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