As Chief Executive Officer, Mr. O’Brien is responsible for setting the strategy and delivering on the full financial potential of Genomind. Prior to Genomind, O’Brien founded and served as chair of Key BioPharma Partners, LLC, a private biopharma consulting firm. He also served as president and CEO of Cipher Pharmaceuticals Inc., AltheRx Pharmaceuticals Inc., Profectus BioSciences Inc. and Solstice NeuroSciences Inc., in addition to his multiple senior global leadership roles within AstraZeneca. O’Brien is board chair for Alto Pharma, a privately held company, and serves on the advisory boards of Greater Philadelphia Life Sciences Congress, and the Hubert J.P. Schoemaker Classic.
Aided by new practice guidelines and recommendations by the Clinical Pharmacogenetics Implementation Consortium (CPIC), the field of pharmacogenomics (PGx) has grown both in those offering testing services and in providers utilizing this technology. At the same time, the FDA is actively creating policy and standards for PGx services by setting special controls associated with over-the-counter PGx testing, issuing a safety alert, and sending warning letters and other communications to laboratories. This session will review recent FDA activity and explore its significance for more substantial changes to diagnostic regulatory policy and implications for patients, providers, and diagnostic developers.