20160506 - May 6, 2016
ISSUE 18 – May 6, 2016PDF

art 42-18 fda on the moon final

Virtual is Not Enough

FDA’s Critics Call for Full Integration of Oncology Center Under Biden’s Moonshot

The White House moonshot to accelerate progress in cancer research directs FDA to consolidate its oncology portfolio.

However, oncology insiders say the manner in which the presidential initiative will be implemented could make the difference between political balderdash and genuine improvement in FDA regulation of cancer therapies.

The entire controversy boils down to the interpretation of one word: Virtual.

Moonshot Director Addresses AAADV Workshop

Greg Simon, executive director of the cancer moonshot task force, addressed the FDA-sponsored workshop for Accelerating Anticancer Agent Development and Validation in North Bethesda, Md., May 4.

He discussed the goals for the moonshot initiative, how the program could fit into the next presidential administration, and how to take the project international.

Slamming the Door

Part XI: Gilman’s Teachable Moment

During our first conversation in the spring of 2012, Gilman said that he would go public unless he received assurances that CPRIT would retain its integrity after his departure.

He wanted guarantees that the structure he built would not be turned into a political pigsty. With guarantees being hard to come by, it was obvious that he would end up slamming the door hard. Publicly.

FDA to Regulate All Tobacco Products, Including E-Cigs, In Historic Expansion

FDA issued final regulations for all tobacco products, including electronic cigarettes, cigars and hookah. The rules, with provisions aimed at restricting youth access and requiring premarket clearance for new products, will take effect Aug. 8.

The federal regulations include: not allowing tobacco products to be sold to persons under the age of 18, both in person and online; requiring age verification by photo ID; not allowing the selling of covered tobacco products in vending machines, unless in an adult-only facility; and not allowing the distribution of free samples.

National Academy of Sciences Elects 105 Members

The National Academy of Sciences elected 84 new members and 21 foreign associates from 14 countries in recognition of their distinguished and continuing achievements in original research.

Those elected today bring the total number of active members to 2,291 and the total number of foreign associates to 465. Foreign associates are nonvoting members of the academy.

Funding Opportunity

CureSearch Taking Applications
For Pediatric Research Awards

CureSearch for Children’s Cancer is taking applications for its International Grand Challenge Awards addressing three challenges in pediatric cancer treatment. The awards will be worth between $2 million and $3 million.

In Brief
  • American Cancer Society and CVS Health launch three-year antismoking campaign
  • Pershing Square Sohn Research Alliance funds seven young investigators

  • Sean Parker recognized by the Vatican for philanthropic work

  • Richard O’Reilly receives inaugural Society of Memorial Sloan Kettering Prize

  • David Weiner receives professorship and grant from W.W. Smith Charitable Trust

  • Canadian Cancer Clinical Trials Network launches national awareness campaign

Drugs and Targets
  • Eribulin receives EU approval in liposarcoma

  • Health Canada approves Lynparza in ovarian cancer

  • CHMP issues positive opinions for Imbruvica and Afinitor

  • AstraZeneca and Foundation Medicine to collaborate on diagnostic assays

  • AbbVie and CytomX Therapeutics to collaborate on probody drug conjugates

 

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