Bernie Kuca has a proven track record in clinical and regulatory operations leading several development projects.  Her most recent role has been as the Head of Clinical/Regulatory Operations at Allievex overseeing the development of an Enzyme Replacement Therapy (ERT) for the treatment of MPS IIIB.  Bernie brings a wealth of experience in the pharmaceutical/biotech industry in her various clinical operations, clinical project management and regulatory roles. Her therapeutic experience includes oncology, CNS, antihistamines and anti-infectives. Bernie has broad experience ranging from monitoring to clinical leadership as well as providing regulatory and strategic input. Prior to Allievex, she was the Head of Clinical/Regulatory Operations at CoLucid Pharmaceuticals, leading the clinical development of lasmiditan for the acute treatment of migraine headaches.  Previously serving at Peptimmune, Oscient, Sepracor and Genetics Institute, in roles of increasing responsibility, she was a key clinical contributor on products progressing from INDs to successful NDAs and S-NDAs. She has led multiple multi-site, multi-country studies and has presented at industry sponsored conferences.

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Bernie has a Bachelor’s degree in Biology from the State University of New York at Buffalo, a Master’s of Science in Applied Anatomy and Physiology from Boston University and a Graduate Certificate of Special Studies in Administration and Management from Harvard University Extension School. She serves on the volunteer Board of Directors and Executive Committee of Can Do MS, a National non-profit.