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

Hosted by Julio G. Martinez-Clark

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Episodes

128

Latest episode

Aug 2026

Language

EN-US

About the show

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.

Listen to episodes

60 recent

August 7, 2026Episode 13356 min

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.

July 11, 2026Episode 13239 min

Matt DeNardo, Chief Product Officer at Axoft

In this episode, we’re joined by Matt DeNardo , a biomedical engineer and product development leader with a passion for transforming complex clinical challenges into innovative medical technologies. Matt shares how his approach combines the rigor of systems engineering with the creativity of design thinking, enabling teams to translate unmet clinical needs into clear product strategies and successful execution. From aligning user needs and regulatory considerations to leading cross-functional teams through every stage of development, he offers valuable insights into what it takes to bring meaningful healthcare innovations to market. Holding an M.S. in Biomedical Engineering from Northwestern University and a B.S.E. in Bioengineering from the University of Pennsylvania, Matt has spent his career at the forefront of medical technology, continuously exploring emerging technologies that can improve patient outcomes and shape the future of healthcare.

June 15, 2026Episode 13153 min

Daniel Chen, Founder and CEO at Synthetic Design Lab

In this episode of Global Trial Accelerators, we speak with Daniel S. Chen, MD, PhD, Founder and CEO of Synthetic Design Lab and former Global Head of Cancer Immunotherapy Development at Genentech/Roche. Daniel shares insights from his pioneering work in cancer immunotherapy, the development of breakthrough therapies such as atezolizumab, and the future of oncology innovation. We also discuss the Cancer-Immunity Cycle, translational science, and what it takes to accelerate the path from discovery to patient impact.

June 5, 2026Episode 13055 min

Shareef Mahdavi, Founder at PX Movement

Shareef Mahdavi joins the podcast to discuss how patient experience directly impacts practice growth, referrals, and retention. He shares the strategies that helped transform Laser Eye Center of Silicon Valley by improving how patients felt throughout their journey — leading to stronger reviews, increased leads, and long-term growth.

May 15, 2026Episode 12951 min

Joseph Geraci, CSO/CTO & Co-Founder at NetraMark

In this episode, we sit down with Dr. Joseph Geraci — mathematical physicist, medical scientist, and AI innovator — to explore how artificial intelligence is transforming the future of medicine and clinical research. Dr. Geraci began his career in quantum computing and mathematical physics, earning his PhD under renowned scientist Dr. Daniel Lidar with research supported by DARPA and the U.S. Army’s Disruptive Technology Office. He later expanded his work into artificial intelligence for medicine, oncology, and neuroscience, where he uncovered a critical problem in modern healthcare: traditional disease labels often fail to capture the true complexity and diversity of patients. This realization led him to found NetraMark and develop NetraAI, a groundbreaking AI platform designed to learn from small, noisy clinical datasets. Using a novel mathematically-augmented framework and long-range memory mechanisms, NetraAI can identify hidden and explainable patient subpopulations with extraordinary precision — helping pharmaceutical companies improve clinical trial outcomes and better match treatments to the patients most likely to benefit. In this conversation, Dr. Geraci shares insights on quantum algorithms, machine learning, the limitations of modern clinical trials, and how explainable AI could redefine our understanding of disease, health, and intelligence itself.

April 17, 2026Episode 12946 min

Gary Zammit, President & CEO at Clinilabs Drug Development Corporation

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.

April 10, 2026Episode 12753 min

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

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.

March 27, 2026Episode 12652 min

Robert Packard, President at Medical Device Academy, Inc

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.

March 20, 2026Episode 12536 min

Kristen Mittal, Co-founder and CEO of Mittal Consulting

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.

March 13, 202632 min

Tina Soulis, Founder and Director at Alithia Life Sciences

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 .