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  1. 1. Vol. 37 No. 3 Jan. 21, 2011 © Copyright 2011 The Cancer Letter Inc. All rights reserved. Price $395 Per Year. To subscribe, call 800-513-7042 or visit PO Box 9905 Washington DC 20016 Telephone 202-362-1809Talking Back: FDA Faces Two ChallengesOver Avastin & Prostate Cancer Prevention By Paul Goldberg FDA Reviews BPH, Talking back to FDA’s oncology division used to be considered Hair Loss Indicationscounterproductive, like fighting city hall. For Prostate Drugs But in 2011, something seems to have changed. The agency’s decisions . . . Page 3in cancer are being vigorously challenged by complex commercial, academicand political constituencies. The challenges stem from two separate cases: Genentech Seeks • For the first time, FDA has revved up the machinery for removing To Run Newan indication under the accelerated approval process, and the company that Confirmatory Trialholds the indication slated for removal—Genentech—is fighting back. On Jan. . . . Page 418, Genentech requested a hearing to challenge the decision to withdraw the (Continued to page 2) ASCO Takes No PositionIn the Cancer Centers: On Avastin BattleGray Moves to OHSU Knight Cancer Institute; . . . Page 6Roswell Park Gets $4.3mil for Disparity Program In the Cancer Centers: JOE GRAY joined the Oregon Health & Science University KnightCancer Institute and was named chair that institution’s Department of Indiana UniversityBiomedical Engineering. His job is to establish the programs of the Center Gets $3.4 Millionfor Spatial Systems Biomedicine, where he serves as director. The center For Palliative Studieswill use a combination of physics, biomedical engineering, chemistry and . . . Page 7biology to study how cancer cells grow. Gray began moving his research team to OHSU from the Lawrence Funding Opportunities:Berkeley National Laboratory starting Jan. 1. J&J Seeks Grant Gray said the multidisciplinary center would develop the teams and Nominations, LLSinfrastructure to create next-generation cell “assembly manuals” that would Issues RFPdescribe how molecular aberrations in cells function as a system and how . . . Page 8function is modulated by anatomic context. “Research in the past several decades has been focused on understandingthe molecular components of cancer,” he said. “The next phase of researchwill determine how the parts work together. Once you know how the partswork together in individual patients and in anatomic context, it will be easierto understand how to develop more effective and durable treatments.” Gray’s contributions to science include inventions of aspects offlow cytometry. Also, he was a key participant in the development ofthe fluorescence in situ hybridization (FISH) and comparative genomicshybridization (CGH) tests.Gray is a former professor at the Departments of (Continued to page 7)
  2. 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: 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 colorectalThe Cancer LetterPage 2 • Jan. 21, 2011
  3. 3. cancer drug UFT. to add information about chemoprevention to the label. Academics, including the ODAC chairman and However, physicians who support the indicationseveral 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 extremelyCancer 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 isby 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 PreventionGenentech 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 themarket, and the controversy stems from supplemental subsequent analyses done on PCPT data haveNew 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 bypredict how the agency’s mechanism for withdrawing a significant amount,” Baker, an oncologist at theaccelerated approval will function and how effective the University of Michigan, said in a SWOG’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 factgenerating about $1 billion in sales in the breast cancer that prostate cancer risk reduction for the thousands ofindication. 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 ahas stopped, and the proportion of new prescriptions has choice would have much preferred to take a pill everydecreased from 59 percent prior to the ODAC decision day and not have cancer to deal with,” Baker said. “Ifto 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 andactions, but despite this uncertainty (and an agreed-upon dutasteride actually increased high-Gleason scoremarketing moratorium), a substantial core level of use prostate cancer, why did they then fail to remove thecontinues,” the company said in the filing. “This use drugs from the market for a large population of men withpattern 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’sand, in particular, are not finding that the drug has an comments is posted at toxicity profile.” newsletters/2010/12/index.asp?A=spotlight The document is posted at FDA officials said they are, in fact, reviewinggene/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 ofmembers noted that Avodart and Proscar are associated these drugs for their approved uses for BPH and hairwith higher incidence of high-grade tumors, which could loss,” said Karen Mahoney, the agency spokesman. “Wejeopardize Avodart’s labeled indication as a treatment cannot say more at this point since our review isof benign prosthetic hyperplasia. ongoing.” Proscar, which has gone off-patent, is approved GSK spokesman Rob Perry said the company hasfor 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 wasby the agency. Its presentation was based on the results disappointment for the prospects of developing a way toof 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. 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 paclitaxelThe Cancer LetterPage 4 • Jan. 21, 2011
  5. 5. allowed for prolonged exposure to both the cytotoxic As presented by the investigators at the Decemberand anti-angiogenic agents, as evidenced by a median 2010 San Antonio Breast Cancer Symposium, recentchemotherapy duration of 7.3 months for Avastin plus data analyses from AVADO suggest that plasmapaclitaxel, compared with a median chemotherapy VEGF-A may be a potential predictive marker forduration of 5.1 months for paclitaxel alone. Avastin activity. In contrast, treatment durations with combinations Patients with high levels of VEGF-A had a PFSwith docetaxel and anthracyclines are limited by the hazard ratio of 0.49 (standard dose), whereas patientscumulative 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 oflimitations on exposure to docetaxel (maximum of nine VEGF-A may be more likely to derive a more substantial3-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 scientifically27 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 hastolerability 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 inconfirmatory trials for E2100. Although the differential preclinical and over 100 in clinical studies) have beeneffect 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, lungbenefit observed in these studies (including differences cancer, and brain cancer) for prognostic and predictivewithin RIBBON1 for capecitabine compared with the biomarkers.other chemotherapies) establishes a real and credible These biomarkers include plasma and tumorhypothesis 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, VEGFMemorandum when it dismisses the hypothesis that was a strong prognosticbut not predictivemarkerpaclitaxel 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 withthat paclitaxel is a preferred chemotherapy partner samples order to maintain accelerated approval; rather,Genentech should have the opportunity to conduct a NCCN vs. ODACfurther study while accelerated approval is maintained. In the filing, Genentech argues that members of the advisory committee that voted 12 to 1 to removeGenentech’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 panelconfirmatory 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 itsconfirmatory study of Avastin: a double-blind, recommendation for use of Avastin in combinationrandomized, multicenter, phase III study designed to with paclitaxel, after having reviewed the same data thatcharacterize 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 updatedE2100. on the basis of an evidence-based process, with explicit PFS would be the primary efficacy endpoint, review of scientific evidence by multidisciplinary panelsand OS, 1-year survival, and response rate would be of expert physicians. The contrasting conclusions ofsecondary efficacy endpoints. This study would include ODAC and the NCCN may stem from the differinga biomarker component to identify patients who may composition of these groups and their distinct more likely to derive a more substantial benefit from ODAC is a heterogeneous panel of advisorsAvastin. consisting of oncologists with different specialty The Cancer Letter Vol. 37 No. 3 • Page 5
  6. 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 processThe Cancer LetterPage 6 • Jan. 21, 2011
  7. 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 Knightwe do not feel that it is appropriate for us to take a pro Cancer Institute recruited Marilyn Owens to serve asor con decision on the outcome of that process,” said chief operating officer of the OHSU Knight DiagnosticSledge, the Ballve-Lantero Professor of Oncology Laboratories, which will offer tests that create a detailedand 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 ofregarding what represent acceptable endpoints in clinical operations for Caris Life Science and has held seniortrials of cancer drugs, and encourage the FDA to work positions at IMPATH Inc., Genzyme Genetics and thewith the oncology community to examine the process Nichols which such endpoints are determined, and to makethe endpoints as clear as possible so that the drug ROSWELL PARK CANCER INSTITUTEdevelopment community can generate advances in an received a five-year, $4.3 million grant from the NCIefficient 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 reducechallenges to the agency’s expected action on Proscar cancer health disparities in three counties of Westernand Avodart. However, Schellhammer said the AUA- New York.ASCO guideline committee review is being organized Deborah Erwin, director of cancer healthand 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 U54Indiana 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 ofLaboratory Medicine and Radiation Oncology at the RPCI, the Community Health Center of Buffalo andUniversity of California, San Francisco, and director Niagara Falls, the P2 Collaborative, the Health Networkof the Division of Life Sciences at Lawrence Berkeley in Chautauqua County, the University at Buffalo and theNational Laboratory. He served as principal investigator Niagara Falls Memorial Medical Center. The projectof 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 throughBiology award, a DOD Innovator Project on early cancer improved access to screening, early detection, anddetection, 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 informationmembers from Lawrence Berkeley National Laboratory for the Data Bank and BioRepository, a large databaseincluding Paul Spellman, a genome scientist and key maintained at RPCI that supports research at RPCI andparticipant in The Cancer Genome Atlas project, who other institutions;will contribute to the new center and serve as a faculty • Innovative tobacco-cessation techniques usingmember in the Department of Molecular & Medical voice-recognition technology; andGenetics. • Training and career development. Gray will also recruit six new faculty in aspects Martin Mahoney, of the Departments of Healthof multiscale imaging science, reporter chemistry and Behavior and Medicine at RPCI will help directcell and tissue engineering who will hold primary another component of the program, to “promote theappointments 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 physicianshis wife, Penny. in the community can record automated-delivery phone The Cancer Letter Vol. 37 No. 3 • Page 7
  8. 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 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 Cancer LetterPage 8 • Jan. 21, 2011
  9. 9. DEPUTY DIRECTOR POSITION AVAILABLEThe University of California, Irvine is recruiting a physician scientist for a tenured position atthe 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 programfocused on either basic/translational investigations or clinical/translational science. This isa senior leadership position within a National Cancer Institute designated ComprehensiveCancer 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 thenext CCSG review, responsibilities of the Deputy Director will expand in the near future toinclude transitioning the Center with new leadership.Applicants must hold an MD or equivalent degree, be board certified in their cancer relatedsub-specialty, and be eligible to obtain an active license to practice medicine in the state ofCalifornia.For more information, contact Krista Hollinger, MPH at Procedure: Interested candidates must submit a cover letter, curriculum vitae,statement of research, statement of teaching, and contact information for 3-5 references viathe University of California’s Academic Personnel RECRUIT system at 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