Barbara Lopez Kunz, Global Chief Executive, DIA

“We’re here this week because we imagine a world where powerful health interventions and tools are rapidly discovered, developed, approved, and made accessible to all.
The world’s changed. It places much greater demands on young people. They’re living in a more networked world marked by enormous amounts of information and knowledge, but also heightened risks, lower social mobility, and greater inequality. It’s well known that many young people are surprisingly unhealthy. Their health issues result from lack of food access, risky behaviors, and heightened psychological vulnerability. The result is obvious: increased incidence of diseases like obesity, diabetes, mental health disorders, and substance abuse disorders, just to name a few. New approaches are being developed to address some of these difficulties and to understand the root causes.

How can we play a role in guiding the future trajectory of health by addressing globalization of therapeutic development? How can we truly integrate patient-centricity and inclusivity into our work? What are the lasting benefits of artificial intelligence and digitization of healthcare? I am confident that we’ll all walk away from this meeting with new understandings and insights, and more clarity on the roles that we can all play in improving the future. ”

 

Robert Califf, Commissioner, US FDA and Honorary Co-Chair

“To address the increasingly complex scientific and medical challenges we face, it’s essential that we continue to expand the sources, quality, and types of data that we use to analyze these issues, as well as the means we employ to prospectively plan for gathering the right data in the right context, ingesting the data, and applying the right study designs and analysis methods to derive knowledge from this information.

The effective use of digital tools can also play an essential role in strengthening collaborative efforts that are needed among regulators from different countries in addressing some of the global challenges we’re facing. We need a much more comprehensive set of reliable evidence than currently available. The failure to share data in a transparent fashion is a major factor holding us back. As you attend the meeting and think about how to improve our system, I hope you’ll consider how effective we could be if we revamped the foundational system for sharing data.”

 

Emer Cooke, Executive Director, European Medicines Agency

“When we regulators do things together, we can do so much more globally for better patient outcomes. We’ve shown we can do things differently. We’ve shown that we can be more innovative. Now our challenge is to translate some of these learnings into innovation in our daily business, using these opportunities to support the development of products that better meet patients, locally and globally.

The future of global healthcare is all about innovation that knows no limits, knows no borders, and pushes new frontiers. As regulators, how do we contribute to this brave new world? Let me focus on three areas: translating artificial intelligence into real tools that make a difference in how clinical trials are performed, how endpoints are designed, and how we get patient feedback; using real-world evidence to meet their needs; and using digitalization not only to enable patient-centricity but to also future-proof our own operational infrastructure capability and security.”

Read the full article on the DIA Global Forum website