European Epidemiological Forum

Regulators, health technology assessment (HTA) bodies, academics, bio-pharmaceuticals companies, payers, and patients are presently rethinking the healthcare ecosystem and facing diverse and increasing challenges at different levels. In this conceptual modelling of the healthcare ecosystem, the potential value of Real-World Data (RWD) for decision making has never been more relevant.
Real-World studies seek to provide complementary evidence to that provided by randomized controlled trials. While the latter provide evidence of efficacy, Real-World Data provide information on therapeutic effectiveness in a real-world practice setting.
Pharmaceutical companies need to focus on innovative and targeted therapies both due to the increased competition in the sector, and of the number of better structured and demanding patients’ groups or associations. Pharmaceutical companies are presently discussing on:

• How does RWD contribute to translational research?
• Whether there are any companies optimally leveraging RWD and how its application to biobanks can better advance innovation and discovery of targeted therapies?
• What are the structural and logistical needs for this to be effective?
• What have we already learned about the process?

Regulatory bodies face the challenge of ensuring that only safe and effective medicines reach patients; a decision which so far has only been substantiated upon data from RCTs. They actually need to know:

• Whether other stakeholders can help them in the process and how?
• Where and how do we using RWD in the drug development and approval process?
• What has already been achieved in the field and what the success factors are?

Payers, and HTA bodies want to make sure that the most innovative and novel medicines reach patients who need them most as quickly as possible; and that these medicines provide value for money to all parties: patients and health care systems. They may ask themselves:

• How can sponsors better demonstrate the value of their innovative medicines using RWD?
• How can they work with decision-makers to establish agreed upon standards for RWE research?
• How do recent frameworks (FDA, NICE, etc) help advance RWE research?

What brings all stakeholders at the same level is the need for new paradigms for a more performing healthcare ecosystem that reduce the gap between its representation and its implementation. Emerging e-health models and applications can greatly contribute to it, particularly, if hand-in-hand with Real-World Data Studies. The European Epidemiological Forum will review the progress and perspectives on the value of RWD in the drug life cycle, will discuss what RWD promises, what the barriers may be and what a successful story may look like.

Scientific Board:
Christian Agboton - Sr Global Brand Medical Director at Takeda
Maurille Feudjo Tepie - Observational Research Director at Amgen
Michele Intorcia - HEOR Senior Director at Apellis Pharmaceuticals

Who should attend?
The conference is addressed to professionals with a deep interest in drug development, healthcare decision making, academia and healthcare research, belonging to department such as: Medical Affairs, R&D, HTA/Market access, Medical Informatics, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biostatistics and Data Management from Pharmaceutical, Biotechnology and Medical Device companies, CROs, Universities/Hospitals, Academic Research, Patient Associations and Healthcare Organizations.