Chris has been conducting health outcomes studies for the past 20 years. Prior to founding Endpoint Outcomes, which specializes in the development, evaluation and validation of clinical outcomes assessments, he was a founding member of the US office of Mapi Values and a Director of Economic and Outcomes studies. During his 12 years at Mapi Values he directed numerous PRO studies and specialized in projects with a FDA regulatory component (and has developed over 40 COA measures). His key areas of interest are qualitative research, Delphi panels, measurement methodology, and regulatory requirements for labelling and promotional claims. Prior to working at Mapi Values, Chris worked at Astra Pharmaceuticals and for several years as an outcomes researcher in a large contract research organization in the United States, France and the Netherlands. Chris has over 100 publications, book chapters and presentations in the field of outcomes research. Chris holds a Bachelor of Arts from the University of Massachusetts, a Master of Public Health (epidemiology and biostatistics) from Tufts University, and a Master of Philosophy in Management, Economics and Politics and a PhD in Health Economics from the University of St Andrews, Scotland, UK.
For 10 years Chris taught in the Drug Regulatory Affairs Master’s degree program at Massachusetts College of Pharmacy and Allied Health Sciences and was Course Director of Pharmacoeconomics (and currently adjunct faculty) for the MS program in Pain Research, Education and Policy at Tufts University School of Medicine.
Dave’s research interests lie at the intersection of modern psychometric theory of latent variable models and biostatistical analysis of clinical trial data. He has worked on over 100 clinical trials and real-world studies as well as represented several companies at FDA and EMA meetings.
Dave received his MA and PhD degrees in cognitive and quantitative psychology at the University of Nebraska-Lincoln. After a brief stint constructing psychometric interviews for a human resources company, he has worked in pharmaceutical research since 2001, first at MDS Pharma Services and PPD. While at Furiex Pharmaceuticals, Dave was part of a team that developed a new treatment for irritable bowel syndrome from proof of concept to FDA approval within five years and EMA approval a year thereafter. Most recently, he has also supported drug development and commercialization teams as a statistical and psychometric expert, heading two centers of excellence specializing in building health economic models, conducting analysis of real-world data, and analyzing clinical trial data for the drug portfolios within Allergan’s Global Value and Evidence Department.
As part of her research role at Endpoint Outcomes, Brooke is responsible for conducting qualitative research studies to develop clinical outcome assessments to be used as novel endpoints in clinical trials to support labeling claims. In addition to conducting qualitative research, Brooke has experience developing FDA and EMA dossiers, attending FDA meetings, and navigating the FDA’s Drug Development Tool Qualification process. Brooke has worked across a variety of therapeutic areas, with a concentration in gastroenterology and dermatology. Previously, Brooke worked at Ironwood Pharmaceuticals and was responsible for developing and implementing the PRO strategy in primarily gastrointestinal diseases. In addition to industry work, Brooke held various positions, including Research Manager, at Adelphi (Mapi) Values where she developed study protocols, performed literature reviews, conducted patient interviews, analyzed qualitative data, developed reports and wrote regulatory dossiers. Brooke received a Bachelor of Arts in Psychology from Bates College in Lewiston, Maine.
Zoe has over 30 years of experience in US and international healthcare management, outcomes research, epidemiology, health economics, program design and evaluation, patient advocacy and quality of care. Her therapeutic areas of focus are: urology, cardiovascular disease, psychiatry, and women’s reproductive health. She was previously a Senior Director in the PRO Center at Pfizer and Senior Director of Market Access, Urology at Pfizer where she led a multidisciplinary team of health economists, outcomes researchers, PRO and Pricing & Reimbursement Specialists in furthering the understanding of overactive bladder and lower urinary tract symptoms and their impact and treatment.
During her time at Pfizer, Zoe led the development and validation of several new and exisiting PROs and 2 landmark multinational epidemiology studies; one in OAB, EPIC, and the first ever LUTS study, EpiLUTS. Zoe has authored several book chapters on Urology PROs and is a member of the IQIQ advisory board. She has a Masters in Public Health and a PhD in Health Behavior.
Martha Gauthier is a Director at Endpoint Outcomes in Boston. In this role, Martha leads the collection, analysis, and reporting of patient-level data to aid in the development or validation of patient, clinician, or observer reported outcomes. Additionally, Martha has experience developing FDA dossiers in support of labeling claims. Martha has experience working in a variety of therapeutic areas, including dermatology, women’s health, gastrointestinal disorders, neurology, and pediatric congenital diseases. Martha has worked in the field of qualitative research for over ten years (with six years at Endpoint Outcomes) with a variety of populations. Prior to working at Endpoint Outcomes, Martha worked as a Research Associate at Adelphi Values where she was involved in the development and implementation of qualitative research to develop outcome measures. Martha holds a BA in Sociology from Bates College and an MA in Applied Sociology from the University of Massachusetts Boston.
Nate leads projects involving the development and validation of health outcomes measures, including patient-reported and observer-reported questionnaires, and clinician-completed screening forms. Nate has participated in multiple aspects of the development process of health outcomes measures, including interviewing patients and caregivers; qualitative data analysis; preparation of project reports and manuscripts; quantitative data collection and management; and drafting regulatory dossiers in support of FDA and EMA labeling claims. Nate has also managed multiple Delphi panels, which have led to establishing expert consensus in new treatment paradigms and aiding in the development of clinician-reported and patient-reported measures. Nate has experience in numerous therapeutic areas including dermatology, gastrointestinal disorders, gynecology, neurology, ophthalmology, pain, pediatric congenital diseases, and oncology. Nate previously worked at Adelphi Values as a Senior Research Associate. He received his MPH from Tufts University and BS in Human Biology from Michigan State University.
Shayna is responsible for leading project teams in the development and modification of clinical outcome assessments. Her experience includes literature and instrument reviews, the design and development of study instruments, providing recommendations for patient-reported outcome development and clinical outcome assessment strategy, preparation of FDA dossiers and other materials for regulatory support, and manuscript development. Shayna has experience across different therapeutic areas, but her specialization is rare diseases, particularly in pediatric populations. Shayna holds a Bachelor of Science in Health and Exercise Science from Wake Forest University and a Master of Public Health from Boston University.
Brandon provides psychometric support to project teams at Endpoint Outcomes. His substantive research interests are focused on the application of modern psychometric methods (i.e., IRT) to the analysis of patient-reported outcomes in clinical trials. Prior to joining Endpoint Outcomes, he worked as a psychometrician for the Massachusetts Department of Elementary and Secondary Education and as a research methodologist for a global health and education NGO located in Massachusetts. Brandon has extensive experience working as a either a high-level quantitative support specialist or project lead for a variety of measure development projects. Brandon holds an MA and PhD in Child Study and Human Development from Tufts University, where he received training in education research methods and psychometrics.
When not studying at Northeastern University, Kat is Endpoint Outcomes’ one woman billing and receiving department. Additionally, Kat manages contracts, and handles office and administrative needs for both the Boston and Long Beach offices. Prior to working at Endpoint Outcomes, Kat held various positions in retail management.
Julie leads project teams in collecting, coding, and analyzing patient-level data to aid in the development of patient, clinician or observer reported outcomes. Since joining Endpoint Outcomes in 2016, Julie has worked in a variety of therapeutic areas including dermatology, women’s health, ophthalmology, and rare diseases. Julie’s prior research experience includes studying gestational and type 2 diabetes disparities, healthy aging, autism spectrum disorder, and a project utilizing a virtual genetic counselor to collect family health histories. Julie graduated with a Bachelor of Arts degree in Biological Sciences and a minor in Science in Human Culture from Northwestern University as well as a Master in Public Health degree from Boston University. Julie also completed the Leadership Education in Neurodevelopmental and related Disabilities (LEND) Fellowship at the E.K. Shriver Center at UMASS Medical School.
As a Project Manager at Endpoint Outcomes, Megha oversees psychometric and statistical studies that help inform the development of clinical outcome assessments used by pharmaceutical and biotech companies in clinical trials. Before joining Endpoint Outcomes Megha worked in hospital operations for a digital healthcare startup and hospital administration at a breast cancer center. She also worked in the retail industry as a Project Manager in product content strategy. Megha graduated from Boston University with an MBA and Master in Public Health and completed her undergraduate education in Public Health from Rutgers University.
Michelle is responsible for coordinating patient recruitment activities across all studies, including liaising with patients and physicians to manage consent, screening, enrollment and other related activities. She is also responsible for managing IRB submissions and approvals across all studies. Additionally, Michelle supports other project and research related activities, such as data entry and quality checking documents. Prior to joining Endpoint Outcomes, she worked as a Research Technician at Boston Medical Center on a clinical trial testing the effectiveness of delivering diabetes self-management education using virtual world technology versus a face-to-face medical group visit format.
Michelle also has research experience on studies identifying methods to advance transitional care services for patients and caregivers, reduce hospital readmission rates among patients with depression, and feasibility testing of a cognitive behavioral therapy intervention delivered by relational agent technology. Michelle holds a Bachelor of Science degree in Biological Anthropology and a Bachelor of Arts degree in Spanish from the Pennsylvania State University and a Master of Arts in Medical Anthropology and Cross Cultural Practice from Boston University School of Medicine.
Adriana is responsible for coordinating patient recruitment activities across all studies, including liaising with patients and physicians to manage consent, screening, enrollment and other related activities. She is also responsible for managing IRB submissions and approvals across all studies. Additionally, Adriana supports other project and research related activities, such as quality checking documents. Adriana has undergraduate research experience in health disparities among Latinos. Adriana holds a Bachelor of Science in Public Health from University of California, San Diego.
Maggie is responsible for collecting, coding and analyzing patient-level data for the development and validation of patient, clinician or observer reported outcomes. Maggie previously worked at the University of Washington Stress and Development Lab, where she assisted with studies involving the influence of stress on children’s social, emotional, and brain development. Maggie holds a Bachelor of Arts degree in Psychology with a minor in Women and Gender Studies from Bates College in Lewiston, Maine.
Elizabeth is responsible for collecting, coding and analyzing patient-level data for the development and validation of patient, clinician or observer reported outcomes. Elizabeth has experience working in a variety of therapeutic areas including immunotherapy, oncology, cognitive psychology, and dermatology. Prior to joining Endpoint Outcomes, Elizabeth worked as a Project Manager at Atara Biotherapeutics, where she was involved in qualitative research, CMC development, and regulatory submission planning for projects involving cytotoxic T lymphocyte immunotherapy. She also interned at Kythera Biopharmaceuticals (acquired by Allergan). Additionally, Elizabeth volunteered through Global Medical Brigades in Tegucigalpa, Honduras, where she helped to set up a mobile clinic and provide medical treatment and health education. Elizabeth holds a Bachelor of Arts degree in Cognitive Science and a minor in Neuroscience from Occidental College in Los Angeles, CA.
Elliott is a Senior Research Associate at Endpoint Outcomes and is responsible for collecting, coding and analyzing patient-level data for the development and validation of patient, clinician or observer reported outcomes. Elliott previously worked at The Fenway Institute where he helped conduct a state-level health needs assessment for transgender and non-binary populations. Elliott holds a Bachelor of Science degree in Biological Sciences from Wayne State University as well as a Master in Public Health degree from Boston University.
Adrian is a Senior Research Associate for Psychometrics & Statistics at Endpoint Outcomes and is responsible for providing research support to project teams for the psychometric evaluation and validation of patient, clinician, or observer reported outcomes. Adrian previously worked at the Claremont Evaluation Center, where he helped to manage and analyze educational evaluative data regarding curriculum impact on student outcomes. His interests lie primarily in the application of factor analysis, structural equation models, and robust estimation. Adrian holds a Bachelor of Arts degree in Honors Psychology from California State University, Northridge, and a Master of Arts degree in Organizational Behavior & Evaluation from Claremont Graduate University.
Julia is responsible for collecting, coding, and analyzing patient-level data for the development and validation of patient, clinician, or observer reported outcomes. Julia previously worked at NORC at the University of Chicago where she provided research and management support for projects spanning a variety of public health topics including tobacco surveillance and control, health equity, transportation safety, and emergency preparedness. Prior to NORC, Julia worked on grant-funded research study at a Surgical Weight Loss Clinic at the Penn State Medical Center. Julia holds a Bachelor of Science degree in Health Science with a minor in Women and Gender Studies from Boston University.
Ian is responsible for collecting, coding, and analyzing patient-level data for the development and validation of patient, clinician, and observer reported outcomes. Prior to joining Endpoint Outcomes, Ian spent a year with AmeriCorps as a Site Coordinator for Reading Partners in Baltimore, Maryland. Additionally, Ian has worked for the nonprofit SeriousFun at a camp for children with illnesses such as cancer, heart conditions, rheumatoid arthritis, blood disorders, asthma, gastrointestinal disorders, and craniofacial anomalies. Ian holds a Bachelor of Arts with honors in Music and concentrations in Chemistry and Mathematical Methods from Bates College in Lewiston, Maine.
Kathy is responsible for collecting, coding and analyzing patient-level data for the development and validation of patient, clinician or observer reported outcomes. Prior to joining Endpoint Outcomes, Kathy interned at The Fenway Institute where she worked alongside the behavioral health sciences team to study the feasibility and acceptability of a digital HIV pre-exposure prophylaxis pill to monitor medication adherence in high-risk populations. Additionally, Kathy has worked as a research assistant in a mental health lab dedicated to developing digital interventions for individuals with severe mental illness. Kathy holds a Bachelor of Arts degree in Biology with a minor in Public Health from Boston University.
Christine is responsible for collecting, coding, and analyzing patient-level data for the development and validation of patient, clinician, and observer reported outcomes. Additionally, Christine is responsible for coordinating patient recruitment activities across all activities, including liaising with patients and physicians to manage consent, screening, enrollment, and other related activities. Prior to joining Endpoint Outcomes, Christine worked as an undergraduate research assistant for Urban Catholic Teacher Corps for a study that measured elementary students’ faith and grit. Additionally, she worked at Dana-Farber Cancer Institute as an undergraduate research assistant to collect feedback on a program algorithm focused on improving cancer symptom management through clinical decision support. Christine holds a Bachelor of Arts degree in Applied Psychology and Human Development and Psychology from Boston College.
Subiksha is responsible for collecting, coding, and analyzing patient-level data for the development and validation of patient, clinician, and observer reported outcomes. Prior to joining Endpoint Outcomes, Subiksha worked as an undergraduate research assistant for the Knowlton Lab of Cognitive Neuroscience on a study that investigated memory selectivity in schizophrenic patients. Subiksha holds a Bachelor of Science degree in Neuroscience from University of California Los Angeles.
Kailee is responsible for collecting, coding and analyzing patient-level data for the development and validation of patient, clinician or observer reported outcomes. Prior to joining Endpoint Outcomes, Kailee worked as an undergraduate research assistant in the Social Perception Lab, running multiple studies that examined the role of social identity in stereotyping and prejudice. In this position, she contributed to both electroencephalogram (EEG) and behavioral studies. Kailee holds a Bachelor of Science degree in Psychological and Brain Sciences from the University of California, Santa Barbara.