Newsletter | December 22, 2025

12.22.25 -- CEOs Talk FDA, China, Funding Sources

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Clinical trials drive medical progress, and SCOPE brings the community together to advance them. Returning February 2–5, 2026, in Orlando, SCOPE builds on 2025’s record 4,500+ attendees, 630 speakers, and 300 exhibitors. The 2026 program features 30 tracks, new additions in Market Access, Safety, and Therapeutic Areas, major awards, and expanded coverage of AI, patient-centric design, site engagement, and trial operations. SCOPE unites global leaders shaping the future of clinical research. www.SCOPEsummit.com

FROM THE EDITOR

Galien Forum: CEOs Talk FDA, China, Funding Sources

Part two of a two-part series covering FDA Commissioner Makary’s comments at the Galien Forum, plus coverage of a CEO roundtable on FDA, China, and funding.

INDUSTRY INSIGHTS

Why Community-Rooted Recruitment Is The Future Of Clinical Trials

Despite clinical trial awareness campaigns and site expansions, trials continue to fall short in reaching the patients who need them most, resulting in a shift toward community-rooted recruitment.

How One Biotech Company Is Accelerating The Drug Discovery Workflow

See how biotech innovation is accelerating drug discovery through AI, miniaturized workflows, and collaborative technologies to reshape how therapies are developed and delivered.

How Real-World Data On Site Costs Accelerates Clinical Trial Success

Outdated budgeting slows oncology trials. Real-world site cost data enables faster planning, smoother startup, and better patient care through smarter, evidence-based financial decisions.

Study Data Success: Expertise, Collaboration, And Transparency

To strengthen cross-functional performance, teams should commit to building shared understanding, improving communication, and continuously refining their approach.

The CHO Toolkit: Flexible Solutions For Complex Molecules

A modular cell line development platform helps overcome biologic complexity. Learn how flexibility and expert support drive success from early development through commercial manufacturing.

Patient Recruitment Strategies: Fixing The Friction In Trial Enrollment

Drawing on insights from real-world studies and behavioral health programs, this session provides a practical roadmap for turning a patient’s “no” into an informed, empowered “yes.”

Maximizing Clinical Data Insights With Advanced Analytics Platforms

To achieve drug approval, trials must collect, combine, and analyze diverse data sets that support operational, safety review, risk management, and other analyses crucial to development.

Building Blocks: The Ultimate Guide To AI In Clinical Trials

This comprehensive guide provides an authoritative, in-depth look at AI's role in accelerating drug development and improving patient outcomes, with special focus on emerging agentic AI technologies.

Biopharma Giant Streamlines Infrastructure With Proprietary Software

Archiving legacy QMS systems into a centralized platform reduced costs, simplified access, and improved efficiency for a global diagnostics company undergoing quality process harmonization.