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
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...
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 soft...
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 min...
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 ...
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 nav...
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 hea...
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 Contro...
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 Regenerative Medicine Program and led the department's largest recombinant biologics program through Phase II. Luis was a...
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 Project Management Professional (PMP) certification. Etienne has managed cross-functional teams for updating legacy products as...
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 business goals. Ruben started his career developing hardware and software for medical devices, spending countless hours readin...
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 global healthcare companies in roles ranging from strategic marketing and new product development to health economics and reim...
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 advanced econometrics course on program impact evaluation using observational data and a course on behavioral economics and ...
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 helping others follow the best practices available and avoid the missteps that can derail their health technology problems. ...
Yoku Sashida is the CEO & Co-Founder at Kenko Solutions, a company dedicated to managing and developing biomedical projects based on technology. He is responsible for opening economic relationships, capturing technology-based projects, forming work teams to carry out technological development, and administrative and financial accounting. The first product of its own is ecglove, the wearable able to determine the s...
Luis Santiago is PEGASI's CEO and CTO. By training, he is a social communicator and marketing and public relations professor. By profession, he is a self-taught programmer, technology project manager, and Product Owner, with more than 14 years of experience in the area. He has ventured into banking, IT, and Digital Health. Luis was recognized in 2016 as one of the Young Leaders of the Americas by the American Sta...
Dave is the Co-Founder & Executive Chairman at MultiFunctional Imaging, a University of Utah startup company that provides software solutions for improving the efficiency and accessibility of multi-tracer imaging with PET, PET/CT, and PET/MRI scanners. Dolan’s career has been built on successes centering around the commercialization and customer adoption of innovative MedTech products/services. Spanning from Fortu...
Josh Cohn has 15 years of experience in the medical device field, rising to National Sales Director of PENTAX Medical, a major endoscope provider. He has a strong history of leading successful sales organizations, building winning strategies, and launching disruptive programs aimed at changing marketplace conventions. As product champion and strategist for all EUS sales, he has attended hundreds of procedures and has ...
Mr. Bigio is a professor in the biomedical engineering department, responsible for the Senior Capstone Design project. Currently, he is also serving as the department head. He comes to the university after having spent 30 years of professional experience working for large multinationals in different parts of the world, including the development of high technology start-ups in Silicon Valley, commercialization of techn...
Widy is the Co-Founder and CEO of two technology companies with vast experience ranging from robotics, product design, fabrication, and automation to the electronic assembly of consumer products, food and beverage tech, biotech, medical devices, and pharmaceutical industries. Widy spent 40+ years living in Puerto Rico, and 20+ supporting pharmaceutical, biotechnology, and medical device companies with a presence in mu...
Mauricio A. Berdugo, MD, MPH, is currently the Director of Medical Affairs at Humacyte, Inc. Mauricio has worked in different capacities within the CRO, pharma, diagnostics, and biotech industries in the USA and globally, including Latin America, Europe, and Asia over the past 9 years. His clinical and academic research stems from HIV/AIDS, cardiovascular disease, pulmonary disease, renal disease, and orthopedic spin...
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