Cambridge Healthtech Institute’s 9th Annual
Accessing and Generating RWD
Sources and Strategies for Generating Regulatory Grade RWD
FEBRUARY 19-20, 2020
Real-world evidence solutions have changed the design and execution of clinical trials and post-marketing research. Data generated in real-world data-based studies is essential for multiple stakeholders within and outside pharmaceutical companies, such
as regulatory agencies, payers, health care management organizations, formulary inclusion decision makers, healthcare professionals, and patients. CHI’s 9th Annual Accessing and Generating RWD conference is designed to facilitate knowledge exchange
around all aspects of real-time, real-world data generation, its quality and applications.
Stay on and attend Part 2 (Thurs-Fri): Leveraging RWD for Clinical and Observational Research
Scientific Advisory Board
Cathy Critchlow, PhD, Vice President, Center for Observational Research, Amgen
Hui Cao, PhD, Executive Director, Real World Evidence, Global Medical Affairs, Novartis Pharmaceuticals
Charles Makin, Global Head, Real World Evidence Strategy, Biogen
Marc Berger, MD, Chair, Real World Evidence Advisory Committee, SHYFT Analytics
Preliminary Agenda
Outcomes Ascertainment at the Speed of Digital: The Hugo Experience
Harlan M. Krumholz, MD, SM, Director, Yale-New Haven Hospital Center for Outcomes Research and Evaluation
Demystifying Fit-for-Purpose Data
Gracie Lieberman, Senior Director, Regulatory Policy, Genentech
Considerations on the Use of Real-World Data in Trial Design
Demissie Alemayehu, PhD, Vice President, Biostatistics, and Head of Statistical Research and Data Science, Pfizer
The Use of Real-World Evidence in Clinical Design to Support Regulatory Decision-Making
Elodie Baumfeld Andre, PhD, Senior Director, Epidemiology Strategy & Policy Lead, Worldwide Safety and Regulatory, Pfizer
Role of Real-World Evidence in Comprehensive Product Evidence Generation Plans
Cathy Critchlow, PhD, Vice President, Center for Observational Research, Amgen
RWD in Oncology and Immuno-Oncology Research
Michael Kelsh, PhD, Director, Center for Observational Research, Amgen
Machine Learning with Real World Data
John Page, MD, ScD, Medical Director and Lead of Predictive Analytics, Center for Observational Research, Amgen Inc.
Risk-Based Safety Monitoring for Oncology Clinical Trials
Sean Zhao, MD, PhD, Head of US Patient Safety, AstraZeneca Pharmaceuticals LP, US Medical Affairs
Making the (Regulatory) Grade: Approaches to Data Quality in RWE
Emily Castellanos, MD, Associate Medical Director, Flatiron Health
Fox Insight: Driving Discovery with the Patient Voice
Lindsey Riley, MPH, Senior Associate Director, Research Partnerships, The Michael J. Fox Foundation for Parkinson's Research
Patient Advocacy Collaboration: A Value RWD Resource
Virginia Spitzer, Executive Director, Foundation for Sarcoidosis Research