Approval / Commercialization — Publications
Resources and insights tagged approval commercialization from Headwater.
Publications
GSKEmory UniversityAmgen Inc.University of North Carolina at Chapel HillAarhus UniversityYesRegeneron PharmaceuticalsNational Cheng Kung UniversityColumbia University
Advancing Principled Pharmacoepidemiologic Research to Support Regulatory and Healthcare Decision Making: The Era of Real-World Evidence
Publications
43
Total Publications
8
Abstract/Manuscript
26
Oral Presentation
9
Poster Presentation
2026 · Poster Presentation · Jazz Pharmaceuticals · Methods/Pharmacoepi
Real-world polypharmacy and healthcare resource utilization after early-line treatment with cannabidiol for Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex
Read more →2026 · Poster Presentation · Jazz Pharmaceuticals · Methods/Pharmacoepi
Real-World Dose Trajectory Patterns and Impact on Polypharmacy Burden and New Antiseizure Medication (ASM) Prescriptions in Patients With Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS), or Tuberous Sclerosis Complex (TSC) Receiving Cannabidiol (CBD)
Read more →2026 · Poster Presentation · Jazz Pharmaceuticals · Methods/Pharmacoepi
Real-World Effectiveness of Cannabidiol on Antiseizure Medication Cycling, Polypharmacy, and Healthcare Resource Utilization: A US Claims Analysis.
Read more →2025 · Abstract/Manuscript · GSK
Advancing Principled Pharmacoepidemiologic Research to Support Regulatory and Healthcare Decision Making: The Era of Real-World Evidence
Read more →2025 · Poster Presentation · Yes · Methods/Pharmacoepi
Assessing artificial censoring weights for clone censor weighting studies: A simulation-based approach
Read more →2025 · Poster Presentation · No · Methods/Pharmacoepi
Real-world (RW) second-line (2L) treatment (tx) patterns and clinical outcomes in patients (pts) with HER2-overexpressing biliary tract cancer (BTC).
Read more →2025 · Poster Presentation · Jazz Pharmaceuticals · Methods/Pharmacoepi
Effect of Cannabidiol on Antiseizure Medication Cycling, Polypharmacy, and Healthcare Resource Utilisation in Patients With Dravet Syndrome, Lennox-Gastaut Syndrome, or Tuberous Sclerosis Complex: Real-World Data from a US Claims Analysis
Read more →2024 · Abstract/Manuscript
Staging and clean room: Constructs designed to facilitate transparency and reduce bias in comparative analyses of real-world data
Read more →2024 · Oral Presentation · Yes · Methods/Pharmacoepi
Making the Case for Negative Control Outcome Studies in a Real-World Evidence Setting
Read more →2024 · Oral Presentation · Yes · Methods/Pharmacoepi
Seeing Eye to Eye: Enhancing Inter-Team Communication for Reproducible Real-World Evidence
Read more →2024 · Oral Presentation · Yes · Methods/Pharmacoepi
Comparing causal estimands from a sequential nested trial emulation with a treatment decision design to a conventional single point randomized trial: A simulation study
Read more →2024 · Poster Presentation · University of North Carolina at Chapel Hill · Methods/Pharmacoepi
Addressing RWE Challenges in Real-Time: The 'Clean Room Committee' Approach
Read more →2024 · Poster Presentation · Yes · Methods/Pharmacoepi
Utilizing Patient Electronic Medical Records to Transform Clinical Trials
Read more →2024 · Poster Presentation · Yes · Methods/Pharmacoepi
Prediction in claims databases for epidemiological research
Read more →2024 · Abstract/Manuscript
Gating and clean room: Constructs designed to facilitate transparency and reduce bias in comparative analyses of real-world data
Read more →2023 · Abstract/Manuscript · University of North Carolina at Chapel Hill
Pragmatic considerations for negative control outcome studies to guide non-randomized comparative analyses: A narrative review
Read more →2023 · Abstract/Manuscript · University of North Carolina at Chapel Hill
Controlling for Differential Regression-To-The-Mean via Propensity Scores: A Simulation Study
Read more →2023 · Oral Presentation · Yes · Methods/Pharmacoepi
Methods and New Approaches in Pragmatic Trials
Read more →2023 · Oral Presentation · Yes · Methods/Pharmacoepi
Characterizing the Distribution of Multiple Negative Control Outcome Risk Differences
Read more →2023 · Oral Presentation · Yes · Methods/Pharmacoepi
Orthogonalized Regression for Causal Inference: A Pharmacoepidemiologist's Dream?
Read more →2023 · Oral Presentation · Yes · Methods/Pharmacoepi
An Analytic Method to Weight Longitudinal Treatment Patterns for Visualization with Sankey Diagrams
Read more →2022 · Abstract/Manuscript · University of North Carolina at Chapel Hill
DAG With Omitted Objects Displayed (DAGWOOD): a framework for revealing causal assumptions in DAGs
Read more →2022 · Oral Presentation · Yes · Methods/Pharmacoepi
In-Hospital Treatment Patterns Among Patients Hospitalized with COVID-19 in the United States
Read more →2022 · Oral Presentation · No · Methods/Pharmacoepi
One Design to Rule Them All: The Clone-Censor-Weight Design as a General Framework for Epidemiologic Studies
Read more →2022 · Oral Presentation · Yes · Methods/Pharmacoepi
The impact of parametric assumptions on the bias-variance tradeoff for causal analysis of time-to-event outcomes
Read more →2022 · Oral Presentation · University of North Carolina at Chapel Hill · Methods/Pharmacoepi
Fusion Designs for Indirect Treatment Effects
Read more →2022 · Oral Presentation · University of North Carolina at Chapel Hill · Methods/Pharmacoepi
On Teaching Advanced Epidemiologic Methods
Read more →2022 · Oral Presentation
Illustration of Two Fusion Designs and Estimators Get access Arrow
Read more →2022 · Oral Presentation · Yes · Methods/Pharmacoepi
Disparities in Prevalence of Urinary Incontinence among a Nationally Representative Sample of Men, 2005-2016: Findings from the Urologic Diseases in America Project
Read more →2021 · Abstract/Manuscript · University of North Carolina at Chapel Hill
Use of negative control outcomes to assess the comparability of patients initiating lipid-lowering therapies
Read more →2021 · Oral Presentation · No · Methods/Pharmacoepi
Use of negative control outcomes to detect mismeasured confounders in administrative data
Read more →2021 · Oral Presentation · University of California Los Angeles · Methods/Pharmacoepi
Fusion designs and estimators for treatment effects
Read more →2020 · Abstract/Manuscript · University of North Carolina at Chapel Hill
Who are we missing? Underrepresentation of data sources used for pharmacoepidemiology research in the United States
Read more →2020 · Oral Presentation · No · Methods/Pharmacoepi
Real world treatment patterns following the initiation of proprotein convertase subtilisin/kexin type 9 antibody inhibitors among adults in the United States, 2015-2019
Read more →2020 · Oral Presentation · University of North Carolina at Chapel Hill · Methods/Pharmacoepi
Estimating the Effect of Depression on HIV Transmission Risk Behaviors Among People Who Inject Drugs in Vietnam: A Causal Approach
Read more →2020 · Oral Presentation · University of North Carolina at Chapel Hill · Methods/Pharmacoepi
G-computation for policy-relevant effects of interventions on time-to-event outcomes
Read more →2019 · Oral Presentation · University of North Carolina at Chapel Hill · Methods/Pharmacoepi
Using Instrumental Variables to Address Bias from Unobserved Confounders
Read more →2019 · Oral Presentation · University of North Carolina at Chapel Hill · Methods/Pharmacoepi
Commentary: Compositional data call for complex interventions
Read more →2019 · Oral Presentation · University of North Carolina at Chapel Hill · Methods/Pharmacoepi
Using Bounds to Compare the Strength of Exchangeability Assumptions for Internal and External Validity
Read more →2019 · Oral Presentation · University of North Carolina at Chapel Hill · Methods/Pharmacoepi
Informative censoring by health plan disenrollment among commercially insured adults
Read more →2019 · Oral Presentation · University of North Carolina at Chapel Hill · Methods/Pharmacoepi
Nonparametric Bounds for the Risk Function
Read more →2018 · Oral Presentation · No · Methods/Pharmacoepi
Performance of machine learning algorithms for hysterectomy risk prediction among women with endometriosis in the United States
Read more →2018 · Oral Presentation · University of North Carolina at Chapel Hill · Methods/Pharmacoepi
A Practical Example Demonstrating the Utility of Single-world Intervention Graphs
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