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Day Two - CET/CEST (Cent Europe Summer, GMT+2)
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Day Two - CET/CEST (Cent Europe Summer, GMT+2)
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08:45 - 09:15
Morning Coffee
Showing 4 of 4 Streams
SEMINAR 1: OPERATIONS
SEMINAR 2: TECHNOLOGY & INNOVATION
SEMINAR 3: OUTSOURCING & PARTNERING
SEMINAR 4: Boardroom Discussions
09:15 - 09:30
Opening Remarks
- Behtash Bahador - Director, Health Literacy, Center for Information & Study on Clinical Research Participation (CISCRP), USA
09:30 - 10:00
Context of Use for Wearable Technology – Establishing a Digital Biomarker as a Recognized End Point for Clinical Development
- Hui Zhang - Executive Director, Digital Office, Eli Lilly & Co.
10:00 - 10:30
Personalizing Engagement Strategies Based on Site Performance
- Ashley Wills - Senior Director, Clinical and Medical Data, Analytics, and Insights, Mirati Therapeutics
10:30 - 11:00
Please move to another track
09:15 - 09:30
Opening Remarks
- Nancy Meyerson-Hess - Quality Management GCP, Lindis Biotech GmBh
09:30 - 10:00
Context of Use for Wearable Technology – Establishing a Digital Biomarker as a Recognized End Point for Clinical Development
- Hui Zhang - Executive Director, Digital Office, Eli Lilly & Co.
10:00 - 10:30
Decentralised Trails Designed for Chronic Conditions
- Paul Bodfish - Consultant, Medical Research Network
10:30 - 11:00
How to leverage clinical technology integrations and automation to make a positive difference for trial sites, patients and sponsors
- Fred Sibeaud - Director, Data Management, IQVIA Technologies
- Kevin Landalls - VP & GM, IRT, IQVIA Technologies
09:15 - 09:30
Opening Remarks
- Ignacio (Iggy) Handal - Chief Executive Officer, CLINICOM (& Winner of the 2022 Christine Pierre Clinical Trials Lifetime Achievement Award)
09:30 - 10:00
VIRTUAL: FDA Diversity Plan – Sponsor Case Study
- LaShell Robinson - Senior Director, Head Diversity, Equity & Inclusion in Clinical Research, Takeda Pharmaceuticals
10:00 - 10:30
Impact Results from Mobile Community Education Engagement Initiative on Perceptions and Behaviors Related to Clinical Research Among Underserved Populations: Leveraging Learnings to Inform your Clinical Trial Diversity Plans
- Behtash Bahador - Director, Health Literacy, Center for Information & Study on Clinical Research Participation (CISCRP), USA
10:30 - 11:00
Why your outsourcing partnership model should be as agile as your clinical development plan
- Neil Berger - Vice President, FSP Commercial and Operational Strategy, Parexel
09:15 - 11:00
(VIP Meeting Area) - Boardroom Discussion Session: Global Sourcing and Procurement
- Julianne Hull - CEO, WenStar Enterprises
11:00 - 11:45
Morning Coffee & Networking
Showing 3 of 3 Streams
SEMINAR 1: OPERATIONS
SEMINAR 2: TECHNOLOGY & INNOVATION
SEMINAR 3: OUTSOURCING & PARTNERING
11:45 - 12:15
The Netherlands: European hub for your clinical research
- Peter Gisberts - Director U-TRIAL the Utrecht Trial Innovation Alliance & THINC. Healthcare, UMC Utrecht
12:15 - 13:00
PANEL: Collaboration Models to Drive Meaningful Innovation
- Piper Fromy - Program Lead, Digital Measures Development, Digital Medicine Society (DiMe)
- Paul Bouten - Consultant Clinical Sourcing Manager, PharmCMed
11:45 - 12:15
VIRTUAL: Regulatory Considerations in Digital Clinical Innovation: A Risk Based Approach
- Sarah Bilali - Director, Global Regulatory Affairs Devices, UCB
12:15 - 13:00
PANEL: Trying to Define what AI Actually Means in Clinical Trials
- Himanshu Joshi - Assistant Professor, Institute for Healthcare Delivery Science, Mount Sinai Health System
- Prasanna Rao - Senior Director, Global Head of AI/ML, Clinical Data Sciences, Global Product Development, Pfizer
- Hui Zhang - Executive Director, Digital Office, Eli Lilly & Co.
- Sarah Bilali - Director, Global Regulatory Affairs Devices, UCB
- Rohit Nambisan - Chief Executive Officer & Founder, Lokavant
11:45 - 12:15
Pre-Competitive Collaboration to Enable Digital Transformation
- Piper Fromy - Program Lead, Digital Measures Development, Digital Medicine Society (DiMe)
12:15 - 13:00
PANEL: Collaboration Models to Drive Meaningful Innovation
- Piper Fromy - Program Lead, Digital Measures Development, Digital Medicine Society (DiMe)
- Paul Bouten - Consultant Clinical Sourcing Manager, PharmCMed
13:00 - 14:05
Lunch & Networking
Showing 4 of 4 Streams
SEMINAR 1: OPERATIONS
SEMINAR 2: TECHNOLOGY & INNOVATION
SEMINAR 3: OUTSOURCING & PARTNERING
SEMINAR 4: Boardroom Discussions
14:05 - 14:15
Opening Remarks
- Behtash Bahador - Director, Health Literacy, Center for Information & Study on Clinical Research Participation (CISCRP), USA
14:15 - 14:45
Advanced Therapy Spotlight: How are Outsourcing Models Changing to Make Way for Innovative Therapies
- Kevin Zikaras - Vice President, Clinical Development Operations, TCR2 Therapeutics Inc.
14:45 - 15:15
Evaluation of PK in DCT
- Tsvetelina Ivanova - Chief Compliance Officer, Comac Medical Ltd.
14:05 - 14:15
Opening Remarks
- Nancy Meyerson-Hess - Quality Management GCP, Lindis Biotech GmBh
14:15 - 14:45
Digital Health in the Circular Economy
- Jason LaRoche - Director| Focus Area Leader: Environmental Sustainability in Clinical Research, Janssen Clinical Innovation
14:45 - 15:15
Wearables, Digital Measures and Continuous Monitoring
- Joss Langford - Chief Technology Officer, Activinsights
14:05 - 14:15
Opening Remarks
- Roger Legtenberg - Senior Partner, Partners for Patients, admedicum GmbH & Co KG
14:15 - 14:45
Approaches to Enhance Generalizability of Clinical Trials: Real-World Data, Novel Designs and Digital Solutions
- Demissie Alemayehu - Adjunct Professor, Columbia University
14:45 - 15:15
Please move to another track
14:05 - 15:15
(VIP Meeting Area) - Boardroom Discussion Session: Can We Sustain Adoption of Trial Innovation in the Current Economic Environment?
- Craig Lipset - Founder & Advisor, Clinical Innovation Partners
- Francesca Properzi - Director of Research, DT Consulting
15:15 - 15:45
Afternoon Coffee, Networking & Self Massage Workshop
Late Afternoon Session
Showing 3 of 3 Streams
SEMINAR 1: OPERATIONS
SEMINAR 2: TECHNOLOGY & INNOVATION
SEMINAR 3: OUTSOURCING & PARTNERING
15:45 - 16:15
Change Orders in Clinical Trials
- Peter Theisohn - VP Resource Management in Clinical Development & Operations, Bayer-Pharma R&D, Bayer
15:45 - 16:15
Novel Approaches to Ensuring Quality while Maximising Resource
- Nancy Meyerson-Hess - Quality Management GCP, Lindis Biotech GmBh
15:45 - 16:15
Please move to another track
16:15 - 16:20
End of Conference
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