Impactful Breakthroughs

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

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

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