Arzu Selen joined FDA’s Office of New Drug Quality Assessment as the Associate Director for Biopharmaceutics, FDA announced. She will be the principal advisor to ONDQA on policy matters and programs for assessing drug release specifications or dissolution and quality-by-design issues.
Selen joined the FDA’s Office of Clinical Pharmacology in 1997, where most recently she was the deputy division director of the Division of Clinical Pharmacology IV in the Office of Clinical Pharmacology. She has also held positions in the pharmaceutical industry with Parke-Davis and Zeneca Pharmaceuticals and was director of pharmacokinetics for Alkermes.
Gene Express has appointed Colette Saccomanno to be the company's director of business development, the company said last week.
Saccomanno, who has a sales and marketing background, most recently was program manager at ArisGlobal and was a senior account executive at Galt Associates. She also served as account executive at Covance Laboratories' Early Development segment, which is now Abbott Molecular, and at Bio-Rad Laboratories.
NextGen has appointed Jake Orville as vice president of global sales, the company said last week.
Orville comes to NextGen from Third Wave Technologies, where he was vice president of sales and business development.
Orville takes over for Geoff Alms, who moves to a lead role in North American development.
The Personalized Medicine Coalition this week awarded Elizabeth Nabel, director of the National Heart, Lung, and Blood Institute, its 2006 Leadership in Personalized Medicine Award “for her insights into the molecular basis of cardiovascular disease and her leadership in steering those advances into clinical practice on a national scale,” the PMC said in a statement.
At the helm of the NHLBI, Nabel “champions the exploration of the genetics in large-scale population studies,” the PMC said, including the Women's Health Initiative. Also, in February she helped launch a genetic study as part of the Framingham Heart Study. Her addition, called the Framingham Genetic Research Study, seeks to identify genes underlying cardiovascular and other chronic diseases.