PODCAST · business
Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere
by Julio G. Martinez-Clark
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?<ul
-
125
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.
-
124
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.
-
123
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.
-
122
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.
-
121
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.
-
120
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.
-
119
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.
-
118
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.
-
117
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, raise capital, and expand their enterprise value across industries including technology, healthcare, and industrial integrated technology. His work spans major innovation hubs such as New York and Silicon Valley, as well as international markets.Through his professional journey, Gregory discovered that even when companies overcome major challenges—from raising capital to scaling operations—success can still feel incomplete if founders, executives, or employees struggle internally.His new book explores how individuals can remove internal roadblocks to achieving their dreams in business, family life, and personal fulfillment. Through a powerful real-life story, he shares insights on letting go of our deep attachment to outcomes, financial results, and expectations in order to rediscover happiness, purpose, and balance.
-
116
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 startups.As founder of several health-technology companies and former Chief Scientist of GE Cardiology, Dr. Albert brings rare insight into both clinical medicine and medical device innovation. His inventions, including consumer ECG technology that gained global attention, have helped redefine remote cardiac monitoring and patient empowerment.During the episode, we discuss Dr. Albert’s entrepreneurial journey, lessons from building and exiting startups, the evolution of digital health, and the future of cardiovascular technology. This conversation provides valuable perspective for founders, clinicians, and anyone interested in healthcare innovation.
-
115
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 executive roles, with the last 10 years dedicated to clinical investigation. Originally trained in psychology, his curiosity and passion for continuous learning have driven a career that blends science, strategy, and people-centered leadership.As CEO of Leon Research, a full-service CRO operating in Southern Europe, Alfonso leads with a clear mission: to grow the organization by empowering its people and staying true to core principles of intelligence, creativity, flexibility, and honesty. Through AICROS, he has also played a key role in designing and implementing sales and marketing strategies that strengthen client relationships and expand business opportunities across the CRO alliance.
-
114
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 by Steven in 2015, MATTER provides an accelerator-as-a-service solution for health systems, life sciences companies, payers, and foundations seeking to collaborate with startups, while also working directly with established companies to strengthen their innovation capabilities.Steven previously served as Senior Vice President at Pritzker Group, where he helped create 1871, Chicago’s digital startup center and the world’s top-ranked business incubator in 2018. His background also includes leadership roles at Abbott and public service as a legislative assistant to U.S. Senator Carol Moseley-Braun.In this episode, we discuss the evolution of healthcare innovation, building successful startup ecosystems, and how organizations can work more effectively with entrepreneurs to drive meaningful change.
-
113
Pablo Yarza, Founder & CEO att 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. He explains how poor-quality or inaccessible data can significantly delay research and development projects, and why this issue is often underestimated.These challenges led him to found BIOINFILE, a company with a clear mission: to make high-quality data more accessible to R&D professionals across sectors. As Pablo firmly believes, good data is the foundation of progress.
-
112
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 approach allows trusted healthcare providers and their patients to benefit from clinical trials as a care option—without requiring physicians to become investigators or risking patient leakage. By aligning provider incentives, MedVector opens access to millions of patients who are traditionally excluded from clinical research.In this episode, we discuss the challenges of patient recruitment, the importance of diversity in clinical trials, and how MedVector is redefining provider participation in clinical research.
-
111
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 perspective to the world of clinical innovation.Fluent in four languages and driven by collaboration, his career has led him to focus on the transformative power of AI in biotechnology. He is currently part of Biorce, an AI-powered organization redefining how the pharmaceutical industry, biotech companies, hospitals, and clinical trial teams develop new therapies. Their goal: to make breakthrough treatments more accessible and affordable by uniting advanced technology with human insight.
-
110
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, science-driven solutions for vaginal health management.Sonal shares her journey from research scientist to entrepreneur, the insights that shaped Uvisa Health’s mission, and the importance of designing products that truly respond to women’s real needs. We explore her multidisciplinary approach—combining clinical research, product design, and technology—to rethink how women’s health challenges are understood and addressed.
-
109
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 investment landscapes. From biotech and MedTech to AI, robotics, and venture capital, his perspective bridges finance and technology in today’s fast-changing world. Tune in to hear how he’s built global partnerships and what drives his success in the ever-evolving world of investment and entrepreneurship.
-
108
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 innovation to global drug approvals—advancing programs valued at over $1 billion. He has held senior leadership roles as Global Head of Psychiatry at Johnson & Johnson, Vice President & Fellow at Mitsubishi Tanabe Pharma, and Chief Medical Officer at Zynerba and BioVie. His contributions include several successful FDA approvals, including Risperdal Consta®, Invega®, Invega Sustenna®, and Radicava®. At BioVie, he currently serves as Executive Vice President, Head of R&D, and Chief Medical Officer, as well as Principal Investigator on a $13 million U.S. Department of Defense study on Long COVID. A Life Fellow of the American Psychiatric Association and Fellow of the American Neurological Association, Dr. Palumbo brings a rare combination of scientific innovation and executive leadership—bridging translational medicine, enterprise strategy, and patient impact.
-
107
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 ethical standards, building strong relationships with government, and shaping a regulatory landscape where healthcare innovation can thrive. His leadership has also been recognized by The Peak, which honored him in 2023 for emerging leadership in healthcare. Tune in for an insightful conversation on the future of psychedelic medicine, biotech innovation, and the policies driving change in healthcare.
-
106
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 Latinos in Bio. She shares insights from her leadership journey at companies like Genzyme, Aegerion Pharmaceuticals, and Novelion Therapeutics, and discusses the future of biotech, the role of angel investing, and why diversity in innovation matters. Tune in to hear how Carolina is shaping the next generation of biotech leaders and building a more inclusive innovation ecosystem.
-
105
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 firm focused on advancing theranostic solutions and radioligand therapies—pioneering approaches that are shaping the future of cancer treatment.
-
104
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 technology, and how personalized medicine is shaping the future of healthcare. Tune in to learn how cutting-edge research in genomics and biotechnology is being translated into real-world therapies and diagnostics.
-
103
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 cost-effective. His recent accomplishments include winning an R&D 100 Award for his work in biopolymer technologies. In 2009, his company Biosortia was awarded a $6 million ARPA-E grant from the U.S. Department of Energy for its algal harvesting technology—work that paved the way for Biosortia’s cutting-edge drug discovery platform. Throughout his career, Ross has been widely recognized for his entrepreneurial leadership, including being named Ernst & Young Ohio Entrepreneur of the Year and receiving the U.S. Small Business Administration’s “Business Person of the Year” award, presented to him by then-Vice President Al Gore.
-
102
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 Imperial College London’s Institute of Global Health Innovation, Gianluca has led billion-pound research programs like the NHS Digital Academy and the REACT COVID-19 study. His published work on digital health evaluation has been cited hundreds of times, and through Prova Health he now works with global pharma and AI-medtech scale-ups to accelerate evidence generation and build lasting capabilities. Fluent in four languages and trained in both economics and marketing at Bocconi University, Gianluca brings a rare mix of scientific rigor and commercial insight—making him an invaluable voice in the race to deliver safer, smarter healthcare at scale.
-
101
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 & Johnson to leading multiple startups, Justin offers a rare, insider’s perspective on driving biotech innovation from concept to clinic. If you’re interested in cutting-edge oncology, translational science, and biotech entrepreneurship, you won’t want to miss this episode.
-
100
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 market—including biosimilars, gene therapies, mRNA vaccines, and advanced protein delivery systems. He has published hundreds of books and scientific papers, sharing both the science and the art of making life-saving treatments accessible to patients. With over 100 U.S. biotechnology patents—all offered royalty-free—Dr. Niazi is a true advocate for innovation and global health equity.
-
99
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 ambiguity into actionable strategy, and executing bold roadmaps that drive outsized results. We dive into how he’s helped scale companies from near-zero to over $35M in ARR in under two years, his success accelerating growth through global distributor networks, and his role as an embedded executive and board director across early- to mid-stage ventures. With a fiercely competitive mindset, deep strategic insight, and hands-on operational expertise, Steve walks us through how he tackles complex challenges in global supply chains, commercialization in highly regulated markets, and successful exits via M&A and IPO. This episode is a must-listen for founders, operators, and investors in the HealthTech space who want to understand what it takes to turn overlooked opportunities into industry-defining success stories.
-
98
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 evolved from consultancy company to a full fledge medical device and health IT-distributor with its in house hard- and software service teams and regulatory services. i2medi is focused on cardiology as well as health IT solutions for hospitals and the group operates with affiliated companies in Brazil Colombia and Mexico, as well as in Germany to maintain close contact to its European clients. Andrés and i2medihave a proven track record in achieving guideline acceptance with national clinical societies in LATAM for new technological innovations. By this means they are paving the way for innovations to private and public health insurance reimbursements.Andres has also proven track record as Senior Executive in Biotronik, Abbot and caresyntax (former St. Jude Medical) driving business growth, managing key accounts, and overseeing global operations. He is an expert in sales, market access, marketing, and strategic planning with deep knowledge of the European and Latin American markets. His analytical skills and business acumen are supported by a Ph.D. in Biochemistry and an MBA.
-
97
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 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.
-
96
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 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.
-
95
Daniel Estay, Founder & CEO at SonoVascular
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!
-
94
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 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.
-
93
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 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.
-
92
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 Regenerative Medicine Program and led the department's largest recombinant biologics program through Phase II. Luis was a DARPA Service Chief Fellow and Academy Professor at the United States Military Academy, West Point. Luis received his PhD in Biological Engineering from MIT where he was a Hertz Foundation Fellow.
-
91
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 Project Management Professional (PMP) certification. Etienne has managed cross-functional teams for updating legacy products as well as developing new medical devices. His expansive knowledge, experience, and passion for medical devices are evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high-quality products to market.
-
90
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 business goals. Ruben started his career developing hardware and software for medical devices, spending countless hours reading scientific papers, twitching circuits, refining algorithms, and preparing technical reports to deliver products right on time. In a nutshell, his experience as an engineer revolves around developing Class I and II active and sterile medical devices (bio-instrumentation and software); this includes defining design inputs and producing design outputs following state-of-the-art industry standards such as ISO 13485, ISO 14971, IEC 62304 and the IEC 60601 series.
-
89
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 global healthcare companies in roles ranging from strategic marketing and new product development to health economics and reimbursement. Also, Ernesto led several Market Access projects across the US, Europe, Latin America, and the Middle East; Ernesto is the CEO and Founder of ValueConnected.Ernesto also coordinates the ValueConnected team in applying Artificial Intelligence (AI) and Data Science to address significant unmet needs in healthcare, accelerating the adoption rate of medical technologies that can generate value for patients, payers, and providers. He holds an MBA from the University of Texas at Austin, US, and a Bachelor’s degree in Business Administration from Fundação Armando Ávares Penteado(FAAP), in São Paulo, Brazil.
-
88
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 advanced econometrics course on program impact evaluation using observational data and a course on behavioral economics and public health.
-
87
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 helping others follow the best practices available and avoid the missteps that can derail their health technology problems. He has had the privilege to work with local and international companies across most countries in Latin America, helping them to achieve multi-million sales results and establish lasting and efficient global-local collaborations. He is a Licensed Medical Doctor in Mexico City. He is working on finishing his Master's degree in Information Technology for Healthcare while leading the Medical Devices workgroup of the Mexican HealthTech Association.
-
86
Yoku Sashida, CEO & Co Founder at Kenko Solutions
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 state of the heart in less than 60 seconds.
-
85
Luis Santiago, CEO at PEGASI
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 State Department, and in 2020 as one of the 35 Innovators under 35 in Latin America by the MIT Technology Review magazine. He has participated in dozens of international forums and events pointing out the importance of Healthcare digitalization in Latin America.
-
84
Dave Dolan, Co-Founder & Executive Chairman at MultiFunctional Imaging
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 Fortune 500 corporations through startups, businesses have benefitted from his track record of success in turning medical device innovation into record growth, high market share, and attractive market valuations. He is a trusted business leader who draws upon an analytical and data-driven approach with KOLs, advising boards of directors, investors, C-level executives, and other stakeholders in identifying and capitalizing on opportunities to advance each organization’s strategic vision.
-
83
Josh Cohn, Chief Commercial Officer at EndoSound
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 established relationships with key opinion leaders, hospital and ASC administrators, and device distributors. In his current role as CCO, Josh will be responsible for the pre-and post-commercialization Sales and Marketing strategy designed to ensure the integrated commercial success of the organization.
-
82
David Bigio, Department Head of Biomedical Engineering at Universidad de los Andes
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 technology used in large infrastructure projects, and coordinating strategic projects for a multinational consortium. Mr. Bigio clearly understands current challenges and opportunities in the biomedical engineering field. He is very focused on improving the education and skills of graduates in order to provide companies with better employees. He has been working with the Biomedical engineering students during their senior capstone design project to address two important aspects of their education; help them improve on the ‘soft’ skills that future employers expect from them, and also teach them about how to become entrepreneurs to give them employability alternatives and promote a much-needed activity in our country.
-
81
Widy Medina, CEO & Co-Founder at Telebionix
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 multiple Latin American locations. He led an automation firm that exposed him to FDA regulations, manufacturing, and compliance during that time. Today, he leads a medical device company with a unique RPM product to capture biomarkers and allow those to be maintained in a safe digital format for exchange with healthcare professionals or as a personal health tracking system.
-
80
Mauricio Berdugo, Director of Medical Affairs at Humacyte
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 spine surgery. Mauricio graduated from medical school at the Universidad Evangelica de El Salvador, completed his Master of Public Health degree from Kaplan University, and he is currently pursuing a Fellowship with the American College of Healthcare Executives.
-
79
James Reinstein, President & Chief Executive Officer at Conformal Medical
James has more than 25 years of medical device experience and is currently the CEO of Conformal Medical. Prior to joining Conformal, he led Saranas and private companies such as Drawbridge Health, and Aptus Endosystems as their President, CEO, and member of the board of directors. He held a similar role at the publicly traded medical laser company, Cutera from 2017 to 2019. He was part of the management team that led the turn-around at Cyberonics where he was the EVP & Chief Commercial Officer. James spent 17 years at Boston Scientific in various roles and functions including business development, marketing, and general management. Most of his career at Boston Scientific was spent working and living in Europe, Asia, and Latin America. Additionally, Mr. Reinstein has served as a board director for several medical companies, including publicly traded Mainstay Medical in Dublin, Ireland, Pixium-Vision based in Paris, France, and Monteris Medical a privately held company located in Minnesota. James began his professional career with Proctor & Gamble after earning his Bachelor of Arts in Marketing (BA) degree from the Terry College of Business at the University of Georgia in Athens. He also completed graduate studies at INSEAD in Fontainebleau, France.
-
78
Gabriel Garza, Co-founder & Managing Director at DocTour
Gabriel Alejandro Garza Caro is Co-founder & Managing Director at DocTour who works with international travelers and tourists to solve their health problems during their travel. With innovation in tech & processes, a completely new hybrid model has been created to attend to all travelers’ medical needs. Gabriel believes that empowerment, teamwork, strategic planning, and communication are key fundamentals for startups to develop in order to establish early, the way to success in today’s health tech environment. Gabriel is trained in Business Process Management and in Project and Portfolio Management as a Project Management Officer. For Gabriel, the most rewarding part of his role is the ability to innovate and think out of the box to solve everyday business and market challenges.Prior to working at DocTour, Gabriel began as a Business Process Consultant and Project Manager at CEMEX, where he collaborated to map, design, and create the new CEMEX’s processes, system, and software and implement it in some European countries and in México. Gabriel holds a University Degree in International Commerce from the Instituto Tecnológico y de Estudios Superiores de Monterrey (ITESM) in México and a Master's Degree in Economics and Society and Master's Degree in Economics of Territorial Development from the Université Toulouse Capitole in France.
-
77
Tomás Iglesias, CEO at Zubia
Tomás Iglesias is a medical doctor/master in hospital administration/Front-end developer. Tomás is the CEO of Zubia, LATAM's largest digital health marketplace a platform that connects digital health platforms with users that need their services. Currently in 25 countries with more than 400,000 visitors in 10 months from launch, and the co-founder and leader of HealthX, Mexico's largest health-tech community. Tomás is highly passionate about helping others and connecting health with technology. In 2020, created LATAM's most used COVID-19 suspected case self-assessment platform, reaching 194 countries, 24 million users, and generation 2,500 telemedicine consultations per day.
-
76
Ethan Russo, CEO at CannabisResearch.org & Nishi Whiteley, Chief Operating Officer at CReDO
Dr. Ethan Russo and Nishi Whiteley have worked together for almost 10 years in efforts to:improve the scientific understanding of the endocannabinoid system (ECS) and how the cannabis plant modulates itassist small and large cannabis companies in product formulationadvise companies on cannabis genetics enhancementsconsult on pre-clinical and clinical research design.“We share a vision of making cannabis better and safer believing in a future in which knowledge of the endocannabinoid system and its therapeutic modulation via the cannabis plant will result in superior highly individualized medicines, aids to wellness, enhanced lifestyles, and novel non-toxic industrial products”.Ethan Russo, MD, is a board-certified neurologist, psychopharmacology researcher, and author. He is the Founder and CEO of CannabisResearch.org. Previously, he was Director of Research and Development at the International Cannabis and Cannabinoids Institute (ICCI) based in Prague, Czech Republic. Medical Director of PHYTECS (2015-2017), a biotechnology company researching and developing innovative approaches targeting the human endocannabinoid system, and from 2003-2014, he served as Senior Medical Advisor, medical monitor, and study physician to GW Pharmaceuticals, United Kingdom for numerous Phase I-III clinical trials of Sativex® for alleviation of cancer pain unresponsive to optimized opioid treatment and initial studies of Epidiolex® for intractable epilepsy.Nishi Whiteley (pronounced Nee-sha), is the co-founder and Chief Operating Officer at CReDO. She has twenty-five-plus years of international business development experience in cannabis, agriculture, wellness, green energy, and food industries. She has had leadership roles on projects in corporate America and for the US Foreign Ag Service in over 10 countries, in startups, a state agency, and non-profits; as well as worked for foreign governments and met with international leaders in Cuba, Mexico, and the Dominican Republic to open trade and advance development programs. She has worked on investment projects in 8 countries.
We're indexing this podcast's transcripts for the first time — this can take a minute or two. We'll show results as soon as they're ready.
No matches for "" in this podcast's transcripts.
TOPICS IN THIS SHOW
Loading reviews...
ABOUT THIS 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?<ul
HOSTED BY
Julio G. Martinez-Clark
CATEGORIES
Loading similar podcasts...