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Tuesday, June 21 • 9:00am - 10:00am
#205: Optimizing Evidence Supporting Fit-for-Purpose Digital Clinical Measures Across the Drug Development Life Cycle

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-543-L04-P ; CME 1.00; RN 1.00

Multi-stakeholder experts who participated in the Digital Medicine Society’s (DiMe) The Playbook will define and document evidentiary requirements for digital clinical measures used in a variety of different contexts of use in drug development.

Learning Objectives

Describe the evidentiary requirements for selecting, fit-for-purpose, meaningful digital clinical measures across the drug development lifecycle; Define the different levels of verification and validation needed to support the deployment of digital clinical measures across the drug development lifecycle, spanning pre-screening and exploratory through phase i, phase ii and phase iii to post-market.

Chair

Smit Patel, PharmD

Speaker

Panelist
Ariel Aguilo, MD

Panelist
Betsy Tschosik, PhD

Panelist
Elizabeth Nicki Bush, MHS

FDA Update
Michelle Campbell, PhD


Speakers
avatar for Ariel Aguilo

Ariel Aguilo

Executive Medical Director, Head Americas Oncology, Global Clinical Development, Labcorp Drug Development, Argentina
Ariel Aguiló, MD, is a board certified oncologist specialized in Gastrointestinal tumors. He is an Executive Medical Director and Head of the Americas Oncology Medical Team for Labcorp Drug Development. He provides subject matter expertise and support for the development and conduct... Read More →
avatar for Elizabeth (Nicki) Bush

Elizabeth (Nicki) Bush

Associate VP and Head, Patient-Focused Endpoints and Measurement, Eli Lilly and Company, United States
Elizabeth (Nicki) Bush is Associate Vice President and Head of Patient-Focused Endpoints and Measurement at Eli Lilly and Company, responsible for the design and implementation of patient-centered measurement strategies to support drug development efforts across Lilly’s portfolio... Read More →
avatar for Michelle Campbell

Michelle Campbell

Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States
Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →
avatar for Smit Patel

Smit Patel

Program Director, Digital Medicine Society (DiMe), United States
Dr. Smit J. Patel, PharmD serves at the Digital Medicine Society (DiMe), a global non-profit organization dedicated to better health powered by digital medicine. His work focuses on applied approaches to the safe, effective, ethical, and equitable use of digital technologies to advance... Read More →
BT

Betsy Tschosik

Digital Innovation Chapter Head, Patient-Centered Outcomes Research, Genentech, a Member of the Roche Group, United States
Betsy Tschosik is Head of Digital Innovation in Patient-Centered Outcomes Research (PCOR) at Genentech, bringing expertise in patient-centricity and measurement science to the validation and use of digital measures in drug development. Prior to her current role in digital innovation... Read More →

Tuesday June 21, 2022 9:00am - 10:00am CDT
Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Forum |   02: ClinTrials -ClinOps, Forum
  • Level Intermediate
  • Featured Topics Digital
  • Level Intermediate
  • Feature Topics Digital
  • Credit Type ACPE, CME, RN
  • Tags Forum