The pragmatic shift: Designing trials that fit the real world

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:

Why we need to overcome the operational burden of traditional clinical trials
How a pragmatic study design can enable more research without adding burden
How streamlined trial design and data capture may improve trial access and representativeness

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 Camacho

Head of Clinical Research Collaborations Medical Evidence Generation, BMS

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.

Sara Jackson

Senior Director, Clinical Development, Exact Sciences

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

Vice President of Operations, Exigent Research Network

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.

moderator

Ivy Altomare

Head of Research Oncology, Flatiron Health

Ivy Altomare is a medical oncologist and hematologist who serves as a senior medical director and the head of research at Flatiron Health, where she focuses on conducting outcomes research.

Prior to joining Flatiron in 2021, Ivy was an associate professor at Duke University and the assistant medical director of the Duke Cancer Network, where she practiced community oncology and hematology in underserved rural communities in North Carolina. She is an award-winning educator and maintains an oncology practice at Durham Veterans Hospital.

Ivy received her undergraduate degree from the University of Pennsylvania and an MD from Rutgers New Jersey Medical School. She completed her residency and oncology fellowship at the Icahn School of Medicine at Mount Sinai.