Porter v. Tap Pharmaceutical, et al

Filing 582

Judge Richard G. Stearns: ORDER entered. MEMORANDUM AND ORDER on A. David Mazzone Research Awards Program Accounting Report #4.(Zierk, Marsha)

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS

IN RE LUPRON® MARKETING AND
SALES PRACTICES LITIGATION

M.D.L. No. 1430
Civil Action No. 01-10861

MEMORANDUM AND ORDER ON A. DAVID MAZZONE
RESEARCH AWARDS PROGRAM FIRST ANNUAL PROGRESS and
ACCOUNTING REPORT # 4
April 19, 2013
STEARNS, D.J.
On March 14, 2013, Dr. Philip Kantoff of the Dana-Farber/Harvard Cancer
Center (DF/HCC), the principal investigator for the A. David Mazzone Research
Awards Program,1 and co-principal investigator, Dr. Jonathan Simon, President of the
Prostate Cancer Foundation (PCF), submitted for the court’s review Report #4 for the
program period July 1, 2012, to December 31, 2012. Now in its third year, the
Program supports a total of 93 investigators working on 28 prostate cancer and related

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The Research Awards Program is named in the memory of the Honorable A.
David Mazzone, a much-revered United States District Court Judge who for nineteen
years oversaw the federally-mandated clean up of the Boston Harbor and who died
prematurely of prostate cancer. The Program is funded from a pool of unclaimed
consumer class funds created as part of the settlement of a national class action lawsuit
involving overpricing of the prostate cancer drug Lupron®. See In re Lupron® Mktg.
and Sales Practices Litig., 729 F. Supp. 2d 492 (D. Mass. 2010). The Program is
administered jointly by the DF/HCC and the PCF under supervision of the court.

research projects. The following are milestones compiled during the six months
following the last report.
(1)

A “High Impact Clinical Trial Award” developed by Dr. Kantoff will support an
early phase, multi-institutional clinical trial. Dr. Kantoff expects the award to
have a significant impact on prostate cancer drug development and testing.

(2)

The Lupron Treatable Diseases and Conditions Mechanism awarded its three
available grants during the 2012 funding period (Stacey Missmer, ScD - Cancer
and endometriosis; Jose Teixeira, PhD - Pre-clinical in vivo studies
investigating the efficacy of mTOR inhibitors for uterine fibroids; and Elizabeth
Henske,

MD

-

Targeting

estrogen-dependent

mechanisms

in

lymphangioleiomyomatosis LAM). As the designate funds have been exhausted,
there will be no additional awards in 2013.
(3)

In 2012, the Program experimented with a new training award mechanism to
support pre- and post-doctoral fellows working in prostate cancer research
laboratories.

However, the Program review panel concluded that the

applications received in 2012 did not provide significant added value to the
career development awards. In collaboration with the court representatives, the
Program decided to terminate the pre-post-doctoral fellowship funding
mechanism for 2013. The court is appreciative of the determination of the
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principal investigators and the Scientific Advisory Board (SAB) in ensuring the
financial and scientific integrity of the Program.
The Report also details the 2013 Request For Application (RFAs). In the 2013
cycle, DF/HCC will offer six investigative awards and PCF will continue to offer the
Special Challenge Award. The deadline for Letters of Intent (LIT) was March 8, 2013.
The Program leadership board decided to offer the RFA for High Impact Trials for a
second time for year 2013. The Mazzone Program received 90 LITs involving 212
researchers at 87 institutions. The application deadline was April 5, 2013. After
ranking and review, the SAB will make its final funding decisions on or before June 15,
2013.
The Report also highlights the Mazzone Awards recipients participation in the
Sixth Annual Prostate Cancer Program conference held March 18-20. The event,
co-sponsored by Memorial Sloan-Kettering Cancer Center, Dana-Farber/Harvard
Cancer Center, Johns Hopkins Hospital, and the University of Michigan, featured
Mazzone Award investigators Lorelei Mucci, ScD; Myles Brown, MD; Steven Balk,
MD, PhD; Bill Nelson, MD, PhD; and Massimo Loda, MD, as sessions moderators for
panels on Genomics and Biology; Prognostic and Predictive Markers; Population
Science to inform on prostate cancer etiology: Genetics; and Androgen Receptors.
The 2011 DF/HCC and PCF award recipients will complete their second year
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of research activities in July of 2013. Simultaneously, 2012 DF/HCC and PCF award
recipients will complete their first year of research activities. Each award recipient will
submit an annual scientific progress report and financial report. Progress reports will
be reviewed by Dr. Kantoff and the SAB, and the court if necessary. The court will
receive a further progress report on or before September 30, 2013 .
ORDER
The principal investigator of the A. David Mazzone Research Awards Program,
Dr. Kantoff, and the co-principal investigator, Dr. Simons, are requested to submit to
the court the required research progress and accounting report for all grants (Annual
Report # 5) on or before September 30, 2013.
SO ORDERED.
/s/ Hon. Richard G. Stearns
__________________________
United States District Judge

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