FIORD 2023 Agenda

Back to FIORD 2023

Day 1 Schedule (November 6, 2023): 

Current Landscape of RWE

Regulatory Perspectives

SpeakerDetails
Mark Levenson (Director, Division of Biometrics VII, FDA) FDA Regulations, Guidances, and The Real-World Evidence Program

Catherine Cohet (Senior Pharmacoepidemiologist, RWE Workstream, Data Analytics &
Methods Task Force, EMA)

 Current RWE Landscape and International Guidance: EMA Perspective 

Pharmaceutical Industry Perspectives

SpeakerDetails
Irfan Khan (Global Medical Evidence Generation Lead, Sanofi)

Navigating Medical Evidence Generation from Real-World Data: Experiences in
Cardiovascular Disease and Anticoagulation Therapy
Kajsa Kvist (Scientific Vice President, Novo Nordisk) Challenges with Robust Evidence Generation to Document Cardiovascular Benefits

Specific RWE Study Challenges Day 1

Estimand Specification

SpeakerDetails
Jie Chen (Chief Scientific Officer, Elixir Clinical Research) Estimands in Real-World Evidence Studies with Examples
Gene Pennello (Mathematical Statistician, CDRH, FDA) Clinical Trial Designs for Medical Tests and Their Estimands
Lisa Hampson (Director, Statistical Methodology, Novartis) Combining Target Trial and Estimand Frameworks to Define Causal Estimands

Peter Gilbert (Professor, Biostatistics, University of Washington & Fred Hutch Cancer Center)

 Surrogate Outcomes in Real-World Evidence Studies 

Study Design & Causal Identification

SpeakerDetails
Hector Izurieta (Associate Director, Novel Clinical Investigations, OVRR, CBER, FDA)

Examples of the Use of Self-Controlled Risk Interval (SCRI) and Negative Controls in Real-World Evidence Studies of Vaccine Effectiveness
Iván Díaz (Associate Professor, Population Health, NYU School of Medicine)

Efficiently Transporting Average Treatment Effects to New Populations Using Mediators
and Effect Modifiers
Javier González (Principal Researcher, Microsoft Research Cambridge)

TRIALSCOPE: A Unifying Causal Framework for Scaling Real-World Evidence Generation
with Biomedical Language Models
Chris Holmes (Professor, Biostatistics, University of Oxford) The Role of Experimental Design in Enabling Randomized Trials for RWD Integration

Day 2 Schedule (Novemeber 7th, 2023):

Specific RWE Study Challenges Day 2

Statistical Estimation & Inference

SpeakerDetails
Richard Wyss (Assistant Professor & Lead Scientist, Harvard Medical School)

Targeted Learning for Large-Scale Covariate Adjustment in High-Dimensional Studies Involving Linked Claims with Electronic Health Records
Larry Han (Assistant Professor, Health Sciences, Northeastern University) Multiply Robust Federated Estimation of Targeted Average Treatment Effects
Lars van der Laan (Statistics PhD Student, University of Washington)

Adaptive Targeted Minimum Loss-Based Estimation (A-TMLE) of the Average
Treatment Effect Using Data-Driven Selection of the Effect Model
Sky Qiu (Biostatistics PhD Student, UC Berkeley)

A-TMLE for Combined RCT-RWD Studies

Gilmer Valdes (Associate Professor, Radiation Oncology, UC San Francisco)

Real-World Evidence Study of the Causal Impact of Toxicity on Overall Survival After
Proton Radiation Therapy

Pre-Specification & The Role of Simulations

SpeakerDetails
Lauren Dang (Mathematical Statistician, NIAID)

The Role of Simulations for Pre-Specification of Study Design and Analysis Plans
Based on The Causal Roadmap
Susan Gruber (Co-Founder, TL Revolution; Founder, Putnam Data Sciences)

Power and Pre-Specification: Improving RWE Transparency via Simulation
Hana Lee (Senior Staff Fellow, FDA) Pre-Specification for Real-World Evidence Study Submissions to FDA