PodcastsEconomía y empresaGlobal Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere

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

Julio G. Martinez-Clark
Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere
Último episodio

123 episodios

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

    Gary Zammit, President & CEO at Clinilabs Drug Development Corporation

    17/04/2026 | 46 min
    In this episode, we welcome Gary K. Zammit, a leading expert at the intersection of science, business, and innovation in the life sciences industry.
    Gary is the founder and CEO of Clinilabs, a CNS-focused contract research organization, and the author of Beyond the Science: How People, Process, and Systems Transform the Business of Life Sciences. He also serves as a clinical professor of psychiatry at the Icahn School of Medicine at Mount Sinai and is a fellow of the American Academy of Sleep Medicine.
    With more than 250 published articles and abstracts, Gary has spent his career advancing safer and more effective treatments for psychiatric and neurological disorders. In this conversation, he shares insights from decades of experience—exploring how scientific rigor, operational excellence, and human-centered leadership come together to transform healthcare innovation.
    Tune in for a deep dive into the future of clinical research, entrepreneurship in life sciences, and the systems that drive meaningful impact.
  • Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere

    Joseph Grieco, VP at Tris Pharma & Liza Micioni, Sr. Director at Tris Pharma

    10/04/2026 | 53 min
    In this episode, we speak with Joseph Grieco and Liza Micioni, two experienced leaders in clinical development.
    Joseph Grieco leads clinical programs in neurological disorders at Tris Pharma, focusing on innovative solutions for unmet medical needs.
    Liza Micioni brings over 25 years of experience in global clinical operations, specializing in rare diseases and CNS disorders, with a strong focus on patient-centric approaches.
    Together, they discuss how leadership, innovation, and operational excellence are shaping the future of clinical research.
  • Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere

    Robert Packard, President at Medical Device Academy, Inc

    27/03/2026 | 52 min
    In this episode, we are joined by Robert Packard, a seasoned Quality and Regulatory Affairs professional with over 20 years of experience in the medical device industry and a decade in biotech manufacturing validation and scale-up.
    Robert has held leadership roles in multiple startups, co-founded a laparoscopic imaging company, and previously worked as a lead auditor and instructor for a major Notified Body. His expertise spans 510(k) submissions, CE Marking, Canadian Medical Device Licensing, and the development and implementation of ISO 13485-compliant quality systems.
    He is also passionate about education, producing weekly training content focused on current quality and regulatory challenges.
  • Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere

    Kristen Mittal, Co-founder and CEO of Mittal Consulting

    20/03/2026 | 36 min
    In this episode, we sit down with Kristen Mittal, RAC, PMP, Co-Founder and CEO of Mittal Consulting, a leading regulatory affairs firm supporting medical device innovators.
    With over 10 years of experience across startups and Fortune 500 companies, Kristen brings deep expertise in navigating FDA pathways for Class I, II, and III devices. She shares practical insights on regulatory strategy, accelerating approvals, and building strong post-market frameworks.
    Kristen also highlights her work empowering early-stage ventures and her contributions as an advisory committee member at OHSU, the University of Washington, and UCSF.
    If you're building in MedTech or interested in regulatory strategy, this episode is packed with valuable insights you won’t want to miss.
  • Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere

    Tina Soulis, Founder and Director at Alithia Life Sciences

    13/03/2026 | 32 min
    In this episode, we welcome A/Prof Tina Soulis, a life sciences leader with over 30 years of experience in clinical research, biotechnology, and healthcare.
    Founder of Alithia Life Sciences and academic contributor at the University of Melbourne, Tina has held senior roles including CEO of a CRO, Director of an ASX200 company, and VP of Clinical Strategy and Development.
    She is also one of the few Australian clinical development leaders to successfully guide products from lab discovery to regulatory approval.

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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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