December 04
12:00 pm - 1:00 pm EST

LOCAL TIME

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, 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.

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Ivy Altomare

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.

Trixia Camacho

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.

Noël Brown
moderator

Noël Brown

Managing Director and Head of U.S. Biotechnology Investment Banking, RBC Capital Markets

Noël Brown is the Managing Director and Head of U.S. Biotechnology Investment Banking at RBC Capital Markets, responsible for leading the biotechnology franchise. He has over 20 years of investment banking experience. Noël graduated from the University of Western Ontario and received a law degree from the University of Ottawa and an MBA from the MIT Sloan School of Business.

Plus a speaker from Exact Sciences to be announced