When all of the experts around you say it’s impossible to move the needle forward, how do you still maintain commitment to your research and patients? On the very first episode of Impactful Breakthroughs, Zach Gobst is joined by Jennifer Good, the President & CEO of Trevi Therapeutics, to explore why she has dedicated the past fifteen years to tackling one of medicine’s most overlooked conditions: chronic cough.

Jennifer traces her path from running Pennwest Pharmaceuticals to negotiating a promising compound out of an acquisition and building Trevi from her kitchen table into the $2B public company it is today. She shares how a background in chronic pain research gave her and Co-Founder Dr. Thomas Sciascia a uniquely brain-centered lens on cough, and why listening closely to patients led them to double down on IPF when key opinion leaders told them to walk away. Equal parts science story and entrepreneurial journey, this conversation is a candid look at what perseverance, patient focus, and the willingness to evolve really look like in biotech.

Timestamps

00:00 Episode Start

03:00 Starting Trevi Therapeutics from the kitchen table

05:45 Advice for early entrepreneurs

07:30 Setting checkpoints and sticking to them

08:45 What was missing on chronic cough and IPF

12:45 How chronic pain research unlocked a new view of cough

18:45 Where Trevi fits into the patient experience

22:45 Reflections on her 15-year journey

25:30 Evolving the team as the company grows

32:00 Giving back through rare disease boards and community

34:45 Mentorship shoutouts

Key Takeaways

• The brain matters in cough. While the broader industry was targeting peripheral receptors in the lung, Trevi's neurology-rooted perspective led them to the brain, setting their data apart when everything else failed.
• Stay close to the patient. Jennifer's most powerful moment came from a patient advisory board member who couldn't finish her grocery shopping because of a coughing attack. That story is what drives the work and keeps the north star clear.
• Give yourself a checkpoint, not a cliff. As Jennifer put it, setting a defined window to test your idea, with real deliverables, takes the daily anxiety out of entrepreneurship. You're not on a never-ending rolling stone, you're running an experiment.
• Roles change, people change, and that’s okay. One of Jennifer's hardest and most important leadership lessons: the person who was right for the company at three people may not be the right person at forty-five. Honest self-reflection applies to the whole team, including the CEO.

Guest Shoutouts

• David Meeker MD, Chairman, President, and Chief Executive Officer of Rhythm Pharmaceuticals
• Stuart Falber, Partner and Co-Chair of WilmerHale's Life Sciences Practice
• Paul Freiman, Former Chairman of the Board of Penwest

Resources

• Connect with guest Jennifer Good on LinkedIn
• Check out Trevi Therapeutics
• Connect with host Zach Gobst on LinkedIn
• Check out Leapcure

What does it take to protect the research that could one day save your sight? On this episode of Leap Together, Zach Gobst is joined by Dan Igniewski, Executive Director of the National Alliance for Eye and Vision Research (NAEVR) and the Alliance for Eye and Vision Research (AEVR). With over 20 years in government affairs and patient advocacy, Dan has become one of Washington's most persistent voices for vision research funding, and today's conversation shows exactly why that work matters.

Dan traces his path from early healthcare policy work to championing the National Eye Institute's independence on Capitol Hill, sharing how vision science is quietly leading some of medicine's most exciting frontiers, from the first FDA-approved gene therapy to AI-powered diagnostics and stem cell breakthroughs. He also unpacks NAEVR's “See What Matters” campaign, the mechanics of effective coalition building, and what it really takes to align patients, providers, researchers, and industry around a single message when federal funding is on the line.

Timestamps

00:00  Episode start

01:45  Dan's background and path to advocacy

03:55  What makes vision research unique

05:45  Parallels between policy and clinical research

06:55  Bipartisan support for NIH and the National Eye Institute

08:00  Career inflection points and advocacy wins

11:00  The See What Matters campaign

14:50  Shared challenges in patient engagement

16:55  What makes advocacy most effective

19:40  Mentorship and career guidance

23:15  The power of persistence and confidence

25:30  Closing thoughts

Key Takeaways

• Coalition is everything. When patients, providers, researchers, and industry align around a shared message, Congress listens. No single organization can move policy alone.
• Vision research punches above its weight. From the first FDA-approved gene therapy to stem cell and AI advances, vision scientists have quietly been leading the broader medical research field for decades.
• Don't wait to be taken seriously. As Dan once heard from a colleague: "You've been in the decision-making rooms for years, why do you think suddenly at 30 it's gonna change?" Show up, know your value, and make your point.
• Vigilance is ongoing. Even with recent wins protecting NIH funding, Dan reminds us that staying engaged and vocal is a continuous responsibility, not a one-time effort.

Resources

• Connect with Dan Igniewski on LinkedIn
• Check out the See What Matters Campaign
• Check out the National Alliance for Eye and Vision Research
• Connect with Zach Gobst on LinkedIn
• Check out Leapcure

What happens when a neuroscientist follows his curiosity from the brain to the soil, and then to the stars? In this episode of Leap Together, Zach Gobst sits down with Dr. Joshua Ortiz-Guzman, a gene therapy engineer and developmental neuroscientist turned clinical research leader, industrial biotechnologist, and soil health innovator. Joshua's work spans an unusually wide range: building clinical research capacity in underserved El Paso, Texas; developing microbial biochar technologies that restore degraded soils; banking stem cells to rigorously track regenerative medicine outcomes; and orienting all of it toward a long-term vision of human longevity and space exploration.

This episode explores how environmental health and human health are deeply interconnected, and why that connection is chronically underappreciated in clinical research. Joshua shares how his PhD on brain-driven food intake led him down a rabbit hole from farm-to-table agriculture to emerging environmental contaminants like PFAS ("forever chemicals"), and why he believes the clinical research community can't fully understand drug outcomes without accounting for the environments patients live in.

He also reflects candidly on the challenges of building a research program from scratch in El Paso, a predominantly Spanish-speaking, medically underserved region where providers are overstretched, community trust requires intentional outreach, and groups like the Medical Center of the Americas are making real strides through “promotoras” led education. Joshua's journey from academic idealism to real-world business acumen, from soil pilots in Chihuahua and Colombia with Aurum Tech to a Florida-based stem cell bank called Prodigy Cells, is a rare example of evidence-first rigor applied consistently across human health and environmental systems.

What does it actually take for a high-performing clinical practice to step into research for the first time? In this episode, Zach Gobst sits down with Dr. John Mandeville, a leading oculoplastic surgeon at Ophthalmic Consultants of Boston, to trace his unexpected path from bench science and surgical practice back to clinical research and what he's learned in his first year running studies.

Dr. Mandeville shares how a career spent treating Thyroid Eye Disease (TED) led him to seek out new treatment options when surgical approaches alone weren't enough, and how that curiosity brought him from enrolling a single patient to running eight or nine clinical trials in just twelve months. He reflects honestly on the steep regulatory learning curve, the importance of building the right team, the challenge of managing patient expectations and motivations, and what it really costs, financially and personally, to build a research program inside a busy private practice.

His perspective on patient recruitment is especially candid: from understanding why some patients are eager to enroll, to knowing when to talk someone out of a trial entirely, Dr. Mandeville brings a grounded, empathetic lens to what is often treated as a purely logistical problem.

What happens when a pediatric oncologist who has sat at the bedside of children with cancer decides the best way to help more patients is to leave the clinic entirely? In this episode, Zach Gobst sits down with Dr. Kristiyana Kaneva, a board-certified pediatric hematologist, oncologist, and neuro-oncologist, now Senior Medical Director of Oncology Early Development at AbbVie, to explore what it really takes to bridge the gap between the bench and the patient.

Dr. Kaneva reflects on her training at Children's Hospital Los Angeles, the weight of caring for critically ill children, and the early mentor who first introduced her to the world of precision medicine and pediatric brain tumors. She shares how that spark led her to Tempus AI, where she led an end-to-end team to bring a minimal residual disease (MRD) test for colorectal cancer from concept to commercial launch and what it felt like to see that test making a real difference in the clinic.

Now at AbbVie, Dr. Kaneva discusses the work of oncology early clinical development: shepherding novel molecules through IND submissions and first-in-human Phase 1 trials. She makes the case for why pediatric patients can't be an afterthought in drug development, how FDA regulatory guidance is beginning to close that gap, and why the next generation of in vivo CAR T therapies could transform access for patients around the world.

In this episode, we cover:

• What drew Dr. Kaneva to pediatric oncology as a college student and why she never changed course
• The emotional realities of training at one of the country's busiest pediatric cancer centers
• How precision medicine and a pioneering mentor at CHLA redirected her career toward diagnostics and industry
• Leading the development and commercial launch of an MRD test for colorectal cancer at Tempus AI
• What oncology early clinical development looks like at AbbVie from IND applications to first-in-human trials
• Why pediatric drug development has historically lagged and how the field is slowly catching up
• The promise of off-the-shelf in vivo CAR T therapies and what they could mean for global patient access

Subscribe for more conversations on clinical research innovation that keeps patient needs at the center.

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.