José Javier Handal, Chief Medical Officer at MRx Solution
Send us a textJavier 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, attention to detail, and commitment to excellence enable him to deliver impactful outcomes. Dedicated to advancing healthcare innovation in the region, he leverages leadership, expertise, and collaboration to make significant contributions to clinical research.
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Andrew Ortega-Verdaguer, IntelVasc Inc.
Send us a textToday, 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 studied at several other prestigious international business schools. His expertise and journey in medical innovation make him a key voice in understanding the challenges and opportunities within the industry.
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Daniel Estay, Founder & CEO at SonoVascular
Send us a text 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 complexities of the medtech industry. We delve into his deep understanding of U.S. and international markets, including the opportunities and challenges of emerging markets in Asia Pacific and Latin America. Whether you're a medtech entrepreneur, investor, or enthusiast, this episode is packed with valuable lessons and strategies for driving success in the ever-evolving healthcare landscape. Tune in to explore the future of medtech through Daniel's expert lens!
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Paulo Fernandes, C2O Fundador & Principal
Send us a textPaulo 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 start-up for a group of investors, showcasing his entrepreneurial spirit and commitment to high-impact public health initiatives. Additionally, he has 10 years of experience at the Brazilian Association of Clinical Research Organizations, including 4 years as the President of the Board of Directors. Paulo holds a specialization in Clinical Pharmacology from USCS, a degree in Pharmacy and Biochemistry from FCF-USP, and training in Business and Project Management from FIA, along with an Executive MBA from INSPER.
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Miriam Serrano, Clinical Research Expert
Send us a textMiriam 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 Trial Supplies, Master File, Pharmacovigilance, and Regulatory Affairs within both pharmaceutical industries and CROs, at national and international levels. She is recognized in the sector as a key opinion leader and a local expert in regulatory matters. Her leadership and active participation in gremial improvement initiatives have been pivotal, building synergies with authorities, academic, and industrial colleagues to further the development and progress of Clinical Research.
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 CEONew 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.
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