Global Trial Accelerators™: Fast-Tracking First-in-Human Trials, Anywhere

Daniel Zequeto, Founder & CEO at ODC Life Sciences

In this episode, we speak with Daniel Zequeto, founder of ODC Life Sciences, about the challenges and opportunities of conducting clinical development across Brazil and Latin America. With more than 20 years of experience as a commercial and clinical leader at Abbott, Hospira, Shire, and Alexion, Daniel has worked on both sides of the equation and witnessed firsthand the challenges sponsors face when entering LATAM without the right local infrastructure. Daniel shares his perspective on clinical development, early access, and patient recruitment, with a particular focus on rare diseases, hematology, oncology, nephrology, and neurology. We also explore what biotech companies and pharmaceutical sponsors need to consider when expanding clinical programs into Latin America and how the right local expertise can make a difference in execution and patient recruitment. Daniel Zequeto is the founder of ODC Life Sciences, a specialized clinical execution partner supporting biotech and specialty pharma companies across Brazil and Latin America. Learn more at odclifesciences.com.

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Satabhisa Mukhopadhyay, Founder & Chief Scientist at 4D Path Inc

In this episode, we speak with Dr. Satabhisa Mukhopadhyay, Co-Founder and Chief Scientific Officer of 4D Path and co-inventor of its QPOR™ technology. Dr. Mukhopadhyay discusses her journey from theoretical physics and applied mathematics to cancer systems biology, bioinformatics, and AI/ML. We explore how physics-informed algorithms and computational approaches can transform complex biological data into actionable insights for personalized cancer treatment. She also shares insights into 4D Path’s clinical trials, predictive diagnostic technologies, regulatory strategy, and the challenges of translating AI-driven innovation into real-world cancer care.

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Deborah Morley, Director CV Strategy and Delivery at RQM+

In this episode, we speak with Deborah Morley, an experienced leader in cardiovascular innovation, clinical research, and medical device development. Her career spans academia and industry, with extensive expertise in regulatory strategy and Class III implantable cardiovascular devices, including LVADs and cardiac contractility modulation systems. She currently serves as Director, Cardiovascular Strategy and Delivery and Co-Leader of the Cardiovascular Center of Excellence at RQM+.

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Leonara vidal, Global Clinical Affairs Lead at Gentell

In this episode, we speak with Leonara Vidal, Global Clinical Affairs Lead at Gentell, about her international career in clinical research, healthcare innovation, and medical devices. Leonara shares her journey from nursing and academia in Brazil to leading global clinical affairs initiatives across Europe and the UK, offering insights into clinical evidence, innovation, leadership, and improving patient outcomes.

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Gerardo Noriega, President & CEO at PercAssist, Inc

Today's guest is Gerardo Noriega, a C-level executive, serial entrepreneur, inventor, and advisor in the medical device industry. Having founded five medical device companies and consulted for more than 50 organizations throughout Silicon Valley, Gerardo has spent his career identifying unmet clinical needs, developing innovative technologies, and guiding products from early-stage concepts to successful commercialization. He also serves on the advisory boards of Santa Clara University's Department of Bioengineering, the UCSF Catalyst Program, the UCSF Surgical Consortium, and Simon Fraser University's Bioengineering Innovation Boulevard. In addition, he is an Adjunct Professor at Santa Clara University's Graduate School of Bioengineering. In this episode, we explore medical innovation, entrepreneurship, intellectual property, startup growth, and the future of healthcare technology.

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Matt DeNardo, Chief Product Officer at Axoft

In this episode, we’re joined by Matt DeNardo, a biomedical engineer and product development leader with a passion for transforming complex clinical challenges into innovative medical technologies. Matt shares how his approach combines the rigor of systems engineering with the creativity of design thinking, enabling teams to translate unmet clinical needs into clear product strategies and successful execution. From aligning user needs and regulatory considerations to leading cross-functional teams through every stage of development, he offers valuable insights into what it takes to bring meaningful healthcare innovations to market. Holding an M.S. in Biomedical Engineering from Northwestern University and a B.S.E. in Bioengineering from the University of Pennsylvania, Matt has spent his career at the forefront of medical technology, continuously exploring emerging technologies that can improve patient outcomes and shape the future of healthcare.

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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