Cerebrospinal Fluid Biomarkers for Alzheimer’s Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team

Manuscript Number: 

16-0573R1

Author(s): 
Stephen P. Arnerić, Richard Batrla-Utermann, Laurel Beckett, Tobias Bittner, Kaj Blennow, Leslie Carter, Robert Dean, Sebastiaan Engelborghs, Just Genius, Mark Forrest Gordon, Janice Hitchcock, June Kaplow, Johan Luthman, Richard Meibach, David Raunig, Klaus Romero, Mahesh N. Samtani, Mary J. Savage, Leslie M. Shaw, Diane Stephenson, Robert M. Umek, Hugo Vanderstichele, Brian A. Willis, Susan Yule

Disclosures

Stephen P. Arnerić

  • Consulting Fees:
    I am President of Horizons Pharma Consulting, LLC, and consult in the area of Pain Research and other areas outside of Alzheimer's Disease.
    Equity:
    I own stock and a retirement IRA with Abbott Laboratories and AbbVie; a retirement IRA with Pfizer; and a retirement IRA with Lilly.
    Grants
    • Agency: 
      Members of CAMD pay fees to support the Consortium
      Dates: 
      Annual membership fees are pain in January of each year

Richard Batrla-Utermann

  • Equity:
    Roche Ltd Also employed by Roche Diagnostics Ltd
    Patents/Royalties
    Diagnostic patent on cervical cancer diagnosis

Laurel Beckett

  • Nothing to Disclose

Tobias Bittner

  • Patents/Royalties
    Employee of Roche

Kaj Blennow

  • Consulting Fees:
    Eli Lilly, Fujirebio Europe, IBL International, Novartis, Roche Diagnostics

Leslie Carter

  • Nothing to Disclose

Robert Dean

  • Equity:
    Eli Lilly and Company
    Patents/Royalties
    Employee of Eli Lilly and Company

Sebastiaan Engelborghs

  • Consulting Fees:
    Consulting fees / paid advisory boards: Innogenetics / Fujirebio Europe, Pfizer, Novartis, UCB, Roche diagnostics, Nutricia / Danone, Eli Lilly
    Grants
    • Agency: 
      Janssen Pharmaceutica NV
      Dates: 
      1 OCT 2015 - ONG
    • Agency: 
      ADx Neurosciences
      Dates: 
      1 OCT 2016 - ONG

Just Genius

  • Equity:
    Stocks and stock options from AbbVie Inc.
    Sponsors:
    Full-time employee at AbbVie Inc.

Mark Forrest Gordon

  • Sponsors:
    I am a full-time employee of Boehringer Ingelheim Pharmaceuticals, Inc., one of the member companies in the Coalition Against Major Diseases.

Janice Hitchcock

  • Equity:
    Employee and minor shareholder of Eli Lilly and Company
    Patents/Royalties
    Full-time employee of Eli Lilly and Company

June Kaplow

  • Equity:
    Contrafect
    Patents/Royalties
    I am employed by Eisai Inc. a for profit pharmaceutical company. No patients, or receive royalties nor an expert witness.

Johan Luthman

  • Equity:
    I own shares in mutual funds/retirement funds. I also have equities in AstraZeneca and Merck.
    Sponsors:
    I am an employee of Eisai Pharmaceuticals Inc. Eisai is funding the precompetitive consortium CAMD within The Critical Path Institute (a non-profit organization). The present work was developed within a CAMD projects, the so called CAMD CSF Team, where industry partners work with The Critical Path Institute.

Richard Meibach

  • Equity:
    Own stock in Novartis Pharmaceuticals and has options for future purchase of Novartis Stock
    Sponsors:
    Employed by Novartis Pharmaceuticals. Novartis is a member of CAMD and pays an annual dues. Novartis also sells pharmaceutical products to treat AD and is currently developing new treatments for AD. Novartis however had no direct sponsorship of the study

David Raunig

  • Patents/Royalties
    Pfizer: Pixel compounding method of image analysis/enhancement, QT prolongation statistical methodology, Tumor tissue segmentation image analysis method.

Klaus Romero

  • Nothing to Disclose

Mahesh N. Samtani

  • Equity:
    I own Johnson and Johnson stocks

Mary J. Savage

  • Sponsors:
    I am an employee of Merck and Company who, in part sponsored the manuscript

Leslie M. Shaw

  • Consulting Fees:
    consulting: Novartis; Eli Lilly; Roche
    Grants
    • Agency: 
      NIH U01 AG024904
      Dates: 
      8/1/16-7/31/22
    • Agency: 
      MJFox Foundation for PD Research(BioFIND)
      Dates: 
      2016
    • Agency: 
      Eli Lilly
      Dates: 
      2016
    • Agency: 
      Roche
      Dates: 
      2015-2016

Diane Stephenson

  • Nothing to Disclose

Robert M. Umek

  • Nothing to Disclose

Hugo Vanderstichele

  • Equity:
    Co-founder of ADx NeuroSciences Founder of Biomarkable bvba

Brian A. Willis

  • Equity:
    Minor stockholder in Eli Lilly
    Sponsors:
    Employee of Eli Lilly

Susan Yule

  • Equity:
    Roche shares 219 Roche stock options 5500