20160429 - Apr 29, 2016
ISSUE 17 – April 29, 2016PDF



Guest Editorial

The Moonshot: A View from Europe

By Peter Boyle

“And I believe we need a moonshot in this country to cure cancer.”

With these words, Vice-President Joe Biden gave the first public hint of a new specific, major program to be launched and funded by the U.S. government.

President Barack Obama reiterated this development in his State of the Union address announcing a new national effort to get it done and placing Vice President Biden as leader of this initiative.

The appointment of Vice President Biden to head the initiative is an inspired choice.

Of course, let’s not forget that in 1971 President Richard Nixon launched a not dissimilar initiative and yet 45 years later, there still remains an on-going war against this feared group of diseases, despite progress in many aspects. Times change, knowledge advances, and there are many signs that this new initiative holds out a better chance of success.

 

NCI’s New Genomic Platform Seeks to Enable Data Sharing for Biden’s Moonshot

NCI is preparing to open the Genomic Data Commons, a $20 million big data endeavor aimed at making raw genomic data publicly available.

The GDC, NCI’s largest bioinformatics effort since the ill-fated caBIG, will go live June 1. The database will be interoperable and publicly available to qualified researchers. Anyone will be able to submit data for consideration.

While work on the GDC began over two years ago, the initiative is being launched at a time when leading oncology groups are positioning themselves to play a central role in the White House’s moonshot initiative.

Conversation with The Cancer Letter

NCI’s Staudt and Kibbe: Data Commons Will Publish Annotated Raw Genomic Data

The Genomic Data Commons, NCI’s latest big data project, is poised to become a major player in oncology bioinformatics when it opens June 1.

The GDC aims to become oncology’s go-to database for comprehensive, raw genomics information. NCI officials said this sets the GDC apart from other bioinformatics projects, which are vying to play a role in the White House moonshot initiative.

“When the other groups are sharing the data, what they are doing is sharing very derived data that is divorced from the actual data,” said Louis Staudt, director of NCI’s Center for Cancer Genomics. “The GDC is doing something different.”

Capitol Hill

Senate Committee Looks to Fund Medical Innovation Legislation

Over 150 organizations sent an open letter to the leaders of the Senate Health, Labor, Educations and Pensions Committee, supporting them for advancing legislation that will form the basis of the Senate’s version of the 21st Century Cures Act, which passed the House last year.

The Senate committee has passed 19 bills since February—collectively referred to as medical innovations legislation—which include agreements on NIH funding, support for the Precision Medicine Initiative, and changes to FDA and NIH hiring power. Now, the committee has to work to find ways to pay for the programs before sending the bills to the full Senate.

PCORI Approves $44.4 Million for 21 Research Studies

The Patient-Centered Outcomes Research Institute approved $44.4 million in funding for 21 new patient-centered comparative clinical effectiveness research studies.

Several studies will focus on cancer, including comparing ways to improve colorectal cancer screening, develop a more patient-centered approach to assessing the quality of care for people with cancer, and assessing the effectiveness of different treatment strategies for ductal carcinoma in situ among older women.

In Brief
  • Jennifer Pietenpol named executive vice president for research at Vanderbilt

  • Margaret Foti named an honorary member of the Oncology Nursing Society

  • John Weston named chief operating officer of the Prostate Cancer Foundation

  • Al Benson III elected president of National Patient Advocate Foundation executive board

  • Avinash Desai named vice president at Eisai Inc. 

  • MD Anderson Cancer Center names eight Sabin Family Fellows

  • NCCN publishes patient education materials for NHL

  • Kids v Cancer launches Compassionate Use Navigator tools

  • Albert Einstein College of Medicine enters agreement with Jiangsu Hengrui Medicine

  • Wistar Institute and Cormorant Pharmaceuticals form drug partnership

  • MD Anderson and Summit Medical Group launch partnership in New Jersey

  • Geisinger Health System sets higher accrual goals for DNA sequencing study

  • AbbVie acquires Stemcentrx and Rova-T drug candidate

  • AbbVie forms collaboration with argenx in immuno-oncology

  • Indiana University raises $1.2 million for research at tailgate gala

Drugs and Targets
  • FDA grants approval to Cabometyx tablets in renal cell carcinoma

  • FDA grants Orphan Drug Designation to DelMar’s VAL-083 

 

20160422 - Apr 25, 2016
ISSUE 16 – April 22, 2016PDF



AACR 2016

Biden Asks for Guidance in Leading Moonshot

“There is more brain power in this room than exists in many countries,” said Vice President Joe Biden, addressing over 4,000 members of the American Association for Cancer Research, during a speech that turned personal at times, as he laid out several suggestions for accelerating progress.

As head of the federal government’s cancer moonshot task force, the vice president listed recommendations he has received for reaching the initiative’s goal, not a cure, but completion of a decade’s worth of cancer research in five years. Recommendations include increasing research budgets across the federal government, making it easier to share data, removing paywalls around published research, and incentivizing verification of study results.

“Toward that end, last year, the 2016 budget, and working with Congress, we were able to increase funding by $2 billion for the National Institutes of Health. The largest increase in a decade,” Biden said at the association’s annual meeting April 20 in New Orleans.

 

Comparison with AstraZeneca Drug Hard to Ignore as ODAC Votes Down NSCLC Application from Clovis

A phase III trial will be needed to determine approvability of the Clovis Oncology Inc. agent rociletinib for the treatment of non-small cell lung cancer, the FDA Oncologic Drugs Advisory Committee recommended.

At a meeting April 12, ODAC in effect voted against granting an accelerated approval of rociletinib for the treatment of patients with mutant epidermal growth factor receptor non-small cell lung cancer who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.

Guest Editorial

Thirty Years after Chernobyl: Lessons Learned

By Robert Peter Gale

April 26 marks the 30th anniversary of the Chernobyl nuclear power facility accident in the former Soviet Union. Soon after the accident, I received a call from the Soviet ambassador to the U.S. on behalf of Mikhail Gorbachev asking me to come immediately to Moscow.

The world (but not Soviet citizens) had been following the spread of a radioactive cloud over Europe for several days and I offered the Soviet government access to advanced medical technologies I knew they lacked. I arrived to find about 205 of the most seriously-affected victims had been flown to Hospital 6 in Moscow connected to the Institute for Biophysics.

AACR 2016 – In Brief

Nancy Davidson Begins Term as AACR President; Weinberg Gets Lifetime Achievement Award

Nancy Davidson was inaugurated as president of the American Association for Cancer Research for 2016-2017 at the association’s annual meeting in New Orleans.

Davidson is the director of the University of Pittsburgh Cancer Institute. She also serves as associate vice chancellor for cancer research; the Hillman professor of oncology; a distinguished professor of medicine and pharmacology and chemical biology; and a professor in the Clinical and Translational Science Institute at the University of Pittsburgh School of Medicine. Her research focuses on clinical and translational breast cancer research and cancer biology and treatment.

Also:

Academy of Arts and Sciences Elects 213 Members

The American Academy of Arts and Sciences elected 213 new members, including some of the world’s most accomplished scholars, scientists, writers, artists, as well as civic, business, and philanthropic leaders.

BSA Approves Plan to Expand SEER Infrastructure, Funding, and Research Support Capacity

The NCI Board of Scientific Advisors approved a proposal to expand the infrastructure and capacity of the SEER program, including introducing registries designed specifically to support cancer research projects, an increase of the program’s overall budget, and moving toward a more advanced, uniform data management system.

The new structure of the surveillance program would create core registries, selected through a competition of the U.S. central cancer registries, which would then collect the most comprehensive data to be used for SEER statistics and public use.

 

Cell Therapy Production, Patient Accrual Suspended at Rosenberg’s Lab at NCI

NIH has suspended the facilities that produce investigational compounds for an NCI laboratory engaged in cell therapy production and a National Institute of Mental Health facility producing positron emission tomography materials.

As a result, no new new patients will be enrolled in affected trials until the issues are resolved, NIH said in a press release.

 Drugs and Targets
  • FDA grants approval to Gilotrif tablets in squamous cell lung cancer

  • University of Chicago and AbbVie to form five-year collaboration

20160415 - Apr 18, 2016
ISSUE 15 – April 15, 2016PDF



Parker Bets $250 Million on Immunotherapy

A foundation established by Silicon Valley entrepreneur Sean Parker—founder of Napster and first president of Facebook—has committed $250 million to research in cancer immunotherapy.

The newly founded Parker Institute for Cancer Immunotherapy brings together immunologists from Memorial Sloan Kettering Cancer Center, Stanford University, UCLA, UCSF, MD Anderson Cancer Center and the University of Pennsylvania.

 

Conversation with The Cancer Letter

Parker Mantra: Collaborate Like Hell

The Cancer Letter invited Jedd Wolchok, associate attending physician and chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center, to describe the workings of the just-announced Parker Institute for Cancer Immunotherapy.

Slamming the Door

Part X – Silencing Faculty Voice

In the fall of 2012, just before Al Gilman’s departure, MD Anderson officials cracked down on internal critics.

On Sept. 26, 2012, Raphael Pollock, head of MD Anderson’s Division of Surgery, was summoned to the office of Thomas Burke, then the executive vice president and physician-in-chief, and was relieved of his duties.

Pollock, who is Jewish, was fired on Yom Kippur, the Day of Atonement.

Letter to the Editor

Former MD Anderson Provost Reflects on “Brief, Painful Episode”

By Raymond DuBois

Over the past several weeks, The Cancer Letter has been running a series of articles that report on a past conflict between people at The University of Texas MD Anderson Cancer Center and Nobel Laureate Al Gilman, who led the scientific review teams of the then newly formed Cancer Prevention and Research Institute of Texas.

At the time of the controversy, I was the founding provost and executive vice president at the MD Anderson Cancer Center, a position I enjoyed greatly. While I have no desire to revisit this brief, and somewhat painful episode in my academic career, I have been written into Goldberg’s Texas drama as an important bit player and therefore feel compelled to go on record and provide my view of the story.

FDA Inspects Hospitals for Morcellation Harm;
Congressman Draws VP Biden’s Attention to Issue

FDA has conducted inspections of several hospitals—including Brigham & Women’s Hospital—based on allegations that physicians and administrators did not report patient harm and deaths resulting from power morcellators.

In a March 29 letter to Rep. Mike Fitzpatrick (R-Pa.), the agency said it “takes these issues very seriously.”

“In recent months, we have conducted inspections of hospitals highlighted in your letter, including Brigham & Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center,” FDA officials wrote, responding to a Dec. 18, 2015, letter from Fitzpatrick to the agency’s Office of Criminal Investigations.

Stand Up to Cancer Debuts Catalyst Research Program With Merck, BMS and Genentech

Stand Up to Cancer announced Catalyst, a program that will use funding and materials from the pharmaceutical, biotechnology, diagnostic and medical devices industries to accelerate research on cancer prevention, detection and treatment.

Founding collaborator Merck; and Bristol-Myers Squibb, and Genentech, a member of the Roche Group, will serve as charter supporters.

In Brief
  • Jeffrey Sosman named director of melanoma program at Northwestern

  • Eric Dishman named director of NIH Precision Medicine Initiative Cohort Program

  • Ed Sauter named director of breast surgery at Hartford HealthCare Cancer Institute

  • Maya Martinez-Davis appointed global head of oncology franchise at Merck KGaA
  • Lynn Matrisian named chief research officer for the Pancreatic Cancer Action Network

  • Karin Jooss named chief scientific officer of Gritstone Oncology

  • USPSTF publishes B recommendation for low-dose aspirin regimen for primary prevention of colorectal cancer and cardiovascular disease

  • International Myeloma Foundation to fund large screening study in Iceland

  • MD Anderson Cancer Center dedicates new personalized medicine building

  • UC Davis and Novogene establish campus genomics center

  • University of Florida signs proton therapy contract with Ion Beam Applications
Drugs and Targets
  • FDA grants accelerated approval to Venclexta in CLL

  • FDA approved Epi proColon blood screening test

  • FDA granted priority review for atezolizumab in NSCLC

20160408 - Apr 4, 2016
ISSUE 14 – April 8, 2016PDF



Jacks, Jaffee, Singer Named Co-Chairs of NCI’s Moonshot Blue Ribbon Panel

NCI announced a panel of advisors to inform the scientific direction and goals of Vice President Joe Biden’s National Cancer Moonshot Initiative.

The 28-member Blue Ribbon Panel, a committee of scientific experts, cancer leaders, and patient advocates, will serve as the working group of the National Cancer Advisory Board and provide scientific guidance from opinion leaders in the cancer community.

 

FDA Allows Containment Bags for Power Morcellators; Paper Reports Leakage

FDA granted permission to an Irish company to market the “PneumoLiner,” a first-of-its-kind containment system indicated for isolating and containing uterine tissue during a minimally invasive hysterectomy or myomectomy. The agency announced its action April 7.

Gynecologists will soon be able to use the containment system—designed to prevent dissemination of potentially cancerous tissue—with specific models of power morcellators to conduct laparoscopic surgery in a limited population of women.

ORIEN Partners with Pharma Companies to Develop Precision Medicines with Big Data

The Oncology Research Information Exchange Network and M2Gen formed a bioinformatics collaboration with Celgene Corp.

The partnership, announced April 7, is called the ORIEN Avatar Research Program. The initiative is managed by M2Gen and is designed to generate large amounts of genetic and clinical information on patients consenting to the Total Cancer Care Protocol, a standard operating protocol used by ORIEN member institutions.

Caligiuri Named President-Elect of AACR

Michael Caligiuri was named president-elect by the members of the American Association for Cancer Research. He will officially become president-elect at the AACR’s annual meeting in New Orleans, April 16-20, and will assume the presidency at the 2017 annual meeting.

Caligiuri is director of The Ohio State University Comprehensive Cancer Center and CEO of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. He holds the John L. Marakas Nationwide Insurance Enterprise Foundation chair in cancer research and is a professor in The Ohio State University College of Medicine Departments of Molecular Virology, Immunology and Medical Genetics and Internal Medicine.

In Brief
  • Timothy Eberlein elected Chairman of NCCN Board of Directors

  • Carbone Cancer Center joins NCCN as member institution

  • Larry Kwak wins 2013 Ho-Am Prize in Medicine

  • Joel Helmke named senior vice president of operations at City of Hope
  • Anne Jadwin honored by Sigma Theta Tau nursing honor society

  • Paul Bushdid joins Southern Research

  • Dana Farber and Ontario Institute for Cancer Research join OHSU and Intel’s data cloud program

  • RareCyte signs CRADA with NCI

  • IBM launches Watson center in Milan, Italy

  • Schulman IRB selected for Cancer MoonShot 2020 program
Drugs and Targets
  • EU approves two-dose schedule for Gardasil 9

  • Halaven receives positive opinion from CHMP in liposarcomas

  • OncoBEAM RAS CRC test receives CE mark

  • University of Chicago and Evelo Biosciences enters licensing agreement
20160401 - Apr 1, 2016
ISSUE 13 – April 1, 2016PDF



NCI Makes Plans for Moonshot Dollars

At a meeting of the NCI Board of Scientific Advisors March 29, NCI officials had good news to report:

• The appropriations are increasing, with bipartisan support to boot.

• The White House “moonshot” initiative on cancer is bringing new money and new urgency to the institute’s work.

The cancer program has seen many aggressive mandates and has made many big promises, and it’s worthwhile to remember this current initiative is being launched by an administration that is concluding its term.

 

AVEO Execs Face Fraud Charges from SEC;

Company to Pay $4 Million to Settle

The Securities and Exchange Commission March 29 announced fraud charges against AVEO Pharmaceuticals Inc., a biotechnology company, and three of its former executives.

SEC said the company agreed to pay a $4 million penalty to settle the charges without admitting or denying the allegations.

The agency said it is continuing to pursue its case against three of AVEO’s former officers: CEO Tuan Ha-Ngoc, Chief Financial Officer David Johnston, and Chief Medical Officer William Slichenmyer.

Schools of Public Health: Cancer Moonshot Undervalues Prevention

Over 70 deans and directors of public health programs and institutes signed a letter March 21 asking the White House for to prioritize federal investments in public health and cancer prevention.

The letter, addressed to Vice President Joe Biden, urges the administration to “pay careful attention to the balance between treatment and prevention-related investments.”

In Brief
  • Dinah Singer and Warren Kibbe named acting NCI deputy directors

  • Peter Paul Yu named physician-in-chief at Hartford HealthCare Cancer Institute

  • Greg Simon named executive director of national cancer moonshot initiative

  • Johns Hopkins launches Bloomberg-Kimmel Institute for Cancer Immunotherapy
  • Hyundai Hope on Wheels announces $1 million in pediatric research grants

  • MD Anderson and TESARO form immuno-oncology collaboration

Drugs and Targets
  • FDA publishes draft guidance on biosimilar product labeling

  • FDA approves Defitelio for veno-occlusive disease following transplantation

  • FDA grants Orphan Drug Designation to Iomab-B

 

20160325 - Mar 25, 2016
ISSUE 12 – MARCH 25, 2016PDF



Clifford Hudis Named CEO of ASCO

Clifford Hudis was named CEO of the American Society of Clinical Oncology.

Hudis, who served as ASCO president in 2013 and 2014, is chief of Breast Medicine Service as well as vice president for government relations and chief advocacy officer at Memorial Sloan Kettering Cancer Center.

Hudis, 56, will start the job at the society’s headquarters in Alexandria, Va., June 27. He will succeed Allen Lichter, who is retiring after having held that job for ten years.

 

NEJM Editors: There Will Be No Clarification For Disputed Power Morcellation Story

The New England Journal of Medicine said it stands by the story that has triggered investigations of a potential breach of patient confidentiality.

In a paper that criticized FDA’s regulatory actions that effectively ended power morcellation in gynecology, Lisa Rosenbaum, an NEJM national correspondent, made a statement that some readers interpreted as suggesting that she had access to confidential patient information (The Cancer Letter, March 18).

Rosenbaum is a cardiologist at Brigham & Women’s Hospital, the institution where Amy Reed—a patient who brought national attention to the harm associated with the procedure—underwent her ill-fated hysterectomy. 

Slamming the Door

Part IX – “Furnituregate”

I first heard something about a red sofa that cost an impressive amount of money soon after I started to cover the controversy at the Cancer Prevention and Research Institute of Texas.

The sofa, I was told, was to be purchased with MD Anderson funds for the office of Lynda Chin. I wanted to look into it, but I want to look into many things, and some take precedence over others. This seemed to be fun, but it was undeniably trivial.

The sofa in question was intended for the same entity CPRIT was being asked to fund. Had I been able to get it through my thick skull that the furniture was a part of the same story that was causing the ungluing of CPRIT, I would have filed my freedom of information requests sooner.

NCCN Launches Evidence Blocks as Part of its Guidelines

The National Comprehensive Cancer Network launched its value tool, NCCN Evidence Blocks, which will be presented at its annual conference, March 31 to April 2.

NCCN has published two additional resources since its 2015 meeting: the NCCN Framework and the NCCN Quick Guide Series for patients.

In Brief
  • Maha Hussain joins Northwestern University Lurie Cancer Center

  • Jean-Yves Douillard appointed chief medical officer of ESMO

  • Karmanos promotes five scientific staff members

  • Jennifer Pietenpol receives award from T.J. Martell Foundation
  • Pediatric Oncologist Dennis Hughes pleads guilty to collecting child pornography

  • American Cancer Society receives $1.58 million grant from The Merck Foundation

  • MD Anderson submits plan to comply with Texas “Campus Carry” gun law 

  • The Cancer Letter’s coverage of power morcellation named a finalist in the 2015 Best in Business Awards for Outstanding Business Journalism
Drugs and Targets
  • FDA Approves Roche Hepatits C RNA Test

  • UPenn and Genisphere form photodynamic therapy collaboration

 

20160318 - Mar 18, 2016
ISSUE 11 – MARCH 18, 2016PDF



Brigham Doc’s NEJM Paper Decries Morcellation’s Demise—Did She Get Confidential Patient Information?

Clearly, Lisa Rosenbaum wanted to trigger a heated discussion—but not of the sort she ended up with.

Rosenbaum, a national correspondent at the New England Journal of Medicine, focused on the demise of power morcellation, a once widely used gynecological procedure, which in some cases ended up disseminating undetected uterine sarcomas.

In a paper published in the March 10 issue of the journal and titled “N-of-1 Policymaking—Tragedy, Trade-offs, and the Demise of Morcellation,” Rosenbaum alleges that Amy Reed, a high-profile opponent of power morcellation, had stage IV cancer before her hysterectomy.

Capitol Hill

Senate Bill Gives FDA More Control Over Its Hiring, Salaries and Structure

The FDA and NIH Workforce Authorities Modernization Act was introduced in the Senate by Republican and Democratic leaders of the health committee. The bill aims to help FDA and NIH “attract top talent during this exciting time in science.”

The bill, introduced by Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), looks to improve coordination within and between FDA medical product centers and allow the FDA to update its structure, as well as make it easier for the agency to hire; improve access to scientific meetings for federal employees; and streamline processes for NIH research information collection.

Slamming the Door

Part VIII – A Conversation with DePinho

The $18 million never made it from Austin to Houston.

MD Anderson’s initial stance was to deflect all CPRIT-related questions to CPRIT, but this didn’t make the controversy go away. So, the cancer center suggested that the grant undergo scientific review, as well as commercial.

Recently, I asked Dan Fontaine, MD Anderson’s executive chief of staff why the money never changed hands.

Bunn Wins ASCO Karnofsky Award; Kaelin to Receive Science of Oncology Award

The American Society of Clinical Oncology announced the winners of its highest honors, the Special Awards, to be presented during the 2016 ASCO Annual Meeting in June.

“The exceptional accomplishments of each of our awardees reflect their exemplary dedication to furthering cancer research and serving as a beacon of hope to the cancer community,” said Peter Paul Yu, immediate past president of ASCO and chair of the Special Awards Selection Committee. “It is our honor to recognize their enduring contributions with ASCO’s most prestigious awards.”

Obituaries

UNMC Radiologist Glenn Dalrymple, 81;

and MSKCC Researcher Robert Golbey, 93

Glenn Dalrymple, a radiology professor at the University of Nebraska Medical Center from 1990 to 1996, died March 9 in Omaha after a long battle with colon cancer. He was 81.

 

In Brief
  • Itai Yanai to Lead New Institute at NYU Langone

  • Debra Patt named Editor-in-Chief of JCO Clinical Cancer Informatics 

  • Jennie Crews elected president of Association of Community Cancer Centers

  • Charles Serhan receives Ross Prize from Feinstein Institute for Medical Research
  • American Society of Clinical Oncology publishes State of Cancer Care 2016

  • V Foundation and WWE announce research funding partnership 

  • Providence Health & Services and Institute for Systems Biology 

Drugs and Targets
  • Gilead Halts 6 Zydelig Trials As FDA, EMA Warn of Deaths From Respiratory Infections

  • FDA Grants Orphan Designation to VAL-083

  • FDA Grants Priority Review to Atezolizumab

 

20160311 - Mar 11, 2016
ISSUE 10 – MARCH 11, 2016PDF



CMS Experiment Targets Incentive To Use the Most Expensive Drug

Is Average Sales Price plus 6 percent the right amount to pay doctors under the Medicare Part B program?

Would a smaller margin diminish what may be an incentive for doctors to prescribe the most expensive drugs on the market? With clinical performance being equal, or close enough to equal, is it not better for the doctor’s wallet to bill 6 percent of the highest possible ASP available?

In a move that immediately set off an explosion in the cancer field, the Centers for Medicare and Medicaid Services announced a proposed rule to test new models to improve Part B payment for prescription drugs.

 

Slamming the Door

Part VII: DePinho’s Stock Tip Revisited

On May 25, 2012, I received an email from Len Zwelling:

Paul: It can’t get worse than having our President pushing his own stock on TV. Len.

I clicked on the provided link to CNBC. What I saw was indeed difficult to process: a video of Ron DePinho, extolling the virtues of the stock of AVEO Pharmaceuticals Inc., a company he co-founded.

National Academy of Medicine Calls for Integrated FDA-CMS Pathway for Biomarker Tests

The National Academy of Medicine listed 10 goals for advancing the appropriate use of biomarker tests in precision medicine.

“How do we ensure patients have timely access to appropriate tests that may accurately direct targeted therapies, while at the same time protecting them from potential harm due to the adoption of poorly validated tests or inappropriately used tests?” the report asked, saying that broader implementation was being held back by a lack of consensus over evidentiary standards, inefficient and inconsistent regulatory and reimbursement approaches, the need for a framework for collecting patient data, and translating that data into improved patient outcomes.

Companies, Health Systems Commit to Data Interoperability

Companies that provide 90 percent of electronic health records used by U.S. health care organizations have agreed to improve the flow of health information for consumers and health care providers, HHS officials said.

 

Study: California Hospitals with Low Volumes of Surgeries Associated with Higher Risks

In California, nearly 75 percent of the state’s hospitals performed only one or two surgeries when treating one of 11 selected cancer types in 2014, according to a report from the California Health Care Foundation.

The report linked the low hospital surgery volumes with higher rates of mortality and complications, while evaluating cancers of the bladder, brain, breast, colon, esophagus, liver, lung, pancreas, prostate, rectum and stomach.

Obituary

UNMC Scientist Michael Brattain Dies Unexpectedly at Age 68

Michael Brattain, University of Nebraska Medical Center Eppley Institute professor and associate director for basic research in the Fred & Pamela Buffett Cancer Center, died unexpectedly in his sleep March 5. He was 68.

“Mike was a brilliant scientist who had a prolific scientific career,” said Kenneth Cowan, director of the Eppley Institute and the Buffett Cancer Center. “Mike’s experience and input was extremely valuable to me in many areas within the Buffett Cancer Center.

In Brief
  • Sadik Esener to lead OHSU Center for Early Detection Research

  • Jorge Lopez Jr. Named MSKCC General Counsel

  • Aron Parekh receives research grant from American Cancer Society
  • Robin Mjelle receives grant from Addario Foundation and International Association for the Study of Lung Cancer

  • William Grady receives grant from DeGregario Family Foundation and the Price Family Foundation

  • Baylor College of Medicine and Baylor Scott & White Health enter collaboration

  • Tufts Medical Center and New England Cancer Specialists form affiliation

  • UC San Francisco and Berkeley Lights Inc. form collaboration

Drugs and Targets
  • FDA Approves Xalkori in NSCLC with ROS-1 mutations

  • FDA Approves American College of Radiology Digital Mammography QC Manual

  • Regulatory Authorities in Six Countries approve Yondelis

  • China Food and Drug Administration Approves CINtec PLUS Cytology Test

  • Veritas Genetics introduces whole genome platform for under $1,000

 

20160308 - Mar 8, 2016
BREAKING NEWS – MARCH 8, 2016 

In an Experiment, CMS Will Vary Part B Drug Payments by Providers’ ZIP Codes

Is Average Sales Price plus 6 percent the right amount to pay doctors under the Medicare Part B program?

Would a smaller margin diminish what may be an incentive to prescribe the most expensive drugs on the market? With clinical performance being equal, or close enough to equal, is it not better for the doctor’s wallet to bill 6 percent of the highest possible ASP available?

In a move that immediately set off an explosion in the cancer field, the Centers for Medicare and Medicaid Services is on the verge of announcing a Part B Drug Payment Demo, a project where ASP add-ons would vary based on zip codes.

    20160304 - Mar 4, 2016
    ISSUE 9 – MARCH 4, 2016PDF



    NCI Developing Mouse Models To Succeed NCI-60 Cell Lines

    The NCI-60, a panel of 60 cancer cell lines that have become the Rosetta Stone for the development of anticancer drugs, may be entering its twilight years as NCI develops new, and more expansive, patient-derived xenografts, or PDX models.

    For over 25 years, the NCI-60, a set of about a dozen tissue types—leukemia, non-small cell lung, small cell lung, colon, CNS, melanoma, ovarian, renal, and breast—have been used to perform initial screens on over 100,000 compounds.

     

    Conversation with The Cancer Letter

    Doroshow: Evidence Suggests PDX Models Come Closer to Simulating Human Cancer

    NCI is developing patient-derived xenograft mouse models as a potential substitute for the NCI-60 cell lines, a standard screen which experts say can no longer keep up with advances in cancer research and targeted molecular therapy.

    “The goal is to try to understand whether these new models will be more successful in providing a better reflection of the underlying biology in the context of the clinical history and treatment history of patients from whence the tissues came,” said James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis and deputy director for clinical and translational research.

    Slamming the Door

    Part VI: The Provost’s Choice

    After my conversation with Gilman, I called MD Anderson and asked to talk with somebody about the $18 million grant for a biotech incubator.

    First, folks at the press shop told me that they view the controversy arising from the application as CPRIT’s problem.

    Let’s see: the wife of president of MD Anderson gets a grant seemingly out of turn, causing a political disaster, and this is not an MD Anderson problem?

    National Academy of Medicine Publishes Report on Categorizing Different Ovarian Cancers

    Ovarian cancer should not be categorized as a single disease, but as many different cancers involving the ovary, according to a report published by the National Academy of Medicine.

    Questions remain on how and where various ovarian cancers arise, said the report that also presents research opportunities for reducing the number of women who are diagnosed with or die from ovarian cancers. Roughly two-thirds of women are diagnosed at an advanced stage when the cancer has already spread beyond the ovary, of which less than 30 percent survive past five years. The report was also sponsored by the Centers for Disease Control and Prevention.

    Funding Opportunity

    FDA Providing $2 Million for Natural History Studies in Rare Diseases

    FDA will provide $2 million in two to five research grants for the study of the natural history of rare diseases. The objective of the grants is to expedite the development of products for these conditions.

    The Feb. 29 announcement marks the first time FDA will provide funding through its Orphan Products Grants to collect data on the progression of specific rare diseases in individuals over time.

    In Brief

    • Joan Massagué wins Pezcoller-AACR International Cancer Research Award

    • David Weiner named executive vice president at The Wistar Institute

    • Douglas Levine named director of gynecologic oncology at NYU Perlmutter Cancer Center
    • Lauren Streicher joins Northwestern Medical Group as medical director

    • Michael Bukosky appointed chief operating officer of USMD Holdings Inc.

    • International Cancer Genome Consortium authorizes 1,000th user

    • IBM and New York Genome Center to collaborate using Watson technology

    • Vantage Oncology LLC acquired by McKesson Specialty Health

     Drugs and Targets

    • Imbruvica granted approval for first-line CLL patients

    • Health Canada approves Opdivo for metastatic NSCLC

    • FDA grants orphan drug designation to SELLAS’s WT1 cancer vaccine

    • EMA grants orphan drug designation to venetoclax

    • FDA and EMA grant orphan designations to FLAG-003 for glioma

    • Merck KGaA, Pfizer and Verastem enter into avelumab research agreement

    • NanoString Technologies and Merck to collaborate on Keytruda assay