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Mobile in Clinical Trials

Date: Sep 16, 2024

Location: Philadelphia, PA

Day 1: Tuesday, September 19, 2023
Showing Events in 1 Track from 07:45am to 08:40am
Morning Welcome
7:45AM - 8:15AM
Registration, Coffee and Tea
8:15AM - 8:40AM
Co-Chair's Welcome & Dismantling What’s Working and What’s Not with Mobile Tech in Clinical Studies
Co-Chairs:
Kai Bode, Principle Scientist, Preclinical Development, Merck
Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk
Ella Balasa, Patient, Advocate
Showing Events in 1 Track from 08:40am to 09:25am
KEYNOTE and Morning General Session
8:40AM - 9:00AM
KEYNOTE: Digitizing for the Patient: What’s Working, What’s Not & Next Steps
Keyote:
Amy West, MBA, Head, US Digital Transformation & Innovation, Novo Nordisk
Moderated by:
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
Speakers:
Dina Katabi, PhD, Thuan and Nicole Pham Professor of Electrical Engineering and Computer Science, MIT
Ray Dorsey, MD, David M. Levy Professor of Neurology and Director of the Center for Health + Technology, The University of Rochester Medical Center
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
Moderated by:
Bert Hartog, PhD, Senior Director, Janssen Clinical Innovation, Janssen R&D Global Development, Janssen Pharmaceuticals
Panelists:
Casey Orvin, Chief Commercial Officer, CenExel Clinical Research
Debra Weinstein, MD, VP, Internal Medicine, Science 37
Shafaat Ali Khan, Associate Director, Site Engagement-Clinical Development, Eli Lilly
Tyler Bye, Director, Site Solutions and Product Strategy, WCG
Showing Events in 1 Track from 11:25am to 12:30pm
TECHNOLOGY SHOWCASE AND DEMOS
11:25AM - 12:30PM
Annual Technology Showcase and Demos
Moderated by:
Kai Bode, Principle Scientist, Preclinical Development, Merck
Participating Companies:
Natasha Massias, Senior Solution Architect, Datacubed Health
Anthony Mikulaschek, VP, eCOA, IQVIA
Katie Rowe, Operational Implementation Manager, mdgroup
Emma Eikermann, Product Manager, Mural Health
Anthony Londino, Founder and President, Med-Con Technologies
Erica Smith, PhD, SVP, Business Development and Marketing, Spencer Health Solutions, Inc
Ashley Parrot Lee, Clinical Trials, Key Accounts Manager, Abbott
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
Speaker:
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
Speaker:
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
Speaker:
Jennifer Yip, Associate Director, Digital Trials & Patient Engagement, Novartis
Moderated by:
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
Speakers:
Stacey Higgins, Associate Director, COA & Digital Implementation Team/CDIT, AbbVie
Kristen Bernardi Rader, MBA, MA, COA Partnership Management Team Lead, RWS
2:45PM - 3:05PM
Improving Remote Measures Based on Lessons Learned from Implementing Digital Biomarkers within Trials
Speakers:
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
Speaker:
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
Speaker:
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
Speaker:
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
Speakers:
Jennifer Richards, PhD, Senior Delivery Scientist, VivoSense
2:45PM - 3:05PM
Streamlining Mobile Technology Capabilities for Better Patient Experiences and Richer Data
Speakers:
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
Participants:
Leonard Sacks, MD, Acting Deputy Director, Office of Medical Policy, CDER, FDA
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, MFS, Senior Digital Health Specialist, Center for Devices and Radiological Health (CDRH), 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?
Moderated by:
Adrelia Allen, PharmD, Executive Director, Clinical Trial Patient Diversity, Global Clinical Trial Operations, Merck Research Laboratories
Panelists:
Eileen Doherty, VP and Head, Enabling Business Information Solutions (EBIS), Janssen Pharmaceuticals
Ash Rishi, Founder & Chair of the Board of Trustees, Demand Diversity, a part of COUCH Health
Brian Greene, Vice President, Business Development, Decentralized Clinical Trial Solutions, ICON plc
4:40PM - 5:20PM
Establishing More Collaborative and Strategic Approaches to Implementing Patient-Facing Mobile Technologies
Moderated by:
Kapil Gombar, Director, Clinical Technologies and Innovation, AbbVie
Panelists:
Hassan Kadhim, Business Engagement Lead for Clinical Operations and Development, Vertex Pharmaceuticals
Karen Travers, Associate Principal Consultant, Organizational & Quality Solutions, Halloran Consulting Group
Greg Christie, Chief Product Officer, StudyKIK
Sandeep Bhat, Senior Leader, Digital Health Partnerships and Digital Engagement, Global Clinical Operations, GSK
Andrew Pearlmutter, Associate Director, Patient Centered Outcomes Science (PCOS), BioMarin Pharmaceuticals Inc
5:20PM - 5:40PM
Open Mic Interactive Session: Mobile Technology Lessons Learned to Better Guide Future Clinical Trials
Moderated by:
Ella Balasa, Patient, Advocate
Kai Bode, Principle Scientist, Preclinical Development, Merck
Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk
5:40PM - 5:45PM
Conference Concludes
Showing Events in 1 Track from 07:45am to 08:40am
Morning Welcome
7:45AM - 8:15AM
Registration, Coffee and Tea
8:15AM - 8:40AM
Co-Chair's Welcome & Dismantling What’s Working and What’s Not with Mobile Tech in Clinical Studies
Co-Chairs:
Kai Bode, Principle Scientist, Preclinical Development, Merck
Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk
Ella Balasa, Patient, Advocate
Showing Events in 1 Track from 08:40am to 09:25am
KEYNOTE and Morning General Session
8:40AM - 9:00AM
KEYNOTE: Digitizing for the Patient: What’s Working, What’s Not & Next Steps
Keyote:
Amy West, MBA, Head, US Digital Transformation & Innovation, Novo Nordisk
Moderated by:
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
Speakers:
Dina Katabi, PhD, Thuan and Nicole Pham Professor of Electrical Engineering and Computer Science, MIT
Ray Dorsey, MD, David M. Levy Professor of Neurology and Director of the Center for Health + Technology, The University of Rochester Medical Center
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
Moderated by:
Bert Hartog, PhD, Senior Director, Janssen Clinical Innovation, Janssen R&D Global Development, Janssen Pharmaceuticals
Panelists:
Casey Orvin, Chief Commercial Officer, CenExel Clinical Research
Debra Weinstein, MD, VP, Internal Medicine, Science 37
Shafaat Ali Khan, Associate Director, Site Engagement-Clinical Development, Eli Lilly
Tyler Bye, Director, Site Solutions and Product Strategy, WCG
Showing Events in 1 Track from 11:25am to 12:30pm
TECHNOLOGY SHOWCASE AND DEMOS
11:25AM - 12:30PM
Annual Technology Showcase and Demos
Moderated by:
Kai Bode, Principle Scientist, Preclinical Development, Merck
Participating Companies:
Natasha Massias, Senior Solution Architect, Datacubed Health
Anthony Mikulaschek, VP, eCOA, IQVIA
Katie Rowe, Operational Implementation Manager, mdgroup
Emma Eikermann, Product Manager, Mural Health
Anthony Londino, Founder and President, Med-Con Technologies
Erica Smith, PhD, SVP, Business Development and Marketing, Spencer Health Solutions, Inc
Ashley Parrot Lee, Clinical Trials, Key Accounts Manager, Abbott
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
Speaker:
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
Speaker:
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
Speaker:
Jennifer Yip, Associate Director, Digital Trials & Patient Engagement, Novartis
Moderated by:
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
Speakers:
Stacey Higgins, Associate Director, COA & Digital Implementation Team/CDIT, AbbVie
Kristen Bernardi Rader, MBA, MA, COA Partnership Management Team Lead, RWS
2:45PM - 3:05PM
Improving Remote Measures Based on Lessons Learned from Implementing Digital Biomarkers within Trials
Speakers:
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
Speaker:
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
Speaker:
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
Speaker:
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
Speakers:
Jennifer Richards, PhD, Senior Delivery Scientist, VivoSense
2:45PM - 3:05PM
Streamlining Mobile Technology Capabilities for Better Patient Experiences and Richer Data
Speakers:
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
Participants:
Leonard Sacks, MD, Acting Deputy Director, Office of Medical Policy, CDER, FDA
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, MFS, Senior Digital Health Specialist, Center for Devices and Radiological Health (CDRH), 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?
Moderated by:
Adrelia Allen, PharmD, Executive Director, Clinical Trial Patient Diversity, Global Clinical Trial Operations, Merck Research Laboratories
Panelists:
Eileen Doherty, VP and Head, Enabling Business Information Solutions (EBIS), Janssen Pharmaceuticals
Ash Rishi, Founder & Chair of the Board of Trustees, Demand Diversity, a part of COUCH Health
Brian Greene, Vice President, Business Development, Decentralized Clinical Trial Solutions, ICON plc
4:40PM - 5:20PM
Establishing More Collaborative and Strategic Approaches to Implementing Patient-Facing Mobile Technologies
Moderated by:
Kapil Gombar, Director, Clinical Technologies and Innovation, AbbVie
Panelists:
Hassan Kadhim, Business Engagement Lead for Clinical Operations and Development, Vertex Pharmaceuticals
Karen Travers, Associate Principal Consultant, Organizational & Quality Solutions, Halloran Consulting Group
Greg Christie, Chief Product Officer, StudyKIK
Sandeep Bhat, Senior Leader, Digital Health Partnerships and Digital Engagement, Global Clinical Operations, GSK
Andrew Pearlmutter, Associate Director, Patient Centered Outcomes Science (PCOS), BioMarin Pharmaceuticals Inc
5:20PM - 5:40PM
Open Mic Interactive Session: Mobile Technology Lessons Learned to Better Guide Future Clinical Trials
Moderated by:
Ella Balasa, Patient, Advocate
Kai Bode, Principle Scientist, Preclinical Development, Merck
Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk
5:40PM - 5:45PM
Conference Concludes

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