2. the extent—if any—it needs to be modified as a result
Genentech Files Document of ODAC recommendations and the expected FDA
To Dispute Avastin Decision decision.”
(Continued from page 1) Schellhammer, a professor at Eastern Virginia
metastatic breast cancer indication of the drug Avastin Medical School and medical director of the Virginia
(bevacizumab). Prostate Center, said he was not speaking for the
• A group of doctors is openly disagreeing with guideline committee or the organizations that support it.
recommendations by the Oncologic Drugs Advisory William McGivney, CEO of the National
Committee to bar agents Proscar (finasteride) and Comprehensive Cancer Network, said that to the
Avodart (dutasteride) from being used in prevention best of his knowledge, until recently his group never
of prostate cancer (The Cancer Letter, Dec. 3, 2010). recommended a specific drug or biologic for an
Though no decision has been made, the agency is indication that went directly against a specific negative
expected to deny this indication. recommendation from FDA.
The guideline-writing committee operated jointly This changed in October, when NCCN decided to
by the American Society of Clinical Oncology and the keep the Avastin breast cancer indication in its breast
American Urologic Association is considering convening guideline despite a negative vote from ODAC (The
a meeting to review the ODAC recommendation, Cancer Letter, Oct. 22, 2010).
sources said. “Our docs, who basically see breast cancer patients
If the committee is allowed to convene and if it day and night, look at the data and come up with their
upholds its existing guideline, which recommends these recommendation about bevacizumab or any other drug,”
drugs as an option, this would amount to supporting McGivney said. “In the case that we have right now,
an off-label use that directly contradicts a negative obviously, our guys looked at the data, interpreted it,
determination by the agency, observers said. and stuck with their original recommendation about use
“It is not a certainty” that the panel will change its in combination with paclitaxel.”
recommendation to remove chemoprevention with these
drugs, called 5-alpha reductase inhibitors, said Paul Remember Robert Fildes?
Schellhammer, co-chairman of the panel that formulated More often than not, challenges to FDA actions in
the most recent ASCO-AUA recommendation and past oncology are mounted by small biotech firms that have
president of AUA. “There will be extensive evaluation nothing to lose after the demise of their single product.
and reevaluation by the panel that constructed the Even then, companies rely on surrogates in the
current joint ASCO and AUA guideline to determine academia and patient groups, or surreptitiously make
rounds on Capitol Hill to try to trigger an investigation,
or make on-background calls to a reporter.
A search for exceptions takes one far—very far—
back: to July 31, 1990. On that day, the FDA Biological
® The Cancer Letter is a registered trademark. Response Modifiers Advisory Committee said no to
Editor & Publisher: Paul Goldberg an application for interleukin-2 for the renal cancer
indication. Robert Filders, president and CEO of Cetus
Inc., the drug’s sponsor, held a press conference at which
Editorial, Subscriptions and Customer Service: he blasted FDA officials.
202-362-1809 Fax: 202-379-1787 The agency had erased data tapes, some statements
PO Box 9905, Washington DC 20016 of the medical reviewer amounted to “red herrings,”
General Information: www.cancerletter.com and both the agency and its advisors had taken an
impractical approach by “playing pure science,” Fildes
Subscription $395 per year worldwide. ISSN 0096-3917.
Published 46 times a year by The Cancer Letter Inc. Other
raged (The Cancer Letter/Cancer Economics, August
than "fair use" as specified by U.S. copyright law, none of 1990). Soon after returning to Emeryville, Calif., cigar-
the content of this publication may be reproduced, stored in chomping Fildes found himself out of work.
a retrieval system, or transmitted in any form (electronic, More typical is the position taken by Bristol-Myers
photocopying, or facsimile) without prior written permis- Squibb when this publication focused on the FDA
sion of the publisher. Violators risk criminal penalties and decision to disregard the unanimous recommendation by
damages. Founded Dec. 21, 1973, by Jerry D. Boyd. ODAC and deny the BMS application for the colorectal
The Cancer Letter
Page 2 • Jan. 21, 2011
3. cancer drug UFT. to add information about chemoprevention to the label.
Academics, including the ODAC chairman and However, physicians who support the indication
several committee members, found this appalling. Also, say that the ODAC vote was wrongheaded.
a Congressional committee started to ask questions (The “I think the issue of chemoprevention is extremely
Cancer Letter, July 21, 2000). important, and should go hand-in-hand with early
Fearing revenge from the agency, BMS responded screening, and my opinion and advice to patients is
by trying to make the investigation go away, and to consider it as part of a risk-reduction strategy,”
launched its own internal probe to try to determine how Schellhammer said to The cancer Letter.
the story leaked out. Laurence Baker, chairman of Southwest Oncology
Group, which conducted the Prostate Cancer Prevention
Genentech Takes Aggressive Stance Trial of finasteride, slammed FDA even before the
Today’s challenges to FDA are particularly agency announced its decision.
noteworthy because all the drugs in question are on the “We believe the PCPT trial results and the
market, and the controversy stems from supplemental subsequent analyses done on PCPT data have
New Drug Applications. demonstrated for the first time a proof of principle
Genentech’s case is untested. There is no way to that a drug can reduce the risk of prostate cancer by
predict how the agency’s mechanism for withdrawing a significant amount,” Baker, an oncologist at the
accelerated approval will function and how effective the University of Michigan, said in a SWOG newsletter.
company’s political strategy will be. “That the drug’s prevention benefit was greater in men
Before Genentech’s troubles began, the drug was with lower Gleason scores does not detract from the fact
generating about $1 billion in sales in the breast cancer that prostate cancer risk reduction for the thousands of
indication. men who took part in PCPT was real and was significant.
According to this week’s filing, the drug’s growth “I’ve had a radical prostatectomy, and if given a
has stopped, and the proportion of new prescriptions has choice would have much preferred to take a pill every
decreased from 59 percent prior to the ODAC decision day and not have cancer to deal with,” Baker said. “If
to 35 percent in the fourth quarter of 2010. you are given a choice of not having prostate cancer
“This trajectory shows that clinicians and patients or having prostate cancer, which would you choose,
have modified their treatment choices based on the regardless of whether it would lengthen your life?
uncertainty surrounding the ODAC decision and FDA “If the FDA’s ODAC believed finasteride and
actions, but despite this uncertainty (and an agreed-upon dutasteride actually increased high-Gleason score
marketing moratorium), a substantial core level of use prostate cancer, why did they then fail to remove the
continues,” the company said in the filing. “This use drugs from the market for a large population of men with
pattern indicates that clinicians and patients continue to BPH, some of whom certainly harbor prostate cancer?”
view Avastin as an important option for certain patients The SWOG newsletter article containing Baker’s
and, in particular, are not finding that the drug has an comments is posted at http://swog.org/visitors/
unacceptable toxicity profile.” newsletters/2010/12/index.asp?A=spotlight
The document is posted at http://www.gene.com/ FDA officials said they are, in fact, reviewing
gene/news/news-events/avastin/. the labels of 5-alpha reductase inhibitors in light of
Unlike Genentech, GlaxoSmithKline, the sponsor information presented at ODAC.
of Avodart, is unlikely to adopt an aggressive strategy. “We are considering the recent advisory committee
At the ODAC meeting, the agency and committee discussion in the context of the risks and benefits of
members noted that Avodart and Proscar are associated these drugs for their approved uses for BPH and hair
with higher incidence of high-grade tumors, which could loss,” said Karen Mahoney, the agency spokesman. “We
jeopardize Avodart’s labeled indication as a treatment cannot say more at this point since our review is
of benign prosthetic hyperplasia. ongoing.”
Proscar, which has gone off-patent, is approved GSK spokesman Rob Perry said the company has
for BPH as well as for hair loss. Its sponsor, Merck, confidence in the data supporting the BPH indication.
came to the meeting because it was invited to show up “Our position coming away from the ODAC was
by the agency. Its presentation was based on the results disappointment for the prospects of developing a way to
of the NCI-sponsored Prostate Cancer Prevention Trial. help physicians and patients reduce the risk of prostate
Merck wasn’t asking for a new indication. It sought cancer,” Perry said. “But, on the flip side, we have not
The Cancer Letter
Vol. 37 No. 3 • Page 3
4. changed confidence in position around Avodart as a and RIBBON1, which combined Avastin with other
treatment for BPH.” commonly used chemotherapy partners, were positive
The company expects to receive a letter from FDA studies that met their primary PFS endpoints and
next week. confirmed a positive effect on tumor control.
If professional societies part ways with FDA The lower magnitude of effect on median PFS in
and encourage an off-label use of 5-alpha reductase AVADO and RIBBON1 is an observation consistent
inhibitors for prostate cancer prevention, the company with clinical experience that some chemotherapy agents
will discourage such use, Perry said. (and their dose and schedule) yield different levels of
“We do not promote our medications for off-label clinical benefit.
use,” he said. “We will discourage and not condone this. Genentech viewed AVADO and RIBBON1 as
That is a GSK policy that has been repeatedly affirmed, confirming a clinical benefit of Avastin in MBC. ODAC
and enforced, and reemphasized, and reemphasized, and and FDA came to a contrary conclusion based on the
reemphasized.” lower magnitude of effect on median PFS in these trials.
However, even if FDA views AVADO and
Genentech Wants to Perform Another Trial RIBBON1 as failing to confirm the clinical benefit
In its filing to FDA, Genentech asks the agency of Avastin in MBC for purposes of conversion to full
to extend its accelerated approval for Avastin while the approval, Genentech respectfully submits that this view
company conducts a new confirmatory trial in which does not justify the opposite conclusion of withdrawal.
Avastin would be administered with weekly paclitaxel. AVADO and RIBBON1 do not negate the clinical
In 2008, the agency approved the use of Avastin benefit that FDA recognized when it granted accelerated
in combination with weekly paclitaxel, based on the approval based on the substantial PFS effect observed
Eastern Cooperative Oncology Group’s trial E2100. with Avastin plus paclitaxel. Rather, the data from these
However, confirmatory trials, led by Genentech’s parent additional studies are consistent with an unforeseen
company Roche, sought to expand the indication to other limitation in the designs of the confirmatory trials—
combinations. namely, the degree of difference in the magnitude of
In one of these trials—AVADO—the drug was clinical benefit when Avastin is used in combination with
used with Taxotere (docetaxel) every three weeks. In paclitaxel versus with other chemotherapies.
another trial—RIBBON 1—it was used with a taxane/ As such, the potential exists to characterize further
anthracycline combination in one cohort and with the benefit observed in E2100 with an additional study
capecitabine in another. RIBBON 1 had no weekly specifically testing the combination of Avastin with
taxane arm. weekly paclitaxel. Thus, the totality of the current data
This difference between regimens used with continues to meet the letter and spirit of the accelerated
Avastin could, at least theoretically, affect the outcome approval provisions of the FDCA and FDA’s regulations.
of studies. Breast cancer experts point to a puzzling The data justify the continued availability of
finding: data show that weekly paclitaxel appears to Avastin plus paclitaxel to address the immediate needs
produce greater efficacy than once-every-three-week of women with MBC, who can derive clinical benefit
docetaxel. while an additional study is conducted to characterize
The Roche confirmatory trials produced this clinical benefit more fully.
improvements in progression-free survival, but not of
the magnitude FDA regarded as sufficient to warrant The Paclitaxel Hypothesis
approval (The Cancer Letter, July 23, Sept. 3, 2010). The company would like the new confirmatory
The agency has started the process to remove the trials to focus on the hypothesis that mimics the E2100
breast cancer indication, (The Cancer Letter, Dec. 17, study.
2010). The company’s filing this week signifies that it The filing reads:
intends to fight the withdrawal and initiate the hearings. While multiple hypotheses can be generated for
The Genentech filing reads: why a differential effect would be observed with distinct
In this particular case, the current dataset supports chemotherapy partners, the current lead hypothesis
maintaining accelerated approval of Avastin in is that chemotherapies that provide for prolonged
combination with paclitaxel. combined exposure with Avastin may yield the strongest
In 2008, FDA determined that the data from E2100 treatment effects.
met the standard for accelerated approval. AVADO In E2100, the combination with weekly paclitaxel
The Cancer Letter
Page 4 • Jan. 21, 2011
5. allowed for prolonged exposure to both the cytotoxic As presented by the investigators at the December
and anti-angiogenic agents, as evidenced by a median 2010 San Antonio Breast Cancer Symposium, recent
chemotherapy duration of 7.3 months for Avastin plus data analyses from AVADO suggest that plasma
paclitaxel, compared with a median chemotherapy VEGF-A may be a potential predictive marker for
duration of 5.1 months for paclitaxel alone. Avastin activity.
In contrast, treatment durations with combinations Patients with high levels of VEGF-A had a PFS
with docetaxel and anthracyclines are limited by the hazard ratio of 0.49 (standard dose), whereas patients
cumulative toxicities of the chemotherapy agents. Thus, with low levels of VEGF-A had PFS hazard ratio of 0.86.
the protocols for AVADO and RIBBON1 included This finding suggests that patients with high levels of
limitations on exposure to docetaxel (maximum of nine VEGF-A may be more likely to derive a more substantial
3-week cycles) and anthracyclines (maximum of eight benefit from Avastin.
3-week cycles), corresponding to a maximum of only The relevance of VEGF-A is scientifically
27 or 24 weeks of combined treatment, respectively. plausible given Avastin’s inhibitory activity on the
In retrospect, these restrictions related to the biologic actions of VEGF. A biomarker program has
tolerability of alternate chemotherapies represent been an integral part of Genentech’s research on Avastin.
limitations of their study designs in serving as A large number of markers (over 10,000 in
confirmatory trials for E2100. Although the differential preclinical and over 100 in clinical studies) have been
effect observed in E2100, AVADO, and RIBBON1 studied in a variety of tumor types (including MBC,
is not well understood, the different magnitude of pancreatic cancer, gastric cancer, colorectal cancer, lung
benefit observed in these studies (including differences cancer, and brain cancer) for prognostic and predictive
within RIBBON1 for capecitabine compared with the biomarkers.
other chemotherapies) establishes a real and credible These biomarkers include plasma and tumor
hypothesis that warrant further investigation for a markers, circulating endothelial and progenitor cells,
differential effect for Avastin with paclitaxel. imaging, and genetic polymorphisms. In phase III trials
Given the data, FDA goes too far in its Decision of Avastin, using a first-generation VEGF assay, VEGF
Memorandum when it dismisses the hypothesis that was a strong prognosticbut not predictivemarker
paclitaxel is a preferred partner with Avastin because for Avastin’s efficacy.
the rationale for a “unique interaction between Avastin However, using a second-generation VEGF test,
and paclitaxel … has not been substantiated.” VEGF at baseline demonstrated a potential predictive
Genentech should not be required to have proven effect in MBC and pancreatic cancer for patients with
that paclitaxel is a preferred chemotherapy partner samples available.
in order to maintain accelerated approval; rather,
Genentech should have the opportunity to conduct a NCCN vs. ODAC
further study while accelerated approval is maintained. In the filing, Genentech argues that members of
the advisory committee that voted 12 to 1 to remove
Genentech’s Proposed Trial Avastin’s breast cancer indication were not as qualified
The filing contains the following description of a to evaluate the drug as members of the NCCN panel
confirmatory trial Genentech proposed: who voted in favor of the indication.
Following the 20 July 2010 ODAC meeting, The document reads:
Genentech submitted a proposal to FDA for a In October 2010, the NCCN affirmed its
confirmatory study of Avastin: a double-blind, recommendation for use of Avastin in combination
randomized, multicenter, phase III study designed to with paclitaxel, after having reviewed the same data that
characterize further and confirm the efficacy and safety were considered by the 20 July 2010 ODAC.
of Avastin in combination with paclitaxel, as shown by The NCCN Guidelines are developed and updated
E2100. on the basis of an evidence-based process, with explicit
PFS would be the primary efficacy endpoint, review of scientific evidence by multidisciplinary panels
and OS, 1-year survival, and response rate would be of expert physicians. The contrasting conclusions of
secondary efficacy endpoints. This study would include ODAC and the NCCN may stem from the differing
a biomarker component to identify patients who may composition of these groups and their distinct directives.
be more likely to derive a more substantial benefit from ODAC is a heterogeneous panel of advisors
Avastin. consisting of oncologists with different specialty
The Cancer Letter
Vol. 37 No. 3 • Page 5
6. expertise, statisticians and consumer and patient studies failed to demonstrate its efficacy in the approved
advocates. ODAC is asked to advise FDA on a broad indication, acute myeloid leukemia. Technically, this,
spectrum of oncologic drugs across the spectrum of too, is not a revocation of an indication.
cancer treatment, which is increasingly specialized. • Iressa (gefitinib), sponsored by AstraZeneca,
Only two of the 13 ODAC members at the 20 July 2010 was placed in a restricted access program that barred
ODAC meeting were breast cancer oncologists (one physicians from prescribing it to new patients. This
breast oncologist and one women’s cancer specialist), action, in 2005, was caused by failure of confirmatory
and both were temporary voting members recalled trials to demonstrate a survival advantage. Withdrawal
fromthe 2007 ODAC meeting on E2100 by FDA. procedures are spelled out in 21 CFR Subpart H 314.530.
A key component of the evaluation of Avastin as Here is how the process works:
a treatment option is understanding how patients and • The director of the FDA Center for Drug
physicians can weigh the safety information as part Evaluation and Research writes a letter containing a
of their benefit−risk assessment for Avastin in MBC. “notice of an opportunity for a hearing” on the center’s
Hence, a richer perspective of clinicians on ODAC proposal to withdraw the approval of an application. The
familiar with the use of Avastin in the clinic would letter contains the reasons for the action. This is what has
have been valuable to inform discussion of the use of happened with the Proamatine application last month.
Avastin in MBC. • The sponsor then has 15 days of receipt of the
By contrast, the NCCN Breast Cancer panel notice, the applicant waives the opportunity for a hearing.
comprises clinicians and oncology researchers If the sponsor requests a hearing, the agency announces
specializing exclusively in breast cancer from the NCCN the hearing in the Federal Register. The sponsor then
Member Institutions. Thus, the continued inclusion has 30 days of receipt of the notice of opportunity for a
of Avastin with paclitaxel in the NCCN Guidelines hearing to submit the data and information which would
reflects the recommendations of breast cancer clinicians form the basis of the hearing.
focusing on treatment experiences and clinical realities, • “An advisory committee” would be present at
whereas ODAC’s recommendation reflects the views the hearing, the regulations state. However, it’s not clear
of a heterogeneous advisory panel including a more whether this would be the same committee that would
generalist group of oncologists, statisticians, and others have been consulted on approval. The committee will
evaluating a body of clinical study data as presented by be asked to review the issues involved and to provide
FDA and the sponsor. advice and recommendations to the FDA commissioner.
Individuals with both expertise in breast oncology • The presiding officer, the advisory committee
and experience with the clinical use of Avastin are members, up to three representatives of the applicant,
best positioned to evaluate the benefit−risk balance of and up to three representatives of the center may
Avastin in MBC. Respectfully, we submit these qualities question any person during presentations. No other
are more clearly reflected in the composition of the person attending the hearing may question a person
NCCN Breast Cancer Guidelines panel than in ODAC. making a presentation. The presiding officer may, as a
matter of discretion, permit questions to be submitted
The Process to the presiding officer for response by a person making
Though the 1992 law that created the accelerated a presentation.
approval mechanism allows for removing indications, • The commissioner’s decision would constitute
no drug has ever gone through this process. Accelerated final agency action from which the applicant may
approval drugs have been removed from the market in petition for judicial review.
the past, but via less cumbersome means.
• In 2005, the drug Ethyol (amifostine), ASCO Will Not Take Position on Avastin
marketed by MedImmune, lost one of its indications, Though many oncologists will likely take part in
reducing the cumulative renal toxicity from cisplatin in debates over Avastin, ASCO intends to steer clear of the
non-small cell lung cancer. The drug is still marketed emerging debate, said society president George Sledge.
for its other indications. The indication was withdrawn “ASCO will be making no public comments, pro
voluntarily because of emergence of better treatment or con, regarding Genentech’s appeal of the FDA’s
options for non-small cell lung cancer. decision on Avastin in breast cancer,” Sledge said to
• Last year, Mylotarg (gemtuzumab ozogamicin) The Cancer Letter. “The society’s position, not specific
was withdrawn by the sponsor, Pfizer Inc., because three to this particular drug or indication, is that the process
The Cancer Letter
Page 6 • Jan. 21, 2011
7. of drug approval should be an open and transparent one. At OHSU, Gray also holds the Gordon Moore
“As the FDA has followed a standard review Endowed Chair in Biomedical Engineering.
process that included an open presentation at ODAC, In a related development, the OHSU Knight
we do not feel that it is appropriate for us to take a pro Cancer Institute recruited Marilyn Owens to serve as
or con decision on the outcome of that process,” said chief operating officer of the OHSU Knight Diagnostic
Sledge, the Ballve-Lantero Professor of Oncology Laboratories, which will offer tests that create a detailed
and Professor of Medicine and Pathology at Indiana genetic map of a patient’s tumor.
University Simon Cancer Center. “We do have concerns Owens is the former senior vice president of
regarding what represent acceptable endpoints in clinical operations for Caris Life Science and has held senior
trials of cancer drugs, and encourage the FDA to work positions at IMPATH Inc., Genzyme Genetics and the
with the oncology community to examine the process Nichols Institute.
by which such endpoints are determined, and to make
the endpoints as clear as possible so that the drug ROSWELL PARK CANCER INSTITUTE
development community can generate advances in an received a five-year, $4.3 million grant from the NCI
efficient and collaborative fashion.” Center to Reduce Cancer Health Disparities that will
ASCO has no guideline on the use of Avastin. enable the cancer center and five community health
Sledge said he was not aware of emerging partners to launch a multi-pronged effort to reduce
challenges to the agency’s expected action on Proscar cancer health disparities in three counties of Western
and Avodart. However, Schellhammer said the AUA- New York.
ASCO guideline committee review is being organized Deborah Erwin, director of cancer health
and would be convened “sooner rather than later.” disparities research at RPCI, and Willie Underwood,
of the Department of Urology, are principal co-
In the Cancer Centers: investigators on the U54 grant. A total of 23 Community
Network Programs across the country received U54
Indiana Receives $3.4 Million funding.
For Palliative Care Research The grant will create the Western New York Cancer
(Continued from page 1) Coalition to Reduce Disparities, uniting the efforts of
Laboratory Medicine and Radiation Oncology at the RPCI, the Community Health Center of Buffalo and
University of California, San Francisco, and director Niagara Falls, the P2 Collaborative, the Health Network
of the Division of Life Sciences at Lawrence Berkeley in Chautauqua County, the University at Buffalo and the
National Laboratory. He served as principal investigator Niagara Falls Memorial Medical Center. The project
of an NCI Breast Cancer SPORE for almost 15 years will encompass:
and currently is PI of NCI Center for Cancer Systems • Programs to reduce cancer disparities through
Biology award, a DOD Innovator Project on early cancer improved access to screening, early detection, and
detection, and co-principal investigator of a Stand Up treatment;
to Cancer Dream Team. • Efforts to recruit more Latino volunteers to
Gray will be joined by several research staff contribute biological samples and lifestyle information
members from Lawrence Berkeley National Laboratory for the Data Bank and BioRepository, a large database
including Paul Spellman, a genome scientist and key maintained at RPCI that supports research at RPCI and
participant in The Cancer Genome Atlas project, who other institutions;
will contribute to the new center and serve as a faculty • Innovative tobacco-cessation techniques using
member in the Department of Molecular & Medical voice-recognition technology; and
Genetics. • Training and career development.
Gray will also recruit six new faculty in aspects Martin Mahoney, of the Departments of Health
of multiscale imaging science, reporter chemistry and Behavior and Medicine at RPCI will help direct
cell and tissue engineering who will hold primary another component of the program, to “promote the
appointments in either basic or clinical departments. delivery of smoking-cessation services within both
The recruitment of Gray and his team is part of community-based and primary-care medical settings.”
the OHSU Knight Cancer Institute’s strategy to use the The project will create a registry of smokers and utilize
$100 million gift from Nike Chairman Phil Knight and automated voice recognition so primary care physicians
his wife, Penny. in the community can record automated-delivery phone
The Cancer Letter
Vol. 37 No. 3 • Page 7
8. messages to their patients who smoke, to reinforce The network was established in 2005 as a
the importance of quitting and to provide advice and partnership between the Institute of Cancer Medicine
encouragement. at the University of Oxford and India’s top eight
comprehensive cancer centers.
INDIANA UNIVERSITY MELVIN AND
BREN SIMON CANCER CENTER received a $3.4 Funding Opportunities:
million grant from the Walther Cancer Foundation
to promote research and education of palliative care.
J&J Seeks Award Nominations;
The grant, which creates the Walther Program LLS Issues RFP on Research
in Palliative Care Research and Education, will help JOHNSON & JOHNSON opened a call for
clinicians, researchers and educators at the IU Simon nominations for the 2011 Dr. Paul Janssen Award for
Cancer Center learn to integrate palliative care into Biomedical Research, which recognizes individuals
conventional cancer care and to provide the highest whose scientific research has made, or has the potential
quality of life for patients and their families. to make, significant transformational contributions
The Walther Program in Palliative Care Research toward the improvement of human health.
and Education will build upon the expertise of clinicians N o m i n a t i o n s a r e a v a i l a b l e a t w w w.
and researchers currently engaged in palliative care pauljanssenaward.com and will be accepted until Feb.
at the IU Simon Cancer Center to design, test and 15, 2011, for consideration by an independent selection
implement evidence-based palliative care practices. committee of world renowned scientists. The winner or
Physicians will design and test simulated patient- winners will receive a $100,000 cash prize.
physician conversations about end-of-life care to The 2010 award was presented to Anthony
enhance the quality of communication and decision- Fauci, director of the National Institute of Allergy and
making near the end of life. Infectious Diseases and Erik De Clercq, chairman of
The Palliative Care Research and Education the Department of Microbiology and Immunology of the
program also will provide for healthcare provider Medical School at the Catholic University of Leuven.
education in palliative care; testing novel interventions;
developing and testing innovative programs to address LEUKEMIA AND LYMPHOMA SOCIETY
unmet needs of family caregivers; assessing the impact has identified four specific areas of need, and is soliciting
of palliative care on the health care system; cross- grant applications from scientists and physicians who
disciplinary collaboration with health care providers; are working on these difficult problems.
public advocacy; and resources to recruit a nationally- The RFPs focus on researchers working in the
renowned investigator. following areas:
• Identification and characterization of the
SANOFI-AVENTIS and Oxford University leukemic stem cell in acute myeloid leukemia and
entered into an agreement to conduct multi-phase myelodysplastic syndrome and the identification of
oncology clinical and translational research with potential targeted therapies.
INDOX, India’s leading academic oncology network. • Novel therapeutic strategies for non-cutaneous
Through this partnership, sanofi-aventis will have T-cell lymphoproliferative disorders.
access to the expertise and experience of India’s top • Development of therapeutic strategies for the
oncologists and scientists to conduct clinical research to high-risk myeloma patient.
the highest internationally recognized ethical standards. • Mechanisms underlying long term and late
Under the agreement, sanofi-aventis will provide effects resulting from cancer treatment and the
financial support to Oxford University to manage the development measures to significantly reduce or prevent
INDOX network of eight leading cancer-research these toxicities
centers across India. Applications responsive to these RFPs should be
The university will provide training and support submitted under LLS’s Translational Research Program,
to investigators and research coordinators to help a program designed to help accelerate the movement of
ensure that each center has the capacity, expertise and promising discoveries from the lab to the clinic.
infrastructure to perform early- through late-stage and A detailed description of the LLS Translational
post-marketing clinical trials according to ICH/GCP Research Program and application instructions are
standards. available at https://proposalcentral.altum.com/.
The Cancer Letter
Page 8 • Jan. 21, 2011
9. DEPUTY DIRECTOR POSITION AVAILABLE
The University of California, Irvine is recruiting a physician scientist for a tenured position at
the associate or full professor level who will also be the Deputy Director of the Cancer Center.
We are seeking an experienced translational scientist with an established research program
focused on either basic/translational investigations or clinical/translational science. This is
a senior leadership position within a National Cancer Institute designated Comprehensive
Cancer Center. Responsibilities of the selected individual would include:
(1) Conducting a translational research program with external peer-reviewed funding.
(2) Bridging basic, clinical and cancer control research among the 6 research programs
with the goal of facilitating translational programs, P0-1s, SPOREs and similar multi-in-
vestigator grants and contracts.
(3) Providing senior leadership for the physician-scientists and clinical investigators in
the Center.
(4) Managing the clinical research infrastructure within the center.
(5) Representing the Cancer Center throughout the campus and greater community.
As the current long-term Director has announced his departure from this role following the
next CCSG review, responsibilities of the Deputy Director will expand in the near future to
include transitioning the Center with new leadership.
Applicants must hold an MD or equivalent degree, be board certified in their cancer related
sub-specialty, and be eligible to obtain an active license to practice medicine in the state of
California.
For more information, contact Krista Hollinger, MPH at kholling@uci.edu.
Application Procedure: Interested candidates must submit a cover letter, curriculum vitae,
statement of research, statement of teaching, and contact information for 3-5 references via
the University of California’s Academic Personnel RECRUIT system at http://recruit.ap.uci.edu.
Please reference OEOD# 5012.
The University of California, Irvine has an active career partner program and an NSF AD-
VANCE Program for Gender Equity and is an Equal Opportunity Employer committed to ex-
cellence through diversity.
The Cancer Letter
Vol. 37 No. 3 • Page 9