Advertise on podcast: Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere
Rating
4.9from
This podcast has
123 episodes
Language
EnglishPublisher
Julio G. Martinez-ClarkExplicit
No
Date created
2019/03/18
Latest episode
2026/04/17
Average duration
43 min.
Release period
14 days
Description
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.
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Podcast episodes
Check latest episodes from Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere podcast
Gary Zammit, President & CEO at Clinilabs Drug Development Corporation
2026/04/17
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.
Joseph Grieco, VP at Tris Pharma & Liza Micioni, Sr. Director at Tris Pharma
2026/04/10
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.
Robert Packard, President at Medical Device Academy, Inc
2026/03/27
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.
Kristen Mittal, Co-founder and CEO of Mittal Consulting
2026/03/20
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.
Tina Soulis, Founder and Director at Alithia Life Sciences
2026/03/13
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.
Gregory Mark Hill, Managing Partner at GCH Partners
2026/03/06
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.
David Albert, Founder at AliveCor Inc
2026/02/20
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.
Alfonso García, CEO & BD Director at Leon Research
2026/01/30
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.
Steven Collens, CEO at MATTER
2026/01/16
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.
Pablo Yarza, Founder & CEO att Bioinfile
2026/01/09
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.
Scott Stout, CEO & Co-Founder at MedVector Clinical Trials
2025/12/19
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.
Matteo Talotta, Director of Clinical Solutions at Biorce
2025/12/12
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.
Sonal Pendharkar Kulkarni, Co-founder & CSO at Uvisa Health
2025/12/05
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.
David Kraemer, Founder & Managing Member at 10 || 2 Capital Partners
2025/10/30
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.
Joseph Palumbo, Head of R&D & Chief Medical Officer at BioVie Inc
2025/10/10
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.
Podcast reviews
Read Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere podcast reviews
Pepo12387 2022/06/29
Great podcast!
Wow what a listen. This really gave me a further insight on the medical device business, cant wait for the next episode!
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