Impactful Breakthroughs

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

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

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

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

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/

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

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