1. -LIVE Global Activities-
Follow-up on SURVET
-LIVE Global Activities-
Milan, 05 July 2016
Daniela Bassi
Global Product Manager
Roberto Restelli
Clinical Trial Manager

2. Where we were….

3. …where we are now! ADVOCACY MEDIATION DISSEMINATION
N.2 Advisory Board
KOLs/SURVET Investigators
MEDIATION
LIVE Event
KOLs/Investigators/Local Influencers
DISSEMINATION
(Global & Local Action Plans)

4. Global Materials from L.I.V.E.
LIVE Plenary Session Video
LIVE “Congress Report”
LIVE Objection Handling (Q&A from the plenary session)
LIVE Breaking News (4/6 releases)

5. European Venous Forum - 2016
Date: July 2016
Location: London, UK
AW Satellite Symposium
July
Chairs: A. Nicolaides, GM. Andreozzi
Biomarkers in CVD and DVT (F. Mannello)
Sulodexide in CVD and re-DVT (T. Urbanek)
Pharmacology of Sulodexide (J. Fareed)
Discussion (A. Nicolaides)

6. IUA World Congress - 2016 Date: 05- 09 Oct 2016 Location: Lyon, FR
AW Satellite Symposium
October
Title: Prevention of recurrent VTE. What’s new
Recurrent VTE and key challenges (G. Palareti )
• New data and recent trials investigating the prevention of recurrent VTE (A. Nicolaides)
• Sulodexide in the prevention of recurrent VTE: the SURVET Trial (G.M. Andreozzi)
• Which pharmacological evidences of Sulodexide support the SURVET results? (J. Fareed)

7. Other Projects on going
Editorial by Prof. Fareed et al. to be published on the Journal of International Angiology and the IUA website
Update of the “Prevention and Treatment of Venous Thromboembolism: International Consensus Statement” - International Union of Angiology

9. The Study International Multicenter Prospective Observational
on the management of the prevention of venous thromboembolism (VTE) recurrence in consecutive patients treated for 3-12 months with anticoagulant therapy for a first episode of VTE

10. Primary Objective
To evaluate the decision making process of the physicians on the treatment of patients with a previous VTE episode after an initial period of 3-12 months of standard anticoagulation therapy (regardless of the treatment)

11. Primary Endpoint
Proportion of the therapeutic options independently taken by the physician after the standard anticoagulation therapy period.
3 different choices:
Continue the anticoagulation
Stop the anticoagulation treatment
Switch to another drug
Sample size calculation

12. Secondary Objectives & related endpoints
Reasons of therapeutic choices
Risk of thrombosis
Risk of bleeding
Age of patient
Patient’s preference
Other reasons
VTE recurrence events
Hemorrhagic events
Other events

13. Population
ALL the patients that suffered of a VTE event 3-12 months before the screening visit and treated for that event with anticoagulation.
Follow-up every 3-6 months by visit or phone call
At least 3 years follow-up per patient

14. Action Plan Activity Timeline Draft of proposal Done
Draft of preliminary CRF
Translation in English of CRF
July 2016
Test of the CRF
September - October 2016
Budget, sample size and number of sites definition
September 2016
List of sites
October 2016 – November 2017
CRO selection, protocol and database preparation
Q – Q1 2017
Project start-up
Q1-Q2 2017

15. Critical Success Factors
Accurate centers selections
the right specialists
the high potential centers
Continuous centers tracking
to keep the center engaged
Med Reps Engagement
to guarantee the center follow-up
to monitor the project status

16. The Study-related events
To engage specialists of the centers involved
To build network cross-countries
To enhance the brand awareness
Kick-off Meeting
To keep high the involvement on the project
To share their own experience
To have ad interim analysis
Periodical/Regional Meetings

17. Now it’s your turn….

18. Follow-up on SURVET
-Key Conclusions-

19. DVT≠CVD Conclusion #1 Different disease perception
Different target involved
Different patient profiles

20. Engage KOLs/Influencers
Conclusion #2
Engage KOLs/Influencers
Identify the reference KOLs who will play the role of Local Advocates
Involve them in crucial activities: Advisory Boards, Registry…

21. Understand the current management of DVT patients
Conclusion #3
Understand the current management of DVT patients
Define the patient journey: diagnosis, initiation, continuation, follow-up
Analyze the market of VKA & NOACs

22. Select the appropriate target
Conclusion #4
Select the appropriate target
Define who are the specialists that manage the DVT patients
Determine if penetration and/or coverage

23. Identify the right patients
Conclusion #5
Identify the right patients
Define the patient profile that can benefit from Sulodexide

24. (1891-1951)- Soldier in WW1. Journalist on the army newspaper
( )- Soldier in WW1. Journalist on the army newspaper. His best known book is “The Magic of Believing”, 1948, which has sold well over a million copies.