I-SPY Leadership

At the heart of I-SPY is a truly multidisciplinary dream team of world leaders in medical oncology, surgery, medical imaging, pathology, statistics, clinical trial operations and more.
Principal Investigator
Laura Esserman
MD, MBA
Principal Investigator, University of California, San Francisco
Laura Esserman
MD, MBA
Principal Investigator, University of California, San Francisco
Co-P.I./Principal Statistician
Don Berry
PhD
University of Texas MD Anderson Cancer Center
Don Berry
PhD
University of Texas MD Anderson Cancer Center
Sponsor
Quantum Leap Healthcare Collaborative
Laura Esserman
MD, MBA
Principal Investigator, University of California, San Francisco
Don Berry
PhD
University of Texas MD Anderson Cancer Center

Project Oversight

Anna Barker
PhD
Co-Chair Project Oversight Group, Arizona State University
Anna Barker
PhD
Co-Chair Project Oversight Group, Arizona State University
Dave Mandelkern
MS
Chief Executive Officer, Quantum Leap Healthcare Collaborative
Dave Mandelkern
MS
Chief Executive Officer, Quantum Leap Healthcare Collaborative
David Wholley
D Phil
Foundation for the NIH
David Wholley
D Phil
Foundation for the NIH
Eric Rubin
MD
Merck
Eric Rubin
MD
Merck
Gary Kelloff
MD
National Cancer Institute
Gary Kelloff
MD
National Cancer Institute
Janet Woodcock
MD
FDA
Janet Woodcock
MD
FDA
Richard Pazdur
MD
FDA
Richard Pazdur
MD
FDA
Robert L. Becker, Jr
MD, PhD
FDA
Robert L. Becker, Jr
MD, PhD
FDA
ShaAvhree Buckman-Garner
MD, PhD
FDA
ShaAvhree Buckman-Garner
MD, PhD
FDA
Steve Gutman
MD, MBA
Myraqa, Illumina, Inc.
Steve Gutman
MD, MBA
Myraqa, Illumina, Inc.

Executive Operations Committee

Adam Asare
PhD
Chief Data Officer, Quantum Leap Healthcare Collaborative
Adam Asare
PhD
Chief Data Officer, Quantum Leap Healthcare Collaborative
Angela DeMichele
MD, MSCE
Site Operations Working Group Chair, University of Pennsylvania
Angela DeMichele
MD, MSCE
Site Operations Working Group Chair, University of Pennsylvania
Christina Yau
PhD
University of California, San Francisco
Christina Yau
PhD
University of California, San Francisco
Dave Mandelkern
MS
Chief Executive Officer, Quantum Leap Healthcare Collaborative
Dave Mandelkern
MS
Chief Executive Officer, Quantum Leap Healthcare Collaborative
Don Berry
PhD
University of Texas MD Anderson Cancer Center
Don Berry
PhD
University of Texas MD Anderson Cancer Center
Douglas Yee
MD
Agents Working Group Chair, University of Minnesota
Douglas Yee
MD
Agents Working Group Chair, University of Minnesota
Hope Rugo
MD
Safety Working Group Chair, University of California, San Francisco
Hope Rugo
MD
Safety Working Group Chair, University of California, San Francisco
Jane Perlmutter
PhD, MBA
Patient Advocacy Working Group Chair, Gemini Group Consultancy
Jane Perlmutter
PhD, MBA
Patient Advocacy Working Group Chair, Gemini Group Consultancy
Laura Esserman
MD, MBA
Principal Investigator, University of California, San Francisco
Laura Esserman
MD, MBA
Principal Investigator, University of California, San Francisco
Laura van't Veer
PhD
Biomarker Working Group Chair, University of California, San Francisco
Laura van't Veer
PhD
Biomarker Working Group Chair, University of California, San Francisco
Michelle Melisko
MD
Patient Reported Outcomes Working Group Chair, University of California, San Francisco
Michelle Melisko
MD
Patient Reported Outcomes Working Group Chair, University of California, San Francisco
Nola Hylton
PhD
Imaging Working Group Chair, University of California, San Francisco
Nola Hylton
PhD
Imaging Working Group Chair, University of California, San Francisco
Richard Schwab
MD
Safety Co-Working Group Chair, University of California, San Diego
Richard Schwab
MD
Safety Co-Working Group Chair, University of California, San Diego
Smita Asare
Executive Director of I-SPY Trials, Quantum Leap Healthcare Collaborative
Smita Asare
Executive Director of I-SPY Trials, Quantum Leap Healthcare Collaborative
W. Fraser Symmans
MD
Pathology Working Group Chair, MD Anderson Cancer Center
W. Fraser Symmans
MD
Pathology Working Group Chair, MD Anderson Cancer Center

Focus Groups and Committees

Partner Science Focus Group (PSFG)

The PSFG is designed to give philanthropic and private sector partners the opportunity to hear about the progress of the I-SPY 2 TRIAL and provide active feedback on its implications for drug development and regulatory decision-making. The PSFG includes high-level representatives from academic, non-profit, industry, government, and patient advocate groups.

Independent Agent Selection Committee (IASC)

The IASC is responsible for making the final choices of agents to be tested in the trial based on specified criteria once the agent regimen is recommended by the Agent Working Group. This committee is constituted of individuals with extensive expertise in cancer chemotherapy and drug development, but who do not have any conflict of interest with candidate agents or the companies under consideration.

Data Access & Publication Committee (DAPC)

The Data Access and Publication Committee (DAPC) will meet quarterly and approve requests for access to I-SPY 2 specimens and data, based on recommendations made by the Working Groups. The Committee will also review and approve publications based on I-SPY 2 data to ensure that the data are not misinterpreted.

Advocates

Amy Delson
BA, M.Arch
UCSF Breast Science Advocacy
Amy Delson
BA, M.Arch
UCSF Breast Science Advocacy
Barbara LeStage
Barbara LeStage
Bev Parker
MSW, PhD
Y-ME National Breast Cancer Organization
Bev Parker
MSW, PhD
Y-ME National Breast Cancer Organization
Diane Declarity
Diane Declarity
Diane Heditsian
BA
Patient Advocate, CEO, deClarity Life Sciences​, UCSF Breast Science Advocacy
Diane Heditsian
BA
Patient Advocate, CEO, deClarity Life Sciences​, UCSF Breast Science Advocacy
Jane Perlmutter
PhD, MBA
Patient Advocacy Working Group Chair, Gemini Group Consultancy
Jane Perlmutter
PhD, MBA
Patient Advocacy Working Group Chair, Gemini Group Consultancy
Joan Mancuso
Joan Mancuso
Liz Frank
Liz Frank
Musa Mayer
Musa Mayer
Patricia Haugen
Patricia Haugen
Susie Brain
Susie Brain

Statistical Core

Don Berry
PhD
University of Texas MD Anderson Cancer Center
Don Berry
PhD
University of Texas MD Anderson Cancer Center
Christina Yau
PhD
University of California, San Francisco
Christina Yau
PhD
University of California, San Francisco

I-SPY Working Groups

Agents Working Group
Biomarkers Working Group
Imaging Working Group
Informatics Working Group
Pathology Working
Patient-Reported Outcomes Working Group
Safety Working Group
Site Operations Working Group

Project Management Office

Smita Asare, Executive Director of I-SPY Trials, QLHC
Ruby Singhrao, MS, CCRP, Clinical Ops Manager, UCSF
Lamorna Brown Swigart, PhD, I-SPY Lab Director, UCSF
Gillian Hirst, PhD, Scientific Program Manager, UCSF
Jeff Matthews, PhD, Strategic Consultant, UCSF
Katherine Steeg, Clinical Operations Analyst, UCSF
Jessica Gibbs, Imaging Analyst, UCSF
Melanie Regan, Imaging Analyst, UCSF
Jenny Chen, Quality of Life Analyst, UCSF

Safety and Regulatory

CCS Associates, Inc.
Meera Bose, I-SPY Administrative Assistant, UCSF