-LIVE Global Activities- Follow-up on SURVET -LIVE Global Activities- Milan, 05 July 2016 Daniela Bassi Global Product Manager Roberto Restelli Clinical Trial Manager
Where we were….
…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)
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)
European Venous Forum - 2016 Date: 07- 09 July 2016 Location: London, UK AW Satellite Symposium July 7 - 11.00-12.00 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)
IUA World Congress - 2016 Date: 05- 09 Oct 2016 Location: Lyon, FR AW Satellite Symposium October 7 - 12.30-14.00 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)
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
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
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)
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
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
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
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 Q4 2016 – Q1 2017 Project start-up Q1-Q2 2017
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
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
Now it’s your turn….
Follow-up on SURVET -Key Conclusions-
DVT≠CVD Conclusion #1 Different disease perception Different target involved Different patient profiles
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…
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
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
Identify the right patients Conclusion #5 Identify the right patients Define the patient profile that can benefit from Sulodexide
(1891-1951)- Soldier in WW1. Journalist on the army newspaper (1891-1951)- 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.