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 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.
Episodes
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 approach allows trusted healthcare providers and their patients to benefit from clinical trials as a care option—without requiring physicians to b...
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 perspective to the world of clinical innovation.
Fluent in four languages and driven by collaboration, his career has led him to focus on th...
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, science-driven solutions for vaginal health management.
Sonal shares her journey from research scientist to entrepreneur, the insights that shaped...
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 investment landscapes.
From biotech and MedTech to AI, robotics, and venture capital, his perspective bridges finance and technology in today’...
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 innovation to global drug approvals—advancing programs valued at over $1 billion. He has held senior leadership roles as Global Head of Psych...
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 ethical standards, building strong relationships with government, and shaping a regulatory landscape where healthcare innovation can thriv...
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 Latinos in Bio.
She shares insights from her leadership journey at companies like Genzyme, Aegerion Pharmaceuticals, and Novelion...
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 firm focused on advancing theranostic solutions and radioligand therapies—pioneering approaches that are shaping the future of cancer tre...
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 technology, and how personalized medicine is shaping the future of healthcare.
Tune in to learn how cutting-edge research in genomics and...
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 cost-effective.
His recent accomplishments include winning an R&D 100 Award for his work in biopolymer technologies. In 2009, his company Biosorti...
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 Imperial College London’s Institute of Global Health Innovation, Gianluca has led billion-pound research programs like the NHS Digital Academy an...
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 & Johnson to leading multiple startups, Justin offers a rare, insider’s perspective on driving biotech innovation f...
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 market—including biosimilars, gene therapies, mRNA vaccines, and advanced protein delivery systems.
He has published hundreds of books and scientific p...
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 ambiguity into actionable strategy, and executing bold roadmaps that drive outsized results.
We dive into how he’s helped scale companies fro...
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 evolved from consultancy company to a full fledge medical device and health IT-distributor with its in house hard- and software service t...
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 strategic partnerships, optimizing operations, and ensuring adherence to international research standards. His proactive mindset, attentio...
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 Novartis, Terumo, and Penumbra Inc. Andrew is a proud graduate of the IGNITE Program at Stanford Graduate School of Business and has also studi...
In this episode of LATAM Medtech Leaders, 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 extensive expertise in general management, commercial operations, and business development, he offers a unique perspective on navigating the co...
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 management, and business development. Paulo has worked at renowned CROs such as PPD, Covance, and IQVIA. Recently, he structured a healthcare sector...
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 I-IV clinical trials. Her expertise spans Clinical Monitoring, Quality Assurance, Budgeting, Contracts & Payments Control, Clinical Tr...
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