Annual conference returns to Washington, D.C., Sept. 15-16; addresses challenges in establishing a new paradigm for how evidence of efficacy and safety is generated.

TUCSON, Ariz., June 9, 2026 /PRNewswire/ — Critical Path Institute^® (C-Path) will host its 2026 Global Impact Conference (CGIC) this September at the Washington Marriott at Metro Center in Washington, D.C. The conference runs Sept. 15-16, followed by a dedicated working session, Sept. 17, on One to Millions, C-Path’s initiative to advance therapies from individualized breakthroughs to scalable global solutions. Registration is now open to the global drug development community.

CGIC 2026 convenes leaders across regulatory agencies, industry, academia, and advocacy, along with those with lived experience, for working sessions on solving challenges in current drug development. The conference centers on one of the most consequential solutions that could address key challenges facing drug development today: establishing a new paradigm for how evidence of efficacy and safety is generated, interpreted and acted on. The 2026 program advances CGIC’s multi-year focus on evidence generation, building on 2024 sessions on novel evidence sources, and 2025 sessions on modernizing how evidence is generated. Keynote addresses will be delivered by Michael Davis, M.D., Ph.D., acting director of the FDA’s Center for Drug Evaluation and Research, on Day 1, Sept. 15, and by Janet Woodcock, M.D., former principal deputy commissioner of the FDA, on Day 2, Sept. 16.

“CGIC 2026 is where the global drug development community comes together to confront the most urgent question in the field: how do we transform the evidence generation paradigm so that treatments reach the people who need them faster and more reliably?” said C-Path Chief Executive Officer Klaus Romero, M.D., M.S., FCP. “This conference is the expression of everything C-Path is working toward, and we can’t wait to welcome our global community back to D.C.”

The agenda features voices from across the drug development ecosystem, including regulators, pharmaceutical and biotechnology companies, academic and clinical institutions, advocacy organizations and individuals with lived experiences.

The 2026 agenda spans:

Plenary panels featuring regulators, industry leaders, and those with lived experience
Targeted breakout workshops on near-term priorities across therapeutic areas
Cross-sector networking designed to forge partnerships and advance shared solutions

Sessions will examine the priorities reshaping evidence generation, including artificial intelligence and real-world data, digital health technologies and digitally derived endpoint measures, biomarker and endpoint development, biological staging as a drug development tool, neuroimaging biomarkers in early-stage development, and post-approval evidence generation. The agenda also includes a spotlight on trust and transparency in data sharing for individualized therapies, breakouts addressing lived experience and the regulatory context across therapeutic areas, and discussions on advancing new approach methodologies (NAMs) as drug development tools.

Additionally, on Thursday, Sept. 17, C-Path will convene a dedicated working session on C-Path’s One to Millions initiative, focused on modernizing how individualized therapies are developed, evaluated, and reimbursed at scale.

CGIC 2026 will bring together voices from regulatory agencies, pharmaceutical and biotechnology companies, academic and clinical research institutions, advocacy organizations, payors, and the patient and caregiver community.

C-Path invites its global community of partners, collaborators, and stakeholders to join the conversation in Washington, D.C., this September. Attendance is complimentary for regulatory professionals, nonprofit representatives, and credentialed media. Standard registration fees apply for all other attendees.

To register now and learn more about the conference, agenda, speakers, and travel information, visit the event page at https://bit.ly/CGIC2026.

About Critical Path Institute

Critical Path Institute^® (C-Path) is an independent nonprofit established in 2005 as a public-private partnership in response to the FDA’s Critical Path Initiative. C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org.

Critical Path Institute is supported by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) and is 56% funded by the FDA/HHS, totaling $23,740,424, and 44% funded by non-government source(s), totaling $18,881,611. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.

Media Contacts:

Roxan Triolo Olivas

C-Path

520.954.1634

[email protected]

Kissy Black

C-Path

615.310.1894

[email protected]

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