Helen is an accomplished pharmaceutical executive experienced in helping clients with clinical development programs, regulatory filings, submission strategy and Advisory Committee meetings. She is recognized for her ability to guide clients through critical evaluation of their study data within the framework of evidence for benefit risk that is needed for drug approvals.
As a former practicing internist, Helen brings an objective clinical perspective and the ability to help clients evaluate strategies that can drive regulatory success. She helps clients overcome the “curse of knowledge” by ensuring that complex diseases, mechanisms of action, and clinical trial results are translated in a way that is understandable and meaningful to patients, healthcare professionals, and regulatory agencies. She ensures that the most clinically relevant data is brought to the forefront while preparing clients to identify and address challenging questions regarding perceived limitations.
Prior to joining 3D, Helen was in clinical practice where she acquired a strong sense of what matters most when choosing a therapeutic course for patients. During her work in the pharmaceutical industry, she has held several roles including director of drug safety, and head of clinical and regulatory development for oncology and rare disease therapeutics. Helen holds an undergraduate degree in chemistry from Loyola University and a medical degree from the University of Illinois.
In addition to her passion for working with rare and serious diseases, Helen has held a lifelong interest in mentoring. She has been committed to the development of new professionals in the pharmaceutical industry, serving as a faculty member and course co-director for the Pharmaceutical Education and Research Institute (PERI). Helen is also a lifelong student and believes each client engagement is an opportunity to learn about a new disease and exchange scientific ideas.