1. AACR Project GENIE: The Role of Patients and Patient Advocates in
an International Consortium
Presented By
Shawn M. Sweeney, PhD
Director, AACR Project GENIE Coordinating Center

2. I am an employee of the AACR.
Disclosures
I am an employee of the AACR.
I am VERY BIASED and think that AACR Project GENIE is the best thing ever.
What I tell you are my thoughts and not necessarily reflective of the organization’s thoughts and opinions.
I will be discussing the off-label use of data.
know

3. THANK YOU Thank You The 18,000+ selfless patients who said yes
The 150+ individuals involved in the project
Drs. Charles L. Sawyers and Margaret Foti
Our funders!
THANK
YOU

4. Precision Medicine

5. Learning Healthcare System
AACR Cancer Progress Report 2016

6. Think Big; Start Small Start with a disease like cancer
The molecular changes that fuel:
Initiation
Progression
Recurrence
Are routinely measured and catalogued at scale
Start out internationally with a small group of vanguard practices and expand once things are running.

7. The Consortium: Phase I

8. AACR Project GENIE Goals
Improve clinical decision making by:
linking genotypes with clinical phenotypes
particularly in rare cancers and rare variants in common cancers.
Build a cancer registry containing data of sufficient quality to support therapeutic registration.
Catalyze new clinical and translational research.

9. ? The GENIE Registry Aacr.org/genie/data Clinical question asked
Aggregate tumor-only
NGS data & limited
clinical data set from project
Participants into registry
Necessary short & long-term clinical information linked to data within the registry
Data made publicly
available after defined periods.
Separate, parallel data streams

10. Data (All Types) Workflow
DFCI
MSKCC PM
IGR
De-identified
data
MDACC
CPCT
VICC
JHU
All Data

12. Snapshot of NSCLC EGFR Mutations

13. Metastatic NSCLC Patient

14. Retrieving Clinical Outcomes Data
aacr.org/genie/data ?
Clinical question
asked
Aggregate tumor-only
NGS data & limited
clinical data set from project
Participants into registry
Necessary short & long-term clinical information linked to data within the registry
Data made publicly
available after defined periods.
Separate, parallel data streams

15. Long-term Outcomes 1 2

16. GENIE as Part of A Learning Healthcare System
STEP 1
STEP 2
STEP 3
Aggregate/harmonize
existing baseline data
Add outcome details
from EHR
Continuously update in real time; serve to HCP

17. What Next? ?????? Dedicated Abstractors New Funding Models
Develop More Automation
Add New Technologies
Add New Participants

18. What Do You Mean It’s Not Free?
AACR
Provided $2 million in start-up funds
Philanthropy
Genentech $750k
Boehringer-Ingelheim $200k
Sponsored research
Biotech
Large pharma
Disease foundations
Contractor for academic grants

19. Each record has an associated limited clinical data set.
Summary
AACR Project GENIE is an international cancer registry containing ~19,000 genomic records and growing.
Each record has an associated limited clinical data set.
More detailed clinical data are manually curated in response to specific clinical queries.
The project is now accepting applications for new participants.
The consortium is undertaking a strategic planning exercise to help chart the future.
The project has made initial deliveries on its first two clinical studies and is actively seeking additional projects.

20. Conclusion
THANK YOU
Questions, comments, observations?