Leap Together

Why are pregnant and breastfeeding women still so often excluded from clinical research, and what does that mean for real-world decision-making? In this episode, Laura Brencher, Leapcure's VP of Advocacy, sits down with Marie Teil, UCB's Global Head of Special Patient Populations, to unpack the long-standing evidence gap for women of childbearing age and what it takes to close it responsibly.Marie shares why inclusion has to be intentional from the start, how earlier data generation supports more informed conversations between patients and clinicians, and what “ethical” truly looks like when patients are left without evidence. The conversation touches on growing global momentum, including evolving ICH guidance aimed at supporting the inclusion of pregnant and breastfeeding individuals in clinical trials and what leaders across the ecosystem can do today to move the field forward.In this episode, we cover:Why excluding pregnant/breastfeeding populations creates real-world risk and uncertaintyDesigning inclusive studies as a default, not an afterthoughtBuilding trust-driven, evidence-based approaches that support patients and physiciansProgress in the field and why upcoming global guidelines matterA principle to carry forward: protect women through research, not from researchSubscribe for more conversations on clinical research innovation that keeps patient needs at the center.

In this episode of Leap Together, Zach sits down with Robin Schmidt, a clinical operations expert, to unpack the behind-the-scenes work that makes clinical research move. With over 30 years of experience across pharma and biotech, Robin shares her journey into clinical trials, the “village” it takes to execute studies well, and why culture and respectful partnerships are often the difference between a smooth trial and a painful one.Robin also offers a clear walkthrough of the clinical trial lifecycle; what phases 1, 2, and 3 are designed to prove, why safety monitoring is so intensive, and how teams turn trial data into real-world treatment options. From COVID-era shifts toward telehealth and home health nursing to the rise of AI tools that have potential to reduce administrative burden, the conversation highlights how clinical operations are evolving fast and why trust with patients, sites, and partners remains non-negotiable.

In this episode of Leap Together, host Zach Gobst sits down with Vish Srivastava, Co-Founder and CEO of Century Health, to explore how AI and real-world clinical data can accelerate breakthrough treatments and create more inclusive research.Vish shares his journey into healthcare technology, shaped by both professional experience and deeply personal motivation, and explains why so much of today’s most valuable clinical insight lives outside academic medical centers. Together, they discuss the challenges of unlocking fragmented community-based data, the limitations of traditional registries, and why underrepresented patient populations hold the key to answering some of medicine’s most important unanswered questions.The conversation also dives into Century Health’s thoughtful approach to applying AI in healthcare: why trust, transparency, and validation matter, how models are evaluated against human clinicians, and what it really takes to build AI systems that can be relied on for research and patient impact.From founding a company in a complex healthcare ecosystem to designing AI that earns clinical trust, this episode is a candid look at what it means to take the harder path in order to make a meaningful difference for patients.

Pulmonologist Dr. Tejaswini Kulkarni, Director of Interstitial Lung Disease at UAB, joins Leap Together to share how she approaches diagnosing and managing Interstitial Lung Diseases (ILDs), particularly Idiopathic Pulmonary Fibrosis (IPF), and why patient education must guide every step. She discusses improving access for rural communities, designing ethical, truly patient-centric trials, and capturing outcomes that matter through registries and patient-reported outcomes. Tune in for practical ways sponsors, sites, and advocates can collaborate without compromising care or research quality.

In this epsiode of Leap Together, Tris Pharma’s Head of Clinical Operations, Liza Micioni, distills 25+ years of end-to-end study leadership. She discusses how durable physician relationships speed decisions and drive site follow-through, and how steady cross-functional rhythms keep “your delay becomes my delay” from taking root. Liza unpacks the real trade-offs of the clin-ops triangle: time, budget, and quality. She explains that quality is non-negotiable, while timelines and budgets need to flex to meet reality. She shares practical stories of creative, “figure-it-out” logistics, when extending a timeline is the right call, and a grounded take on where AI truly helps (and where it doesn’t) in today’s trials.Above all, her north star never wavers: improving individual lives, one patient at a time.