Quantum Leap Healthcare Collaborative

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.
VIEW:      Executive Leadership     |      Working Groups     |     Investigators     |     Staff     
Principal Investigator
Laura Esserman
MD, MBA
University of California, San Francisco
Laura Esserman
MD, MBA
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
University of California, San Francisco
A 501C(3) charitable organization
Don Berry
PhD
University of Texas MD Anderson Cancer Center

Executive Operations Committee

Angela DeMichele
MD, MSCE
Site Operations Chair
University of Pennsylvania
Angela DeMichele
MD, MSCE
University of Pennsylvania
Don Berry
PhD
Principal Statistician
University of Texas MD Anderson Cancer Center
Don Berry
PhD
University of Texas MD Anderson Cancer Center
Douglas Yee
MD
Agents Chair
University of Minnesota
Douglas Yee
MD
University of Minnesota
Hope Rugo
MD
Safety Chair
University of California, San Francisco
Hope Rugo
MD
University of California, San Francisco
Jane Perlmutter
MBA, PhD
Patient Advocate Chair
Gemini Group Consultancy
Jane Perlmutter
MBA, PhD
Gemini Group Consultancy
Laura Esserman
MD, MBA
Principal Investigator
University of California, San Francisco
Laura Esserman
MD, MBA
University of California, San Francisco
Laura van't Veer
PhD
Biomarkers Chair
University of California, San Francisco
Laura van't Veer
PhD
University of California, San Francisco
Nola Hylton
PhD
Imaging Chair
University of California, San Francisco
Nola Hylton
PhD
University of California, San Francisco
Richard Schwab
MD
Safety Co-Chair
University of California, San Diego
Richard Schwab
MD
University of California, San Diego
Smita Asare
Quantum Leap Healthcare Collaborative
Smita Asare
Quantum Leap Healthcare Collaborative
W. Fraser Symmans
MD
Pathology Chair
MD Anderson Cancer Center
W. Fraser Symmans
MD
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 Parkinson
MD
President, Chief Executive Officer, ESSA Pharma
David Parkinson
MD
President, Chief Executive Officer, ESSA Pharma
David Wholley
M Phil
Foundation for the NIH
David Wholley
M Phil
Foundation for the NIH
Gary Kelloff
MD
National Cancer Institute
Gary Kelloff
MD
National Cancer Institute
Janet Woodcock
MD
FDA
Janet Woodcock
MD
FDA
Reena Philip
PhD
FDA
Reena Philip
PhD
FDA
Richard Pazdur
MD
FDA
Richard Pazdur
MD
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.

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.

Data Safety Monitoring Board (DSMB)

DSMB meets monthly and its purpose is to assure subject safety in the trial. Members have the responsibility for assurance that the trial is conducted to a high standard. Responsibilities include assessing the risk of the trial, monitoring adverse event reporting, reviewing compliance progress, recommending modifications, and provide immediate responses to significant adverse events on an ongoing basis.

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
Meera Bose, I-SPY Administrative Assistant, UCSF

Clinical Research Associates

Aminat Alausa
Janelle Jones
Jill Parker
Juli Leduc
Lorena Kanu
Reggie Gladney

Safety and Regulatory

CCS Associates, Inc.