Sandra and Edwin will be joining the current Leads, Jane Owens and Janet Low. You can learn more about the new Leads via the Optimizing the Use of Data Standards page. The Safety Analytics Working Group also welcomes two new Leads: Mac Gordon and Ellis Unger. Mac Gordon has a master’s in statistics and graduate certificates in public health, pharmacovigilance and pharmacoepidemiology and has been with Johnson & Johnson for 15 years and in industry for 20 years. Mac has been involved with lupus research since joining the organisation, with focus areas in late-development immunology and clinical trial safety.Ellis Unger, MD, is a Principal Drug Regulatory Expert at Hyman, Phelps & McNamara, a leading consulting FDA law firm. Dr Unger is a board-certified cardiologist, who retired from the U.S. Food and Drug Administration following a 24-year career, where he served in senior leadership roles in the Office of New Drugs, Center for Drug Evaluation and Research (CDER).Mac and Dr Unger will be joining Mary Nilsson, Greg Ball and Scott Proestel. You can learn more about the new Leads on theSafety Analyticspage. Our data standards community, which is comprised of leaders and experts responsible for the governance and implementation of data standards across the biopharmaceutical industry, authored a new white paper, which highlights current challenges in data standardisation across the biopharma industry and identifies opportunities where we can work together to tackle them. |