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

In this episode, we welcome Dr. Ryan Beal, Founder and CEO of Dyve Biosciences, to discuss an innovative transdermal drug delivery approach targeting tumor acidity to help the immune system better recognize and attack cancer cells.

A physician and serial entrepreneur, Ryan brings extensive experience in pharmaceutical innovation, clinical development, and healthcare entrepreneurship. Join us to explore the science behind Dyve Biosciences and the future of cancer treatment.

In this episode of the MedTech Podcast, we welcome Sandi Schaible, Founder of Bonded in Science and ISO TC 194 WG14/WG1 Expert. With over 25 years of experience, Sandi brings valuable insights into chemical characterization, regulatory strategy, and scientific leadership in the medical device industry.

In this episode, we speak with Gennaro Maida, a healthcare technology executive working at the intersection of wearable technology, clinical research, and artificial intelligence.

Gennaro is CEO/CMIO of Denovo Innovations Group, Director of Clinical Products at Tactical Rehabilitation, and recently served as CMIO of The Cena Group. He also serves on the American Heart Association's Health Tech Advisory Group.

Our conversation explores how sensor data can be transformed into meaningful clinical evidence, including PPG and HRV signal processing, HIPAA-compliant remote data capture for multi-site studies, and AI architectures designed to support clinical and regulatory...

Episode 140: Gennaro Maida – From Wearable Sensors to Clinical Evidence

In this episode, we speak with Gennaro Maida, a healthcare technology executive working at the intersection of wearable technology, clinical research, and artificial intelligence.

Gennaro is CEO/CMIO of Denovo Innovations Group, Director of Clinical Products at Tactical Rehabilitation, and recently served as CMIO of The Cena Group. He also serves on the American Heart Association's Health Tech Advisory Group.

Our conversation explores how sensor data can be transformed into meaningful clinical evidence, including PPG and HRV signal processing, HIPAA-compliant re...

Dr. Ben Holmes: 3D Printing, MedTech, and the Future of Joint Repair

In this episode, we speak with Dr. Ben Holmes, CEO and Co-Founder of Nanochon, a medical technology company developing Chondrograft™, a 3D-printed synthetic implant designed to repair damaged cartilage and restore joint function for patients who are not yet candidates for knee replacement.

Dr. Holmes holds a Ph.D. in Biomedical Engineering from The George Washington University and a B.S. in Mechanical and Aerospace Engineering from the University of Virginia. His research has focused on...

In this episode, we are joined by Allison Komiyama, Founder of Bluestocking Health, for a conversation about medical devices, regulatory strategy, clinical evidence, and the journey of bringing innovative medical technologies to market.

Allison has spent most of her career helping medical device companies navigate the regulatory process and successfully bring their technologies to market. Over the past seventeen years, she has been involved in hundreds of FDA pre-submissions and premarket submissions covering a wide range of medical device technologies.

Her career includes serving as an FDA reviewer in the Center for Devices and Radiological...

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...

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.

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+.

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.

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...

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 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.

 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. 

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 di...

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...

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.

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...

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...

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.

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 ca...

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, le...

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...

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 <...

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...