2018 Agenda

session types:
GENERAL SESSIONs
Hear from the FDA, academic researchers, and other thought leaders on the current and future state of real-world evidence.
BREAKOUT SESSIONs: RWE STRATEGY
Learn how leading researchers are applying real-world evidence across the drug development lifecycle.
BREAKOUT SESSIONs: DATA SCIENCE
Dive into methods specific to analyzing real-world data in sessions led by Flatiron data scientists and your peers.
Tuesday, November 6
4:00pm — 8:00pm
Arrivals & Registration
MGM National Harbor Hotel
6:00pm — 9:00pm
Welcome Reception
Join us to network with the Flatiron team and your peers.
Bellagio Ballroom, MGM National Harbor Hotel
Wednesday, November 7
7:30am — 8:25am
Breakfast
Bellagio Ballroom, MGM National Harbor Hotel
8:30am — 9:20am
The Promise of Real-World Evidence
GENERAL SESSION
SPEAKERs:
Amy Abernethy, MD, PhD
Chief Medical Officer / Chief Scientific Officer & SVP - Oncology at Flatiron Health
Zach Weinberg
Co-Founder, President & COO at Flatiron Health
9:20am — 10:15am
Leveraging Real-World Evidence for Regulatory Use
GENERAL SESSION
The interest in real‐world evidence in a regulatory context is rapidly growing. Recent advances in data quality and experience with appropriate regulatory use cases are crucial steps towards effective use of RWE for regulatory decision-making.

This session will introduce a quality checklist for regulatory-grade RWE and will present recent applications of RWE for regulatory use cases. A key feature of this session is a moderated discussion among regulatory thought leaders from the FDA, life sciences and real-world data experts about the current and future use of regulatory-grade real-world evidence.
SPEAKERs:
Rebecca Miksad, MD, MPH
Senior Medical Director, Research Oncology at Flatiron Health
Amy Abernethy, MD, PhD
Chief Medical Officer / Chief Scientific Officer & SVP - Oncology at Flatiron Health
Sean Khozin, MD, MPH
Associate Director, Oncology Center of Excellence at FDA
Mike Kelsh, PhD, MPH
Executive Director, Center for Observational Research at Amgen
Katherine Tsokas, JD
Regulatory Head of Regenerative Medicine & Advanced Therapy at Janssen
Director, Regenerative Medicine & Advanced Therapy Network at Johnson & Johnson
10:15am — 10:45am
Networking Break
10:15am — 10:45am
These activities will be open during the networking break.
Abstraction Lab
Get hands-on with Flatiron’s clinical abstraction tools. See how Flatiron’s proprietary technology supports the generation of regulatory-grade real-world data.
Ask the Experts
Meet one-on-one with Flatiron statisticians, engineers, and product experts to discuss questions specific to working with Flatiron real-world data.
Research Showcase
Learn about innovative applications of Flatiron real-world evidence in this showcase of published research conducted by Flatiron’s research partners.
10:45am — 11:35am
Building Capabilities to Realize the Potential of Real-World Evidence
BREAKOUT SESSION: RWE STRATEGY
Succeeding with real-world evidence is as much about organizational capabilities as it is about analytical techniques. This session will explore how research organizations are building the capabilities needed to succeed with real-world evidence.

This panel discussion will cover topics including outsourcing vs. insourcing, establishing centralized COE vs. decentralized capabilities, traditional trialists vs. RWE-specific talent, how other teams have evolved to become RWE proficient, and how RWE becomes integrated in product lifecycle teams.
MODERATOR:
Shane Woods, PhD
Vice President, Life Sciences at Flatiron Health
SPEAKERs:
Bill Capra, PhD
Global Head of Real World Data-Science Oncology at Roche/Genentech
David Anstatt
Executive Director, Center for Observational Research & Data Sciences at Bristol-Myers Squibb
A.J. Fedor
Executive Director, Commercial Services at Tesaro
Brian Bradbury
Executive Director, Center for Observational Research at Amgen
Tools for Reproducible Real-World Data Analyses: Part 1
BREAKOUT SESSION: DATA SCIENCE
The need for utilization of reproducible tools is growing rapidly as analyses of real-world data become more frequent, involve larger datasets, and employ more complex methods. Led by Flatiron data scientists, this session will showcase numerous real-world examples to illustrate the principles of structuring and organizing a modern data analysis, literate statistical analysis tools, version control, software testing and debugging, and demonstrate how to develop reproducible reports.
SPEAKERs:
Carrie Bennette, MPH, PhD
Senior Methodologist at Flatiron Health
Josh Kraut
Senior Data Insights Engineer at Flatiron Health
11:40am — 12:30pm
The Role of Machine Learning & Natural Language Processing in Real-World Evidence
BREAKOUT SESSION: RWE STRATEGY
The increase in availability of real world evidence has been accompanied by the need to improve data processing technology in order to efficiently draw insights from large amounts of heterogeneous data. This session will demystify Machine Learning and natural language processing (NLP) and describe their evolving role in real world evidence. We will discuss Flatiron's guiding principles for applying these techniques, case studies showing how we're leveraging them today, and ways in which we plan to expand their impact in the future.
SPEAKERs:
Ben Birnbaum, PhD
Senior Staff Software Engineer, ML Team at Flatiron Health
Josh Haimson
Product Manager at Flatiron Health
Geetu Ambwani
Data Insights Lead at Flatiron Health
Tools for Reproducible Real-World Data Analyses: Part 2
BREAKOUT SESSION: DATA SCIENCE
The need for utilization of reproducible tools is growing rapidly as analyses of real-world data become more frequent, involve larger datasets, and employ more complex methods. Led by Flatiron data scientists, this session will showcase numerous real-world examples to illustrate the principles of structuring and organizing a modern data analysis, literate statistical analysis tools, version control, software testing and debugging, and demonstrate how to develop reproducible reports.
SPEAKERs:
Carrie Bennette, MPH, PhD
Senior Methodologist at Flatiron Health
Josh Kraut
Senior Data Insights Engineer at Flatiron Health
12:30PM — 1:30pm
Lunch
Bellagio Ballroom, MGM National Harbor Hotel
12:30PM — 4:20pm
Abstraction Lab
Get hands-on with Flatiron’s clinical abstraction tools. See how Flatiron’s proprietary technology supports the generation of regulatory-grade real-world data.
Ask the Experts
Meet one-on-one with Flatiron statisticians, engineers, and product experts to discuss questions specific to working with Flatiron real-world data.
Research Showcase
Learn about innovative applications of Flatiron real-world evidence in this showcase of published research conducted by Flatiron’s research partners.
1:35PM — 2:30pm
Conducting Research with a Clinico-Genomic Database
GENERAL SESSION
Augmenting genomic data with clinical outcomes provides a powerful resource for researchers interested in the clinical implications of genomic profiles. In this session, we will discuss the techniques researchers have used to analyze this new dataset as well as unique challenges that need to be considered in designing the right use cases.
SPEAKERs:
Ken Carson, MD, PhD
Senior Medical Director at Flatiron Health
Anish Thomas, MBBS, MD
Investigator, Developmental Therapeutics Branch at National Cancer Institute
Craig Tendler, MD
Vice President, Oncology Clinical Development & Global Medical Affairs at Janssen
Gaurav Singal, MD
VP, Data Strategy & Product at Foundation Medicine
2:30PM — 3:45pm
Development and Validation of Real-World Endpoints
GENERAL SESSION
Real-world endpoints have the potential to disrupt the traditional development lifecycle: from supporting R&D to addressing post-marketing commitments. Discover how real-world endpoints are enabling new approaches and how Flatiron is partnering with regulatory and industry stakeholders to develop and validate them.
MODERATOR:
Aracelis Torres, MPH, PhD
Senior Quantitative Scientist at Flatiron Health
SPEAKERs:
Amy Abernethy, MD, PhD
Chief Medical Officer / Chief Scientific Officer & SVP - Oncology at Flatiron Health
Sean Khozin, MD, MPH
Associate Director, Oncology Center of Excellence at FDA
Mitch Higashi, PhD
Vice President, Health Economics and Outcomes Research at Bristol-Myers Squibb
3:45pm — 4:15pm
Networking Break
4:20PM — 5:15pm
The Role of Real-World Evidence in Regulatory Decision-Making
GENERAL SESSION
Flatiron’s Amy Abernethy and Dr. Rick Pazdur of the FDA will discuss the agency’s engagement with RWE to date, the path forward for RWE, and the future of cancer care.
SPEAKERs:
Amy Abernethy, MD, PhD
Chief Medical Officer / Chief Scientific Officer & SVP - Oncology at Flatiron Health
Rick Pazdur, MD
Director, Oncology Center of Excellence at FDA
7:00pm — 10:00pm
Evening Reception
Enjoy dinner, craft wine and music overlooking views of The Capitol and Anacostia River from Washington, DC's only commercial winery.
District Winery
385 Water Street SE
Washington, DC
Thursday, November 8
7:30am — 8:45am
Breakfast
Bellagio Ballroom, MGM National Harbor Hotel
8:00AM — 8:45AM
These activities will be open during breakfast.
Abstraction Lab
Get hands-on with Flatiron’s clinical abstraction tools. See how Flatiron’s proprietary technology supports the generation of regulatory-grade real-world data.
Ask the Experts
Meet one-on-one with Flatiron statisticians, engineers, and product experts to discuss questions specific to working with Flatiron real-world data.
Research Showcase
Learn about innovative applications of Flatiron real-world evidence in this showcase of published research conducted by Flatiron’s research partners.
9:00am — 9:45am
A Conversation with Greg Simon
GENERAL SESSION
Flatiron's Amy Abernethy will speak with Greg Simon of the Biden Cancer Initiative about opportunities for innovation in the current healthcare system in order to accelerate treatment options for cancer patients.
SPEAKERs:
Greg Simon, JD
President at Biden Cancer Initiative
Amy Abernethy, MD, PhD
Chief Medical Officer / Chief Scientific Officer & SVP - Oncology at Flatiron Health
9:45am — 10:30am
The Academic Perspective on Real-World Evidence
GENERAL SESSION
Flatiron's academic partners will share their perspective on partnering with life sciences organizations on health outcomes research, and how RWE can be leveraged to drive greater collaboration.
MODERATOR:
Neal Meropol, MD
Vice President, Research Oncology at Flatiron Health
SPEAKERs:
Cary Gross, MD
Professor of Medicine; Director, National Clinician Scholars Program at Yale
Ron Mamtani, MD, MSCE
Assistant Professor of Medicine at the Hospital of the University of Pennsylvania
Yu-Ning Wong, MD, MSCE
Clinical and Analytics Leader at Janssen Scientific Affairs
10:30am — 10:50am
Networking Break
10:30AM — 12:00PM

Abstraction Lab
Get hands-on with Flatiron’s clinical abstraction tools. See how Flatiron’s proprietary technology supports the generation of regulatory-grade real-world data.
Ask the Experts
Meet one-on-one with Flatiron statisticians, engineers, and product experts to discuss questions specific to working with Flatiron real-world data.
Research Showcase
Learn about innovative applications of Flatiron real-world evidence in this showcase of published research conducted by Flatiron’s research partners.
10:50am — 11:55am
Exploring the Applications of a Real-World External Control Arm
BREAKOUT SESSION: RWE STRATEGY
External control arms utilizing real-world data hold great promise for researchers — including allowing them to expand the impact of single arm trials by adding a high-quality, contemporaneous comparator. In this session, speakers will assess this opportunity with Flatiron real-world-data and review case studies on how Flatiron partners are establishing  external controls for research and regulatory settings.
SPEAKERs:
Somnath Sarkar, PhD
VP, Head of Quantitative Sciences at Flatiron Health
Bill Capra, PhD
Global Head of Real-World Data Science Oncology at Roche/Genentech
Yanping Wang, PhD
Head of Oncology Statistics at Eli Lilly
Methods for Leveraging Real-World Evidence to Construct External Control Cohorts
BREAKOUT SESSION: DATA SCIENCE
One important potential application of real-world data is the development of external control arms for clinical trials. Although promising, construction of an external control arm using real-world data often requires using advanced statistical methods to ensure validity and address potential sources of bias.

This session will highlight the key methodological considerations and challenges in building external control arms using real-world data derived from Flatiron data — illustrated both through internal research as well research conducted by our life sciences partners. In doing so, we’ll provide recommendations for addressing these challenges to improve transparency, reproducibility and validity.
SPEAKERs:
Carrie Bennette, MPH, PhD
Senior Methodologist at Flatiron Health
Meghna Samant, PhD
Senior Director, Quantitative Sciences at Flatiron Health
Jiawen Zhu, PhD
Statistical Scientist at Roche/Genentech
Rajeshwari Sridhara, PhD
Director Division of Biostatistics V, Center for Drug Evaluation and Research at FDA
12:00pm — 12:05pm
Abstraction Lab Winners Announced
12:05pm — 12:30pm
Closing Remarks from a Flatiron Medical Oncologist
GENERAL SESSION
Flatiron's SVP of Clinical Oncology will discuss what the impact of real-world evidence looks like through the eyes of a practicing oncologist.
SPEAKER:
Bobby Green, MD
SVP, Clinical Oncology at Flatiron Health
12:30pm
Lunch & Departures

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