Virtual: Drug Information Association Annual Meeting 2021

Innovation Theater:

Accelerating Clinical Trial Recruitment: A New Path To Speed Enrollment

Kinetic Innovation Theater: Monday, 6/28/2021

12:00 午後 - 12:30 午後 ET

The operational expense of trials is both direct and opportunity. Reducing those costs often hinges on a key variable: speed to enrollment. The unique data + media environment in the high-impact, high-competition U.S. market gives us the ability to bend the curve of typical enrollment by increasing the number of trial candidates via an underutilized channel. In this presentation, Syneos Health will introduce and share cases about Digital Amplifier, an important lever in enrolling trials faster.

Presenter:

• Brooke Bellk, VP, Program Strategy 
• Claire Riches, SVP Global Client Solutions

Partnering to Innovate: The Way Forward for Decentralized Clinical Trials

DCT Innovation Theater: Tuesday, 6/29/2021

11:00 午前 - 11:30 午前 ET

Digital health technologies have the potential to increase efficiency and data capture, while creating exciting new ways to accelerate patient access, improve retention and increase diversity.  The use of these capabilities can reduce patient burden, streamline study operations and collect previously unobtainable data – including real world data – to help accelerate the discovery, development and approval of new products. But, we know there is no “one size – fits all” solution to decentralizing a clinical trial. Thoughtful orchestration and seamless integration of innovative solutions throughout each stage of the product development lifecycle results in solutions with the consistency and operational quality to deliver time after time.

Presenter:

• Scott Scarola, Vice President Decentralized solutions Operations 
• Noolie Gregory, Vice President of Decentralized Trial Operations 

Featured Sessions:

Forum | Developing, Implementing, and Operating REMS Programs 

Wednesday, 6/23/2021

9:30 午前 -12:30 午後 ET

Throughout the course, we cover lessons learned over the last decade of REMS implementation, and how implementation approaches continue to evolve to support safe use and product access, while reducing overall burden of REMS on the healthcare landscape.

Authors:

• Jemma Contreras
•  Melissa Landers

Panel | Is There a Role for Federal Incentives to Stimulate Greater Diversity in Clinical Trials?

Tuesday,  6/29/2021

4:00 午後 - 5:00 午後 ET

With combined experience running studies and drafting FDA rules, this panel will show why guidance on trial diversity has not produced results. 

Presenter:

• Stephen Keith

Panel | Using Real-World Data in Single-Arm Trials

Thursday, 7/01/2021

10:00 午前 ET

This exercise-based workshop will have case studies on different people management strategies, activities on self-awareness, role plays on diverse behaviors, and approaches to promote team-work. The participants will be encouraged to share their experiences on the specific situations. The activities will help participants to learn and develop skills to face stressful, pressure and conflicts and manage behaviors through role plays. Situations will include exercises on recognition and acknowledgement of oneself and others.

Presenter:

• David Thompson

Poster, ePoster available throughout DIA | Proactive/Prospective Feasibility Studies Trials

TBD

This presentation provides an overview of proactive global proactive feasibility assessments, to show how they can yield valuable information regarding rare disease patient recruitment and site selection for rare disease clinical trials as well as every other aspect of drug development and market access. We will discuss the pros and cons of using a proactive global feasibility approach and offer suggestions on how to improve the process based on the presenter’s experience when conducting such studies. Lastly, we will offer additional perspective on alternative tools in our feasibility armamentarium, such as digital patient identification methods.

Presenter:

• Ray Huml

Forum | Development of Shared System andn Shared REMS: Best Practices and Lessons Learned

Thursday, 7/01/2021

10:00 午前 -11:00 午前 ET

This forum will focus on best practices and lessons learned for the development and implementation of Shared REMS. These topics will be discussed from the perspectives of the FDA, leaders in industry, and other stakeholders

Presenter:

• Jemma Contreras
• Keven Holman 
• Kishore Gopu

Forum | CTTI: Quality by Design for Clinical Trials: A Hands-On, Multi-Stakeholder Workshop

Date:  Tuesday, 6/29/2021

2:00 午後 - 3:00 午後 ET

Apply new resources supporting key elements of quality by design (QbD), including capturing trial-specific factors that are critical to successful completion and safety, and proactively addressing risks of ‘errors that matter’. Design an organizational strategy for implementing QbD, including application of a maturity model and metrics framework to evaluate current state, identify priorities, and track progress.

Presenters: 

• Ansalan Stewart, FDA
• Dagmar Görtz, Janssen
• Helen Howitt, Syneos
• Zachary Hallinan, CTTI (chair)