Archives: Agenda

PANEL: Navigating Uncertainty: Mitigating the Impact of External Factors on Clinical Trials in Europe

External factors, including geopolitical tensions and global conflicts, can significantly disrupt clinical trials in Europe, affecting timelines, budgets, and patient recruitment. This session will analyze the implications of these external influences on clinical research and discuss strategies that pharma and biotech companies can employ to mitigate risks and maintain trial integrity.

This session will also cover the EFPIA paper which states “60,000 fewer clinical trial places for Europeans, despite global surge in research projects. “For Europe to be competitive, it needs to function as a unified region” says Nathalie Moll.

 

·       Understand the impact of global conflicts and external factors on clinical trials in Europe.

·       Identify specific challenges posed by geopolitical events, regulatory changes, and market dynamics.

·       Explore strategies and best practices for mitigating risks associated with external factors.

·       Discuss the importance of adaptability and contingency planning in clinical trial management.

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