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Integrating Pharmacoproteomics into Early-Phase Clinical Development: State-of-the-Art, Challenges, and Recommendations

by Savita Nandal 1,* and Tal Burt 2,*
1
Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA
2
Burt Consultancy, 2616 Erwin Rd, Durham, NC 27705, USA
*
Authors to whom correspondence should be addressed.
Academic Editors: Sabrina Angelini and Gloria Ravegnini
Int. J. Mol. Sci. 2017, 18(2), 448; https://doi.org/10.3390/ijms18020448
Received: 16 December 2016 / Revised: 17 January 2017 / Accepted: 18 January 2017 / Published: 19 February 2017
(This article belongs to the Special Issue Pharmacogenetics and Personalized Medicine 2016)
Pharmacoproteomics is the study of disease-modifying and toxicity parameters associated with therapeutic drug administration, using analysis of quantitative and temporal changes to specific, predetermined, and select proteins, or to the proteome as a whole. Pharmacoproteomics is a rapidly evolving field, with progress in analytic technologies enabling processing of complex interactions of large number of unique proteins and effective use in clinical trials. Nevertheless, our analysis of clinicaltrials.gov and PubMed shows that the application of proteomics in early-phase clinical development is minimal and limited to few therapeutic areas, with oncology predominating. We review the history, technologies, current usage, challenges, and potential for future use, and conclude with recommendations for integration of pharmacoproteomic in early-phase drug development. View Full-Text
Keywords: proteome; proteomics; drug development; early phase development; clinical development; biomarker; Omics; clinical research; phase 0; phase 1; phase 2; proof-of-concept; proof-of-mechanism; proof-of-principle; first-in-human (FIH) studies; pharmacogenomics; pharmacometabolomics; pharmacokinetics (PK); pharmacodynamics (PD); drug toxicity proteome; proteomics; drug development; early phase development; clinical development; biomarker; Omics; clinical research; phase 0; phase 1; phase 2; proof-of-concept; proof-of-mechanism; proof-of-principle; first-in-human (FIH) studies; pharmacogenomics; pharmacometabolomics; pharmacokinetics (PK); pharmacodynamics (PD); drug toxicity
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Nandal, S.; Burt, T. Integrating Pharmacoproteomics into Early-Phase Clinical Development: State-of-the-Art, Challenges, and Recommendations. Int. J. Mol. Sci. 2017, 18, 448.

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