Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere
by Jesús E. Moreno
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
Episodes
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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...
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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...
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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…
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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...
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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...
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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,...
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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...
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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...
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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...
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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...
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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…
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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...
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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,...
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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…
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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…
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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...
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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…
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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...
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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,...
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Gregory Mark Hill, Managing Partner at GCH Partners
In this episode, we welcome Gregory Mark Hill, Managing Partner at GCH Partners, an investment holding firm working globally with family offices, asset managers, foundations, and public and private companies. Gregory has spent more than two decades helping entrepreneurs and organizations grow,...
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David Albert, Founder at AliveCor Inc
This episode features David E. Albert, MD, a physician-inventor and serial entrepreneur whose work has shaped modern digital cardiology. Over a 30-year career, Dr. Albert has developed life-saving medical technologies and successfully translated many of those innovations into high-impact…
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Alfonso García, CEO & BD Director at Leon Research
In this episode, we welcome Alfonso, CEO at Leon Research and Managing Board Member and Marketing Director at AICROS, for an in-depth conversation on leadership, clinical research, and business development in the pharmaceutical industry. Alfonso has 14 years of experience in managerial and...
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Steven Collens, CEO at MATTER
This episode features Steven Collens, CEO of MATTER, a premier healthcare incubator and innovation hub that has supported over 1,000 healthcare startups. MATTER helps entrepreneurs and organizations innovate faster and more efficiently while increasing the likelihood of long-term success. Founded...
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Pablo Yarza, Founder & CEO at Bioinfile
In this episode, we sit down with Pablo Yarza, a bioinformatics expert with over 15 years of experience developing advanced databases for both academic and industrial applications. Throughout his career, Pablo has gained deep insight into one of the most critical challenges in R&D: data curation....
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Scott Stout, CEO & Co-Founder at MedVector Clinical Trials
This episode features Scott Stout, who is helping reshape clinical trial recruitment through MedVector’s innovative HCP Recruitment model. By engaging community physicians in a new way, MedVector enables access to larger and more diverse patient populations for clinical trial sites. Their…
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Matteo Talotta, Director of Clinical Solutions at Biorce
This episode features Matteo Talotta, a global leader with experience across banking, academia, government, and a wide range of organizations — from start-ups and scale-ups to large multinationals. After working in Canada, Italy, the U.S., Spain, and Romania, Matteo brings a rich, multicultural...
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Sonal Pendharkar Kulkarni, Co-founder & CSO at Uvisa Health
In this episode, we’re joined by Sonal Pendharkar Kulkarni, Ph.D., Co-founder and Chief Science Officer at Uvisa Health. With a background that bridges women’s health, the microbiome, digital health innovation, and medical device development, Sonal is at the forefront of creating smarter,...
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David Kraemer, Founder & Managing Member at 10 || 2 Capital Partners
In this episode, we sit down with David M. Kraemer, Founder of a boutique investment bank and former Vice President at Merrill Lynch and Wilshire Consulting. With deep experience across public and private markets, David shares insights on capital formation, innovation, and navigating complex...
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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...
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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...
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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...
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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...
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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...
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Ross Youngs, Founder & CEO of Biosortia
Today’s guest is Ross O. Youngs, Founder and CEO, with over 35 years of experience inventing products, technologies, and processes across multiple industries. He holds more than 75 patents worldwide and is driven by a passion for creating innovations that are better, faster, and more...
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Gianluca Fontana, CEO & Co-Founder of Prova Health
Today we’re joined by Gianluca Fontana, CEO and Co-Founder of Prova Health—the London-based advisory firm helping digital health and life sciences innovators prove their value with rock-solid clinical and economic evidence. With a background as a McKinsey consultant and Deputy Director at…
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Justin Chickles, CEO & Co-Founder of Glycyx Therapeutics
Could opioids be silently undermining cancer immunotherapy? This week, Justin Chickles — CEO and co-founder of Glycyx Therapeutics — explains how his team is tackling this overlooked challenge with axelopran, a breakthrough therapy now advancing to Phase 2 trials. From his early career at Johnson…
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Sarfaraz Niazi, Professor, Pharmaceutical Sciences
Today’s guest is Dr. Sarfaraz K. Niazi, a globally recognized biopharmaceutical scientist, regulatory advisor, prolific author, and inventor. Dr. Niazi works closely with regulatory authorities to streamline guidelines and help companies comply in bringing biotherapeutic products to...
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Steve Duddy, Founder and CEO at Duddy Executive Services Inc
In this episode, we sit down with Steve Duddy, a powerhouse executive with over 20 years of experience leading high-impact transformations across startups and Fortune 500 companies like 3M and Johnson & Johnson. Steve shares his unique approach to uncovering hidden opportunities, turning…
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Andrés Herrero-Yraola, CEO & Founder at i2medi
Andrés Herrero is a dynamic entrepreneur with over 25 years of experience in the healthcare and medical device industries. Andrés has founded his company “i 2 medi” ten years ago with the purpose to gain market access for innovative medical device companies in Latin America. Today the company has...
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José Javier Handal, Chief Medical Officer at MRx Solution
Javier Handal is a Medical Doctor with expertise in clinical research and pharmaceutical industry operations. As the leader of MRx Solution, a Site Management Organization (SMO), he is driving the development of a robust network of research sites across Central America. Javier excels in building...
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Andrew Ortega-Verdaguer, IntelVasc Inc.
Today, we have the privilege of speaking with Andrew, a distinguished leader with over 15 years of international experience in marketing, commercial excellence, and business strategy. Throughout his career, he has led large teams at top pharmaceutical and medical device companies, including...
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Daniel Estay, Founder & CEO at SonoVascular
In this episode of Global Trial Accelerators™, we sit down with Daniel Estay, a seasoned medical technology executive with a wealth of global experience. Daniel shares insights from his journey leading and developing fully integrated businesses across small, mid-sized, and large companies. With...
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Paulo Fernandes, C2O Fundador & Principal
Paulo Fernandes is a distinguished clinical research executive with extensive experience in international clinical trials across various phases and therapeutic areas. With a solid foundation in the CRO industry, he has successfully held roles in project management, start-up, operations…
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Miriam Serrano, Clinical Research Expert
Miriam is a seasoned professional in Health and Law, specializing in Sanitary Regulation and Clinical Research. With over 20 years of experience, she has a track record in planning and executing global, regional, and local clinical development programs, including Bioequivalence studies and Phase...
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Luis Alvarez, CEO and Founder of Theradaptive
Luis is the CEO and Founder of Theradaptive and developed the concept for targeted therapeutic delivery during and following a combat tour in Iraq where several of his soldiers suffered severe extremity injuries. Previously, Luis was the co-founding Deputy Director of the Department of Defense...
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Etienne Nichols, Medical Device Guru
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has manufacturing and product development experience, even aiding in developing combination drug-delivery devices, from startups to Fortune 500 companies, and holds a...
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Ruben Gaitan Ortiz, CEO at Alandra Medical
Ruben is the CEO of Alandra Medical. He has dual qualifications in engineering and technology entrepreneurship combined with 16 years of experience in medical device development. Self-motivation, adaptability, trainability, and entrepreneurial drive are his key tools for achieving personal and...
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Ernesto M. Nogueira, CEO at ValueConnected
Ernesto has 27 years of experience leading healthcare strategies to drive access and expansion for new products, developing value propositions for public and private stakeholders, and assessing global market opportunities for healthcare companies. He has worked for both government agencies and...
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Antonio Trujillo, Ph.D, Health Economist & Professor
Dr. Antonio Trujillo is an Associate Professor in the Department of International Health with expertise in health economics, the economics of aging, and applied econometrics. Antonio is the co-director of the Master of Health Science (MHS) in Global Health Economics degree program. He teaches an...
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Carlos Medina, CRO Mexico, Central America, and Caribbean at Hasten LLC
Carlos Medina is a Medical Doctor who works with health technology professionals to help them make the best technology for patient care available across Latin America. Carlos has witnessed the many benefits and risks that come with applying technology to solve health problems and is dedicated to...
Topics in this show
About this show
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
Hosted by
Jesús E. Moreno
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