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Tuesday, June 29 • 4:00pm - 5:00pm
#262 SL: Frameworks for Digital Endpoints via the IND Pathway

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-593-L04-P; CME 1.00; IACET 1.00; RN 1.00

This panel will discuss current frameworks for digital endpoints that can be used by individual sponsors in their drug development programs, as well as remaining challenges for using digital tools to capture endpoint data.

Learning Objectives

Discuss frameworks for digital endpoints that could be used by individual sponsors in their drug development programs; Describe current challenges in using digital tools to capture endpoint data and possible approaches to address this problem.

Chair

Megan Doyle, JD, MPH

Speaker

Panelist
Elektra Papadopoulos, MD, MPH

Panelist
Lindsay Stiles Kehoe, MS

Panelist
Andy Coravos

Panelist
Lauren Oliva, PharmD, RPh



Speakers
avatar for Lauren Oliva

Lauren Oliva

Global Regulatory Policy Lead, New Technologies, Biogen, United States
Lauren Oliva is the Global Regulatory Policy Lead for New Technologies at Biogen. She oversees the development and execution of R&D’s policy roadmap for digital health technologies and gene therapy to enable Biogen’s neuroscience portfolio. She is passionate about patient centric... Read More →
avatar for Megan Doyle

Megan Doyle

Global Policy Lead, Digital Health, Diagnostics, Oncology, & Combination Product, Amgen, United States
Megan Doyle is an attorney and policy professional with more than 13 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public... Read More →
avatar for Andy Coravos

Andy Coravos

Co-Founder, Chief Executive Officer, Elektra Labs, United States
Andy Coravos (@andreacoravos) is the CEO/co-founder of Elektra Labs, building a digital medicine platform focusing on digital biomarkers for decentralized clinical trials. She serves as a research collaborator at the Harvard-MIT Center for Regulatory Sciences. Formerly, she served... Read More →
avatar for Lindsay Kehoe

Lindsay Kehoe

Project Manager, Clinical Trials Transformation Initiative (CTTI), United States
Lindsay Kehoe is a project manager at the Clinical Trials Transformation Initiative (CTTI), currently managing the implementation of CTTI's digital Novel Endpoints project. Prior to joining CTTI, she coordinated genetic and rare disease clinical trials at Children’s National Medical... Read More →
avatar for Elektra Papadopoulos

Elektra Papadopoulos

Deputy Director (acting) Division of Clinical Outcome Assessment, OND, CDER, FDA, United States
Dr. Papadopoulos serves as the Deputy Director (acting) of the Division of Clinical Outcome Assessment in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The Division provides consultation to CDER’s Review Divisions as well as other FDA Centers on... Read More →


Tuesday June 29, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum