Role of a Statistician in Drug Development in AI World

Abstract Number:

1019 

Submission Type:

Invited Panel Session 

Participants:

Vipin Arora (1), Brian Tracey (3), Paul Schuette (4), Kent Koprowicz (5), Christopher Miller (6), Xiaochun Li (7), Vipin Arora (2)

Institutions:

(1) Eli Lilly and Company, N/A, (2) Eli Lilly and Company, San Diego, CA, (3) Takeda, Boston, MA, (4) CDER FDA, Silver Springs, MD, (5) Axio, a Cytel Company, N/A, (6) AstraZeneca Pharmaceuticals LP, N/A, (7) Indiana University School of Medicine, N/A

Chair:

Vipin Arora  
Eli Lilly and Company

Panelist(s):

Brian Tracey  
Takeda
Paul Schuette  
CDER FDA
Kent Koprowicz  
Axio, a Cytel Company
Christopher Miller  
AstraZeneca Pharmaceuticals LP
Xiaochun Li  
Indiana University School of Medicine

Session Organizer:

Vipin Arora  
Eli Lilly and Company

Session Description:

Topic: Role of a Statistician in Drug Development in AI World

Abstract: AI and statisticians both handle significant amount of data. Can AI tools and statisticians offer the most desirable human-machine collaboration to advance solutions of complex problems that we have? Is there an ideal role of AI tools in conceptual design and optimization of clinical trials including identification of biomarkers? Are there risks of non-statisticians using AI tools and assume roles of pseudo statisticians to make wrong decisions? What are the most exciting advantages of AI as a tool to statisticians? Will there be best practices and guidance to use an AI tool in near future?

Panelists:

Brian Tracey
Director, Statistics,
Takeda, Boston, MA
brian.tracey@takeda.com

Paul Schuette
Scientific Computing Coordinator for the Office of Biostatistics – CDER, FDA
Silver Springs, Maryland
Paul.Schuette@fda.hhs.gov

Chris Miller
Vice President - Biometrics
Astra Zeneca
Gaithersburg - Maryland
chris.miller@astrazeneca.com

Kent Koprowicz
Vice President, DMC - Cytel
kent.koprowicz@cytel.com

Xiaochun Li, Professor
Department of Biostatistics and Health Data Science
Center for Computational Biology and Bioinformatics
School of Medicine, Fairbanks School of Public Health,
Indiana University, Indianapolis, IN
xiaochun@iu.edu

Sponsors:

Biopharmaceutical Section 2
Section for Statistical Programmers and Analysts 1
Section on Statistical Computing 3

Theme: Statistics and Data Science: Informing Policy and Countering Misinformation

No

Applied

Yes

Estimated Audience Size

Medium (80-150)

I have read and understand that JSM participants must abide by the Participant Guidelines.

Yes

I understand and have communicated to my proposed speakers that JSM participants must register and pay the appropriate registration fee by June 1, 2024. The registration fee is nonrefundable.

I understand