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Tuesday, June 21 • 4:15pm - 5:15pm
#268: Life Science Research Innovation Powered by Real-World Data

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-22-581-L04-P ; CME 1.00; RN 1.00

Real-world data (RWD) is increasingly easier to access, regulators are supportive of its use to improve drug development and success stories are being published at an ever expanding pace. This session will both provide an update as to where external control arms are in the respective life and hype cycles of adoption and provide a lens into the future of computer modeling leveraging RWD. This session includes case studies and learnings from ECA/In Silico implementations and will address if there is any future in classic randomized clinical trial (RCT) designs.

Learning Objectives

Describe how life science drug development is changing because of innovation powered by RWD; Apply novel biosimulation in the development new molecular entities and associated safety and risk mitigation strategies including expanded indications; Discuss the hype around ECAs/SCAs and where they best fit.


Keith Wenzel


The Hype Cycle of Synthetic, External Control Arms and a Lens into the Future of Randomized Controlled Trials
Manish Khatri

Novel In Silico Clinical Trial for NME, SrLC, REMS, and Expanded Approval of Marketed Products
Jeffrey Difrancesco, MBA, MSc


Jeffrey Difrancesco

Executive Vice President and Chief Life Science Officer, Tabula Rasa Healthcare Inc, United States
Jeffrey DiFrancesco, M.Eng, M.Sci., SSMBB, is the Executive Vice President and Chief Life Science Officer at Tabula Rasa HealthCare in Moorestown, N.J. With over thirty-five years of technology, healthcare, and life science experience, Mr. DiFrancesco specializes in commercializing... Read More →
avatar for Manish Khatri

Manish Khatri

Director, Scientific Lead - data42, Global Drug Development, Novartis, Switzerland
Manish has focused his career with laser focus on making the science of medicines data driven. He has expertise in integrating data & technology with pharmaceutical R&D. His career spans CRO industry and R&D analytics consulting companies both in traditional clinical development and... Read More →
avatar for Keith Wenzel

Keith Wenzel

Senior Director, Scientific Data Organization, Parexel International, United States
Mr. Wenzel has worked for Parexel for over fifteen years. His background includes product, corporate, and personnel management; sales and marketing; and information systems experience. These skills have been applied within the life sciences and health care industries through working... Read More →

Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session |   03: Data-Tech in Clinical Trials, Session
  • Level Advanced
  • Featured Topics RWD-RWE
  • Level Advanced
  • Feature Topics RWD-RWE
  • Credit Type ACPE, CME, RN
  • Tags Session