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Wednesday, June 21 • 4:00pm - 5:15pm
#366: Are We Ready for Telemedicine-Powered Clinical Trials?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-515-L04-P; CME 1.25; IACET 1.25; RN 1.25

Telemedicine enables remote monitoring and interaction with patients to enhance care provision and treatment decisions. These tools used in routine care have enormous potential in providing ways to enable better monitoring of trial participants, and ease participation and engagement with less reliance on clinic visits. This session explores whether we are adequately primed to effectively use telemedicine. Where challenges exist what needs to be changed about the system or telemedicine approach to enable better usage? We will also consider how best telemedicine is used, or not, in clinical trials with reference to some practical examples. Are we driving to a world in which clinical care is not based on an in-person interaction with a health care provider?

Learning Objectives

Describe telemedicine, including the drivers for and barriers to its use in clinical trials and care.

Chair

Karen D Weiss, MD, MPH

Speaker

Straight From the Horse’s Mouth: Lessons Learned From Legal and Regulatory Challenges of Real Remote Trials
Gerrit Hamre

A Telemedicine Proof of Concept Study Evaluating the Remote Detection of Alzheimer’s Disease and Categorization of Severity
Penny Randall, MD

Can Mobile Apps Faciltate the Use of Telemedicine
Wayne Amchin, MA, MPA, RAC



Moderators
KW

Karen Weiss

Vice President, Global Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
Karen Weiss MD, MPH is the VP for Regulatory Policy and Intelligence for Janssen Pharmaeutical Companies of J&J. She joined J&J in January 2012 after a 22 year career at the US FDA, where she served in a number of postions, within first CBER and then CDER. Before joining FDA, Kar... Read More →

Speakers
avatar for Wayne Amchin

Wayne Amchin

Senior Consumer Safety Officer, DCRP, ODE I, OND, CDER, FDA
Wayne manages the pulmonary arterial hypertension (PAH) portfolio, which includes many drug-device combination products, along with other therapeutic areas. He is the winner of the FDA’s Innovation Lab 1st Prototype Challenge for Mobile Apps, and he is developing the first mobi... Read More →
avatar for Gerrit Hamre

Gerrit Hamre

Clinical Project Manager, Clinical Trials Transformation Initiative (CTTI)
Mr. Hamre manages the development and implementation of CTTI projects. Prior to joining CTTI, he worked at the FDA on legislative issues regarding the drug approval process, antibacterial drug development, manufacturing quality, and generic drugs. Before joining the FDA, Mr. Hamr... Read More →
avatar for Penny Randall

Penny Randall

Global Therapeutic Head, CNS, QuintilesIMS
Dr. Randall is Vice President and Global Therapeutic Head of the CNS at QuintilesIMS. Her scientific focus is on optimizing trial design and implementation to minimize the risk of inconclusive trials. She is also interested in leveraging disruptive technologies to modernize and a... Read More →
KW

Karen Weiss

Vice President, Global Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
Karen Weiss MD, MPH is the VP for Regulatory Policy and Intelligence for Janssen Pharmaeutical Companies of J&J. She joined J&J in January 2012 after a 22 year career at the US FDA, where she served in a number of postions, within first CBER and then CDER. Before joining FDA, Kar... Read More →


Wednesday June 21, 2017 4:00pm - 5:15pm
S504abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616