The purpose of RWE&Epi is to conduct scientific observational research within disease areas and medical conditions of relevance for Lundbeck to support clinical drug development, real world Pharma-Epidemiological research, and patient experience and preference studies.

In general, RWE&Epi conducts the following scientific research:

Epidemiology Studies: observational Epidemiology studies to improve understanding of the core disease features, patient profiles, disease burden, health resource utilization, and unmet needs for patients.

Pharmaco-Epidemiology Studies: observational Pharmaco-Epidemiology studies to describe real world medical treatment, patient treatment journey, and outcome studies.

Post- Authorization Safety Studies (PASS) and Post-authorization Effectiveness studies (PAES): studies conducted in agreement with regulatory authorities to monitor and document the safety profile (PASS) and/or effectiveness profile (PAES) in real-world clinical practice.

The members of RWE&Epi are highly specialized researchers within Epidemiological Research, Registry Studies, Pharmaco-Epidemiology and other quantitative study types. Furthermore, RWE&Epi collaborates closely with specialists in Data Science.

RWE&Epi conduct their research in partnership with internal as well as external public and private partners to e.g., meet regulatory safety requirements, drive research with public scientific research institutions, and/or to document effectiveness and safety of Lundbeck’s treatments in routine clinical care.

Observational research at Lundbeck follows various external guidance, such as:

• Guidelines for Good Pharmacoepidemiology Practices (GPP),
• ENCePP Guide on Methodological Standards in Pharmacoepidemiology, 
• the Framework for US FDA’s Real-World Evidence Program,
• Good practices of a joint ISPE/ISPOR task force,
• US FDA’s Guidance on Patient Focused Drug Development,
• Recommendations from the Innovative Medicines Initiative on Patient Preferences in Benefit-Risk assessments,
• EMA’s Good Practice Guide for the use of the Metadata 5 Catalogue of Real-world Data Sources,
• Guidance from US FDA on Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making,
  
• Recommendations from US FDA on terminology within RWE.

Lundbeck’s Observational Research Committee (ORC) oversees the design and execution of observational research at Lundbeck.

Lundbeck’s Observational Research Committee (ORC) oversees the design and execution of observational research at Lundbeck. The purpose of the ORC is to:

• Assist Lundbeck employees in adhering to good pharmacoepidemiologic research principles and any other relevant international or national regulatory guideline
• Promote scientifically sound pharmacoepidemiologic research by encouraging rigorous data collection, analysis, and reporting.
• Provide a framework for conducting and evaluating pharmacoepidemiologic studies.
• To facilitate the appropriate utilization of technical resources by promoting careful study design and planning of study conduct.
• To facilitate transparency and ethical integrity in research conduct

Please contact the ORC if you have any questions and/or wish to learn more about Lundbeck’s RWE&Epi department.