Daniela C. Oniciu

Daniela C. Oniciu has two decades of industry expertise and executive leadership in (bio)pharmaceutical companies, with a broad reach across the entire spectrum of pharmaceutical development: early discovery and medicinal chemistry, chemical R&D and nonclinical operations, integrated clinical development planning (nonclinical/clinical/CMC) for all clinical phases and NDA, translational medicine. Dr. Oniciu is an inventor of bempedoic acid (Nexlitol, Nilemdo), an FDA- and EMA-approved drug for the treatment of dyslipidemia and cardiovascular risk, and was a co-leader of its CMC and nonclinical program for early clinical phases. Dr. Oniciu’s expertise encompasses process development and manufacture of small molecules, biologics, and lipids; she led teams of CMC operations from early R&D to production of global clinical supply and was an inventor and head of development of several nonclinical small molecule programs in the United States and European Union. Dr. Oniciu was a co-founder of four biotechs and CROs and instrumental in launching emerging companies. Dr Oniciu has experience in multiple therapeutical areas: cardiovascular, lipid and liver disorders, NAFLD/NASH, inflammation, cancer, ophthalmic, neuroprotective, cannabinoid, and endocrine drugs. Dr. Oniciu’s prior positions include Vice-President of Preclinical R&D and Manufacturing at Gemphire Pharmaceuticals Inc., Senior Director of Chemistry at Cerenis Therapeutics Holding SA, Associate Director of Chemistry at Pfizer Global Research and Development, and Senior Director of Chemical R&D at Esperion Therapeutics Inc. Dr. Oniciu has recently founded Creative Pharma Advisors LLC to provide independent advice for the pharmaceutical industry. She is a Courtesy Faculty in the Chemistry Department of the University of Florida at Gainesville. Dr. Oniciu received her MS in Chemical Engineering and her PhD in Chemical Engineering and Organic Chemistry Technologies from the Polytechnic Institute of Bucharest (Romania), where she held faculty positions from 1985 until 1997.