Ομιλία - Παρουσίαση: Dr. Piotr Iwanowski, National Board Member, Polish Association for Good Clinical Practice (GCPpl) & Associate VP Clinical Research Europe, Wockhardt Bio AG Τίτλος Παρουσίασης: «The Five Things Changing the Landscape of Clinical Research»

1. The Five Things
Changing the Landscape
of Clinical Research
(Here and Now)
Piotr Iwanowski
1. Polish Association for Good Clinical Practice (GCPpl)
2. Wockhardt Bio AG
Athens, 14th December, 2017

2. The EU Clinical Trial Regulation
(536/2014)

3. • "De-centralised" model of EU-wide clinical trial authorisation
• Coordinated 2-Part assessment procedure amongst Member States
• One clinical trial application form and supporting dossier to cover
• The EU Portal to become the technical axe of the process
• Risk-based approach for documentation, approval timelines, monitoring,
liability (eg., new category of low-intervention trials)
• Re-formatting of national systems for ethics review of clinical trials required
for many EU Member States
The EU Clinical Trial Regulation
(536/2014)

4. Source FGCP "Workshops How to Ensure Optimal Ethical Review within the New Clinical Trials Regulation? ", 13.Apr.2016, Brussels
Fergus Sweeney, European Medicines Agency
"This is the first time a pharmaceutical regulation
has been made entirely dependent
on a software system"
Fergus Sweeney, EMA

5. Source FGCP "Workshops How to Ensure Optimal Ethical Review within the New Clinical Trials Regulation? ", 13.Apr.2016, Brussels
Fergus Sweeney, European Medicines Agency
"This is the first time a pharmaceutical regulation
has been made entirely dependent
on a software system"
Fergus Sweeney, EMA

6. The e-Revolution of Capturing
Patient Data

7. The e-Revolution of Capturing Patient Data:
the e-Health Records
Source: Maciej Garmulewicz, Centrum Systemów Informacyjnych Ochrony Zdrowia, Warsaw, Poland
Sharing Health Records: yesterday and tomorrow

8. The e-Revolution of Capturing Patient Data:
the e-Patient Reported Outcomes
• ePRO/eDiary is becoming the industry standard
• ePRO delivers improved data quality and reduced variability, particularly in the
diary setting
• ePRO tools/modes:
• Handheld devices
(smartphones – online, off-line)
• Tablets
• Web (PC)
• Digital Pen
• Special devices (e.g. glucose meters, blood pressure devices)
• Bring Your Own Device concept

9. The e-Revolution of Capturing Patient Data:
the e-Consent
Source Luigi Visani, Exom Group srl

10. The e-Revolution of Capturing Patient Data
• EU:
• Reflection paper on expectations for electronic source data and data
transcribed to electronic data collection tools in clinical trials, EMA, 2010
• USA:
• Use of Electronic Health Record Data in Clinical Investigations, Guidance
for Industry, FDA, 2016
• Use of Electronic Informed Consent – Questions and Answers, Guidance
for Institutional Review Boards, Investigators and Sponsors, FDA, 2016
• Use of Electronic Records and Electronic Signatures in Clinical
Investigations Under 21 CFR Part 11 – Questions and Answers, Guidance
for Industry (DRAFT GUIDANCE), FDA, June 2017

11. Access to Clinical Data

12. Access to Clinical Data

13. Access to Clinical Data (EU)
New EMA
Policy

14. Access to Clinical Data (USA)

15. Clinical Development
of Biosimilars

16. Clinical Development of Biosimilars
reference
product
biosimilar
product

17. 2005
First EMA guidance
released for biosimilar
drug delekopments
2006 (April)
First biosimilar authorised in EU
(Omnitrope®, Sandoz)
2013
First biosimilar monoclonal antibody
authorised in EU
(infliximab)
2006 (May)
First „generic” biological drug
(Omnitrope®,
Sandoz)
authorised in USA (though via a generic
pathway)
2015
First biosimilar drug authorised in USA
(filgrastim)
Clinical Development of Biosimilars

18. Clinical Development of Biosimilars
• Currently (November 2017): 33 biosimilars for 14 biologic drugs authorised in
EU
• Only in 2017: 10 new authorisations!
„Over the last 10 years, the
EU monitoring system for
safety concerns has not
identified any relevant
difference in the nature,
severity or frequency of
adverse effects between
biosimilar medicines and
their reference medicines.”
http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf

19. Clinical Development of Biosimilars
Source:
BioPharma-Reporter.com, 2014
Saturation with clinical trials of biosimilars

20. Risk-Based Monitoring

21. Risk-Based Monitoring

22. Risk-Based Monitoring

23. Risk-Based Monitoring