights into the innovative approaches shaping the industry's landscape. His profound knowledge and experience position him as a thought leader, offering invaluable perspectives on the challenges and opportunities in biotech, making this episode a compelling resource for industry executives seeking to implement strategies for commercial success in the biotech sector. Biography: Mathai Mammen is a world-renowned innovator in drug discovery, development, and team and company building. He brings significant global R&D and corporate leadership experience to his role as CEO, President and Chairman at FogPharma. Most recently, Mathai was a member of the executive committee at Johnson & Johnson, where he served as executive vice president of pharmaceuticals, R&D. During his tenure, he spearheaded a significant evolution of Janssen's R&D, one of the largest R&D organizations in the world. Mathai was a key leader in Johnson & Johnson's bold foray into COVID vaccines and he helped drive Janssen's substantial growth to become one of the top pharmaceutical companies globally. Under Mathai's leadership, Janssen R&D executed 40+ acquisitions and licenses and 350+ strategic partnerships and collaborations. A central pillar of his strategy was data science, which he used to couple recent revolutionary advances in data, compute and algorithmic approaches to every aspect of discovering and developing medicines. Mathai led his team to global approvals of eight new medicines, including Tremfya™, Darzalex Faspro™, Balversa™, Carvykti™, Rybrevant™, Ponvory™, Spravato™ and Tecvayli™, with many additional global approvals for expanded indications of marketed products. Prior to his role at Johnson & Johnson, Mathai served as senior vice president at Merck, where he was responsible for multiple research areas, including cardiovascular, metabolic and renal diseases, immunology, oncology and immuno-oncology. Before Merck, he led R&D at Theravance, Inc., a company he co-founded out of graduate school based on his work at Harvard University with Dr. George Whitesides. Under his leadership, Theravance advanced a robust pipeline of multiple development-stage compounds resulting in five approved pharmaceutical products, and separated into two companies: Theravance Biopharma, Inc. and Innoviva, Inc. In addition to his extensive corporate experience, Mathai currently serves on the board of directors of 10x Genomics, Inc. He has authored more than 150 peer-reviewed publications and patents. Mathai holds an M.D. from the Harvard Medical School and Massachusetts Institute of Technology (HST) and a Ph.D. in chemistry from Harvard University.
Cody Shandraw, President and Co-Founder of Healing Realty Trust, aims to provide robust mental and behavioral health treatment facilities. The lack of infrastructure has been a significant hurdle for expanding the commercialization of drugs that require longer in-office visits and space to accommodate the needs of patients undergoing treatments. The emerging field of psychedelics for treating neurological conditions like PTSD requires clinicians to understand the physical requirements for treatment facilities to provide privacy and comfort during the extended time necessary for many of these treatments. Cody explains, "In 2020, it was a really interesting stat that I was made aware of at one of the conferences down here in Miami. It was around a drug called Spravato, which is an intranasal ketamine drug. And they were very excited about the launch. It was in development for quite some time, and unfortunately, it didn't commercialize, I think, to their expectations. I asked one of the drug reps down here in Florida why he thought that was, and he said it was a really simple answer: the lack of infrastructure." "It's a unique drug, and we've only seen this a couple of times. Maybe proton therapy or dialysis centers where when a new therapy is approved, you need that infrastructure to go along with that therapy. And that is what Spravato was. You actually had to be in a clinic for two hours after administration for Spravato. So it was a very unique thing. And a lot of the legacy behavioral mental health providers that would be the target market for that drug, they didn't want to disrupt normal patient inflows into their clinic. So it took a couple of years. When that drug was launched, there were less than a hundred clinics in the United States offering that. Today, there are 2,700 of those clinics, and now Spravato is a blockbuster drug." #HealingRealtyTrust #CommercialRealEstate #BehavioralHealth #EmergingTherapies #PsychedelicAssistedTherapy #PatientAccess #HealthcareInfrastructure #ImprovingBehavioralHealth HealingRT.com Listen to the podcast here
Cody Shandraw, President and Co-Founder of Healing Realty Trust, aims to provide robust mental and behavioral health treatment facilities. The lack of infrastructure has been a significant hurdle for expanding the commercialization of drugs that require longer in-office visits and space to accommodate the needs of patients undergoing treatments. The emerging field of psychedelics for treating neurological conditions like PTSD requires clinicians to understand the physical requirements for treatment facilities to provide privacy and comfort during the extended time necessary for many of these treatments. Cody explains, "In 2020, it was a really interesting stat that I was made aware of at one of the conferences down here in Miami. It was around a drug called Spravato, which is an intranasal ketamine drug. And they were very excited about the launch. It was in development for quite some time, and unfortunately, it didn't commercialize, I think, to their expectations. I asked one of the drug reps down here in Florida why he thought that was, and he said it was a really simple answer: the lack of infrastructure." "It's a unique drug, and we've only seen this a couple of times. Maybe proton therapy or dialysis centers where when a new therapy is approved, you need that infrastructure to go along with that therapy. And that is what Spravato was. You actually had to be in a clinic for two hours after administration for Spravato. So it was a very unique thing. And a lot of the legacy behavioral mental health providers that would be the target market for that drug, they didn't want to disrupt normal patient inflows into their clinic. So it took a couple of years. When that drug was launched, there were less than a hundred clinics in the United States offering that. Today, there are 2,700 of those clinics, and now Spravato is a blockbuster drug." #HealingRealtyTrust #CommercialRealEstate #BehavioralHealth #EmergingTherapies #PsychedelicAssistedTherapy #PatientAccess #HealthcareInfrastructure #ImprovingBehavioralHealth HealingRT.com Download the transcript here
In this episode, Christopher Koddermann interviews Dr. Sam Banister: co-founder and chief scientific officer of Psylo, an Australian biotech company developing next-generation psychedelics. Banister discusses how he got involved in drug development, how Psylo came about, and the hallucinogenic and non-hallucinogenic 5-HT2A agonists Psylo is working on. He talks about the compromise between immediate need and ambition, and the ethical considerations and possibilities behind developing non-hallucinogenic compounds: What can we take from the psychedelic experience for people who aren't ideal candidates for one? Is the psychedelic experience truly necessary? And for what indications will these new Gen 3 compounds be most useful? He discusses: What we can infer about the volatility of biotech and the state of the psychedelic industry based on recent mergers and acquisitions The long-term challenges of drug development and the scalability of treatment options How the initial success of Spravato has played a role in allaying fears around new compounds Head twitch response and concerns it's not as accurate of a metric as we've believed Australia's decision to down-schedule psilocybin and MDMA, and the speed of implementation and licensing: How long will it be before people have easy access? What he sees for the future and why we need to be careful with language around expectations and more! Click here to head to teh show notes page.
Johnson & Johnson (JNJ) convened its earnings call on Tuesday, January 23rd, 2024, providing insights on the state of the company and the direction it hopes to take in the near future. Joaquin Duato, CEO of Johnson & Johnson, expressed contentment with the company's performance, particularly within their pulmonary franchise. "Overall, we're very happy with the trajectory of our pulmonary franchise in 2023. And we expect a similar trajectory as macitentan, OPSUMIT, and Tadalafil become standard of care", Duato stated during the earnings call. The year 2023 saw Johnson & Johnson report full-year sales of $85.2 billion, reflecting a growth rate of 7.4%. According to the earnings call, this performance was largely attributed to key products in their Innovative Medicine business such as DARZALEX, ERLEADA, STELARA, and TREMFYA, contributing substantially to the company's Oncology division. Following the recent launch of CARVYKTI, TECVAYLI, TALVEY, and SPRAVATO, Johnson & Johnson has broadened its scope in the oncology market. The firm also mentioned on the call that despite the ongoing recovery from the global pandemic, they marked notable increases in electrophysiology, heart recovery, surgery, orthopedics, and Vision, surpassing pre-pandemic levels in their MedTech business. Johnson & Johnson also shared its prospective plans and investment strategies. Acknowledged in the call, the company intends to allocate $15 billion towards research and development in 2023, underlining their commitment to innovation and pipeline advancement. In an effort to strengthen their oncology portfolio, JNJ plans to pursue strategic acquisitions, notably Ambrx, while simultaneously focusing on commercial execution, product differentiation, and expansion within the MedTech sector, as stated in the earnings call. The Johnson & Johnson earnings call highlighted steady financial performance and constant growth. With a focus on research and development, the company aims to introduce innovative products and engage in strategic acquisitions to support long-term growth and sustainability. As mentioned in the earnings call, amidst a competitive healthcare industry, the attributes that distinguish Johnson & Johnson are their emphasis on innovation and their dedication to meeting the evolving needs of patients globally. Remaining cautiously optimistic, it's important to note that these are plans based on the current circumstances and market trends, the actualization of which is dependent on a plethora of internal and external factors. JNJ Company info: https://finance.yahoo.com/quote/JNJ/profile For more PSFK research : www.psfk.com This email has been published and shared for the purpose of business research and is not intended as investment advice.
It's never too early to get a jump start on your holiday shopping, especially when it comes to the gadgets that everyone will want this season. If you have a tech enthusiast on your holiday shopping list, find out the latest must-have items you need to start shopping for! Retail expert Justine Santaniello talks about her top tech gifts for the 2023 holiday season. Justine will showcase gifts that not only feature next-level technology, but also offer unique ways to spend quality time with family and friends through the holiday season and beyond. Clinical depression, also known as major depressive disorder (MDD), is one of the most common mental disorders in the United States. MDD symptoms may include depressed mood, loss of interest or pleasure in daily activities, change in sleep, appetite or weight, diminished concentration, feelings of worthlessness, decreased movement and slowed thoughts, suicidal ideation and/or fatigue or loss of energy. Approximately one-third of adults in the U.S. with MDD may have treatment-resistant depression (TRD) – which means they haven't responded adequately to two or more antidepressant medications during the same depressive episode.Dr. Chepke, a Board-Certified psychiatrist in Huntersville, North Carolina specializes in treating adult patients with treatment-resistant depression, and discusses the signs and symptoms of challenging-to-treat depression and outline a treatment option for treatment-resistant depression, including SPRAVATO® (esketamine) CIII nasal spray, along with the risks and benefits of taking the medication.Thanksgiving is the busiest travel week of the year when parents face the stress of traffic and sometimes the challenge of dealing with a child who is car sick. Pediatrician and Social Media Star, Dr. Mona Amin, identifies factors that can cause kids to feel queasy while traveling and provide tips for helping little ones avoid car sickness
Dr. Craig Chepke, MD, FAPA discusses the signs and symptoms of challnging-to-treat depression and and outlines a treatment option for treatment-resistant depression, including SPRAVATO (esketamine) CIII nasal spray, along with the risks and benefits of taking the medication. Dr. Nazlie Latefi shares the science behind truly effective cold remedies unlocking the secrets of your respiratory system and making the most of the defense you already have. Applied Biological Laboratories has been on the forefront of cold and flue research for decades. Inflammation is the cause of cold and flu symptons!
Dr. Craig Chepke, MD, FAPA discusses the signs and symptoms of challnging-to-treat depression and and outlines a treatment option for treatment-resistant depression, including SPRAVATO (esketamine) CIII nasal spray, along with the risks and benefits of taking the medication. Dr. Nazlie Latefi shares the science behind truly effective cold remedies unlocking the secrets of your respiratory system and making the most of the defense you already have. Applied Biological Laboratories has been on the forefront of cold and flue research for decades. Inflammation is the cause of cold and flu symptons!
In this episode, we meet the Psycho Family, Ariel's fictional relatives who live up to their name. Ariel also chats about some of her psycho dating experiences and receiving Spravato, a ketamine derivative for treating depression. DM me here
OSMINDOsmind is the premier platform for psychedelic-assisted psychotherapy practices. The all-in-one platform includes purpose-built charting for ketamine, SPRAVATO, psychotherapy and more; as well as patient tools for the therapeutic alliance that include 40+ validated rating scales and a patient app for journaling and secure messaging too. Visit Osmind using our link below:osmind.org/asocEpisode Description:In this episode, we interview Max Wolff. Max Wolff is a psychologist and psychotherapist, and serves as the Head of Psychotherapy Training and Research at the MIND Foundation. We discuss the EPIsoDE psilocybin trial that Max is involved with in Germany, perspectives on how to properly conduct psychedelic therapy, differences between Germany and the United States when it comes to therapy and psychedelics, and more.Show Notes:-4:00 EPIsoDE Study (Clinical Trial):https://episode-study.de/https://mind-foundation.org/research/episode-study/-41:00 Psychotherapy in Germany:https://www.ncbi.nlm.nih.gov/books/NBK279513/#:~:text=Statutory%20health%20insurers%20cover%20up,part%20of%20group%20therapy%20sessions.-48:30 Insight Conference in Berlin:https://insight-conference.eu/-55:30 MIND Foundation:https://mind-foundation.org/Learning to Let Go journal article:https://www.frontiersin.org/articles/10.3389/fpsyt.2020.00005/full
Show Description: In this fascinating episode, Brian is joined by Denise Rue, who is a hypnotherapist, social worker, and experienced psilocybin retreat facilitator. Brian and Denise dive deep into the nature of psychedelic therapy and the retreat experience, from preparation through integration. Denise shares her perspective on the role of a psychedelic therapist and what it takes to successfully facilitate psychedelic experiences for clients with a wide range of goals and backgrounds. The particular utility of group work with psychedelics is explored, as are topics of dealing with challenging psychedelic experiences, “deprogramming” beliefs about psychedelics and mental health, relating to psychedelic medicines as teachers, and the mystical and spiritual impacts psychedelics can have on individuals who choose to work with these medicines. OSMINDOsmind is the premier platform for psychedelic-assisted psychotherapy practices. The all-in-one platform includes purpose-built charting for ketamine, SPRAVATO, psychotherapy and more; as well as patient tools for the therapeutic alliance that include 40+ validated rating scales and a patient app for journaling and secure messaging too. Visit Osmind using our link below:osmind.org/asoc
OSMINDOsmind is the premier platform for psychedelic-assisted psychotherapy practices. The all-in-one platform includes purpose-built charting for ketamine, SPRAVATO, psychotherapy and more; as well as patient tools for the therapeutic alliance that include 40+ validated rating scales and a patient app for journaling and secure messaging too. Visit Osmind using our link below:osmind.org/asocDid you miss out on Psychedelic Science 2023? Or did you go and want to spend time revisiting some of the highlights? In this episode Brian shares some of his experiences at the conference including learning about the latest science on psychedelics and what it was like to be immersed in a large, diverse psychedelic community of 12,000 people. We critically evaluate the search for the “non-psychedelic psychedelic” and discuss the tension between the hope for a better culture and the need to be cautious. Brian also shares how queerness and psychedelics can both be agents for infusing awe and wonder into our capitalistic flatland culture.
Dr. Martha Koo, Owner of Neuro Wellness Spa and the Medical Director at Clear Recovery Center, a residential detox and intensive outpatient treatment center for individuals struggling with mental health, addiction, and dual diagnoses, is double Board Certified in Psychiatry and Addiction Medicine and joins Ashley and Sam in this episode to discuss alternative forms of treatment for those with dual diagnosis including eating disorders. As a Psychiatrist in Los Angeles for over 25 years, Dr. Koo has enjoyed her private practice, providing outpatient psychotherapy, psychoanalysis and pharmacological treatment for individuals, couples, and families. A pioneer in the development and application of Transcranial Magnetic Stimulation (TMS), Dr. Koo is the founder of Neuro Wellness Spa, where she offers TMS, Magnetic E-Resonance therapy, iv ketamine, Spravato, iv nutrition, and photobiomodulation as novel interventions for treatment-resistant mental illness. You can find Dr. Koo on Instagram at: @neurowellnessspa If you enjoy our show, please rate, review, subscribe, and tell your friends and colleagues! Interested in being a guest on All Bodies. All Foods.? Email podcast@renfrewcenter.com for a chance to be featured. All Bodies. All Foods. is a podcast by The Renfrew Center. Visit us at: https://renfrewcenter.com/
This Episode's SponsorOSMINDOsmind is the premier platform for psychedelic-assisted psychotherapy practices. The all-in-one platform includes purpose-built charting for ketamine, SPRAVATO, psychotherapy and more; as well as patient tools for the therapeutic alliance that include 40+ validated rating scales and a patient app for journaling and secure messaging too. Visit Osmind using our link below: osmind.org/asocIn this episode, we speak with Jon Dennis. Jon is a lawyer by training, and has played an integral role in the development of Measure 109 in Oregon. He also serves as the Executive Director of a pending facilitator training program. We discuss the development of policy surrounding psychedelics in the United States, including making space for community use, safety considerations, populism vs elitism, accessibility, and more. 12 states are currently in the process of developing legislation surrounding psychedelics, and we discuss how states can build on and learn from one another throughout this process.Guest Biography:Jon Dennis is a lawyer, activist, and entrepreneur in the psychedelics ecosystem. He is the executive director of Vital Oregon, a psilocybin facilitator training program by Psychedelics Today, and the co-host of the “Eyes on Oregon” podcast from Psychedelics Today. Jon is a member of the Chacruna Institute's Council for the Protection of Sacred Plants. He is a member of the Psychedelics Bar Association and sits on its Religious Use Committee. Jon serves on the Executive Committee of the Oregon State Bar Practice Section on Cannabis and Psychedelics and is a founding member of the Entheogenic Practitioners Council of Oregon.Show Notes:Article about Measure 109 not being psilocybin-assisted therapy: https://chacruna.net/oregon-legalized-psilocybin-supported-adult-use/Story about boy who died: https://www.wftv.com/news/local/federal-judge-dismisses-ayahuasca-churchs-request-overturn-dea-decision/DA3FHCYUP5GMJNW26NY7WHWX6U/Measure 109, Measure 110:Oregon Psilocybin Services (Measure 109): https://www.oregon.gov/oha/ph/preventionwellness/pages/oregon-psilocybin-services.aspxMeasure 110: https://www.oregon.gov/oha/hsd/amh/pages/measure110.aspxIllinois legislation:https://www.ilga.gov/legislation/BillStatus.asp?DocTypeID=HB&DocNum=1&GAID=17&SessionID=112&LegID=14183Graham Boyd Horizons Northwest: https://www.youtube.com/watch?v=3UTWxaW7edkNatural Medicine Health Act:
In this episode, Joe interviews Nick Kadysh: Founder and CEO of PharmAla Biotech and member of the board of directors for The Canadian Psychedelic Businesses Association. PharmAla Biotech is a Toronto-based Life Sciences company with two focuses: contracting with manufacturers to provide researchers with GMP MDMA (created under Good Manufacturing Practice regulations), and creating and researching novel analogs of MDMA. And just today, they announced that Health Canada has authorized them (and their distribution partner, Shaman Pharma) to supply their LaNeo™ MDMA for the treatment of a patient under Canada's Special Access Program – the first time this has happened in Canada. He discusses the creation of PharmAla and why their model changed from primarily researching analogs to manufacturing; why they're operating out of Canada and using manufacturers instead of running the lab themselves; the excitement around Australia's recent about-face on MDMA and psilocybin-assisted therapy; the bureaucracy of U.S. drug policy and how much a broken supply chain affects the whole industry; bad IP and companies filing rapid fire patents; why creating new analogs of MDMA is so important; and why the psychedelic space needs to bring culture along with us. He also talks about Spravato, cannabis and risks of cancer, THC nasal sprays, and research he's most excited about: that MDMA seems to alleviate dyskinesia caused from Parkinson's disease, and that MDMA could improve social anxiety in people with autism. He's aiming to run a clinical trial and believes they have developed a safe MDMA analog that the autistic community will respond to very well. www.psychedelicstoday.com
Dr. Reid Robison, Chief Clinical Officer at Numinus, joins Paul F. Austin to discuss psychedelic research, legislation, & complementary modalities. Find episode links, summary, and transcript here. Dr. Robison shares the challenges and innovations in psychedelic therapy, drawing from his own clinical research and current projects at Numinus, a mental health company that brings safe, evidence-based psychedelic-assisted therapies to people in need. Explore topics such as the efficacy of psychedelic-assisted therapies, the pros and cons of psychedelic patents, and the need for multimodal approaches to mental health care. Dr. Reid Robison is a board-certified psychiatrist and Chief Clinical Officer at Numinus, where he oversees clinical services, including teaching and training in ketamine-assisted psychotherapy, for the company's clinics across the US and Canada. He has led over 200 clinical trials in neuropsychiatry and previously served as coordinating investigator for the MAPS-sponsored MDMA-assisted psychotherapy study of eating disorders. Dr. Robison is currently principal investigator for a number of psychedelic medicine studies with psilocybin, LSD, and DMT. As a researcher and early adopter of ketamine in psychiatry, Dr. Robison got his first grant to study that medicine in 2011, around which time he also led a pivotal IV ketamine study for treatment-resistant depression. To date, Dr. Robison has guided thousands of ketamine therapy journeys and Spravato dosing sessions, and has also worked in ayahuasca retreat settings abroad. Dr. Robison is an adjunct professor at both the University of Utah and Brigham Young University, and board chair of the Psychedelic Institute, focused on education and research. Highlights: Dr. Robison's journey into the world of psychedelics, from ketamine research to psilocybin advocacy on Capitol Hill. How patents can expand access to psychedelic therapy through health insurance. Dr. Robison's innovative studies and projects at Numinus. The need for a new standard of mental health care and the role of complementary modalities in achieving it. Exploring modalities complementary to psychedelic therapy. The promise of personalized mental health care. The pioneering efforts of Numinus in offering employee psychedelic mental health care via ketamine. The future of insurance and the potential for greater coverage of ketamine-assisted psychotherapy. What's on the horizon at Numinus. Key Links: Dr. Robison's Website Numinus Episode Sponsors: Numinus Third Wave's Mushroom Grow Kit
Dr. Sam Zand, Co-founder & Chief Medical Officer of Better U, joins Paul F. Austin for a rich conversation on at-home ketamine-assisted therapy. As a practicing psychiatrist and the Chief Medical Officer of Better U, Dr. Sam Zand utilizes his expertise in neuroplasticity to help patients address the root cause of their problems and establish new ways of thinking. After initial psychedelic medicine research at Johns Hopkins University, Dr. Zand began treating patients clinically with ketamine in 2019. He now teaches psychedelic medicine rotations to psychiatry residents and medical students and is an advocate and spokesperson for the FDA-approved esketamine, Spravato. He is trained in general psychiatry, addiction recovery, and psychotherapy, and has a passion for psychedelic therapy, crisis intervention, relationship counseling, and integrated spiritual therapy. In addition to being a co-founder of Better U, Dr. Zand is also the owner and CEO of a national telepsychiatry service, Anywhere Clinic. He has merged his passions for lifestyle medicine, performance coaching, and entrepreneurship to establish platforms that build leaders and medical healers. He assisted in Crisis Intervention Training for the Las Vegas Metropolitan Police Department, helped create mental skills departments for professional sports teams and corporations, and has worked with industry leaders, corporate executives, and pro athletes. Dr. Zand is passionate about increasing education to end the stigma that surrounds mental health topics, advancing the integration of psychiatry and spirituality, and making clinically proven, innovative new therapies more accessible for all. Find episode links, summary, and transcript here. Highlights: Understanding the differences between Spravato and generic ketamine, and the role each might play in the future of psychedelic-assisted therapy. ‘The Skill of Psychedelics' - looking at medicines like ketamine in the bigger picture of healing, growth, and transformation. Dr. Zand's Four phases of healing: Heal, Grow, Love, Transcend What differentiates Better U from other telemedicine psychedelic-assisted therapy services Dr. Zand on effective dosing, intention-setting, and utilization of psychotherapy. Exploring the correlation between dissociative experience and positive transformation How ego actualization and ego dissolution fit into the greater path of healing and transformation. Transcending pathology and the disease-care model of mental healthcare to embrace the biopsychosocial-spiritual model. The ‘Powered by Better U' Model of collaboration to bring beneficial ketamine treatments beyond the clinic. Closing Episode Links: Better U Better Universe Foundation Dr. Zand on LinkedIn Recent clinical trial on the safety and efficacy of at-home ketamine treatments Third Wave's Guide to Ketamine MAPS This podcast is brought to you by Third Wave's Mushroom Grow Kit. The biggest problem for anyone starting to explore the magical world of mushrooms is consistent access from reputable sources. That's why we've been working on a simple, elegant (and legal!) solution for the past several months. Third Wave's Mushroom Grow Kit and Course has the tools you need to grow mushrooms along with an in-depth guide to finding spores. This episode is also brought to you by Apollo Neuro, the first scientifically validated wearable that actively improves your body's resilience to stress. Apollo engages with your sense of touch to deliver soothing vibrations that signal safety to the brain. Clinically proven to improve heart rate variability, it can actually enhance the outcomes of your other efforts like deep breathing, yoga, meditation, and plant medicine. Apollo was developed by a friend of Third Wave, Dr. David Rabin M.D Ph.D., a neuroscientist and board-certified psychiatrist who has been studying the impact of chronic stress in humans for nearly 15 years. Third Wave listeners get 15% off—just use this link.
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