Working with Stars: Meet Arie Regev, M.D., FAASLD
Dr. Arie Regev is one of the top hepatotoxicity experts. After a long career in academia and pharma, he is now helping pharmaceutical companies when a hepatotoxicity risk assessment is needed. There are many fascinating aspects to his journey in hepatology and PV. Read how you can be a top scientist while focusing on one single objective...
How did you become a liver expert?
A bit by serendipity, during internal medicine training, my department chief was a very famous hepatologist and brought me into liver clinics, where I began to understand the patients and liver diseases in greater depth. I later completed gastroenterology, hepatology, and transplant hepatology fellowships. I felt very attracted to this world. Hepatology appealed to me because it brings together many disciplines: it has aspects of infectious diseases, metabolic disorders, immunology, toxicology, it is complex, it has procedural aspects, it is a multi-faceted area.
What did patient safety come to mean for you?
I developed a passion for that aspect in drug development. When a patient takes a pill and puts it in his or her mouth, or injects a medicine, it requires an enormous level of trust that we don't always appreciate, that people who developed this drug took every measure to make sure that it is safe. Safety work means ensuring that during drug development we have taken every reasonable measure to understand risks, communicate them clearly, and make the benefit-risk balance visible to patients and prescribers. I became very passionate about this.
What was your role at Eli Lilly? (Arie retired recently from Lilly)
I spent nearly 20 years there. I led the Liver Safety Advisory Committee, a multidisciplinary group including chemists, ADME experts, veterinary pathologists, epidemiologists, gastroenterologists, hepatologists, and others. Over the years, Lilly created a total of 9 such groups for different safety areas which was called the Safety Advisory Hub, which I led for nearly 15 years. I became Vice President of Global Patient Safety. I remained closely involved in liver safety across the portfolio, including liver safety questions related to due diligence for potential acquisition of new drugs. That really gave me a lot of exposure to a broad spectrum of novel drugs, some of which had unusual or unfamiliar types of drug-related hepatic adverse events It has been a learning experience like no other; I can’t thank Lilly enough for that opportunity.
What surprised you about working in pharma?
One major lesson was learning how to work constructively with bias. Drug development teams may spend 10 or 15 years on a molecule and become deeply attached to it. I had to learn how to help teams see safety concerns very collaboratively and very gently, especially when those concerns challenged beliefs they had held for years. This was different from clinical medicine, where I was more accustomed to explaining my view directly to patients or physicians.
How does consulting compare with your work at Lilly?
I would describe my current consulting work as almost a continuation of what I did at Lilly. When advising a company, I feel as though I am still sitting with a drug development team, trying to help them succeed while understanding safety implications. I enjoy the collaborative problem-solving and the uncertainty involved in determining whether findings represent true drug-induced liver injury, underlying disease, or another cause. I enjoy it tremendously, especially because it allows me to work with different groups while maintaining the same sense of shared purpose.
What do you believe made you successful?
I am passionate about what I do. My work matters for individual patients who will benefit from the drug while being aware of potential liver risks and be appropriately monitored for them. Teamwork is also essential, as you cannot do this work in isolation. You cannot sit and work on liver safety on your own in your own office. You have to talk to people. It is important to work with experts in nonclinical safety, chemistry, animal pathology, regulatory science, and clinical development. Also, the fact that I collaborated with multiple external groups, such as CIOMS, and IQ DILI, a consortium of drug companies focused on drug-induced liver injury, which I co-founded in 2016, was very helpful to my success. Collaboration is extremely important.
What do you enjoy outside work?
I love to travel. I enjoy tennis and many other activities, but travel is at the top of the list. For me visiting new places and meeting people from different parts of the world is deeply rewarding. It is probably the best pastime that a person can do.
What would you want to be remembered for?
Rather than being remembered for a successful drug that I helped develop, I would rather be remembered for harms that never occurred because safety concerns were recognized and addressed. Things that I prevented from happening to patients, not the drug that I saved, but patients that I saved. This is about fulfilling the promise made to patients when they trust a medicine: that every possible effort was made to understand, prevent, and communicate its risks. We don't get a medal for preventing things because they never happen, but this is what I would like it to be remembered for.
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