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Eva is an experienced pharmaceutical executive, she holds a Master degree in Computer Science and two doctoral degrees in Measurement Science/Biostatistics. Eva obtained Master of Administrative Science degree with focus on Global Leadership and Administration at the Farleigh Dickinson University and Master in Biotechnology Enterprise and Entrepreneurship degree at the Johns Hopkins University.
She has authored over 150 publications and presentations, and was awarded research fellowships in Germany, Sweden and France.
Dr. Krusinska has over twenty years of managerial and leadership experience in pharmaceutical industry in the U.S., both on CRO and sponsor’s side of the business. Eva spent 14 years at GlaxoSmithKline where she led a biostatistics and data management department of up to 100 staff. Subsequently, she joined NPS Pharmaceuticals and worked on orphan drugs, Natpara and Gattex. After the acquisition of NPS by Shire Pharmaceuticals, Dr. Krusinska actively participated in the integration activities of biostatistics and data management assets.
She possesses vast international regulatory submission expertise on biostatistics and data management side. It includes Rx drugs, Biologics, OTC drugs, devices, gene therapy, medical food, and nutraceuticals.
Over the span of her experience,
Eva provided due diligence services, statistical advice on clinical development plans, delivered statistical input to study protocols, regulatory briefing documents, integrated summaries of efficacy and safety, responses to regulatory queries, scientific publications, and authored statistical analysis plans. Eva participated in Special Protocol Assessments (SPA), sat on Data Safety and Monitoring Boards, represented companies at FDA meetings and AdCom Committee meetings, as well as in legal challenges by competitors.
Dr. Krusinska has vast experience in clinical trial methodology including cross-over and parallel designs, sequential and adaptive designs, categorical data analysis, longitudinal data analysis, multiplicity control, composite endpoints, and multivariate analysis.
Eva’s therapeutic area experience spans Rare diseases including gene therapy, Endocrine & Metabolic disorders including diabetes, CNS including Alzheimer’s disease and Lewy body dementia, Pulmonary diseases, Allergy, Cardiology, Dermatology, Genitourinary disorders, Virology, Gastrointestinal diseases, Nephrology, Pain, Addiction, Oncology & Hematology, and Oral Care.
eva.krusinska@pharmalandconsulting.com
Eva is currently conducting an independent research in the following areas:
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