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TEVA Theorem Clinical Research Introduction

We are passionate about being your partner.

Michael Towse

on 16 August 2013

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Transcript of TEVA Theorem Clinical Research Introduction

3 years of dedicated Gastroenterology experience
Global, Multi-Country, Program Management Experience
Experienced in all countries proposed for TEVA program
Located in close proximity for TEVA
Anne Macek, MD, FAAP
19 years Clinical Investigator
7 years Medical Director Theorem
Medical Monitor for previous Crohn’s Disease Studies
Kevin Bickford, Global Program Director
Jorg Hackstein, Project Manager, Europe
UC and IBD (IBS) experience in both IMP and Medical Device sector
Large program management experience
Experience bringing compounds from Phase I through submission
The Theorem Response Team
Natalia Karel, MD, PhD., Lead CRA, Europe
12.5 Years Industry experience
Extensive Gastroenterology experience and relationships with KOL’s across Europe
Crohn's specific experience
Has already worked with proposed CRA’s in all European countries for TEVA program
Susie Milton, Lead CRA, North America
CCRA with 12 yrs experience in the Clinical Research industry
Previous CCRC with 6 yrs as a Site Manager/Study Coordinator working in GI, leading and training all the site SCs in IBD studies especially Crohn’s
Worked on studies for Adalimumab, Natalizumab, Certolizumab approvals
Passionate about working with Crohn's disease patients
Theroem's Global Footprint
Karen Keyer, Project Manager, North America
18+ Years Industry Experience in Phase I to IV on both the CRO and sponsor side
Extensive experience in management of complex studies, focusing on the logistics required for successful conduct with multiple vendors
5+ years experience with patient reported outcome studies
33 Offices, coverage in over 60 countries
Theorem has personal relationships with Gastroenterology sites globally
Theorem's proactive branding suggestions
All CRA's have been identified
Average 12.8 Years Industry Experience
Average 11 Years CRA Experience
Average Years of Gastroenterology Experience is 5 Years
90% have Crohn's Disease Experience
Cindy Massey, Site Engagement Specialist
13 Years Crohn's Disease Experience
Involved in Theorem Clinical Research Training
Liason with sites
Joseph Sgherza, Franchise Manager
20 years Crohn's Disease Experience
Experience with Laquinimod compound
Extensive Phase III Global Program Experience
A personal passion for Crohn's Disease research
Offers TEVA
62 Years of Gastroenterology Experience
255 Gastroenterology studies
69 Crohn’s Studies
Compounds - Asacol, Humira, Cimzia, Tysabri, STA-5326, Remicade, Ustekinumab

We are passionate about
becoming your partner.
Full transcript