6th Clinical Trial Agreements Summit

Foley partners Monica Chmielewski, vice chair of the firm’s Health Care Practice Group, Kyle Faget, and Nate Beaver, co-chairs of the firm’s Medical Devices Area of Focus, are speaking at Dynamic Global Events’ 6^th Clinical Trial Agreements (CTA) Summit on August 21-22. Faget, who is co-chair of the Summit, is speaking in the session “Map the Best Methods for Outsourcing Clinical Trials Agreement Attorneys” and Chmielewski is speaking in the session “Grasp the Intricacies of Research Misconduct” on August 21.

On August 22, Chmielewski is moderating the panel titled “Assess How the New Regulatory Landscape Will Affect Trials in 2025 and Beyond” with Beaver and Faget as speakers.

DGE’s 6^th Clinical Trial Agreements Summit will provide attendees with detailed and insightful discussions on how to navigate the intricacies of company mergers, CTA negotiations, new regulatory landscapes, and more.

Grasp the Intricacies of Research Misconduct

In 2023, the U.S. Department of Health and Human Services proposed updates to revise the Public Health Service Policies on Research Misconduct, addressing critical issues such as confidentiality clauses, site audit rights, data integrity, and financial implications. These changes may necessitate revisions to current CTAs.

• Identify the challenges associated with the new proposed changes.
• Examine how sites and sponsors are impacted.

Map the Best Methods for Outsourcing Clinical Trials Agreement Attorneys

Outsourcing CTAs is typically managed through Clinical Research Organizations (CRO) and vendors. CTA attorneys bring valuable expertise in budget development, informed consent forms, patient recruitment, data integrity, intellectual property rights, and more. How does collaborating with CROs differ from working with attorneys?

• Discuss the responsibilities that attorneys and CROs deal with in the negotiation process.
• Weigh the pros and cons of working with each.

Panel: Assess How the New Regulatory Landscape Will Affect Trials in 2025 and Beyond

In 2025, significant regulatory changes are reshaping the clinical trial landscape. However, the full impact of these changes remains uncertain as the industry navigates this evolving environment. How will the new legislation influence diversity guidance, global regulatory variations, trial designs, Medicaid implications, and other critical areas in the future?

• Analyze the importance of understanding the current legislative landscape.
• Highlight any new regulatory changes and how they are affecting trials.
• Predict what the regulatory future will look like.