Porter v. Tap Pharmaceutical, et al

Filing 591

Judge Richard G. Stearns: ORDER entered. MEMORANDUM AND ACKNOWLEDGING RECEIPT AND REVIEW OF MAZZONE AWARDS PROGRAMMATIC REPORT #10.(Zierk, Marsha)

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
MDL NO. 1430
MASTER FILE NO. 01-CV-10861-RGS
IN RE: LUPRON® MARKETING AND
SALES PRACTICES LITIGATION
MEMORANDUM ACKNOWLEDGING RECEIPT AND REVIEW
OF MAZZONE AWARDS PROGRAMMATIC REPORT #10
April 11, 2016
STEARNS, D.J.
On March 30, 2015, Dr. Myles A. Brown of the DanaFarber/Harvard Cancer Center (DF/HCC), the principal investigator for the
A. David Mazzone Research Awards Program (Program), 1 and co-principal
investigator, Dr. Jonathan Simon, President of the Prostate Cancer
Foundation (PCF), submitted the tenth in a series of Program Reports. This
Report covers the period from July 1, 2015, to December 31, 2015.
After dedicated service as the principal investigator for the Program,
Dr. Philip Kantoff accepted a position as Chairman of the Department of
Medicine at Memorial Sloan Kettering Cancer Center in New York City. Dr.
Myles Brown is Dr. Kantoff’s able successor. Dr. Brown has been actively
involved with the Mazzone Program since its inception, both as an award
recipient and a peer reviewer. Dr. Brown is a prominent leader in the field
of breast and prostate cancer research. From 2002-2010, he served as Chief
of the Division of Molecular and Cellular Oncology at the Dana-Farber
Cancer Institute (DFCI), and currently is the Director of the Center for
Functional Cancer Epigenetics at DFCI.
1

The Mazzone Awards Program, over its life, has supported the work of
146 investigators involved in forty-one separate prostate cancer and related
research projects worldwide, as well as funding community outreach
programs, career development for treatment specialists, and basic and
advanced research training. 2 With the work of the Program coming to a
close, Report #10 provides a cumulative summary of the Program’s
accomplishments. The court has appended the Report for the benefit of all
of those who are interested in the achievements of this historical
undertaking. The court expresses special appreciation for the stewardship
of Dr. Kantoff, Dr. Brown, Dr. Simon, and Dr. Soule, and for the
groundbreaking work of the many investigators whose accomplishments will
be fully celebrated in the Fifth Annual Report of Scientific Progress and
Accounting due on September 30, 2016.
SO ORDERED.
/s/ Hon. Richard G. Stearns
UNITED STATES DISTRICT JUDGE

On August 6, 2010, this court awarded the surplus funds from the
Lupron® Class Settlement Pool to Dana-Farber/Harvard Cancer Center
(DF/HCC) and the Prostate Cancer Foundation (PCF) to be distributed
according to the terms of the proposal submitted to the court on May 20,
2010, as modified and approved by the court. The Program issued four
annual rounds of Requests for Applications from 2011-2014. As of 2015, the
Program has awarded the funding available from the Settlement and has
“graduated” its first class of grant recipients.
2

A. David Mazzone
Research Awards Program
Report #010

Programmatic Report Period: July 1, 2015 to December 31, 2015
Principal Investigator: Myles A. Brown, MD
Dana-Farber/Harvard Cancer Center
Co-Principal Investigator: Jonathan Simons, MD
Prostate Cancer Foundation
Respectfully Submitted to
U.S. District Court for the District of Massachusetts
Boston, Massachusetts
March 30, 2016

Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Boston Children’s Hospital
Dana-Farber Cancer Institute
Harvard Medical School
Harvard School of Public Health
Massachusetts General Hospital

Table of Contents
Introduction ..................................................................................................................................... 2
2015 Programmatic Activity ........................................................................................................... 2
Program Progress and Reporting .................................................................................................... 3
Change in Principal Investigator ..................................................................................................... 4
Appendix 1: Mazzone Awards Program Funding Structure as of 2015 ......................................... 6
Appendix 2: Mazzone Awards Program Grantees, 2011 – 2014.................................................... 8
Appendix 3: Program Reporting Schedule ................................................................................... 17

1

A. David Mazzone Awards Program
Programmatic Report Period: July 1, 2015 to December 31, 2015
Introduction
The A. David Mazzone Awards Program is a grant awarded by the U.S. District Court for the
District of Massachusetts (the Court) to Dana-Farber/Harvard Cancer Center (DF/HCC) in
conjunction with the Prostate Cancer Foundation (PCF). Under the leadership of Dr. Phil
Kantoff, succeeded by Dr. Myles Brown in 2015, the Mazzone Program supports collaborative
and innovative cancer research, career development, community outreach, and training projects
to address a range of research needs in prostate cancer and Lupron-treatable diseases. This report
describes programmatic activities during the second half of calendar year 2015.
The Program was designed to issue a call for applications on an annual basis until the funding
assigned to the various mechanisms was fully spent. To that end, the Program issued four rounds
of requests for applications (RFAs) from 2011 to 2014 and distributed grants in accordance with
the approved proposal. Appendix 1 in this report provides a financial summary of the funding
distribution as approved by the Program’s Scientific Advisory Board and the Massachusetts
District Court.
The Program established a national presence as a source of funding for prostate cancer research.
Most importantly, the Program fostered an unprecedented effort for institutions to collaborate on
inter-institutional Prostate Cancer research projects breaking down barriers to knowledge
dissemination and collaboration. In the coming six months, the program will continue to actively
monitor and evaluate the progress of funded projects in preparation for the fifth annual report of
scientific progress and accounting, which is due to the Court by September 30, 2016.
At the end of its fifth year, the program supported a total of 146 investigators working on 41
projects at institutions across the United States. Appendix 2 provides a detailed list of Mazzone
Awards Program Grantees for years 2011 to 2014. These projects include thirty five projects
funded by DF/HCC through six award mechanisms and six projects funded through the PCF
Mazzone Challenge Awards mechanism.
2015 Programmatic Activity
As of 2015, the Program had awarded all its funding opportunities and therefore, it did not issue
a request of applications this year. The activity of the Program focused primarily on monitoring
existing grantees and managing administrative processes related to the maintenance and closing
of those existing awards.
As it is summarized in Appendix 1, “Funding Structure”, the total funding approved by the Court
was issued to grantees over the agreed-upon 4-year period. The table provides information on
actual grants amounts for the award mechanisms authorized for DF/HCC and PCF. DF/HCC
issued grants in the total amount of $5,530,000 and PCF issued grants totaling $5,000,000 as of
2014. The total amount funded and committed plus DF/HCC overhead assessment of 1,170,000,
total the grant actual estimated funding of $11,700,000. (see Table 2 Below for grants
distribution as provided on the original grant application).

2

In accordance with the approved Funding Structure, the Court disbursed two payments of
$4,000,000 each in November 2010 and November 2012; Payments of $2,000,000 and
$1,585,000 were issued in January 2015 and December 2015 respectively. At the time of the
December 2015 payment, the Court reserved a final disbursement of approximately $115,000 to
be issued to DF/HCC upon satisfactory submission and approval of progress and accounting
reports due to the Court by September 2016.
It is possible that some of the remaining active Mazzone funded projects will require a no-cost
extension for the period of 2016 to 2017. In such case, the Program will continue to monitor
those projects and will prepare and submit a final progress and accounting report in September
2017.
Table 2. Grant Awards Approved by the Court
Number of
Awards
6
4
5
4
3
9
1

Total
Allocation
600,000
400,000
500,000
2,000,000
300,000
900,000
160,000

Award Category
Career Development
Community Outreach
Disparities Research
High Impact Award (Original Number was 5)
Lupron-Treatable Diseases and Conditions
Project Development
Student Training

Amount
100,000
100,000
100,000
500,000
100,000
100,000
160,000

New (2012): High Impact Clinical Trials (1 reallocated from High Impact)
New (2012): Seed Funding - Community Outreach Proposal Development

500,000
10,000

1
1

500,000
10,000

1,000,000

5

5,000,000
10,370,000

Prostate Cancer Foundation Special Challenge Awards
Total Approved Allocation for All Mechanisms

Notes: in 2012, the Court authorized the DF/HCC contingent of the Mazzone Program to create a new award
category for “High Impact Clinical Trials” by reallocating one of the five originally approved “High Impact
Awards”. This new award was issued in 2013. A one-time seed funding grant was awarded to Dr. Glenn Bubley in
2012. The deliverable, which was received in a timely manner, was a reviewed and improved grant application from
Dr. Bubley in 2012. Finally, in 2014, the Court approved allocation of funding for Disparities Research, Community
Outreach, and Student Training for $160,000 which had not been allocated in the original Program proposal above.

Program Progress and Reporting
As of July 2015, 2012 DF/HCC and PCF award recipients completed their no cost extension
periods, 2013 grantees completed their second year and 2014 grantees completed their first year
of research activities. Each award recipient produced the required annual scientific progress
report and financial reports. Over the late fall of 2015, the Program continued to issue payments
on active projects and continued to monitor program activity. The Program submitted to the
Court the annual progress and accounting report in October 2015 for the period of activity
ending in July 31, 2015. A copy of the Program reporting schedule to the Court is provided in
Appendix 3.
Progress reports are reviewed by the Program’s Principal Investigator and as necessary
distributed to the members of the SAB for additional review or approval. If investigators
demonstrate adequate progress toward the goals of the project, recipient institutions are issued
continued support and payments based on financial reports and invoices signed by dully
authorized accounting officers at the recipient institutions. Annual progress and accounting

3

reports guidelines and requirements are stipulated to each grantee institution in grant contractual
agreements at the time of issuing each grant.
In conclusion, DF/HCC and PCF are pleased with the ongoing progress of the Mazzone Award
Program and are committed to ensuring that the program continues to support and foster
innovative collaborative research in 2016.
Change in Principal Investigator
In the fall of 2015, Dana-Farber/Harvard Cancer Center requested and received approval from
the Court to change the Principal Investigator of record for the Mazzone Awards Program. After
providing a remarkable and dedicated service as principal investigator for the past five years, Dr.
Kantoff relinquished leadership of the Program as part of his relocation to take a new position as
Chairman of the Department of Medicine at Memorial Sloan Kettering Cancer Center in New
York City.
Dr. Kantoff was replaced in the capacity as Principal Investigator by Dr. Myles Brown, DanaFarber Cancer Institute. Dr. Brown has been an enthusiastic supporter of the Mazzone Program
over the years. In several occasions, he served as peer reviewer and he himself had the honor of
receiving a Mazzone Project Development award in 2011. Dr. Brown is intimately
knowledgeable of the Mazzone program and a prominent contributor in the field of Breast and
Prostate Cancer research. Following is a brief profile summary of Dr. Brown.
Myles A. Brown, MD
Director, Center for Functional Cancer Epigenetics
Professor of Medicine, Harvard Medical School
Dr. Brown obtained his undergraduate degree in Biology from Yale University and his M.D.
from the Johns Hopkins University School of Medicine. He completed training in Internal
Medicine at the Brigham and Women's Hospital while doing research with David Livingston at
the Dana-Farber. He went on to complete training in Medical Oncology at the Dana-Farber and
postdoctoral research with Phillip Sharp at MIT. Following the completion of his training he
joined the faculty of the Dana-Farber and Harvard Medical School. From 2002-2010 he served
as Chief of the Division of Molecular and Cellular Oncology at the Dana-Farber. In 2010
together with Shirley Liu he founded the Center for Functional Cancer Epigenetics at the DanaFarber.
Dr. Brown's research laboratory focuses on elucidating the epigenetic factors underlying the
action of steroid hormones. This work has important implications both for normal physiology
and for the treatment of hormone dependent malignancies including breast and prostate cancer.
He is recognized for three seminal discoveries. His lab opened the steroid receptor coregulator
field, illuminated the dynamic nature of receptor and coregulator interaction with the genome
and elucidated the importance of epigenetically determined distant cis-regulatory steroid receptor
binding sites. His contributions have uniquely reformulated the understanding of steroid
hormone action in normal physiology and in hormone-dependent cancer.

4

The overall aim of research in our laboratory is the elucidation of the factors underlying the
hormonal responsiveness of human cancers. This work is focused primarily on the role of steroid
hormone receptors and their coregulators. We are currently defining the programs of gene
expression controlled by steroid hormones and their receptors in relevant cell types using a
combination of approaches including gene expression profiling and "ChIP-chip." In addition we
are testing the hypothesis that coregulators act as mediators of the differential activity of
receptors bound by agonist and antagonist ligands. In addition we are asking whether alterations
in coregulator function play a role in both resistance to endocrine therapy and in carcinogenesis.
This work has focused primarily on the role of estrogen receptor and its coregulators in breast
cancer and androgen receptor and its coregulators in prostate cancer.
Background:
Board Certification
Medical Oncology, 1989
Internal Medicine, 1986
Fellowship:
Massachusetts Institute of Technology, Cancer Biology, 1987-1990
Dana-Farber Cancer Institute, Medical Oncology, 1986-1989
Residency:
Brigham and Women's Hospital, Internal Medicine, 1982-1986
Medical School:
Johns Hopkins University School of Medicine, 1978-1982

5

Appendix 1: Mazzone Awards Program Funding Structure as of 2015

6

A. David Mazzone Awards Program
Funding Structure Plan- Five Years (2010 - 2015)
Revised by Juan Carlos Hincapie on December 23, 2015

Court Disbursement
Date Issued
Expected Disbursement
IDC
PCF
DF/HCC

Tranche 1
(2011-2013)

Tranche 2
(2012-2014)

Tranche 3
(2013-2015)

Tranche 4
(2015-2016)

Tranche 4
(2016-2017)

Nov-10

Nov-12

Jan-15

Nov-15

Nov-16

4,000,000
400,000
1,800,000
1,800,000

4,000,000
400,000
1,800,000
1,800,000

2,000,000
200,000
1,200,000
600,000

1,585,000
158,500
200,000
1,226,500

115,000
11,500
0
103,500

Total

11,700,000
1,170,000
5,000,000
5,530,000

Estimated Awards Funding Distribution by DF/HCC for 2011 - 2015 Based on Original Grant Proposal Approved by the Court
The following table shows the expected funding distribution per the proposal approved by the Court and expected adjustments for distribution changes to award mechanisms.

Award funding will run from August to July and it will be distributed to grant recipients based on a cost reimbursement method.
Program funding received November 2010 will support 75% of award payments for Round 1 from August 2011 to July 2012. Funding received in November 2012 will support final award payments
(25%) for round 1 and 75% of Round 2 awards from August 2012 to July 2013. Funding received in November 2014 will support final award payments (25%) for Round 2 and new awards from August
2013 to July 2015 and additional allocation for 2014 - 2016.

Award Category
Career Development
Community Outreach
Disparities Research
DR Additional Allocation 2014
High Impact Award
Lupron-treatable
Project Development
Student Training
ST Additional Allocation 2014
New Awards Approved in 2012
High Impact Trials
Seed Fund Community Outreach
Total DF/HCC

PCF

Number of
Awards
Approved
6
4
5
2

Total
Funding
Approved
600,000
400,000
500,000
140,000

4
3
9
8
2

2,000,000
300,000
900,000
160,000
20,000

1
1

500,000
10,000
5,530,000

11

5,000,000

2

5

Total Approved Direct Expense
Indirect Cost Assessment
Total Estimated in Grant Proposal
Actual Projected Disbursement

Number of
Number of
Awards Total Funding
Awards
funded 18% Round 1 (75% funded 22%
of total of total award
of total
will fall in
Proposals
Proposals
received for this period of received for
time)
(2011-2013)
(2012-2014)
3
225,000
2
0
0
1
2
150,000
2
1
1
4
2

375,000
75,000
300,000
12,793

2
2
3
2

Total
Funding
Round 2
(75% of
awards
plus 25%
from
Round 1)
225,000
75,000
200,000

Number of
Awards
funded 18%
of total
Proposals
received for
(2013-2015)
1
1
1

500,000
175,000
325,000
17,013

3
0
2
4

Total
Funding
Round 3 Special RFA
(100% of 2014, 67% of
total
awards
plus 25% Proposals
from received for
Round 2) (2014-2016)
150,000
125,000
150,000
2
1,325,000
50,000
275,000
130,194

Total
Grand
Funding
Total
Round 4
(100% of 2 Projected
Direct
final
Cost
awards)
600,000
200,000
500,000
140,000
140,000
2,200,000
300,000
900,000
160,000
20,000
20,000

0
0
1
500,000
500,000
1
10,000
0
10,000
1,137,793
12
1,527,013
9 2,705,194
2
160,000 5,530,000
0
DF/HCC Variance from Expected Total Disbursement: cted Total Disbursement:
2,000,000

2

2,000,000

1

500,000

1

500,000

10,530,000
1,170,000
11,700,000
11,700,000

Notes:
In 2012, two one-time seed funding Community Outreach awards for $10,000 each were approved . Only one seed project was funded in 2012
In 2012 one High Impact award was divided evenly between two projects.
In 2013, two out of four $100K Community Outreach grants remained unfunded. $200K was reallocated to fund a partial High Impact Project
In 2013, PCF funded one partial Mazzone Challenge Award. The remainder ($500K) to be awarded through a 2014 RFA
In 2014, DF/HCC funded 2 additional Disparities Research Grants for $140K total, plus $20K additional Funding for Student training , PCF funded one partial Mazzone Challenge
Award with the remainder ($500K) from 2013

7

5,000,000

Appendix 2: Mazzone Awards Program Grantees, 2011 – 2014

8

Mazzone Awards Program -- Prostate Cancer Foundation Projects Funded as of 2014
2011 Prostate Cancer Foundation

2012 Prostate Cancer Foundation

2013 Prostate Cancer
Foundation

2014 Prostate Cancer
Foundation

Imaging Biomarkers of Treatment
Response Using NaF PET/CT Imaging:
a Prostate Cancer Clinical Trials
Consortium (PCCTC) Effort
PI: Glenn Liu, MD (UW Carbone
Cancer Center)
Collaborators: Michael Morris, MD
(Memorial Sloan-Kettering Cancer
Center); William Dahut, MD (National
Cancer Institute); Steven Larson, MD
(Memorial Sloan-Kettering Cancer
Center); Peter Choyke, MD (National
Cancer Institute); Robert Jeraj, PhD,
(UW Carbone Cancer Center)

Promoter-Driven Molecular
Radiotherapy for Prostate Cancer
PI: Martin Pomper, MD, PhD (Johns
Hopkins Medicine)
Collaborators: George Sgouros, PhD
(Johns Hopkins Medicine); Paul
Fisher, PhD (Virginia
Commonwealth University).

T Cell Receptor Gene
Therapy for Treatment of
Lethal Prostate Cancer
PI: David Baltimore, Ph.D.
(California Institute of
Technology)
Collaborators: Owen N.
Witte, M.D. (University of
California, Los Angeles);
Lili Yang, Ph.D. (University
of California, Los Angeles);
Michael T. Bethune, Ph.D.
(California Institute of
Technology)

Induction of Synthetic Lethality with
Epigenetic therapy (ISLET) for Systemic
Treatment of Prostate Cancer
PI: William G. Nelson, MD, PhD (Johns
Hopkins Medicine)
Collaborators: Srinivasan
Yegnasubramanian, MD, PhD (Johns
Hopkins Medicine); Jun O. Liu, PhD,
(Johns Hopkins Medicine); Stephen B.
Baylin, MD (Johns Hopkins Medicine);
Michael A. Carducci, MD (Johns
Hopkins Medicine); Martin J. Aryee,
PhD (Johns Hopkins Medicine)

Targeting the p160 Steroid Receptor
Coactivators (SRCs) as a Novel
Approach for the Treatment of
Castration-Resistant Prostate Cancer
PI: Bert O’Malley, MD (Baylor
College of Medicine)
Collaborators: Nancy Weigel, PhD;
Ming-Jer Tsai, PhD; Francesco
DeMayo, PhD; Michael Ittman, MD,
PhD; Nicholas Mitsiades, MD, PhD;
Sean McGuire, MD, PhD, (Baylor
College of Medicine)

Synergistic Immune and lipid
Metabolism Targeting for
Metastatic Prostate Cancer
Therapy
PI: Jennifer Wu, PhD, (Medical
University of South Carolina)
Collaborators: James S Norris,
PhD (Medical University of
South Carolina); Michael Lilly,
MD (Medical University of
South Carolina); Xiang Liu,
MD, PhD (Medical University
of South Carolina); Ali
Goshayan, MD (Medical
University of South Carolina);
Richard Drake, PhD (Medical
University of South Carolina);
Ann-Marie Broome, PhD
(Medical University of South
Carolina); Elizabeth GarrettMayer, PhD (Medical
University of South Carolina).

9

Mazzone Awards Program -- Dana-Farber/Harvard Cancer Center Projects Funded as of 2014

2011 High Impact

2012 High Impact

2013 High Impact

Functional Annotation of Prostate Cancer Risk
Loci Discovered through Genome Wide
Association Studies
PI: Matthew Freedman, MD (DFCI)
Collaborator: Gerhard Coetzee, PhD
(USC/Norris Cancer Center - Keck School of
Medicine).

Molecular Characterization Of Gleason 3
Tumors That Progress To Gleason 4
PI: Steven Balk, (Beth Israel Deaconess
Medical Center)
Collaborator: Wei Li (Baylor College of
Medicine).

Co-targeting AR and ERG to treat advanced
prostate cancer
PI: Karen Knudsen, PhD (Thomas Jefferson
University).
Collaborators: Felix Feng, MD (University of
Michigan); Myles Brown, MD (Dana-Farber
Cancer Institute).

Defining the spectrum of resistance to
androgen ablation therapy in prostate cancer
PI: Levi Garraway (Dana-Farber Cancer
Institute)
Collaborators: William Hahn (Dana-Farber
Cancer Institute), Mark Rubin (Weill Cornell
Medical College).

Genome-wide analysis of response to androgen
deprivation therapy
PI: Mark Pomerantz, MD (Dana-Farber Cancer
Institute)
Collaborators: Matthew Freedman, MD (DanaFarber Cancer Institute); Christopher Sweeney,
MBBS (Dana-Farber Cancer Institute); Manish
Kohli, MBBS (Mayo Clinic); Svitlana
Tyekucheva, PhD (Dana-Farber Cancer
Institute).
Targeting Androgen Receptor PathwayIndependent Prostate Cancer (APIPC)
PI: Peter Nelson, MD (Fred Hutchinson Cancer
Research Center).
Collaborators: Marc Vidal, PhD (Dana Farber
Cancer Institute); Muneesh Tewari, MD, PhD
(Fred Hutchinson Cancer Research Center).

10

2013 High Impact Clinical Trials
Clinical Trials Assessing Mechanisms
Mediating Sensitivity and Resistance to
Enzalutamide
PI: Mary-Ellen Taplin, MD (Dana Farber
Cancer Center).
Collaborators: Bruce Montgomery, MD
(University of Washington); Elahe Mostaghel,
MD, PhD (Fred Hutchinson Cancer Research
Center); Xin Yuan, MD, DSc (Beth Israel
Deaconess Medical Center); Steven Balk, MD,
PhD (Beth Israel Deaconess Medical Center);
Glenn Bubley, MD (Beth Israel Deaconess
Medical Center); Mark Pomerantz, MD (Dana
Farber Cancer Center); Colm Morrissey, PhD
(University of Washington).

11

2011 Project Development

2012 Project Development

2013 Project Development

Epigenetic Reprogramming of AR Function in
CRPC
PI: Myles Brown, MD. (Dana-Farber Cancer
Institute).

Castration-Resistant Luminal Cells in the
Prostate
PI: Zhe Li (BWH)
Collaborator: Stuart Orkin (Children’s Hospital
Boston).

Developing Novel Targeted Therapies for
Advanced Prostate Cancer
PI: Karen Cichowski, PhD (Brigham and
Women's Hospital).

Pharmacological validation of Etk/BMX as a
target for the treatment of prostate cancer
PI: Nathanael Gray, PhD. (Dana-Farber Cancer
Institute)
Collaborator: Steven Balk, MD, PhD (Beth
Israel Deaconess Medical Center).

Developing a Blood-based Metabolomic
Signature of Gleason Score
PI: Massimo Loda (DFCI)
Collaborators: Kathryn Penney (Brigham and
Women's Hospital), Svitlana Tyekucheva
(Harvard School of Public Health).

Targeting the Co-Activator Site on the
Androgen Receptor
PI: Gregory Verdine, BS, PhD (Harvard
University – Chemistry Department)
Collaborator: Levi Garraway, MD (DanaFarber Cancer Institute).

Cancer Stem Cells Targeting in Castration
Resistant Prostate Cancer
PI: Pier Paolo Pandolfi, MD., PhD (Beth Israel
Deaconess Medical Center).

Nanoplatforms for Localized Chemo Radiation
Therapy for Prostate Cancer
PI: Robert Cormack (DFCI)
Collaborators: Anthony D’Amico (DanaFarber Cancer Institute), Alec Kimmelman
(Dana-Farber Cancer Institute), Mike
Makrigiorgos (Dana-Farber Cancer Institute),
Srinivas Sridhar (Northeastern University).

DNase-seq for Cost-effective Identification of
Functional Mutations in Prostate Cancers
PI: Xiaole Shirley Liu, PhD (Dana-Farber
Cancer Institute)
Collaborators: Myles Brown, MD (DanaFarber Cancer Institute) Levi Garraway, MD,
PhD (Dana-Farber Cancer Institute) Soumya
Raychaudhuri, MD, PhD (Harvard Medical
School).

12

2011 Lupron-Treatable Diseases and
Conditions

2012 Lupron-Treatable Diseases and
Conditions

Cancer and Endometriosis
PI: Stacey Missmer, ScD (Brigham and
Women’s Hospital)
Collaborators: Rulla Tamimi, ScD (Brigham
and Women’s Hospital); Jiali Han, PhD
(Brigham and Women’s Hospital).

Targeting estrogen-dependent mechanisms in
lymphangioleiomyomatosis (LAM)
PI: Elizabeth Henske, MD (Brigham and
Women’s Hospital)
Collaborator: Jane Yu, PhD (Brigham and
Women’s Hospital).
Pre-clinical in vivo studies investigating the
efficacy of mTOR inhibitors for uterine fibroids
Aaron Styer, PhD Replaced:
Jose Teixeira, PhD (Massachusetts General
Hospital)
Collaborator: Bradley Quade, MD (Brigham
and Women’s Hospital).

13

2011 Disparities Research

2012 Disparities Research

2013 Disparities Research

2014 Disparities Research

Enhancing Usability of the
Personal Patient Profile-Prostate
(P3P) for Black and Hispanic Men
PI: Donna Berry, PhD, RN (DanaFarber Cancer Institute)
Collaborators: Julia Hayes, MD
(Dana-Farber Cancer Institute)
Martin Sanda, MD (Beth Israel
Deaconess Medical Center) Seth
Wolpin, PhD, MPH, RN
(University of Washington).

Estimating The Prostate Cancer
Burden Attributed To Lifestyle
And Genetic Factors Among
African-American And White Men
PI: Lorelei Mucci (Harvard
School of Public Health)
Collaborators: Edward
Giovannucci (Harvard School of
Public Health), Massimo Loda
(Dana-Farber Cancer Institute),
Lisa Signorello (Vanderbilt
University).

Chronic stress and racial
disparities in prostate cancer
PI: Lisa Signorello, ScD (Harvard
School of Public Health).
Collaborators: Jennifer Rider, ScD
(Harvard School of Public
Health); Sebastien Haneuse, PhD
(Harvard School of Public
Health); Unnur Valdimarsdottir,
PhD (University of Iceland).

Do Baseline Prostate Specific
Antigen (PSA) Levels Predict
Advanced Prostate Cancer in
African-American Men?
PI: Mark Preston, MD, MPH
(BWH)
Collaborator: Lorelei Mucci, ScD
(HSPH)

Understanding Racial Differences
in Prostate Cancer Mortality
PI: Nancy Keating, MD, MPH
(Harvard Medical School)
Collaborators: Glen Taksler, PhD
(New York University) David
Cutler PhD (Harvard University
School of Economics).

Factors Influencing Willingness
To Participate In Biobanking
Among Black Men With And AtRisk For Prostate Cancer
PI: Karen Emmons (Dana-Farber
Cancer Institute)
Collaborators: Laura Hayman
(University of Massachusetts
Boston), J Jacques Carter (Beth
Israel Deaconess Medical Center,
Aymen Elfiky (Dana-Farber
Cancer Institute), Christopher
Lathan (Dana-Farber Cancer
Institute).

Whole genome sequencing based
identification of clinically relevant
genomic aberrations specific to
prostate cancer cases in African
Americans
PI: Zoltan Szallasi, MD (BCH)
Co-PI: Matthew Freedman, MD
(DFCI)
Collaborator: Mark Pomerantz,
MD (DFCI)

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2011 Community Outreach

2012 Community Outreach

2013 Community Outreach

Engaging African American Faith Communities in
Prostate Cancer Education
PI: Jennifer D. Allen, DSc, MPH, RN (Dana-Farber
Cancer Institute)
Collaborator: Donna Berry (Dana-Farber Cancer
Institute).

Shared Medical Appointments: An Innovative
Approach to Prostate Cancer Survivorship Care
PI: Larissa Nekhlyudov, MD, MPH (Harvard
Vanguard Medical Associates).
Collaborators: Ann Partridge, MD, MPH (DanaFarber Cancer Institute); Wilmer Roberts, MD,
PhD (Harvard Vanguard Medical Associates);
Michael Pistiner, MD, MMSc (Harvard
Vanguard Medical Associates); Aymen Elfiky,
MD, MPH (Dana-Farber Cancer Institute);
Christopher Recklitis, PhD, MPH (Dana-Farber
Cancer Institute); Sarah Reed, MPH,MSW
(Dana-Farber Cancer Institute).

Seed funding grant ($10K)for proposal development
for: Enhancing the effectiveness, mission and
outreach of an ongoing community prostate cancer
support group
PI: Glenn Bubley, MD (Beth Israel Deaconess
Medical Center)

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2011 Career Development

2012 Career Development

2013 Career Development

Probing androgen receptor signaling in
circulating tumor cells in prostate cancer
PI: David Miyamoto, MD, PhD (Massachusetts
General Hospital)
Collaborator: Daniel Haber, MD, PhD
(Massachusetts General Hospital).

Within-Person Molecular Differences in
Primary Versus Metastatic Prostate Cancer
PI: Julie Kasperzyk (Brigham and Women’s
Hospital)
Collaborators: Steven Balk (Beth Israel
Deaconess Medical Center), Giovanni
Parmigiani (Harvard School of Public Health,
Meir Stampfer (Brigham and Women’s
Hospital).

Impact on Prognosis of Inter- and Intratumor
Heterogeneity In Prostate Cancer
PI: Jennifer Sinnott, PhD
Collaborators: Lorelei Mucci, ScD (Harvard
School of Public Health), Giovanni Parmigiani,
PhD (Dana-Farber Cancer Institute). Massimo
Loda, MD (Dana-Farber Cancer Institute);
Kathryn Penney, ScD (Brigham and Women's
Hospital).

Prostate cancer genetic variants, molecular
alterations and mRNA expression
PI: Kathryn Penney, ScD, BA (Brigham and
Women’s Hospital)
Collaborator: Massimo Loda, MD (Brigham
and Women’s Hospital).

Inflammation and Tissue Microenvironment As
Predictors Of Prostate Cancer Risk, Mortality
And Therapy Response Among Men With An
Initially Benign TURP
PI: Jennifer Rider (Harvard School of Public
Health)
Collaborators: Lorelei Mucci (Harvard School
of Public Health), Giovanni Parmigiani (DanaFarber Cancer Institute), Christopher Sweeney
(Dana-Farber Cancer Institute), Michelangelo
Fiorentino (Harvard School of Public Health),
Ove Andren (University of Orebro)

Phosphorus and calcium intake, tumor
microenvironment and prostate cancer
progression
PI: Kathryn Wilson, Sc.D. (Harvard School of
Public Health)
Collaborators: Lorelei Mucci, MPH, ScD
(Brigham and Women’s Hospital), Edward
Giovannucci, MD, ScD (Harvard School of
Public Health), Michelangelo Fiorentino, MD,
PhD (Harvard School of Public Health).
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Appendix 3: Program Reporting Schedule

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