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DIAmond Sessions

Conversations on Today's Priorities

Hear from the top thought-leaders on global, interdisciplinary topics about the future of therapeutics, and how they affect you. Our DIAmond Sessions will bring together innovators from industry, academia, and government agencies to discuss key concepts, and have a conversation on today’s priorities.

  • Major European Regulatory Science Challenges

    March 30, 9:00AM - 10:30AM

    The commitment for enabling early patient access to new innovative medicines is one of the major challenges in regulatory science. From a regulator’s perspective, early access tools are in place in the EU and the US in order to support early approval. In addition, real world evidence (RWE) presents a significant opportunity to improve regulatory decision making. Technological advances permit collection of real world data (RWD) from an increasing number of sources like patient registries and electronic patient records etc., while new artificial Intelligence approaches permit to translate these data into RWE. This cross functional DIAmond session will discuss opportunities and challenges from the regulator (EU and US), industry and patient perspective.

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  • Current Trends and Solutions in Global Clinical Operations

    March 30, 9:00AM - 10:30AM

    Precision medicine targets better-defined (but smaller) populations and more drugs get developed in these smaller populations. Orphan drug designations (FDA) increased steadily from 195 in 2010 to 354 in 2015, which created new challenges from site and subject identification to subject adherence and retention. Patient-centricity is finally understood as a key to success in clinical development, and multiple concepts, from registries to focus groups, become a standard in development concepts.

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  • Global Regulatory Convergence

    March 31, 9:00AM - 10:30AM

    The session will provide examples of initiatives undertaken by regulators to support innovative drug development and regulatory science-based decision making, and will present initiatives with enhanced patient perspectives on the medicines R&D processes of the treatment development life cycle. We will also explore the views from a patient group, FDA, and EMA on the impact of regulatory convergence and ways forward to maintain sustainable global drug development and an effective regulatory process.

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  • Clinical Development Partnering 2.0

    March 31, 9:00AM - 10:30AM

    Our Industry is celebrating some amazing achievements - pharmaceutical organisations are spending more than ever on R&D, product pipelines have nearly doubled in the past 10 years, and innovation is being highlighted every single day. Despite these successes, clinical research remains costly and inefficient. Site Investigators continue to face significant challenges in working with CROs and Sponsors. Could collaboration drive the change so desperately needed in the industry? This session will explore the efforts underway between three industry organisations that are working together to reduce administrative burdens placed on investigator sites, and increase study success. Please join leaders from the Society for Clinical Research Sites (SCRS), The Association of Clinical Research Organizations (ACRO) and TransCelerate BioPharma, Inc. to better understand solutions that will address protocol complexity, monitoring structures, communications, contracts, and budgets.

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