Archives: Agenda

Clinical trials surged in H1 2025! What happened and what you must know to stay ahead

GlobalData’s clinical trials data indicates that new trials initiated in H1 2025 has increased significantly over previous years. In addition to surprising Wall Street, this has shaken up the biopharma competitive landscape and created major opportunities for CROs, CDMOs, Pharma Tech, and consultancies. Behind the headlines, clinical trial reporting lags, shifting start dates, and withdrawals make it easy to miss where the real growth is happening.

This session breaks down what drove the surge, where the next wave is coming from, and how early signals can give you the edge on predicting future market shifts. Whether you run trials, manufacture at scale, or advise life sciences companies, this is about being prepared, before your competitors are.

Interactive Breakfast Speaker-Hosted Roundtable Discussions

With drinks and refreshments, interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will run twice and be led by a table moderator and will focus on a different challenge within clinical trials. Roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Roundtable 1 Navigating the latest release of ICH E6 (R3): How are you carrying out gap assessments of processes and what changes are you making?

Hosted by Christina Sanchez, Director, Clinical Quality Assurance, Neurocrine Biosciences
Roundtable 2 Postproduction handling and administration of biologics drugs 

Hosted by Kevin Zen, Director, Opthea
Roundtable 3 Collaborative solutions between Sponsors and CROs for accurate site budgeting and forecasting

Hosted by Richard Firth, Associate Director, Development Business Operations, Arcturus Therapeutics
Roundtable 4 Emerging startup company trends and challenges
Roundtable 5 Implications of the latest administration on clinical trial progress

CLOSING PANEL DISCUSSION: Ensuring your FSP model is a success

  • Working closely with FSP vendors: how much oversight do you need?
  • Benefits and challenges of moving to an FSP outsourcing model
  • Comparing vendor management strategies between pharma and biotechs: do you need a different approach?
  • Why is FSP becoming a popular outsourcing model: what benefits can this offer sponsors?

Moderator: Amanda Murphy, Senior Director, Data Intelligence & Solutions, GlobalData

CLOSING PANEL DISCUSSION Genuine, constructive partnerships: Effective approaches to CRO management without compromising efficiency, quality and patient safety

  • Setting up for success with large CROs in terms of contract structures, financial terms and governance from a small biotech perspective
  • Implementing a gold standard strategic partnership to avoid common pitfalls and improve vendor selection
  • Knowing when to outsource and detailing key activities to be performed for each vendor service to ensure proper oversight
  • Factoring in necessary contracts and approvals for vendor selection in study timelines

Moderator: Robert Loll, SVP, Business Development & Strategic Planning, Praxis

Practical ways ICON is using AI to address common delivery pain points

  • Predict high-performing sites and investigators to accelerate enrolment
  • Forecast site activation timelines with greater accuracy
  • Anticipate post-marketing commitments earlier in the process
  • Enhance TMF compliance and quality through intelligent automation
  • Accelerate and streamline site contracting for faster study start-up
  • Drive operational efficiency and cost savings through robotic process automation