Layfield-Christopher-BHR-Baltimore-2014

.... Use or disclosure of information appearing on this sheet is subject to the restrictions set forth on the title page of this proposal.
Christopher Layfield
Senior Quality Systems Specialist
Education
M.P.H., Public Health Epidemiology, George Washington University, 2007
B.S., Microbiology, University of Maryland, College Park, 1996
Other Training
Certifications:
Certified Quality Auditor, American Society for Quality, 2013
Registered Assistant Laboratory Animal Technician, American Association for Laboratory Animal
Science, 2007 (expired)
Programming Language:
Visual Basic for Applications
Database Management Applications:
MS Access, SQL
Systems / Platforms:
SharePoint, SharePoint Designer, MS Office
Qualifications
Mr. Layfield has a Master of Public Health in Epidemiology with over 15 years of experience with U.S.
Food and Drug Administration (FDA) and U.S. Environmental Protection Agency (EPA) Good Laboratory
Practices regulatory experience in cGxP and International Organization for Standardization (ISO)
systems. His experience includes auditing to federal and state regulatory, client, and Battelle
requirements supporting public health and biological research. This includes toxicological, immunological
vaccines and development of immunological and enzymatic assays for the detection of toxins and
pathogens.
Mr. Layfield has received certification as a Certified Quality Auditor by the American Society for Quality
and is currently the Quality Assurance (QA) Manager for major Health and Consumer Solutions’ contracts
including the Center for Medicare and Medicaid Services (CMS) Measure and Instrument Development
(MIDS), the National Heart Lung and Blood Institutes (NHLBI) Healthy Communities Study (HCS). Mr.
Layfield provides quality assurance oversight to Battelle’s Eastern Science and Technology Center,
including the GLP Biomarkers program, ISO9001/17025 compliant Physical Engineering Geophysical
Laboratory supporting the Tooele Chemical Agent Disposal Facility, the Applied Research and Laboratory
Operations and the Pueblo Chemical Agent-Destruction Pilot Plant supporting the Center for Biological,
Radiological, Nuclear, and Electrical (CBRNE) program, and the CBRNE Analytical and Remediation
Activity (CARA) Mobile Expeditionary Laboratory (MEL) at Aberdeen Proving Grounds.
He was the QA Manager for the Agency for Healthcare Research and Quality’s (AHRQ) Quality Indicator
Program and the Compliance Officer for the National Children’s Study at Battelle. Mr. Layfield managed
the data coordinating center for the National Children’s Study Autism formative research project. In this
role he coordinates data collection, storage, and delivery of data from all study partners. As Review
Coordinator for the Laboratory Medicine Best Practices Initiative, Mr. Layfield coordinated and managed
topic creation, literature review activities, expert panel review, and data analysis.
Prior to joining Battelle, Mr. Layfield audited, managed, and contributed to non-clinical toxicology research
for Bridge Pharmaceuticals and BioReliance. He created compliance programs to meet regulatory
requirements of 21 CFR Part 11 at BioReliance. Mr. Layfield also acted as the National Toxicology
Program data manager for BioReliance in support of non-clinical toxicology research at BioReliance. He

Christopher Layfield Page 2
Use or disclosure of information appearing on this sheet is subject to the restrictions set forth on the title page of this proposal.
has additional experience with genetic toxicology research including in vitro cytogenetics, sister chromatid
exchange, single-cell gel electrophoresis, Syrian hamster embryo cell transformation, and Ames testing.
Employment History
2014–Present Senior Quality Systems Specialist
Battelle Health and Consumer Solutions
2012-2014 Manager
Battelle Health & Analytics
2010–2012 Research Scientist
Battelle Health & Analytics
2009–2010 Quality Assurance Auditor
Battelle
2008–2009 Quality Assurance Specialist
Aerotek (for Battelle)
Nottingham, Maryland
2007–2008 Toxicology Associate
Bridge Pharmaceuticals
Gaithersburg, Maryland
2005–2007 Senior Associate Scientist
Adecco USA (for BioReliance as independent contractor)
Frederick, Maryland
1999–2005 Senior Associate Scientist
BioReliance, Invitrogen Bioservices
Rockville, Maryland
Battelle Experience
 CBRNE Analytical and Remediation Activity (CARA) Mobile Expeditionary Laboratory (MEL)
Client: U.S. Department of Defense (DoD, Army)
Mr. Layfield is the Quality Assurance Manager responsible for providing support to and training for the
CBRNE CARA MEL Quality Assurance Managers. Mr. Layfield is primarily responsible to ensure that
the CARA MEL is meets the requirements of the Quality Control Plan and other requirements for
CASARM certification. He is primarily responsible for providing audit support to the CARA MEL
internal auditors, reviewing CASARM Audit findings and the CARA MEL response for compliance and
to ensure the CARA MEL group resolves any findings. Mr. Layfield will manage the quality
improvement process for the CARA MEL training program, to include the revision, improvement, and
validation of the Training and Certification forms using a standardized systems development life
cycle.
 IDIQ: Assessment of Tobacco Pharmacology and Behavior in Humans
Client: Food and Drug Administration, Center for Tobacco Products (FDA, CTP)
Mr. Layfield is the Quality Assurance Manager with oversight responsibility for this contract
mechanism for the FDA. The primary objective of this IDIQ contract is to evaluate the impact of
tobacco products on human behavior, topography, and pharmacology, including clinical
pharmacokinetics and pharmacodynamics. Under this contract, Battelle will be expected to perform

studies that will assess the impacts of tobacco products on dependence, craving, withdrawal, choice
behavior, use behavior and topography, harm perception, physiological and pharmacodynamics
effects, and measurements of biomarkers of exposure (e.g., nicotine, cotinine, CO, TSNAs). All
laboratory studies carried out under this IDIQ will be required to follow Good Laboratory Practices
(GLP). For clinical pharmacology studies, use of a Clinical Pharmacology Unit and Good Clinical
Practices (GCP) will be required. Data collected under this contract will inform FDA on the behavioral
and pharmacological effects associated with tobacco product use, and may guide tobacco product
policies and regulations.
o Task Order #1: Dependence Behaviors and Nicotine Pharmacokinetics Associated with blu
Electronic Cigarettes in Current Users
Mr. Layfield is the Quality Assurance Manager on this study investigating dependence behaviors
and nicotine pharmacokinetics associated with e-cigarette use in the experienced user. E-
cigarette experience appears to have a significant impact on nicotine delivery and systemic
exposure. Due to their capacity to deliver substantial amounts of nicotine, e-cigarettes may
precipitate or maintain nicotine dependence. Although systematic assessments of e-cigarette
dependence behaviors are limited, it is important to understand how these products affect
nicotine dependence and withdrawal behaviors. The proposed study to be supports FDA’s CTP’s
research priorities by investigating dependence behaviors and nicotine pharmacokinetics
associated with e-cigarette use in the experienced user. The study will also assess urinary
cotinine and TSNA levels during an ad libitum period, and begin to establish the prevalence of
these biomarkers of exposure in e-cigarette users.
o Task Order #2: Effect of the Format of Moist Smokeless Tobacco Behaviors (loose vs.
portioned) on Nicotine Exposure, Use Behaviors and Tobacco Dependence in Current
Users
Mr. Layfield is the Quality Assurance Manager on this study that investigates smokeless tobacco
use behaviors, toxin exposure, and dependence associated with current use. Data collection
efforts for this study include biospecimen collection to assess biomarkers of exposure to nicotine,
topography collection to ascertain use behavior and dependence and behavioral questionnaires
to estimate levels of dependence in these current smokeless tobacco users using their own
products. This study will provide the FDA with a fundamental understanding of how dependence,
use and exposure differ as a function of smokeless tobacco form. These aspects are important to
understand the acute effects of smokeless tobacco use as a function of form (loose vs. portioned)
and will contribute to the discussion of public health implications of smokeless tobacco use.
o Task Order #3: Effect of pH of Smokeless Tobacco Products on the Pharmacokinetics of
Nicotine in Current Users
This study aims to compare the pharmacokinetics of nicotine after a single use of smokeless
tobacco products with varying pH values. Nicotine is a weak base, and with an increase of pH, the
proportion of unprotonated or “free base” nicotine increases. In this form, nicotine is readily
absorbed through the buccal mucosa. Thus, the pH of ST products plays a significant role in the
amount of free nicotine available to the user. In this study, the pH values of the smokeless tobacco
will be manipulated to four distinct pH values (between 5.0 and 8.6) to determine the influence of
pH on nicotine absorption (time to peak, peak concentration, total absorption) following product
use. Repeated blood draws will be performed and plasma will be assayed for nicotine content. The
study will inform FDA regulatory decisions, and help determine how differences in pH levels relate
to nicotine exposure, behavioral and clinical outcomes.
o Task Order #4: Nicotine Pharmacokinetics and Salivary pH of Large and Small Cigar
Smokers (Cigar pH Study)
This study is investigating the impact of cigar tobacco pH on nicotine pharmacokinetics and
exposure after buccal absorption. In particular, it is designed to evaluate the relationship between

tobacco pH, salivary pH, and nicotine exposure in non-inhaling small and large cigar smokers.
This project consists of a two phase laboratory-based study and a clinical study focusing on adult,
non-inhaling cigar smokers. In the first phase of the laboratory component of the study, chemical
characterization of twenty cigars currently on the market will be performed to analyze for nicotine
content and concentration, and tobacco pH (Lab Study Phase I). This analysis will then inform the
selection of the study products to be used in the clinical phase of the study, which is a single
center, randomized, semi-blinded, triple cross-over study. Clinical data collection will also include
bio-specimen collection to assess baseline biomarkers of exposure and nicotine
pharmacokinetics. Following the clinical phase, participants’ own brand of cigars will then be
chemically characterized for nicotine content and concentration, and tobacco pH (Lab Study
Phase II). Ultimately, this study will inform how cigar tobacco pH affects nicotine bioavailability
and nicotine absorption.
 Measures Management System
Client: Centers for Medicare and Medicaid Services
In its role as the Measures Manager, Battelle assists CMS and its measure development contractors
as they use the Blueprint to develop, implement, and maintain health care quality measures. Battelle
consults and provides technical assistance on a variety of issues related to measure development,
harmonization, and maintenance. Mr. Layfield is the Quality Assurance Manager for the MIDS
contract. He is responsible for ensuring all tasks meet the quality standard contract, contributes to
and implements Lean solutions and continuous improvements. He ensures deliverables are
processed through a rigorous quality control and technical review process.
 NIH Healthy Communities Study: How Communities Shape Children’s Health
Client: National Institutes of Health, National Heart, Lung, and Blood Institute; Centers for Disease
Control and Prevention; and Robert Wood Johnson Foundation
The National Institutes of Health (NIH) Healthy Communities Study (HCS): How Communities Shape
Children’s Health is the first nationwide effort to comprehensively and systematically assess the
relationship between community programs and policies targeting childhood obesity and childhood
obesity outcomes, including longitudinal trajectories of Body Mass Index (BMI), diet, and physical
activity. This NIH-sponsored $29.5 million project is led by the National Heart, Lung, and Blood
Institute (NHLBI), with additional funding from the National Cancer Institute, the National Institute of
Child Health and Human Development, the National Institute of Diabetes and Digestive and Kidney
Diseases, and the Office of Behavioral and Social Sciences Research; and collaboration from the
Centers for Disease Control and Prevention and the Robert Wood Johnson Foundation.
The HCS is a five-year observational study that combines current/prospective and retrospective
quantitative and qualitative data. Battelle––along with partners from the Universities of South
Carolina, California-Berkeley, and Kansas––will document the evolution of programs and policies
over the past 10 years in more than 100 communities; assess aspects of each community’s physical
activity and nutrition environment; collect data on BMI, diet, and physical activity from a sample of up
to 81 children in each participating community, with more detailed measures collected on a subset of
these children; and abstract the children’s height and weight history over the past 10 years from their
medical charts. Findings from this nationwide scientific study will identify characteristics of community
programs and policies that may help reduce childhood obesity rates. The goal is to inform public
health practice and policy by identifying community approaches that may work best for reducing
childhood obesity rates.
Mr. Layfield is the QA Manager for this project. He will oversee and coordinate quality control
procedures and review for all data collection for the project. In addition, he will coordinate quality
control activities for the QA/QC staff of the university partners and will create a QA/QC Manual and
Manual of Operations for the project. Mr. Layfield will further perform IMS testing and will act as the
SharePoint administrator for the suite of internal and external SharePoint sites supporting this study.
He will develop the sites as necessary and support all external client accounts.

 The Laboratory Medicine Best Practices Initiative
Client: Centers for Disease Control
The Laboratory Medicine Best Practices project is developing and testing methods for producing
systematic effectiveness reviews for making evidence-based recommendations related to pre- and
post-analytic laboratory medicine practices for multiple topic areas. This work is innovative for
incorporating unpublished along with published studies on the effectiveness of laboratory practices. A
network of laboratory and health care organizations provide unpublished studies of practice
effectiveness. The project is also developing an approach to building an organizational structure with
adequate resources to routinely produce published evidence reviews and evidence-based
recommendations for multiple laboratory medicine topic areas. One of the first studies published
evaluated the effectiveness of barcoding for reducing patient specimen and laboratory identification
errors. A total of 17 observational studies of which almost half were unpublished favored barcoding
with an overall high strength of evidence rating. The findings were published in Clinical Biochemistry,
and the recommendation was that barcoding did reduce laboratory errors as an evidenced-based
“best practice”.
Mr. Layfield is a Review Coordinator for the Routine Use of Coagulation testing and Cardiac Markers
topics. He will conduct topic discovery and preliminary statement of best practice, convene expert
panels, perform and coordinate literature reviews and evaluation, coordinate data abstraction and
meta-analysis, and contribute to manuscripts for publication. Mr. Layfield will further prepare materials
for presentation to the client and the project Workgroup.
 National Children’s Study – Johns Hopkins University Study Center Formative Research
Project: Development and Validation of an Autism Case Confirmation Approach for Use in the
NCS
Client: Drexel University under subcontract to Johns Hopkins University
Funding: National Institutes of Health, National Institute of Child Health and Human Development
The National Children’s Study (NCS) is the largest study ever undertaken to assess the effects of the
environment on child and adult health. To help inform the main study, several formative research
projects are currently underway. This formative research study will help to develop a brief tool to
detect autism in 3 year olds that can be administered by NCS interviewers. Battelle will serve as the
Data Coordinating Center (DCC) for all 10 participating sites and also provide local interviewers for
data collection in Baltimore. Research clinics will identify families with a 3-year-old already scheduled
for a clinical exam to assess autism or another developmental disability and recruit those families into
this study. Study participation will involve an additional visit to the clinic prior to the scheduled clinical
assessment for the completion of three study instruments: (1) a parent interview, (2) a video guided
parent report (VGPR), and (3) a structured play interaction between the child and assessor. Clinicians
will then report findings from the clinic exam using the fourth study instrument.
Mr. Layfield is managing the Data Coordinating Center activities for this project. He is designing the
DCC protocol to be FISMA-compliant at the moderate level, establishing relationships with the local
autism clinic at Kennedy Krieger Institute, and managing the External SharePoint Site and client
accounts for study coordination. He will be providing regular study progress reports to the client.
 AHRQ Support for Quality Indicators
Client: Agency for Healthcare Research and Quality
This project support the AHRQ Quality Indicators (AHRQ QI) and provides technical support to users,
maintains and develops new indicators, and develops software that health professionals can apply to
their own hospital discharge data. The AHRQ QI consists of four modules: the Prevention Quality
Indicators (PQI), the Inpatient Quality Indicators (IQI), the Patient Safety Indicators (PQI), and the
Pediatric Quality Indicators (PDI). These measures are used for purposes of quality improvement and
comparative reporting. Until October 2004 Battelle supported this project as a subcontractor, was

subsequently awarded a follow-on contract as the prime, and was recently awarded a second follow-
on contract.
Mr. Layfield is the Quality Assurance Manager for the recently awarded follow-on contract. He will
create a Quality Management System and coordinate with Functional Area Leaders and Task
Leaders to develop appropriate Quality Assurance Project Plans. He will perform quality system
audits and oversee quality control activities. On an annual basis, Mr. Layfield will present findings
from Quality Assurance work to the Management Team and to the client. He will act as the
SharePoint Administrator for the suite of extranet sites supporting AHRQ reporting. Previously he was
responsible for completing the annual updates to the Technical Specifications and Quality Indicator
Use Guides. He composed annual reports based on the monthly reports created by the project
managers of the AHRQ contract components.
 Guide to Community Preventive Services Diabetes Review Update
Client: Centers for Disease Control and Prevention, Epidemiology and Analysis Program Office /
Community Guide Branch
Battelle is conducting an update to the existing systematic reviews on the effectiveness of diabetes
prevention and control interventions as part of the CDC’s Guide to Community Preventive Services
(available at http://www.thecommunityguide.org/diabetes). The interventions include self-
management education, case management, and disease management. The purpose of the updates
is to ensure that the recommendations provided by the independent Community Preventive Services
Task Force reflect the best evidence currently available. The project will involve the production of
materials to clearly communicate the findings from the updated evidence reviews and the Task Force
recommendations to key audiences of researchers, practitioners, and other relevant decision-makers.
The updated reviews and related communication materials are expected to be extremely valuable for
helping researchers and research-funding agencies identify important gaps in our current knowledge,
and for informing the actions of public health officials and other decision-makers. This project will help
to address the national diabetes priorities described in Healthy People 2020. Mr. Layfield was one of
the review coordinators, responsible for the development and implementation of the literature review
screening and abstraction database. He participated in the literature review, abstraction, and
Community Guide update.
 Exploring Health Disparities in Integrated Communities: Prince George’s County
Client: Johns Hopkins University, Bloomberg School of Public Health, Center for Health Disparities
Solutions
Funding: National Institutes of Health, National Center for Minority Health and Health Disparities
In recent years there has been an explosion of interest in racial and ethnic inequalities in health
status and access to quality healthcare. This area of research has begun to evolve beyond studies
that merely describe health disparities, with increasing attention being paid to efforts to explain them.
For this study, researchers plan to disentangle race from socioeconomic status and racial segregation
by examining the health status of adults residing in census tracts where African Americans and
whites live with similar socioenvironmental risks and have similar socioeconomic status. Battelle staff
are screening every household in one census tract in Prince George’s County to identify every eligible
adult and are conducting an in-person computer-assisted personal interview (CAPI) and collecting
height, weight, waist circumference, and blood pressure measurements with each. Mr. Layfield
supervises the study performance and coordinates with study personnel to oversee interviewer data
collection and to pursue issue resolution with interviewers and data collection software. He further
coordinates training, scheduling, and distribution of hardware and incentives and is responsible for
communications with the Principal Investigator (PI) and coordination of study materials with PI.
 National Children’s Study – Johns Hopkins University Study Center, Baltimore County and
Montgomery County, Maryland Study Locations
Client: Johns Hopkins University, Bloomberg School of Public Health

The National Children’s Study will follow a representative sample of children from early life through
adulthood, seeking information to prevent and treat such health problems as autism, birth defects,
diabetes, heart disease, and obesity. NICHD awarded a Study Center in 2007 to the Johns Hopkins
University (JHU) consortium consisting of JHU and Battelle. In each of Baltimore and Montgomery
Counties we will enroll and follow sufficient women to ensure 250 live births per year over a 4-year
recruitment period. Battelle is responsible for conducting subject recruitment activities, conducting
field data collection activities including environmental and biological sample collection, implementing
QA/QC procedures, shipping samples/data to the coordinating center, and preparing reports. As part
of a formative research study to evaluate alternative models of recruitment, women in Montgomery
County will soon be contacted through community media (print ads, radio spots, billboards,
community events, mailed flyers, social media sites, etc.) for enrollment in a reduced data collection
protocol.
Mr. Layfield served as a Study Coordinator/Compliance Officer providing regulatory expertise to meet
all applicable requirements for the NCS at the Baltimore and Montgomery County sites. Mr. Layfield
coordinated and reported incidents for the two sites. He maintained training files and databases as
necessary to ensure all staff were compliant to the requirements of the NCS requirements, federal
and state regulations and Battelle requirements.
 National Children’s Study – Johns Hopkins University Study Center Formative Research
Project: Measuring Race, Ethnicity, Language Need and Health Literacy for use in the NCS
Client: Johns Hopkins University, Bloomberg School of Public Health
This formative research study was designed to help to inform the issue of health disparities for the
National Children’s Study. Battelle served as the Data Coordinating Center (DCC) for all 4
participating sites and also provided local interviewers for data collection in Baltimore. Two cohorts of
participants were recruited from local clinics at each site. Women who were pregnant with their first
child and past their 20th week of gestation were interviewed at two times, once while pregnant and
again 6 months later. Mothers of children aged 6 months to 5 years were interviewed once. Interviews
were administered as Computer-Assisted Personal Interviews (CAPI) with some Audio-CASI (self-
administered) sections. The first 65 participants (and their children) from each cohort also provided
saliva samples at the time of interview to be assessed for markers of stress.
Mr. Layfield managed the Data Coordinating Center for this project. He designed the DCC protocol to
be FISMA-compliant at the moderate level, monitored study progress, and provided regular study
progress reports to the client. He also managed the External SharePoint site and client accounts to
facilitate all site activity and data delivery.
Prior to joining Battelle, Mr. Layfield served as a Quality Assurance Auditor for Battelle in Aberdeen, MD,
from February 2009 to April 2010.
 Quality Assurance Auditor, Battelle, Aberdeen
As a Quality Assurance Auditor, Mr. Layfield audited data and reports for GLP and SOP compliance
and consistency. He also audited study files, documents and records, and facility documents, then
reported findings to the study team management. Other crucial duties included:
o Performed critical phase inspections, issued corrective action requests, registered deviation
reports, reviewed and registered calibration status notifications and investigative reports and
other internal registrations
o Assisted QA management with client visits
o Managed QAU files and performed document control procedures and acted as the central point
for these documents
o Updated QAU databases, maintained QAU log-in system, and supplied and maintained various
QAU indices

o Acted as the BEST SOP administrator, QAU point of contact for validation, and maintained QAU
work authorizations spreadsheet
Prior Professional Experience
AEROTEK, NOTTINGHAM, MD
As a Quality Assurance Specialist for Battelle through contract with Aerotek, Mr. Layfield assisted lead
auditors with review of data and reports for GLP and SOP compliance and consistency. He audited study
files, documents and records, and reported findings to study team and management. Other duties
included:
o Issued corrective action requests, registered deviation reports, reviewed and registered
calibration status notifications, and investigative reports and other internal registrations.
o Assisted QA management with client visits.
o Managed QAU files and performed document control procedures and acted as the central point
for these documents.
o Updated QAU databases, maintained QAU log-in system and supplies, and maintained various
QAU indices.
o Acted as the BEST SOP administrator, QAU point of contact for validation annual review
reminders and maintained QAU work authorizations spreadsheet.
BRIDGE GPS, GAITHERSBURG, MD
As a Toxicology Associate, Mr. Layfield coordinated study meetings, created reporting schedules, and
ensured that study-related events were performed as scheduled. He also:
o Monitored animal/technical procedures integral to study conduct, communicated findings to
Toxicology Associate/Study Director, monitored critical phases of study.
o Reviewed study data, prepared data summaries as necessary for Study Director or Sponsor.
o Conducted and reviewed statistical analysis of study data.
o Created narrative shell of report, including materials and methods, compiled and reviewed
subcontractor and professional reports for accuracy, coordinated report production with report
associate and documentation specialist, prepared initial QA audit findings and coordinated
responses from organizational groups.
o Finalized study report, resolved QA audit findings and coordinated archival activity of study
materials.
o Provided respirator fit testing and new employee respirator training for all employees who were
required to wear a respirator for work functions.
ADECCO USA, FREDERICK, MD
As Senior Associate Scientist for BioReliance through contract with Adecco USA, Mr. Layfield
designed, developed, and validated Excel spreadsheets used for data analysis of raw data in
compliance with 21 CFR Part 11. He also provided statistical assistance as necessary for assay
development, performance, or analysis of data. In addition, he created and supported assay
validation procedures and methods with appropriate data collection and data analysis tools. Mr.
Layfield further continued work performed while employed by BioReliance, Invitrogen bioservices.
BIORELIANCE, INVITROGEN BIOSERVICES, ROCKVILLE, MD
As Senior Associate Scientist, Mr. Layfield developed and defined validation procedures/program and
SOPs for spreadsheet validation in accordance to current standards and 21 CFR Part 11. He also:
o Managed all spreadsheet validation projects, prepared validation protocols and reports, installed
validated templates to network, provided training on use of validated spreadsheets, and
supported all validated and non-validated spreadsheets.

o Maintained all spreadsheets in valid condition; updated and improved spreadsheets on a regular
basis or when production environment or user requested changes to spreadsheets.
o Provided statistical assistance as necessary for assay development, performance, or analysis of
data.
o Created and supported assay validation procedures and methods with appropriate data collection
and data analysis tools.
o Performed gap analysis as necessary for assays currently in use prior to validation.
BIORELIANCE, ROCKVILLE, MD
As Technical Report Writer, Mr. Layfield analyzed data generated during various laboratory studies
and prepared final reports for studies. The study types included toxicity/carcinogenicity evaluation,
enzyme induction, oncogenicity testing, human tumor passage procedures, cell proliferation,
inhalation and polymerase chain reaction (PCR) testing for DNA plasmid distribution. The data
analyzed included clinical observations, gross necropsy findings, clinical pathology parameters,
histopathology and microbial infectivity/clearance. A statistical analysis of numerical data was
performed using the appropriate parametric or non-parametric statistical computer programs. Mr.
Layfield also coordinated National Toxicology Program (NTP) studies as an administrator using
hardware/software designed and provided by NTP. Responsibilities included maintenance of
equipment, daily reporting to NTP, data analysis, report generation, study scheduling and set up. Mr.
Layfield wrote reports that described the materials and methods used to conduct the study and the
results of the various tests employed, which were submitted by clients to the Regulatory Agencies
(EPA and FDA) for registration of particular test articles.
As a member of the technical staff, Mr. Layfield performed study-specific and sponsor-specific
protocols and operated, maintained, and calibrated of laboratory equipment such as coulter counters,
CO2 incubators, centrifuges, and balances. He also prepared tissue culture media and various
reagents, maintained cell lines in culture, formulated and implemented test article dilution schemes. In
addition, he performed cell harvest techniques such as, preparation of slides and staining solutions,
performed Giemsa and differential (Hoechst) staining techniques, slide cover slipping, coding and
archiving. Mr. Layfield further performed evaluation of cell cycle kinetics and mitotic inhibition and
maintained complete and accurate records of tasks performed as required by Good Laboratory
Practice regulations of all data collected and complied.
Professional Activities and Recognition
Honors and Awards
 Battelle’s Outstanding Performance Award 2015 (RJ Reynolds Tobacco GLP Qualification Audit)
 Battelle’s Scientific & Technical Team Achievement Award 2012 (Laboratory Medicine Best
Practices)
 Battelle’s Operational Excellence Achievement Award Nominee 2012
 Battelle Outstanding Performance Award 2010 (Harford County Public Schools’ Future 11)
Memberships
American Society for Quality (ASQ)
Mid-Atlantic Regional Society for Quality (MARSQA)
Publications and Presentations
Publications
Layfield C, Rose J, Alford A, Snyder SR, Apple FS, Chowdhury FM, Kontos MC, Newby LK, Storrow AB,
Tanasijevic M, Leibach E, Liebow EB, Christenson RH. Effectiveness of practices for improving the
diagnostic accuracy of Non-ST-Elevation Myocardial Infarction in the Emergency Department: A
Laboratory Medicine Best Practices™ systematic review. Clin Biochem. 2015;48(4-5):204-12.

Snyder SR, Favoretto AM, Baetz RA, Derzon JH, Madison BM, Mass D, Shaw CS, Layfield CD,
Christenson RH, Liebow EB. Effectiveness of practices to reduce blood culture contamination: A
Laboratory Medicine Best Practices systematic review and meta-analysis. Clin Biochem. 2012; 45(13-
14):999-1011.
Presentations
Weinstein N, Layfield C. The Art and Science of the Semi-Structured Interview. 2015 International Field
Directors and Technology Conference, Ft. Lauderdale, FL, May 2015.
Brustrom J, Jackson JE, Cubbins L, Layfield C. Risk and Protective Factors for Physical and Mental
Function among Community Dwelling Older Adults. 2015 Gerontologic Society of America, Orlando
Florida, November 2015.

Layfield-Christopher-BHR-Baltimore-2014

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