Delivering confidence in precision medicine: strategies for potency, safety, and long-term success

Elizabeth Donahue is a Senior Director of Project Management in the Peri- and Post-Approval Studies and Real-World Evidence team. She brings over 17 years of CRO experience to her position. As an operational subject matter expert, Elizabeth is instrumental in the strategic delivery of trials with varying study design, including Phase III clinical trials, observational studies, registries, chart reviews, and long-term follow-up studies. Her therapeutic experience focuses on rare diseases, pediatric studies and cell and gene therapies, which encompasses multiple indications in endocrinology, hematology, neurology and more. Elizabeth is also a member of CRG’s Rare Disease and Pediatrics Center of Excellence, a group dedicated to delivering expertise and supporting clinical study teams across a variety of rare indications and those affecting children. 

Amy Lavelle, Ph.D. is a seasoned research scientist and biopharmaceutical professional with over 18 years of experience in bioanalytical research. She holds a B.S. in Biology and a Ph.D. in Human and Molecular Genetics from Virginia Commonwealth University.Amy began her career at Commonwealth Biotechnologies, Inc., and later joined PPD, part of Thermo Fisher Scientific. She has progressed through various roles, currently serving as Director of Bioanalytical Labs, where she oversees operations in Biomarkers, Molecular Genomics, and Flow Cytometry.Throughout her career, Amy has focused on project management, regulatory compliance, and client relations, significantly contributing to Phase I-III clinical trials and pre-clinical studies. She is an active member of professional organizations like AAPS and ASCGT and has shared her expertise through numerous publications and conference presentations.Amy's leadership in the biopharmaceutical industry is marked by her technical proficiency, dedication to professional development, and commitment to community involvement.