Episodes

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 Depar...

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 te...

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 disco...

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. Global Trial Accelerators™ is produced by bioaccess® — the first-in-human CRO for the U.S. and Latin America. Explore first-in-human trials: bioaccessla.com/firs...

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 medi...

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...

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 operati...

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...

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...

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 Silic...

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.

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.

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 …

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 ...

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.

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.

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.

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.

Dr. Palumbo is a physician-scientist with 30+ years leading programs in psychiatry, neurology, and neurodegenerative disease across Johnson & Johnson/Janssen, Mitsubishi Tanabe, Zynerba, and BioVie, with contributions to FDA registrations such as Risperdal Consta, Invega, Invega Sustenna, and Radicava. He emphasizes the formative role of early mentors and cross-disciplinary collaboration throughout his path from medical training at George Washington University and Yale into industry leadership.[1] - Trends in clinical research: He highlights rising diversity in the field and the value of multi-disciplinary talent (engineers-physicians-scientists) enabling systems biology approaches. He notes a positive shift toward starting with the right scientific questions and then applying technology (including AI) as a tool, rather than leading with tools. He also underscores the growing power of patient advocacy in steering research priorities toward real unmet needs across areas such as vacc…

- Guest: Nicholas Kadysh, CEO of PharmAla Biotech, a company pioneering GMP-grade MDMA production and recognized as a top-performing Canadian market stock in 2023. He also serves as Chair of Psychedelics Canada, leading efforts to strengthen legal and ethical standards and advance government engagement and policy in the psychedelic medicine sector. - Core themes: - Biotech innovation in psychedelic-assisted therapies, with a focus on pharmaceutical-grade MDMA manufacturing and compliance. - The evolving future of psychedelic medicine, including clinical translation, regulatory pathways, and integration into healthcare systems. - Policy and public affairs: how industry standards, advocacy, and government collaboration shape responsible growth and patient access in this emerging field. - Takeaways: - PharmAla’s strategy centers on quality, regulatory rigor, and supply readiness for clinical and potential therapeutic use cases. - Industry maturation depends on robust…

In this episode, we sit down with Carolina Alarco, 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.

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.

Robert serves as the CEO for medAppraise Inc., a health technology startup focused on transforming the health and wellness of employees in large industrial corporations through the use of a state-of-the-art musculoskeletal health evaluation solution. In addition, Robert currently serves as president of RNB Ventures Consulting Inc, which is a medical device/technology consultancy firm. RNB Ventures Consulting aim is to provide medical/clinical affairs consulting expertise to medical device and IV...

Ram is a serial entrepreneur with 25 years of experience in the ophthalmic pharmaceutical and device industry. Ramgopal is Inventor, Founder, and Chief Executive Officer of LensGen, Inc., a clinical-stage medical device company that is developing a novel intraocular lens for presbyopia. The Company has received support from one of the largest medical device companies in the world, and this led to LensGen closing a $28.0 million Series A Financing in May 2018. Currently, he is also Chairman of t...