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

Julio G. Martinez-Clark
  • 4.9 (7)
  • Business
  • Updated Biweekly

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 CEO New 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.

  1. 1d ago

    Gennaro Maida, CEO and Founder at Bluestocking Health, LLC

    Episode 140: Gennaro Maida – From Wearable Sensors to Clinical Evidence In this episode, we speak with Gennaro Maida, a healthcare technology executive working at the intersection of wearable technology, clinical research, and artificial intelligence. Gennaro is CEO/CMIO of Denovo Innovations Group, Director of Clinical Products at Tactical Rehabilitation, and recently served as CMIO of The Cena Group. He also serves on the American Heart Association's Health Tech Advisory Group. Our conversation explores how sensor data can be transformed into meaningful clinical evidence, including PPG and HRV signal processing, HIPAA-compliant remote data capture for multi-site studies, and AI architectures designed to support clinical and regulatory evidence. Gennaro also discusses the challenges surrounding digital biomarkers, the importance of establishing "ground truth," and why AI-generated inferences must remain distinct from validated clinical facts. He holds a BME from Duke University and an MS in Medicine from Hahnemann University, with a focus on cardiac surgery outcomes.

    Gennaro Maida, CEO and Founder at Bluestocking Health, LLC

  2. Sep 25

    Benjamin Holmes, Chief Executive Officer at Nanochon

    Dr. Ben Holmes: 3D Printing, MedTech, and the Future of Joint Repair In this episode, we speak with Dr. Ben Holmes, CEO and Co-Founder of Nanochon, a medical technology company developing Chondrograft™, a 3D-printed synthetic implant designed to repair damaged cartilage and restore joint function for patients who are not yet candidates for knee replacement. Dr. Holmes holds a Ph.D. in Biomedical Engineering from The George Washington University and a B.S. in Mechanical and Aerospace Engineering from the University of Virginia. His research has focused on biomaterials and 3D printing for orthopedic tissue repair. Since co-founding Nanochon in 2016, Dr. Holmes has helped secure nearly $12 million in funding through NSF grants, venture capital, and other awards. He has also guided the company to its first-in-human clinical trial. As a published researcher, patent holder, entrepreneur, and healthcare innovator, Dr. Holmes offers a unique perspective on the journey from biomedical research and engineering to the development and clinical evaluation of medical devices. In this conversation, we discuss the science behind 3D-printed orthopedic implants, the challenges of developing innovative medical devices, the realities of funding a medtech startup, and the potential of advanced manufacturing and biomaterials to transform patient care.

    Benjamin Holmes, Chief Executive Officer at Nanochon

  3. Sep 18

    Allison Komiyama, CEO and Founder at Bluestocking Health, LLC

    In this episode, we are joined by Allison Komiyama, Founder of Bluestocking Health, for a conversation about medical devices, regulatory strategy, clinical evidence, and the journey of bringing innovative medical technologies to market. Allison has spent most of her career helping medical device companies navigate the regulatory process and successfully bring their technologies to market. Over the past seventeen years, she has been involved in hundreds of FDA pre-submissions and premarket submissions covering a wide range of medical device technologies. Her career includes serving as an FDA reviewer in the Center for Devices and Radiological Health (CDRH), as well as founding AcKnowledge Regulatory Strategies, LLC in 2014. Following its acquisition in 2021, Allison continued working with medical device companies of all sizes and across different device types throughout the product life cycle. In 2025, she founded Bluestocking Health with the goal of creating more conversations around medical devices, science, clinical evidence, and healthcare, while helping innovative technologies communicate their value and ultimately improve people's lives. Allison holds a degree in Molecular & Cell Biology from the University of California, Berkeley, and a doctorate in Neuroscience from Stanford University. She also earned her Regulatory Affairs Certification (US) in 2014 and became a RAPS Fellow in 2024. In this conversation, Allison shares her experience and insights into the medical device industry, FDA regulatory pathways, clinical evidence, and the importance of communicating the value of MedTech innovation. 🎧 Listen to the full episode to learn more about the intersection of science, regulation, and medical technology.

    Allison Komiyama, CEO and Founder at Bluestocking Health, LLC

  4. Sep 11

    Daniel Zequeto, Founder & CEO at ODC Life Sciences

    In this episode, we speak with Daniel Zequeto, founder of ODC Life Sciences, about the challenges and opportunities of conducting clinical development across Brazil and Latin America. With more than 20 years of experience as a commercial and clinical leader at Abbott, Hospira, Shire, and Alexion, Daniel has worked on both sides of the equation and witnessed firsthand the challenges sponsors face when entering LATAM without the right local infrastructure. Daniel shares his perspective on clinical development, early access, and patient recruitment, with a particular focus on rare diseases, hematology, oncology, nephrology, and neurology. We also explore what biotech companies and pharmaceutical sponsors need to consider when expanding clinical programs into Latin America and how the right local expertise can make a difference in execution and patient recruitment. Daniel Zequeto is the founder of ODC Life Sciences, a specialized clinical execution partner supporting biotech and specialty pharma companies across Brazil and Latin America. Learn more at odclifesciences.com.

    Daniel Zequeto, Founder & CEO at ODC Life Sciences

  5. Sep 4

    Satabhisa Mukhopadhyay, Founder & Chief Scientist at 4D Path Inc

    In this episode, we speak with Dr. Satabhisa Mukhopadhyay, Co-Founder and Chief Scientific Officer of 4D Path and co-inventor of its QPOR™ technology. Dr. Mukhopadhyay discusses her journey from theoretical physics and applied mathematics to cancer systems biology, bioinformatics, and AI/ML. We explore how physics-informed algorithms and computational approaches can transform complex biological data into actionable insights for personalized cancer treatment. She also shares insights into 4D Path’s clinical trials, predictive diagnostic technologies, regulatory strategy, and the challenges of translating AI-driven innovation into real-world cancer care.

    Satabhisa Mukhopadhyay, Founder & Chief Scientist at 4D Path Inc

  6. Aug 28

    Deborah Morley, Director CV Strategy and Delivery at RQM+

    In this episode, we speak with Deborah Morley, an experienced leader in cardiovascular innovation, clinical research, and medical device development. Her career spans academia and industry, with extensive expertise in regulatory strategy and Class III implantable cardiovascular devices, including LVADs and cardiac contractility modulation systems. She currently serves as Director, Cardiovascular Strategy and Delivery and Co-Leader of the Cardiovascular Center of Excellence at RQM+.

    Deborah Morley, Director CV Strategy and Delivery at RQM+

  7. Aug 21

    Leonara vidal, Global Clinical Affairs Lead at Gentell

    In this episode, we speak with Leonara Vidal, Global Clinical Affairs Lead at Gentell, about her international career in clinical research, healthcare innovation, and medical devices. Leonara shares her journey from nursing and academia in Brazil to leading global clinical affairs initiatives across Europe and the UK, offering insights into clinical evidence, innovation, leadership, and improving patient outcomes.

    Leonara vidal, Global Clinical Affairs Lead at Gentell

  8. Aug 7

    Gerardo Noriega, President & CEO at PercAssist, Inc

    Today's guest is Gerardo Noriega, a C-level executive, serial entrepreneur, inventor, and advisor in the medical device industry. Having founded five medical device companies and consulted for more than 50 organizations throughout Silicon Valley, Gerardo has spent his career identifying unmet clinical needs, developing innovative technologies, and guiding products from early-stage concepts to successful commercialization. He also serves on the advisory boards of Santa Clara University's Department of Bioengineering, the UCSF Catalyst Program, the UCSF Surgical Consortium, and Simon Fraser University's Bioengineering Innovation Boulevard. In addition, he is an Adjunct Professor at Santa Clara University's Graduate School of Bioengineering. In this episode, we explore medical innovation, entrepreneurship, intellectual property, startup growth, and the future of healthcare technology.

    Gerardo Noriega, President & CEO at PercAssist, Inc
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About

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 CEO New 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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