DIA 2024 Day #1

One of the prevailing themes of the first day of DIA 2024 was that the biopharmaceutical industry needs to be more comfortable with assuming a greater level of risk if it is to continue achieving the breakthroughs needed to improve patient outcomes.

Technologies such as artificial intelligence (AI), the increased use of cell and gene therapies to target specific conditions, and unconventional ways of engaging diverse patient communities are demonstrating positive returns — and those should just be the beginning.

"As regulators, our bedrock has to be that products are high-quality, safe, and effective," said Peter Marks, Director, Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration ( FDA ), as part of the opening plenary discussion. "But we have to be ready to evolve with the science. We don't want our regulations to get stale. We have to keep adapting."

AI has been used to improve healthcare in several areas, including identifying certain molecules that hold promise in the early stages of drug development and collating patient data to uncover alternative approaches to treatment.

Martin Hodosi , Partner, Healthcare and Life Sciences Practices at 科尔尼 , moderated a DIAmond session, "Navigating the Trusted, Responsible, and Ethical Horizon of Artificial Intelligence." He shared research that showed $215 billion is being spent primarily in North America on AI, but only about $8 billion is devoted to health care applications.

"We need to think about how we can optimize the way that we work to drive innovation within this landscape," Hodosi said. "But also, we do need to go onto this long journey of addressing the resetting of our rules, and we perhaps need to think differently about how we set rules for something that is moving so quickly."

During “The Cost of Moving the Needle on Clinical Trial Representation: Strategies for Diversity Budget Planning,” Monica Eason , a Clinical Operations Portfolio Leader and Diversity and Inclusion Leader at Genentech , spoke about how there had long been a belief that designing clinical trials to include members of diverse populations would impede their progress and that sponsors have had to “bust those myths.”

"There is a need to be bold and brave in this space," Eason said. "When you’re pioneering new DE&I initiatives, you’re working in uncharted territory. Make sure you have a culture of innovation and risk-taking with that DE&I lens."

And renowned inventor and entrepreneur Dean Kamen , who said during the plenary discussion that he fails "more than anybody I know," said there's no shame in taking a risk and falling short.

"You can fail in a way where the project fails, not the people," said Kamen, who also gave one of the keynote addresses. "And if you fall down seven times and stand up eight, you're still a winner, and you've learned from the mistakes."

The Global Annual Meeting will continue today with a second DIAmond session, “International Regulatory Convergence: Regulatory Science to Address Challenges Brought by Pharmaceutical Innovation,” as well as additional sessions on AI and precision medicine and forums led by regulators from the FDA and the Brazilian Health Regulatory Agency (ANVISA).