DIA 2022 Global Annual Meeting

June 19-23, 2022 | Chicago, IL

The DIA 2022 Global Annual Meeting returns in-person to bring industry, regulators, academics, and patients together to co-create, problem-solve, and discuss global and local challenges facing professionals in the life sciences community. This year, DIA is offering the Global Annual Meeting as an in-person event hosted in the dynamic city of Chicago.

Join Avoca for the following sessions:

Wednesday, June 22 • 1:45pm – 2:45pm

#343: Redefining the Value Proposition for Innovation: Connecting Data, Technology, and Quality to Improve Outcomes

Clinical trialists have access to an enormous amount of structured and unstructured data originating from a variety of sources. One of the most significant challenges that biopharma organizations face is how to effectively harness this data to inform decision making and to improve clinical trial outcomes. Biopharma organizations are beginning to leverage technology such as Artificial Intelligence and Machine Learning and utilizing risk-based methods with the intention of driving greater efficiency, improving quality and achieving better outcomes. In this session, we will be exploring the intersection of technology, data and quality and the pursuit of driving higher quality across the clinical trial continuum. Case Studies focused on the use of AI/ML to enable better outcomes and risk-based approaches to manage data quality and improve signal detection will be presented by industry thought leaders in the areas of data science, technology and innovation.

Learning Objectives

Describe the intersection of technology, data and quality and the pursuit of driving higher quality across the clinical trial continuum; Implement AI/ML methods to enable better outcomes and risk-based approaches to manage data quality and improve signal detection.

Chair

Patricia Leuchten; WCG Avoca

Speakers

Mark Gregory Opler, PhD, MPH; WCG MedAvante-ProPhase
Joseph Geraci, PhD; Netramark Corp
Jonathan Rowe, PhD, MA, MS; ZS

Wednesday, June 22 • 4:15pm – 5:15pm

#373: Effective Oversight Strategies of CROs and Digital Technology Vendors: How to Comply with Health Authority Expectations

Increased Health Authority scrutiny of services outsourced to vendors delegated to execute clinical trial activities make it imperative that sponsors have a clear understanding of how to meet expectations for on-going vendor oversight of the sponsor’s delegation of services to their vendors – including risk-based quality management. Sponsors need a consistent global approach to select, contract, and provide oversight to an expanding variety of GCP vendors including CROs and those in digital technology and data acquisition (eCOA, etc.). During this session, speakers will review relevant changes to the FDA Compliance Program Manual updated September 2021, share insights about how sponsors can utilize a risk-based approach to vendor qualification, selection and auditing and how to use KPIs, quality metrics and analytics to monitor performance and identify potential quality issues.

Learning Objectives

Describe oversight of the CRO throughout the lifecycle of the engagement including risk-based approaches to vendor qualification and audits; Evaluate updates in the FDA Compliance Program Manual for CRO oversight published in September 2021; Identify data to analyze quality risks and resources needed to train and equip staff to conduct oversight of RBQM performed by a CRO.

Chair

Linda Sullivan, MBA; WCG Avoca

Speakers

Liz Wool, BSN; Wool Consulting Group
Joseph Gotowko, MBA, PMP; Exelixis
Stacey L Basham; AbbVie

Thursday, June 23 • 10:00am – 11:00am

#409: How to Build and Support a Culture that Values Critical Thinking and Open, Proactive Dialogue About Quality

The newly adopted ICH E8(R1), section 3.3.1 encourages organizations to “create a culture that values and rewards critical thinking and open, proactive dialogue about what is critical to quality for a particular study or development program, going beyond sole reliance on tools and checklists.” This has generated many questions across the industry including: what is a culture of quality, how can organizations encourage and reward quality cultural behaviors, and how can organizations to measure and monitor quality culture? This session will explore how organizations are cultivating an environment that fosters critical thinkers, why quality culture should be an elemental attitude integrated in organizational structures and behaviors and how to measure, monitor and support desired quality culture behaviors.

Learning Objectives

Discuss the key components and success factors of a culture of quality; Describe three culture of quality enablers and how to apply them successfully to clinical development activities; Determine metrics for monitoring quality culture and how to analyze them and define action plans.

Chair

Linda Sullivan, MBA; WCG Avoca

Speakers

Dagmar Goertz; Janssen-Cilag
Michael Torok, PhD; Astellas
Leslie Sam; Leslie Sam and Associates