Mobile Tech in Clinical Trials Agenda 2024 Page

Cindy Geoghegan, Patient Advocate, -

9:00AM - 9:25AM

A Novel Mobile Technology that Detects and Tracks Parkinson’s Disease that Enables Greater Patient Participation through the Fully Remote Capabilities

Ray Dorsey, MD, David M. Levy Professor of Neurology and Director of the Center for Health + Technology, The University of Rochester Medical Center

Dina Katabi, PhD, Director, IT Center for Wireless Technology, MIT

Showing Events in 1 Track from 09:25am to 10:00am

Morning Networking Break and Breakfast

9:25AM - 10:00AM

Morning Networking Break and Breakfast

Showing Events in 1 Track from 10:00am to 11:20am

Morning General Session Continued

10:00AM - 10:45AM

INTERACTIVE SESSION - How to Drive Change and Adoption with Mobile Technologies in Trials

Facilitated by:

Michelle Shogren, CEO, Innovate in What You Do!

10:45AM - 11:20AM

Addressing the Impact of Mobile/Digital Technologies on Sites: What Needs to Be Done to Reduce the Burden on Investigators, Coordinators and Patients

Bert Hartog, PhD, Senior Director, Janssen Clinical Innovation, Janssen R&D Global Development, Janssen Pharmaceuticals

Panelists:

Tyler Bye, Director, Site Solutions and Product Strategy, WCG

Shafaat Ali Khan, Associate Director, Site Engagement-Clinical Development, Eli Lilly

Joanne Monaghan, RN, CCRC, Clinical Operations Manager, Boston Clinical Trials

Casey Orvin, Chief Commercial Officer, CenExel Clinical Research

Debra Weinstein, MD, VP, Internal Medicine, Science 37

Showing Events in 1 Track from 11:25am to 12:30pm

TECHNOLOGY SHOWCASE AND DEMOS

11:25AM - 12:30PM

Annual Technology Showcase and Demos

Kai Bode, Director, Digital Innovation and Patient Strategy, Global Digital Analytics & Technologies Team, Merck

Participating Companies:

Emma Eikermann, Product Manager, Mural Health

Anthony Londino, Founder and President, Med-Con Technologies

Natasha Massias, Senior Solution Architect, Datacubed Health

Anthony Mikulaschek, VP, eCOA, IQVIA

Ashley Parrot Lee, Clinical Trials, Key Accounts Manager, Abbott

Katie Rowe, Operational Implementation Manager, mdgroup

Erica Smith, PhD, SVP, Business Development and Marketing, Spencer Health Solutions, Inc

Participating Companies:

Showing Events in 1 Track from 12:30pm to 01:30pm

Lunch and Networking

12:30PM - 1:30PM

Lunch and Networking

Showing Events in 2 Tracks from 01:30pm to 03:05pm

TRACK A:

Track Chair:

Anthony K. Taylor, DHSc, MSPharm, Director, Clinical Study Patient Platform and Decentralized Clinical Trials, AbbVie

1:30PM - 1:50PM

Measuring What Matters to Patients: Engaging with Patients when Developing Passive-monitoring COAs

Jessica Braid, Principal Patient-Centered Outcomes Research (PCOR) Scientist and Head of Digital Innovation Chapter, Roche

1:50PM - 2:10PM

Scaling Mobile Technologies and Digital Biomarkers to Personalize Therapy Development

Jiao Li, Digital Health Project Manager, Chugai Pharmaceutical Co.

Jaydev Thakkar, MBA, Chief Operating Officer, Biofourmis

2:10PM - 2:30PM

How Novartis is Engaging with Sites in Early Clinical Development to Better Implement Mobile Technologies in Trials

Jennifer Yip, Associate Director, Digital Trials & Patient Engagement, Novartis

Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk

2:30PM - 2:45PM

eCOA Translation Strategy: Tips for Optimal Sponsor, eCOA Vendor, and Language Services Provider Collaboration

Kristen Bernardi Rader, MBA, MA, COA Partnership Management Team Lead, RWS

Stacey Higgins, Associate Director, COA & Digital Implementation Team/CDIT, AbbVie

2:45PM - 3:05PM

Improving Remote Measures Based on Lessons Learned from Implementing Digital Biomarkers within Trials

Stephen Ruhmel, MPH, Associate Director, Janssen Clinical Innovation, Janssen

TRACK B:

Track Chair:

Danielle Horton, Associate Director, Tech and Innovation, Gilead Sciences

1:30PM - 1:50PM

An Otsuka Case Study on Implementing Wearable and Digital Technologies

Debbie Profit, PhD, VP, Clinical Management and Applied Innovation, Otsuka

1:50PM - 2:10PM

How “Mobile” Decentralized Elements Can Empower More Patients to Participate in Trials

Edward Triebell, Executive Director, Product Development of Digital Health, MRN

2:10PM - 2:30PM

Unwinding from Technology Overload: Creating a New Strategic Plan for Adopting and Implementing Mobile Technologies

Krista Russell, MSHI, Head, Digital Health Solutions, Takeda

2:30PM - 2:45PM

Case Study on Partnering with Rett Syndrome Patients throughout the Drug Development Process

Jennifer Richards, PhD, Senior Delivery Scientist, VivoSense

2:45PM - 3:05PM

Streamlining Mobile Technology Capabilities for Better Patient Experiences and Richer Data

Matt Noble, SVP, Product Management, Medidata

Showing Events in 1 Track from 03:05pm to 03:30pm

Afternoon Networking Break

3:05PM - 3:30PM

Afternoon Networking Break

Showing Events in 1 Track from 03:30pm to 04:00pm

FDA GUIDANCES ON DIGITAL TECHNOLOGIES

3:30PM - 4:00PM

FDA Update on Digital Technologies in Clinical Trials

Moderated By:

Ebony Dashiell-Aje, PhD, Executive Director, Patient Centered Outcomes Science (PCOS), Biomarin

Participants:

Hussein Ezzeldin, PhD, Senior Staff Fellow, Office of Biostatistics and Pharmacovigilance, Division of Analytics and Benefit-Risk Assessment, Analytics & Real World Evidence Branch, FDA

Bray Patrick-Lake, Senior Digital Health Specialist, Center for Devices and Radiological Health, FDA

Leonard Sacks, MD, Acting Deputy Director, Office of Medical Policy, CDER, FDA

Showing Events in 1 Track from 04:00pm to 05:45pm

DE&I AND STRATEGIC COLLABORATIONS

4:00PM - 4:40PM

Temperature Check: How are Mobile and Digital Technologies Enabling Traditionally Underrepresented Communities to Participate in Clinical Trials?

Adrelia Allen, PharmD, Director, Clinical Trial Patient Diversity, Global Clinical Trial Operations, Merck

Panelists:

Eileen Doherty, VP and Head, Enabling Business Information Solutions (EBIS), Janssen Pharmaceuticals

Brian Greene, Vice President, Business Development, Decentralized Clinical Trial Solutions, ICON plc

Ash Rishi, CEO, COUCH Health

4:40PM - 5:20PM

Establishing More Collaborative and Strategic Approaches to Implementing Patient-Facing Mobile Technologies

Aman Thukral, Head of Digital Operations and Clinical Systems, AbbVie

Panelists:

Sandeep Bhat, Senior Leader, Digital Health Partnerships and Digital Engagement, Global Clinical Operations, GSK

Greg Christie, Chief Product Officer, StudyKIK

Hassan Kadim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS

Andrew Pearlmutter, Associate Director, Patient Centered Outcomes Science (PCOS), BioMarin Pharmaceuticals Inc

Karen Travers, Associate Principal Consultant, Organizational & Quality Solutions, Halloran Consulting Group

5:20PM - 5:40PM

Open Mic Interactive Session: Mobile Technology Lessons Learned to Better Guide Future Clinical Trials