Regulatory Science

DIA is currently seeking industry leaders to participate in and support a research study titled Understanding and measuring treatment tolerability of immune-oncology (I-O) treatment in selected cancers. Understanding tolerability as part of the development and delivery of I-O therapies is an integral part of including patient preference as mandated by the 21st Century Cures Act into programs and clinical decision-making. However, there are significant challenges with collecting information about tolerability from patients. For example, current definitions of tolerability are incomplete and there is little if any consensus about its definition. Furthermore, tools that can adequately measure patient-reported data are needed to facilitate the collection of robust, reliable, valid, interpretable tolerability data in clinical development.

To bridge this gap, DIA is establishing a Working Group including pharmaceutical organizations, regulatory representatives, patient advocacy representatives, oncologists, healthcare providers, researchers, and academia, among other subject matter experts to contribute to the understanding of tolerability for I-O in selected cancers and to develop guidance on:

Phase 1. Currently Launching! Landscape Research

Develop a comprehensive compilation of information on tolerability key concepts based on a literature review and interviews/focus groups’ inputs. For more information on the purpose of this effort, click here.

Phase 2. Develop or adapt a PRO instrument

Create an instrument for the measurement of treatment tolerability in a selected line of treatment in cancer.

To learn more about DIA’s Research projects, contact Science@DIAglobal.org

Think Tank- Regulatory System Innovation through Collaboration and Reliance

Reliance is considered the hallmark of a modern, efficient regulatory framework and a 21st-century regulatory tool, as it can effectively be used to focus resources and speed up approval timelines while strengthening regulatory systems.

At the margins of DIA Europe 2023, regulators from different regions and industry experts came together for a Workshop to discuss the practical aspects of collaboration and reliance. This workshop highlighted practical experiences by regulators from around the world and industry, leveraging case studies showing different collaborative and reliance pathways and discussing critical factors to identify effective reliance models that enable efficient use of resources and faster access to medicines. The breakout groups discussed: What are the gaps in information sharing to enable risk-based abridged reviews? Risk-Based Review - What is product sameness for you and what do you need it to be? How can we minimize country regulatory requirements that are not necessarily justified from the point of view of modern international regulatory science?

Key issues that had been identified as important enablers for regulatory reliance are:

• Global dossier submission vs complying with country-specific requirements
• Use of assessment reports containing confidential information
• Ensuring sameness of the product assessed in the reference country
• Efficient management of post-approval changes

For workshop highlights and the next steps, please refer to DIA Global Forum.

To access the final Outcomes report, click here.

To watch more content on this subject, check the recording of the DIA Europe 2023 “International Collaboration: Reliance in Action” DIAmond Session, here.