On April 27, 2020 Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, reported that it has appointed Rudolf Baumgartner, M.D., as Chief Medical Officer and Head of Clinical Development starting on May 1, 2020 (Press release, Saniona, APR 27, 2020, View Source [SID1234556639]). Dr. Baumgartner brings more than 20 years of experience leading multiple pharmaceutical development programs from discovery through approval and launch, in both large and small pharmaceutical companies.
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"Rudi’s clinical development expertise will be critical as Saniona advances its’ mid/late stage development of Tesomet in two rare eating disorders: Prader Willi Syndrome and hypothalamic obesity," said Rami Levin, President and Chief Executive Officer of Saniona. "As we pursue our End of Phase 2 meeting with the FDA and determine the regulatory path for bringing Tesomet to patients in these indications, we look forward to Rudi’s insights and expertise to build out the clinical development team and progress our programs through to commercialization."
"This is an exciting time to join the Saniona team, as the company builds on its strong scientific roots to become a U.S.-based biopharmaceutical company preparing for late-stage trials of Tesomet in two rare diseases," said Baumgartner. "The two diseases for which we are evaluating Tesomet, hypothalamic obesity and Prader-Willi Syndrome, both lack approved treatment options and represent significant unmet needs for patients and their families."
Dr. Baumgartner is a physician-scientist with a proven track record of leading cross-functional teams through multiple development programs from Investigational New Drug (IND) applications through New Drug Application (NDA) submissions and product approvals. Trained in basic immunology, he brings to Saniona significant expertise across a broad array of therapeutic areas, including inflammation and auto-immune diseases. Most recently, he served as Chief Medical Officer for the Flatley Discovery lab, a non-profit foundation working in the rare disease space of Cystic Fibrosis. Prior to that, he was the Executive Vice President and Chief Medical Officer for Inotek Pharmaceuticals, where he was instrumental in writing the S1 and co-leading the company’s IPO. At Inotek Pharmaceuticals, he oversaw clinical development and operations, medical affairs, regulatory affairs, biostatistics, preclinical development, and intellectual property. Before Inotek, Dr. Baumgartner held senior-level development positions at Sepracor and Merck & Co. He began his medical career as a clinician-scientist at the National Institutes of Health (NIH), in the Laboratory of Molecular Immunology at the National Heart, Lung, and Blood Institute (NHLBI). He completed his M.D. at Pennsylvania State University, his residency in Internal Medicine at the University of Michigan, and his fellowship in Pulmonary and Critical Care Medicine at Johns Hopkins University.