Why do so many rare disease families, especially families of color, still feel unseen in research, and what would it take to build clinical trials that truly meet them where they are? In this episode, Laura Brencher, Leapcure’s VP of Advocacy, sits down with Dini Rao, co-founder of Colors of Hope and a Prader-Willi Syndrome (PWS) advocate, to explore what equitable research looks like when day-to-day caregiving is already a full-time job.

Dini shares how Colors of Hope was born from a simple but powerful goal; helping families feel less alone. Dini discusses how that community lens translates directly into better research participation: clearer education, trusted messengers, and study experiences designed around real constraints. Dini points to evidence that physician workforce diversity can have measurable health impacts, specifically, findings related to racial gaps in cardiovascular mortality (ref 1). Together, Laura and Dini unpack why representation isn’t just a “nice to have,” how sponsors and sites can reduce friction without sacrificing quality, and why listening to caregivers is essential to ethical, patient-centered progress in rare disease research.

In this episode, we cover:

• How community-building can remove barriers to research participation and reduce isolation for families
• What “patient-centered” means when caregivers are balancing complex, round-the-clock needs
• Why diversity in rare disease research requires trust, cultural humility, and sustained outreach
• Practical ways to make trials more accessible (communication, logistics, support) while protecting quality

To learn more about Colors of Hope, check out https://www.pwscolorsofhope.org/

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Reference:

1. Alsan, Marcella; Garrick, Owen; Graziani, Grant. “Does Diversity Matter for Health? Experimental Evidence from Oakland.” American Economic Review, 109(12), Dec 2019. https://www.aeaweb.org/articles?id=10.1257/aer.20181446

Pulmonary fibrosis trials are advancing quickly, but many studies still struggle to enroll and complete on time. In this episode, Zach Gobst sits down with Dr. Aaron Milstone, a pulmonologist and principal investigator, to talk about what enrollment really looks like from the site side and what it takes to support patients through participation with dignity, clarity, and trust.

Dr. Milstone shares how pulmonary research has become increasingly competitive, why thoughtful pre-screening against inclusion/exclusion criteria protects both patients and study quality, and how practical logistics for patients, like travel and lodging support, can be the difference between someone being able to participate or not. The conversation highlights what happens when recruitment is treated as a partnership with sites and patients, not just a pipeline.

In this episode, we cover:

• Why pulmonary fibrosis trials are especially competitive for enrollment and what that means for sites and sponsors
• The role of careful pre-screening to ensure the right patients are approached for the right studies
• How travel and lodging support can reduce participation barriers without compromising trial rigor
• What builds (and erodes) trust for patients considering research participation
• Why enrollment success is essential to completing studies and generating evidence patients can rely on

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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 uncertainty
• Designing inclusive studies as a default, not an afterthought
• Building trust-driven, evidence-based approaches that support patients and physicians
• Progress in the field and why upcoming global guidelines matter
• A principle to carry forward: protect women through research, not from research

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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.

In this episode of the Leap Together podcast, we’re honored to feature Dr. Todd Bertoch, principal investigator and pain management researcher. Drawing on decades in the OR and more than 160 clinical trials, Dr. Bertoch shares how the opioid-first era shaped his early career and why he now champions multimodal, mechanism-targeted approaches that prioritize function, safety, and real-world impact.

Join us as Dr. Bertoch breaks down why pain is so hard to measure, how sites and sponsors can reduce participant burden without sacrificing rigor, and the moments that pushed him to challenge entrenched norms in study design. We also explore practical strategies for improving recruitment and retention, communicating realistic pain goals with patients and caregivers, and where the field is headed as new non-opioid targets and smarter endpoints emerge.

Tune in for a clear, grounded conversation on building faster, more inclusive pain studies and on what it takes to move beyond “raise the dose” toward care that truly improves patients’ lives.

In this episode of Leap Together, Zachary Gobst talks with Dr. Michele Reynolds, a family medicine physician turned ACRP-certified principal investigator who has led more than 400 clinical trials over three decades. What began as a “lucky accident” became a career defined by precision, patient education, and strong sponsor partnerships.

Dr. Reynolds shares how mentorship shaped her approach, why building trust with monitors and recruitment teams leads to better outcomes. She discusses how she’s navigated changes in the industry, from recruiting “right-fit” participants to contributing to pivotal vaccine research during COVID-19.

From lessons learned in the field to insights on maintaining a fulfilling lifestyle in research, this conversation is a masterclass in running studies that make a difference for both science and patients.

On this episode of Leap Together, Dr. Mark Gorovoy joins host Zach Gobst to reflect on a remarkable career at the cutting edge of ophthalmic surgery. As a pioneer of DSAEK, Dr. Gorovoy shares how embracing high-volume surgical practice, learning from complications, and staying patient-focused led to major breakthroughs in corneal care. This episode dives into the art of innovation in medicine, from early skepticism to system-wide adoption, and why some treatments can reshape care forever. An episode for anyone passionate about progress in clinical trials, ophthalmology, and patient-centered innovation.