RWE, Market Access, Pricing & Reimbursement Global Congress 2022 Europe

Agenda at a Glance

Day 1 - Congress

Day 1: Tuesday 1st March 2022

Matthias Heck, Attorney-at-law, Senior Director, International TA Policy Strategy, Alexion Astra Zeneca Rare Disease

CURRENT TRENDS & STRATEGIES

  • Reforms to National Reimbursement system and pricing processes in Europe
    Updates to Managed Entry and Early Access Pathways
    Greater adoption of Real World Evidence (RWE)
    Increase Cross-Border Collaboration as a potential means of controlling cost

Moderator:

Matthias Heck, Attorney-at-law, Senior Director, International TA Policy Strategy, Alexion Astra Zeneca Rare Disease

Panellist:

  • Paolo Morgese, EU Director Market Access & Member Relations, Alliance for Regenerative Medicine
  • Marisca Marian, Oncology Market Access Strategy Leader, Bayer
  • Mario Ouwens, PhD, Senior Statistical Science Director, AstraZeneca
  • Frameworks for RWD collection in EAP
  • Regional variability in major global markets
  • Recent regulatory updates and practical examples

Graham Sidorowicz, EVP Commercial, Bionical Emas

Rakesh Davda, Head of Real World Data & Market Access, Bionical Emas

  • Recognize the potential of Personalized Medicine in Oncology / Cancer Patients benefits;
  • Identify challenges which could be encountered during HTA process;
  • Develop strategies to overcome or to remove any barrier for Patient Access to Precision Oncology;

Marisca Marian, Oncology Market Access Strategy Leader, Bayer

  • Who is TSM?
  • Early Access v Named Patient path.
  • Terms and outlines.
  • Risks, liability, benefits.
  • Challenges and overcoming those
  • Including the named patient access into the product life cycle (the role of the patient and early
    engagement, RWE/RWD).
  • What’s in it for Pharma?

Katrin Schepp, General Counsel, The SocialMedwork

  • Addressing the barriers to access to lifesaving plasma-derived medicines
  • Understanding formal and therapeutic patient access challenges
  • Plasma collection policies in Europe

Maarten Van Baelen, Executive Director, PPTA

  • The Do’s and Don’ts of contractual negotiations
  • The role of real-world evidence
  • How to find the right endpoints for outcome-based agreements

Victor Maertens, Government Affairs, EUCOPE

  • How are patient registries used to generate real-world data for rare diseases and orphan drugs
  • Does different stakeholder types have different RWE information needs for decision making?

Martine Zimmermann, SVP, Head Regulatory Affairs, R&D & Commercial Quality, Alexion

  • RWD as input into HTA dossier
  • Examples of RWD use as part of reimbursement submissions
  • Challenges and limitations related to RWD use

Monika Szkultecka-Debek, Vice President, Qualitas Vitae Institute Foundation

  • Some perspectives from the pharmaceutical industry on the use of RCT and RWE

Mario Ouwens, PhD, Senior Statistical Science Director, AstraZeneca

  • Overview of current considerations around orphan drug assessment
  • Recent and expected trends around evolution of assessment criteria
  • Anticipated impact on evaluation of orphan drugs in German
  • Overall perception of orphan drug commercial opportunity due to assessment trends

David Bower, Principal, Head of Market Access Excellence, Clarion

Networking Drinks Reception

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