Research

precision medicine
causal inference
regulatory & policy
methodology
trial design
machine learning
data quality
applications
endpoints
access

Join our ongoing series of virtual presentations and discussions exploring the principles, practices and possibilities of applying RWE in oncology research.

Past sessions

REGULATORY

Beyond synthetic controls: Near-term opportunities for regulatory RWE

Guests from:

Eli Lilly and Company, Bristol Myers Squibb, Flatiron Health

Includes:

Session details

Q&A session

Downloadable slides

Watch full session

58min

Session Clips

Watch clip

Near-term opportunities to leverage RWE for regulatory use

Lynn Howie, MD
Flatiron Health
09:48

Watch clip

Using RWD to provide natural history information

Pranav Abraham, PhD
Bristol Myers Squibb
12:16

Watch clip

Using RWD to fill evidence gaps in the post-approval space: New dosing regimen for cetuximab

Kristin Sheffield, PhD
Eli Lilly and Company
10:05

APPLICATIONS

Opportunities to use EHR-derived RWE to inform HTA decision-making

Guests from:

NICE, Fred Hutch, Flatiron Health

Includes:

Session details

Q&A session

Downloadable slides

Watch full session

57min

Session Clips

Watch clip

Can Early U.S. Adoption of Cancer Drugs Inform HTA Decision-Making?

Páll Jónsson, PhD
NICE
12:17

Watch clip

Enhanced Cost-Effectiveness Analysis using EHR Data for Real-World Value

Akshay Swaminathan
Flatiron Health
07:40

APPLICATIONS

The role of real-world data in tumor-agnostic drug development

Guests from:

Janssen, Merck, Foundation Medicine

Includes:

Session details

Q&A session

Downloadable slides

Watch full session

1:00:09

Session Clips

Watch clip

Prevalence of TMB-H and association with survival in patients with less common solid tumors

Chelsea Shao, PhD, MPH
Merck
09:51

Watch clip

Trends and challenges in tumor-agnostic drug development

Mike Spencer, MSc
Janssen
11:28

Watch clip

Tumor site agnostic drug development: A genomics perspective

Jeff Venstrom, MD
Foundation Medicine
11:08

Watch clip

Characteristics and outcomes of real-world patients with MSI-H solid tumors treated with pembrolizumab

Tamara Snow
Flatiron Health
08:04

APPLICATIONS

How to best leverage RWE in 2021: Perspectives from early adopters

Guests from:

Novartis, Eli Lilly and Company, Bristol Myers Squibb

Includes:

Session details

Q&A session

Watch full session

57:08

REGULATORY & POLICY

Applying RWE to regulatory applications

Guests from:

FDA, Janssen, Pfizer, Roche

Includes:

Session details

Q&A session

Transcript

Downloadable slides

Watch full session

1:15:15

Session Clips

Watch clip

Getting real: real world evidence in oncology drug approvals

Chana Weinstock, MD
FDA
11:00

Watch clip

Integrating clinical & genomics real-world data to support new drug application

Kiran Patel, MD
Janssen
14:01

Watch clip

Postmarket real world data perspectives: IBRANCE (palbociclib) males case

Albert L. Kraus, PhD
Pfizer
12:04

Watch clip

Kadcyla (T-DM1) in HER2+ mBC: label update on LVEF following a post approval commitment – based on RWD

Thibaut Sanglier, PharmD, MPH, PhD
Roche
13:39

Applications

Precision oncology: how RWD is advancing clinico-genomic research

Guests from:

Moores Cancer Center, Roche/Genentech, Bristol Myers Squibb, Foundation Medicine

Includes:

Session details

Q&A session

Transcript

Downloadable slides

Watch full session

50:45

Session Clips

Watch clip

Impacting complex genomic/immune landscapes: precision medicine in the real-world cancer clinic

Razelle Kurzrock, MD
Moores Cancer Center
13:33

Watch clip

Use of a clinico-genomic database (CGDB) for R&D

Michael D. Taylor, PharmD, PhD
Genentech
10:25

Watch clip

STK11 and KEAP1 mutations as prognostic biomarkers in an observational real-world lung adenocarcinoma cohort

Simon Papillon-Cavanagh, PhD
Bristol Myers Squibb
07:10

Research

Past sessions

REGULATORY

Beyond synthetic controls: Near-term opportunities for regulatory RWE

Guests from:

Includes:

Session Clips

Near-term opportunities to leverage RWE for regulatory use

Using RWD to provide natural history information

Using RWD to fill evidence gaps in the post-approval space: New dosing regimen for cetuximab

APPLICATIONS

Opportunities to use EHR-derived RWE to inform HTA decision-making

Guests from:

Includes:

Session Clips

Can Early U.S. Adoption of Cancer Drugs Inform HTA Decision-Making?

Enhanced Cost-Effectiveness Analysis using EHR Data for Real-World Value

APPLICATIONS

The role of real-world data in tumor-agnostic drug development

Guests from:

Includes:

Session Clips

Prevalence of TMB-H and association with survival in patients with less common solid tumors

Trends and challenges in tumor-agnostic drug development

Tumor site agnostic drug development: A genomics perspective

Characteristics and outcomes of real-world patients with MSI-H solid tumors treated with pembrolizumab

APPLICATIONS

How to best leverage RWE in 2021: Perspectives from early adopters

Guests from:

Includes:

REGULATORY & POLICY

Applying RWE to regulatory applications

Guests from:

Includes:

Session Clips

Getting real: real world evidence in oncology drug approvals

Integrating clinical & genomics real-world data to support new drug application

Postmarket real world data perspectives: IBRANCE (palbociclib) males case

Kadcyla (T-DM1) in HER2+ mBC: label update on LVEF following a post approval commitment – based on RWD

Applications

Precision oncology: how RWD is advancing clinico-genomic research

Guests from:

Includes:

Session Clips

Impacting complex genomic/immune landscapes: precision medicine in the real-world cancer clinic

Use of a clinico-genomic database (CGDB) for R&D

STK11 and KEAP1 mutations as prognostic biomarkers in an observational real-world lung adenocarcinoma cohort

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