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11th RWE, Market Access, Pricing & Reimbursement 2024 Americas

Defining Value to Obtain Informed Evidence Optimizing Patient Access to Medicines

Day 1 - Monday 9th September 2024

TRENDS & STRATEGIES

  • Trends that will continue to impact, Market Access, Pricing and Reimbursement in healthcare
  • Unlocking data from early access
  • Effective communications with internal and external stakeholders
  • Embracing the digital vision
  • Future trends and developments in the healthcare distribution
  • Keeping on top of pricing and market access trends
  • Identify a clinical or economic advantage and generate the appropriate clinical and health
    economic evidence to support a strong value proposition
  • The importance of Patient-Reported Outcomes
  • Unlocking data from early access
  • Effective communications with internal and external stakeholders
  • Embracing the digital vision
  • Understanding the intricate regulatory landscape
  • Navigating complex requirements to achieve and maintain market access in the US and around the world
  • Practical approaches and strategic planning
  • Best practices
  • Benefits of understanding differences across stakeholders
  • Multiple stakeholder approach to planning and delivering evidence is required
    A dedicated strategy to meet their specific evidence needs
    Determine whether a multiple stakeholder approach is justified.
  • New landscape for risk-sharing agreements among manufacturer, payer and patients
  • Understand the benefits of a good collaboration between payers and pharma companies to ensure patient access
  • What do the decision-makers on drug usage think today about how the industry is responding to the immense challenges it is facing?
  • Addressing the factors that made the launch environment more challenging
  • Capabilities needed for an effective drug launch
  • How to best leverage outsourced partners to achieve success.
  • Best practices to achieve successful commercialisation.

REAL-WORLD EVIDENCE

  • Recent advances in digital and advanced analytics for RWE generation
  • What role can it play across the pharma value chain?
  • What are the important aspects involved in utilising RWE to support product effectiveness?
  • How can this be used to advance reimbursement model?
  • Major factors contributing to the pharmaceutical industry’s excitement about RWE
  • Addressing the challenges of collecting and consolidating RWD data that can be put to good use.
  • Important role of RWE clinical trials
  • Real-world data and evidence as a more integral part of the drug development process.

Jason Noto, Senior Vice President, US Market Access, AVEO Oncology

  • How is RWD and RWE bringing innovation to patients and gaining approval
  • Importance of RWD in transforming clinical research and clinical trial design
  • Experiences to date and identify practical and technological considerations to further implement real-world clinical research
  • The use of RWD early in the process to boost trial diversity and inclusion
  • Challenge in setting diversity goals early in clinical trial planning
  • Development of a diversity plan to ensure adequate representation of racial and ethnic
    subgroups in clinical trials
  • Utilizing RWE in the post-marketing setting to complement clinical trial findings and support post-marketing requirements or commitments for safety and efficacy data in a diverse patient population
  • Why is RWE increasingly being recognised and acknowledged as an evolution in product research and development.
  • How does RWE help regulators, pharmaceutical companies and clinicians better identify trends and patterns in patient outcomes
  • Understanding the risks & opportunities to both payer and industry
  • How does real-world evidence help ensure market access?
  • It’s use in supporting a robust post market surveillance and accelerating products to market
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