title: In Vivo Imaging in Pharmaceutical Development and Its Impact on the 3Rs.
abstract: It is well understood that the biopharmaceutical industry must improve efficiency along the path from laboratory concept to commercial product. In vivo imaging is recognized as a useful method to provide biomarkers for target engagement, treatment response, safety, and mechanism of action. Imaging biomarkers have the potential to inform the selection of drugs that are more likely to be safe and effective. Most of the imaging modalities for biopharmaceutical research are translatable to the clinic. In vivo imaging does not require removal of tissue to provide biomarkers, thus reducing the number of valuable preclinical subjects required for a study. Longitudinal imaging allows for quantitative intra-subject comparisons, enhancing statistical power, and further reducing the number of subjects needed for the evaluation of treatment effects in animal models. The noninvasive nature of in vivo imaging also provides a valuable approach to alleviate or minimize potential pain, suffering or distress.
authors.affiliation: Barry R. Campbell is an Associate Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Kenilworth, New Jersey. Dinko Gonzalez Trotter, PhD, is a Senior Director in Early Clinical Development at Regeneron Pharmaceuticals, Inc., in Tarrytown, New York. Catherine D. Hines, PhD is a Director in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Manishkumar Patel, PhD is a Principal Scientist in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Weisheng Zhang is a Senior Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Boston, Massachusetts. Jeffrey L. Evelhoch, PhD, is Vice President of Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania.
authors.forename: Barry R
authors.initials: BR
authors.lastname: Campbell
authors.affiliation: Barry R. Campbell is an Associate Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Kenilworth, New Jersey. Dinko Gonzalez Trotter, PhD, is a Senior Director in Early Clinical Development at Regeneron Pharmaceuticals, Inc., in Tarrytown, New York. Catherine D. Hines, PhD is a Director in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Manishkumar Patel, PhD is a Principal Scientist in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Weisheng Zhang is a Senior Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Boston, Massachusetts. Jeffrey L. Evelhoch, PhD, is Vice President of Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania.
authors.forename: Dinko
authors.initials: D
authors.lastname: Gonzalez Trotter
authors.affiliation: Barry R. Campbell is an Associate Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Kenilworth, New Jersey. Dinko Gonzalez Trotter, PhD, is a Senior Director in Early Clinical Development at Regeneron Pharmaceuticals, Inc., in Tarrytown, New York. Catherine D. Hines, PhD is a Director in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Manishkumar Patel, PhD is a Principal Scientist in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Weisheng Zhang is a Senior Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Boston, Massachusetts. Jeffrey L. Evelhoch, PhD, is Vice President of Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania.
authors.forename: Catherine D G
authors.initials: CD
authors.lastname: Hines
authors.affiliation: Barry R. Campbell is an Associate Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Kenilworth, New Jersey. Dinko Gonzalez Trotter, PhD, is a Senior Director in Early Clinical Development at Regeneron Pharmaceuticals, Inc., in Tarrytown, New York. Catherine D. Hines, PhD is a Director in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Manishkumar Patel, PhD is a Principal Scientist in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Weisheng Zhang is a Senior Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Boston, Massachusetts. Jeffrey L. Evelhoch, PhD, is Vice President of Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania.
authors.forename: Wenping
authors.initials: W
authors.lastname: Li
authors.affiliation: Barry R. Campbell is an Associate Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Kenilworth, New Jersey. Dinko Gonzalez Trotter, PhD, is a Senior Director in Early Clinical Development at Regeneron Pharmaceuticals, Inc., in Tarrytown, New York. Catherine D. Hines, PhD is a Director in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Manishkumar Patel, PhD is a Principal Scientist in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Weisheng Zhang is a Senior Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Boston, Massachusetts. Jeffrey L. Evelhoch, PhD, is Vice President of Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania.
authors.forename: Manishkumar
authors.initials: M
authors.lastname: Patel
authors.affiliation: Barry R. Campbell is an Associate Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Kenilworth, New Jersey. Dinko Gonzalez Trotter, PhD, is a Senior Director in Early Clinical Development at Regeneron Pharmaceuticals, Inc., in Tarrytown, New York. Catherine D. Hines, PhD is a Director in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Manishkumar Patel, PhD is a Principal Scientist in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Weisheng Zhang is a Senior Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Boston, Massachusetts. Jeffrey L. Evelhoch, PhD, is Vice President of Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania.
authors.forename: Weisheng
authors.initials: W
authors.lastname: Zhang
authors.affiliation: Barry R. Campbell is an Associate Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Kenilworth, New Jersey. Dinko Gonzalez Trotter, PhD, is a Senior Director in Early Clinical Development at Regeneron Pharmaceuticals, Inc., in Tarrytown, New York. Catherine D. Hines, PhD is a Director in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Manishkumar Patel, PhD is a Principal Scientist in Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania. Weisheng Zhang is a Senior Principal Scientist in Translational Biomarkers at Merck Research Laboratories in Boston, Massachusetts. Jeffrey L. Evelhoch, PhD, is Vice President of Translational Biomarkers at Merck Research Laboratories in West Point, Pennsylvania.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Evelhoch
mesh_terms: D023401:Animal Use Alternatives; D000818:Animals; D015415:Biomarkers; D003952:Diagnostic Imaging / Q000379:methods*; D006801:Humans; D023421:Models, Animal; D012106:Research
chemical_list: D015415:Biomarkers
keywords: 3Rs; drug development; drug safety; imaging; mechanism of action; target engagement; treatment response