Increased discussions about pragmatic trials have encouraged experts across the healthcare ecosystem to explore ways to design and conduct clinical trials more efficiently. Research professionals from across disciplines are asking, “could we generate high quality evidence with lower burden through the inclusion of pragmatic elements into more clinical trials?”
In this webinar, oncology experts from biopharma, diagnostics, community research, and tech sectors will discuss their experience in this emerging field, and share their views on how and why clinical studies need to be aligned with routine clinical practice. Experts from BMS, Exact Sciences, Exigent Research, and Flatiron Health with different backgrounds, focused on the same mission of easier-to-run clinical trials, will cover:
Attendees responsible for designing clinical trials, running clinical trials, assessing treatment safety and efficacy, or building evidence strategies, will walk away with practical knowledge of how pragmatic elements can be incorporated into future clinical trial design and execution, including the limitations of such trials.
Trixia brings a wealth of experience from Home Office Medical, Clinical Development and Field Medical and has a proven track record of leading teams to deliver against drug development/medical needs across BMS portfolio. She has overall accountability for working with external partners to develop and drive Clinical Research Collaborations (CRC), inclusive of late and early assets aimed at accelerating BMS’ drug development decisions. As the WW Medical Vice President of Portfolio Strategy & Early Assets Hematology & Oncology, she evolved the WW Medical Early Asset team, expanding support across hematology and oncology early assets and represented Medical on the Therapeutic Area Strategy Core Team. Previously, Trixia worked in Global Drug Development as Clinical Development Lead across GI tumors, Morab (Fra ADC) and SC nivolumab and then Clinical Development Team Leader, Opdivo/Yervoy. Trixia showed tremendous strategic leadership in advancing these large programs through many key milestones (amendments, database locks and global regulatory submissions). She managed drug developers through modification of ongoing studies, numerous read outs and high-quality global submissions resulting in changes to the standard of care for oncology patients. Prior to R&D, Trixia held several roles of increasing responsibility (Field Medical, Field Leadership, Medical Strategy and Medical-led research) within solid tumor oncology & hematology Medical Affairs units at BMS, AMGEN and Onyx Pharmaceuticals. In addition to her outstanding leadership and partnership with key stakeholders, Trixia has a history of building strong teams with a passion for people development. She holds a Doctor of Pharmacy from Rutgers University, Ernest Mario School of Pharmacy and is an alumni of the Rutgers Post-doctorate Fellowship Program.
Jackson has more than a decade of experience leading the clinical development of medical devices in cancer diagnostics and precision care. For the past three years, Jackson has led the Clinical Development team at Exact Sciences, where she champions innovative approaches to clinical study design and execution. Her team enables the generation of critical clinical evidence that influences regulatory approvals, guidelines, and payer coverage of Exact Science’s portfolio of leading edge products. Before her tenure in clinical development, Jackson was a Global Research Project Director and Medical Communications Manager in the biopharmaceutical industry. She earned her Ph.D. in Biochemistry and Molecular Genetics from the University of Pittsburgh School of Medicine.
Caroline Merillat is a seasoned clinical research professional with over 17 years of experience, including 15 years dedicated to oncology research. Her extensive career spans roles across all aspects of clinical research, underscoring her comprehensive expertise and leadership in the field. Caroline’s career experiences include eight years with the University of Michigan and six years with the Mayo Clinic, where she contributed to groundbreaking advancements in oncology. She joined QCCA in 2021 and has been instrumental in building Exigent Research over the last two years, a role she finds especially rewarding.
Ivy Altomare, MD, is a Medical Oncologist and Senior Medical Director at Flatiron Health, where she serves as the Clinical Lead for the Flatiron Research Network and Head of Research Oncology, Clinical Research. She is an award-winning medical educator, an established clinical researcher, and current member of the National Comprehensive Cancer Network (NCCN) Quality & Outcomes Committee.
Prior to joining Flatiron, Ivy served on faculty at Duke University for 15 years as an Associate Professor and was the Assistant Medical Director for the Duke Cancer Network. She has authored/co-authored over 50 publications including manuscripts, abstracts and book chapters, and has been an invited speaker at numerous events sponsored by the Clinical Trials Transformation Initiative (CTTI), the Cancer Business Exchange, NCCN, ASCO, ASH, OncLive and the Physicians Education Resource, to name a few.
At Flatiron, Dr. Altomare interfaces with the Academic Medical Centers and Community Oncology practices that use Flatiron's interoperable digital tools to support and accelerate prospective clinical research. She works with pharma sponsors and NCI-funded cooperative groups to evaluate the program and study design for trials enhanced by Flatiron technology, and assesses the validity and feasibility of running tech-enhanced trials in the Flatiron Research Network. She also maintains an active community oncology practice at the Veteran's Hospital in Durham, NC.