Devoted to Men’s Health: Lessons Learned with Robert Dudley
Robert Dudley, Chairman, CEO and President of Clarus Therapeutics, guided the development of the blockbuster testosterone replacement therapy, AndroGel. Here, Bob reveals his lessons learned and shares how he has tackled the challenges around a newly launched TRT – the first oral softgel approved by the FDA.
Robert Dudley | | Longer Read
Success happens at the convergence of passion, tenacity, collaboration, and significant unmet needs
How I got to where I am today feels somewhat serendipitous. With a PhD in pharmacology and toxicology, my background is in drug development and examining how drugs work. Early on in my career, I joined a small entrepreneurial company called Gynex Pharmaceuticals that had an interest in testosterone replacement. It was my first foray into the world of testosterone replacement therapy, which we fondly abbreviated to TRT.
My initial work was on a sublingual testosterone product licensed from the NIH in the US, but its pharmacokinetic profile necessitated thrice daily dosing and the FDA was concerned about peak well above the upper limit of normal for testosterone. After a stint as VP of Clinical Development at a biotechnology company (BioTechnology General Corp.), I took a job as Vice President of R&D at Unimed Pharmaceuticals. It was here that I was approached by Besins Iscovesco (Paris, France) about developing a dihydrotestosterone (DHT) gel product as an androgen replacement therapy for men. Besins already had a DHT gel approved for use in France and Belgium but felt it could do well in the US. My response was, “Well, no – the FDA will not embrace a DHT gel because of concerns (at that time) about DHT’s potential role in prostate cancer.” Nevertheless, I went on to tell the company that I would be interested in collaborating with their team on a testosterone gel (T-gel) formulation...
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