As many of you know, I was with FDA for many years and I recently decided to leave U.S. federal government service. It was a difficult decision. I enjoyed my job at the Agency and especially enjoyed working with such a talented and dedicated group of professionals. I was fortunate to be at the right place at the right time. My latter years were marked by a rapidly increasing realization that the Agency was drowning in data and ill-equipped to handle the ever increasing deluge of data and information needed to make timely and effective regulatory decisions. From this realization, the Office of Computational Science (OCS) was born and I was lucky to be one of the founding members to help shepherd it in its infancy. In the short time it's been in existence, under the strong leadership of Dr. Lilliam Rosario, it has had a tremendous impact in modernizing the regulatory review process. I'm convinced the best is yet to come.
Some of you may not know, but I left the Agency briefly in 2009-2010 for about 14 months. During that time, I did some independent consulting. The experience was very rewarding, but there were so many unfinished projects back at FDA that interested me. I gladly returned to work on those projects (such as the Janus Clinical Trials Repository) when the OCS was launched. Now that these projects have become part of the fabric of the organization, I felt it was a good time to leave knowing that Computational Science at the Agency is alive and well.
So I'm returning to the consulting world. I have named my new company Semantica LLC in part because I believe better representation of and communication around the meaning, or semantics, of clinical trials data is the key to improving clinical research processes, from discovery to patient care. I look forward to remaining engaged and working with many of you on modernizing the clinical research enterprise from a medical informatics perspective. It's an exciting journey, one that I think will make a huge a difference in patient care and public health.