IQVIA (NYSE:IQV), a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, shared recommendations for strengthening the United States as a leading destination for early clinical development during the U.S. House Committee on Energy and Commerce Subcommittee on Health hearing, "Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role in Advancing U.S. Drug Development."

Recommendations were presented by Dr. Cynthia Verst, president, Design and Delivery Innovation, Research and Development Solutions at IQVIA, who highlighted the importance of making the path from scientific discovery to first-in-human studies more defined and efficient while maintaining the U.S. Food and Drug Administration’s high standards for patient safety and data integrity. Her testimony focused on opportunities to modernize early clinical development, support more collaborative regulatory engagement and strengthen the broader infrastructure needed to translate scientific discoveries into potential treatments.

"The United States has an opportunity to strengthen its position as a leading destination for clinical research by creating a clearer and more efficient path from discovery to early clinical development," said Dr. Verst. "A more risk-proportionate approach to first-in-human studies, combined with timely scientific advice and stronger connections across the research ecosystem, can help promising treatments enter clinical trials sooner while preserving the patient protections that make the FDA the global gold standard."

The time and resources required to prepare an investigational new drug application is a significant barrier for sponsors seeking to initiate first-in-human studies in the United States. This is particularly important for emerging biopharmaceutical companies, which drive more than 75% of new Phase I trial starts and often depend on timely regulatory advice to guide development decisions and secure staged investment.

Dr. Verst outlined several opportunities to improve the U.S. early clinical development environment:

Establish fit-for-first-in-human minimum datasets that support safe-to-proceed decisions without compromising patient safety.
Enable more flexible, iterative interactions with FDA reviewers as scientific and regulatory questions become relevant throughout development.
Expand access to timely scientific advice, particularly for emerging biopharmaceutical companies.
Strengthen the country’s bench-to-clinic infrastructure by connecting government agencies, research institutions, community practices and private-sector clinical development capabilities.
Improve patient finding and trial matching while maintaining appropriate privacy protections and making participation in clinical research more operationally viable for community practices.

The hearing examined how Congress and the FDA can modernize regulatory requirements for early-stage clinical development while maintaining standards for safety and effectiveness. It also considered opportunities to improve clinical research through innovative trial designs, digital health technologies, high-quality clinical data and greater coordination across clinical protocols.

IQVIA will continue working with Congress, the FDA, the U.S. Department of Health and Human Services, biopharmaceutical sponsors, investigators and patient communities to advance solutions that reinforce American biomedical innovation and help bring better medicines to patients faster.

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About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI^®, advanced analytics, the latest technologies and extensive domain expertise. IQVIA is committed to using AI responsibly, with AI-powered capabilities built on best-in-class approaches to privacy, regulatory compliance and patient safety, and delivering AI to the high standards of trust, scalability and precision demanded by the industry. With approximately 93,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.

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Kerri Joseph, IQVIA Investor Relations (kerri.joseph@iqvia.com)

+1.973.541.3558

Alissa Maupin, IQVIA Media Relations (alissa.maupin1@iqvia.com)

+1.919.923.6785