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Impactful Breakthroughs

This is Impactful Breakthroughs, the podcast where we highlight top leaders driving breakthroughs in clinical research and life sciences.

Each episode features candid and inspiring conversations with the people who have dedicated their lives to shaping the future of healthcare. You'll hear stories from the physicians who've run hundreds of clinical trials, biotech founders chasing the next cure, surgeons pioneering new techniques, and patient advocates who turned their own diagnoses into a mission to help others.

Hosted by Zach Gobst, who has spent his career working alongside clinical trial teams and patient communities, be sure to subscribe on Apple Podcasts, Spotify, or wherever else you listen.

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25 episodes
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#7
Wednesday · 39 min
Leesa Gentry - Chief Clinical Officer at RenovoRX
While clinical science has made tremendous strides over the last few decades, the clinical operations stringing it all together have barely moved. Today’s guest, Leesa Gentry, can’t believe that gap still exists, and has spent most of her career working on it. Leesa is the Chief Clinical Officer at RenovoRX, a Bay Area based life sciences company developing innovative targeted oncology therapies and delivery systems. On this episode of Impactful Breakthroughs, she speaks with Zach Gobst about lean teams, sponsor and CRO relationships, and where AI belongs in clinical research. A consistent throughline in their conversation is Leesa’s dedication to fostering human relationships to best advance the research. She believes that CRO dynamics are inherently set up to be adversarial with constant cost and time pressure. With most sponsors “rolling studies into a ball and tossing it over a fence,” her solution is to envelop CROs directly into her teams, empowering them to truly contribute. Her take on AI is direct and actionable: It’s here to stay, so figure out how you can use it to clear your head so you can think about what is around the corner, and keep a human in anything that involves patient care. Timestamps 00:00 Episode Start 02:30 How Leesa went from psychology to clinical research 05:00 Precision medicine and the end of the linear path 06:50 What led Leesa to RenovoRx over two other offers 08:05 A de-risked drug delivered straight to the tumor 11:15 What a lean clinical team actually needs 13:55 Why Leesa is often called a cowboy 20:25 Building one team across cultures 23:10 Running a Phase III without a CRO 30:45 Invest in metrics that actually matter 32:10 What 30 years of revolutions taught Leesa about AI 36:50 Leesa's mentors and closing reflections Key Takeaways Don’t be afraid of the next challenge. Leesa has been called a cowboy on more than one occasion in her career, crediting the name to her habit of taking on work people have already claimed is impossible. If you reframe challenges as opportunities, you never know where you’ll find yourself next. The fact that you launched it means nothing. Leesa is blunt about vanity milestones in clinical technology. Go-live is not a valuable metric, and a dashboard nobody enters data into is still garbage in, garbage out. Be intentional about the products you leverage and the metrics you showcase. The best use of AI right now is clearing your head. Leesa has watched revolutions get oversold before, decentralized trials included, usually because someone threw technology at a problem without understanding how sites and patients would see it. Her practical advice is to use AI on tracking and categorizing so people get their thinking time back, and to keep humans on patient care, patient decisions and ethics. No one will love the work like you do. Leesa recognizes that when outsourcing projects, it’s incredibly difficult to align everyone to row in the same direction. Her solution is to treat CROs, 1099s, and consultants as direct parts of her team, setting clear incentives and allowing them to take full ownership of their contributions. Guest Shoutouts Charles D. Wells, MD, Chief Medical Officer and Head of Medical Development, The Gates Medical Research Institute K. Angela Macfarlane, JD, Chief Executive Officer, Perceive Biotherapeutics, Inc. Resources Connect with guest Leesa Gentry on LinkedIn Check out RenovoRX Connect with host Zach Gobst on LinkedIn Check out Leapcure
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#6
October 14 · 31 min
Dave Hine - AVP, Financial Services, Suvoda
What could clinical research learn from an industry where nothing ships until every system works perfectly in tandem with one another? Dave Hine, AVP of Financial Services at Suvoda, brings a deep background in rigorous systems engineering to today’s episode of Impactful Breakthroughs. Suvoda is a global clinical trial technology company which provides a unified software platform to manage complex and time-sensitive clinical studies. In today’s conversation, Dave speaks with host Zach Gobst about what an aerospace engineer noticed when he walked into clinical research and could not stop noticing. Dave studied aerospace engineering, worked flight test and computational fluid dynamics software for the Navy, and joined Greenphire in 2018 as its only sales engineer. Today, he leads the team focused on site payments and budgeting. The two of them get into interoperability and why it stalls in clinical trials, using military technology as the counterexample. Despite having parts manufactured by a handful of private agencies, each element of an F-18 is federally mandated to work seamlessly together. They also cover how COVID was the moment the public finally understood what a clinical trial was, and what survived from the decentralized trial wave. The throughline is a habit most listeners can use directly: treat every process, vendor relationship, and team decision as one system, then ask who is accountable when a piece of it fails. That is the lens Dave brings to site payments, and it holds up as well in a study budget as it does on an aircraft. Timestamps 00:00 Episode Start 01:40 Dave’s journey to aerospace engineering 02:55 Nine years of deep systems experience 04:10 What brought Dave to clinical trials in 2018 05:20 The importance of interoperability 08:45 Why Dave stayed in clinical trials 10:50 COVID as a turning point for the entire industry 12:50 Assume best intent, in both directions 16:40 Delegation, standards, and leading a team 23:30 Where AI helps and where it should not 26:20 Advice, mentors, and thank yous Key Takeaways Systems thinking would be an enormous win for patients and clinicians. Dave learned to design for interoperability at the Navy, where every part had to work with one another, regardless of manufacturer. Clinical research has many buyers and no one willing to carry that risk for competitors, and Dave is blunt that incentives often run the wrong way. Risk assessments need to be accessible. Despite being required, Dave points out that risk assessments are still rarely understood well due to overcomplication. In his work today he strips risk down to high, medium, and low, color coded, enabling anyone to get the whole picture from just a glance. "I would rather have AI edit my summary than me edit an AI summary." Dave uses AI note takers constantly and says they save real time, but his objection is to the order of operations. He argues for writing client-facing summaries yourself first and treating AI as the editor, keeping critical thinking with the human. Assume best intent, in both directions. Dave describes himself as loud and opinionated, and says he now apologizes proactively when he suspects he has landed wrong. This experience has also taught him about the inverse, and he now reminds himself that someone else's decision comes from a different set of experiences, not bad intent. Guest Shoutouts Andrew Sutton, VP of Business Development, Conquest Research Benjamin Mell, Director of Site Sales, CRIO Jim Murphy, Operating Partner, The Riverside Company Wayne Baker, Chief Revenue Officer, ValGenesis Kyle Cunningham, Chief Product Officer, RealTime eClinical Solutions Justin Vega, Head of Solutions Consulting, Financial, Suvoda Heather Horville, Solutions Consultant, Suvoda. Andrew Gerrard, Solutions Consultant, Suvoda. Resources Connect with guest Dave Hine on LinkedIn Check out Suvoda Connect with host Zach Gobst on LinkedIn Check out Leapcure
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#5
September 30 · 23 min
Dr. Karen Correa - VP Clinical Development Operations, Boehringer Ingelheim
After 30 years in clinical research, most people would tell you they've seen it all. But for today's guest, Dr. Karen Correa, three decades in the industry has only deepened her conviction that it’s less critical to know everything, and much more important to know everyone. Karen is the VP of Clinical Development Operations at Boehringer Ingelheim, and on this episode of Impactful Breakthroughs she speaks with Zach Gobst about what it really takes to build teams and cultures that deliver for patients. The two talk about why culture is the real unmet need in clinical development today. When processes, science, and timelines are all clearly established, company culture is the thing that can't be downloaded or rushed, and yet it's where everything begins and ends. Karen also opens up about the mentors who shaped her character, each pouring something different into her: truth, compassion, curiosity, and courage. And when it comes to the inevitable challenges that come with a career of this scope, Karen has a reframe that stays with you. A delay is not a denial. Keep knocking. That no is going to become a yes someday. Because at the end of it all, she's never lost sight of why the work matters, and that's exactly the kind of north star that keeps the best leaders going. Timestamps 00:00 Episode Start 01:45 How Karen's career in clinical research began 04:45 Understanding the patient experience from every angle 05:30 Why culture is the real unmet need in pharma 09:00 The mentors who shaped Karen's character and courage 12:30 Reframing challenges as learning opportunities 15:25 Finding your circle and embracing vulnerability 16:00 Being intentional about personal growth 17:15 How Karen is approaching AI today 19:55 What's energizing Karen about the future of clinical research Key Takeaways Culture is the real unmet need. When everyone in the industry already possesses the hard science skills, team culture is the only thing left. Karen believes it’s where everything begins and ends, but yet it’s still an overlooked aspect across the board. I don't want to know everything. I want to know everyone. Karen's approach to growth and vulnerability is simple. Surround yourself with people who are brighter than you, lean on them when you don't have the answers, and contribute what you know to the circle in return. Be kind to yourself. Karen reframes challenges not as setbacks but as redirections. Moments that force you down a different path you might not have found otherwise. Keep knocking, she says. That no is going to become a yes someday. Keep your leadership authentic. Karen credits many mentors for helping to build her into the leader she is today. She says “Leadership is about knowing who you are and refusing to compromise on that foundation.” Curiosity is a form of humility. Karen reminds us all to stay curious and teachable throughout our careers. “The best leaders never assume that they've arrived. They stay open, stay hungry, and stay teachable.” Guest Shoutouts Ubavka DeNoble MD, Corporate Vice President, Patient Technology Solutions/Growth, PAREXEL Christine Enciso, Vice President, Development Services and Operational Excellence, Regeneron Jeremy Chadwick, Chief Operating Officer, Kymera Therapeutics Brian Meltzer MD, Vice President, Clinical Research, Alexion Pharmaceuticals, Inc. Resources Connect with guest Karen Correa on LinkedIn Check out Boehringer Ingelheim Connect with host Zach Gobst on LinkedIn Check out Leapcure
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#4
September 16 · 25 min
Kate Stratton - Executive Director, Lipodystrophy United
What does it look like to truly amplify the voices of those suffering from a rare disease, especially when you yourself have such a personal connection? On this episode of Impactful Breakthroughs, Zach Gobst sits down with Kate Stratton, Executive Director of Lipodystrophy United, a patient-driven global community dedicated to improving the lives of those affected by lipodystrophy through advocacy, community, and research. Kate shares how her empathetic approach to patient advocacy was shaped. From her own mother’s experience navigating a 37-year diagnostic odyssey, to her experiences working with Planned Parenthood and asylum seekers, she emphasizes the importance of direct conversations rather than assumptions. You’ll also hear Kate’s journey navigating imposter syndrome and her advice for any young entrepreneurs out there looking to make their ideas a reality. This conversation is a testament to what happens when personal experience, genuine empathy, and a refusal to wait for permission all come together in one person. Timestamps 00:00 Episode Start 01:55 Kate's personal path into patient advocacy 04:15 Lipodystrophy and how it affects the body 07:00 The common thread across all advocacy work 09:25 Patient voices matter most 12:15 Ensuring no one gets put in the wrong box 14:45 Being a young leader and navigating imposter syndrome 16:20 What Kate has learned from openness and collaboration 19:15 What's next for Lipodistrophy Untied 21:45 Kate’s advice for younger generations Key Takeaways One patient's experience is not a population. Kate is emphatic that true patient-centricity means continuously expanding the network of voices you listen to rather than relying on a single story or a token representative. After two years leading Lipodystrophy United, she still learns something new every time she speaks with a community member. Amplify, don't replace. Kate's approach to advocacy across immigration, health policy, and now rare disease, has always been the same: listen deeply, then lift others' voices rather than substituting your own. It's a philosophy that builds trust and creates lasting change. Just decide to do it. If you believe you can do something, you probably can. Surrounding yourself with people who are doing unconventional things and not waiting for external validation is what separates those who make an impact from those who talk about it. Age is not a barrier to impact. Kate has seen firsthand how quickly change can be made. At 23 she’s already expanded her team, published research, raised over $250,000 for the organization, and secured an FDA meeting for patients. Guest Shoutouts Andra Stratton, President and Co-Founder of Lipodystophy United Sabine Tilp, Journalist, Patient Advocate and leader of the German Lipodystrophy Network Resources Connect with guest Kate Stratton on LinkedIn Check out Lipodystrophy United Connect with host Zach Gobst on LinkedIn Check out Leapcure
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#3
September 2 · 31 min
Francesca Barone - Chief Scientific Officer, Candel Therapeutics
How far can curiosity take you when you’re not afraid of the unknown? For today’s guest, Francesca Barone, it led her across continents and disciplines as she navigated her way to the forefront of cancer immunotherapy. Francesca is the Chief Scientific Officer at Candel Therapeutics, and on this episode of Impactful Breakthroughs she speaks with Zach Gobst about how Candel is developing multimodal biological immunotherapies to help patients fight cancer. Francesca shares the driving force, her “backpack theory,” behind the journey she’s taken. Rather than settling into comfort, she believes every few years you should pack up what you've learned and head toward a new challenge entirely. It’s a belief that has carried her from academic rheumatology to leading cutting-edge oncology drug development, navigating language barriers, cultural shifts, and an industry that wasn't yet ready to believe in what her team was building. She also shares what it took to push Candel's novel intratumoral delivery approach through years of skepticism, why her physician background has been her greatest superpower in biotech, and what it really means to keep patients at the center even when your work may feel far removed. Behind every compassionate use request, every data point, and every clinical trial, there is a patient and a family. And for Francesca, that's always been reason enough to keep going. Timestamps 00:00 Episode Start 01:45 Why Francesca moved from academia to biotech 03:55 The power of stretching beyond your comfort zone 09:30 You're only as good as your team 10:15 Candel's novel approach to fighting cancer 13:35 Overcoming skepticism and remaining committed 17:05 The human side of drug development 19:20 A patient stories that say it all 23:25 Mentors who shaped Francesca’s journey 29:30 Closing reflections on purpose and impact Key Takeaways Explore curiosity throughout your career. Francesca's guiding philosophy is simple: every few years, pack up what you know and head somewhere new. The discomfort of starting over in a new field, a new country, or a new challenge is exactly where the best growth happens. Patients are better at designing trials than we are. When patients are truly embedded in your drug development process, you avoid mistakes you wouldn't have seen coming. Assuming you already know what will serve patients best is a trap that leads science in the wrong direction Find your conviction. Candel's intratumoral delivery was once met with investor skepticism and industry doubt. Now major pharma companies are building similar programs. Believing in your data when others don't is part of the job. Steady leadership is contagious. Francesca credits Candel CEO Paul Peter Tak with modeling a calm, thoughtful leadership style that she has worked to channel in herself, particularly in turbulent moments. In science and life, the ability to stay grounded in a storm makes everyone around you steadier too. Guest Shoutouts Guido Valesini, Professor of Rheumatology at Sapienza University of Rome Christopher Buckley, Kennedy Trust Feldmann Maini Professor of Translational Medicine at University of Oxford Paul Peter Tak, President, CEO, and Board Director of Candel Therapeutics Resources Connect with guest Francesca Barone on LinkedIn Check out Candel Therapeutics Connect with host Zach Gobst on LinkedIn Check out Leapcure
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#2
August 19 · 26 min
Becky Weber - EVP of Sales, Lunit
What happens when a career built on the cutting edge of health technology suddenly extends to become deeply personal? On this episode of Impactful Breakthroughs, Zach Gobst is joined by longtime friend Becky Weber, the EVP of Sales at Lunit Cancer Screening. Lunit, formerly Volpara Health, provides AI-powered software for breast cancer screening and early detection, supporting over one million screenings annually. With 20 years working at the intersection of health and technology, Becky walks through her journey from shadowing surgeries as a teenager, to helping build HealthKit at Apple, to ultimately joining the team at Lunit following her own breast cancer diagnosis. You’ll hear her share why mission alignment has proven to be the secret in Lunit’s successful merger with Volpara, what she believes it’ll take to navigate regulatory hurdles safely in the AI era, and how her perspective on life and career has completely pivoted. Equal parts personal story and industry insight, this conversation serves as a reminder that the most powerful driver in health technology is the reason behind it. Timestamps 00:00 Episode Start 01:35 Becky's journey in health tech 04:05 A breast cancer diagnosis which changed it all 08:45 Following your passions 12:09 Prioritizing team impact over personal politics 13:45 Why startups beat big companies for the puzzle-solvers 14:45 Lunit's two-sided platform and the AI difference 17:10 The interval cancer study proving their work 20:25 Hiring for personal connection to the mission 22:10 Mentors who made a difference 22:50 The convergence of research, product, and diagnosis 25:00 AI, regulation, and the rocket ship problem Key Takeaways Personal connection drives performance. Just like in her own story, Becky has found that the candidates with personal ties to breast cancer consistently outperform those who don’t. Data is already changing what's possible. Lunit's AI would have reduced confirmed interval cancers by a third in a study out of Mass General Brigham, meaning women who would have faced late-stage diagnoses could have been found earlier. That's not a future promise, it's happening now. Drop the politics, focus on the outcome. Becky is candid about how her perspective on work shifted after her diagnosis. Empire building, org size, and resume padding simply stopped mattering. What replaced it was something much simpler and more freeing – to get the best result for the patient. The guidelines were built for a train, not a rocket ship. As Becky put it, the regulatory frameworks governing AI in medicine were designed for a different era. Figuring out how to move fast responsibly is the real challenge ahead. Guest Shoutouts Dr. Manisha Bahl, Radiologist at Massachusetts General Hospital Teri Thomas, CEO of Mach7 Technologies & Former CEO of Volpara Health / Lunit Cancer Screening Resources Connect with guest Becky Weber on LinkedIn Check out Lunit Cancer Screening Connect with host Zach Gobst on LinkedIn Check out Leapcure
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#1
August 5 · 35 min
Jennifer Good - President & CEO, Trevi Therapeutics
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
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#19
June 24 · 23 min
Dan Ignaszewski - Executive Director, National Alliance for Eye and Vision Research
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
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#18
April 24 · 46 min
Dr. Joshua Ortiz-Guzman - Director of Clinical Research and Translational Scientist
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.
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#17
March 30 · 37 min
Dr. John Mandeville - Oculoplastic Surgeon and Principal Investigator
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.
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#16
March 11 · 33 min
Dr. Kristiyana Kaneva - Senior Medical Director of Oncology Early Development at AbbVie
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.
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#15
February 25 · 23 min
Dini Rao - Co-founder of Colors of Hope and PWS Advocate
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/ Subscribe for more conversations on clinical research innovation that keeps patient needs at the center. Reference: 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
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#14
February 11 · 35 min
Dr. Aaron Milstone - Pulmonologist and Principal Investigator
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 Subscribe for more conversations on clinical research innovation that keeps patient needs at the center.
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#13
January 28 · 27 min
Marie Teil - Global Head of Special Patient Populations at UCB
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 Subscribe for more conversations on clinical research innovation that keeps patient needs at the center.
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#12
January 12 · 32 min
Robin Schmidt - Clinical Operations Expert
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.
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#11
January 5 · 31 min
Vish Srivastava - Co-founder and CEO of Century Health
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.
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#10
Nov 11, 2025 · 43 min
Dr. Tejaswini Kulkarni - Investigator and Director of Interstitial Lung Disease at UAB
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.
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#9
Sep 22, 2025 · 32 min
Liza Micioni - Tris Pharma Head of Clinical Operations
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.
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#8
Sep 1, 2025 · 27 min
Dr. Todd Bertoch - Principal Investigator and Pain Management Researcher
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.
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#7
Aug 15, 2025 · 21 min
Dr. Michele Reynolds - Multispecialty Research Principal Investigator
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.
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