Archives: Agenda

PANEL The Clinical Trial Landscape for Small to Mid-Sized Biopharma in Europe

  • New regulations and guidance around clinical trials in the EU: how will this impact you?
  • Staff turnover and layoffs: handling changes in the industry in order to ensure success
  • Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor company
  • An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?

KEYNOTE PANEL Where is the clinical trial industry headed this year and beyond?

  • Patient centricity in clinical trials: how can burden be reduced in order to make trials easier for patients to
    participate in?
  • Navigating new regulations around clinical trials smoothly and successfully
  • Technological developments into 2025 and beyond: what changes can we expect to see in the next 3-5
    years?
  • The impact of artificial intelligence: how far can we expect to move forward in the next 12 months?

 

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.

Additional topic suggestions:

Adaptive study design: creating a trial that is flexible and responsive to change

  • Assessing the advantages of adaptive design over traditional fixed designs and how this can improve your clinical trial efficiency
  • Key considerations for adaptive design
  • What additional flexibility is available when using adaptive design?

CASE STUDY: Overcoming operational challenges for a CAR-T trial: learnings and best practice

  • How are CAR-T trials unique from an operational standpoint: what do you need to consider?
  • Designing KPIs and other metrics to measure the efficiency of your CAR-T trial
  • Best practice in collaboration with CROs, vendors and other partners to make your CAR-T trial a success

Creating a budget that works for hybrid trials

  • Introducing elements of decentralization into your trial while remaining cost-conscious
  • Maximizing ROI on investment in new technology to support hybrid trials
  • Where can hybridization of trials help to minimize costs and reduce timelines?

Leveraging AI to design a cutting-edge patient recruitment strategy

  • Utilizing AI to minimize patient recruitment costs and maximize speed of enrolment
  • An overview of how data driven technology is able to enhance patient recruitment in trials
  • Leveraging AI and ML to reach a wider population when recruiting for a clinical study 

CASE STUDY: eConsent and the benefits for patients, sites, investigators and sponsors

  • Using eConsent as a tool to speed up recruitment and thus overall trial timelines
  • The regulatory landscape surrounding eConsent: what challenges are there to this?
  • Maintaining a relationship with patients in order to ensure consent is informed in remote settings

Using data and information from electronic medical records in order to shorten patient recruitment timelines

  • What are the benefits of electronic medical records and how can they enhance patient recruitment processes?
  • Navigating challenges and overcoming hurdles when using electronic medical records
  • Using electronic medical records in conjunction with other methods of identifying and screening patients in order to shorten timelines and reduce overall costs 

Risk based quality management systems: an overview of solutions available in the market

  • Best practice in processes for risk based management
  • Tools available to streamline risk based management and how to best leverage these
  • How can risk based quality management be used effectively in order to maximize trial success

Utilizing technology to maximize patient engagement and retention

  • Increasing patient touchpoints without increasing burden through the use of technology
  • The importance of having lighter, more frequent touchpoints in order to increase communications and improve relationships with patients
  • Assessing technologies available for supporting patient engagement and retention

Real world data in clinical trials: how can you utilize this effectively?

  • Navigating FDA and international regulations around the use of RWE in clinical trials
  • Understanding the full potential of RWE and how this can benefit your trial
  • Collecting and analyzing RWE effectively: how to address and overcome challenges

CASE STUDY: Practical challenges when running a rare disease trial in the US

  • The regulatory landscape for rare disease trials in the US: what do you need to be aware of?
  • Learnings and outcomes from running a rare disease trial: where were the main hurdles
  • Working with CROs and vendors in order to deliver a successful orphan drug clinical trial 

Forecasting and budgeting for your clinical trial

  • Ensuring your trial is both cost-conscious and efficient without compromising on quality
  • Techniques, processes and technology to improve forecasting and budgeting
  • Avoiding common mistakes to keep your clinical trial budget on track