Archives: Agenda

During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

Roundtable 1
Mitigating risk in clinical supply chain
Pernille Hemmingsen, Chief Technology Officer, Adcendo

Roundtable 2
Engaging with CROs: defining deliverables and agreements
Asger Dahlgaard, VP of Quality Assurance and Regulatory Affairs, BioPorto Diagnostics A/S

Roundtable 3
Considering DCT trial design and impact on both the patient and company
John Zibert, Chief Medical Officer, Coegin Pharma

• Assessing outcomes from over 70 interviews with life science industry pioneers
• Reviewing what clinical professionals wish would be different in the life sciences industry
• Suggesting next steps towards further evolving clinical trials

• Planning and scheduling considerations
• Understanding the requirements and importance of chain of identity and chain of custody within cell therapy trials
• Vetting critical partners and identifying technology tracking systems to assist with cell therapy supply

• Sharing insights on collaborations with clinical CROs on previous clinical studies
• Preparing for a clinical trial with a University Hospital in Denmark
• Choosing and developing the right trial design

• We will examine the high cost of doing nothing
• What is the status quo and can technology help?
• Vendor management – tackling one of the biggest challenges
• The role that AI can play
• What you can gain by embracing technology

• Overview of global clinical trials for 2023
• Assessing key sponsors, top interventions and looking at the trial landscape for 2023
• Looking at key obstacles for terminated trials and evaluation of completed trials which have achieved endpoint status

• Driving true benefits for clinical research through digital health technology
• Learnings from barriers created by integration of digital health
• Improving processes and focusing on delivering digital health as a tool

• Orphan drug market: Illustrate the unique challenges of developing a drug for rare diseases
• Patient-focused drug development: Designing patient-centered clinical trials
• Operational considerations: Endpoint selection; reducing the burden of participation; cost; sites; patient concierge services
• Collaboration: Focus on the need for collaboration in this space: sponsors, CRO (Clinical Research Organizations), patients, patient advocacy groups, investigators, vendors

Regulatory bodies are promoting Risk Based (Quality) Monitoring as a best practice in clinical trials to correct data quality issues as early as possible in the trial lifecycle.  Since this involves the identification of specific patterns in large datasets, artificial intelligence can support us in doing this efficiently.

• How can AI find specific patterns that humans might miss
• Interactions between AI and humans in RB(Q)M
• Real life examples in respiratory