20150116 - Jan 16, 2015
ISSUE 2 – JAN. 16, 2015PDF

Duke Scientist: I Hope NCI Doesn’t Get Original Data

In May 2008, the Blue Devils of genomic medicine were facing a mortal threat.

An NCI biostatistician was demanding the data Duke University scientists used to derive the predictors of response in ovarian cancer.

This inquiry had the potential to sink Duke’s technology that was purported to analyze tumors and use genomic insight to identify the optimal treatment for each patient. According to Duke’s projections, cancer treatment decisions are made 700,000 times a year in the U.S. alone.

Multiply that by $3,000—the going rate for advanced tests at that time—and you have $2.1 billion.

How the “Bad Luck” Cancer Paper Was Misread by the Press

How much of the potential to develop cancer is due to plain “bad luck”?

A paper published Jan. 1 in Science titled, “Variation in cancer risk among tissues can be explained by the number of cell divisions,” generated a mild controversy when the authors’ use of the term “bad luck” caught on in the press.

Conversation with The Cancer Letter
Kramer: Our Cancer Risk Is Not in the Stars

The stochastic process of stem cell divisions should not be equated with bad luck, said Barnett Kramer, director of the NCI Division of Cancer Prevention, focusing on misinterpretations of the “Bad Luck” paper by Cristian Tomasetti and Bert Vogelstein, of Johns Hopkins University School of Medicine.

AVEO Cuts Workforce by 66%, Ending Research Functions

AVEO Oncology announced plans to cut its workforce by two-thirds, end its internal research functions, and vacate up to 80 percent of its facilities, including laboratory and vivarium locations. The biotechnology company was co-founded by Ronald DePinho, president of MD Anderson Cancer Center.

The restructuring would leave about 20 full-time positions.

 

FASEB Offers Recommendations To Improve Research Funding

The Federation of American Societies for Experimental Biology called for a re-examination of the way research is funded in the U.S., in a report detailing the challenges facing researchers and the threats to continued progress in the field.

The report, Sustaining Discovery in Biological and Medical Science: A Framework for Discussion, presents a series of recommendations to alleviate them.

 

Obituary
Dorothy “Dottie” Thomas, 92, “Mother of Bone Marrow Transplantation”

Dorothy “Dottie” Thomas, wife and research partner to 1990 Nobel laureate E. Donnall Thomas, died Jan. 9, at her home near Seattle. She was 92. 

Don Thomas, pioneer of the bone marrow transplant and former director of the Clinical Research Division at Fred Hutchinson Cancer Research Center, preceded her in death on Oct. 20, 2012, also at age 92.

In Brief

  • MD Anderson’s Andrew Lee moves to Texas Center for Proton Therapy

  • A. Eugene Washington named chancellor for health affairs at Duke University

  • Julie Brahmer named director of thoracic oncology at Johns Hopkins Kimmel Cancer Center

  • Naiyer Rizvi named director of thoracic oncology at NewYork-Presbyterian/Columbia University Medical Center

  • Seton Hall University and Hackensack University Health Network to form four-year, private medical school

  • Roche acquires Bina Technologies Inc.

  • Karmanos Cancer Institute receives $5 million grant from the Dresner Foundation

  • ASCO and College of American Pathologists announce partnership

  • Mount Sinai Health System and Valley Health System announce collaboration

  • Pelotonia awards six grants to Ohio State

  • Genentech and Human Longevity Inc. announce multi-year agreement

  • MD Anderson, Intrexon, and Ziopharm announce sublicensing agreement with the University of Minnesota

  • Amgen and MD Anderson announce research agreement

20150109 - Jan 9, 2015
ISSUE 1 – JAN. 9, 2015PDF

Internal Emails Raise New Questions
Duke Officials Silenced Med Student Who Reported Trouble in Anil Potti’s Lab

Duke University would have avoided embarrassment, a misconduct investigation and a lawsuit, had its top administrators paid closer attention to a thoughtful report by a medical student who saw problems in the lab of the disgraced scientist Anil Potti.

Documents obtained by The Cancer Letter show that Duke’s deans were warned about Potti’s misconduct in late March and early April 2008, at the time when clinical trials of the now discredited Duke genomic technology were getting started.

The three-page document was penned by Bradford Perez, then a third-year medical student and a Howard Hughes Medical Institute scholar.

Instead of rewarding the student’s brilliance with a plaque and a potted plant, Potti’s collaborator and protector, Joseph Nevins—aided by a phalanx of Duke deans—pressured the young man to refrain from making a final complaint and reporting the matter to HHMI.

The Med Student’s Memo

An Appreciation
Joseph McLaughlin, 66, Cancer Epidemiologist

Joseph McLaughlin, an internationally recognized epidemiologist who made numerous contributions towards increasing understanding of the causes of cancer, died unexpectedly Dec. 10, 2014.

He directed key research in the United States and abroad clarifying the roles of tobacco, obesity, diet, occupation and other factors in the etiology of several cancers, especially kidney cancer, for which he was considered among the world’s experts. He led some of the largest studies exploring the etiology of renal cell and renal pelvis cancers, quantifying levels of risk associated with multiple lifestyle and environmental factors.

Obituary
Anthony Murgo, of the FDA Office of Hematology and Oncology Products

Anthony (Tony) J. Murgo, died Dec. 17, 2014 after a courageous year-long battle with cancer. He was a passionate research physician with a kind bedside manner. 

Murgo was a dedicated federal employee for 25 years, serving in multiple capacities at FDA and NCI. As the associate director of regulatory science of the FDA’s Office of Hematology and Oncology Products, Murgo was the liaison between that office and NCI’s Cancer Therapy Evaluation Program. Within OHOP, Murgo also served as a medical reviewer, a team leader and a division director for Division of Oncology Products 1.

Drugs and Targets

  • Accelerated Approval Granted to Opdivo in Metastatic Melanoma
  • FDA approved a supplemental biologics license application for Gazyva
  • FDA approved an updated version of MarginProbe
  • FDA granted Fast Track designation to SGX301
  • Polaris Group’s lead product candidate, ADI-PEG 20 receives US and EU orphan designations
  • Amgen and Kite Pharma entered into a strategic research collaboration
  • Taiho Oncology Inc. submits NDA for TAS-102
In Brief

  • Donald Trump named CEO of Inova Cancer Care and Research Institute

  • Dario Altieri named CEO of The Wistar Institute

  • Sharmila Makhija named chair of the Department of Obstetrics & Gynecology and Women’s Health at Albert Einstein College of Medicine

  • Nipun Merchant joins Sylvester Comprehensive Cancer Center

  • St. Jude receives $2 million pledge from InfinityQS International Inc.

  • NCI Director Harold Varmus addresses NCI staff and grantees with an outlook on the new year

20141219 - Dec 19, 2014
ISSUE 47 – DEC. 19, 2014PDF

Congress Plans to Accelerate Development of Drugs, Devices

The House Committee on Energy and Commerce is spearheading legislation aimed streamlining development of drugs and medical devices. 

The bipartisan initiative, called “21st Century Cures,” was launched April 30, and is led by Rep. Fred Upton (R-Mich.), chairman of the committee, and Rep. Diana DeGette (D-Colo.), chief deputy whip.

Research Advocates Prepare to Face Republican-led Congress

The 113th Congress staggered through its final spending bill, approving $1.1 trillion in a massive “cromnibus” Dec. 13, keeping most of the federal government funded through September 2015, and locking in a half-percent increase for NIH and NCI in FY2015.

Biomedical research advocates bemoaned the modest increase in funding—$150 million for NIH and $27 million for NCI—and questioned Congress’s commitment to scientific progress. 

Half-Percent NIH, NCI Budget Raise Is Not Enough, Advocates Say

The Cancer Letter asked leaders of science and cancer advocacy groups to comment on the half-percent increases in federal funding for NIH and NCI in fiscal 2015, and on the prospects of science funding when Republicans take control of Congress in January. 

Conversation with The Cancer Letter
Is Republican Control Better Than Two-Party Stalemate?

As Congress goes into recess and Democrats relinquish their eight-year control of the Senate, advocates for biomedical research are rethinking their approaches to a political reality not observed in nearly a decade: a Republican-controlled Congress.

Jennifer Zeitzer, director of legislative relations at the Federation of American Societies for Experimental Biology, a coalition that represents 27 scientific societies and over 120,000 researchers worldwide, says she is optimistic about prospects for science funding in the 114th Congress. 

The reason: both sides have learned that stalemates benefit no one.

ACS President & COO Resigns Unexpectedly; Was Seen as Contender for CEO Position

Gregory Bontrager resigned from his position as chief operating officer and president of the American Cancer Society.

His resignation was announced in an email from ACS Chief Executive Officer John Seffrin Dec. 18. No reason for the departure was cited. 

Bontrager, who became the COO in 2007 and president in 2013, was, in effect, the society’s second-most-powerful official, and one of the engineers of its current move to a centralized structure.

The Cancer Letter is taking a Holiday Break. 

The next issue will be published on Jan. 9, 2015.

ODAC To Advise FDA on First Biosimilars Application Jan. 7

The FDA Oncologic Drugs Advisory Committee will meet Jan. 7, 2015, to discuss a biologics license application for a proposed biosimilar to Amgen Inc.’s Neupogen (filgrastim).

The biosimilar application, submitted by Sandoz Inc., will be the first such application to be filed and discussed by an FDA advisory committee. 

NCI Advisory Board Approves Three Concepts

At a meeting Dec. 2, the NCI Board of Scientific Advisors approved three concepts during a joint meeting with the National Cancer Advisory Board.

Editorial

A Record-Breaking Year for The Cancer Letter

2014 was a transformative year for The Cancer Letter. 

• We launched a new website that makes our content possible to read online without downloading PDF files. 

• We made the website “responsive,” enabling it to adapt to all screen sizes, including smartphones and tablets. Now, about a third of our readers use these devices. An app will be available shortly.

Regulatory Approvals

  • FDA expanded the approved use of Cyramza to include metastatic NSCLC
  • FDA approves Somatuline Depot Injection (lanreotide) for metastatic GEP-NETs
  • Lynparza (olaparib) and companion diagnostic approved in gBRCAm advanced ovarian cancer
  • 510(k) clearance granted to Narrow Band Imaging for bladder cancer patient
  • FDA clears Advaxis immunotherapy phase I/II trial IND application
  • Genentech submits new drug application for cobimetinibn
In Brief

  • Fabien Calvo named chief scientific officer of Cancer Core Europe

  • OSUCCC – James moves into new cancer hospital

  • MD Anderson and UnitedHealthcare launch bundled payment program

  • Ohio State University names 2014 James Hope Award winners

  • Washington University at St. Louis genome center receives $25 million pledge

  • George Washington University Cancer Institute receives $150,000 from Center for Advancing Health

  • Northwestern University’s Lurie Comprehensive Cancer Center enters research agreement with NeoGenomics Inc.

  • Oregon Health & Science University and FEI expand Living Lab for Cell Biology agreement

  • Cancer Treatment Centers of America select WIRB-Copernicus Group to help expand its clinical research program