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Monday, June 25 • 1:45pm - 2:45pm
#132: New Approaches, Novel Endpoints, and Next-Generation Trials

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Component Type: Workshop
Level: Intermediate

Using a case study, we will illustrate CTTI recommended practices for selecting, developing, and including technology-derived endpoints in regulatory trials. Participants can apply best practices learned to other scenarios, including their own work.

Learning Objectives

Describe approaches to identifying mobile technology-derived outcome measures that are most valuable and warrant development; Review approaches for optimizing the efficiency of technology-derived novel endpoint development; Discuss how to include and position technology-derived novel endpoints to be most impactful.


Jennifer C Goldsack


Jessie Bakker, PhD, MS

Daniel Rollings Karlin, DrMed, MA, FAPA

Komathi Stem, MS


Jessie Bakker

Senior Manager, Clinical Trials, Philips Respironics
avatar for Jennifer Goldsack

Jennifer Goldsack

Senior Project Manager, CTTI
Jen Goldsack is a Senior Project Manager at the Clinical Trials Transformation Initiative (CTTI). Jen leads two projects within CTTI's Mobile in Clinical Trials (MCT) Program; the MCT Novel Endpoints, and MCT Mobile Devices projects.

Daniel Karlin

Head of Clinical, Informatics, and Regulatory Strategy, Pfizer Inc
Dan is the Head of Clinical, Informatics, and Regulatory Strategy for Digital Medicine and Pfizer Innovation Research Lab, where he manages strategy for multiple aspects of Pfizer’s collaborative digital measurement and endpoint development efforts. Dan is board certified in Psychiatry... Read More →

Komathi Stem

Founder and Chief Executive Officer, monARC Bionetworks
Komathi Stem, MS is passionate about transforming drug development by rethinking the way clinical trials are designed & executed. As an entrepreneurial systems thinker, she is focused on sparking an ecosystem change that accelerates research through greater collaboration across the... Read More →

Monday June 25, 2018 1:45pm - 2:45pm EDT
E and E Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA