Patient Centric Blood Sampling and Quantitative Analysis E-Book
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- Herausgeber: John Wiley & Sons
- Kategorie: Wissenschaft und neue Technologien
- Serie: Wiley Series on Pharmaceutical Science
- Sprache: Englisch
PATIENT CENTRIC BLOOD SAMPLING AND QUANTITATIVE ANALYSIS Authoritative resource providing a complete overview of patient centric blood sampling, as well as its benefits and challenges Patient Centric Blood Sampling and Quantitative Analysis focuses on the growing interest in alternative means to standard phlebotomy and analytical workflows for the collection and analysis of high-quality human biological samples for the quantitative determination of circulating drugs, their metabolites, and endogenous substances for clinical trials, routine healthcare and neonatal screening. The book clearly explains the benefits and constraints of having patients collect small volumes of blood in locations outside of a clinic (e.g at home), including: patient convenience; less invasive procedures; increased frequency of sampling; applicability to collecting samples from the young, elderly, and those in remote locations; greater frequency; and lower cost per sample. Readers will learn about approaches for successfully implementing patient centric sampling workflows in a number of scenarios, including the clinical setting and in the analytical laboratory. Edited by four recognized experts in this field, with additional specialists in the discipline enlisted to write the component chapters, enabling greater depth and detail to be added and further raising the scientific standing of the publication, Patient Centric Blood Sampling and Quantitative Analysis includes information on: * Basics of patient centric blood sampling and techniques and approaches that are available and in development for the collection and analysis of the samples * Science behind patient centric blood sampling and its implications regarding human healthcare and wellbeing * Application areas of patient centric sampling, including drug development, clinical chemistry/pathology, therapeutic drug monitoring, and more * Practical approaches to successful implementation for existing and developing purposes and workflows, and case studies to support implementation within an organization Giving the reader a broad understanding of what patient centric sampling is and where it might be applied for existing and potential future areas, Patient Centric Blood Sampling and Quantitative Analysis is an essential resource on the subject for many different types of laboratories, areas of clinical research and healthcare, including those in pharmaceutical, clinical, and research functions.
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Veröffentlichungsjahr: 2023
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Table of Contents
Cover
Table of Contents
Series Page
Title Page
Copyright Page
List of Contributors
Foreword
Preface
1 Patient Centric Healthcare – What's Stopping Us?
1.1 The Evolution of Future Health Systems
1.2 Exploring the Barriers to Home Sampling
1.3 Conclusion: The Changing Role of Home Sampling
References
2 Tips for Successful Quantitative Assay Development Using Mitra Blood Sampling with Volumetric Absorptive Microsampling
2.1 What is Volumetric Absorptive Microsampling?
2.2 Tip 1—Ensure the Use of a Correct Sampling Procedure to Prevent Volume‐Related Biases
2.3 Tip 2—Working with Wet Whole Blood
2.4 Tip 3—Working with Dried Whole Blood
2.5 Tip 4—Optimizing Extraction Efficiencies from VAMS
2.6 Conclusions
References
3 Preanalytical Considerations for Implementation of Microsampling Solutions
3.1 Introduction
3.2 Sample Matrices
3.3 Alternate Sample Acceptance Criteria
3.4 Collection
3.5 Transportation and Sample Stability
3.6 Preanalytical Processing
3.7 Overall Conclusions
References
4 Collection and Bioanalysis of Quantitative Microsamples
4.1 Introduction
4.2 Practical Implications in Clinical Settings
4.3 Microsampling Devices—A Patient‐Centered Approach
4.4 New Development Areas
4.5 Summary of Currently Available Patient Centric Sampling Technologies
4.6 Microsampling Analysis by LC‐MS—Analytical Considerations
4.7 Conclusions
References
5 Automation in Microsampling
5.1 Introduction
5.2 Automation of Dried Blood Microsampling Analysis Coupled to (LC‐)MS/MS: What’s Available?
5.3 Integration Into a Clinical Laboratory
5.4 Conclusions and Future Perspectives
Acknowledgments
References
6 Over 50 Years of Population‐Based Dried Blood Spot Sampling of Newborns; Assuring Quality Testing and Lessons Learned
6.1 Overview of Population‐Based Newborn Screening
6.2 Public Perceptions of NBS
6.3 Characteristics of the DBS Matrix and Its Utility in NBS
6.4 Methods Used in NBS
6.5 Conclusion
Acknowledgments
Conflicts of Interest
References
7 Considerations for Implementation of Microsampling in Pediatric Clinical Research and Patient Care
7.1 Introduction
7.2 Considerations for Implementation
7.3 Conclusion
References
8 Simplification of Home Urine Sampling for Measurement of 2,8‐Dihydroxyadenine in Patients with Adenine Phosphoribosyltransferase Deficiency
8.1 Introduction
8.2 Methods
8.3 Results
8.4 Discussion
8.5 Conclusions and Future Directions
References
9 Utilization of Patient Centric Sampling in Clinical Blood Sample Collection and Protein Biomarker Analysis
9.1 Introduction
9.2 Current Patient Centric Sampling Landscape
9.3 Clinical Proteome Profiling Technologies for Testing Patient Centric Microsampling Devices
9.4 Clinical Sample Collection with Tap Device: A Clinical Case Study
9.5 Discussion
References
10 Enabling Patient Centric Sampling Through Partnership
*
10.1 Introduction
10.2 Pre‐Study Considerations
10.3 The Case Study
10.4 Summary
References
11 Perspectives on Adopting Patient Centric Sampling for Pediatric Trials
11.1 Overview and Why
11.2 Challenges and Current Status
11.3 Solutions: How Do We Get This Done
11.4 Summary
References
Index
End User License Agreement
List of Tables
Chapter 3
Table 3.1 Optimum, Desirable, and Minimum Analyte Performance Specification...
Table 3.2 Analyte Specific Performance Specifications from CLIA and the EFL...
Table 3.3 Measured Hemolysis Index for Plasma Samples Obtained Using Three ...
Table 3.4 Proposed Summer and Winter Excursions for Testing Analyte Stabili...
Chapter 4
Table 4.1 General Considerations for Analytical Workflow Using Microsamplin...
Table 4.2 Classification of LC Columns According to the Inner Diameter (ID)...
Table 4.3 Analytical Figures of Merit for Standard, Capillary, and Nanoflow...
Chapter 5
Table 5.1 Overview of published applications employing automated DBS extrac...
Table 5.2 Overview of the potential advantages and hurdles for implementati...
Chapter 6
Table 6.1 Observed Causes of Unacceptable DBS Specimens.
Table 6.2 Impact of Temperature, Humidity, Desiccant, and Time on Analytes ...
Table 6.3 Specimen Collection and Handling Interferences and Their Impact o...
Table 6.5 Infant Conditions or Treatments that can Cause Interferences in N...
Table 6.6 Current QC and PT DBS Offerings from NSQAP as of 2023.
Table 6.7 Newborn Screening Molecular Tests Performed in the United States....
Chapter 8
Table 8.1 Experimental Factors and Settings for the Design of Experiments....
Table 8.2 Experimental Conditions for the Optimized UPLC‐MS/MS urinary 2,8‐...
Table 8.3 Intra‐ and Interassay Precision and Accuracy of 2,8‐Dihydroxyaden...
Table 8.4 Clinical Characteristics of Patients with Adenine Phosphoribosylt...
Chapter 9
Table 9.1 Study Subject Baseline Characteristics. Subject Baseline Characte...
Table 9.2 Pearson Correlation Curve Characteristics of Different Proteins S...
Table 9.3 Pearson Correlation Curve Characteristics of Different Proteins S...
Table 9.4 Pearson Correlation Curve Characteristics of Different Proteins S...
Chapter 10
Table 10.1 Considerations When Assessing the Feasibility of a PCS Approach....
Table 10.2 PK and PD Samples Collected, Assays Required, and Use of the Dat...
Chapter 11
Table 11.1 Estimated Pediatric Blood Volumes.
List of Illustrations
Chapter 2
Figure 2.1 Mitra with VAMS microsamplers being used to collect capillary blo...
Figure 2.2 Effect of percentage hematocrit (HCT) and analyte concentration o...
Figure 2.3 Differences in percentage extraction recovery of four drugs from ...
Figure 2.4 Effect of percentage blood hematocrit (HCT) on mean percentage re...
Figure 2.5 Screening the right solvents for maximizing extraction efficienci...
Figure 2.6 Using pH to suppress (a) acid (Diclofenac [p
K
a
4.15] and Naproxen...
Figure 2.7 96‐Autorack™ used for lab processing of dried blood VAMS samples ...
Figure 2.8 Optimized extraction recovery of probe compounds from whole blood...
Figure 2.9 Rate of VAMS publications over time (data compiled from various s...
Chapter 3
Figure 3.1 Serum versus plasma comparison of AST, BUN, and cholesterol. Blac...
Figure 3.2 Serum versus plasma comparison for creatinine, glucose, and total...
Figure 3.3 Serum versus plasma comparison data for albumin, calculated globu...
Figure 3.4 Venous serum and plasma versus capillary serum and plasma compari...
Figure 3.5 Venous serum and plasma versus capillary serum and plasma data fo...
Figure 3.6 Serial capillary sampling data for AST, BUN, creatinine, choleste...
Figure 3.7 Image of the blades and additional information for the lancets ut...
Figure 3.8 Normalized plasma measurements obtained from lancing three differ...
Figure 3.9 Temperature logger data for temperature controlled packages shipp...
Figure 3.10 Temperature logger data for a package (without temperature contr...
Figure 3.11 Jaffé versus enzymatic creatinine assay comparison data. Black d...
Figure 3.12 Creatinine whole blood stability for two different assays for bo...
Chapter 4
Figure 4.1 Advantages associated with the use of microsampling devices and t...
Figure 4.2 DBS workflow for sample collection and analysis. The collection a...
Figure 4.3 Illustration of three hematocrit levels of whole blood (20, 45, a...
Figure 4.4 A selection of cellulose and noncellulose‐based whole blood sampl...
Figure 4.5 Capillary whole blood sampling devices. (a) Vitrex Medical self‐s...
Figure 4.6 Microfluidic‐DBS devices. (a) Capitainer qDBS collects an unknown...
Figure 4.7 Illustration of ESI and nano‐ESI: Comparison of ions efficiency....
Figure 4.8 Chromatographers dilemma: Correlation between chromatographic spe...
Figure 4.9 Sensitivity gains observed due to change in column diameter and f...
Figure 4.10 PicoChip
®
technology (a); anatomy of a Pico Frit
®
colu...
Chapter 5
Figure 5.1 Commercially available (semi‐)automated punching and pipetting in...
Figure 5.2 Schematic workflow of an automated extraction instrument. Followi...
Chapter 6
Figure 6.1 Publications featuring dried blood spots (DBS) and newborns scree...
Figure 6.2 Expansion of the Newborn Screening Quality Assurance Program (NSQ...
Figure 6.3 Newborn Screening Quality Assurance Program hallmark events timel...
Chapter 7
Figure 7.1 Simple schematic for the process of VAMS™ sample collection, extr...
Figure 7.2 Visual representation of (a) blank VAMS device (no blood), (b) no...
Figure 7.3 Comparison of the % difference in under ‐, normal, and overloadin...
Figure 7.4 In vitro comparison of whole blood, whole blood VAMS, and plasma....
Figure 7.5 Summary of survey results for the preference of plasma versus VAM...
Chapter 8
Figure 8.1 Overview of adenine metabolism. Adenine is oxidized by xanthine o...
Figure 8.2 Urinary 2,8‐dihydroxyadenine crystals. (a) The characteristic med...
Figure 8.3 D‐optimal design (a) and central composite face (CCF) design (b)....
Figure 8.4 Regression coefficients plot scaled and centered for peak height ...
Figure 8.5 Counterplot for the peak height (a) and retention time (b) of 2,8...
Figure 8.6 Multiple reaction monitoring (MRM) chromatogram of 2,8‐dihydroxya...
Figure 8.7 Scatter plot of 24‐hr urinary 2,8‐dihydroxyadenine (DHA) excretio...
Chapter 9
Figure 9.1 Study design and workflow. Healthy volunteer study design and sam...
Figure 9.2 Typical Venous_0 plasma samples. The venous sample collected thro...
Figure 9.3 Typical TAP_72 plasma samples post‐centrifugation. TAP‐collected ...
Figure 9.4 Typical TAP_72 blood samples upon transferring from TAP device.
Figure 9.5 Harboe method‐based hemoglobin concentration comparison between s...
Figure 9.6 Flatted projections of first three principal components comparing...
Figure 9.7 Principal component loading factor analysis comparison highlights...
Figure 9.8 SomaScan profiling data comparison between sampling groups (Venou...
Figure 9.9 Volcano plots comparing the entire 5,080 SOMAmer profile between ...
Figure 9.10 Correlation plots of ELISA data in normal scale. (a) CRP compari...
Figure 9.11 Correlation plots of ELISA data in normal scale. (a) Glycoprotei...
Figure 9.12 Correlation plots of ELISA data in normal scale. (a) HAMP compar...
Chapter 10
Figure 10.1 The complexities of interactions in a large organisation when lo...
Figure 10.2 Bridging PK (and PD) involved comparing data from both plasma, w...
Guide
Cover Page
Series Page
Title Page
Copyright Page
List of Contributors
Foreword
Preface
Table of Contents
Begin Reading
Index
WILEY END USER LICENSE AGREEMENT
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Wiley Series on Pharmaceutical Science and Biotechnology: Practices, Applications, and Methods
Series Editor:Mike S. LeeNew Objective
Mike S. Lee (ed.) • Integrated Strategies for Drug Discovery Using Mass Spectrometry
Birendra Pramanik, Mike S. Lee, and Guodong Chen (eds.) • Characterization of Impurities and Degradants Using Mass Spectrometry
Mike S. Lee and Mingshe Zhu (eds.) • Mass Spectrometry in Drug Metabolism and Disposition: Basic Principles and Applications
Mike S. Lee (ed.) • Mass Spectrometry Handbook
Wenkui Li and Mike S. Lee (eds.) • Dried Blood Spots—Applications and Techniques
Ayman F. El‐Kattan (ed.) • Oral Bioavailability Assessment: Basics and Strategies for Drug Discovery and Development
Mike S. Lee and Qin Ji (eds.) • Protein Analysis using Mass Spectrometry: Accelerating Protein Biotherapeutics from Lab to Patient
Naidong Wng and Wenying Jian (eds.) • Targeted Biomarker Quantitation by LC‐MS
Wenkui Li, Wenying Jian, and Yunlin Fu (eds.) • Sample Preparation in LC‐MS Bioanalysis
Neil Spooner, Emily Ehrenfeld, Joe Siple, and Mike S. Lee (eds.) • Patient Centric Blood Sampling and Quantitative Bioanalysis: From Ligand Binding to LC‐MS
Patient Centric Blood Sampling and Quantitative Bioanalysis
Edited by
Neil Spooner
Spooner Bioanalytical SolutionsHertford, UK
Emily Ehrenfeld
New ObjectiveCambridge, MA, USA
Joe Siple
New ObjectiveCambridge, MA, USA
Mike S. Lee
New ObjectiveCambridge, MA, USA
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List of Contributors
Catherine E. AlbrechtLabcorp Drug DevelopmentGeneva, [email protected]
Cecilia ArfvidssonIntegrated Bioanalysis, ClinicalPharmacology and Safety Sciences,Biopharmaceuticals, R&D,AstraZeneca, Gothenburg,[email protected]
Christopher BaileyIntegrated Bioanalysis, ClinicalPharmacology and Safety Sciences,Biopharmaceuticals, R&D,AstraZeneca, Cambridge, [email protected]
Stephanie CapeLabcorp Drug DevelopmentMadison, WI, [email protected]
Marc Yves ChalomSens Representações ComerciaisSao Paulo, Sao Paulo, [email protected]
Bradley B. CollierLaboratory Corporation of AmericaHoldings (LabCorp), Center forEsoteric Testing, Burlington, NC, [email protected]
Suzanne K. CordovadoCenters for Disease Control andPreventionAtlanta, GA, [email protected]
Carla D. CuthbertCenters for Disease Control andPreventionAtlanta, GA, [email protected]
Sigrid DeprezLaboratory of ToxicologyFaculty of Pharmaceutical SciencesGhent University, Ghent, [email protected]
Vidar O. EdvardssonChildren’s Medical CenterLandspitali–The National UniversityHospital of Iceland, Reykjavik, Iceland
Faculty of Medicine, School of HealthSciences, University of IcelandReykjavík, [email protected]
Amy M. Gaviglio4ES CorporationSan Antonio, TX, [email protected]
Russell P. GrantLaboratory Corporation of AmericaHoldings (LabCorp), Center forEsoteric Testing, Burlington, NC, [email protected]
Arkady I. GusevBiomarker DevelopmentNovartis Institutes of BioMedicalResearch, Inc.Cambridge, MA, [email protected]
Liesl HeughebaertLaboratory of ToxicologyFaculty of Pharmaceutical SciencesGhent University, Ghent, [email protected]
Rachel JonesCheshire, [email protected]
Carlos Roberto V. KifferLaboratório Especialista deMicrobiologia ClínicaDisciplina de InfectologiaEscola Paulista de MedicinaUniversidade Federal de São Paulo(UNIFESP), Sao PauloSao Paulo, [email protected]
Joseph LoureiroDisease Area XNovartis Institutes of BiomedicalResearch, Inc.Cambridge, MA, [email protected]
Kristina MercerCenters for Disease Control andPreventionAtlanta, GA, [email protected]
Peyton K. MiesseLaboratory Corporation of AmericaHoldings (LabCorp), Center forEsoteric Testing, Burlington, NC, [email protected]
Dmitri MikhailovBiomarker DevelopmentNovartis Institutes of BioMedicalResearch, Inc.Cambridge, MA, [email protected]
Ganesh S. MoorthyChildrens Hospital of Philadelphia,Perelman School of Medicine,University of Pennsylvania, 3400Civic Center Boulevard, Building 421,Philadelphia, PA 19104, [email protected]
Robert NelsonLabcorp Drug DevelopmentGeneva, [email protected]
Regina V. OliveiraNúcleo de Pesquisa em Cromatografia(Separare)Departamento de QuímicaUniversidade Federal de São CarlosSao Carlos, Sao Paulo, [email protected]
Runolfur PalssonInternal Medicine ServicesLandspitali–The National UniversityHospital of IcelandReykjavik, Iceland
Faculty of MedicineSchool of Health SciencesUniversity of IcelandReykjavík, [email protected]
Konstantinos PetritisCenters for Disease Control andPreventionAtlanta, GA, [email protected]
Silvia Alonso RodriguezTranslational Science andExperimental Medicine Early R&IBiopharmaceuticals R&DAstraZeneca, Cambridge, [email protected]
Jenny RoyleMediPaCe LimitedLondon, [email protected]
James RudgeTrajan Scientific and MedicalCrownhill Business CentreMilton Keynes, [email protected]
Hrafnhildur L. RunolfsdottirInternal Medicine ServicesLandspitali—The National UniversityHospital of IcelandReykjavik, [email protected]
Paul SeverinLabcorp Drug DevelopmentMadison, WI, [email protected]
Christophe P. StoveLaboratory of ToxicologyFaculty of Pharmaceutical SciencesGhent University, Ghent, [email protected]
Veronique StoveDepartment of Laboratory MedicineGhent University HospitalGhent, Belgium
Department of Diagnostic SciencesFaculty of Medicine and Health SciencesGhent University, Ghent, [email protected]
Unnur A. ThorsteinsdottirFaculty of Pharmaceutical SciencesSchool of Health SciencesUniversity of IcelandReykjavik, [email protected]
Margret ThorsteinsdottirFaculty of Pharmaceutical SciencesSchool of Health SciencesUniversity of IcelandReykjavik, Iceland
ArcticMass, Reykjavik, [email protected]
Christina VedarChildrens Hospital of Philadelphia,Perelman School of Medicine,University of Pennsylvania, 3400Civic Center Boulevard, Building 421,Philadelphia, PA 19104, [email protected]
Nick VerougstraeteLaboratory of ToxicologyFaculty of Pharmaceutical SciencesGhent University, Ghent, Belgium
Department of Laboratory MedicineGhent University HospitalGhent, [email protected]
Alain G. VerstraeteDepartment of Laboratory MedicineGhent University HospitalGhent, Belgium
Department of Diagnostic SciencesFaculty of Medicine and HealthSciencesGhent University, Ghent, [email protected]
Enaksha WickremsinheLilly Research LaboratoriesEli Lilly and CompanyIndianapolis, IN, [email protected]
Jinming XingBiomarker Development, NovartisInstitutes for BioMedical Research,Inc., Cambridge, MA, [email protected]
Athena F. ZuppaChildrens Hospital of Philadelphia,Perelman School of Medicine,University of Pennsylvania,Philadelphia, PA, [email protected]
Foreword
Many of the contributors to this book were authoring their chapters whilst living through a global pandemic, which has changed healthcare and health politics forever, and this book could not have been written at a better time.
Sitting here today, we are facing unprecedented change in international health systems—with spiralling costs, increasing cultural and national disparity in healthcare delivery and acceptance, ageing populations, and infrastructures that are decades old. The world around healthcare is moving at a faster pace than the institution can cope with. In today’s world mobile phones and technology are now commonplace in many households. Telehealth and virtual consultancies are, in some cases, gradually replacing traditional face‐to‐face appointments. And people are starting to accept wellness and prevention as ways that they themselves can tackle the onset of disease.
The boundaries of healthcare are finally beginning to change from the clinic walls and reach out into people’s lives. Not only does this result in a healthcare system that is more accessible, but it also brings the possibility of healthcare being culturally tailored for populations and delivered in more sensitive and acceptable ways. Of reaching, and supporting, the most vulnerable in our society.
At the center of this reform is the ability to test and monitor for known illnesses outside of the clinic itself. Patient‐centric sampling involves the patient or caregiver taking small amounts of body fluid—blood or saliva as examples—in the comfort of a person’s home. Recent technological advances have made this possible, making user friendly, simple, safe, and even painless devices available. These are then packaged as directed and then either posted or collected and sent to a central laboratory for processing. The implementation of this approach, however, is fraught with challenges that need to be overcome before it can be fully integrated as the standard approach that healthcare reaches for first. From the learnings of the pandemic we have real life examples where patient‐centric sampling has been successfully implemented within and across countries.
This book shines a light on the whole approach. It presents a balanced look across all aspects—the challenges, technological requirements, assays, processes, delivery … all the way through to the human behavior and ways to integrate into the norm. It discusses everything we have learnt from the long and rich microsampling history and how this can be used to deliver for the rapidly changing expectations and requirements of future populations and healthcare services. It outlines the unique challenges and opportunities presented through use of patient‐centric sampling in the clinical trials that are so essential for developing new medicines.
Every one of the authors in this book wrote their chapters to help others. They represent a diverse background of expertise and share their experiences, insights, and case studies with astonishing honesty, openness, and integrity. This partnership between people is unified by a belief in the welfare of others. It gives a unique insight into the systematic changes that must be undertaken to allow the full potential of patient‐centric care to be realized. Throughout, these insights are supported and enhanced by the author’s real‐life case studies and experiences of using this approach in practice.
It is hoped that by sharing this, you will be the next to add to this wave of change—to join the innovators and make a difference. If we all do this, then together we can play our part in ensuring healthcare becomes accessible and acceptable to those who need it most, the patients.
Jenny Royle
Matthew Barfield
Preface
There is an increasingly broad understanding that the collection of biological samples for the quantitative determination of analytes for healthcare and the support of clinical trials needs to be performed in a manner that puts the needs of the patient at the center. The technologies to enable high quality samples to be collected in a location such as the home, pharmacist, local doctor’s surgery, or other locations that are convenient to the patient, rather than at a centralized clinical center, are now readily available. Furthermore, the clamour for this change has gained momentum during the recent COVID‐19 pandemic, where all of us were reluctant to go to clinical facilities. Despite this, change is always difficult, particularly for something as well established as the processes for the collection and analysis of blood samples. Thankfully, there is an increasing body of leaders, represented by the authors of the chapters in this book, who realize the benefits of these solutions and understand that by working together across inter‐ and intra‐organizational boundaries we can break down the barriers to their routine adoption and bring benefits to the patient.
A previous book in this series, Dried Blood Spots, edited by Wenkui Li and Mike Lee, set the benchmark for our understanding of the benefits of these patient‐centric sampling technologies and how they can be implemented in a number of scenarios. This book builds upon those strong foundations, to bring us up to date with how this exciting and fast‐moving field has developed. The authors, who are looking to enable the routine use of these technologies for the benefit of their fellow humans, generously share their observations, experiences, concerns, and visions of the future. As such, this book is another benchmark in the continuing change that is healthcare and analytical science. We can say with certainty that there is further change to come in this field and as such we look forward to working as a community to facilitate these important and inevitable changes.
The editors sincerely thank all the distinguished authors for the provision of their wonderful chapters and for their patience and persistence with this project through the difficult events of the pandemic. It has definitely been worth the wait! We also wish to thank the editorial staff at John Wiley & Sons for their unwavering and patient support to this project that is a small part of the phenomenal series edited by Mike Lee.
Neil Spooner
Emily Ehrenfeld
Joe Siple
Mike S. Lee
