FIORD 2022 Agenda

Day 1 Schedule (November 17, 2022): 

Current Landscape: Best practices, emerging areas, gaps and needs

Landscape (current status and directions/challenges)

SpeakerDetails
Motiur Rahman (FDA) Regulatory

Kajsa Kvist (Novo Nordisk)
David Martin (Moderna)

Pharma 

Andy Williams & Charlie Barr (Parexel)

Clinical Trial

Martin Ho (Google Health)

Causal and Statistical Methods 1 

Hana Lee (FDA)
Ivan Diaz (Cornell University)
Judea Pearl (University of California, Los Angeles)

Causal and Statistical Methods 2 

Susan Gruber (Putnam Data Science)
Emre Kiciman (MSR)

Software and Dissemination

Maya Petersen (Univeristy of California, Berkeley)

Pharma 

Day 2 Schedule (Novemeber 18th, 2022):

Best-practice recommendation for statistical methods to integrate observational and randomized data: specific use cases 

Use case 1: Safety and monitoring

SpeakerDetails

Richard Wyss (Harvard Univeristy)
Brian Williamson (Kaiser Permanente)

Case Studies from FDA-funded innovation
Center, Sentinel Project, other safety analysis

Regulatory/Academia/Private Sector

Panel Discussion

Use case 2: Secondary indications

SpeakerDetails
Lauren Dang (University of California, Berkeley)

Case Study: Semaglutide and cardiovascular outcomes

Regulatory/Academia/Private Sector

Panel Discussion

Use case 3: Expanded populations

SpeakerDetails
Miguel Hernan (Harvard University)

Case Study: COVID-19 vaccines

Regulatory/Academia/Private Sector

Panel Discussion

Use case 4: Clinical benefit

SpeakerDetails

Bettina Hansen (University of
Toronto/Rotterdam)

Case Study: How to do phase 4 studies for NASH to demonstrate end-stage liver disease benefit? Livmarli for Alagille Syndrome

Regulatory/Academia/Private Sector

Panel Discussion