FDA advisors say no to MDMA. What’s the impact? With Josh Hardman

Greg and Matias interview Dr. Jim Adams, professor and autism researcher at Arizona State University and President of Gut-Brain-Axis Therapeutics, on groundbreaking research in autism.In this episode, we discuss:The latest advancements in microbiome therapy for autismHow the gut-brain axis is shaping new therapeutic approachesThe role of nutritional interventions in supporting individuals with autismEnvironmental factors and toxins influencing autism developmentCredits:Created by Greg Kubin and Matias SerebrinskyHost: Matias Serebrinsky & Greg KubinProduced by Jonathan A. Davis,  Nico V. Rey & Caitlin NerFind us at businesstrip.fm and psymed.venturesFollow us on Instagram and Twitter!Theme music by Dorian LoveAdditional Music: Distant Daze by Zack Frank

Matias interviews Elizabeth Horn, founder of the 2m Foundation, on the current state of autism and what can we do about it.In this episode, we discuss:The rising prevalence of autism and its impact on societyHow 2m Foundation is funding research and solutionsEnvironmental and biological factors contributing to autismPhilanthropy and venture capital through the Autism Impact FundCredits:Created by Greg Kubin and Matias SerebrinskyHost: Matias Serebrinsky & Greg KubinProduced by Jonathan A. Davis,  Nico V. Rey & Caitlin NerFind us at businesstrip.fm and psymed.venturesFollow us on Instagram and Twitter!Theme music by Dorian LoveAdditional Music: Distant Daze by Zack Frank

Greg and Matias interview Dana Watt, a Partner at Breakout Ventures, about genetic medicine for brain and mental health.In this episode, we discuss:How genetic therapies work: addressing underlying causes, not just symptomsThe opportunities and challenges for genetic therapies for brain healthExploring effective delivery of genetic payloadsCommercial viability and insurance considerationsCredits:Created by Greg Kubin and Matias SerebrinskyHost: Matias Serebrinsky & Greg KubinProduced by Jonathan A. Davis,  Nico V. Rey & Caitlin NerFind us at businesstrip.fm and psymed.venturesFollow us on Instagram and Twitter!Theme music by Dorian LoveAdditional Music: Distant Daze by Zack Frank

Greg and Matias interview Jay Sanguinetti, founder of Sanmai Technologies, a startup using transcranial focused ultrasound for the treatment of mental health conditions. Jay has a background in academia, having worked at the University of Arizona and started the SEMA Lab (Science Enhanced Mindful Awareness).In this episode, we discuss:The science behind transcranial focused ultrasound and its therapeutic potential for mental healthThe risks and considerations involved in using focused ultrasound technology for mental health treatmentsJay's experience transitioning from academia to founding a mental health technology startupThe regulatory landscape that Sanmai Technologies will navigate as they bring this novel neurotechnology to marketCredits:Created by Greg Kubin and Matias SerebrinskyHost: Matias Serebrinsky & Greg KubinProduced by Jonathan A. Davis,  Nico V. Rey & Caitlin NerFind us at businesstrip.fm and psymed.venturesFollow us on Instagram and Twitter!Theme music by Dorian LoveAdditional Music: Distant Daze by Zack Frank

Greg and Matias interview Tim Marjenin, a regulatory consultant at MCRA with 16 years of experience at the FDA, to discuss the regulatory landscape for neurotechnology devices.Tim provides insights into the FDA approval process for neurotech devices, drawing from his extensive experience on the FDA's Neurostimulation-Neurology Devices Team. The episode explores the evolving field of neurotechnology and its regulatory challenges.In this episode, we discuss:Different regulatory pathways for neurological devices (510(k), De Novo, PMA)FDA's approach to novel neurotechnologies like brain-computer interfaces (BCIs)Considerations for invasive vs. non-invasive neurotech devicesThe importance of cybersecurity in neurotechnologyCommon mistakes companies make in the regulatory process and how to avoid themThe potential future of neurotechnology, including human augmentation and telepathyCreated by Greg Kubin and Matias SerebrinskyHost: Matias Serebrinsky & Greg KubinProduced by Jonathan A. Davis,  Nico V. Rey & Caitlin NerFind us at businesstrip.fm and psymed.venturesFollow us on Instagram and Twitter!Theme music by Dorian LoveAdditional Music: Distant Daze by Zack Frank and Krotoa by Makropulos

Greg and Matias interview Gurdane Bhutani, an investor at MBX Ventures, to discuss the impact of environmental toxins on health and the field of exposomics.Gurdane is an expert in environmental health, with a background in Epidemiology and Environmental Health Sciences. He provided insights into the pervasive nature of environmental toxins and their implications for public health. This episode also has a guest appearance from Bruce Blumberg, a Professor of Developmental and Cell Biology at UC Davis.In this episode, we discuss:The widespread presence of environmental toxins and their link to diseases like Parkinson's and autismThe field of exposomics and lifetime environmental exposuresObesogens (chemicals whose exposure makes you fat)Startups building solutions for better diagnostics, green chemistry, and water treatmentPractical lifestyle changes to reduce exposure to harmful chemicals and improve healthCredits:Created by Greg Kubin and Matias SerebrinskyHost: Matias Serebrinsky & Greg KubinProduced by Jonathan A. Davis,  Nico V. Rey & Caitlin NerFind us at businesstrip.fm and psymed.venturesFollow us on Instagram and Twitter!Theme music by Dorian LoveAdditional Music: Distant Daze by Zack Frank and Temperance by Eltham House

Greg and Matias interview Josh Hardman, founder and editor of Psychedelic Alpha, to discuss the recent FDA advisory committee meeting on Lykos Therapeutics’ MDMA-assisted therapy for PTSD.Josh is a leading writer covering the intersection of psychedelics and business. He provided live reporting and analysis of the AdComm meeting.In this episode, we discuss:The FDA advisory committee process and its implications for drug approvalsFunctional unblinding and expectancy effects in psychedelic clinical trialsPotential impacts on the broader psychedelic medicine industryThe future of psychedelic-assisted psychotherapy protocolsNeuroplastogen development and non-hallucinogenic approachesChallenges around therapy, safety, and regulatory pathways for psychedelic medicinesCredits:Created by Greg Kubin and Matias SerebrinskyHost: Matias Serebrinsky & Greg KubinProduced by Jonathan A. Davis,  Nico V. Rey & Caitlin NerFind us at businesstrip.fm and psymed.venturesFollow us on Instagram and Twitter!Theme music by Dorian LoveAdditional Music: Distant Daze by Zack Frank

Software, hardware, and biotechnology are playing an increasingly transformative role in our mental health and wellness. Join us as we discuss what investors look for in these new companies and how they separate what’s real — and what’s near-term — from what’s hype. We’ll explore AI-powered tools for mental health, the new area of “enerceuticals” (energy replacing the “pharma”), psychedelics, and why what’s in your gut is so important to your mental state. Hear from investors who have a wide view of this growing startup landscape and better understand which new ventures are likely to succeed.This is a live panel from South by South West 2024 with panelists Matias Serebrinsky of PsyMed Ventures and Business Trip and Amy Kruse of Satori Capital, moderated by Christie Nicholson of Studio For Communicating Complexity and Dan Blumberg of Modern Product Minds and the CRAFTED. podcast.For more on CRAFTED., Dan's Webby-honored podcast featuring founders and leaders discussing what it really takes to build incredible products and companies, listen here: crafted.fm  Credits:Created by Greg Kubin and Matias SerebrinskyHost: Matias Serebrinsky & Greg KubinProduced by Jonathan A. Davis,  Nico V. Rey & Caitlin NerFind us at businesstrip.fm and psymed.venturesFollow us on Instagram and Twitter!Theme music by Dorian LoveAdditional Music: Distant Daze by Zack Frank

Matias hosted a panel at The Battery SF with renowned psychedelics experts, Nolan Williams, Allison Feduccia, Matt Baggott.Nolan is a Stanford professor currently researching ibogaine among other areas in psychiatry and radiology, and he's a founder of TMS company Magnus Medical. Allison is the founder of Psychedelic Support, a platform providing psychedelic education, community and a provider directory. And Matt is founder and CEO of Tactogen, a biotech company developing compounds similar to MDMA.In this episode, we discuss…The effects and mechanisms of different psychedelics (MDMA, psilocybin, ibogaine)The role of therapy/support during psychedelic experiencesScalability, accessibility, and optimal therapeutic useDigital solutions, new care models, and policy changes Credits:Created by Greg Kubin and Matias SerebrinskyHost: Matias Serebrinsky & Greg KubinProduced by Jonathan A. Davis,  Nico V. Rey & Caitlin NerFind us at businesstrip.fm and psymed.venturesFollow us on Instagram and Twitter!Theme music by Dorian LoveAdditional Music: Distant Daze by Zack Frank

Matias interviews Lili Brillstein about how to work collaboratively with healthcare payers (the ones that reimburse for medical expenses).Lili is a pioneer in the field, having previously led one of the largest bundled payment initiatives at Horizon Blue Cross Blue Shield. She currently is the founder of her own advisory firm, BCollaborative, where she helps startups and providers develop value propositions that resonate with payers and create models that can be successfully administered. In this episode, they discuss:What payers want and their key prioritiesStrategies to communicate startup value propositions to payersThe role of interim successes for chronic conditionsHow to align payers, providers, and startupsFee-for-service vs. value-based care modelsCredits:Created by Greg Kubin and Matias SerebrinskyHost: Matias Serebrinsky & Greg KubinProduced by Jonathan A. Davis,  Nico V. Rey & Caitlin NerFind us at businesstrip.fm and psymed.venturesFollow us on Instagram and Twitter!Theme music by Dorian LoveAdditional Music: Distant Daze by Zack Frank