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

REGULATORY GRADE RWD

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

RWD FOR TRIAL DESIGN AND REGULATORY DECISIONS

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

CROSS-COMPANY RWE PLATFORM DEVELOPMENT

Role of Real-World Evidence in Comprehensive Product Evidence Generation Plans

Cathy Critchlow, PhD, Vice President, Center for Observational Research, Amgen

SUPPLEMENTING CANCER RESEARCH WITH RWD

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

ENHANCING PATIENT’S ROLE IN RWD-BASED RESEARCH

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

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

INTERACTIVE BREAKOUT DISCUSSION GROUPS

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing: www.scopesummit.com/breakouts

 

Stay on and attend Part 2 (Thurs-Fri): Leveraging RWD for Clinical and Observational Research




For more details on the conference, please contact:
Marina Fishtinsky, MD

Executive Director, Conferences

Cambridge Healthtech Institute

Phone: (+1) 781-972-5496

Email: mfilshtinsky@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.5457

Email: iquigley@healthtech.com

 

Companies L-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.1349
Email: prose@healthtech.com