- Voyage of Discovery: Why we crossed the ocean for our FIH Trial
- Speed Dating: Choosing partners for the clinical research dance
- Do You Feel a Draft?: Endless iterations of study-specific documents
- H-Wrecked: navigating unexpected reefs in the journey to study start-up
- Out of Site, Out of Mind
Archives: Agenda
PANEL DISCUSSION: Identifying patients as equal partners and including their voice in all stages of drug development
- Acknowledging the value that patients can bring to every stage of the drug development pathway
- Engaging patients and advocacy groups early on in the clinical trial design process
- How minimizing participant burden leads to on-time enrollment and completion
- Combining patient perspectives with those of healthcare professionals to create a holistic trial model
- Highlighting how to compensate patients
Moderator: Amanda Murphy, Senior Director, Data Intelligence & Solutions, GlobalData
Lunch and networking
END OF CONFERENCE
Chair’s closing remarks
Registration
PANEL DISCUSSION: Where is the clinical trial industry headed?
- Moving studies forward on unknown territory: Funding clinical trials amidst recent research policy changes and abrupt NIH cuts
- Shining light on the changing scope of the FDA: Discussion of the latest changes under the new administration including years of critical DEI work
- Technological developments into 2026 and beyond: what changes can we expect to see in the next 3-5 years?
- Navigating the constantly evolving vendor and CRO landscape as a small to mid-sized sponsor company
Moderator: Robert Loll, SVP, Business Development & Strategic Planning, Praxis
From sample to strategy: Holistic laboratory partnership to enable delivery of modern trial designs
- Integrating central lab expertise early in trial design to avoid fragmented workflows and costly delays
- Enhancing trial efficiency and biomarker strategy through proactive collaboration with laboratory partners
- Positioning lab providers as co-authors of research success, offering insights on biomarkers, assays, sample logistics, and data flow
- Ensuring protocols are both scientifically robust and operationally feasible by embedding lab considerations from the outset
FDA’s Office of Import Operations (OIO): Updates and tips for supporting importation of safe and quality FDA-regulated products
- Organizational Updates
- Nationalized Entry Review
- Pharmaceuticals import and entry transmission compliance requirements
- Biologics import and entry transmission compliance requirements