PSI RWD SIG Webinar: Real-World Evidence Submission - a Case Study in Lung Transplantation

Date: Tuesday 22nd March 2022
Time: 13:30-15:00 GMT | 09:30-11:00 ET
Speakers: Tae Hyun Jung (U.S. Food and Drug Administration), Tim Weaver (Chronic Disease Research Group), Richard Croy (Astellas), David Nimke (Astellas) and Josephine Wolfram (Astellas)

Who is this event intended for? Statisticians or other professionals with an interest in the use of real world data in the regulatory setting. 
What is the benefit of attending? To hear first-hand experience of a successful RWE-based submission from different stakeholder perspectives.


You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI =Free of charge
To register for the session, please click here.


The FDA Real-World Evidence (RWE) Framework was published in Dec. 2018, shedding some light on how Real-World Data (RWD) can be used to support regulatory decision making. This guidance was greatly welcomed in an environment that focuses on efficiency and innovative trial designs. Yet, three years out, there are not many examples of RWE in practice, especially of situations where RWE is the exclusive source of evidence supporting new drug indications. Recently, tacrolimus was approved for Lung transplantation based solely on RWE and we would like to share our experience with statisticians in the pharmaceutical community.

Three stakeholders – the sponsor, RWD vendor and FDA - will share their experiences of the submission and approval process. Topics to be covered include relevant project background & context, identification/selection of RWD, study design & key analysis methods, operational considerations related to study conduct & quality, submission content and labeling.

Speaker details




Rick Croy,
David Nimke,
Josie Wolfram

Rick has been working in clinical development as a statistician in the pharmaceutical industry for over 20 years. For more than 10 of those years, he has been a global statistical lead on various projects, including tacrolimus for transplantation.

David is the Real World Evidence-US Lead at Astellas Advanced Informatics and Analytics. His team of observational researchers and analysts conduct research using secondary use databases. Previously, he worked in epidemiology and RWE groups at Astellas, AbbVie, and Abbott Laboratories. David holds a Doctor of Public Health from University of North Carolina.

Josie joined the pharmaceutical industry 25 years ago. Following a few years at GSK, she joined Fujisawa in Munich then Astellas in the Netherlands in various statistical roles. She currently leads a small team focused on leveraging real world data to support development projects.

Richard Croy, David Nimke and Josephine Wolfram will share the background and rationale to pursue this submission, the approach, and key discussion points with the FDA leading up to the submission and during review.

Considerations for the choice of RWE and Real-World Data (RWD) used in the pivotal RWD study will be discussed along with the study design elements, key results and challenges.

Operational considerations for study conduct and submission will also be addressed

Tim Weaver


Tim Weaver works as a biostatistician in the area of organ transplantation with the Chronic Disease Research Group. In that role he has conducted research using the SRTR database as well as simulation analysis of the organ allocation system.

Tim Weaver will discuss the source of the RWD, the Scientific Registry of Transplant Recipients database, and the observational nature of the data with its implications for the study design and considerations for analysis. Technical aspects of the data-processing code development, data transfer, and results submission will also be discussed.

Tae Hyun (Ryan) Jung

Tae Hyun Jung, Ph.D., is a Senior Statistical Reviewer in FDA/CDER/OTS/OB/DBVII. He has comprehensive NDA/BLA/PMR review experience from phase III/phase IV safety focused reviews, and phase III efficacy reviews including RWE efficacy. He is also leading multiple RWE/RWD research projects using machine learning/artificial intelligence, evidence synthesis, data quality, and synthetic data. Tae Hyun completed his PhD degree in Biostatistics at Yale University.

Tae Hyun Jung will share FDA review perspectives and challenges during the review process. Also, the importance of getting quality patient-level data in RWE submission will be addressed.



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