he subject of real-world data—“big data” from electronic medical records, claims, prescription databases, and other sources—is becoming more and more real, as industry and regulators look to use real-world data as real-world evidence in clinical research and therapeutic product development. Global Forum Regional Editor for Europe Julie O’Brien (Pfizer) leads the below exploration of the current and potential future states of real-world data and real-world evidence from the perspectives of the regulated and the regulators, with Jennifer Dudinak (Bristol Myers Squibb) and Max Wegner (Bayer AG).

eal-world data (RWD) offers the possibility of providing important information to help inform regulatory decision-making. But turning this possibility into reality still depends on the quality and reliability of the data. With appropriate efforts to ensure data quality, RWD can support regulatory decisions in Japan (and other countries/regions as well). Close collaboration between health authorities, study sponsors, and data owners is critical in better understanding and overcoming issues in making this possible.

he impact of self-advocacy and the importance it plays in my life as a cancer survivor and patient advocate is significant. Diagnosed with Stage IV triple-negative breast cancer in 2017, I overcame an abundance of medical bias and lack of health literacy to save my life. With an original estimate of a 4% chance of survival, I am now one of the 12% of patients diagnosed with metastatic triple-negative breast cancer to make it to the five-year life expectancy benchmark.

here has been a shift from late phase to early phase design and toward novel drug development in Asia Pacific (APAC), with particularly significant growth in China from 2012 to 2021. In 2021, one speaker noted, APAC accounted for approximately 50% of new global trials with an increasing trend of phase 1 to phase 4 trials being conducted in the region.

DA has recently met several significant milestones which underline its commitment to public health and safety. This commitment was highlighted by the 1,000th label change made by the Office of Pediatric Therapeutics (within the last year) to ensure safe and effective medical products for children. FDA has also prioritized updating labels for opioids to provide greater clarity for when and how they should be used. FDA is also working to expand over-the-counter sales of hearing aids, drugs with conditions for nonprescription use, and other products.

enerative artificial intelligence (AI) is heralding a transformative era in healthcare, and ChatGPT and other large language models (LLMs) are prominent among these innovations. The profound impact of these applications spans various domains including improved patient communication, drug discovery, medicine and device safety monitoring, and the integration of diverse data sources. Indeed, the potential of these advancements is already shaping the way we approach our work today while stimulating our imaginations about their possibilities for the future.

ow can data technology experts effectively communicate the benefits and capabilities of artificial intelligence (AI) to life science professionals in the same way that these professionals learned to explain the benefits and capabilities of medicines to patients? DIA Global Head of Science and Scientific Strategy Courtney Granville explores answers to this question with Sridevi Nagarajan (Head of Digital Regulatory Strategy, AstraZeneca) and Michael Meighu (Director of Consulting and Expert Consultant, CGI) at the DIA Global Annual Meeting 2023 in Boston.

IA Global Annual Meeting 2023 Honorary Co-Chair David Mukanga, deputy director of Africa Regulatory Systems for the Bill and Melinda Gates Foundation and DIA Global Forum regional editor for Africa, discusses with Global Forum Editor-in-Chief Alberto Grignolo the emergence and rollout of the African Medicines Agency, the need for local and international partnerships in Africa, the significance of a professional from Africa serving as honorary co-chair this year, and much more.

n April 2023, the Australian Department of Health and Aged Care launched an independent Health Technology Assessment (HTA) Policy and Methods Review of the Australian government’s funding and subsidy schemes for providing medicines, medical services, immunizations, and life-saving drugs to the citizens of Australia. This review is a major commitment under the Strategic Agreement 2022-27 between the Commonwealth of Australia and Medicines Australia, the leading association of the research-based medicines industry in Australia.