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Workshop Report: Crystal City VI—Bioanalytical Method Validation for Biomarkers

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Abstract

With the growing focus on translational research and the use of biomarkers to drive drug development and approvals, biomarkers have become a significant area of research within the pharmaceutical industry. However, until the US Food and Drug Administration’s (FDA) 2013 draft guidance on bioanalytical method validation included consideration of biomarker assays using LC-MS and LBA, those assays were created, validated, and used without standards of performance. This lack of expectations resulted in the FDA receiving data from assays of varying quality in support of efficacy and safety claims. The AAPS Crystal City VI (CC VI) Workshop in 2015 was held as the first forum for industry-FDA discussion around the general issues of biomarker measurements (e.g., endogenous levels) and specific technology strengths and weaknesses. The 2-day workshop served to develop a common understanding among the industrial scientific community of the issues around biomarkers, informed the FDA of the current state of the science, and will serve as a basis for further dialogue as experience with biomarkers expands with both groups.

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Acknowledgments

The authors would like to thank and acknowledge the efforts of a number of people who contributed to a successful workshop:

Speakers: Sriram Subramanian, Steven Piccoli, Lauren Stevenson, Andrew Hoofnagle, Bradley Ackerman, Richard King, James Mapes, Lakshmi Amaravadi, Medha Kamat, and Noriko Katori

Panelists: John Kadavil, Michael Skelly, Russell Grant, Christopher Evans, Lorin Bachmann, Hendrik Neubert, Paul Rhyne, Binodh DeSilva, Russell Weiner, and Masood Kahn

Session Chair: Faye Vazvei

Notetakers: Eric Fluhler, Jianing Zeng, Theingi Thway, and Stephanie Fraiser

Moderators: Roger Hayes, Omar Laterza, Binodh Desilva, and Patrick Bennett and the AAPS meeting team led by Elizabeth Scuderi: Kimberly Brown, Sandy Hawken, Teresa Homrich, Grace Jones, Kate McHugh, Scott Didawick, Ian Hoch, and Todd Reitzel

Author information

Authors and Affiliations

  1. Bioanalytical Solution Integration, Burlington, New Jersey, USA

    Mark E. Arnold

  2. U.S. Food and Drug Administration, Silver Spring, Maryland, USA

    Brian Booth

  3. Pfizer Inc., Groton, Connecticut, USA

    Lindsay King

  4. Pfizer Inc., La Jolla, California, USA

    Chad Ray

Authors
  1. Mark E. Arnold
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  2. Brian Booth
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  3. Lindsay King
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  4. Chad Ray
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Corresponding author

Correspondence to Mark E. Arnold.

Additional information

The views expressed are those of the authors and do not reflect official policy of the FDA. No official endorsement by the FDA is intended or should be inferred.

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Arnold, M.E., Booth, B., King, L. et al. Workshop Report: Crystal City VI—Bioanalytical Method Validation for Biomarkers. AAPS J 18, 1366–1372 (2016). https://doi.org/10.1208/s12248-016-9946-6

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  • DOI: https://doi.org/10.1208/s12248-016-9946-6

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