The DIA 2020 community just completed another full day of meaningful dialogue – virtually! This year’s conference offers attendees and the industry the opportunity for new digital learning options. Today we are highlighting several on-demand educational sessions featuring IQVIA’s thought leaders. We hope these recaps help to continue important conversations about advancing human health in tangible ways today and in the future:
- “Combination Therapies of Investigational Agents,” included Katie Laessig, MD, vice president of Therapeutic Strategy for Design and Delivery Innovation, as a panelist. Given this area requires layers of technical and regulatory consideration, Katie and fellow medical professionals educated the audience on a realm of requirements needed to support the development of combination therapies of investigational drugs, such as how to determine optimal regimen in the combination dose escalation. Katie and the panel focused on relevant U.S.-specific regulations as they discussed examples from case studies of the types of supporting evidence needed to commercially register these combination products.
- For the “Impact of Advanced Data Analytics Capabilities on Quality and Compliance Activities” forum, a panel of data and analytics experts, including Rajneesh Patil, senior director, Clinical Operations at IQVIA, spoke about how to apply data analytics techniques to enhance quality control of clinical research. Rajneesh shed light on the value of implementing artificial intelligence and machine learning solutions to better assess site risk and compliance in research. These models support important early detection of safety signals and offering predictive models for adverse event patterns and risks, which in turn leads to enhanced data quality and quicker and better decision-making with patient safety in mind.
- During a session simply titled “Wearables,” Sabrina Steffen, senior director, Data Management Innovation, Data Sciences, Safety & Regulatory, IQVIA, co-led a discussion exploring the legal, regulatory and practical issues surrounding the use of wearables and related data use in clinical practice. Sabrina laid out the numerous ways this data can be used in practice — from trials to patient monitoring to early diagnosis — and all the challenges to consider for innovators, including patient consent processes and legal and regulatory frameworks.
- Uwe Trinks, Global Practice lead, IQVIA, joined the on-demand panel “Data Related International Policy and Strategy: EudraVigilance Database (EVDAS)” to discuss the regulatory perspective regarding the use of EVDAS to further evaluate validated signals and solutions for handling data from this large database. The session also shared key elements critical to pharmaceutical companies’ compliance with the European General Data Protection Regulation, which protects personal data.
Additionally, several IQVIA subject matter experts are sharing their research and insights in the Professional Poster E-Gallery:
- PP07-54: Global Pharmacovigilance Strategic Management and Oversight: Study of a Partnership Model by Anand Haruger, director, Service Operations, Pharmacovigilance Project Leadership and Strategic Solutions
- PP02-25: Socio-Ecological Elements Involved in Racial and Ethnic Minority Recruitment Practices for Industry-Sponsored Clinical Trials by Becky Johnson, associate director, Global Patient and Site Solutions Strategy
- PP12-89: Reimbursement of Orphan Drugs in EU-5 between 2010-2019: A Landscape Assessment by Tulika Paul, associate consultant
Here we are at the end of another jam-packed, insightful day at the virtual DIA 2020 Annual Meeting, covering topics that help the industry from trial design and planning all the way through to commercialization. And there’s still more to come, so stay tuned!
For DIA 2020 attendees and others interested in connecting with IQVIA thought leaders at the conference, please visit the IQVIA virtual booth or contact us here. Let’s keep the conversations around advancing human health moving forward together.