PML Consortium EMA/FDA Workshop on PML July 2011 PML Consortium - - PowerPoint PPT Presentation

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PML Consortium EMA/FDA Workshop on PML July 2011 PML Consortium - - PowerPoint PPT Presentation

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PML Consortium EMA/FDA Workshop on PML July 2011 PML Consortium and Funding 1 1 PML Consortium Confidential V ision and Mission Vision The Consortium aims to find methods to predict, prevent and treat PML. Mission Perform research to

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1 1 PML Consortium Confidential

PML Consortium

EMA/FDA Workshop on PML July 2011 PML Consortium and Funding

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Vision and Mission

Vision The Consortium aims to find methods to predict, prevent and treat PML. Mission Perform research to reduce occurrence, morbidity and mortality of PML through:

Multi-company, not-for-profit, collaborative approach

Shared strategy, investment, data acquisition & analysis and communication

Multi-year commitment from member organizations

PML Consortium Confidential

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Overview

 Vision and Mission  Organization  Funding structure  Sustainability

PML Consortium Confidential

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PML Consortium

Secretariat (Drinker Biddle & Reath) provides legal (including antitrust), scientific, project management, and administrative support.

PML Consortium Confidential

(Working Groups)

BOARD OF DIRECTORS

Chair: Sophie Banzet

Communications

Chair: Ilse Peterson

Regulatory Affairs

Chair: Jacques Mascaro

Clinical

Chair: Marianne Gerber

Research

Chair: Susan Goelz :

Patient Advisors

Advisory Board

Chair: David Clifford

Scientific Advisory Board

Chair: David Clifford

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Member Companies

 Current Members

Biogen Idec

Bristol-Myers Squibb

Elan

Pfizer

Roche

PML Consortium Confidential

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Scientific Advisory Board

Remit

Represent the interests of the recipients of the Consortium’s work, including physicians and the scientific community;

Provide feedback and advice on Consortium activities;

Provide insight into advancements in the scientific and medical communities; and

Assist the Consortium in disseminating information about PML, in collaboration with the Consortium’s Working Groups.

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Scientific Advisory Board

Composition

David Clifford, Chair, Washington University School of Medicine

Eugene Major, National Institutes of Health

John Seeger, Harvard Medical School

Alessandro Sette, La Jolla Institute of Allergy and Immunology

Kenneth Tyler, University of Colorado School of Medicine

Thomas Weber, University of Hamburg

Monica Vinhas, EMA Observer

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Patient Advisors

Collaborate with the Consortium to:

Ensure the utility of the website through content review;

Facilitate dissemination of knowledge about PML

Assist expansion of network to include other entities focused on PML drug discovery

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Key Accomplishments

Consortium established as a legal entity (December 2009) 2010-2011

Agreement on funding

Creation of Advisory Board

Two new members (BMS and Pfizer)

Clinical database in place

Initiation of development of processes for standardization of data and sample collection, banking and storage

Academic Collaborative Research Network grants, symposia and workshops

Engagement with EMA, FDA and National MS Society

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Near-Term Priorities

2011-2012

Website

Further Academic Collaborative Research Network grants, symposia and workshops

Increase interface with patient association(s)

Explore risk stratification, diagnostic and treatment options

Recruit new partners

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Funding

Member companies have a sustained commitment to provide expertise, personnel and funding to advance the goals of the Consortium

In accordance with the Consortium Bylaws, the budget is shared

  • n equity across all member companies

Decisions on PML activities

Consensus between companies

Prioritization of the activities in relation to the vision and mission of the consortium

Budgetary considerations

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Funding & Considerations

Current state: funding driven by current member companies

Results needed to maintain member companies’ engagement

Awareness is critical and additional partners are important

Challenges:

Individual corporate priorities

Long-term funding for the Consortium

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Consortium Board of Directors

Biogen Idec Teresa Compton, PhD Barry Ticho, MD, PhD Bristol-Myers Squibb Dolca Thomas, MD Steven Nadler, PhD Elan Lori Taylor, PhD Nicki Vasquez, PhD (Vice Chair) Pfizer Claudio Carini, PhD Tom Kawabata, PhD Roche Sophie Banzet, MD (Chair) David Yocum, MD

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Contact Information

Jacques Mascaro, Elan

jacques.mascaro@elan.com

Michael Poirier, Biogen Idec

michael.poirier@biogenidec.com

Michael Richardson, Bristol-Myers Squibb

michael.richardson@bms.com

Barbara Repetto-Wenzl, Roche

barbara.repetto-wenzl@roche.com

Jim Jamieson, Secretariat

ballard.jamieson@dbr.com

PML Consortium Confidential