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Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere

Julio G. Martinez-Clark
Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere
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  • Joseph Palumbo, Head of R&D & Chief Medical Officer at BioVie Inc
    Today we’re joined by Dr. Joseph M. Palumbo, a physician-scientist, mentor, and therapeutics developer with more than three decades of leadership in psychiatry, neurology, and neurodegenerative research. Dr. Palumbo has led groundbreaking work across the full R&D spectrum—from preclinical innovation to global drug approvals—advancing programs valued at over $1 billion. He has held senior leadership roles as Global Head of Psychiatry at Johnson & Johnson, Vice President & Fellow at Mitsubishi Tanabe Pharma, and Chief Medical Officer at Zynerba and BioVie. His contributions include several successful FDA approvals, including Risperdal Consta®, Invega®, Invega Sustenna®, and Radicava®. At BioVie, he currently serves as Executive Vice President, Head of R&D, and Chief Medical Officer, as well as Principal Investigator on a $13 million U.S. Department of Defense study on Long COVID. A Life Fellow of the American Psychiatric Association and Fellow of the American Neurological Association, Dr. Palumbo brings a rare combination of scientific innovation and executive leadership—bridging translational medicine, enterprise strategy, and patient impact.
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  • Nicholas Kadysh, CEO at PharmAla Biotech
    In this episode, we welcome Nicholas Kadysh, CEO of PharmAla Biotech, the company pioneering GMP MDMA production and named the top-performing stock on the Canadian capital markets in 2023 by The Market Herald. As Chair of Psychedelics Canada, Nicholas has been instrumental in advancing legal and ethical standards, building strong relationships with government, and shaping a regulatory landscape where healthcare innovation can thrive. His leadership has also been recognized by The Peak, which honored him in 2023 for emerging leadership in healthcare. Tune in for an insightful conversation on the future of psychedelic medicine, biotech innovation, and the policies driving change in healthcare. 
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    32:51
  • Carolina Alarco, Founder & Principal, Bio Strategy Advisors
    In this episode, we sit down with Carolina [Last Name], a senior biotech executive with over 25 years of experience in the biopharmaceutical industry. Carolina is the Founder & Principal of Bio Strategy Advisors, serves on multiple biotech and nonprofit boards, and is the Co-Founder & Co-Chair of Latinos in Bio. She shares insights from her leadership journey at companies like Genzyme, Aegerion Pharmaceuticals, and Novelion Therapeutics, and discusses the future of biotech, the role of angel investing, and why diversity in innovation matters. Tune in to hear how Carolina is shaping the next generation of biotech leaders and building a more inclusive innovation ecosystem. 
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    37:17
  • Jason Hurt, Founder & CEO of Theragnostic Insights
    In this episode, we are joined by Dr. Jason Hurt, a clinician-scientist and entrepreneur with extensive experience in radiopharmaceutical development, clinical trial strategy, and oncology drug development. In March 2025, Dr. Hurt founded Theragnostic Insights, a consulting and strategic advisory firm focused on advancing theranostic solutions and radioligand therapies—pioneering approaches that are shaping the future of cancer treatment. 
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  • Martin Schiller, Founder & CEO of Heligenics Inc
     In this episode, we sit down with Dr. Martin R. Schiller, Prabhu Endowed Professor at UNLV, Founding Director of the Nevada Institute of Personalized Medicine, and founder of Heligenics Inc. Dr. Schiller shares his journey from academia to entrepreneurship, the breakthroughs behind the GigaAssay technology, and how personalized medicine is shaping the future of healthcare. Tune in to learn how cutting-edge research in genomics and biotechnology is being translated into real-world therapies and diagnostics. 
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Acerca de Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere

Hosted by bioaccess® CEO, Julio G. Martinez-Clark, the Global Trial Accelerators™ podcast delivers actionable insights for Medtech, Biopharma, and Radiopharma innovators battling lengthy timelines and costly delays. Each episode features candid conversations with clinical trial pioneers, regulatory strategists, and startup founders who’ve slashed 6–12 months off approvals by leveraging emerging regions like Latin America, Eastern Europe, and Australia.What You’ll Learn:Speed Secrets: How to secure ethics approval in 4–6 weeks (vs. 6+ months in US/EU) using harmonized pathways like MINSA (Panama), ALIMS (Serbia), and Australia’s CTN.Cost-to-Speed Hacks: Operational strategies to reduce trial budgets by 30% while maintaining FDA/EMA compliance.Global Patient Access: Leverage treatment-naive populations in cardiology, rare diseases, and advanced therapies across 50+ pre-vetted sites.Why Listen?Actionable Playbooks: Reverse-engineer success stories from startups that enrolled cohorts 50% faster and secured Series B funding 12–18 months early.Regulatory Intel: Stay ahead of shifting LATAM, Balkans, and APAC guidelines with on-the-ground experts.Future-Proof Insights: Explore decentralized trials, AI-driven recruitment, and post-trial commercialization in $1B+ markets.“bioaccess®’s Serbia site activated in 8 weeks-9 months faster than our EU delay. This podcast is why we partnered with them.”– Digital Health Startup CEONew episodes drop weekly. Subscribe to unlock your shortcut to global trial velocity.Brought to you by bioaccess® – Turning “anywhere” into accelerated FDA/EMA submissions since 2010.
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