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

Dr. Sarita Joshi, an experienced pediatrician specialized in hematology oncology and transfusion medicine, serves as Senior Medical Director on the Medical Oncology/Hematology team at PPD clinical research business of Thermo Fisher Scientific. She oversees medical monitoring of early phase oncology clinical trials, leveraging precision medicine in the development of novel cancer therapeutics. Her expertise includes first-in-human clinical trials, safety monitoring, biomarker-driven clinical development, and the evaluation of novel therapies: cellular and other immunotherapies. She has collaborated across multidisciplinary clinical development teams to support protocol design, safety oversight, and strategic decision-making throughout the drug development process. Dr. Joshi is committed to integrating clinical expertise with scientific innovation to improve cancer drug development.

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.

Dr. Lawrence Lamb leads scientific and translational strategy as scientific co-founder, Executive Vice President, and Chief Scientific Officer of IN8Bio. During his training in transplantation immunology at the South Carolina Cancer Center, he was the first to describe the association between relapse-free survival and homeostatic gdT cell recovery in high-risk leukemia patients. While continuing this work as an Associate Professor and later Professor of Medicine at the University of Alabama at Birmingham, Dr. Lamb developed the scientific support for chemotherapy resistant gdT cell-based immunotherapy for high-grade brain tumors.  These programs led to successful IND approvals for leukemia and glioblastoma investigator-initiated Phase I trials in collaboration with IN8Bio and a robust corporate pipeline of gdT cell focused therapies.