Fierce Clinical Summit 2024

8:00am EDT

Attendee Registration and Networking Breakfast

9:00am EDT

Workshop A: Analytical Approaches to Measuring Quality: From Theory to Practical Implementation Workshop B: TBA

12:00pm EDT

Networking Lunch

1:00pm EDT

Workshop D: Innovation Day & Afternoon Reception Presented by IQVIA Technologies

1:30pm EDT

Workshop C: TBA

4:30pm EDT

Networking Reception

5:30pm EDT

Workshop Day Concludes

7:45am EDT

Registration and Networking Breakfast

8:30am EDT

Chairperson’s Opening Remarks

8:45am EDT

Keynote: Modernizing Clinical Trials for the Next Era of Drug Development

9:15am EDT

Presentation: TBA

9:45am EDT

Keynote Panel: Strategies to Improve Diversity, Equity and Inclusion in Oncology Clinical Trials

10:30am EDT

Networking Break

11:00am EDT

Keynote Panel: Can Patients Derisk Clinical Trial Innovation?

11:45am EDT

Panel Discussion with IQVIA

12:30pm EDT

Networking Lunch

1:30pm EDT

Clinical Operations Track - Chairperson’s Opening Remarks Clinical Quality Track - Chairperson’s Opening Remarks DCT & Technology Track - Chairperson’s Opening Remarks Medical Writing Track - Chairperson’s Opening Remarks

1:45pm EDT

Being Comfortable with the Uncomfortable: Integration of a Site Engagement Function Building a Framework for Efficient Health Authority Inspections Designing Disease Area DCT Approaches Navigating a Global Medical Writing Vendor Transition

2:15pm EDT

Financial Empowerment: Fueling Site and Patient Engagement for Successful Clinical Trials Optimizing Sponsor-provided Technology to Become Inspection Ready Presentation: TBA Presentation: TBA

2:45pm EDT

Panel: Explore the Potential of AI in Clinical Trial Operations Panel: Unlocking Value: Integrating RBQM End-to-End Panel Discussion: TBA Panel : Health Literacy in Clinical Research to Drive Patient Engagement

3:30pm EDT

Networking Break

4:00pm EDT

From Partnership to Performance: Using a Sponsor-CRO Partnership to Overcome Resource Restraints in Building Site Engagement The Astellas-CSU PharmD Industry Rotation Partnership Toward Excellence: Technology Standards Redefining Modern Trials Evolution of Clinical Medical Writing and Publications: A Small Biotech Perspective

4:30pm EDT

Presentation: TBA Presentation: TBA Presentation: TBA Presentation: TBA

5:00pm EDT

Panel: Optimizing Clinical Trials Post-Pandemic Through Efficient Trial Design Panel: Navigating the New Normal of Inspection Readiness Panel Discussion: TBA Panel: Innovative Ideas to Sustain and Grow Cross-Functional Relationships Between Sponsor and Medical Writing Service Providers

5:45pm EDT

Networking Reception

6:45pm EDT

Day 1 of Summit Concludes

7:45am EDT

Registration and Networking Breakfast

8:30am EDT

Chairperson’s Opening Remarks

8:45am EDT

9:15am EDT

Presentation: TBA

9:45am EDT

Keynote Panel: Transforming Clinical Trials: Integrating People, Processes, and Technology for Next-Generation Biopharma Innovation

10:30am EDT

Networking Break

11:00am EDT

Building an Optimized Clinical Study Delivery Engine

11:30am EDT

Presentation: TBA

12:00pm EDT

Panel Discussion: TBA

12:45pm EDT

Networking Lunch

1:45pm EDT

Clinical Operations Track - Chairperson’s Opening Remarks Clinical Quality Track - Chairperson’s Opening Remarks DCT & Technology Track - Chairperson’s Opening Remarks Medical Writing Track - Chairperson’s Opening Remarks

2:00pm EDT

Practical Applications of Analytical Technology for Regulatory Submissions Risky Business – Like the 80s Film But Different From Theory to Action in Decentralized Trials: Reshaping Assumptions for Long-Term Adoption Exploring Emerging Regulatory Guidance on Technology Innovations in Clinical Research

2:30pm EDT

Presentation: TBA Presentation: TBA Presentation: TBA Presentation: TBA

3:00pm EDT

Panel: Ensuring Data Reliability Under the New ICH E6(R3) Guidelines Panel: A Risk-Based Approach to Vendor Management in an Evolving Regulatory Landscape Panel: Leveraging Investigator and Site Engagement to Drive Patient Recruitment and Decentralized Clinical Trial Success Panel Discussion: TBA

3:45pm EDT

Summit Concludes