Archives: Agenda

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

Crafting the Perfect Collagen Beverage

  • Introduction of company
  • Introduction of ingredient collagen and bioactive collagen peptides
  • Collagen in beverages opportunities
  • Technical feasibility in beverages
  • New product teaser