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.
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.
Martha is responsible for managing the collection, coding and analysis of patient-level data to aid in the validation or development of patient, clinician, or observer reported outcomes. Martha has experience working in a variety of therapeutic areas, including dermatology, neurology, and pediatric congenital diseases. Martha has worked in the field of qualitative research for over five years 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. Additionally, Martha served as a Research Associate at the Institute for Community Inclusion at the University of Massachusetts Boston, conducting research with individuals with disabilities as well as service providers to those individuals. Martha holds a Bachelor of Arts in Sociology from Bates College and a Master of Arts in Applied Sociology from the University of Massachusetts Boston.
Mary Lynn is responsible for leading data collection and analysis efforts to aid in the development of patient, clinician, or observer reported outcome assessments. Mary Lynn has participated in multiple aspects of the clinical outcome assessment (COA) development process such as FDA and EMA dossier preparation; instrument review; semi-structured interviewing of patients, caregivers, and clinical experts; eCOA versus pen-and-paper equivalency testing; and survey administration, data collection, and analysis. Mary Lynn has experience working in a variety of therapeutic areas including neurology, dermatology, oncology, and gastroenterology. Prior to joining Endpoint Outcomes, Mary Lynn worked as a Research Study Coordinator at the Institute for Community Inclusion, at the University of Massachusetts Boston. In this role, Mary Lynn contributed to research that investigated the role of the public service delivery system for adults with disabilities in the United States. Mary Lynn holds a Bachelor of Science in Psychology from St. John Fisher College, and an Master of Science in Organizational Psychology from the University of Hartford.
Shayna is responsible for managing the collection, coding and analysis of patient-level data to aid in the development of patient, clinician or observer reported outcomes. Shayna’s research experience includes both qualitative and quantitative research in the fields of integrative medicine and health disparities. Prior to working at Endpoint Outcomes, Shayna worked at Boston Medical Center as a Research Coordinator to provide integrative medicine services to disadvantaged populations and to reduce hospital readmission rates among patients with depression. Additionally, Shayna completed field work in Kenya, where she worked with the Ministry of Health to evaluate health outcomes among the Maasai tribe in rural areas. Shayna holds a Bachelor of Science in Health and Exercise Science from Wake Forest University and a Master of Public Health from Boston University.
Ted supports project teams in collecting, coding and analyzing patient-level data for the development and validation of patient, clinician, or observer reported outcomes. Since joining Endpoint Outcomes in 2013, Ted has been notably involved in a number of studies involving pediatric and rare disease populations. Ted has professional experience interacting with and working alongside healthcare officials at state health departments, clinicians and public health nurses, and patients in a variety of disease-based scenarios. Most notable are his experiences working with infectious diseases and prostate cancer, and in resource-limited populations where access to healthcare is limited. Ted graduated from Bates College with a Bachelor of Science degree in general biology and a concentration in Sub-Saharan African studies.
Siobhan 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, Siobhan supports other project and research related activities, such as quality checking documents. Prior to joining the Endpoint Outcomes, she worked as a milieu counselor at a facility for adults with severe and persistent mental illnesses. Siobhan also has undergraduate experience conducting qualitative research for a study examining emotional intelligence and mental health stigma. Siobhan holds a Bachelor of Arts degree in Psychology from Connecticut College in New London, CT.
Christina is responsible for collecting, coding, and analyzing patient-level data for the development and validation of patient, clinician, or observer reported outcomes. Christina’s prior research experience includes the study of goal-setting in caregiver and care-recipient relationships, sharing behavior in young children, and induced emotion within an ironic process theory situation. She has also worked with hospital staff on the Child and Adolescent Unit at the Western Psychiatric Institute and Clinic where she focused on patient observation and interactions. Christina holds a Bachelor of Science in Psychology and a Bachelor of Arts in Professional Writing with a minor in Photography from Carnegie Mellon University.
Julie’s responsibilities include collecting, coding and analyzing patient-level data to aid in the development of patient, clinician or observer reported outcomes. Julie has qualitative research experience in the fields of gestational and type 2 diabetes disparities, healthy aging, and autism spectrum disorder. Prior to joining Endpoint Outcomes, Julie worked as a research assistant on 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.
Caitlin collects, codes, and analyzes subject-level data for the development and validation of patient, clinician, or observer reported outcome assessments. Caitlin’s previous research includes supporting qualitative projects involving the relationships between culture and health. She has experience coding and analyzing interviews with Brazilian immigrants for an NIH funded study on transnationalism and health, and she conducted focus groups and interviews with breastfeeding peer counselors as part of a quality improvement project with the Massachusetts Women, Infants, and Children (WIC) program. Caitlin holds a Bachelor of Arts in International Relations and a Master of Public Health from Tufts University.
Kayla supports project teams in collecting, coding and analyzing patient-level data for the development and validation of patient, clinician or observer reported outcomes. Kayla’s prior research experience includes the study of phantom limb pain and personalized prosthetics at Walter Reed National Military Medical Center in Bethesda, MD. She has also worked on projects involving the social determinants of Type II Diabetes and improving hospital readmission rates at Boston Medical Center. Kayla holds a Bachelor of Arts degree in Botany and Molecular Biology from Dartmouth College.
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.
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.
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.
Chris is responsible for collecting, coding, and analyzing patient-level data for the development and validation of patient, clinician, and observer reported outcomes. Chris previously worked at California Polytechnic State University, San Luis Obispo in the Computational Chemistry lab, where he assisted in modeling proteins using molecular dynamics. Chris also worked with people in custody in the San Luis Obispo County Jail and at the Maxine Lewis Memorial Shelter where he utilized trauma-informed care to promote rehabilitation. Chris holds a Bachelor of Arts degree in Sociology with a minor in Global Politics from California Polytechnic State University, San Luis Obispo.
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.