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YEAR ONE PROGRESS
What a difference a little time makes?

The Translational Safety Biomarker Pipeline Project (TransBioLine) is a 5-year Innovative Medicines Initiative (IMI), which kicked off in February 2019. The main objective is to generate exploratory and confirmatory data supporting regulatory qualification and acceptance of novel safety biomarkers for each of the five target organ system work packages (kidney, liver, pancreas, vascular, and central nervous system) for application in drug development. Additionally, it comprises six enabling work packages, including miRNA (liquid biopsy), biobank and assay development, data management, regulatory interactions, and communication packages.

In just a short time, the world is incredibly different due to the COVID-19 pandemic impacting our work and family lives, however, TransBioLine colleagues continue to work and push the critical deliverables to deliver therapies to patients.

Key accomplishments year one
Pre LOI and/or status update submissions and pre LOI meetings for all packages.
LOI submissions for kidney, liver, vascular and neuro packages with formal acceptance of LOI to biomarker qualification for vascular
Biomarker advice meeting with EMA. Consulted with FDA and EMA to accelerate the qualification timelines. Goal by end of June 2020 is to submit all the LOI, with a couple of biomarker advice meetings with EMA and begin to draft qualification package
Research plans for all organ work packages finalized
Harmonized informed consent and patient information forms for prospective sample and data collection
SOPs and validation plans for assay platforms (eg., immunoaffinity-mass spectrometry-based assays (IA-MS), Simoa and NGS for profiling miRNAs signatures)
Operational Biobank and SOPs for sample collection, processing, sample shipment, storage, and analysis
Training videos for sample processing and shipment to Biobank for all organ work packages
TranSMART and eCRF data management platforms implemented
Data transfer platform (OwnCloud) operational
Statistical and bioinformatics plans/template for SAP
Shashi Ramaiah
Pfizer

"I am proud to work with incredibly talented and dedicated EFPIA and academic investigators to deliver these important milestones. We are on-track to complete LOI submissions and EMA interactions for all packages by the end of 2020. The next 12 months are critical for patient recruitment for generating pilot biomarker data needed to draft a qualification plan."

Shashi Ramaiah
Consortium Leader
Pfizer
Bruno Stieger
University of Zurich

"The first year has demonstrated that one of the largest public-private partnerships of European and American scientists focusing on the development and regulatory qualification of new safety biomarkers is the right approach for obtaining qualification of novel biomarkers. These biomarkers will not only make development of new drugs more efficient and safer but will also improve the diagnosis of drug-induced organ injury of existing drugs. We are excited to move into the next phase."

Bruno Stieger
Consortium Coordinator
University of Zurich
Consortium Meetings
TransBioLine Kick-off Meeting
March 2019,
in Basel, Switzerland
The TransBioLine consortium met the first time in March 2019, Basel. Read more about the meeting and the concept of TransBioLine…
TransBioLine 2nd Consortium Meeting September 2019,
in Sitges, Spain
The TransBioLine consortium met the second time in September 2019, Sitges. The event featured interesting discussions between the TransBioLine Consortium members. The TransBioLine project was presented in detail, through each work package, while all were invited to ask questions and comment. Discussions were mainly focused on the outline of the clinical studies and on data management/analysis in the TransBioLIne project and served as an important and successful team forming event.
Dissemination and outreach

The launch of the project was actively promoted and disseminated, and hence it had a broad online presence. Please see below which media covered the kick-off of our project.

EUREKALERT
LABMATE-ONLINE
GLOBAL BRANDS MAGAZINE
INTERPHARMA
UZH MEDIA
TRIALSITENEWS
LIVERPOOL MEDIA
SIGNATOPE MEDIA
EUROPEAN BIOTECNOLOGY
LISAVIENNA
TAMIRNA MEDIA
PHARMACEUTICAL NETWORKING
SWT
BIO-M ORGANIZATION
27/11/2018 - Regular oral presentation
IMI2 TransBioLine project
Guruprasad Aithal (6. UNOTT)
Fourth meeting of CIOMS Working Group (WG) on Drug-Induced Liver Injury (DILI)
1/03/2019 - Invited oral presentation
An overview of the innovative medicine initiative (IMI) TransBioLine Project
Shashi Ramaiah (21. Pfizer)
Annual meeting of the Society of Toxicology, Baltimore, MD
14/03/2019 - Regular oral presentation
Working Group 1 Presentation
Jane Grove (6. UNOTT)
COST Action CA17112: Working Group meeting, Málaga
15/03/2019 - Invited oral presentation
Case definition and phenotypes. Grading Severity and Predicting outcome in DILI. The benefits of Registries
Guruprasad Aithal (6. UNOTT)
COST Action CA17112: Training School, Málaga
1/05/2019 - Poster
Liver Injury by Checkpoint Inhibitors
Alexander L Gerbes (5. LMU)
2019 FDA/AASLD DILI Conference
8/05/2019 - Invited oral presentation
The value of collecting bio-samples in clinical trials
Gerd A. Kullak-Ublick (24. Novartis)
2019 FDA/AASLD DILI Conference
17/05/2019 - Invited oral presentation
Recent advances in pancreatic diseases
Robert Sutton (17. ULIV)
6th National Pancreas Patient and Public Forum
18/05/2019 - Panel Discussion
Why no drug to treat pancreatitis
Robert Sutton (17. ULIV)
Digestive Disease Week 2019
7/07/2019 - Invited oral presentation
Translational Models for Drug-Induced Liver Injury
Chris Goldring (17. ULIV)
49th Drug Metabolism Gordon Research Conference
15/07/2019 - Invited oral presentation
Translational and Mechanistic Biomarkers of Liver injury
Chris Goldring (17. ULIV)
IUTOX 15th International Congress of Toxicology, Co-Hosted by SOT
23/09/2019 - Regular oral presentation
Circulating microRNAs: non-invasive tissue- and mechanism-specific biomarkers in drug safety pharmacology
Matthias Hackl (9. TAmiRNA)
SPS annual meeting 2019
23/09/2019 - Regular oral presentation
Cardiovascular Safety Biomarkers: Bidirectional Translational Approaches
Tanja Zabka (25. Roche)
SPS annual meeting 2019
01/10/2019 - Regular oral presentation
Drug - induced Liver Injury by Herbals and prescription drugs
Alexander L Gerbes (5. LMU)
International Digestive Disease Forum 2019
23/09/2019 - Poster
Transbioline - Biobanking at the International Level
Dana Briesemeister (15. Charité)
Europe Biobank week event 2019
8/10/2019 - Invited oral presentation
Drug - induced Liver Injury in Children
Andreas Benesic (5. LMU)
GPGE 2019
10/10/2019 - Regular oral presentation
IMI TransBioLine project: paving the way to research collaborations in DILI
Guruprasad Aithal (6. UNOTT)
2nd Working Groups & 3rd Core Group Meetings COST Action 17-112 PRO-EURO DILI NET
10/10/2019 - Regular oral presentation
Are patients with pre-existing chronic liver disease at higher DILI risk?
Guruprasad Aithal (6. UNOTT)
COST Action CA17112: Core Group Meeting, Palermo
10/10/2019 - Regular oral presentation
Working Group 1 Presentation
Jane Grove (6. UNOTT)
COST Action CA17112: Core Group Meeting, Palermo
10/10/2019 - Invited oral presentation
IMI TransBioLine project: paving the way to research collaborations in DILI
Guruprasad Aithal (6. UNOTT)
COST Action CA17112: Core Group Meeting, Palermo
22/11/2019 - Invited oral presentation
RAPID-I: infliximab in acute pancreatitis
Robert Sutton (17. ULIV)
The 2019 Annual Meeting of the Pancreatic Society of Great Britain and Ireland
Our next planned events

3rd Consortium Meeting, Online format

8-9 September 2020

4th Consortium Meeting, Amsterdam

19-20 April 2021

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