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