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May 7-10
Boston, MA
Booth #516
Community oncology serves a more diverse, more inclusive patient journey. Inherent in that service is the need to address Social Determinants of Health (SDOH), which present both challenges and opportunities in the equity and advancement of cancer care.
As a catalyst of advancement, we are actively addressing these challenges head on –integrating experience, intelligence, empathy and hope into next-generation oncology innovation.
MONDAY
The Utility of “Single Exposure” versus Causal Architecture Approaches in Real-World Research
May 8, 2023
HOPE Studies
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Whether you’re focused on capturing unique data to power provider engagement or are looking to real-world evidence to catalyze groundbreaking research, we can help you meet your goals and achieve the best patient outcomes.
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Zhaohui Su, PhD
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Sarah Reinwald, MSN, APRN, OCN, CCRP
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Rupa Iyer, MS
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Lisa
Herms, PhD
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Sarah Spark, RN, BSN, MHA/MBA
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Andy Osterland, PharmD, MS
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Research Presentations
ISPOR 2023
Our Featured Researchers
FDA Public Comment Letters
Learn More
Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (FDA-2021-D-1214)
Data Standards for Drug and Biological Submissions Containing Real- World-Data: Guidance for Industry (FDA-2021-D-0548)
Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry (FDA-2021-D-1146)
Re: Real-World Data: Assessing Electronic Health Records (EHRs) and Medical Claims Data to Support Regulatory Decision-Making for Drugs and Biological Products
(FDA-2020-D-2307)
Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (FDA-2021-D-1214)
Data Standards for Drug and Biological Submissions Containing Real- World-Data: Guidance for Industry (FDA-2021-D-0548)
Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry (FDA-2021-D-1146)
Re: Real-World Data: Assessing Electronic Health Records (EHRs) and Medical Claims Data to Support Regulatory Decision-Making for Drugs and Biological Products
(FDA-2020-D-2307)
Poster
at 12.15 - 1.15 EDT
Andy Osterland, PharmD, MS
TM
Lisa Herms, PhD
Associate Director
Expertise and Experience
Dr. Herms is an international HEOR professional with proven experience leading and overseeing RWE studies in collaboration with pharmaceutical industry and academic partners. She has a special interest in the growing use of RWE, including development and validation of novel research methodologies within oncology, as well as the dissemination of RWE findings for research and regulatory purposes.
Education & Background
Dr. Herms holds a Masters in International Health Economics/Health Policy from the London School of Economics and Political Science and a PhD in Economics from American University, focusing on applied microeconomics and health economics. In previous roles, she has led healthcare market research functions. Dr. Herms also has extensive experience designing and leading RWE and HEOR studies, as well as managing and providing leadership to a team of researchers and biostatisticians.
Zhaohui Su, PhD
Sarah Reinwald, MSN, APRN, OCN, CCRP
Sarah Spark, RN, BSN, MHA/MBA
Lisa
Herms, PhD
Rupa Iyer, MS
Andy Osterland, PharmD, MS
LET'S CONNECT
May 9, 2023
TUESDAY
Assessing the Quality of Real-World Data and Real-World Evidence in Oncology Research:
A Cohesive Framework for Researchers
Poster
at 12.15 - 1.15 EDT
Zhaohui Su, PhD
Mapping the Flow of Biomarker Testing Information, from Test Order Through Impact on Treatment Decision-making:
A Case Study in Metastatic NSCLC
Poster
at 5.45 - 6.45 EDT
Rupa Iyer, MS
Considerations for Common Exclusion Criteria in Real-world (RW) Retrospective Observational Studies in Oncology
Poster
at 5.45 - 6.45 EDT
Lisa Herms, PhD
May 10, 2023
WEDNESDAY
Real-World Outpatient Cost of Care Among Patients with Melanoma Treated in the US Community
Poster
at 09.00 - 10.00 EDT
Zhaohui Su, PhD
Real-World Outpatient Cost of Care Among Patients with Non-small Cell Lung Cancer (NSCLC) Treated in the US Community
Poster
at 09.00 - 10.00 EDT
Zhaohui Su, PhD
Understanding the Value of Chart Abstraction for Assessing Oral Treatment History in the Oncology Outpatient Setting
Poster
at 5.45 - 6.45 EDT
Sarah Spark, RN, BSN, MHA/MBA
Sarah Reinwald, MSN, APRN, OCN, CCRP
Schedules
LET'S CONNECT
Zhaohui Su, PhD
VP, Biostatistics
Expertise and Experience
Dr. Su is VP of Biostatistics at Ontada, and a scientific leader with 25 years of experience in applying statistical, epidemiological, and machine learning methods to Real-World studies. His research interest and expertise are in oncology study design, data organization, epidemiological methods, predictive models, handling missing data, regression analysis for categorical, and continuous and survival data.
Education and Background
Dr. Su was VP of Real-World Evidence (RWE) Analytics at OM1, Inc., responsible for conducting Real-World Data (RWD) and RWE analytics and other biostatistical and epidemiological activities, including research, publication, and regulatory submissions. Prior to joining OM1, he was Sr. Director of Biostatistics at Quintiles, Inc., leading a large Biostatistics team in analyzing data from Real-World and late phase studies, and doing methodological research in comparative effectiveness and safety. Before 2009, Dr. Su was Head of the Optimization of Antiretroviral Therapy Section, Harvard School of Public Health (HSPH), Chair of the Design and Analysis Review Committee at HSPH for conducting clinical trials, retrospective and prospective observational data analysis. He has been a statistical reviewer for multiple medical journals since 2004, and has been a Statistical Editorial Board member and a scientific reviewer for Patient-Centered Outcomes Research Institute since 2015. Dr. Su received his PhD degree in Statistics from Kansas State University.
LET'S CONNECT
Sarah Spark, RN, BSN, MHA/MBA
Director of Clinical Data Quality
Expertise and Experience
Sarah Spark is the Director of Clinical Data Quality with the Clinical Data Services team, where she oversees the data and quality control for electronic medical record chart abstraction. Sarah is a Registered Nurse with 20+ years in the healthcare industry and experience in both adult and pediatric oncology.
Education and Background
Sarah holds a Bachelor of Science in Nursing from the University of Texas Medical Branch and a Masters Healthcare Administration/Business Administration from The University of Houston Clear Lake. She has held various nursing management roles in a variety of settings.
LET'S CONNECT
Sarah Reinwald, MSN, APRN, OCN, CCRP
Oncology Clinical Data Quality Lead
Expertise and Experience
Sarah Reinwald has been a board-certified oncology nurse for over 14 years, practicing in both inpatient and outpatient settings. She is an Oncology Certified Nurse (OCN ) and is a Certified Clinical Research Professional (CCRP ).
Education and Background
Sarah Reinwald holds a Master of Science in Nursing from the University of Saint Joseph in West Hartford, CT. Prior to joining Ontada, Sarah spent over 6 years working as an Advanced Practice Registered Nurse and Clinical Research Nurse educator with the Yale Cancer Center/Smilow Phase I Program.
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LET'S CONNECT
Rupa Iyer, MS
Senior Data Scientist
Expertise and Experience
Rupa Iyer is a Data Scientist with a passion for discovering insights and stories from data.
She has over 18 years of experience as a data professional in many domains, including healthcare, education, manufacturing, and consulting.
Education & Background
Rupa Iyer holds a Masters in Computer Science and will be graduating with a Masters in Biomedical Informatics from University of Texas Health Science Center at Houston in May 2023.
LET'S CONNECT
Andy Osterland, PharmD, MS
Research Scientist
Expertise and Experience
Dr. Osterland is a Health Economics and Outcomes Research (HEOR) professional with 5+ years of experience analyzing real-world data sets, including electronic health record (EHR) and medical and pharmacy claims data for research and quality improvement initiatives. His research interests include oncology, cardiovascular and liver disease, social determinants of health, and biosimilars.
Education & Background
Dr. Osterland completed his PharmD at Mercer University, postdoctoral fellowship at Baylor Scott & White Health, and MS in Health Outcomes at the University of Texas at Austin. His prior experience includes various roles in analytics, managed care, and medical information at Humana, Dymaxium, and UCB.
*Top 5% finalist for ISPOR 2023 Research Presentation Awards.
Across the Continuum of RWD Use Cases in Oncology:
From Early Signals to Regulatory Decision Making
Nicholas J. Robert, MD
Ontada Chief Medical Officer
Amy K. O’Sullivan, PhD
Ontada SVP & Chief Scientific Officer
Tues, May 9 | 3:45 pm – 4:15 pm
Presented at the ISPOR 2023
Exhibit Hall Theater
This presentation is not an official educational offering of ISPOR 2023, and is not sponsored, endorsed or accredited by ISPOR.
Let's Connect
Contact us
May 15-18
Washington, DC
Booth 217
Our Featured Researchers
May 8, 2023
MONDAY
May 8, 2023
MONDAY
Assessing the Quality of Real-World Data and Real-World Evidence in Oncology Research:
A Cohesive Framework for Researchers
*Top 5% finalist for ISPOR 2023 Research Presentation Awards.
Poster
at 12.15 - 1.15 EDT
Zhaohui Su, PhD
Mapping the Flow of Biomarker Testing Information, from Test Order Through Impact on Treatment Decision-making:
A Case Study in Metastatic NSCLC
Poster
at 5.45 - 6.45 EDT
Rupa Iyer, MS
Considerations for Common Exclusion Criteria in Real-world (RW) Retrospective Observational Studies in Oncology
Poster
at 5.45 - 6.45 EDT
Lisa Herms, PhD
Understanding the Value of Chart Abstraction for Assessing Oral Treatment History in the Oncology Outpatient Setting
Poster
at 5.45 - 6.45 EDT
Sarah Spark, RN, BSN, MHA/MBA
Sarah Reinwald, MSN, APRN, OCN, CCRP
May 9, 2023
TUESDAY
May 9, 2023
TUESDAY
Real-World Outpatient Cost of Care Among Patients with Melanoma Treated in the US Community
Poster
at 09.00 - 10.00 EDT
Zhaohui Su, PhD
Real-World Outpatient Cost of Care Among Patients with Non-small Cell Lung Cancer (NSCLC) Treated in the US Community
Poster
at 09.00 - 10.00 EDT
Zhaohui Su, PhD
May 8, 2023
MONDAY
Our Featured Researchers
HOPE Studies
TM
Learn More
Ontada at a glance
Learn More
Publications
Learn More
FDA Public Comment Letters
Learn More
Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (FDA-2021-D-1214)
Data Standards for Drug and Biological Submissions Containing Real- World-Data: Guidance for Industry (FDA-2021-D-0548)
Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry (FDA-2021-D-1146)
Re: Real-World Data: Assessing Electronic Health Records (EHRs) and Medical Claims Data to Support Regulatory Decision-Making for Drugs and Biological Products
(FDA-2020-D-2307)
Let's Connect.
© 2022 Ontada LLC
Research Presentation
Get in Touch
Ontada