Driving breakthroughs in cancer care:
At ASCO 2023, we are excited to showcase our latest advancements in oncology research and our commitment to helping patients with cancer.
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Our use of real-world data allows us to enhance the representativeness of cancer treatment trials and generate insights into diverse patient populations, thus unlocking the opportunities for improving health equity.
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Our clinical research technology ensures more effective, efficient, and less burdensome clinical trials through trial design decision-making, optimized patient enrollment, clinical data acquisition and automated data delivery.
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Finally, our advanced AI methodologies, such as machine learning and natural language processing, allow us to learn more from patients, faster, so we can accelerate oncology drug development and answer timely research questions as the standard of care changes.
Aligned with ASCO 2023’s theme of “Partnering with patients: The cornerstone of cancer care and research,” our research aims to revolutionize how we understand and address diverse patient experiences, bringing us closer to better, more equitable cancer care. As we explore how real-world evidence and technology can improve cancer treatments and make them more accessible, we remain committed to using data for good. We are excited to share our insights with the scientific community and continue to work towards reimagining the infrastructure of cancer care.
From chip to bedside—Oncology in silico R&D
Friday, June 2
9:00 AM – 10:30 AM CT
The McKinsey Cancer Center will be hosting its 15th Annual Cancer Center Congress Series Symposium at ASCO 2023. Javier Jimenez, MD, MPH, Chief Medical Officer, will join this year’s panel discussion focusing on oncology data and the applications of machine learning and artificial intelligence to clinical development.
Visit our booth #23127
Sign up here to schedule time with Flatiron’s Chief Medical Officer to discuss your plans for ensuring diversity in clinical trials and to learn more about our new, bespoke solution of data-backed services that supports clinical trial related diversity plans for biopharma sponsors.
Through Flatiron’s data and bench of experts, we can address diversity needs and regulatory guidance at all planning stages.
Javier Jimenez, MD, MPH
Chief Medical Officer
AVAILABILITY:
Saturday, June 3, 12:00 PM – 1:00 PM CT
Sunday, June 4, 11:00 AM – 12:00 PM CT
Javier is responsible for defining and executing the company’s strategic vision for real-world evidence, providing thought leadership and guidance around novel clinical research methods, and partnering with clients and stakeholders across academia, life sciences and government agencies to further the use of real-world data.
NEW OFFERING
Clinical trial diversity planning solution
Our solution leverages data derived from diverse patient populations, at the point of care, offering actionable, accurate insight. No matter what stage you are in, Flatiron can help you design, or refine a trial diversity plan that addresses FDA guidelines.
Meet our experts at ASCO
Learn more about our thought leaders that will be on the ground at ASCO, bringing invaluable expertise and knowledge.
Blythe Adamson, PhD, MPH
Senior Director, MSO Engagement
Blythe is a senior principal investigator specializing in real-world data for biopharma and clinical trial sites. With 15+ years of experience and advanced degrees in pharmacoepidemiology and economics, she collaborates with clients in life sciences, academia, and government to generate meaningful insights on the value of medicine, improving patient outcomes. Notable achievements include serving as a head pandemic data scientist at The White House and roles at ISPOR, Bill and Melinda Gates Foundation, and Fred Hutch Cancer Center.
Emily Akin, MBA
Research Network Lead
Emily leads the Research Network at Flatiron, partnering with clinical trial sites on how to best benefit from technology designed to make their work easier and more efficient. She works with both academic and community oncology sites on a daily basis. Emily has more than 20 years of experience in the clinical research industry, running global clinical trials and managing large, remote teams. Emily holds a B.A from The University of Kansas and an MBA from University of Missouri-Kansas City.
Emily Castellanos, MD
Senior Medical Director
Emily leverages her clinical and research expertise to develop innovative approaches to real-world evidence generation and inform product strategy. Her interests include integrated approaches to real-world data, such as clinico-genomics, clinico-claims, or imaging data, as well as novel approaches to real-world study design. In addition to her role at Flatiron, Emily maintains a clinical practice specializing in breast malignancies at Fox Chase Cancer Center.
Aaron Cohen, MD, MSCE
Medical Director, Machine Learning
Aaron is a medical oncologist, clinical informatician, and health outcomes researcher who serves as the clinical lead for the machine learning team and focuses on the use of natural language processing and machine learning to facilitate cancer research and care. In addition to his role at Flatiron, Aaron has a faculty appointment at the NYU School of Medicine in the Department of Medicine and maintains a clinical practice at Bellevue Hospital, with a focus on solid organ malignancies.
Alex Deyle, M.Eng
General Manager, Clinical Research
Alex leads Flatiron’s Clinical Research business unit, helping sponsors and research sites design better studies, broaden access to and representativeness of clinical trials, accelerate timelines, and reduce the operational burden usually associated with clinical research. Alex has over 15 years of experience working with oncology-focused pharmaceutical and biotech companies to address a wide range of strategic and operational challenges. He has a bachelor of science in biological engineering and a master of engineering in biomedical engineering from Cornell University.
Hugh Levaux, PhD
Vice President, Head of Clinical Research Growth Strategy
Hugh leads growth strategy for Flatiron’s Clinical Research business unit, helping to identify future investment and partnership opportunities. Hugh has over 20 years of dedicated experience in clinical trial design and operations and has developed multiple market-leading, trial-related technologies. Hugh holds a Ph.D. in Policy Analysis from the RAND Graduate School and has also received master’s degrees in international economics and international relations from SAIS at Johns Hopkins University and international politics from Université Libre de Bruxelles in Belgium.
Neal Meropol, MD
Vice President, Scientific & Clinical Lead, Clinical Research
Neal is a medical oncologist, clinical investigator, outcomes researcher and health tech executive. At Flatiron, Neal drives the development of technological innovations to enable clinical research to take place wherever care is delivered. He is the current chair of the NCI Director's Clinical Trials and Translational Research Advisory Committee (CTAC), previously served on ASCO’s board of directors, and as chair of the National Cancer Institute Gastrointestinal Cancer Steering Committee. Prior to joining Flatiron, Neal was Professor and Chief of the Division of Hematology and Oncology at University Hospitals Cleveland Medical Center and Case Western Reserve University, and Associate Director for Clinical Research at the Case Comprehensive Cancer Center.
May Pini, MD, MPH
Senior Medical Director, Head of Research Oncology, RWE
May leverages her experience as a medical oncologist and researcher to accelerate learning through the generation of real-world evidence in order to improve patient care and outcomes. Prior to joining Flatiron, May worked for Premier, Inc. and was an assistant professor and health services researcher in the departments of Clinical Cancer Prevention and Gastrointestinal Medical Oncology at MD Anderson Cancer Center.
Stephanie Reisinger, MBA
Senior Vice President & General Manager, RWE
Stephanie leads the Real-World Evidence business unit, setting the strategy to drive long term growth and to accelerate Flatiron’s leadership in the way real-world oncology data is collected, combined and analyzed. Stephanie joined Flatiron in 2022, with 20 years of experience leading businesses at the intersection of real-world patient data, technology, and analytics within the life sciences industry. Prior to Flatiron, she served as the General Manager of Life Sciences Data and Analytics at Veradigm, an analytics subsidiary of Allscripts.
Matt Reynolds, PhD
Vice President, Scientific Engagement
Matt is an epidemiologist who has been in the pharmaceutical and consulting arena for 24 years with expertise in real-world data and its fitness of use for pharmaceutical needs. In his new role at Flatiron, Matt will work closely with biopharma customers to understand their unique oncology evidence needs, scope and define scientific solutions tailored to address these goals, and advance Flatiron's capabilities in RWE analytic services.
Craig Serra, MS, MBA
Head of Commercial Solutions and Partnerships, Clinical Research
At Flatiron, Craig works with biopharma sponsors and CROs in the clinical research space, helping them leverage technology and data to design and support more effective clinical trials. Craig has worked in the pharmaceutical industry for over 20 years in the areas of clinical development, clinical technology, digital, innovation, strategy, and business management.
Deepika Singh, MBA
Senior Principal, Life Sciences
Deepika is responsible for establishing and growing strategic partnerships with biopharma across the East Coast. She has extensive experience across R&D, HEOR and Commercial and partners with biopharma to develop solutions that unlock use cases across the product life cycle. She is also responsible for scaling Flatiron’s recently launched analytic, scientific, and consultative services. Prior to joining Flatiron, Deepika was at Deloitte, where she worked with biopharma to establish in-house RWE capabilities and unlock innovative use cases such as the use of RWE to inform trial strategy, pragmatic trials, and post-marketing commitments.
Lauren Sutton, MBA
Senior Director and Head of Product, Clinical Research
Lauren leads the strategy and design of products for Flatiron’s Clinical Research business unit. Lauren creates products for biopharma sponsors, CROs, and clinical research sites, ensuring technical stability, interoperability, and technology designed to support new working models. Lauren has over a decade of experience in the clinical research industry, is a published thought leader, and frequently speaks at clinical research events.
Steve Swanson, MS
Vice President, Life Sciences Partnerships
Steve is a founding member of Flatiron’s San Francisco office and is responsible for building partnerships with biopharma companies and health tech startups who are innovating in the oncology ecosystem. He also leads commercialization efforts across Flatiron’s RWE portfolio which spans clinical, genomic, and imaging data modalities as well as analytics. Prior to Flatiron, Steve led biopharma client engagements at IQVIA with an emphasis on global pricing, market access, and portfolio strategy.
Shane Woods, PhD
Chief Commercial Officer
Shane leads the commercial organization that develops partnerships with life sciences companies, advancing our customers’ research priorities through new approaches to evidence. Shane has over a decade of experience in the oncology space. Prior to joining Flatiron in 2014, he partnered with leading oncology-focused biopharmaceutical companies to support their R&D and commercial strategies. Shane is a scientist by training, having completed research appointments in cancer biology at several academic institutions, including Harvard Medical School and the University of Notre Dame.
Our research
ORAL ABSTRACT SESSION
Tumor mutational burden (TMB) measurement from an FDA-approved assay and real-world overall survival (rwOS) on single-agent immune checkpoint inhibitors (ICI) in over 8,000 patients across 24 cancer types
Gandara D, Agarwal N, Gupta S, Klempner S, Andrews M, Mahipal A, Subbiah V, Eskander R, Carbone D, Snider J, Bouzit L, Cho-Phan C, Price M, Li G, Quintanilha J, Huang R, Ross J, Fabrizio D, Oxnard G, Graf R
Date & Time: Sunday, June 4, 9:45 AM CT
Session Location: Arie Crown Theater
Abstract Number: 2503
To evaluate the clinical validity of the FDA-approved TMB measurement test, this study analyzed a large real-world dataset of over 8,000 patients with 24 different cancer types who received single-agent immune checkpoint inhibitors and had validated rwOS endpoint data.
ORAL ABSTRACT SESSION
Practice- and provider-level inequities in next-generation sequencing (NGS) testing by race/ethnicity for patients (pts) with advanced non-small cell lung cancer (aNSCLC) treated in the community setting
Vidal G, Jain N, Fisher A, Sheinson D, Lofgren K, Ma E, Yu E, Comment L, Miksad R, Daniel D
Date & Time: Tuesday, June 6, 8:00 AM CT
Session Location: S100bc
Abstract Number: 6508
The findings from this study can help researchers and policy-makers identify areas where policy interventions can be implemented to promote greater equity in access to NGS testing.
POSTER DISCUSSION SESSION
Mediators of racial/ethnic inequities in clinical trial participation among US patients with cancer, 2011-2022
Guadamuz JS, Calip GS, Ryals CA, Altomare I, Wang X
Date & Time: Saturday, June 3, 4:30 PM CT
Session Location: E350
Abstract Number: 6511
Poster Board Number: 3
This research uncovers social determinants of health factors that play a role in the disparate participation of patients from different racial/ethnic backgrounds in clinical trials involving 22 types of solid and blood cancers.
POSTER SESSION
Real-world response endpoints in patients with mNSCLC treated with chemotherapy across real-world datasets
McKelvey B, Garrett-Mayer E, Belli A, Brown T, Dow J, Espirito J, Kluetz P, Ma Xinran, McCracken A, Mishra-Kalyani P, Natanzon Y, Potter D, Rivera D, Stires H, Stewart M, Allen J
Date & Time: Saturday June 3, 1:15 PM CT
Session Location: Hall A
Abstract Number: 6595
Poster Board Number: 87
Developing a reliable clinician-assessed real-world response endpoint can help regulators characterize drug effectiveness using RWD sources to inform regulatory decision-making.
POSTER SESSION
Survival analysis of patients treated at oncology practices with more aggressive end-of-life practice patterns
Canavan M, Wang X, Ascha M, Miksad R, Showalter T, Calip G, Gross C, Adelson K
Date & Time: Saturday, June 3, 1:15 PM CT
Session Location: Hall A
Abstract Number: 6562
Poster Board Number: 54
Continuing treatment beyond the point of benefit can result in adverse outcomes. By addressing the knowledge gap of whether oncology practice-level “aggressive” use of SACT at the EOL is associated with overall survival benefit among all patients with advanced solid tumors, we can help to develop more effective interventions to improve the quality of care.
POSTER SESSION
Evaluating generalizability of practice-changing randomized clinical trials in non-small cell lung cancer using machine learning-based in-silico trials
Orcutt X, Mamtani R, Sondhi A, Cohen A, Parikh R
Date & Time: Sunday, June 4, 8:00 AM CT
Session Location: Hall A
Abstract Number: 9130
Poster Board Number: 118
The objective of this study was to evaluate the generalizability of survival outcomes reported in five phase III trials that led to changes in clinical practice for patients with advanced non-small cell lung cancer in the first-line setting.
POSTER SESSION
Metastatic patterns and outcomes by HER2 and hormone receptor status in patients with metastatic breast cancer
Yuan Q, Castellanos E, Fidyk E, Schwed K, Estevez M, Nemeth S, Linzmayer R, Cohen A
Date & Time: Sunday, June 4, 8:00 AM CT
Session Location: Hall A
Abstract Number: 1031
Poster Board Number: 252
In this study, researchers aimed to understand the prognostic implications of HER2-low status by examining the distribution of metastases as well as real-world overall survival according to HER2 and hormone receptor status.
POSTER SESSION
Technology-enabled clinical trials: Intentional capture of source data in the electronic-health record and direct transfer to trial database in a phase II multicenter trial
Royce T, Falk S, Xiao F, Boyd M, Bramwell L, Shelley A, Sutton L, Morgan R, Mader P, Taiclet T, Alve A
Date & Time: Monday, June 5, 1:15 PM CT
Session Location: Hall A
Abstract Number: 1568
Poster Board Number: 162
This study focuses on a pilot implementation of transferring structured EHR data to an electronic data capture (EDC) system in a Phase II multicenter clinical trial.
POSTER SESSION
Trial eligibility criteria and diversity among patients with advanced non small cell lung cancer
Kaur M, Frahm F, Ascha M, Guadamuz JS, Gottesman A, Leybovich B, Sondhi A, Zhao Y, Meropol N, Royce T
Date & Time: Monday, June 5, 1:15 PM CT
Session Location: Hall A
Abstract Number: 1566
Poster Board Number: 160
The FDA has provided guidance supporting the use of real-world data in the development of diversity plans for clinical trials. These plans may involve the implementation of more inclusive or broader eligibility criteria to enhance the participation of populations historically underrepresented in clinical trials. This study examined the impact of expanding eligibility criteria on the diversity of participants with advanced non-small lung cancer.
POSTER SESSION
Effectiveness of PARP inhibitor maintenance therapy (mPARPi) in advanced ovarian cancer (OC) by BRCA1/2 and HRD signature in real-world practice
Richardson D, Quintanilha J, Grof R, Danziger N, Washington C, Dockery L, Snow T, Afghahi A, Frachioni A, Elvin J, Moore K
Date & Time: Monday, June 5, 1:15 PM CT
Session Location: Hall A
Abstract Number: 5583
Poster Board Number: 278
Using the Flatiron Health-Foundation Medicine Clinico-Genomic Database, this study aimed to compare the effectiveness of mPARPi in real-world practice based on two biomarkers: BRCA1/2 mutation and/or a novel biomarker called HRD signature.
POSTER SESSION
Clinical pathways innovation: A lesson on the value of clinician based feedback and collaboration with Flatiron Health
Davella C, Bange E, Singh A, Dougherty D, Gabriel P, Maniango R, Miao J, Harvey C, Ricottone M, Shulman L
Date & Time: Monday, June 5, 1:15 PM CT
Session Location: Hall A
Abstract Number: 1578
Poster Board Number: 172
Examining the impact clinician-based feedback had on improving the usability of the Flatiron Assist tool may provide valuable insights into how we can overcome this adoption challenge, ultimately leading to improved care and outcomes for cancer patients.
ONLINE PUBLICATION
Representativeness in cancer treatment trials in community and academic settings
Altomare I, Wang X, Falk S, Kaur M, Guadamuz JS, Xiao F, Meropol N, Zhao Y
The representativeness of clinical trial participants with cancer is a crucial aspect in the generalizability of research findings to the broader patient population. However, the impact of practice setting on the representativeness of trial participants remains unknown.
