Gary Ingenito, MD, PhD, has more than 30 years of experience in the field of pharmaceutical development; including drugs, biologics, devices and combination products. During this time, Dr. Ingenito has held executive responsibilities for clinical research, regulatory affairs, pharmacovigilance, and medical affairs at pharmaceutical companies and contract research organizations. His development and regulatory experience spans multiple therapeutic areas, from early stage products through post-approval, across the US, Europe, and Japan. Most recently, Dr. Ingenito was the Chief Medical and Regulatory Officer at Catalyst Pharmaceuticals, Inc.
Dr. Ingenito holds an undergraduate degree from The Johns Hopkins University, a medical degree from Jefferson Medical College, and a PhD in microbiology/immunology from Thomas Jefferson University. He completed a post-graduate residency in neurology at the University of Miami. Dr. Ingenito is a member of the Board of Directors for the Addario Lung Cancer Medical Institute.
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Alka Bahal: Welcome to The Think Factory’s Workplace Podcast, powered by OGC Solutions. My name is Alka Bahal. I’m a partner with Outside General Counsel Solutions and the Chair of our Corporate Immigration Services Group. I’ll be your host today.
I’m very pleased to have with me today Gary Ingenito, accomplished healthcare executive with extensive leadership experience across clinical development, regulatory affairs, and medical operations. Welcome to the podcast, Gary!
Dr. Gary Ingenito: Thank you. It’s a pleasure to be here.
Alka Bahal: So can you start by telling us how did you decide or what first inspired you to pursue both an MD and a PhD?
Dr. Gary Ingenito: I was looking to be an academic physician. I had done research through my college years and even into high school and found that the research and then the application, so the translational aspects of research into clinical practice or treatments was very exciting.
Alka Bahal: Very interesting. Now a lot of medical researchers have just an MD. How did the fact that you had a PhD influence how you pursue your clinical research and your career path? Would it have been different if you only had one or the other?
Dr. Gary Ingenito: I think and feel that a PhD really is a way of training your thinking into critical questioning, evaluating the results, planning the strategy of what you’re going to do next with research, and then continuing to build a story around whatever project you’re working on. So for me at least, it gave me good critical thinking approach. […]
Alka Bahal: […] In your 25 plus years in pharmaceuticals, have you seen changes in clinical trial design or regulatory science that have impacted how drugs are developed now versus 30 years ago?
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