Making the Right Call Between Patient Safety and Risking Company Success

Leadership calls for courage. People with life-threatening, chronic liver diseases need treatments, but right now, limited FDA-approved therapies are available. CymaBay Therapeutics is one company in the space with the promising pipeline compound seladelpar. However, in 2019 when some patients with an advanced form of fatty liver disease showed possible tissue damage at the end of a Phase 2 trial, CEO Sujal Shah called “time-out” on all clinical trials. PM360 asked Shah about his decision.

Sujal Shah, CEO, CymaBay Therapeutics

PM360: The findings later determined the tissue damage was present in these patients before they even entered the study, but at the time how difficult was your choice to suspend trials?

Sujal Shah: Our mission is to prolong and improve the lives of patients with liver diseases and it’s our responsibility to understand the risk-benefit of our treatment alternatives. It was a difficult decision because I knew halting all trials would not only put seladelpar’s future in peril, but would also likely put the company’s future at risk. At the same time, it was the right decision and the only decision we could make when considering our first priority is patient safety.

Despite facing significant challenges, we committed to a comprehensive safety evaluation led by an independent panel of world-leading pathologists and hepatologists. After a thorough review, the panel determined no clinical, biochemical, or histological evidence of seladelpar-related liver injury in the study and unanimously supported re-initiating trials. Based on this investigation, the FDA lifted the clinical holds on seladelpar across all indications we were evaluating at the time.

You came to healthcare from the investment community, first at Credit Suisse and then Citibank, before joining CymaBay as CFO in 2013 and taking the company public in 2014. How did that background inform your leadership decisions?

I started my career, in fact, on a lab bench where I learned the importance of data-driven decision-making in life sciences before moving to Wall Street. As an investment banker, I always felt the best decisions we made were also driven by data. In drug development, we serve patients whose lives depend on decisions we make every day, and so we have a responsibility to be transparent and timely in our communication and action. That’s the only way to operate, and though we shouldn’t need a business case to support doing the right thing, history shows businesses that prioritize morality do better consistently.

What gets you out of bed in the morning?

I get to partner with a remarkable team of people at CymaBay and in the medical community. I have the privilege of learning from patients and working with patient advocacy groups who inspire us to never give up. We don’t have time to waste as patients and their families are depending on the work we do. Our priority is getting seladelpar through Phase 3, through regulatory review, and, hopefully, to patients. Every day, I look at how we’re approaching that mission and ask how CymaBay can be more responsive to patient needs. That’s a powerful motivator—one that inspires all of us to push forward relentlessly.

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