Kristy Iglay, PhD, MPH

​Evidence Synthesis, systematic literature reviews, meta-analytic techniques, pharmacoepidemiology studies.

Kristy has over 15 years of combined experience in medical communications and outcomes research. Prior to becoming an epidemiology consultant, she led evidence generation activities supporting access and reimbursement at a large pharmaceutical company. She has also provided insight into strategic communication planning, continuing medical education programs, and product promotion activities across various therapeutic areas.  Kristy has extensive experience in the design and execution of real-world observational studies and has served as a member of the Pharmacy Quality Alliance’s Measure Development Team.

Kristy leads our Evidence Synthesis efforts, including systematic literature reviews.

Susan Hartmaier, MSc, PhD

COA/PROs for labeling, clinical outcome assessments, patient reported outcomes, qualitative research (patient interviews and focus groups), landscape analysis of fit-for-purpose COA/PRO measures.

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Susan Hartmaier has more than 20 years of experience in the development, validation and strategy of patient reported outcomes (PROs) and other clinical outcome assessments that might serve as endpoints in randomized clinical trials.  She is a trained interviewer of patients, physicians or other stakeholders, and an expert on regulatory requirements for the measurement properties of PROs, including reporting requirements for content validity and patient input, reliability, construct validity and responsiveness. 

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Susan leads our Endpoint Strategy efforts.

Panagiotis Mavros, PhD

Health economics statistics, outcomes research, payer strategy, value proposition, external control arms.

Panagiotis is an econometrician with an expertise in observational research methods and their application to the healthcare industry. He has over 30 years of experience, 22 of which were in the bio-pharmaceutical industry, with a focus on study design, methods and analysis for observational studies relying on RWD. He specializes in causal inference designs and has contributed to innovative approaches of addressing causal questions in the healthcare industry. Prior to joining the industry, he acted as assistant professor, Department of Economics, at Wayne State University. He earned his doctorate degree in economics from Cornell University.

Molly Aldridge, MPH

Epidemiology, medical writing, observational research, evidence synthesis, training, patient- and physician-facing communications.

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Molly Aldridge has over 20 years of experience in research and writing in multiple areas, including public health and pharmacoepidemiology. She has been a key contributor to the design and execution of numerous observational research programs and regulatory submissions. Over the past six years, Molly has leveraged her expertise in R&D within the pharmaceutical realm in her career as a medical writer. She is experienced in the development of health and medicine-related communications for patients, providers, researchers, and regulatory bodies in the U.S. and globally.

Katherine Brind'Amour, PhD, MS, CHES

Maternal and child health, medical writing, evidence synthesis, endpoint development, patient- and physician-facing communications.

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Katherine (Katie) Brind’Amour has been engaged in health program design, health education, evaluation research and medical writing since 2006. She specializes in health literacy audits and content strategy for medical communications aimed at both professional and lay audiences, from preclinical to post-market. Katie has designed and executed communication programs, investigator training programs, advisory boards, clinical trial materials, and systematic literature reviews for many of the world’s top pharmaceutical companies and medical research institutions.

Thomas Rhodes, PhD

Biostatistics, epidemiology, observational study methods, natural history studies.

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Thomas Rhodes has nearly 30 years of experience in the pharmaceutical industry in statistics and epidemiology, most recently in data analytics for pharmacoepidemiology database research.  His epidemiological expertise includes epidemiology methods, analytic techniques for comparative effectiveness research and pragmatic randomized trials.  He has designed and conducted observational research studies and served as a co-principal investigator on a natural history study of prostate disease.

Pradeep Rajan, ScD

Epidemiology, observational studies, evidence synthesis, studies of epidemiologic association.

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Pradeep has over 15 years of experience in academic and government institutions focused on improving public health. He has designed and conducted studies on the relationship between human biomarkers of exposure and neurobehavioral function. He has experience in epidemiological study design and analysis with a focus on genetic, environmental, and pharmacoepidemiologic studies

Dena Rosen Ramey, ABD

Pharmacoepidemiology, product development strategy, RWE, observational studies, COA/PROs for labeling.

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Dena is a highly experienced researcher with over 24 years of pharmaceutical and 10 years of academic research experience in pharmacoepidemiology, outcomes research, real world evidence, comparative effectiveness and safety, clinical trials, and prospective observational and database studies. She has extensive experience with non-interventional post-authorization safety and efficacy studies and adjudication of clinical trial endpoints as well as endpoint development including clinician outcome assessments, patient reported outcome measures, and composite endpoints. Dena also has broad expertise on clinical, regulatory, and  access/reimbursement strategy; filings and responses; labeling, and aggregate safety reports.

Katherine Harris, DrPH

Clinical biostatistics, design and analysis of clinical trials, statistical methods.

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With over 40 years of experience in biostatistics at multiple companies in the pharmaceutical industry, Kathy Harris is skilled in the design and analysis of phase IIB - III randomized controlled clinical trials, adaptive trials and analysis.  She develops protocols, statistical analysis plans (SAPs), tabular and graphical display templates. She reviews programming specifications and performs analysis of clinical trials, surveys and observational studies. She has extensive strategic experience, including planning for and participating in regulatory meetings.

Rachel Leahy, PhD

Quality assurance, regulatory submissions & compliance, SOP creation, RWE auditing, literature reviews, patient privacy.

Rachel Leahy, PhD, is a distinguished regulatory affairs and quality advisor with expertise spanning pharmaceuticals, biologics, and medical devices. As Principal Consultant, she leads global regulatory strategy and compliance efforts, specializing in GMP, GCLP, and GCP audits, regulatory submissions, medical writing, and technology transfer. Rachel has a keen interest in developing harmonized quality auditing standards for real world evidence with an emphasis on patient privacy protections. Previously, Rachel orchestrated remediation planning and authored pivotal regulatory submissions. Her career is underpinned by a PhD in Cellular and Molecular Biology from Kent State University and the Lerner Research Institute at the Cleveland Clinic, where her research on disease pathogenesis led to multiple peer-reviewed publications and conference presentations. Dr. Leahy remains actively engaged in professional organizations like RAPS and ISPE, consistently enhancing her expertise through ongoing education and symposium participation.

Chintan Dave, PharmD, PhD

Pharmacoepidemiology, health economics, RWE, comparative effectiveness and safety.

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Chintan is a pharmacoepidemiologist and health economist with a proven track record of designing, executing, and publishing impactful studies in real-world evidence, comparative safety and effectiveness, and health economics. He has published extensively in prestigious journals such as NEJM, JAMA: Internal Medicine, JAMA Neurology, Annals of Internal Medicine, Circulation, and Diabetes Care, with multiple first or senior author contributions. Chintan is currently a faculty member at Rutgers University, overseeing industry fellowships and partnerships at the Rutgers Center of Pharmacoepidemiology and Treatment Sciences (PETS) and co-directing the Rutgers Center for Health Outcomes, Policy, and Economics (HOPE). He specializes in leveraging large real-world databases, and employing advanced statistical and epidemiological methods for confounding adjustment and causal inference, with a focus on cardiometabolic diseases and chronic conditions.

Glenn Davies, DrPH, MS

Health economic statistics, meta-analytic techniques and modeling, reimbursement, outcomes research, COA/PROs for labeling.

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Health outcomes researcher with over 30 years of experience in clinical trials, health economics and outcomes research. He received his MS (1988) and DrPH (1994) in Biostatistics from the University of North Carolina in Chapel Hill.  Dr Davies began his career with Research Triangle Institute analyzing clinical trial data in AIDS and cardiovascular disease as well as working on studies for the Environmental Protection Agency. Glenn started in the pharmaceutical industry with Merck in the Epidemiology department in 1995. He developed and validated patient reported outcome measures and conducted analyses of observational data to support clinical trial development in a variety of disease areas including asthma, migraine, cardiovascular disease, antifungals, and herpes zoster. Dr Davies later made the transition into health economics at Merck and was involved in several aspects of HTA submissions including economic model development, meta-analyses, and secondary data analysis for cardiovascular disease and diabetes. Davies has collaborated on HTA submissions for several key countries including UK (NICE), Canada (CADTH), Australia (PBAC), US (ICER) as well as other countries throughout the globe. Dr Davies also served as a mentor for post-doctoral candidates and summer interns during his career at Merck. Davies has co-authored over 40 publications in the literature and is a member of the International Society of Pharmacoeconomic and Outcomes Research (ISPOR). He is currently an independent consultant and an Adjunct Faculty member in the College of Life Sciences and the College of Population Health at Thomas Jefferson University.

Chiun-Fang Chiou, PhD

COA/PRO strategy, outcomes research, health economic statistics, reimbursement.

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Chiun-Fang Chiou is a seasoned expert with over 25 years of hands-on research experience in various settings including 20 years in the pharmaceutical and medical device industry supporting clinical development and market access. He has worked in global, regional, and local levels and all therapeutic areas including spending five years in Asia-Pacific. He has led or co-led projects in development and validation of patient reported outcome (PRO) measures, health economics analyses, and real-world evidence and has published extensively. He received his PhD in economics from the University of Washington.

Doug Watson, PhD

Pharmacoepidemiology, outcomes research, observational study design and methods.

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Doug is an expert consultant in observational research, pharmacoepidemiology, epidemiology, outcomes research, and clinical research in the pharmaceutical industry. He has over 30 years of experience in health-related research, including 23 years in the pharmaceutical industry supporting clinical development, and designing and conducting post-authorization safety studies, benefit-risk assessments, and observational studies for products in various therapeutic areas. He has published extensively in the medical literature, is a fellow of the International Society for Pharmacoepidemiology and a former adjunct scholar for the Center for Clinical Epidemiology and Biostatistics, Univ. of Pennsylvania School of Medicine.

Samantha Drover, PhD

Qualitative research, quantitative research, mixed methods, RWE.

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Samantha Drover is currently an Epidemiologist with ICES (Toronto, Ontario, Canada) and has 10 years of multidisciplinary health research experience. Samantha has expertise conducting large-scale epidemiologic analyses in multiple contexts, including studies using administrative health data and multinational studies. In addition to her epidemiologic framework, Samantha has experience developing and validating patient-reported outcomes (PROs) and other experimental instruments. Samantha completed her PhD in Epidemiology at the Gillings Global School of Public Health at the University of North Carolina-Chapel Hill, with her dissertation focusing on the association of maternal thyroid function and childhood executive function. Samantha also holds a MSc in Psychology from Queen’s University (Kingston, Ontario, Canada), where she designed and taught a course on scale validation.

Christopher Kolman, MS

Project manager, data analysis, financial planning, budget manager

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With a distinguished career spanning over three decades, Chris has demonstrated exceptional expertise in financial planning, business integration, and medical excellence within the pharmaceutical industry. Most recently, Chris was Director of Medical Excellence, responsible for global initiatives enhancing medical affairs and outcomes research practices, collaborating closely with strategic operations and business technology teams.
Prior to this role, Chris worked in Finance, where he played a pivotal role in financial planning and reporting, budget management, and integration of newly acquired assets. Throughout his career, he has worked in various scientific, strategic, and operational positions, including roles in epidemiology, biostatistics, clinical sciences, and business operations.
Chris holds a Master of Science in Statistics from Villanova University and is certified in Six Sigma. Chris has a proven track record in leadership, process improvement, and project Management.