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

Jesús E. Moreno
  • 4.9 (7)
  • Business
  • Updated Weekly

Hosted by Jesús E. Moreno (Business Development Director, bioaccess®), Global Trial Accelerators™ is a clinical trials podcast for life-sciences founders and innovators in MedTech, Biotech/Biopharma, and Radiopharma, focused on first-in-human (FIH) and early feasibility studies. The show is produced by bioaccess® and was founded by Co-Founder & CEO Julio G. Martinez-Clark.bioaccess® is a CRO purpose-built for first-in-human (FIH) trials, serving MedTech, Biopharma, and Radiopharma startups. This podcast delivers strategies, regulatory insights, and founder stories to get your technology into humans faster and affordably, with data designed to support FDA and EMA submissions.Each episode features candid conversations with clinical trial pioneers, regulatory strategists, and founders who have compressed timelines, reduced costs, and generated the clinical evidence investors demand by drawing on on-demand clinical research capability across the Americas.What You'll Learn:- Regulatory pathways across Latin America (Colombia, Mexico, Brazil, Chile, Argentina, Panama, Ecuador, El Salvador, Dominican Republic, Paraguay, and more)- Why ethics approval in 4–8 weeks (vs. 6–12 months in the US/EU) changes the game for startups- Strategies to generate FIH data that unlocks your next funding round or acquisition- The Innovation Runway: from prototype to clinical milestones before capital runs out- Lessons from more than 130 episodes with leaders from seed-stage startups to Fortune 500 MedTech companies- Decentralized trials, AI-driven recruitment, and post-trial commercializationSubscribe to unlock your shortcut from first-in-human to exit.Brought to you by bioaccess®, an FIH-dedicated CRO for healthcare startups. Faster timelines, lower costs. Since 2010.

  1. 5d ago

    Ryan Beal, Chief Executive Officer at Dyve Biosciences

    In this episode, we welcome Dr. Ryan Beal, Founder and CEO of Dyve Biosciences, to discuss an innovative transdermal drug delivery approach targeting tumor acidity to help the immune system better recognize and attack cancer cells. A physician and serial entrepreneur, Ryan brings extensive experience in pharmaceutical innovation, clinical development, and healthcare entrepreneurship. Join us to explore the science behind Dyve Biosciences and the future of cancer treatment.

    Ryan Beal, Chief Executive Officer at Dyve Biosciences

  2. Oct 16

    Sandi Schaible, Founder & President at Bonded in Science

    In this episode of the MedTech Podcast, we welcome Sandi Schaible, Founder of Bonded in Science and ISO TC 194 WG14/WG1 Expert. With over 25 years of experience, Sandi brings valuable insights into chemical characterization, regulatory strategy, and scientific leadership in the medical device industry.

    Sandi Schaible, Founder & President at Bonded in Science

  3. Oct 9

    Gennaro Maida, CEO and Founder at Denovo Innovations Group

    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 Denovo Innovations Group

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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+
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About

Hosted by Jesús E. Moreno (Business Development Director, bioaccess®), Global Trial Accelerators™ is a clinical trials podcast for life-sciences founders and innovators in MedTech, Biotech/Biopharma, and Radiopharma, focused on first-in-human (FIH) and early feasibility studies. The show is produced by bioaccess® and was founded by Co-Founder & CEO Julio G. Martinez-Clark.bioaccess® is a CRO purpose-built for first-in-human (FIH) trials, serving MedTech, Biopharma, and Radiopharma startups. This podcast delivers strategies, regulatory insights, and founder stories to get your technology into humans faster and affordably, with data designed to support FDA and EMA submissions.Each episode features candid conversations with clinical trial pioneers, regulatory strategists, and founders who have compressed timelines, reduced costs, and generated the clinical evidence investors demand by drawing on on-demand clinical research capability across the Americas.What You'll Learn:- Regulatory pathways across Latin America (Colombia, Mexico, Brazil, Chile, Argentina, Panama, Ecuador, El Salvador, Dominican Republic, Paraguay, and more)- Why ethics approval in 4–8 weeks (vs. 6–12 months in the US/EU) changes the game for startups- Strategies to generate FIH data that unlocks your next funding round or acquisition- The Innovation Runway: from prototype to clinical milestones before capital runs out- Lessons from more than 130 episodes with leaders from seed-stage startups to Fortune 500 MedTech companies- Decentralized trials, AI-driven recruitment, and post-trial commercializationSubscribe to unlock your shortcut from first-in-human to exit.Brought to you by bioaccess®, an FIH-dedicated CRO for healthcare startups. Faster timelines, lower costs. Since 2010.

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