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Mobile in Clinical Trials

Date: Sep 16, 2024

Location: Philadelphia, PA

Day: Monday, September 16, 2024
Showing Events in 1 Track from 07:45am to 09:45am
Morning General Session
7:45AM - 8:15AM
Registration
8:25AM - 8:35AM
Co-Chair’s Welcome
Co-Chairs:
Mackenzie Abramson, MPH, Patient Advocate and Sr. Manager, Research Program Communications, Global Genes
Kai Bode, Principle Scientist, Preclinical Development, Merck
Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk
8:35AM - 9:05AM
What Patients Really Want (or Don’t Want): Preferences and Needs for Digital Technologies in Clinical Trials
Panelists:
Mackenzie Abramson, MPH, Patient Advocate and Sr. Manager, Research Program Communications, Global Genes
Patrick Gee Sr, PhD, JLC, Patient Advocate, Founder & Chief Executive Hope Dealer, iAdvocate, Inc
Celline Mitchell, Patient Advocate & Clinical Research Assistant, Randomize Now
Rucha Shah, Patient Advocate, and Assistant Clinical Research Project Manager, ECOG-ACRIN Cancer Research Group
9:05AM - 9:35AM
Site Perspectives on Navigating Adoption Hurdles with Mobile Tech to Enhance Clinical Trial Recruitment and Retention
Panelists:
Jillian Agnew, RN, CCRC, Clinical Research Coordinator, St Johns Center for Clinical Research
Mahasweta Dutt, MS, MRA, CCRC, Associate Director- Clinical Research Operations, Office of Clinical Research, Penn Medicine
Rucha Shah, Patient Advocate, and Assistant Clinical Research Project Manager, ECOG-ACRIN Cancer Research Group
Moderator:
Marie Emms, Head, Patient Engagement and Recruitment, BMS
9:35AM - 9:45AM
Open Q&A with Patients and Sites on DHTs in Clinical Trials
Led by:
Mackenzie Abramson, MPH, Patient Advocate and Sr. Manager, Research Program Communications, Global Genes
Kai Bode, Principle Scientist, Preclinical Development, Merck
Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk
Showing Events in 1 Track from 09:45am to 10:15am
Grand Opening Break and Networking
9:45AM - 10:15AM
Grand Opening Break and Networking
Showing Events in 1 Track from 10:15am to 12:05pm
Morning General Session Continued
10:15AM - 10:45AM
Next Generation Investment to Support Patients and Sites Remotely in Clinical Trials - Navigating the Landscape and Practical Steps for Success
Moderator:
Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk
Panelists:
Kurt Lumsden, VP Study Operations, Hawthorne Effect, Inc.
Amanda Moore, Vice President, Program Leadership and Clinical Operations, Abeona Therapeutics
Casey Orvin, Chief Commercial Officer, Alcanza Clinical Research, LLC
Zak Smith, Senior Data Scientist, Tufts Center for the Study of Drug Development
10:45AM - 11:25AM
Interactive Session: Working Through Key Challenges in Implementing Mobile Technology Options for Patients to Expand Access and Optimize Trial Outcomes
Led by:
Mackenzie Abramson, MPH, Patient Advocate and Sr. Manager, Research Program Communications, Global Genes
Ebony Dashiell-Aje, PhD, Executive Director, Patient Centered Outcomes Science (PCOS), BioMarin Pharmaceutical Inc
11:25AM - 12:05PM
Annual Technology Showcase and Demos
Led by:
Kai Bode, Principle Scientist, Preclinical Development, Merck
Participants:
Geoff Gill, CEO, Verisense Health, Inc.
Matthew Jones, Director of Product Management, Spencer Health Solutions
Anthony Mikulaschek, VP, Commercialization, IQVIA Patient Suite
Wessam Sonbol, CEO, Delve Health
Participating Companies:
Showing Events in 1 Track from 12:05pm to 01:05pm
Lunch and Networking
12:05PM - 1:05PM
Lunch and Networking
Showing Events in 2 Tracks from 01:05pm to 01:40pm
Track 1: AI Integration in Mobile Tech Panel
Track Chair:
Dan Eversole, PhD, Associate Director, Digital Strategy, Takeda
1:05PM - 1:40PM
How can AI be Utilized in Mobile Technologies and What's Next?
Led by:
Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk
Track 2: New Novel Endpoints & Digital Biomarkers Panel
1:05PM - 1:40PM
Panel: Adopting New Novel Endpoints and Digital Biomarkers via Wearable Devices
Moderator:
Stephen Ruhmel, MPH, Clinical Strategy Lead for Digital Endpoints, Sanofi
Panelists:
Melissa Ceruolo, VP, Biomarker Analytics, Medidata
Bharat Koyani, Associate Director, Digital Biomarker, Regeneron
Katerina Placek, PhD, Senior Manager, Digital Health Sciences, Takeda
Hao Zhang, PhD, MBA, Director, Digital Healthcare Innovation, Mitsubishi Tanabe Pharma America
Showing Events in 1 Track from 01:40pm to 03:55pm
Afternoon Track Choices
1:40PM - 3:55PM
Two Track Choices: Case Studies Demonstrating the Impact of Mobile Technologies on Patient Support in Clinical Trials
Participating Companies:
Showing Events in 2 Tracks from 01:40pm to 02:20pm
Track 1
Track Chair:
Dan Eversole, PhD, Associate Director, Digital Strategy, Takeda
1:40PM - 2:00PM
Moderna: The Impact of Mobile/Digital Tech in Pediatric Trials
Speaker:
Mackenzie McKinney, Sr. Manager, Patient Centricity, Moderna
2:00PM - 2:20PM
Chiesi Farmaceutici: Patient and Provider Insights from Decentralized Trials in Respiratory to Help Shape the Future of Patient-Centric Research
Speaker:
Eva Topole, MD, Clinical Digital Health and Innovation Lead, Chiesi Farmaceutici S.p.A
Track 2
1:40PM - 2:00PM
AstraZeneca: New Thinking in Reaching More Communities Remotely
Speakers:
Eileen Babcock, PA-C, MBA, Senior Director of Clinical Operations, AstraZeneca
Maria Jison, MD, Global Clinical Head, AstraZeneca
2:00PM - 2:20PM
Pfizer Case Study
Speaker:
Christopher Dell, MBA, Senior Manager of Patient Solutions, Pfizer
Showing Events in 1 Track from 02:35pm to 03:00pm
Afternoon Break and Networking
2:35PM - 3:00PM
Afternoon Break and Networking
Showing Events in 2 Tracks from 03:00pm to 03:40pm
Track 1 Continued
3:00PM - 3:20PM
GSK: Tailoring Digital Implementation for Patient-Centric Trials
Speaker:
Brandon Maggio, Director, Digital & Process Optimization, GSK
3:20PM - 3:40PM
Merck: Advancing Clinical Trials Through Digital Accessibility - Strategies for Inclusive Design
Speaker:
Stephen Framil, DMA, Corporate Global Head of Accessibility, Merck
Track 2 Continued
3:00PM - 3:20PM
BMS: Rethinking Technology in Clinical Trials: Empowering Omni-Channel Collaboration to Reduce Site and Sponsor Burden
Speaker:
McKenzie Maddox, IT Business Analyst, Patient & Site Engagement, Drug Development IT, BMS
3:20PM - 3:40PM
Clemson Rural Health: Scaling Mobile Health Units for Clinical Trials - Bridging Healthcare Gaps
Speakers:
Kristie Boswell, DNP, APRN, FNP-C, Assistant Director, Mobile Operations, Clemson Rural Health, Clemson University
Jeremy Shields, Clinical Research Associate, Clemson Rural Health, Clemson University
Showing Events in 1 Track from 03:55pm to 05:45pm
Afternoon General Session
3:55PM - 4:00PM
Attendees Return to General Session for Afternoon Sessions
4:00PM - 4:40PM
Demonstrating the Value and ROI of Digital Technologies in Trials
Moderator:
Zak Smith, Senior Data Scientist, Tufts Center for the Study of Drug Development
Panelists:
Jakob Alme, Director, Digital Innovation, Sage Therapeutics
Greg Christie, Chief Product Officer, StudyKIK, a Syneos Health Company
Christina Fawcett, Director of Digital Health Delivery, GSK
Alex Simmonds, MBA, Drug Development Innovation Lead, BMS
Edward Triebell, MBA, Commercial Executive Director, MRN Technologies
4:40PM - 5:20PM
Addressing Globalization Challenges in Digital Health Technologies (DHTs) Implementation
Moderator:
Hao Zhang, PhD, MBA, Director, Digital Healthcare Innovation, Mitsubishi Tanabe Pharma America
Panelists:
Sandeep Bhat, Digital Engagement Lead, Global Clinical Operations, GSK
Sid Jain, VP, Global Development Data Science & Digital Health, Johnson & Johnson Innovative Medicine
Madelaine MacKay, Sr Director, eClinical Development & Delivery, ICON plc
5:20PM - 5:45PM
FDA Guidance and New Agency Initiatives on Digital Health Technologies in Clinical Trials
Speaker:
Leonard Sacks, MD, Acting Deputy Director, Office of Medical Policy, CDER, FDA
Showing Events in 1 Track from 05:45pm to 05:50pm
End of Conference
5:45PM - 5:50PM
End of Conference
Showing Events in 1 Track from 07:45am to 09:45am
Morning General Session
7:45AM - 8:15AM
Registration
8:25AM - 8:35AM
Co-Chair’s Welcome
Co-Chairs:
Mackenzie Abramson, MPH, Patient Advocate and Sr. Manager, Research Program Communications, Global Genes
Kai Bode, Principle Scientist, Preclinical Development, Merck
Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk
8:35AM - 9:05AM
What Patients Really Want (or Don’t Want): Preferences and Needs for Digital Technologies in Clinical Trials
Panelists:
Mackenzie Abramson, MPH, Patient Advocate and Sr. Manager, Research Program Communications, Global Genes
Patrick Gee Sr, PhD, JLC, Patient Advocate, Founder & Chief Executive Hope Dealer, iAdvocate, Inc
Celline Mitchell, Patient Advocate & Clinical Research Assistant, Randomize Now
Rucha Shah, Patient Advocate, and Assistant Clinical Research Project Manager, ECOG-ACRIN Cancer Research Group
9:05AM - 9:35AM
Site Perspectives on Navigating Adoption Hurdles with Mobile Tech to Enhance Clinical Trial Recruitment and Retention
Panelists:
Jillian Agnew, RN, CCRC, Clinical Research Coordinator, St Johns Center for Clinical Research
Mahasweta Dutt, MS, MRA, CCRC, Associate Director- Clinical Research Operations, Office of Clinical Research, Penn Medicine
Rucha Shah, Patient Advocate, and Assistant Clinical Research Project Manager, ECOG-ACRIN Cancer Research Group
Moderator:
Marie Emms, Head, Patient Engagement and Recruitment, BMS
9:35AM - 9:45AM
Open Q&A with Patients and Sites on DHTs in Clinical Trials
Led by:
Mackenzie Abramson, MPH, Patient Advocate and Sr. Manager, Research Program Communications, Global Genes
Kai Bode, Principle Scientist, Preclinical Development, Merck
Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk
Showing Events in 1 Track from 09:45am to 10:15am
Grand Opening Break and Networking
9:45AM - 10:15AM
Grand Opening Break and Networking
Showing Events in 1 Track from 10:15am to 12:05pm
Morning General Session Continued
10:15AM - 10:45AM
Next Generation Investment to Support Patients and Sites Remotely in Clinical Trials - Navigating the Landscape and Practical Steps for Success
Moderator:
Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk
Panelists:
Kurt Lumsden, VP Study Operations, Hawthorne Effect, Inc.
Amanda Moore, Vice President, Program Leadership and Clinical Operations, Abeona Therapeutics
Casey Orvin, Chief Commercial Officer, Alcanza Clinical Research, LLC
Zak Smith, Senior Data Scientist, Tufts Center for the Study of Drug Development
10:45AM - 11:25AM
Interactive Session: Working Through Key Challenges in Implementing Mobile Technology Options for Patients to Expand Access and Optimize Trial Outcomes
Led by:
Mackenzie Abramson, MPH, Patient Advocate and Sr. Manager, Research Program Communications, Global Genes
Ebony Dashiell-Aje, PhD, Executive Director, Patient Centered Outcomes Science (PCOS), BioMarin Pharmaceutical Inc
11:25AM - 12:05PM
Annual Technology Showcase and Demos
Led by:
Kai Bode, Principle Scientist, Preclinical Development, Merck
Participants:
Geoff Gill, CEO, Verisense Health, Inc.
Matthew Jones, Director of Product Management, Spencer Health Solutions
Anthony Mikulaschek, VP, Commercialization, IQVIA Patient Suite
Wessam Sonbol, CEO, Delve Health
Participating Companies:
Showing Events in 1 Track from 12:05pm to 01:05pm
Lunch and Networking
12:05PM - 1:05PM
Lunch and Networking
Showing Events in 2 Tracks from 01:05pm to 01:40pm
Track 1: AI Integration in Mobile Tech Panel
Track Chair:
Dan Eversole, PhD, Associate Director, Digital Strategy, Takeda
1:05PM - 1:40PM
How can AI be Utilized in Mobile Technologies and What's Next?
Led by:
Adama Ibrahim, MBA, VP, Digital Strategy and Change Management, Novo Nordisk
Track 2: New Novel Endpoints & Digital Biomarkers Panel
1:05PM - 1:40PM
Panel: Adopting New Novel Endpoints and Digital Biomarkers via Wearable Devices
Moderator:
Stephen Ruhmel, MPH, Clinical Strategy Lead for Digital Endpoints, Sanofi
Panelists:
Melissa Ceruolo, VP, Biomarker Analytics, Medidata
Bharat Koyani, Associate Director, Digital Biomarker, Regeneron
Katerina Placek, PhD, Senior Manager, Digital Health Sciences, Takeda
Hao Zhang, PhD, MBA, Director, Digital Healthcare Innovation, Mitsubishi Tanabe Pharma America
Showing Events in 1 Track from 01:40pm to 03:55pm
Afternoon Track Choices
1:40PM - 3:55PM
Two Track Choices: Case Studies Demonstrating the Impact of Mobile Technologies on Patient Support in Clinical Trials
Participating Companies:
Showing Events in 2 Tracks from 01:40pm to 02:20pm
Track 1
Track Chair:
Dan Eversole, PhD, Associate Director, Digital Strategy, Takeda
1:40PM - 2:00PM
Moderna: The Impact of Mobile/Digital Tech in Pediatric Trials
Speaker:
Mackenzie McKinney, Sr. Manager, Patient Centricity, Moderna
2:00PM - 2:20PM
Chiesi Farmaceutici: Patient and Provider Insights from Decentralized Trials in Respiratory to Help Shape the Future of Patient-Centric Research
Speaker:
Eva Topole, MD, Clinical Digital Health and Innovation Lead, Chiesi Farmaceutici S.p.A
Track 2
1:40PM - 2:00PM
AstraZeneca: New Thinking in Reaching More Communities Remotely
Speakers:
Eileen Babcock, PA-C, MBA, Senior Director of Clinical Operations, AstraZeneca
Maria Jison, MD, Global Clinical Head, AstraZeneca
2:00PM - 2:20PM
Pfizer Case Study
Speaker:
Christopher Dell, MBA, Senior Manager of Patient Solutions, Pfizer
Showing Events in 1 Track from 02:35pm to 03:00pm
Afternoon Break and Networking
2:35PM - 3:00PM
Afternoon Break and Networking
Showing Events in 2 Tracks from 03:00pm to 03:40pm
Track 1 Continued
3:00PM - 3:20PM
GSK: Tailoring Digital Implementation for Patient-Centric Trials
Speaker:
Brandon Maggio, Director, Digital & Process Optimization, GSK
3:20PM - 3:40PM
Merck: Advancing Clinical Trials Through Digital Accessibility - Strategies for Inclusive Design
Speaker:
Stephen Framil, DMA, Corporate Global Head of Accessibility, Merck
Track 2 Continued
3:00PM - 3:20PM
BMS: Rethinking Technology in Clinical Trials: Empowering Omni-Channel Collaboration to Reduce Site and Sponsor Burden
Speaker:
McKenzie Maddox, IT Business Analyst, Patient & Site Engagement, Drug Development IT, BMS
3:20PM - 3:40PM
Clemson Rural Health: Scaling Mobile Health Units for Clinical Trials - Bridging Healthcare Gaps
Speakers:
Kristie Boswell, DNP, APRN, FNP-C, Assistant Director, Mobile Operations, Clemson Rural Health, Clemson University
Jeremy Shields, Clinical Research Associate, Clemson Rural Health, Clemson University
Showing Events in 1 Track from 03:55pm to 05:45pm
Afternoon General Session
3:55PM - 4:00PM
Attendees Return to General Session for Afternoon Sessions
4:00PM - 4:40PM
Demonstrating the Value and ROI of Digital Technologies in Trials
Moderator:
Zak Smith, Senior Data Scientist, Tufts Center for the Study of Drug Development
Panelists:
Jakob Alme, Director, Digital Innovation, Sage Therapeutics
Greg Christie, Chief Product Officer, StudyKIK, a Syneos Health Company
Christina Fawcett, Director of Digital Health Delivery, GSK
Alex Simmonds, MBA, Drug Development Innovation Lead, BMS
Edward Triebell, MBA, Commercial Executive Director, MRN Technologies
4:40PM - 5:20PM
Addressing Globalization Challenges in Digital Health Technologies (DHTs) Implementation
Moderator:
Hao Zhang, PhD, MBA, Director, Digital Healthcare Innovation, Mitsubishi Tanabe Pharma America
Panelists:
Sandeep Bhat, Digital Engagement Lead, Global Clinical Operations, GSK
Sid Jain, VP, Global Development Data Science & Digital Health, Johnson & Johnson Innovative Medicine
Madelaine MacKay, Sr Director, eClinical Development & Delivery, ICON plc
5:20PM - 5:45PM
FDA Guidance and New Agency Initiatives on Digital Health Technologies in Clinical Trials
Speaker:
Leonard Sacks, MD, Acting Deputy Director, Office of Medical Policy, CDER, FDA
Showing Events in 1 Track from 05:45pm to 05:50pm
End of Conference
5:45PM - 5:50PM
End of Conference

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